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MS2_dynamic_1_shot400
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: The objective of the study was to establish the specific use of advice and exercise by physiotherapists , for the management of chronic low back pain ( LBP ) . A question naire was mailed to a r and om sample of 600 members of the Irish Society of Chartered Physiotherapists . Open and closed questions were used to obtain information on treatments provided to chronic LBP patients . Respondents ' treatment goals were also investigated , along with the typical methods used to assess treatment outcome . Four hundred and nineteen of the sample returned the question naire ; 280/419 ( 67 % ) indicated that they currently treated LBP of which 76 % ( n=214 ) were senior grade therapists . Advice and exercise , respectively , were the treatments most frequently used for chronic LBP : advice was most commonly delivered as part of an exercise programme , with strengthening ( including core stability ) the most frequently used exercise type . Supervision of exercise and follow-up advice were underutilised with respect to the recommendations of relevant clinical guidelines . Pain relief was an important treatment goal . Emphasis on exercise programme supervision , incorporating reassurance that its safe to stay active and ' hurt does not mean harm ' , must be more effectively disseminated and promoted in practice . The influence of follow-up advice on exercise adherence warrants further investigation Background Traction is commonly used for the treatment of low back pain ( LBP ) , predominately with nerve root involvement ; however its benefits remain to be established . The aim of this study was to test the feasibility of a pragmatic r and omized controlled trial to compare the difference between two treatment protocol s ( manual therapy , exercise and advice , with or without traction ) in the management of acute/sub acute LBP with ' nerve root ' involvement . Methods 30 LBP patients with nerve root pain were recruited and r and omly assigned to one of two treatment groups . Primary outcome measures were the : McGill pain question naire , Rol and Morris disability question naire , and the SF36 Question naire ; recorded at baseline , discharge , 3 and 6 months post-discharge . Results 27 patients completed treatment with a loss of another four patients at follow up . Intention to treat analysis demonstrated an improvement in all outcomes at follow up points but there appeared to be little difference between the groups . Conclusion This study has shown that a trial recruiting patients with ' nerve root ' problems is feasible . Further research based upon a fully powered trial is required to ascertain if the addition of traction has any benefit in the management of these patients .Trial Registration Registration number : IS RCT BACKGROUND AND PURPOSE Since the release of acute low back pain management guidelines in 1994 , little was known about the effect of these guidelines on clinical practice . The purpose of this study was to examine physical therapists ' reported management of acute and subacute lumbar impairment . SUBJECTS One in 10 registered physical therapists who were r and omly selected from southern Ontario , Canada , ( n=454 ) and all registered physical therapists from northern Ontario ( n=331 ) were surveyed . METHODS In the question naire , case scenarios covered 3 areas related to the management of lumbar impairment : ( 1 ) physical examination , ( 2 ) treatment and recommendations , and ( 3 ) therapists ' beliefs regarding its management . RESULTS Five hundred sixty-nine question naires were returned ( response rate=72.5 % ) . Only data obtained for therapists ( n=274 ) whose weekly workload included more than 10 % of people with lumbar impairment were used in the analysis . Overall , patient education , exercise , and electrotherapeutic and thermal modalities were the preferred interventions for acute lumbar impairment ( symptom onset of less than 5 weeks ) with or without sciatica , whereas exercise and work modification were preferred for subacute lumbar impairment ( symptom onset of 5 weeks or longer ) . There was a trend of using electrotherapeutic and thermal modalities with uncertain effectiveness . Only 46.3 % of the therapists agreed or strongly agreed that practice guidelines were useful for managing lumbar impairment . DISCUSSION AND CONCLUSION Although the physical therapists surveyed , in general , followed the guidelines in managing acute lumbar impairment , they felt uncertain regarding the value of practice guidelines . Future research should focus on identifying effective treatment approaches and exploring the effectiveness of practice guidelines Background Patients with signs of nerve root irritation represent a sub-group of those with low back pain who are at increased risk of persistent symptoms and progression to costly and invasive management strategies including surgery . A period of non-surgical management is recommended for most patients , but there is little evidence to guide non-surgical decision-making . We conducted a preliminary study examining the effectiveness of a treatment protocol of mechanical traction with extension-oriented activities for patients with low back pain and signs of nerve root irritation . The results suggested this approach may be effective , particularly in a more specific sub-group of patients . The aim of this study will be to examine the effectiveness of treatment that includes traction for patients with low back pain and signs of nerve root irritation , and within the pre-defined sub-group . Methods / Design The study will recruit 120 patients with low back pain and signs of nerve root irritation . Patients will be r and omized to receive an extension-oriented treatment approach , with or without the addition of mechanical traction . R and omization will be stratified based on the presence of the pre-defined sub-grouping criteria . All patients will receive 12 physical therapy treatment sessions over 6 weeks . Follow-up assessment s will occur after 6 weeks , 6 months , and 1 year . The primary outcome will be disability measured with a modified Oswestry question naire . Secondary outcomes will include self-reports of low back and leg pain intensity , quality of life , global rating of improvement , additional healthcare utilization , and work absence . Statistical analysis will be based on intention to treat principles and will use linear mixed model analysis to compare treatment groups , and examine the interaction between treatment and sub-grouping status . Discussion This trial will provide a method ologically rigorous evaluation of the effect OUTPUT: Most of the orthopaedic physical therapists in the United States who responded to our survey reported that they used lumbar traction , though not necessarily consistent with proposed criteria that identify patients most likely to benefit from traction . They used various traction delivery modes/parameters and used traction within comprehensive plans of care incorporating multiple interventions . Professional characteristics ( education levels and clinical specialist credentialing ) were associated with traction usage INPUT: BACKGROUND Recent guidelines for those with acute low back pain have advocated early resumption of normal activity and increased physical activity . Little is known about the relationship between low back pain and physical activity , and on the impact of that relationship on the promotion of increased levels of physical activity within a general practice population . OBJECTIVES We aim ed to explore associations between factors that influence changes in physical activity and the way individuals perceive and behave with their low back pain , and the impact of those perceptions and behaviour on physical activity . METHODS Twenty-seven informants were chosen using a purposive sample from a larger group of individuals who , because of their low back trouble , had been referred by their GPs to a community-based , single-blind , r and omized controlled trial ( RCT ) at the University of York , which is evaluating the effectiveness and cost-effectiveness of a progressive exercise programme . Fifty-four interviews were conducted with this subgroup of the RCT ; four informants were interviewed once , 19 twice and four of them three times . Interviews were transcribed and analysed using manual and computer-aided approaches . RESULTS Physical activity was perceived as ( i ) activities of daily living , ( ii ) activities causing breathlessness that they went out of the way to do and ( iii ) more competitive-type activity . The avoidance of physical activity and fear of pain returning were the two main factors directly associated with informants ' backs and changes in physical activity . These two factors hindered increases in physical activity , even though the majority of informants believed strongly that being physically active helped ease their low back pain . CONCLUSIONS When advocating that individuals with acute low back pain return to or increase physical activity , it is important that clinicians identify avoidance of physical activity and /or fear of pain at the earliest stage in order to tailor advice and reassurance appropriately . If avoidance of activity and fear of pain is identified and clinicians want to encourage patients to take up and sustain increased physical activity , they should explore issues of fear of pain , and avoidance of and confidence to do physical activities , in addition to other factors influencing physical activity OBJECTIVES To investigate the course of low back pain ( LBP ) in a general population over 5 years . DESIGN Prospect i ve population -based survey by postal question naires in 1991 , 1992 , and 1996 . SETTING The municipal of Ebeltoft , Denmark . SUBJECTS Two thous and people aged 30 to 50 years , representative of the Danish population . Main outcome measure Number of days with low back pain during the past year . RESULTS One thous and three hundred seventy were recruited of whom 813 ( 59 % ) were followed to 5 years . The responders could be divided into 3 groups with regard to LBP : no pain , short-term pain , and long-lasting/recurring pain . More than one third of people who experienced LBP in the previous year did so for > 30 days . Forty percent of people with LBP > 30 days at baseline remained in that group 1 and 5 years later , and 9 % with LBP > 30 days in year 0 were pain free in year 5 . People with LBP in year 0 were 4 times more likely to have LBP in year 1 , and 2 times more likely to be affected in year 5 . CONCLUSIONS Low back pain should not be considered transient and therefore neglected , since the condition rarely seems to be self-limiting but merely presents with periodic attacks and temporary remissions . On the other h and , chronicity as defined solely by the duration of symptoms should not be considered chronic Background Non-specific chronic low back pain ( NSCLBP ) has become a significant problem due to high healthcare utilization , rising costs of care and perceived limitations of effectiveness of many current treatments . Systematic review s have repeatedly concluded that , on average across participants , exercise for NSCLBP appears effective in decreasing pain and improving function . Not all people with NSCLBP benefit from exercise programs and it would assist care-providers and care-seekers if factors that impact on program effectiveness and success were identified . Methods and design The study will be a r and omised controlled trial comparing an exercise rehabilitation program informed by a participant preferences question naire compared to a program without this guideline for patients with chronic low back pain . A sample of 150 patients will be recruited in Melbourne , Australia through community-based healthcare clinics that provide supervised exercise rehabilitation programs for people with non-specific chronic low back pain . Clinicians will be r and omly assigned to exercise preferences question naire or no question naire and participants will be allocated in a concealed manner . A qualitative focus group study of exercise instructor feedback about the exercise preferences instrument will be embedded in the research design . Two qualitative focus group studies will also be conducted for participants in the intervention and the control groups to obtain feedback about participants ' experiences of the two types of exercise programs . The primary outcomes will be functional ability , pain , fear avoidance , exercise adherence . Discussion This trial will evaluate the effectiveness of individualised exercise prescription compared to usual exercise prescription for NSCLP and , using feedback following the trial , refine the exercise preferences question naire OBJECTIVES To explore the views of participants in a r and omized controlled trial of physical treatments for low back pain about the treatment packages they received in the trial . METHODS Within a r and omized controlled trial that found small to moderate benefits from adding a manipulation package or an exercise programme to general practice care , we elicited participants ' views on the treatment using an open question in participant question naires . These data were analysed using an adapted framework approach . RESULTS We received a total of 1259 comments from 1334 participants . Participants r and omized to usual general practice care reported dissatisfaction with receiving only ' usual care ' , which consisted of providing analgesic medication without providing an explanation for their pain . Those r and omized to a manipulation package felt the intervention was appropriate to their needs and commonly reported striking benefits . Participants assigned to the exercise programme developed a sense of self-reliance in managing back pain , although some failed to be sufficiently motivated to continue their exercise regimen outside the classes . CONCLUSIONS This qualitative analysis has found much clearer differences between the groups than the main quantitative analysis . This suggests that some of the added value from being allocated to additional physical treatment for OUTPUT:
Participants believed that there were distinctions between general activity , real/fitness exercise , and medical exercise . People participating in exercise classes and group work may be more comfortable when matched for abilities and experience . When an intervention interferes with everyday life and appears to be ineffective or too difficult to implement , people make a reasoned decision to discontinue . DISCUSSION People are likely to prefer and participate in exercise or training programs and activities that are design ed with consideration of their preferences , circumstances , fitness levels , and exercise experiences
MS2_dynamic_1_shot401
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: Microleakage is related to recurrent decay , inflammation of vital pulps , and reinfection of previously treated root canals . The purpose of this investigation was to compare the abilities of new adhesive cements and conventional nonadhesive controls to prevent microleakage under stainless steel crowns on primary anterior teeth . St and ardized preparations were made , and stainless steel crowns were adapted . Specimens were assigned r and omly to cement groups : zinc phosphate ( ZP ) , polycarboxylate ( PC ) , glass-ionomer ( GI ) , resin-modified glass-ionomer ( RMGI ) , RMGI with a dentin bonding agent ( RMGI + DBA ) , adhesive composite resin ( ACR ) and zinc oxide eugenol ( ZOE ) . Specimens were stored in water , aged artificially , stained , embedded , and sectioned , and the microleakage was measured . Group means and st and ard errors were calculated . ANOVA discerned differences among groups ( P < 0.0001 ) , and Turkey 's multiple comparisons testing ( P < 0.05 ) ranked the groups from least to most microleakage as follows : [ RMGI + DBA , RMGI , ACR , GI ] , [ ZP ] , and [ PC , ZOE ] . The adhesive cements significantly reduced microleakage In the last years several dental adhesives have been developed . They are supposed to chemically adhere to dentin and a liner to protect the pulp is not used . The aim of this study was to compare the short-term pulpal reaction , in an intra-toothpair study , between a dental adhesive , Scotchbond 2 , and a lining system , Tubulitec , in combination with P-50 in surface-sealed cavities . Deep buccal cavities in 16 human pairs of premolars , 32 teeth , were restored in vivo with a light cured composite resin , P-50 . To minimize bacterial contamination all cavities were treated with a cleanser , Tubulicid , and the cavities were surface-sealed with temporary cement , Coltosol . One tooth in each pair , the test , was treated with Scotchprep Dentin Primer and Scotchbond 2 Light Cure Dental Adhesive . In the other tooth in the pair , the control , Tubulitec Primer and Liner were used . The teeth were extracted after 6 - 14 days . The sections were evaluated for degree of inflammation and the presence of bacteria . Irrespective of treatment of dentin the majority of teeth , 23 , including one pulpal exposure , revealed no inflammation or a few inflammatory cells . In four test teeth , including one pulpal exposure , and two controls , growth of bacteria was found on the cavity walls and slight or moderate inflammation was seen in the corresponding pulps . In one test and two control teeth slight inflammation was seen but no bacteria could be detected . In the absence of bacteria Scotchbond 2 did not seem to irritate the pulp . ( ABSTRACT TRUNCATED AT 250 WORDS Three intermediary base material s , a zinc oxide-eugenol ( Cavitec ) and two calcium hydroxide liners ( Life and Dycal ) , were selected at r and om for use as a base beneath amalgam or composite restorations on humans following complete caries removal . Life and Dycal , selected at r and om , were also used as direct and indirect pulp capping agents as clinical ly indicated . Clinical evaluations of signs and symptoms were made before treatment and at one-week , six-month , and one-year intervals following treatment . Histological evaluations were performed on three complete caries removal teeth and 18 direct pulp capping teeth six months following treatment . No significant differences in clinical symptomatology result ed between the material s in the complete caries removal group or the indirect and direct pulp capping groups Concern about the survival of microorganisms in deep carious lesions may often lead to unnecessary exposure of the pulp during final excavation . There are reasons , therefore , to initiate systematic studies on the alternative procedure known as stepwise excavation . Clinical evaluation of stepwise excavation was performed on 31 deep carious lesions considered to result in pulp perforation by traditional excavation . This study examines the clinical and microbiological alterations during the final excavation performed during long intervals ( 6 - 12 months ) after the initial treatment that included peripheral dentine excavation and removal of the central cariogenic biomass and the superficial necrotic dentine . The dentine colour and consistency were assessed by means of st and ardized scales before application of a Ca(OH)2 compound and a temporary sealing for 6 - 12 months . Re assessment s were performed before the after final excavation . Microbiological dentine sample s were obtained in 19 r and omly selected lesions by a sterile bur , transferred to and diluted in reduced transport fluid , and plated on tryptic soy agar . After anaerobic incubation at 37 degrees C for 7 days , total colony-forming units per millilitre were counted from ( 1 ) peripheral excavated and hard dentine ( control ) , ( 2 ) central demineralized dentine before and final excavation , and ( 3 ) central dentine after the final excavation . Six sample s of central demineralized dentine were without any cultivable flora increasing to 9 sample s after the final excavation . The clinical dentine changes occurring during stepwise excavation were characterized by enhanced hardness of the dentine which was associated with a marked reduction in bacterial growth after the final excavation . Despite the presence of bacteria in the excavated dentine none of the carious lesions result ed in pulp perforation , suggesting that the initial removal of the cariogenic biomass appears to be essential for control of caries progression . Stepwise excavation is not only an appropriate treatment of deep carious lesions but is also considered a suitable model for microbiological studies to determine the bacteria persisting in clinical ly OUTPUT: The findings from this review do not suggest that there should be any significant change from accepted conventional practice procedures when the pulp of the carious tooth is considered . INPUT: PURPOSE To evaluate whether the hybrid layer significantly contributes to the seal of adhesive Class V restorations placed in vivo and to the bond strength obtained in vitro . MATERIAL S AND METHODS 20 periodontally severely compromised anterior teeth were selected for the leakage study . In each tooth , one round 3 mm wide V-shaped cavity with a maximum depth of 2 mm was prepared on the labial surface crossing the cementum-enamel junction . The sample teeth were r and omly divided into two groups of ten sample s each : in Group 1 , Scotchbond Multi- Purpose Plus was applied in combination with Z-100 following the manufacturer 's instructions . In Group 2 the bonding procedure was the same as in Group 1 , except that after the phosphoric acid treatment , the cavities were treated with 5 % NaOCl for 2 min . Following a period of clinical service of 60 - 90 days , the teeth were extracted and processed for the leakage test . RESULTS At the enamel site , 30 % of the sample s of Group 1 and 70 % of the sample s of Group 2 showed dye penetration . At the dentin site , 50 % of the sample s of Group 1 showed leakage , while all the sample s of Group 2 were severely infiltrated . Statistically significant differences between the groups both for the enamel sites ( P < 0.05 ) and for dentin-cementum sites ( P < 0.001 ) were found . Bond strength tests were performed on 2 mm thick dentin slides of tapered Class I cavities ( n = 10 in each group ) . The mean bond strength value obtained from cavities treated without NaOCl was 15.23 ( + /-1.40 ) MPa and with NaOCl treatment 20.52 ( + /-1.70 ) MPa . Statistical analysis showed significant differences ( P < 0.05 ) between the two groups . No hybrid layer was detected on the NaOCl-treated sample s by scanning electron microscopy It has been shown previously that the smear layer created during instrumentation of the root canal promotes apical microleakage . The purpose of the present study was to investigate the effect of removal of the smear layer on apical microleakage , using the fluid filtration method . Thirty-six single-rooted human premolar teeth were used . Six of the teeth were selected r and omly as controls , and the remaining 30 teeth were r and omly divided into two groups of 15 teeth each . For the first group ( group 1 ) teeth were irrigated with NaOCl only ( smear layer not removed ) . In the second group ( group 2 ) the teeth were irrigated with 15 % EDTA , followed by NaOCl to remove the smear layer . Both groups were filled with thermoplasticized gutta-percha ( Obtura II ) using glass-ionomer cement as sealer . All teeth were stored at 37 degrees C and 100 % humidity for 2 days . Apical microleakage of the filled root canal was measured by the fluid filtration technique . Hydraulic conductance was measured by the movement of an air bubble in a capillary tube after a pressure of 200 mm Hg was applied to the system . The mean microleakage rate of group 1 and group 2 were 13.0 ( SD + /- 5.1 ) and 16.9 ( SD + /- 15.3 ) nl/s , respectively . Removal of the smear layer caused significantly more apical microleakage ( p < 0.05 , Student 's t test ) than when the smear layer was left intact AIM The purpose of this study was to evaluate the sealing ability of two contemporary endodontic obturation and restorative techniques and material s. METHODOLOGY Seventy-nine extracted human single-rooted teeth were distributed r and omly in two experimental groups of 36 and 37 specimens ( groups 1 and 2 , respectively ) , one group of three positive controls and one of three negative controls . The teeth were radiographed preoperatively , accessed , and instrumented . After smear layer removal , the teeth in group 1 were obturated using the System B and Obtura and were restored coronally with Core Paste using Tenure as a bonding agent . The teeth in group 2 were obturated using the Microseal technique and were restored coronally with amalgam using Panavia 21 as a bonding agent . All teeth in groups 1 and 2 were coated with three layers of nail varnish on all of their surfaces apart from the apical 4.0 mm and the coronal area above the cemento-enamel junction . The positive control teeth were obturated , restored coronally and completely coated with varnish , whereas the negative control teeth were not obturated , restored coronally , nor coated with varnish . The teeth were radiographed postoperatively and retained in saline solution for 10 days . For the next 10 days they were submerged in India ink . Subsequently all teeth were demineralized , dehydrated and rendered transparent . Dye penetration was measured using a stereomicroscope . RESULTS All material s and techniques provided minimal to zero dye penetration , apart from one specimen in the Core Paste group that showed 4.0 mm of dye penetration . The Wilcoxon rank sum test and t-test showed no statistically significant differences and all material s and techniques tested presented with a high degree of acceptability . CONCLUSIONS It was concluded that these contemporary techniques and material s provide equally good results , but long-term studies are needed for outright inferences to be drawn relative to their clinical performance In light of the in vitro S. sanguis bacterial migration observed deep into root dentin , an in vitro system was developed to determine the viability of these bacteria at the end of migration . Also of interest is whether the smear layer formed during root canal instrumentation modifies migration into root dentinal tubules . Forty-eight bovine root dentin sample s were r and omly split into two groups . Group 1 dentin blocks were not instrumented and were treated with 17 % ethylenediamine tetraacetic acid and OUTPUT:
Under the conditions of these in vitro leakage studies , it is concluded that smear layer removal improves the fluid-tight seal of the root canal system whereas other factors such as the obturation technique or the sealer , did not produce significant effects
MS2_dynamic_1_shot402
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: CONTEXT The Systolic Hypertension in the Elderly Program ( SHEP ) demonstrated that treating isolated systolic hypertension in older patients decreased incidence of total stroke , but whether all types of stroke were reduced was not evaluated . OBJECTIVE To investigate antihypertensive drug treatment effects on incidence of stroke by type and subtype , timing of strokes , case-fatality rates , stroke residual effects , and relationship of attained systolic blood pressure to stroke incidence . DESIGN The SHEP study , a r and omized , double-blind , placebo-controlled trial began March 1 , 1985 , and had an average follow-up of 4.5 years . SETTING AND PARTICIPANTS A total of 4736 men and women aged 60 years or older with isolated systolic hypertension at 16 clinical centers in the United States . INTERVENTIONS Patients were r and omly assigned to receive treatment with 12.5 mg/d of chlorthalidone ( step 1 ) ; either 25 mg/d of atenolol or 0.05 mg/d of reserpine ( step 2 ) could be added ( n = 2365 ) ; or placebo ( n = 2371 ) . MAIN OUTCOME MEASURES Occurrence , type and subtype , and timing of first strokes and stroke fatalities ; and change in stroke incidence for participants ( whether in active treatment or placebo groups ) reaching study -specific systolic blood pressure goal ( decrease of at least 20 mm Hg from baseline to below 160 mm Hg ) compared with participants not reaching goal . RESULTS A total of 85 and 132 participants in the active treatment and placebo groups , respectively , had ischemic strokes ( adjusted relative risk [ RR ] , 0.63 ; 95 % confidence interval [ CI ] , 0.48 - 0.82 ) ; 9 and 19 had hemorrhagic strokes ( adjusted RR , 0.46 ; 95 % CI , 0.21 - 1.02 ) ; and 9 and 8 had strokes of unknown type ( adjusted RR , 1.05 ; 95 % CI , 0.40 - 2 . 73 ) , respectively . Four subtypes of ischemic stroke were observed in active treatment and placebo group participants , respectively , as follows : for lacunar , n = 23 and n = 43 ( adjusted RR , 0.53 ; 95 % CI , 0.32 - 0.88 ) ; for embolic , n = 9 and n = 16 ( adjusted RR , 0.56 ; 95 % CI , 0.25 - 1.27 ) ; for atherosclerotic , n = 13 and n = 13 ( adjusted RR , 0 . 99 ; 95 % CI , 0.46 - 2.15 ) ; and for unknown subtype , n = 40 and n = 60 ( adjusted RR , 0.64 ; 95 % CI , 0.43 - 0.96 ) . Treatment effect was observed within 1 year for hemorrhagic strokes but was not seen until the second year for ischemic strokes . Stroke incidence significantly decreased in participants attaining study -specific systolic blood pressure goals . CONCLUSIONS In this study , antihypertensive drug treatment reduced the incidence of both hemorrhagic and ischemic ( including lacunar ) strokes . Reduction in stroke incidence occurred when specific systolic blood pressure goals were attained . JAMA . 2000;284:465 - Background Since drug-related emergency department ( ED ) visits are common among older adults , the objectives of our study were to identify the frequency of drug-related problems ( DRPs ) among patients presenting to the ED with non-specific complaints ( NSC ) , such as generalized weakness and to evaluate responsible drug classes . Methods Delayed type cross-sectional diagnostic study with a prospect i ve 30 day follow-up in the ED of the University Hospital Basel , Switzerl and . From May 2007 until April 2009 , all non-trauma patients presenting to the ED with an Emergency Severity Index ( ESI ) of 2 or 3 were screened and included , if they presented with non-specific complaints . After having obtained complete 30-day follow-up , two outcome assessors review ed all available information , judged whether the initial presentation was a DRP and compared their judgment with the initial ED diagnosis . Acute morbidity ( “ serious condition ” ) was allocated to individual cases according to predefined criteria . Results The study population consisted of 633 patients with NSC . Median age was 81 years ( IQR 72/87 ) , and the mean Charlson comorbidity index was 2.5 ( IQR 1/4 ) . DRPs were identified in 77 of the 633 cases ( 12.2 % ) . At the initial assessment , only 40 % of the DRPs were correctly identified . 64 of the 77 identified DRPs ( 83 % ) fulfilled the criteria “ serious condition ” . Polypharmacy and certain drug classes ( thiazides , antidepressants , benzodiazepines , anticonvulsants ) were associated with DRPs . Conclusion Elderly patients with non-specific complaints need to be screened systematic ally for drug-related problems . Trial Registration Clinical Trials.gov : Osteoporosis is responsible for about 1.3 million fractures in the United States each year [ 1 ] . Further , recent research has shown that the risk for most types of fracture in elderly women is related to low bone mass ; thus , the public health impact of osteoporosis may , in fact , be much greater [ 2 ] and is projected to increase over the next several decades [ 3 ] . Postmenopausal estrogen replacement is the current recommended therapy for the prevention of osteoporosis [ 4 ] . However , the use of estrogen is not wides OUTPUT: Our results suggest that thiazides are efficacious in preventing cardiovascular events for this population group . Low-dose regimens of thiazides may be safer than high-dose ( low quality of evidence ) , and a history of gout may increase the risk of adverse events ( low quality of evidence ) . Conclusions The use of low dose treatment with thiazides for the management of hypertension in adults aged 65 and older seems justified , unless a history of gout is present . INPUT: CONTEXT The Systolic Hypertension in the Elderly Program ( SHEP ) demonstrated that treating isolated systolic hypertension in older patients decreased incidence of total stroke , but whether all types of stroke were reduced was not evaluated . OBJECTIVE To investigate antihypertensive drug treatment effects on incidence of stroke by type and subtype , timing of strokes , case-fatality rates , stroke residual effects , and relationship of attained systolic blood pressure to stroke incidence . DESIGN The SHEP study , a r and omized , double-blind , placebo-controlled trial began March 1 , 1985 , and had an average follow-up of 4.5 years . SETTING AND PARTICIPANTS A total of 4736 men and women aged 60 years or older with isolated systolic hypertension at 16 clinical centers in the United States . INTERVENTIONS Patients were r and omly assigned to receive treatment with 12.5 mg/d of chlorthalidone ( step 1 ) ; either 25 mg/d of atenolol or 0.05 mg/d of reserpine ( step 2 ) could be added ( n = 2365 ) ; or placebo ( n = 2371 ) . MAIN OUTCOME MEASURES Occurrence , type and subtype , and timing of first strokes and stroke fatalities ; and change in stroke incidence for participants ( whether in active treatment or placebo groups ) reaching study -specific systolic blood pressure goal ( decrease of at least 20 mm Hg from baseline to below 160 mm Hg ) compared with participants not reaching goal . RESULTS A total of 85 and 132 participants in the active treatment and placebo groups , respectively , had ischemic strokes ( adjusted relative risk [ RR ] , 0.63 ; 95 % confidence interval [ CI ] , 0.48 - 0.82 ) ; 9 and 19 had hemorrhagic strokes ( adjusted RR , 0.46 ; 95 % CI , 0.21 - 1.02 ) ; and 9 and 8 had strokes of unknown type ( adjusted RR , 1.05 ; 95 % CI , 0.40 - 2 . 73 ) , respectively . Four subtypes of ischemic stroke were observed in active treatment and placebo group participants , respectively , as follows : for lacunar , n = 23 and n = 43 ( adjusted RR , 0.53 ; 95 % CI , 0.32 - 0.88 ) ; for embolic , n = 9 and n = 16 ( adjusted RR , 0.56 ; 95 % CI , 0.25 - 1.27 ) ; for atherosclerotic , n = 13 and n = 13 ( adjusted RR , 0 . 99 ; 95 % CI , 0.46 - 2.15 ) ; and for unknown subtype , n = 40 and n = 60 ( adjusted RR , 0.64 ; 95 % CI , 0.43 - 0.96 ) . Treatment effect was observed within 1 year for hemorrhagic strokes but was not seen until the second year for ischemic strokes . Stroke incidence significantly decreased in participants attaining study -specific systolic blood pressure goals . CONCLUSIONS In this study , antihypertensive drug treatment reduced the incidence of both hemorrhagic and ischemic ( including lacunar ) strokes . Reduction in stroke incidence occurred when specific systolic blood pressure goals were attained . JAMA . 2000;284:465 - The Systolic Hypertension in the Elderly Program ( SHEP ) , a r and omized , double-masked , placebo-controlled trial of 4736 persons , was design ed to assess the efficacy of antihypertensive drug treatment to reduce the risk of fatal and nonfatal strokes among people age 60 and over with isolated systolic hypertension . The statistical method used in interim monitoring of results was conditional power ( or stochastic curtailment ) . The findings did not become conclusive until near the completion of the trial , and therefore SHEP was continued to its scheduled closing date . The trial demonstrated a 36 % reduction in the incidence of stroke in the active treatment group ( P = .0003 ) . In addition to evaluating overall efficacy of treatment , the monitoring process considered such other issues as nonstroke outcomes , lag time between first report of stroke and final confirmation of stroke diagnosis , consistency of results across subgroups , and completeness of follow-up . The purpose of this article is to review these factors with primary emphasis on the statistical aspects BACKGROUND There are scant data on the effect of body mass index ( BMI ) ( calculated as weight in kilograms divided by the square of height in meters ) on cardiovascular events and death in older patients with hypertension . OBJECTIVE To determine if low body mass in older patients with hypertension confers an increased risk of death or stroke . PATIENTS Participants were 3975 men and women ( mean age , 71 years ) enrolled in 17 US centers in the Systolic Hypertension in the Elderly Program trial , a r and omized , double-blind , placebo-controlled clinical trial of lowdose antihypertensive therapy , with follow-up for 5 years . MAIN OUTCOME MEASURES Five-year adjusted mortality and stroke rates from Cox proportional hazards analyses . RESULTS There was no statistically significant relation of death or stroke with BMI in the placebo group ( P = .47 ) , and there was a U- or J-shaped relation in the treatment group . The J-shaped relation of death with BMI in the treated group ( P = .03 ) showed that the lowest probability of death for men was associated with a BMI of 26.0 and for women with a BMI of 29.6 ; the curve was quite flat for women across a wide range of BMI s. For stroke , men and women did not differ , and the BMI nadir for both sex OUTPUT:
Antihypertensive drugs used in the treatment of adults ( primary prevention ) with mild hypertension ( systolic BP 140 - 159 mmHg and /or diastolic BP 90 - 99 mmHg ) have not been shown to reduce mortality or morbidity in RCTs . More RCTs are needed in this prevalent population to know whether the benefits of treatment exceed the harms
MS2_dynamic_1_shot403
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: Background —Epidemiological studies suggest that tea consumption decreases cardiovascular risk , but the mechanisms of benefit remain undefined . Endothelial dysfunction has been associated with coronary artery disease and increased oxidative stress . Some antioxidants have been shown to reverse endothelial dysfunction , and tea contains antioxidant flavonoids . Methods and Results —To test the hypothesis that tea consumption will reverse endothelial dysfunction , we r and omized 66 patients with proven coronary artery disease to consume black tea and water in a crossover design . Short-term effects were examined 2 hours after consumption of 450 mL tea or water . Long-term effects were examined after consumption of 900 mL tea or water daily for 4 weeks . Vasomotor function of the brachial artery was examined at baseline and after each intervention with vascular ultrasound . Fifty patients completed the protocol and had technically suitable ultrasound measurements . Both short- and long-term tea consumption improved endothelium- dependent flow-mediated dilation of the brachial artery , whereas consumption of water had no effect ( P < 0.001 by repeated- measures ANOVA ) . Tea consumption had no effect on endothelium-independent nitroglycerin-induced dilation . An equivalent oral dose of caffeine ( 200 mg ) had no short-term effect on flow-mediated dilation . Plasma flavonoids increased after short- and long-term tea consumption . Conclusions —Short- and long-term black tea consumption reverses endothelial vasomotor dysfunction in patients with coronary artery disease . This finding may partly explain the association between tea intake and decreased cardiovascular disease events BACKGROUND Polyunsaturated fatty acids ( PUFAs ) are intrinsic cell membrane components and closely involved in neurotransmission and receptor function . Lower omega-3 levels are associated with increased risk of coronary artery disease ( CAD ) , increases in cardiac events in CAD patients , and depression . We sought to examine relationships between depression and serum levels of omega-3 and omega-6 PUFAs in patients recovering from acute coronary syndromes ( ACS ) . METHODS We carried out a case-control study of serum PUFA levels and current major depression in 54 age- and sex-matched pairs approximately 2 months following ACS . RESULTS Depressed patients had significantly lower concentrations of total omega-3 and docosahexaenoic acid ( DHA ) , and higher ratios of arachidonic acid ( AA ) to DHA , AA to eicosapentaenoic acid ( EPA ) , and n-3 to n-6 than controls . There were no baseline differences in any potential risk or protective factors for depression . CONCLUSIONS Results are consistent with previous reports in depressed patients without CAD , and with literature concerning omega-3 levels and risk of CAD events . Dietary , genetic , and hormonal factors may all play a role in both depression and CAD . Both prospect i ve studies and r and omized trials are needed to help clarify the interrelationships Abstract —Epidemiological studies suggest that tea consumption is associated with a decreased risk of cardiovascular events , but the mechanisms of benefit remain undefined . Platelet aggregation is a precipitating event in cardiovascular disease , and tea contains antioxidant flavonoids that are known to decrease platelet aggregation in vitro . To test the effect of tea consumption on platelet aggregation , we r and omized 49 patients with coronary artery disease to either 450 mL of black tea or water consumed initially , followed by 900 mL of tea or water daily for 4 weeks in a crossover design . Ex vivo platelet aggregation in platelet-rich plasma was assessed in response to ADP and thrombin receptor-activating peptide at baseline and 2 hours and 4 weeks after beverage consumption . We observed dose-dependent platelet aggregation in response to each agonist , and neither relation was altered by acute or chronic tea consumption . Plasma flavonoids increased with acute and chronic tea consumption , indicating adequate absorption of tea flavonoids . In conclusion , these results demonstrate that acute and chronic black tea consumption does not affect ex vivo platelet aggregation in patients with coronary artery disease . These findings suggest that an effect of tea flavonoids on platelet aggregation is unlikely to be the explanation for the reduction in risk of cardiovascular events noted in epidemiological studies BACKGROUND The Lyon Diet Heart Study is a r and omized secondary prevention trial aim ed at testing whether a Mediterranean-type diet may reduce the rate of recurrence after a first myocardial infa rct ion . An intermediate analysis showed a striking protective effect after 27 months of follow-up . This report presents results of an extended follow-up ( with a mean of 46 months per patient ) and deals with the relationships of dietary patterns and traditional risk factors with recurrence . METHODS AND RESULTS Three composite outcomes ( COs ) combining either cardiac death and nonfatal myocardial infa rct ion ( CO 1 ) , or the preceding plus major secondary end points ( unstable angina , stroke , heart failure , pulmonary or peripheral embolism ) ( CO 2 ) , or the preceding plus minor events requiring hospital admission ( CO 3 ) were studied . In the Mediterranean diet group , CO 1 was reduced ( 14 events versus 44 in the prudent Western-type diet group , P=0.0001 ) , as were CO 2 ( 27 events versus 90 , P=0.0001 ) and CO 3 ( 95 events versus 180 , P=0 . 0002 ) . Adjusted risk ratios ranged from 0.28 to 0.53 . Among the traditional risk factors , total cholesterol ( 1 mmol/L being associated with an increased risk of 18 % to 28 % ) , systolic blood pressure ( 1 mm Hg being associated with an increased risk of 1 % to 2 % ) , leukocyte count ( adjusted risk rati OUTPUT: Results show substantial evidence for the efficacy of n-3 oils in reducing cardiovascular mortality and one mechanism may be related to the stabilisation of vulnerable atherosclerotic plaques , although the effects on progression of atherosclerosis , haemostatic activity and vascular inflammation remain equivocal . Promising data also exist for the efficacy of flavonoid-rich foods for improving endothelial function , although strong clinical endpoint evidence is lacking . The variation in the efficacy of certain nutrients in CHD patients may be explained by genetics , existing risk factors , psychosocial factors and method ological issues , although these are often not adequately taken into consideration . INPUT: Background / Objectives : Coffee is the most widely consumed beverage in the world , but its effect on the cardiovascular system has not been fully understood . Coffee contains caffeine and antioxidants , which may influence endothelial function , both of which have not yet been investigated . The objective of this study was to investigate the acute effects of coffee on endothelial function measured by brachial artery flow-mediated dilation (FMD).Subjects/ Methods : A total of 20 ( 10 males and 10 females ) healthy non-obese subjects underwent a double-blind , crossover study . Subjects ingested one cup of caffeinated ( CC ) and one cup of decaffeinated ( DC ) Italian espresso coffee in r and om order at 5- to 7-day intervals . Results : Following CC ingestion , FMD decreased progressively and significantly ( mean±s.e.m . : 0 min , 7.7±0.6 ; 30 min , 6.3±0.7 ; 60 min , 6.0±0.8 % ; ANOVA ( analysis of variance ) , P<0.05 ) , but it did not significantly increase after DC ingestion ( 0 min , 6.9±0.6 ; 30 min , 8.1±0.9 ; 60 min , 8.5±0.9 % ; P=0.115 ) . Similarly , CC significantly increased both systolic and diastolic blood pressure ; this effect was not observed after DC ingestion . Blood glucose concentrations remained unchanged after ingestion of both CC and DC , but insulin ( 0 min , 15.8±0.9 ; 60 min , 15.0±0.8 μU/ml ; P<0.05 ) and C-peptide ( 0 min , 1.25±0.09 ; 60 min , 1.18±0.09 ng/ml ; P<0.01 ) blood concentrations decreased significantly only after CC ingestion . Conclusions : CC acutely induced unfavorable cardiovascular effects , especially on endothelial function . In the fasting state , insulin secretion is also likely reduced after CC ingestion . Future studies will determine whether CC has detrimental clinical ly relevant effects , especially in unhealthy subjects Food and beverages rich in polyphenols with antioxidant activity are highlighted as a potential factor for risk reduction of lifestyle related diseases . This study was conducted to eluci date total polyphenol consumption from beverages in Japanese people . Total polyphenol ( TP ) contents in beverages were measured using a modified Folin-Ciocalteu method removing the interference of reduced sugars by using reverse-phase column chromatography . A beverage consumption survey was conducted in the Tokyo and Osaka areas in 2004 . R and omly selected male and female subjects ( 10 - 59 years old , n = 8768 ) recorded the amounts and types of all nonalcoholic beverages consumed in a week . Concentration of TP in coffee , green tea , black tea , Oolong tea , barley tea , fruit juice , tomato/vegetable juice , and cocoa drinks were at 200 , 115 , 96 , 39 , 9 , 34 , 69 , and 62 mg/100 mL , respectively . Total consumption of beverages in a Japanese population was 1.11 + /- 0.51 L/day , and TP contents from beverages was 853 + /- 512 mg/day . Coffee and green tea shared 50 % and 34 % of TP consumption in beverages , respectively , and contribution of each of the other beverages was less than 10 % . TP contents in 20 major vegetables and 5 fruits were 0 - 49 mg and 2 - 55 mg/100 g , respectively . Antioxidant activities , Cu reducing power , and scavenging activities for DPPH and superoxide , of those sample s correlated to the TP contents ( p < 0.001 ) . Beverages , especially coffee , contributed to a large share of the consumption of polyphenols , as antioxidants , in the Japanese diet Epidemiological studies indicate that habitual coffee consumption lowers the risk of diabetes and cardiovascular diseases . Postpr and ial hyperglycemia is a direct and independent risk factor for cardiovascular diseases . We previously demonstrated that coffee polyphenol ingestion increased secretion of Glucagon-like peptide 1 ( GLP-1 ) , which has been shown to exhibit anti-diabetic and cardiovascular effects . We hypothesized coffee polyphenol consumption may improve postpr and ial hyperglycemia and vascular endothelial function by increasing GLP-1 release and /or reducing oxidative stress . To examine this hypothesis , we conducted a r and omized , acute , crossover , intervention study in healthy male adults , measuring blood parameters and flow-mediated dilation ( FMD ) after ingestion of a meal with or without coffee polyphenol extract ( CPE ) . Nineteen subjects consumed a test meal with either a placebo- or CPE-containing beverage . Blood biomarkers and FMD were measured at fasting and up to 180 minutes postpr and ially . The CPE beverage led to a significantly lower peak postpr and ial increase in blood glucose and diacron-reactive oxygen metabolite , and significantly higher postpr and ial FMD than the placebo beverage . Postpr and ial blood GLP-1 increase tended to be higher after ingestion of the CPE beverage , compared with placebo . Subclass analysis revealed that the CPE beverage significantly improved postpr and ial blood GLP-1 response and reduced blood glucose increase in the subjects with a lower insulinogenic index . Correlation analysis showed postpr and ial FMD was negatively associated with blood glucose increase after ingestion of the CPE beverage . In conclusion , these results suggest that coffee polyphenol consumption OUTPUT:
Conclusion : The results from this meta- analysis suggest a beneficial short-term effect of coffee intake on EF as measured by FMD . Base on systematic review results acute and chronic intake of coffee products may exerts an unfavorable effect on AS .
MS2_dynamic_1_shot404
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: BACKGROUND Although dietary restriction often results in initial weight loss , the majority of obese dieters fail to maintain their reduced weight . Diet-induced weight loss results in compensatory increase of hunger , craving and decreased ghrelin suppression that encourage weight regain . A high protein and carbohydrate breakfast may overcome these compensatory changes and prevent obesity relapse . METHODS In this study 193 obese ( BMI 32.2±1.0kg/m(2 ) ) , sedentary non diabetic adult men and women ( 47±7years ) were r and omized to a low carbohydrate breakfast ( LCb ) or an isocaloric diet with high carbohydrate and protein breakfast ( HCPb ) . Anthropometric measures were assessed every 4weeks . Fasting glucose , insulin , ghrelin , lipids , craving scores and breakfast meal challenge assessing hunger , satiety , insulin and ghrelin responses , were performed at baseline , after a Diet Intervention Period ( Week 16 ) and after a Follow-up Period ( Week 32 ) . RESULTS At Week 16 , groups exhibited similar weight loss : 15.1±1.9 kg in LCb group vs. 13.5±2.3 kg in HCPb group , p=0.11 . From Week 16 to Week 32 , LCb group regained 11.6±2.6 kg , while the HCPb group lost additional 6.9±1.7 kg . Ghrelin levels were reduced after breakfast by 45.2 % and 29.5 % following the HCPb and LCb , respectively . Satiety was significantly improved and hunger and craving scores significantly reduced in the HCPb group vs. the LCb group . CONCLUSION A high carbohydrate and protein breakfast may prevent weight regain by reducing diet-induced compensatory changes in hunger , cravings and ghrelin suppression . To achieve long-term weight loss , meal timing and macronutrient composition must counteract these compensatory mechanisms which encourage weight regain after weight loss BACKGROUND Energy or calorie restriction ( CR ) has consistently been shown to produce weight loss and have beneficial health effects in numerous species , including primates and humans . Most individuals , however , are unable to sustain weight losses induced through reductions in energy intake , potentially due to increased hunger levels . The effects that prolonged CR has on subjective aspects of appetite have not been well studied . Thus , the present study tested the effect of 6 months of caloric restriction on appetite in healthy , overweight men and women . METHODS Forty-eight overweight men and women with a body mass index ( BMI ; kg m(-2 ) ) between 25 - 29.9 took part in a 6-month study and were r and omised into one of four groups : healthy diet ( control ) ; 25 % CR ; 12.5 % CR plus exercise ( 12.5 % increased energy expenditure ; CR + EX ) ; low-calorie diet [ LCD ; 3724 kJ day(-1 ) ( 890 kcal day(-1 ) ) until 15 % of initial body weight was lost , then maintenance ] . Appetite markers ( i.e. hunger , fullness , desire to eat , etc . ) were assessed weekly during a fasting state . RESULTS Body weight was significantly reduced in all three energy-restricted groups ( CR = -10.4 + /- 0.9 % ; CR + EX = -10.0 + /- 0.8 % ; and LCD = -13.9 + /-0.7 % ) , indicating that participants were adherent to their energy restriction regimen , whereas the healthy diet control group remained weight stable ( control = -1.0 + /- 1.1 % ) . Despite these significant weight losses , appetite ratings of participants in the three energy-restricted groups at month 6 were similar to the weight stable control group . CONCLUSIONS CR regimens with low fat diets producing significant weight losses have similar effects on appetite markers over a 6-month time period compared to a weight stable control group Few well-controlled trials have evaluated the effects that macronutrient composition has on changes in food cravings during weight loss treatment . The present study , which was part of the Preventing Overweight Using Novel Dietary Strategies ( POUNDS LOST ) trial , investigated whether the fat and protein content of four different diets affected changes in specific food cravings in overweight and obese adults . A sample of 811 adults were recruited across two clinical sites , and each participant was r and omly assigned to one of four macronutrient prescriptions : 1 ) low fat ( 20 % of energy ) , average protein ( 15 % of energy ) ; 2 ) moderate fat ( 40 % ) , average protein ( 15 % ) ; 3 ) low fat ( 20 % ) , high protein ( 25 % ) ; 4 ) moderate fat ( 40 % ) , high protein ( 25 % ) . With few exceptions , the type of diet that participants were assigned did not differentially affect changes in specific food cravings . Participants assigned to the high-fat diets , however , had reduced cravings for carbohydrates at month 12 ( p<0.05 ) and fruits and vegetables at month 24 . Also , participants assigned to high-protein diets had increased cravings for sweets at month 6 and month 12 ( ps<0.05 ) . Participants in all four dietary conditions reported significant reductions in food cravings for specific types of foods ( i.e. , high fat foods , fast food fats , sweets , and carbohydrates/starches ; all ps<0.05 ) . Cravings for fruits and vegetables , however , were increased at month 24 ( p<0.05 ) . Calorically restricted diets ( regardless of their macronutrient composition ) yielded significant reductions in cravings for fats , sweets , and starches whereas cravings for fruits and vegetables were increased Behavioral OUTPUT: CONCLUSIONS Calorie restriction is associated with reduced food cravings supporting a de-conditioning model of craving reductions . INPUT: BACKGROUND Ad libitum , low-carbohydrate diets decrease caloric intake and cause weight loss . It is unclear whether these effects are due to the reduced carbohydrate content of such diets or to their associated increase in protein intake . OBJECTIVE We tested the hypothesis that increasing the protein content while maintaining the carbohydrate content of the diet lowers body weight by decreasing appetite and spontaneous caloric intake . DESIGN Appetite , caloric intake , body weight , and fat mass were measured in 19 subjects placed sequentially on the following diets : a weight-maintaining diet ( 15 % protein , 35 % fat , and 50 % carbohydrate ) for 2 wk , an isocaloric diet ( 30 % protein , 20 % fat , and 50 % carbohydrate ) for 2 wk , and an ad libitum diet ( 30 % protein , 20 % fat , and 50 % carbohydrate ) for 12 wk . Blood was sample d frequently at the end of each diet phase to measure the area under the plasma concentration versus time curve ( AUC ) for insulin , leptin , and ghrelin . RESULTS Satiety was markedly increased with the isocaloric high-protein diet despite an unchanged leptin AUC . Mean ( + /-SE ) spontaneous energy intake decreased by 441 + /- 63 kcal/d , body weight decreased by 4.9 + /- 0.5 kg , and fat mass decreased by 3.7 + /- 0.4 kg with the ad libitum , high-protein diet , despite a significantly decreased leptin AUC and increased ghrelin AUC . CONCLUSIONS An increase in dietary protein from 15 % to 30 % of energy at a constant carbohydrate intake produces a sustained decrease in ad libitum caloric intake that may be mediated by increased central nervous system leptin sensitivity and results in significant weight loss . This anorexic effect of protein may contribute to the weight loss produced by low-carbohydrate diets BACKGROUND Reproduction has been identified as an important factor for long-term weight gain among women . A previous efficacy trial has successfully produced postpartum weight loss ; however , the effectiveness of this intervention needs to be established . OBJECTIVE This study was design ed to evaluate the short- and long-term effectiveness of a diet behavior modification treatment to produce weight loss in postpartum women within the primary health care setting in Sweden . DESIGN During 2011 - 2014 , 110 women with a self-reported body mass index ( BMI ; in kg/m(2 ) ) of ≥27 at 6 - 15 wk postpartum were r and omly assigned to the diet behavior modification group ( D group ) or the control group ( C group ) . Women r and omly assigned to the D group ( n = 54 ) received a structured 12-wk diet behavior modification treatment by a dietitian and were instructed to gradually implement a diet plan based on the Nordic Nutrition Recommendations and to self-weigh ≥3 times/wk . Women r and omly assigned to the C group ( n = 56 ) were given a brochure on healthy eating . The primary outcome was change in body weight after 12 wk and 1 y. The retention rate was 91 % and 85 % at 12 wk and 1 y , respectively . RESULTS At baseline , women had a median ( 1st , 3rd quartile ) BMI of 31.0 ( 28.8 , 33.6 ) , and 84 % were breastfeeding . After 12 wk , median weight change in the D group was -6.1 kg ( -8.4 , -3.2 kg ) compared with -1.6 kg ( -3.5 , -0.4 kg ) in the C group ( P < 0.001 ) . The difference was maintained at the 1-y follow-up for the D group , -10.0 kg ( -11.7 , -5.9 kg ) compared with -4.3 kg ( -10.2 , -1.0 kg ) in the C group ( P = 0.004 ) . In addition , the D group reduced BMI , waist circumference , hip circumference , and body fat percentage more than did the C group at both 12 wk and 1 y ( all P < 0.05 ) . CONCLUSION A low-intensity diet treatment delivered by a dietitian within the primary health care setting can produce clinical ly relevant and sustainable weight loss in postpartum women with overweight and obesity . This trial was registered at clinical trials.gov as NCT01949558 BACKGROUND The regional Mediterranean Diet has been associated with lower risk of disease . OBJECTIVE We tested the health effects of the New Nordic Diet ( NND ) , which is a gastronomically driven regional , organic , and environmentally friendly diet , in a carefully controlled but free-living setting . DESIGN A total of 181 central ly obese men and women , with a mean ( range ) age of 42 y ( 20 - 66 y ) , body mass index ( in kg/m(2 ) ) of 30.2 ( 22.6 - 47.3 ) , and waist circumference of 100 cm ( 80 - 138 cm ) were r and omly assigned to receive either the NND ( high in fruit , vegetables , whole grains , and fish ) or an average Danish diet ( ADD ) for 26 wk . Participants received cookbooks and all foods ad libitum and free of charge by using a shop model . The primary endpoint was the weight change analyzed by both completer and intention-to-treat analyses . RESULTS A total of 147 subjects [ 81 % ( NND 81 % ; ADD 82 % ) ] completed the intervention . A high dietary compliance was achieved , with significant differences in dietary intakes OUTPUT:
Qualitative assessment of other anthropometric indices also showed a beneficial effect of this dietary pattern in improving body fat and BMI values ; however , these findings are not conclusive because of limited number of studies . Adherence to the ND significantly improves body weight ; however , there is also no certainty that this diet is effective for improving other anthropometric indices .
MS2_dynamic_1_shot405
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: This study explored the diagnostic utility of the composite scores of Immediate Post-Concussion Assessment and Cognitive Testing ( ImPACT ) and Post Concussion Symptom Scale scores ( PCSS ) . Recently concussed high school athletes ( N=72 ) were tested within 72 h of sustaining a concussion , and data were compared to non-concussed high school athletes with no history of concussion ( N=66 ) . Between-groups MANOVA revealed a significant multivariate effect of concussion on test performance ( p<.001 ) ; univariate ANOVAS revealed all six measures contributed to the between-groups differences . A discriminant function analyses was conducted to measure the ability of the five ImPACT composite scores , as well as the PCSS to classify concussion status . One discriminant function was identified that consisted of the Visual Memory , Processing Speed , and Impulse Control composite scores PCSS , which correctly classified 85.5 % of the cases . Approximately 82 % of participants in the concussion group and 89 % of participants in the control group were correctly classified . Using these data , the sensitivity of ImPACT was 81.9 % , and the specificity was 89.4 % . As part of a formal concussion management program , ImPACT is a useful tool for the assessment of the neurocognitive and neurobehavioral sequelae of concussion , and can also provide post-injury cognitive and symptom data that can assist a practitioner in making safer return to play decisions STUDY OBJECTIVE To assess clinical features that might reliably predict the need for computed tomography ( CT ) imaging in pediatric head trauma . DESIGN / SETTING /TYPE OF PARTICIPANT : Prospect i ve cohort of 324 head CT scans performed on 322 consecutive trauma patients at an urban children 's hospital . RESULTS Sixty-two percent of patients were male . The mean age was 7.1 years ( 10 days to 20.6 years ) ; half were less than 5 years of age . The two most frequent mechanisms of injury were falls ( 32 % ) and motor vehicle accidents ( 25 % ) . Abnormalities were detected in 74 scans . Intracranial injuries were apparent in 39 patients ( 12 % ) ; 16 had a concomitant fracture . An isolated cranial abnormality was observed on 35 scans ( 11 % ) . Loss of consciousness , amnesia for the event , a Glasgow Coma Scale ( GCS ) of less than 15 , and the presence of a neurologic deficit were more common in children with intracranial injury ( P < .05 ) . Vomiting , seizures , and headache were not discriminating clinical features . No single characteristic consistently identified the children with an intracranial injury . Of the 195 children who were neurologically intact ( GCS , 15 ) at the time of presentation , 11 ( 5 % ) had evidence of intracranial pathology on CT scan . CONCLUSION This study demonstrates a poor correlation between the clinical symptoms of significant traumatic brain injury and findings on CT Objective Compare the visuomotor response times of children after a mild traumatic brain injury ( mTBI ) with those of noninjured children matched for age , sex , and premorbid level of physical activity . Design Prospect i ve cohort study . Setting Pediatric trauma center . Participants Thirty-eight children aged 7 to 16 years in each group . Children with mTBI had a mean Glasgow Coma Scale score of 14.8 and were considered normal on a neurological assessment carried out at the time of hospital discharge . Noninjured children were friends of those with mTBI . Intervention Assessment s of response time were conducted at 1 , 4 , and 12 weeks after mTBI and at corresponding time intervals for the control children . Main Outcome Measures The response speed subtest of the Bruininks-Oseretsky Test of Motor Proficiency ( BOTMP ) ; reaction and movement time for upper and lower extremities , for simple , choice , and reversed choice response time paradigms . Results Over the assessment period , children with mTBI performed worse than the control group only on the response speed subtest of the BOTMP . The mTBI children however tended to have slower movement times 1 week postinjury for the reversed choice response time paradigm for the lower extremities . Conclusions Some children with mTBI may have some problems in response time persisting until 12 weeks postinjury . Further research is required to better identify and underst and the severity of these problems and determine their impact , if any , on participation in physical activities STUDY OBJECTIVE We evaluate the diagnostic accuracy of clinical decision rules and physician judgment for identifying clinical ly important traumatic brain injuries in children with minor head injuries presenting to the emergency department . METHODS We prospect ively enrolled children younger than 18 years and with minor head injury ( Glasgow Coma Scale score 13 to 15 ) , presenting within 24 hours of their injuries . We assessed the ability of 3 clinical decision rules ( Canadian Assessment of Tomography for Childhood Head Injury [ CATCH ] , Children 's Head Injury Algorithm for the Prediction of Important Clinical Events [ CHALICE ] , and Pediatric Emergency Care Applied Research Network [ PECARN ] ) and 2 measures of physician judgment ( estimated of < 1 % risk of traumatic brain injury and actual computed tomography ordering practice ) to predict clinical ly important traumatic brain injury , as defined by death from traumatic brain injury , need for neurosurgery , intubation greater than 24 hours for traumatic brain injury , or hospital admission greater than 2 nights for traumatic brain injury . RESULTS Among the 1,009 children , 21 ( 2 % ; 95 % confidence interval [ CI ] 1 % to 3 % ) had clinical ly important traumatic brain injuries . Only physician practice and PECARN identified all clinical ly important traumatic brain injuries , with ranked sensitivities as follows : physician OUTPUT: Findings Vali date d tools are available to assist clinicians in the diagnosis and management of pediatric mTBI . A significant body of research exists to identify features that are associated with more serious TBI-associated intracranial injury , delayed recovery from mTBI , and long-term sequelae . Conclusions and Relevance This systematic review was used to develop an evidence -based clinical guideline for the diagnosis and management of pediatric mTBI . INPUT: Background Neurocognitive testing has been endorsed as a “ cornerstone ’ of concussion management by recent Vienna and Prague meetings of the Concussion in Sport Group . Neurocognitive testing is important given the potential unreliability of athlete self-report after injury . Relying only on athletes'ormalities after injury . Study Design Case control study ; Level of evidence , 3 . Methods High school and college athletes with a diagnosed concussion were tested 2 days after injury . Postinjury neurocognitive performance ( Immediate Postconcussion Assessment and Cognitive Testing ) and symptom ( postconcussion symptom ) scores were compared with preinjury ( baseline ) scores and with those of an agex and education-matched noninjured athlete control group . “ Abnormal ” test performance was determined statistically with Reliable Change Index scores . Results Sixty-four percent of concussed athletes reported a significant increase in symptoms , as judged by postconcussion symptom scores , compared with preinjury baseline at 2 days after injury . Eighty-three percent of the concussed sample demonstrated significantly poorer neurocognitive test results relative to their own baseline performance . The addition of neurocognitive testing result ed in a net increase in sensitivity of 19 % . Ninety-three percent of the sample had either abnormal neurocognitive test results or a significant increase in symptoms , relative to their own baseline ; 30 % of a control group demonstrated either abnormalities in neurocognitive testing or elevated symptoms , as judged by postconcussion symptom scores . For the concussed group , use of symptom and neurocognitive test results result ed in an increased yield of 29 % overreliance on symptoms alone . In contrast , 0 % of the control group had both symptoms and abnormal neurocognitive testing . Conclusion Reliance on patients ’ self-reported symptoms after concussion is likely to result in underdiagnosis of concussion and may result in premature return to play . Neurocognitive testing increases diagnostic accuracy when used in conjunction with self-reported symptoms This study explored the diagnostic utility of the composite scores of Immediate Post-Concussion Assessment and Cognitive Testing ( ImPACT ) and Post Concussion Symptom Scale scores ( PCSS ) . Recently concussed high school athletes ( N=72 ) were tested within 72 h of sustaining a concussion , and data were compared to non-concussed high school athletes with no history of concussion ( N=66 ) . Between-groups MANOVA revealed a significant multivariate effect of concussion on test performance ( p<.001 ) ; univariate ANOVAS revealed all six measures contributed to the between-groups differences . A discriminant function analyses was conducted to measure the ability of the five ImPACT composite scores , as well as the PCSS to classify concussion status . One discriminant function was identified that consisted of the Visual Memory , Processing Speed , and Impulse Control composite scores PCSS , which correctly classified 85.5 % of the cases . Approximately 82 % of participants in the concussion group and 89 % of participants in the control group were correctly classified . Using these data , the sensitivity of ImPACT was 81.9 % , and the specificity was 89.4 % . As part of a formal concussion management program , ImPACT is a useful tool for the assessment of the neurocognitive and neurobehavioral sequelae of concussion , and can also provide post-injury cognitive and symptom data that can assist a practitioner in making safer return to play decisions Objective Computerized neurocognitive assessment tools ( NCATS ) are often used as a screening tool to identify cognitive deficits after mild traumatic brain injury ( mTBI ) . However , differing methodology across studies renders it difficult to identify a consensus regarding the validity of NCATs . Thus , studies where multiple NCATs are administered in the same sample using the same methodology are warranted . Method We investigated the validity of four NCATs : the ANAM4 , CNS-VS , CogState , and ImPACT . Two NCATs were r and omly assigned and a battery of traditional neuropsychological ( NP ) tests administered to healthy control active duty service members ( n = 272 ) and to service members within 7 days of an mTBI ( n = 231 ) . Analyses included correlations between NCAT and the NP test scores to investigate convergent and discriminant validity , and regression analyses to identify the unique variance in NCAT and NP scores attributed to group status . Effect sizes ( Cohen 's f2 ) were calculated to guide interpretation of data . Results Only 37 ( 0.6 % ) of the 5,655 correlations calculated between NCATs and NP tests are large ( i.e. r ≥ 0.50 ) . The majority of correlations are small ( i.e. 0.30 > r ≥ 0.10 ) , with no clear patterns suggestive of convergent or discriminant validity between the NCATs and NP tests . Though there are statistically significant group differences across most NCAT and NP test scores , the unique variance accounted for by group status is minimal ( i.e. semipartial R2 ≤ 0.033 , 0.024 , 0.062 , and 0.011 for ANAM4 , CNS-VS , CogState , and ImPACT , respectively ) , with effect sizes indicating small to no meaningful effect . Conclusion Though the results are not overly promising for the validity of the four NCATs we investigated , traditional methods of investigating psychometric properties may not be appropriate for computerized tests . We offer several conceptual and method ological considerations for future studies regarding the validity of NCATs OBJECTIVES To prospect ively examine the relationship of sport-related concussion with depression and neurocognitive performance and symptoms among male and female high school and college athletes . A secondary objective was to explore age and sex differences . DESIGN Pretest , multiple posttest , repeated- measures design . SETTING Laboratory . PARTICIPANTS High school and collegiate athletes ( N=7 OUTPUT:
Robust RT deficits were observed acutely following concussion . Minimal magnitude differences were noted when comparing between- and within-subject effects , suggesting that pre-injury baselines may not add clinical value in determining post-injury RT impairment . RT deficits persisted up till the intermediate-term ( 21–59 days post-injury ) timeframe and indicate lingering deficits exist . Mean effect size differences were observed between RT measure types and computerized neurocognitive testing platforms ; however , all categories displayed negative effects consistent with impaired RT following concussion .
MS2_dynamic_1_shot406
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: The study of the peripheral skeletal muscle function in patients with chronic obstructive pulmonary disease ( COPD ) is of growing interest , but often requires biopsies , usually with the Bergström technique . The current study was design ed to test the validity of a minimally invasive technique : the microbiopsy . In 17 patients with COPD and four normal subjects , two specimens of the vastus lateralis were taken percutaneously under local anaesthesia , one with a 16-gauge needle ( microbiopsy ) and the other with the Bergström needle . The enzymatic activity of citrate synthase ( CS ) and phosphofructokinase ( PFK ) , and the myosin heavy chain ( MyoHC ) composition were measured for both techniques . The subjects reported no pain or much less with the microbiopsy compared with the Bergström biopsy . The microbiopsy sample weight reached 55±17 mg . The two techniques showed excellent agreement for CS activity and MyoHC composition . The PFK activity did not differ statistically between the techniques , but the agreement was moderate . The agreement between both biopsy techniques was stable over time . The median ( range ) fibre number within the microbiopsy specimens was 144 ( 38–286 ) . In conclusion , the current study shows the feasibility and validity of a minimally invasive muscle biopsy technique that appears more comfortable for subjects , compared with the Bergström technique The aim of this study was to investigate the effects of mobilisation on respiratory and haemodynamic variables in the intubated , ventilated abdominal surgical patient . Mobilisation was defined as the progression of activity from supine , to sitting over the edge of the bed , st and ing , walking on the spot for one minute , sitting out of bed initially , and sitting out of bed for 20 minutes . Seventeen patients with age ( mean + /- SD ) 71.4 + /- 7.1 years satisfied inclusion criteria . Respiratory and haemodynamic parameters were measured in each of the above positions and compared with supine . In the 15 subjects who completed the protocol , st and ing result ed in significant increases in minute ventilation ( VE ) from 15.1 + /- 3.1 l/min in supine to 21.3 + /- 3.6 l/min in st and ing ( p < 0.001 ) . The increase in VE in st and ing was achieved by significant increases in tidal volume ( VT ) from 712.7 + /- 172.8 ml to 883.4 + /- 196.3 ml ( p = 0.008 ) and in respiratory rate ( fR ) from 21.4 + /- 5.0 breaths/min to 24.9 + /- 4.5 breaths/min ( p = 0.03 ) . No further increases were observed in these parameters beyond st and ing when activity was progressed to walking on the spot for one minute . When supine values were compared with walking on the spot for one minute , inspiratory flow rates ( VT/TI ) increased significantly from 683 + /- 131.8 ml/sec to 985.1 + /- 162.3 ml/sec ( p = 0.001 ) with significant increases in rib cage displacement ( p = 0.001 ) and no significant increase in abdominal displacement ( p = 0.23 ) . Arterial blood gases displayed no improvements following mobilisation . Changes in VT , fR , and VE were largely due to positional changes when moving from supine to st and ing Objective : To determine whether early activity is feasible and safe in respiratory failure patients . Design : Prospect i ve cohort study . Setting : From June 1 , 2003 , through December 31 , 2003 , we assessed safety and feasibility of early activity in all consecutive respiratory failure patients who required mechanical ventilation for > 4 days admitted to our respiratory intensive care unit ( RICU ) . A majority of patients were treated in another intensive care unit ( ICU ) before RICU admission . We excluded patients who required mechanical ventilation for ≤4 days . Patients : Eight‐bed RICU at LDS Hospital . Interventions : We assessed patients for early activity as part of routine respiratory ICU care . We prospect ively recorded activity events and adverse events . We defined three activity events as sit on bed , sit in chair , and ambulate . We defined six activity‐related adverse events as fall to knees , tube removal , systolic blood pressure > 200 mm Hg , systolic blood pressure < 90 mm Hg , oxygen desaturation < 80 % , and extubation . Measurements and Main Results : During the study period , we conducted a total of 1,449 activity events in 103 patients . The activity events included 233 ( 16 % ) sit on bed , 454 ( 31 % ) sit in chair , and 762 ( 53 % ) ambulate . In patients with an endotracheal tube in place , there were a total of 593 activity events , of which 249 ( 42 % ) were ambulation . There were < 1 % activity‐related adverse events , including fall to the knees without injury , feeding tube removal , systolic blood pressure > 200 mm Hg , systolic blood pressure < 90 mm Hg , and desaturation < 80 % . No patient was extubated during activity . Conclusions : We conclude that early activity is feasible and safe in respiratory failure patients . A majority of survivors ( 69 % ) were able to ambulate > 100 feet at RICU discharge . Early activity is a c and i date therapy to prevent or treat the neuromuscular complications of critical illness Objectives : To investigate whether a daily exercise session , using a bedside cycle ergometer , is a safe and effective intervention in preventing or attenuating the decrease in functional exercise capacity , functional status , and quadriceps force that is associated with prolonged intensive care unit stay . A prolonged stay in the OUTPUT: We found that active mobilization may improve muscle strength , functional independence , and the ability to wean from ventilation and may decrease the length of stay in the intensive care unit ( ICU ) and hospital . Active mobilization appears to have a positive effect on physical function and hospital outcomes in mechanical ventilation patients . INPUT: The study of the peripheral skeletal muscle function in patients with chronic obstructive pulmonary disease ( COPD ) is of growing interest , but often requires biopsies , usually with the Bergström technique . The current study was design ed to test the validity of a minimally invasive technique : the microbiopsy . In 17 patients with COPD and four normal subjects , two specimens of the vastus lateralis were taken percutaneously under local anaesthesia , one with a 16-gauge needle ( microbiopsy ) and the other with the Bergström needle . The enzymatic activity of citrate synthase ( CS ) and phosphofructokinase ( PFK ) , and the myosin heavy chain ( MyoHC ) composition were measured for both techniques . The subjects reported no pain or much less with the microbiopsy compared with the Bergström biopsy . The microbiopsy sample weight reached 55±17 mg . The two techniques showed excellent agreement for CS activity and MyoHC composition . The PFK activity did not differ statistically between the techniques , but the agreement was moderate . The agreement between both biopsy techniques was stable over time . The median ( range ) fibre number within the microbiopsy specimens was 144 ( 38–286 ) . In conclusion , the current study shows the feasibility and validity of a minimally invasive muscle biopsy technique that appears more comfortable for subjects , compared with the Bergström technique We hypothesized that patients with chronic obstructive pulmonary disease developing contractile fatigue of the quadriceps during cycle exercise may have characteristic metabolic and muscle features that could increase their susceptibility to fatigue , thus differentiating them from those who do not develop fatigue . We examined , in 32 patients , the fiber-type proportion , enzymatic activities , and capillary density in the vastus lateralis and the arterial blood lactate level during constant work-rate cycling exercise . Contractile fatigue was defined as a postexercise fall in quadriceps twitch force greater than 15 % of resting values . Twenty-two patients developed contractile fatigue after exercise . No significant differences were found between fatiguers and non-fatiguers for the endurance time , fiber-type proportion , and oxidative enzyme activities . The lactate dehydrogenase activity was significantly higher ( p < 0.05 ) and muscle capillarization significantly reduced in fatiguers ( p < 0.05 ) . Compared with non-fatiguers , the arterial lactate level during exercise was significantly higher in fatiguers ( p < 0.001 ) . A significant relationship was found between the fall in quadriceps twitch force and lactate dehydrogenase activity , capillary/fiber ratio , and blood lactate level . We conclude that changes in muscle enzymatic profile and capillarization with a greater reliance on glycolytic metabolism during exercise are associated with contractile fatigue in patients with chronic obstructive pulmonary disease This study aim ed to investigate the relationship between skeletal muscle , fibre type composition , functional respiratory impairment and exercise tolerance in patients with moderate to severe chronic obstructive pulmonary disease ( COPD ) . A group of 22 COPD patients and 10 healthy control subjects were studied . In COPD patients , vital capacity ( VC ) and forced expiratory volume in one second ( FEV1 ) were reduced to 79 % and 51 % , respectively . Diffusion indices ( transfer factor of the lung for carbon monoxide ( TL , CO ) and carbon monoxide transfer coefficient ( KCO ) ) were also reduced . Arterial oxygen tension ( Pa , O2 ) was normal or slightly altered . A maximal exercise test was performed and anaerobic threshold was calculated . Muscle sample s from vastus lateralis were obtained by needle biopsy . Myosin heavy chain ( MHC ) and light chain ( MLC ) isoforms were separated by gel electrophoresis and quantified by densitometry . MHC isoforms were considered as molecular markers of fibre types . The proportion of the fast MHC-2B isoform was increased in COPD patients . TL , CO , KCO , VC and FEV1 were positively correlated with slow MHC isoform content . TL , CO and KCO were also negatively correlated with the content of the fast MHC-2B isoform . No correlation was found between exercise parameters and MHC isoform composition . The co-ordinated expression between MHC and MLC isoforms was altered in COPD patients . We conclude that reduced oxygen availability , probably in combination with muscle disuse , may determine muscle alterations in chronic obstructive pulmonary disease patients . The altered correlations between myosin heavy chain and light chain isoforms suggest that co-ordinated protein expression is lost in chronic obstructive pulmonary disease muscles Dysfunction of the muscles of ambulation contributes to exercise intolerance in chronic obstructive pulmonary disease ( COPD ) . Men with COPD have high prevalence of low testosterone levels , which may contribute to muscle weakness . We determined effects of testosterone supplementation ( 100 mg of testosterone enanthate injected weekly ) with or without resistance training ( 45 minutes three times weekly ) on body composition and muscle function in 47 men with COPD ( mean FEV(1 ) = 40 % predicted ) and low testosterone levels ( mean = 320 ng/dl ) . Subjects were r and omized to 10 weeks of placebo injections + no training , testosterone injections + no training , placebo injections + resistance training , or testosterone injections + resistance training . Testosterone injections yielded a mean increase of 271 ng/dl in the nadir serum testosterone concentration ( to the middle of the normal range for young men ) . The lean body mass ( by dual-energy X-ray absorptiometry ) increase averaged 2.3 kg with testosterone alone and 3.3 kg with combined testosterone and resistance training ( p < 0.001 ) . Increase in one-repetition maximum leg press strength OUTPUT:
RESULTS The forced expiratory volume in 1 s ( FEV(1 ) ) , the ratio of FEV(1 ) to forced vital capacity ( FVC ) and body mass index were positively associated with the proportion of type I fibres in COPD . This review sheds new light on the relationship between skeletal muscle abnormalities and important hallmarks of the disease in severe COPD , and identifies absence of data in GOLD stages 1 - 2 . This review also provides reference values on fibre type composition for diagnostic purpose s in COPD
MS2_dynamic_1_shot407
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: Little consensus exists in the literature regarding methods for determination of the onset of electromyographic ( EMG ) activity . The aim of this study was to compare the relative accuracy of a range of computer-based techniques with respect to EMG onset determined visually by an experienced examiner . Twenty-seven methods were compared which varied in terms of EMG processing ( low pass filtering at 10 , 50 and 500 Hz ) , threshold value ( 1 , 2 and 3 SD beyond mean of baseline activity ) and the number of sample s for which the mean must exceed the defined threshold ( 20 , 50 and 100 ms ) . Three hundred r and omly selected trials of a postural task were evaluated using each technique . The visual determination of EMG onset was found to be highly repeatable between days . Linear regression equations were calculated for the values selected by each computer method which indicated that the onset values selected by the majority of the parameter combinations deviated significantly from the visually derived onset values . Several methods accurately selected the time of onset of EMG activity and are recommended for future use This study investigated whether people with low back pain ( LBP ) reduce variability of movement between the pelvis and thorax ( trunk ) in the transverse plane during gait at different speeds compared to healthy controls . Thirteen people with chronic LBP and twelve healthy controls walked on a treadmill at speeds from 0.5 to 1.72 m/s , with increments of 0.11 m/s . Step-to-step variability of the trunk , pelvis , and thorax rotations were calculated . Step-to-step deviations of pelvis and thorax rotations from the average pattern ( residual rotations ) were correlated to each other , and the linear regression coefficients between these deviations calculated . Spectral analysis was used to determine the frequencies of the residual rotations , to infer the relation of reduced trunk variability to trunk stiffness and /or damping . Variability of trunk motion ( thorax relative to pelvis ) was lower ( P=0.02 ) , covariance between the residual rotations of pelvis and thorax motions was higher ( P=0.03 ) , and the linear regression coefficients were closer to 1 ( P=0.05 ) in the LBP group . Most power of segmental residual rotations was below stride frequency ( ~1 Hz ) . In this frequency range , trunk residual rotations had less power than pelvis or thorax residual rotations . These data show that people with LBP had lower variability of trunk rotations , as a result of the coupling of deviations of residual rotations in one segment to deviations of a similar shape ( correlation ) and amplitude ( regression coefficient ) in the other segment . These results support the argument that people with LBP adopt a protective movement strategy , possibly by increased trunk stiffness BACKGROUND Static trunk flexion working postures and disturbed trunk muscle reflexes are related to increased risk of low-back pain . Animal studies conclude that these factors may be related ; passive tissue strain in spinal ligaments causes subsequent short-term changes in reflex . Although studies have documented changes in the myoelectric onset angle of flexion-relaxation following prolonged static flexion and cyclic flexion we could find no published evidence related to the human reflex response of the trunk extensor muscles following a period of static flexion-relaxation loading . METHODS Eighteen subjects maintained static lumbar flexion for 15 min . Paraspinal muscle reflexes were elicited both before and after the flexion-relaxation protocol using pseudor and om stochastic force disturbances while recording EMG . Reflex gain was computed from the peak value of the impulse response function relating input force perturbation to EMG response using time-domain deconvolution analyses . FINDINGS Reflexes showed a trend toward increased gain after the period of flexion-relaxation ( P < 0.055 ) and were increased with trunk extension exertion ( P < 0.021 ) . Significant gender differences in reflex gain were observed ( P < 0.01 ) . INTERPRETATIONS Occupational activities requiring extended periods of trunk flexion contribute to changes in reflex behavior of the paraspinal muscles . Results suggest potential mechanisms by which flexed posture work may contribute to low-back pain . Significant gender differences indicate risk analyses should consider personal factors when considering neuromuscular behavior Spinal stability is related to both the intrinsic stiffness of active muscle as well as neuromuscular reflex response . However , existing analyses of spinal stability ignore the role of the reflex response , focusing solely on the intrinsic muscle stiffness associated with voluntary activation patterns in the torso musculature . The goal of this study was to empirically characterize the role of reflex components of spinal stability during voluntary trunk extension exertions . Pseudor and om position perturbations of the torso and associated driving forces were recorded in 11 healthy adults . Nonlinear systems- identification analyses of the measured data provided an estimate of total systems dynamics that explained 81 % of the movement variability . Proportional intrinsic response was less than zero in more than 60 % of the trials , e.g. mean value of P(INT ) during the 20 % maximum voluntary exertion trunk extension exertions -415+/-354N/m . The negative value indicated that the intrinsic muscle stiffness was not sufficient to stabilize the spine without reflex response . Reflexes accounted for 42 % of the total stabilizing trunk stiffness . Both intrinsic and reflex components of stiffness increased significantly with trunk extension effort . Results reveal that reflex dynamics are a necessary component in the stabilizing control of spinal stability Study Design . Transverse pelvis and thorax rotations were studied during walking in 39 patients with nonspecific low back pain and 19 healthy participants . Objectives . To gain insight into the consequences of low back pain for gait and to identify clinical ly useful measures for characterizing the quality of walking in patients with low back pain . Summary of Background Data . Gait studies in patients with low back pain have reported a decrease in walking velocity . In normal gait , in-phase pelvis-thorax coordination ( synchronicity ) evolves toward antiphase coordination ( counterrotation ) as walking velocity increases . OUTPUT: We found evidence of a longer response time of muscle activation , which would be in line with splinting behaviour in LBP . No signs of splinting behaviour were found in any of the other outcome measures . Conclusions We conclude that there is currently no convincing evidence for the presence of splinting behaviour in LBP patients , because we found no indications for splinting in terms of kinetic and kinematic responses to perturbation and derived mechanical properties of the trunk . Consistent evidence on delayed onsets of muscle activation in response to perturbations was found , but this may have other causes than splinting behaviour INPUT: Spectral parameters of the surface electromyographic ( EMG ) signal from lumbar back muscles assessed during a fatiguing isometric contraction can be used to classify different categories of low back pain ( LBP ) subjects and control subjects without LBP . In the test protocol currently used at the NeuroMuscular Research Center at Boston University , subjects contract their back muscles at 80 % of their maximal voluntary contraction ( MVC ) force . This fatigue-based protocol has been successfully applied to persons with subacute or chronic LBP ; those in acute pain , however , have not been included because of their inability to perform a maximal exertion . In this paper we will examine the force sensitivity of the currently used EMG parameters and also give an overview of some of our efforts to develop new test procedures . Our goal is to develop force-insensitive surface EMG parameters that can be used for classification purpose s in population s of subjects who develop low trunk extension forces . In addition , the development of a model to predict MVC from anthropometrical measurements will be presented AIM The aim of this study was to investigate the effect of continuous ultrasound ( US ) plus exercise on the endurance of paravertebral muscles of patients with chronic non specific low back pain ( CNSLBP ) . METHODS AND MATERIAL S In this pilot , pretest-posttest study , 22 patients with CNSLBP participated . Patients received 10 sessions of treatment , including continuous US plus exercise therapy , over a period of four consecutive weeks . Median frequency slopes of Iliocostalis and Multifidus muscles as well as holding time during Biering-Sorensen test were measured using surface electromyography . In addition , function and pain were measured using Functional Rating Index ( FRI ) question naire and VAS . RESULTS Five females and 15 males with a mean age of 31.7 years completed the treatment . Descriptive data showed a decrease of 0.01 and 0.02 mean in median frequency slope of right and left Iliocostalis respectively and a mean of 0.08 decrease for both right and left Multifidus muscles . Endurance time increased 1.8 seconds mean . Both function ( 17 % ) and pain ( 24 % ) improved post treatment . CONCLUSION Larger population studies in the context of high quality , r and omized clinical trial are needed to vali date the results The rate of decline in the median frequency ( MF ) of the surface EMG power spectrum ( MFgrad ) has been evaluated for its use in monitoring the fatigability of the erector spinae muscles during the performance of submaximal isometric contractions . MFgrad consistently displayed a highly significant relationship with endurance time for the task ( p < 0.05 ) , giving a slightly better correlation for contractions performed in lordotic postures , with the back muscles in a shortened position , than in flexed postures . No significant difference existed between mean MFgrad values recorded from the right and left erector spinae muscles , at either thoracic or lumbar levels . The back extensor muscles of men were more fatigable than those of women , and this has been discussed in relation to corresponding differences in muscle fiber type relative size . Greater erector spinae muscle fatigability was associated with both the existence of , and the risk of developing , serious low back pain . Possible mechanisms for the association , from retrospective and prospect i ve points of view , have been advanced OBJECTIVE The aim was to explore the validity and reliability of EMG for assessing lumbar muscle fatigue . DESIGN Patients with long-term low-back trouble ( n=57 ) were compared to a healthy reference group ( n=55 ) . Back muscle fatigue and recovery were studied in relation to health-related factors . BACKGROUND EMG spectral variables are important tools in the assessment of patients with low-back trouble . The influence of disability on these variables needs further investigation . METHODS EMG from the lower back muscles was recorded during a 45 s trunk extension at 80 % of maximal voluntary contraction torque and during recovery . Disability was studied using question naires . RESULTS The reliability was high for maximal voluntary contraction torque and EMG initial median frequency , lower for the median frequency slope , and insufficient for median frequency recovery half-time . The patients had lower maximal voluntary contraction torque , higher initial median frequency at L5 level , flatter slope , and longer recovery half-time than the healthy subjects did . However , for subjects with significantly negative slope , indicating fatigue , there was no significant difference in slope between patients and healthy subjects , while , for subjects without such fatigue , patients showed significantly flatter slopes at L5 . The sensitivity/specificity of the test was 86%/78 % . The most significant variables selected with logistic regression were maximal voluntary contraction torque and initial median frequency at L5 . Patients without significantly negative slopes during contraction and /or not exponential-like EMG recovery scored worse on several items concerning disability and self-efficacy . CONCLUSIONS EMG spectral variables in combination with torque might be used for classification . For patients with long-term low-back trouble , the ability to fatigue the lumbar muscles sufficiently to obtain a significantly negative slope during an 80 % maximal voluntary contraction may be a sign of better functioning . RELEVANCE The ability to fatigue the back muscles during a test requiring a high force output might be achieved with back muscle training focused on increasing strength and self-efficacy PURPOSE To determine whether dynamic back muscle endurance exercises in a semisitting position induce more fatigue in back muscles than that in hip extensors in healthy controls as well as in patients with nonspecific chronic low back pain . METHODS Sixteen healthy volunteers and 18 volunteers with nonspecific chronic low back pain performed trunk flexion-extension cycles until exhaustion at 60 % of their strength in a machine design ed for back exercise in a semisitting position with knees ' angle at 135 degrees . The number of cycles and perceived muscle fatigue ( Borg CR-10 scale ) at five areas ( upper and lower back , gluteus , hamstrings , and quadriceps ) were used as fatigue criteria . EMG signals were recorded bilaterally on four back muscles , two hip extensors ( gluteus maximus and biceps femoris ) , and the vastus medial OUTPUT:
We found conflicting data regarding the validity of methods used to examine back muscle fatigue . The Biering-Sorensen test , performed in conjunction with surface electromyography spectral analysis , turned out to be the most widely used and comparatively , the most optimal modality currently available to assess objective back muscle fatigue in daily clinical practise , even though critical limitations are discussed . Implication s for Rehabilitation Despite its limitations , the Biering-Sorensen test is currently the most used , convenient and easily available fatiguing test for lumbar muscles . Pooled mean frequency and half-width of the spectrum are currently the most valid electromyographic parameters to assess fatigue in chronic non-specific low back pain .
MS2_dynamic_1_shot408
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: Auricular acupuncture can be an effective treatment for acute anxiety , but there is a lack of direct comparisons of acupuncture to proven st and ard drug treatments . In this study we compared the efficacy of auricular acupuncture with intranasal midazolam , placebo acupuncture , and no treatment for reducing dental anxiety . Patients having dental extraction s ( n = 67 ) were r and omized to ( i ) auricular acupuncture , ( ii ) placebo acupuncture , and ( iii ) intranasal midazolam and compared with a no treatment group . Anxiety was assessed before the interventions , at 30 min , and after the dental extraction . Physiological variables were assessed continuously . With the no treatment group as control , the auricular acupuncture group , and the midazolam group were significantly less anxious at 30 min as compared with patients in the placebo acupuncture group ( Spielberger Stait-Trait Anxiety Inventory X1 , P = 0.012 and < 0.001 , respectively ) . In addition , patient compliance assessed by the dentist was significantly improved if auricular acupuncture or application of intranasal midazolam had been performed ( P = 0.032 and 0.049 , respectively ) . In conclusion , both , auricular acupuncture and intranasal midazolam were similarly effective for the treatment of dental anxiety Acupuncture is one of the most widely used and broadly research ed of the complementary and alternative therapies , but high- quality trials generally show no benefit over sham acupuncture . Many would view this result as evidence of ineffectiveness for this intervention . This discussion article focuses on the report of a large multicenter r and omized controlled trial of acupuncture for chronic low-back pain ( CLBP ) in the lay and academic press , the ensuing discussion , and its impact on both clinical practice and service provision . The authors suggest that interpretive bias has affected reporting , leading to question able conclusions and advocacy in favor of this form of care that may exceed the evidence . They also suggest that a lack of underst and ing of research into the placebo effect may have contributed to confusion in the interpretation of these trials Background : Auricular acupuncture is a promising method for postoperative pain relief . However , there is no evidence for its use after ambulatory surgery . Our aim was to test whether auricular acupuncture is better than invasive needle control for complementary analgesia after ambulatory knee surgery . Methods : One hundred and twenty patients undergoing ambulatory arthroscopic knee surgery under st and ardized general anesthesia were r and omly assigned to receive auricular acupuncture or a control procedure . Fixed indwelling acupuncture needles were inserted before surgery and retained in situ until the following morning . Postoperative rescue analgesia was directed to achieve pain intensity less than 40 mm on a 100-mm visual analogue scale . The primary outcome measure was the postoperative requirement for ibuprofen between surgery and examination the following morning . Results : Intention-to-treat analysis showed that patients from the control group ( n = 59 ) required more ibuprofen than patients from the auricular acupuncture group ( n = 61 ) : median ( interquartile range ) 600 ( 200–800 ) v. 200 ( 0–600 ) mg ( p = 0.012 ) . Pain intensity on a visual analogue scale was similar in both groups at all time points registered . The majority of patients in both groups believed that they had received true acupuncture and wanted to repeat it in future . Interpretation : Auricular acupuncture reduced the requirement for ibuprofen after ambulatory knee surgery relative to an invasive needle control procedure In alternative health care iridology is used as a diagnostic aid . The diagnosis of gall bladder disease was used to study its validity and interperformer consistency . The presence of an inflamed gall bladder containing gall stones is said to be easily recognised by certain signs in the lower lateral part of the iris of the right eye . Stereo colour slides were made of the right eye . Stereo colour slides were made of the right eye of 39 patients with this disease and 39 control subjects of the same sex and age . The slides were presented in a r and om order to five leading iridologists without supplementary information . The prevalence of the disease was estimated at 56 % . The median validity was 51 % with 54 % sensitivity and 52 % specificity . These results were close to chance validity ( iota = 0.03 ) . None of the iridologists reached a high validity . The median interperformer consistency was 60 % . This was only slightly higher than chance consistency ( kappa = 0.18 ) . This study showed that iridology is not a useful diagnostic aid OBJECTIVES Reflexology is an increasingly popular complementary therapy in which parts of the body are deemed to be represented on the soles of the feet . The aim of this study was to investigate whether this representation can be used as a valid method of diagnosis . METHODS Three experienced reflexologists took part in this study . Eighteen adults with one or more of six specified conditions were identified from primary care records . Two reflexologists , who were blinded to the patients ' conditions and monitored , then examined each patient 's feet and rated the probability that each of the six conditions was present . RESULTS There is little evidence that the distribution of ratings vary with the status of the condition . Receiver operating curves suggest that this diagnostic method is very poor at distinguishing between the presence and absence of conditions . Inter-rater reliability ( kappa ) scores were very low , providing no evidence of agreement between the examiners . CONCLUSION Despite certain limitations to the data provided by this study , the results do not suggest that reflexology techniques are a valid method of diagnosis Iridology is an analysis of health based on examination of the iris of the eye . One hundred forty-three patients had photographs taken of both eyes . Nine-five patients were free of kidney disease , defined as a creatinine level of less than 1.2 mg/dL ( mean OUTPUT: Where this is the case , it is suggested that subjecting these therapies to empirical evaluation may be tantamount to evaluating the absurd INPUT: OBJECTIVE To examine the representativeness of a r and omized controlled trial ( RCT ) sample versus one obtained by consecutive new case ascertainment , for subjects with child bipolar I disorder . METHOD Subjects ( N = 247 ) were out patients who participated in either the National Institute of Mental Health-funded Phenomenology and Course of Pediatric Bipolar Disorders study or the Treatment of Early Age Mania ( TEAM ) study . Both studies required that subjects have current DSM-IV bipolar I disorder ( manic or mixed phase ) and a Children 's Global Assessment Scale ( CGAS ) score < or=60 . All subjects had elation and /or gr and iosity . Subjects in the Phenomenology study were obtained from 1995 to 1998 by consecutive new case ascertainment from design ated pediatric and psychiatric facilities . Subjects in the TEAM RCT were recruited from media and community sources between March 2003 and March 2005 . Assessment instruments included the Washington University in St. Louis Kiddie Schedule for Affective Disorders and Schizophrenia , given separately to parents about their children and to children about themselves , and the CGAS . Logistic regression was used for comparisons . RESULTS The TEAM and Phenomenology groups were similar in age ( 10.4 [ SD = 2.3 ] , 10.9 [ SD = 2.3 ] years , respectively ) and other demography . Both had long current episode duration ( 4.8 [ SD = 2.4 ] , 3.2 [ SD = 2.3 ] years ) and low lifetime use of any mood stabilizer ( 23.6 % , 35.0 % ) . Many mania symptoms and ultradian rapid cycling , psychosis , and suicidality were significantly more prevalent in the RCT sample . CONCLUSIONS Generalization of the RCT sample was supported , because only 7.8 % of Phenomenology subjects did not fit the RCT criteria . Nevertheless , because the RCT subjects were more severely ill , it is unclear if treatment findings from the RCT will be applicable to children with less severe mania . CLINICAL TRIALS REGISTRATION Clinical Trials.gov identifier NCT00057681 ( TEAM study ) BACKGROUND The diagnosis of pediatric bipolar disorders is a controversial topic . If this is mainly due to a bias against a diagnosis in younger children , then just changing the information about the age of a patient should influence the likelihood of a diagnosis despite otherwise identical symptoms . Therefore , we design ed a study to test if the age of a patient will influence diagnostic decisions . We further attempted to replicate an earlier result with regard to " decreased need for sleep " as a salient symptom for mania . METHODS We r and omly sent 1 of 4 case vignettes describing a person with current mania to child/adolescents psychiatrists in Germany . This vignette was systematic ally varied with respect to age of the patient ( 6 vs 16 years ) and the presence/absence of decreased need for sleep but always included sufficient criteria to diagnose a mania . RESULTS One hundred sixteen responded and , overall , 63.8 % of the respondents diagnosed a bipolar disorder in the person described in the vignette . Although age did not affect the likelihood of a bipolar diagnosis , the presence of decreased need for sleep did increase its likelihood . Furthermore , the number of core symptoms identified by the clinicians was closely linked to the likelihood of assigning a bipolar diagnosis . CONCLUSION Certain symptoms such as the decreased need for sleep , and also elated mood and gr and iosity , seem to be salient for some clinicians and influence their diagnoses . Biological age of the patient , however , does not seem to cause a systematic bias against a diagnosis of bipolar disorder in children BACKGROUND Diagnosis of child mania has been contentious . OBJECTIVE To investigate natural history and prospect i ve validation of the existence and long-episode duration of mania in children . DESIGN Four-year prospect i ve longitudinal study of 86 subjects with intake episode mania who were all assessed at 6 , 12 , 18 , 24 , 36 , and 48 months . The phenotype was defined as DSM-IV bipolar I disorder ( manic or mixed ) with at least 1 cardinal symptom ( elation and /or gr and iosity ) to ensure differentiation from attention-deficit/hyperactivity disorder . Parent and child informants were separately interviewed , by highly experienced research nurses , using the Washington University in St Louis Kiddie Schedule for Affective Disorders and Schizophrenia ( WASH-U-KSADS ) . A Children 's Global Assessment Scale score of 60 or less was needed to establish definite impairment . Treatment was by subjects ' community practitioners . SETTING Research unit in a university medical school . PARTICIPANTS Subjects were obtained from psychiatric and pediatric sites by consecutive new case ascertainment , and their baseline age was 10.8 + /- 2.7 years . Onset of the baseline episode was 7.4 + /- 3.5 years . ( Data are given as mean + /- SD . ) MAIN OUTCOME MEASURES Episode duration , weeks ill , recovery/relapse rates , and outcome predictors . RESULTS Prospect i ve episode duration of manic diagnoses , using onset of mania as baseline date , was 79.2 + /- 66.7 consecutive weeks . Any bipolar disorder diagnosis occurred during 67.1 % + /- 28.5 % of total weeks , during the 209.4 + /- 3.3 weeks of follow-up . Subjects spent 56.9 % + /- 28.8 % of total weeks with mania or hypomania ( unipolar or mixed ) , and 38.7 % + /- 28.8 % of these were with mania . Major or minor depression and dysthymia ( unipolar or mixed ) occurred during 47.1 % + /- OUTPUT:
Comparison of manic symptoms across age groups suggested that irritability is a key feature of BD with an onset in childhood , activity is the most prominent in adolescent-onset BD and pressure of speech is more characteristic of adult-onset BD . Conclusions Despite frequent discussion of similarities and differences in phenomenology of mania presenting in different age groups , systematic research is lacking and studies are still required to reliably establish whether the frequency and severity of manic symptoms varies .
MS2_dynamic_1_shot409
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: OBJECTIVE To compare the efficacy of aquatic exercise and a l and -based exercise programme vs control in patients with knee osteoarthritis . METHODS Primary outcome was change in pain , and in addition Knee Injury and Osteoarthritis Outcome Score question naire ( KOOS ) . St and ing balance and strength was also measured after and at 3-month follow-up . Seventy-nine patients ( 62 women ) , with a mean age of 68 years ( age range 40 - 89 years ) were r and omized to aquatic exercise ( n = 27 ) , l and -based exercise ( n = 25 ) or control ( n = 27 ) . RESULTS No effect was observed immediately after exercise cessation ( 8 weeks ) . At 3-month follow-up a reduction in pain was observed only in the l and -based exercise group compared with control ( -8.1 mm , ( 95 % confidence interval -15.4 to -0.4 ; p = 0.039 ) , but no differences between groups were observed for KOOS ; and no improvement following aquatic exercise . Eleven patients reported adverse events ( i.e. discomfort ) in l and -based exercise , while only 3 reported adverse events in the aquatic exercise . CONCLUSION Only l and -based exercise showed some improvement in pain and muscle strength compared with the control group , while no clinical benefits were detectable after aquatic exercise compared with the control group . However , aquatic exercise has significantly less adverse effects compared with a l and -based programme OBJECTIVE To conduct a preliminary investigation of the effects on floatation spa therapy on quality of life in patients with osteoarthritis to see if controlled trials are warranted . DESIGN Uncontrolled clinical trial . SETTING Private floatation spa therapy centre . PATIENTS Fourteen patients with chronic osteoarthritis of the weight-bearing joints , of whom four dropped out . INTERVENTION Six weekly sessions of floatation spa therapy . OUTCOME MEASURES SF36 , AIMS 2 and MYMOP quality -of-life question naires . MAIN RESULTS All patients improved . Differences between baseline and discharge scores showed statistically significant improvement for MYMOP , but not AIMS 2 or SF-36 . CONCLUSIONS Controlled trials of floatation spa therapy for patients with osteoarthritis are warranted BACKGROUND Balneotherapy , traditionally administered during a continuous stay at the Dead Sea area , has been shown to be effective for patients suffering from knee osteoarthritis . OBJECTIVES To evaluate the effectiveness of an intermittent regimen of balneotherapy at the Dead Sea for patients with knee osteoarthritis . METHODS Forty-four patients with knee osteoarthritis were included in a prospect i ve r and omized single-blind controlled study . The patients were divided into two groups : a treatment group ( n=24 ) , which were treated twice weekly for 6 consecutive weeks in a sulfur pool heated to 35 - 36 degrees C , and a control group ( n=20 ) treated in a Jacuzzi filled with tap water heated to 35 - 36 degrees C. Participants were assessed by the Lequesne index of osteoarthritis severity , the WOMAC index , the SF-36 quality of health question naire , VAS scales for pain ( completed by patients and physicians ) , and physical examination . RESULTS A statistically significant improvement , lasting up to 6 months , was observed in the treatment group for most of the clinical parameters . In the control group the only improvements were in the SF-36 bodily pain scale at 6 months , the Lequesne index at 1 month and the WOMAC pain score at the end of the treatment period . Although the patients in the control group had milder disease , the difference between the two groups was not statistically significant . CONCLUSIONS Intermittent balneotherapy appears to be effective for patients with knee osteoarthritis Objectives .To estimate cost and outcomes of the Arthritis Foundation aquatic exercise classes from the societal perspective . Design .R and omized trial of 20-week aquatic classes . Cost per quality -adjusted life year ( QALY ) gained was estimated using trial data . Sample size was based on 80 % power to reject the null hypothesis that the cost/QALY gained would not exceed $ 50,000 . Subjects and Methods . Recruited 249 adults from Washington State aged 55 to 75 with a doctor-confirmed diagnosis of osteoarthritis to participate in aquatic classes . The Quality of Well-Being Scale ( QWB ) and Current Health Desirability Rating ( CHDR ) were used for economic evaluation , supplemented by the arthritis-specific Health Assessment Question naire ( HAQ ) , Center for Epidemiologic Studies -Depression Scale ( CES-D ) , and Perceived Quality of Life Scale ( PQOL ) collected at baseline and postclass . Outcome results applied to life expectancy tables were used to estimate QALYs . Use of health care facilities was assessed from diaries/ question naires and Medicare reimbursement rates used to estimate costs . Nonparametric bootstrap sampling of costs/QALY ratios established the 95 % CI around the estimates . Results .Aquatic exercisers reported equal ( QWB ) or better ( CHDR , HAQ , PQOL ) health-related quality of life compared with controls . Outcomes improved with regular class attendance . Costs/QALY gained discounted at 3 % were $ 205,186 using the QWB and $ 32,643 using the CHRD . Conclusion .Aquatic exercise exceeded $ 50,000 per QALY gained using the community-weighted outcome but fell below this arbitrary budget constraint when using the participant-weighted measure . Confidence intervals around these ratios suggested wide variability of cost effectiveness of aquatic exercise To study the effect of thermal mineral water of Nagybaracska ( Hungary ) on patients with primary knee osteoarthritis OUTPUT: No serious adverse events were reported in the included trials with relation to aquatic exercise . AUTHORS ' CONCLUSIONS There is moderate quality evidence that aquatic exercise may have small , short-term , and clinical ly relevant effects on patient-reported pain , disability , and QoL in people with knee and hip OA . INPUT: The aim of the study was to demonstrate the effectiveness of sulphurous water in patients with osteoarthritis of the h and . Forty-seven patients with osteoarthritis of the h and were enrolled into the double-blind , r and omized , controlled study , satisfying ACR criteria . One group of the patients ( n = 24 ) received balneotherapy , bathing in sulphurous thermal water for 20 min per occasion , 15 times in all during a period of 3 weeks . The control group ( n = 21 ) had a bath exclusively in warm tap water . Assessment s were carried out in both groups on four occasions : at the beginning and at the end of the treatment , and 3 and 6 months after the beginning of the treatment . The parameters studied were the following : pain in the h and , morning stiffness in the joints , grip strength of both h and s , and Health Assessment Question naire Disability Index ( HAQ ) and AUSCAN H and Osteoarthritis Index and EuroQol quality of life question naire . At the end of treatment , the improvement was more pronounced in the patient group treated with the sulphurous water . After 3 months , significant improvement could be detected in all parameters , except the morning stiffness and EQ5D . After 6 months , the values of pain , HAQ and AUSCAN continued to be significantly better in comparison with the baseline values . The improvement in quality of life was significant only at the end of the treatment , 6 months later not any longer . The difference between the two groups was significant after 3 months in point of pain and EQVAS . Balneotherapy and within this the sulphurous spa water alone may be effective for the attenuation of pain in patients with h and osteoarthrosis An increasing body of evidence substantiating the effectiveness of balneotherapy has accumulated during recent decades . In the present study , 42 ambulatory patients ( 23 males and 19 females , mean age 59.5 years ) with degenerative musculoskeletal disease were r and omised into one of two groups — bathing in tap water or in mineral water at the same temperature— and subjected to 30-min balneotherapy sessions on 15 occasions . Study parameters comprised serum levels of sensitised C-reactive protein ( CRP ) , plasma lipids , heat shock protein ( HSP-60 ) and total antioxidant status ( TAS ) . In both groups , CRP levels followed a decreasing tendency , which still persisted 3 months later . At 3 months after balneotherapy , serum cholesterol levels were still decreasing in patients who had used medicinal water , but exhibited a trend towards an increase in the control group . Triglyceride levels followed a decreasing trend in both patient groups . TAS showed a declining tendency in both groups . No changes of HSP-60 levels were observed in either group . Balneotherapy with the thermal water from Hajdúszoboszló spa had a more pronounced physiological effect compared to that seen in the control group treated with tap water in a 3 month period Effect of thermal water with high mineral content on clinical parameters and quality of life of patients with chronic low back pain was studied . In this r and omized controlled , single-blind , follow-up study , 60 patients with chronic low back pain were r and omized into two groups . The treatment group received balneotherapy with thermal-mineral water , and the control group bathed in tap water . Changes of the followings were evaluated : visual analogue scale ( VAS ) for pain , range of motion for the lumbar spine , Oswestry index , EuroQol-5D and Short Form-36 question naires . In the treatment group , the mobility of the lumbar spine , the Oswestry index , the VAS scores and the EuroQoL-5D index improved significantly . SF-36 items improved significantly in the treated group compared with baseline except for two parameters . Our study demonstrated the beneficial effect of balneotherapy with thermal mineral versus tap water on clinical parameters , along with improvements in quality of life Three treatments for non-specific lumbar pain -- balneotherapy , underwater traction bath , and underwater massage -- were assessed in a r and omised prospect i ve controlled trial in 158 out patients . Each group was treated for four weeks and patients were review ed at the end of this period and at 12 months after entry to the trial . The prescription of analgesics and the pain score were significantly reduced in all three treated groups , but there was no difference between the three groups . No significant change occurred in spinal motion and the straight leg raising test . After one year only the analgesic consumption was significantly lower than in the control group Objective : Balneotherapy , a domain of medical science , focuses on utilizing the beneficial effects of medicinal waters . Low back pain is among the most prevalent musculoskeletal disorders affecting a large proportion of the population during their lifetime . Although small in number , all controlled studies published on this subject have demonstrated the benefits of balneotherapy . This present study was undertaken to compare the effects of hydrotherapy with mineral water vs. tap water on low back pain . Patients and Methods : A single-blind clinical study was carried out to appraise the therapeutic efficacy of reduced sulphurous water on 60 patients with low back pain . 30 subjects took baths in reduced sulphurous mineral water , whereas the other 30 patients used modified tap water of matching odor . Parameters determined at baseline , after balneo-/hydrotherapy , and at the end of the 3-month follow-up period included the results of the Visual Analogue Scale ( VAS ) score , the modified Oswestry index , mobility of the spine , antalgic posture , tenderness of the paravertebral muscles on palpation , the dose requirements for analgesics , and the efficacy assessed by the investigators and by the patients . Results : Bathing in mineral water result ed in a statistically significant improvement . This was reflected by the VAS ( p < 0.01 ) and manifested by the mitigation of muscle spasm ( p < 0.01 ) , the alleviation of local tenderness ( p < 0.01 ) , the enhanced flexion-extension and OUTPUT:
A similar effect has been found in chronic pelvic inflammatory disease . The review also revealed that balneotherapy has some beneficial effects on antioxidant status , and on metabolic and inflammatory parameters . Based on the results , we conclude that balneotherapy with Hungarian thermal-mineral waters is an effective remedy for lower back pain , as well as for knee and h and osteoarthritis
MS2_dynamic_1_shot410
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: This clinical trial evaluated , over a 12-month period , the performance of brackets bonded to teeth etched and primed with Transbond Plus Self-Etching Primer ( SEP ) when compared with a conventional separate two-step etch and primer system . Thirty-nine r and omly selected patients requiring fixed appliance therapy were entered into the study . R and om allocation of each etching system , along with a ' split-mouth cross-quadrant ' design was used . A total of 661 brackets were placed by two operators . The failure and survival rates of the brackets were determined for age and gender of the patients , each etching system , operator , mode of failure , tooth position in the dental arch , and number of manipulations prior to curing the adhesive . Statistical analysis showed that SEP had a significantly higher bond failure rate ( 11.2 per cent ) than the conventional etch and primer system ( 3.9 per cent ) at the P = 0.001 level . Cox 's proportional hazards regression showed the conventional etch and primer system to have a 60 per cent reduced chance of bracket failure over a 12-month observation period , while males had a 2.4 times increased risk compared with females . The predominant mode of failure was at the composite enamel interface for the SEP , while for the conventional etch and primer system , it was within the composite adhesive . No statistically significant differences were found for the failure rate with respect to the age of the patient , operator , tooth location , or the number of manipulations of the bracket . This in vivo study showed that brackets bonded using SEP had an increased clinical bond failure rate compared with the conventional , separate , etch and prime system The split-mouth design is a popular design in oral health research . In the most common split-mouth study , each of two treatments are r and omly assigned to either the right or left halves of the dentition . The attractiveness of the design is that it removes a lot of inter-individual variability from the estimates of the treatment effect . However , already about 20 years ago the pitfalls of the design have been reported in the oral health literature . Yet , many clinicians are not aware of the potential problems with the split-mouth design . Further , it is our experience that most statisticians are not even aware of the existence of this design . Since most of the critical remarks appeared in the oral health literature , we argue that it is necessary to introduce the split-mouth design to a statistical audience , so that both clinicians and statisticians clearly underst and the advantages , limitations , statistical considerations , and implication s of its use in clinical trials and advise them on its use in practice Glass ionomer orthodontic adhesives cause less enamel demineralization during fixed orthodontic appliance treatment than do traditional resin-based products . An in vivo r and omized clinical trial was performed comparing the clinical performance of a resin-modified glass ionomer ( RMGI ) adhesive with a no-mix , resin-based ( the control ) adhesive over a 12-month period . The split-mouth technique was used to analyze bracket retention , bracket failure causes , and mode of failure for both adhesives in 61 patients . Bracket-failure rates were 10 % for the RMGI and 4 % for the resin-based adhesive . Both adhesives had 4 times more bracket failures when opposing occlusion was present . The resin-based product demonstrated a higher proportion of resin-to-enamel adhesive failures than did the RMGI . Compared with the resin-based adhesive , the RMGI-bracketed teeth showed improved clinical performance , no enamel surface loss , less enamel demineralization , and faster adhesive removal . However , the RMGI had a 2.6 times greater bracket-failure rate than did the resin-based product The aim of this study was to evaluate , over an 18-month period , the clinical performance of a self-etch adhesive [ Transbond Plus Self Etching Primer ( SEP ) , 3 M Unitek ] compared with a conventional adhesive that employs the etch- and -rinse approach ( Transbond XT , 3 M Unitek ) . One operator , using the straight-wire technique , bonded 567 metallic brackets to the teeth of 30 patients ( age range 12 - 18 years ) in a way that patients acted as self-control . The brackets were bonded following the manufacturers ' instructions except for the fact that the self-etch system was brushed for a longer time than recommended ( 10 - 15 seconds ) since previous investigations have reported that prolonged application times can improve the bonding efficacy of self-etch systems to enamel . The failure modes were visually classified into : adhesive-enamel , adhesive-bracket , and cohesive failure . The survival rates of the brackets were estimated by Kaplan-Meier and log-rank test ( P < 0.05 ) . The failure rates of the self-etch and conventional adhesives were 15.6 and 17.6 per cent , respectively . No significant differences in the survival rate were observed between the material s ( P > 0.05 ) . Most of the failures were cohesive and at the adhesive-enamel interface . There was no difference in the fracture debonding mode . These findings indicate that Transbond Plus SEP can be safely used for orthodontic brackets since the survival rates are similar to the conventional Transbond XT The aim of this study was to compare the clinical performance of a self-etching primer ( SEP ) with a conventional two-step etch and primer [ conventional method ( CM ) ] . The chair time required for bonding was also evaluated . Thirty-seven patients ( 14 males and 23 females ) with a mean age of 16 years 5 months were included in the study . Six hundred and seventy-two brackets were bonded by one operator using a split-mouth design , with either SEP ( Transbond Plus ) or CM ( Transbond XT ) . Bracket failure rates were estimated with respect to bonding procedure , dental arch , type of tooth ( incisor , canine , and premolar ) , and gender . The results were evaluated using the chi-square test . The survival rate of the brackets OUTPUT: We found low- quality evidence that was insufficient to conclude whether or not there is a difference in bond failure rate between SEPs and conventional etching systems when bonding fixed orthodontic appliances over a 5- to 37-month follow-up . INPUT: This study evaluated the shear bond strength of stainless steel brackets bonded to enamel with a new fluoride-releasing orthodontic adhesive system . A total of 140 extracted human bicuspids were r and omly divided into four groups . Group I ( Transbond XT ) was a control group in which enamel was etched with phosphoric acid . For the remaining groups , enamel was conditioned with a self-etching primer ( SEP ) : Group II ( Transbond Plus ) , Group III ( BeautyOrtho Bond ) , and Group IV ( BeautyOrtho Bond + Salivatect ) . Stainless steel brackets were bonded to all tooth sample s. After which , the sample s were stored , thermocycled , tested , and statistically analyzed . Besides bond strength evaluation , the adhesive remnant index ( ARI ) was also evaluated . The shear bond strengths of Groups II , III , and IV were significantly lower than Group I , and Group II was significantly greater than that of Group III . Concerning ARI scores , no significant differences were found between the groups . Further , no enamel fracture was observed during shear bond test with the new SEP . In conclusion , when enamel was conditioned with the new SEP , the mean values of shear bond strength yielded were lower than when it was etched with 37 % phosphoric acid . Nonetheless , these mean values were higher than the average suggested by Reynolds as optimum for clinical treatment The purpose of this study was to determine the effect of changing the crosshead speed of the testing machine on the shear bond strength of orthodontic brackets to enamel while st and ardizing all the other variables . Forty freshly extracted human molars were bonded using the Transbond XT adhesive system ( 3 M Unitek , Monrovia , Calif ) . The teeth were r and omly divided into two groups . In group I , the shear bond strength was measured at a crosshead speed of 5.0 mm/min , and in group II the shear bond strength was measured at a crosshead speed of 0.5 mm/ min . Within half an hour from the initial bonding of each tooth , an occlusogingival load was applied to the bracket , producing a shear force at the bracket-tooth interface . This was accomplished by using the flattened end of a steel rod attached to the crosshead of a Universal Test Machine ( Zwick GmbH & Co , Ulm , Germany ) . The t-test results ( t = 2.71 ) indicated that there was a significant difference ( P = .014 ) in the shear bond strengths between the group tested at a crosshead speed of 5.0 mm/min and the group tested at a crosshead speed of 0.5 mm/min . The mean shear bond strengths for the two groups were 7.0 + /- 4.6 MPa and 12.2 + /- 4.0 MPa , respectively . These findings indicated that it is important to identify the parameters included in shear bond testing in order to enable meaningful comparisons of the performance of different material The purpose of our study was to determine the effect of a 35 % hydrogen peroxide bleaching agent on the shear bond strength of metallic orthodontic brackets . Sixty premolars were r and omly divided into 3 groups of 20 each . Teeth in group A were etched with 37 % phosphoric acid before bonding metallic premolar brackets . Teeth in the other 2 groups were bleached with a 35 % hydrogen peroxide in-office bleaching agent according to the manufacturer 's recommendations . Twenty bleached teeth ( group B ) were bonded immediately , and the other 20 ( group C ) were stored in artificial saliva for 30 days before bonding . Shear bond strength of these brackets was measured on a universal testing machine and recorded in MPa . Adhesive remnant index ( ARI ) scores were determined after the brackets failed . Data were analyzed with analysis of variance ( ANOVA ) and chi-square tests . The shear bond strength values of groups A , B , and C were 12.9 + /- 3.4 , 12.0 + /- 4.6 , and 14.8 + /- 4.0 MPa , respectively . Results of ANOVA showed no statistically significant differences in shear bond strengths between groups ( P > .05 ) . ARI scores were significantly different in all groups . The unbleached group 's failures were primarily at the bracket/adhesive interface , whereas the bleached groups either showed cohesive failures within the adhesive or failed at the adhesive/enamel interface . The results of this study suggest that office bleaching with hydrogen peroxide does not adversely affect the bond strengths of brackets bonded immediately after bleaching or 30 days after bleaching , even though bleaching can result in differences in the failure site The objective of this in vitro bonding study was to evaluate the effectiveness of 2 moisture-insensitive primers , Assure ( Reliance Orthodontic Products , Itasca , Ill ) and MIP ( 3 M Unitek , Monrovia , Calif ) compared with a control hydrophobic primer , Transbond XT ( 3 M Unitek ) . Six groups of 40 premolars were acid etched and bonded using metal orthodontic brackets with the following in vitro protocol s : ( 1 ) Transbond XT primer and adhesive applied to a noncontaminated surface ; ( 2 ) Assure primer applied after saliva contamination ; ( 3 ) MIP primer applied after saliva contamination ; ( 4 ) Assure primer reapplied after saliva contamination ; ( 5 ) MIP reapplied after saliva contamination ; and ( 6 ) Assure adhesive applied after saliva contamination of the primer . All bonded specimens were stored in deionized water at 37 degrees C for 30 days and thermocycled for 24 hours before debonding . Brackets were debonded using a shear-peel load on a testing machine , bond strength was measured in megapascals , and bond failure was analyzed by using the adhesive remnant index . In vitro shear-peel bond strengths were acceptable for all groups , and the bond strengths for Assure and MIP were not significantly affected OUTPUT:
Many studies on in-vitro orthodontic bond strength fail to report test conditions that could significantly affect their outcomes
MS2_dynamic_1_shot411
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: Background and Purpose — A new gait training strategy for patients with stroke seeks to increase walking speed through treadmill training . This study compares the effects of structured speed-dependent treadmill training ( STT ) ( with the use of an interval paradigm to increase the treadmill speed stepwise according to principles of sport physiology ) with limited progressive treadmill training ( LTT ) and conventional gait training ( CGT ) on clinical outcome measures for patients with hemiparesis . Methods — Sixty ambulatory poststroke patients were each r and omly selected to receive 1 of the 3 different gait therapies : 20 subjects were treated with STT , 20 subjects were trained to walk on a treadmill with a 20 % increase of belt speed over the treatment period ( LTT ) , and 20 subjects were treated with CGT . Treatment outcomes were assessed on the basis of overground walking speed , cadence , stride length , and Functional Ambulation Category scores . Results — After a 4-week training period , the STT group scored significantly higher than the LTT and CGT groups for overground walking speed ( STT versus LTT , P < 0.001 ; STT versus CGT , P < 0.001 ) , cadence ( STT versus LTT , P = 0.007 ; STT versus CGT , P < 0.001 ) , stride length ( STT versus LTT , P < 0.001 ; STT versus CGT , P < 0.001 ) , and Functional Ambulation Category scores ( STT versus LTT , P = 0.007 ; STT versus CGT , P < 0.001 ) . Conclusions — Structured STT in poststroke patients result ed in better walking abilities than LTT or CGT . This gait training strategy provides a dynamic and integrative approach for the treatment of gait dysfunction after stroke OBJECTIVE To compare the effects of speed-dependent treadmill training on gait and balance performance in patients with sub-acute stroke . DESIGN Single-blinded r and omized controlled trial . SUBJECTS A total of 26 patients with sub-acute stroke were r and omly assigned to experimental ( n = 13 ) and control ( n = 13 ) groups . METHODS Subjects in the experimental group underwent short interval walking trials with stepwise increases in treadmill speed ( speed-dependent treadmill training ) , following the principles of sprint training . Control subjects received gait training on the treadmill at a steady speed . Gait speed , stride length , cadence , and Berg 's Balance Score were recorded and analysed before and after the 10 training sessions . RESULTS Results of 2-way repeated measures analysis of variance showed significant group × time interactions for gait speed and stride length ( p < 0.05 ) . Within each subject group there were improvements in all gait parameters and Berg ’s Balance Score after the training programme . In addition , the experimental group showed significantly larger increases in gait speed ( mean 0.15 m/s , 95 % confidence interval 0.04–0.26 ) and stride length ( mean 0.16 m , 95 % confidence interval 0.02–0.30 ) than the control subjects . CONCLUSION Speed-dependent treadmill training in patients with sub-acute stroke result ed in larger gains in gait speed and stride length compared with steady speed . The positive findings provide evidence for clinical practice of speed-dependent treadmill training in enhancing gait function after stroke Background — Exercise training reduces the symptoms of chronic heart failure . Which exercise intensity yields maximal beneficial adaptations is controversial . Furthermore , the incidence of chronic heart failure increases with advanced age ; it has been reported that 88 % and 49 % of patients with a first diagnosis of chronic heart failure are > 65 and > 80 years old , respectively . Despite this , most previous studies have excluded patients with an age > 70 years . Our objective was to compare training programs with moderate versus high exercise intensity with regard to variables associated with cardiovascular function and prognosis in patients with postinfa rct ion heart failure . Methods and Results — Twenty-seven patients with stable postinfa rct ion heart failure who were undergoing optimal medical treatment , including & bgr;-blockers and angiotensin-converting enzyme inhibitors ( aged 75.5±11.1 years ; left ventricular [ LV ] ejection fraction 29 % ; & OV0312;o2peak 13 mL · kg−1 · min−1 ) were r and omized to either moderate continuous training ( 70 % of highest measured heart rate , ie , peak heart rate ) or aerobic interval training ( 95 % of peak heart rate ) 3 times per week for 12 weeks or to a control group that received st and ard advice regarding physical activity . & OV0312;o2peak increased more with aerobic interval training than moderate continuous training ( 46 % versus 14 % , P<0.001 ) and was associated with reverse LV remodeling . LV end-diastolic and end-systolic volumes declined with aerobic interval training only , by 18 % and 25 % , respectively ; LV ejection fraction increased 35 % , and pro-brain natriuretic peptide decreased 40 % . Improvement in brachial artery flow-mediated dilation ( endothelial function ) was greater with aerobic interval training , and mitochondrial function in lateral vastus muscle increased with aerobic interval training only . The MacNew global score for quality of life in cardiovascular disease increased in both exercise groups . No changes occurred in the control group . Conclusions — Exercise intensity was an important factor for reversing LV remodeling and improving aerobic capacity , endothelial function , and quality of life in patients with postinfa rct ion heart failure . These findings may have important implication s for exercise training in rehabilitation programs and future studies Low-volume sprint interval training ( SIT ) , or repeated sessions of brief , intense intermittent exercise , elicits metabolic adaptations that resemble traditional high-volume endurance training ( ET ) OUTPUT: Conclusion : High-intensity training is promising as a time-efficient exercise strategy in cardiovascular rehabilitation , but data on endothelial effects in cerebrovascular rehabilitation are warranted . INPUT: Background When people with stroke recover gait speed , they report improved function and reduced disability . However , the minimal amount of change in gait speed that is clinical ly meaningful and associated with an important difference in function for people poststroke has not been determined . Objective The purpose of this study was to determine the minimal clinical ly important difference ( MCID ) for comfortable gait speed ( CGS ) associated with an improvement in the modified Rankin Scale ( mRS ) score for people between 20 to 60 days poststroke . Design This was a prospect i ve , longitudinal , cohort study . Methods The participants in this study were 283 people with first-time stroke prospect ively enrolled in the ongoing Locomotor Experience Applied Post Stroke ( LEAPS ) multi-site r and omized clinical trial . Comfortable gait speed was measured and mRS scores were obtained at 20 and 60 days poststroke . Improvement of ≥1 on the mRS was used to detect meaningful change in disability level . Results Mean ( SD ) CGS was 0.18 ( 0.16 ) m/s at 20 days and 0.39 ( 0.22 ) m/s at 60 days poststroke . Among all participants , 47.3 % experienced an improvement in disability level ≥1 . The MCID was estimated as an improvement in CGS of 0.16 m/s anchored to the mRS . Limitations Because the mRS is not a gait-specific measure of disability , the estimated MCID for CGS was only 73.9 % sensitive and 57.0 % specific for detecting improvement in mRS scores . Conclusions We estimate that the MCID for gait speed among patients with subacute stroke and severe gait speed impairments is 0.16 m/s . Patients with subacute stroke who increase gait speed ≥0.16 m/s are more likely to experience a meaningful improvement in disability level than those who do not . Clinicians can use this reference value to develop goals and interpret progress in patients with subacute stroke Objective : To evaluate the effect of repetitive locomotor training on an electromechanical gait trainer plus physiotherapy in subacute stroke patients . Design : R and omized controlled trial . Setting : Four German neurological rehabilitation centres . Subjects : One hundred and fifty-five non-ambulatory patients ( first-time stroke < 60 days ) . Intervention : Group A received 20 min locomotor training and 25 min physiotherapy ; group B had 45 min physiotherapy every week day for four weeks . Main outcome measures : Primary variables were gait ability ( Functional Ambulation Category , 0 - 5 ) and the Barthel Index ( 0 - 100 ) , blindly assessed at study onset , end , and six months later for follow-up . Responders to the therapy had to become ambulatory ( Functional Ambulation Category 4 or 5 ) or reach a Barthel Index of ≥ 75 . Secondary variables were walking velocity , endurance , mobility and leg power . Results : The intention-to-treat analysis revealed that significantly greater number of patients in group A could walk independently : 41 of 77 versus 17 of 78 in group B ( P B < 0.0001 ) at treatment end . Also , significantly more group A patients had reached a Barthel Index ≥ 75 : 44 of 77 versus 21 of 78 ( P B < 0.0001 ) . At six-month follow-up , the superior gait ability in group A persisted ( 54 of 77 versus 28 of 78 , P B < 0.0001 ) , while the Barthel Index responder rate did not differ . For all secondary variables , group A patients had improved significantly more ( P B < 0.0001 ) during the treatment period , but not during follow-up . Conclusions : Intensive locomotor training plus physiotherapy result ed in a significantly better gait ability and daily living competence in subacute stroke patients compared with physiotherapy alone Background and Purpose — The success of gait rehabilitation after stroke depends on active walking exercises . However , the disabling after-effects of stroke often make such exercises impossible at the onset of therapy . To facilitate treadmill training of paraparetic patients , a robot-driven gait orthosis ( Lokomat ) was developed . We investigated the effects of the Lokomat when used with hemiparetic patients . Methods — The authors conducted a r and omized , controlled pilot study of 30 acute stroke survivors . The treatment group received 30 minutes of robotic training daily and the control group 30 minutes of conventional physiotherapy daily in addition to 30 minutes of conventional physiotherapy for each group . Outcome measures were independence of gait , gait speed , gait parameters , and body tissue composition . Results — After 4 weeks of therapy , the walking ability of the Lokomat group and the control group expressed as the functional ambulation classification was significantly improved . The functional ambulation category ( median± interquartile range ) was at baseline 0±0 in control and 0±1 in the therapy group and increased after therapy to 1±3 in both groups significantly ( P=0.01 ) . There was no significant difference in gain of these parameters between the groups . The Lokomat group had a significantly longer single stance phase ( sec ; mean±SEM ) on the paretic leg when walking on the floor . At baseline , it was 0.19±0.17 and after therapy 0.49±0.07 ( P=0.014 ) . The control group had increased their body weight approximately 1.33±1.40 kg ( mean±SEM ; P=0.046 ) , mostly as fat mass , whereas the Lokomat group had lost fat mass approximately −2.9±1.0 kg ( mean±SEM ; P=0.016 ) and increased their muscle mass approximately 3.36±1.4 kg ( mean± SEM ; P=0.031 ) . Conclusions — This pilot study indicates that Lokomat therapy is a promising intervention for gait rehabilitation . Although there was no difference between groups in gain of functional scores , the Lok OUTPUT:
Mechanically assisted walking with body weight support is more effective than overground walking at increasing independent walking in non-ambulatory patients early after stroke .
MS2_dynamic_1_shot412
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: Objectives : To assess the effectiveness of multidisciplinary rehabilitation in the treatment of fibromyalgia in comparison to st and ard medical care . Methods : Seventy-nine men and women were r and omly assigned to one of two groups . The intervention group consisted of a rheumatologist and physical therapist intake and discharge , 18 group supervised exercise therapy sessions , 2 group pain and stress management lectures , 1 group education lecture , 1 group dietary lecture , and 2 massage therapy sessions . The control group consisted of st and ard medical care with the patients ' family physician . Outcome measures included self-perceived health status , pain-related disability , average pain intensity , depressed mood , days in pain , hours in pain , prescription and nonprescription medication usage , and work status . Outcomes were measured at the end of the 6-week intervention and at 15-month follow-up . Results : Thirty-five out of 43 patients from the intervention group and 36 out of 36 patients from the control group completed the study . There were no statistically significant differences between the 2 groups prior to intervention . Intention-to-treat analysis revealed that the intervention group , in comparison to the control group , experienced statistically significant changes at intervention completion in self-perceived health status , average pain intensity , pain related disability , depressed mood , days in pain , and hours in pain , but no significant differences in nonprescription drug use , prescription drug use , or work status . At 15 months , all health outcomes retained their significance except health status . Nonprescription and prescription drug use demonstrated significant reductions at 15 months . Binary logistic regression indicated that long-term changes in Pain Disability Index were influenced by long-term exercise adherence and income status . Conclusions : Positive health-related outcomes in this mostly unresponsive condition can be obtained with a low-cost , group multidisciplinary intervention in a community-based , non clinical setting Background Massage is increasingly used to manage chronic pain but its benefit has not been clearly established . The aim of the study is to determine the effectiveness of a single session of nurse-administered massage for the short term relief of chronic non-malignant pain and anxiety . Methods A r and omised controlled trial design was used , in which the patients were assigned to a massage or control group . The massage group received a 15 minute manual massage and the control group a 15 minute visit to talk about their pain . Adult patients attending a pain relief unit with a diagnosis of chronic pain whose pain was described as moderate or severe were eligible for the study . An observer blind to the patients ' treatment group carried out assessment s immediately before ( baseline ) , after treatment and 1 , 2 , 3 and 4 hours later . Pain was assessed using 100 mm visual analogue scale and the McGill Pain Question naire . Pain Relief was assessed using a five point verbal rating scale . Anxiety was assessed with the Spielberger short form State-Trait Anxiety Inventory . Results 101 patients were r and omised and evaluated , 50 in the massage and 51 in the control group . There were no statistically significant differences between the groups at baseline interview . Patients in the massage but not the control group had significantly less pain compared to baseline immediately after and one hour post treatment . 95 % confidence interval for the difference in mean pain reduction at one hour post treatment between the massage and control groups is 5.47 mm to 24.70 mm . Patients in the massage but not the control group had a statistically significant reduction in anxiety compared to baseline immediately after and at 1 hour post treatment . Conclusion Massage is effective in the short term for chronic pain of moderate to severe intensity . Trial Registration [ IS RCT N98406653 To evaluate the impact of music on opioid requirements and pain levels during renal lithotripsy using alfentanil patient-controlled analgesia ( PCA ) , we conducted a prospect i ve , blinded , r and omized controlled trial . Patients undergoing lithotripsy were instructed in PCA use and asked to rate their anxiety and select their preferred type of music . They were then premedicated with morphine and ketorolac and r and omly allocated into two groups . Group 1 ( n = 97 ) had music started 10 min before the procedure and maintained until 10 min after its conclusion . Group 2 ( n = 96 ) had music begun at the conclusion of lithotripsy and continued for 10 min . Pain intensity , alfentanil requirement , side effects , quality of analgesia , patient satisfaction , and acceptance of the technique were evaluated . Demographics , alfentanil requirement , pain levels , side effects , quality of analgesia , and patient satisfaction were similar in both groups . The addition of music did not provide any benefit . This result raises the possibility that some nonpharmacologic therapies have minimal impact in setting s where the painful stimulus is moderate to severe and adequate pharmacotherapy is available OBJECTIVE Studies have suggested that the Arthritis Self-Management Program ( ASMP ) course is effective at reducing arthritis pain and health care costs in volunteer participants . There have been no reports of trials of the ASMP in the context of primary care physicians ' practice s , where the potential for spreading the program may be greatest . We conducted a r and omized controlled trial of the ASMP course in a large primary care physician network . METHODS Patients with osteoarthritis , rheumatoid arthritis , or fibromyalgia were recruited for the study . Subjects in the intervention practice s received the 6 week course and those in the control practice s received only the ASMP book , without course . Disability , pain , self-efficacy , mental health , and satisfaction were measured using vali date d instruments at baseline and at 4 months . RESULTS One hundred thirteen patients were recruited for the ASMP course ( intervention ) and completed baseline and 4 month followup question naires . Eighty-four percent completed at least 4 of 6 classes . Seventy-four patients received the ASMP manual ( controls ) and completed both question naires . Patients OUTPUT: In the end , eight controlled trials were included The main results were : • Cognitive-behavioural and sensorial stimulation programs reduce perceived chronic pain . • Interventions based on psycho-education and music therapy programs reduce osteoarticular pain . • Magnetic therapy and guided imagery are interventions that may relieve chronic headache . • An intervention including a physical exercise program in incontinent elderly increases mobility but does not relieve pain , and may even worsen it . Other outcome measures showed an improvement in the quality of life ( sensorial stimulation and guided imagery ) , in depression , disability and empowerment ( music therapy ) and physical functioning ( program of psycho-education ) . INPUT: OBJECTIVES To study the effect of a combination of thalassotherapy , exercise and patient education in people with fibromyalgia . METHODS Patients with fibromyalgia , selected from a rheumatology out-patient department and from members of the Dutch fibromyalgia patient association , were pre-r and omized to receive either 2(1/2 ) weeks of treatment in a Tunisian spa resort , including thalassotherapy , supervised exercise and group education ( active treatment ) or treatment as usual ( control treatment ) . Primary outcome measure was health-related quality of life , measured with the R AND -36 question naire . Secondary measures included the Fibromyalgia Impact Question naire , the McGill Pain Question naire , the Beck Depression Inventory , tender point score and a 6-min treadmill walk test . RESULTS Fifty-eight participants receiving the active treatment reported significant improvement on R AND -36 physical and mental component summary scales . For physical health , differences from the 76 controls were statistically significant after 3 months , but not after 6 and 12 months . A similar pattern of temporary improvement was seen in the self-reported secondary measures . Tender point scores and treadmill walk tests improved more after active treatment , but did not reach significant between-group differences , except for walk tests after 12 months . CONCLUSIONS A combination of thalassotherapy , exercise and patient education may temporarily improve fibromyalgia symptoms and health-related quality of life OBJECTIVES To estimate the cost-effectiveness of an adjuvant treatment course of spa treatment compared with usual care only in patients with fibromyalgia syndrome ( FM ) . METHODS 134 patients with FM , selected from a rheumatology outpatient department and from members of the Dutch FM patient association were r and omly assigned to a 2(1/2 ) week spa treatment course in Tunisia or to usual care only . Results are expressed as quality -adjusted life years ( QALYs ) for a 6-month as well as a 12-month time horizon . Utilities were derived form the Short Form 6D ( SF-6D ) scores and the visual analogue scale ( VAS ) rating general health . Costs were reported from societal perspective . Mean incremental cost per patient and the incremental cost utility ratio ( ICER ) were calculated ; 95 % confidence intervals ( CIs ) were estimated using double-sided bootstrapping . RESULTS The data of 128 ( 55 spa and 73 controls ) of the 134 patients ( 96 % ) could be used for analysis . Improvement in general health was found in the spa group until 6 months of follow-up by both the SF-6D ( AUC 0.32 vs 0.30 , P < 0.05 ) and the VAS ( AUC 0.23 vs 0.19 , P < 0.01 ) . After 1yr no significant between-group differences were found . Mean incremental cost of spa treatment was 1311 Euro per patient ( 95 % CI 369 - 2439 ) , equalling the cost of the intervention ( thalassotherapy including airfare and lodging ) , or 885 Euro per patient based on a more realistic cost estimate . CONCLUSIONS The temporary improvement in quality of life due to an adjuvant treatment course of spa therapy for patients with FM is associated with limited incremental costs per patient Perspectives of patients with fibromyalgia influence their likelihood of participating in r and omized placebo-controlled trials and potentially clash with current , well-established methodology of r and omized controlled trial design . M and ates to use only acetaminophen for breakthrough pain and that require discontinuation of concomitant medications , especially in studies lacking an active comparator arm , could bias a trial cohort to thereby reduce the generalizability of study findings and conclusions . This study evaluates factors affecting willingness to participate in such clinical trials , including the impact of altruism , payment , study duration , forced discontinuation of specific medications , and subject demographics for patients seen by rheumatologists proficient and avidly interested in treating fibromyalgia We aim ed to evaluate the effectiveness of balneotherapy in fibromyalgia management . Fifty women with fibromyalgia under pharmacological treatment were r and omly assigned to either the balneotherapy ( 25 ) or the control ( 25 ) group . Four patients from the balneotherapy group and one patient from the control group left the study after r and omization . The patients in the balneotherapy group ( 21 ) had 2 thermomineral water baths daily for 2 weeks in Tuzla Spa Center . The patients in the control group ( 24 ) continued to have their medical treatment and routine daily life . An investigator who was blinded to the study arms assessed the patients . All patients were assessed four times ; at the beginning of the study , at the end of the 2nd week , the 1st month , and the 3rd month after balneotherapy . Outcome measures of the study were pain intensity , Fibromyalgia Impact Question naire ( FIQ ) , Beck Depression Inventory ( BDI ) , patient ’s global assessment , investigator ’s global assessment , SF-36 scores , and tender point count . Balneotherapy was found to be superior at the end of the cure period in terms of pain intensity , FIQ , Beck Depression Inventory , patient ’s global assessment , investigator ’s global assessment scores , and tender point count as compared to the control group . The superiority of balneotherapy lasted up to the end of the 3rd month , except for the Beck Depression Inventory score and the investigator ’s global assessment score . Significant improvements were observed in PF , GH , and MH subscales of SF-36 during the study period in the balneotherapy group ; however , no such improvement was observed in the control group . Balneotherapy was superior only in VT subscale at the end of therapy and at the end of the third month after the therapy as compared to the controls . It was concluded that balneotherapy provides beneficial effects in patients with fibromyalgia OBJECTIVE To evaluate the feasibility of 8 months of supervised exercise therapy in warm water OUTPUT:
A significant effect on depressive symptoms was not found . The improvements for pain could be maintained at follow-up with smaller effects .
MS2_dynamic_1_shot413
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: BACKGROUND Supplemental oxygen in patients with chronic obstructive pulmonary disease ( COPD ) and exercise hypoxaemia improves exercise capacity and dyspnoea . However , the benefit of oxygen during pulmonary rehabilitation in these patients is still unknown . METHODS Twenty five patients with stable COPD ( mean ( SD ) forced expiratory volume in one second ( FEV1 ) 0.76 ( 0.29 ) l and 30.0 (9.89)% predicted , arterial oxygen tension ( Pao 2 ) 8.46 ( 1.22 ) kPa , arterial carbon dioxide tension ( Paco 2 ) 6.32 ( 1.01 ) kPa ) and significant arterial desaturation on exercise ( 82.0 (10.4)% ) were entered onto a pulmonary rehabilitation programme . Patients were r and omised to train whilst breathing oxygen ( OT ) ( n = 13 ) or air ( AT ) ( n = 12 ) , both at 4 l/min . Assessment s included exercise tolerance and associated dyspnoea using the shuttle walk test ( SWT ) and Borg dyspnoea score , health status , mood state , and performance during daily activities . RESULTS The OT group showed a significant reduction in dyspnoea after rehabilitation compared with the AT group ( Borg mean difference –1.46 ( 95 % CI –2.72 to –0.19 ) ) but there were no differences in other outcome measures : SWT difference –23.6 m ( 95 % CI –70.7 to 23.5 ) , Chronic Respiratory Disease Question naire 3.67 ( 95 % CI –7.70 to 15.1 ) , Hospital Anxiety and Depression Scale 1.73 ( 95 % CI –2.32 to 5.78 ) , and London Chest Activity of Daily Living Scale –2.18 ( 95 % CI –7.15 to 2.79 ) . At baseline oxygen significantly improved SWT ( mean difference 27.3 m ( 95 % CI 14.7 to 39.8 ) and dyspnoea ( –0.68 ( 95 % CI –1.05 to –0.31 ) ) compared with placebo air . CONCLUSIONS This study suggests that supplemental oxygen during training does little to enhance exercise tolerance although there is a small benefit in terms of dyspnoea . Patients with severe disabling dyspnoea may find symptomatic relief with supplemental oxygen Supplemental oxygen improves exercise tolerance of normoxemic and hypoxemic chronic obstructive pulmonary disease ( COPD ) patients . We determined whether nonhypoxemic COPD patients undergoing exercise training while breathing supplemental oxygen achieve higher intensity and therefore improve exercise capacity more than patients breathing air . A double-blinded trial was performed involving 29 nonhypoxemic patients ( 67 years , exercise SaO2 > 88 % ) with COPD ( FEV1 = 36 % predicted ) . All exercised on cycle ergometers for 45 minutes , 3 times per week for 7 weeks at high-intensity targets . During exercise , they received oxygen ( 3 L/minute ) ( n = 14 ) or compressed air ( 3 L/minute ) ( n = 15 ) . Both groups had a higher exercise tolerance after training and when breathing oxygen . However , the oxygen-trained group increased the training work rate more rapidly than the air-trained group . The mean + /- SD work rate during the last week was 62 + /- 19 W ( oxygen-trained group ) and 52 + /- 22 W ( air-trained group ) ( p < 0.01 ) . After training , endurance in constant work rate tests increased more in the oxygen-trained group ( 14.5 minutes ) than in the air-trained group ( 10.5 minutes ) ( p < 0.05 ) . At isotime , the breathing rate decreased four breaths per minute in the oxygen-trained group and one breath per minute in the air-trained group ( p = 0.001 ) . We conclude that supplemental oxygen provided during high-intensity training yields higher training intensity and evidence of gains in exercise tolerance in laboratory testing STUDY OBJECTIVES The slow oxygen uptake ( VO(2 ) ) kinetics observed in COPD patients is a manifestation of skeletal muscle dysfunction of multifactorial origin . We determined whether oxygen supplementation during exercise makes the dynamic VO(2 ) response faster and reduces transient lactate increase . DESIGN Ten patients with severe COPD ( ie , mean [ + /- SD ] FEV(1 ) , 31 + /- 10 % predicted ) and 7 healthy subjects of similar age performed four repetitions of the transition between rest and 10 min of moderate-intensity , constant-work rate exercise while breathing air or 40 % oxygen in r and om order . Minute ventilation ( VE ) , gas exchange , and heart rate ( HR ) were recorded breath-by-breath , and arterialized venous pH , PCO(2 ) , and lactate levels were measured serially . RESULTS Compared to healthy subjects , the time constants ( tau ) for VO(2 ) , HR , carbon dioxide output ( VCO(2 ) ) , and VE kinetic responses were significantly slower in COPD patients than in healthy subjects ( 70 + /- 8 vs 44 + /- 3 s , 98 + /- 14 vs 44 + /- 8 s , 86 + /- 8 vs 61 + /- 4 s , and 81 + /- 7 vs 62 + /- 4 s , respectively ; p < 0.05 ) . Hyperoxia decreased end-exercise E in the COPD group but not the healthy group . Hyperoxia did not increase the speed of OUTPUT: Long term oxygen therapy ( LTOT ) in resting hypoxaemic COPD patients has physiological benefits ( for example , reversal of polycythemia , improved exercise performance , improved neurological status , reduced pulmonary hypertension ) and together with pulmonary rehabilitation may improve health related quality of life (HRQL).2 - 8 Furthermore only LTOT and smoking cessation have been shown to improve survival in patients with COPD .2'3 In a survey of patients with severe COPD treated with LTOT , 50 % did not leave the house ( MRC dyspnoea grade 5 ) and 78 % were breathless while walking around at home and perforning activities of daily living (ADL).9 In advanced COPD , hypoxaemia usually worsens during exercise and induces a transient but marked elevation of pulmonary artery pressure ( PAP ) . Breathing oxygen during exercise produces a small but significant fall of PAP and pulmonary vascular resistance . An attempt to evaluate the efficacy of long term ambulatory oxygen therapy in patients with chronic lung disease on exercise capacity , symptom perception and other relevant measurements of improvement was recently made by a systematic review .11 In this review , 90 abstract s and 17 full text papers were examined but only two trials20'21 investigating the effects of ambulatory oxygen therapy in COPD met the inclusion criteria " 1 and indicated that the treatment of COPD patients with ambulatory domiciliary oxygen therapy failed to show any consistent benefit . There was no clear effect of oxygen therapy on exercise capacity , dyspnoea , HRQL or lung function . One study 20 reported significant improvements in minute ventilation and PaO2 that was not reported by the other.2 ' McDonald et al. 21 concluded that although oxygen supplementation induced some acute increments in exercise performance , such improvements had little impact on patients ' ADL . However their patients did not suffer from severe hypoxaemia and would not have met the criteria for LTOT , unlike the patients of Lilker et al. 20 who concluded that ambulatory oxygen therapy was of INPUT: A prospect i ve , r and omized and controlled study has been performed in 28 patients with severe COPD . A group of 14 has been trained with their lower limbs ( LL ) , while another similar group of 14 patients was also trained with their upper limbs ( UL ) . Results showed improvement in both groups in the endurance test for LL , dyspnea scale , efficiency and muscular working capacity . A considerable improvement was observed in the oxygen uptake at the anerobic threshold ( VO2AT ) which suggests a training effect , expressed through an improvement in exercise tolerance . Only the group who trained UL showed a remarkable improvement in the dyspnea scale , endurance test and maximal static mouth pressure , showing a better intrinsic working capacity and participation of the UL muscles producing those manoeuvres . At the end of training , quality of life was significantly increased and the hospitalization rate was lower in both groups . According to these findings , it is suggested that patients with severe COPD included in training programmes add UL exercises to the LL usually carried out BACKGROUND Supplemental oxygen in patients with chronic obstructive pulmonary disease ( COPD ) and exercise hypoxaemia improves exercise capacity and dyspnoea . However , the benefit of oxygen during pulmonary rehabilitation in these patients is still unknown . METHODS Twenty five patients with stable COPD ( mean ( SD ) forced expiratory volume in one second ( FEV1 ) 0.76 ( 0.29 ) l and 30.0 (9.89)% predicted , arterial oxygen tension ( Pao 2 ) 8.46 ( 1.22 ) kPa , arterial carbon dioxide tension ( Paco 2 ) 6.32 ( 1.01 ) kPa ) and significant arterial desaturation on exercise ( 82.0 (10.4)% ) were entered onto a pulmonary rehabilitation programme . Patients were r and omised to train whilst breathing oxygen ( OT ) ( n = 13 ) or air ( AT ) ( n = 12 ) , both at 4 l/min . Assessment s included exercise tolerance and associated dyspnoea using the shuttle walk test ( SWT ) and Borg dyspnoea score , health status , mood state , and performance during daily activities . RESULTS The OT group showed a significant reduction in dyspnoea after rehabilitation compared with the AT group ( Borg mean difference –1.46 ( 95 % CI –2.72 to –0.19 ) ) but there were no differences in other outcome measures : SWT difference –23.6 m ( 95 % CI –70.7 to 23.5 ) , Chronic Respiratory Disease Question naire 3.67 ( 95 % CI –7.70 to 15.1 ) , Hospital Anxiety and Depression Scale 1.73 ( 95 % CI –2.32 to 5.78 ) , and London Chest Activity of Daily Living Scale –2.18 ( 95 % CI –7.15 to 2.79 ) . At baseline oxygen significantly improved SWT ( mean difference 27.3 m ( 95 % CI 14.7 to 39.8 ) and dyspnoea ( –0.68 ( 95 % CI –1.05 to –0.31 ) ) compared with placebo air . CONCLUSIONS This study suggests that supplemental oxygen during training does little to enhance exercise tolerance although there is a small benefit in terms of dyspnoea . Patients with severe disabling dyspnoea may find symptomatic relief with supplemental oxygen RATIONALE Exercise-induced dynamic hyperinflation contributes to decreased exercise tolerance in chronic obstructive pulmonary disease ( COPD ) . It is unknown whether respiratory retraining ( ventilation-feedback [ VF ] training ) can affect exercise-induced dynamic hyperinflation and increase exercise tolerance . OBJECTIVES To determine whether patients with COPD would achieve longer exercise duration if r and omized to a combination of exercise training plus VF training than either form of training on its own . METHODS A total of 64 patients r and omized to 1 of 3 groups : VF plus exercise ( n = 22 ) , exercise alone ( n = 20 ) , and VF alone ( n = 22 ) . MEASUREMENTS AND MAIN RESULTS Exercise duration before and after 36 training sessions and exercise-induced dynamic hyperinflation and respiratory pattern before and after training were measured . In the 49 patients who completed training , duration of constant work-rate exercise was 40.0 ( + /- 20.4 ) minutes ( mean + /- SD ) with VF plus exercise , 31.5 ( + /- 17.3 ) minutes with exercise alone , and 16.1 ( + /- 19.3 ) minutes with VF alone . Exercise duration was longer in VF plus exercise than in VF alone ( P < 0.0001 ) , but did not reach predetermined statistical significance when VF plus exercise was compared with exercise alone ( P = 0.022 ) ( because of multiple comparisons , P < /= 0.0167 was used for statistical significance ) . After training , exercise-induced dynamic hyperinflation , measured at isotime , in VF plus exercise was less than in exercise alone ( P = 0.014 for between-group changes ) and less than in VF alone ( P = 0.019 for between-group changes ) . After training , expiratory time was longer in VF plus exercise training ( P < 0.001 ) , and it was not significantly changed in the other two groups . CONCLUSIONS The combination of VF plus exercise training decreases exercise-induced dynamic hyperinflation and increases exercise duration more than VF alone . An additive effect to exercise training from VF was not demonstrated by predetermined statistical criteria Supplemental oxygen improves exercise tolerance of normoxemic and hypoxemic chronic obstructive pulmonary disease ( COPD ) patients . We determined whether nonhypoxemic COPD patients undergoing exercise training while breath OUTPUT:
Meta- analysis revealed few clinical ly relevant and statistically significant benefits of " add-on " therapies on exercise performance compared with exercise training .
MS2_dynamic_1_shot414
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: Healing of the extraction socket after tooth removal involves retention of the blood clot followed by a sequence of events that lead to changes in the alveolar process in a three dimensional fashion . This normal healing event results in a minimal loss of vertical height ( around 1 mm ) , but a substantial loss of width in the buccal-lingual plane ( 4 - 6 mm ) . During the first three months following extraction that loss has been shown to be significant and may result in both a hard tissue and soft tissue deformity affecting the ability to restore the site with acceptable esthetics . Procedures that reduce the resorptive process have been shown to be predictable and potentially capable of eliminating secondary surgery for site preparation when implant therapy is planned . The key element is prior planning by the dental therapist to act at the time of extraction to prevent the collapse of the ridge due to the loss of the alveolus . Several techniques have been employed as ridge preservation procedures involving the use of bone grafts , barrier membranes and biologics to provide a better restorative outcome . This review will explore the evidence behind each technique and their efficacy in accomplishing site preparation . The literature does not identify a single technique as superior to others ; however , all accepted therapeutic procedures for ridge preservation have been shown to be more effective than blood clot alone in r and omized controlled studies OBJECTIVE To volumetrically evaluate soft tissue changes of different ridge preservation techniques compared to spontaneous healing 6 months after tooth extraction . MATERIAL S AND METHODS In each of 40 patients , one single-rooted tooth was extracted and four treatment modalities were r and omly assigned to the following groups ( n = 10 each ) : A ) ß-tricalcium-phosphate-particles with a polylactid coating ( ß-TCP ) , B ) demineralized bovine bone mineral with 10 % collagen covered with a collagen matrix ( DBBM-C/CM ) , C ) DBBM with 10 % collagen covered with an autogenous soft tissue punch graft ( DBBM-C/PG ) , D ) spontaneous healing ( control ) . Impressions were obtained before extraction and 6 months later , casts were digitized and volumetric changes at the buccal soft tissues were determined . One-way anova was performed and pair-wise Wilcoxon rank sum test with Bonferroni-Holm method was applied for comparison of differences between two groups . RESULTS After 6 months , horizontal contour changes accounted for -1.7 ± 0.7 mm ( A ) , -1.2 ± 0.5 mm ( B ) , -1.2 ± 0.7 mm ( C ) and -1.8 ± 0.8 mm ( D ) . None of the group comparisons reached statistical significance . CONCLUSIONS Six months after tooth extraction all groups revealed a horizontal volume change in the buccal soft tissue contour . Application of DBBM-C/CM or DBBM-C/PG reduced the amount of volume resorption compared to ß-TCP or spontaneous healing without reaching statistically significant difference PURPOSE This r and omized clinical trial was conducted to assess the safety and effectiveness of the ErhBMP-2 in alveolar bone regeneration as well as preservation of the β-TCP bone graft material that contains ErhBMP-2 . MATERIAL S AND METHODS This study involved 72 patients at the 3 study centers . The patients , who were divided into 2 groups : the experiment group who had ErhBMP-2 coated TCP/HA and the control group who had TCP/HA graft material alone transplanted immediately after tooth extraction . CT was taken before and 3 months after the transplantation and healing status was compared between the two groups . The efficacy endpoints that were used to measure the degree of bone induction included alveolar bone height and 3 measurements of bone width . The paired t test was used to determine the significance of the changes ( P<.05 ) . RESULTS Changes in alveolar bone height were -1.087 ± 1.413 mm in the control group and -.059 ± 0.960 mm in the experimental group ( P<.01 ) . At 25 % extraction socket length [ ESL ] , the changes were 0.006 ± 1.149 mm in the control group and 1.279 ± 1.387 mm in the experimental group . At 50 % ESL , the changes were 0.542 ± 1.157 mm and 1.239 ± 1.249 mm , respectively ( P<.01 for 25 % ESL , and P<.05 for 50 % ESL ) . During the experiment , no adverse reactions to the graft material were observed . CONCLUSION ErhBMP-2 coated β-TCP/HA were found to be more effective in preserving alveolar bone than conventional β-TCP/HA alloplastic bone graft material The aim of the study was to determine the fate of demineralized freeze-dried bone allograft ( DFDBA ) used in conjunction with a barrier membrane in the management of extraction sockets and deficient alveolar ridges , and to compare the amount of bone formed with that found in untreated sites . Ten biopsies were obtained from 8 grafted patients . Five biopsies were harvested from untreated sites during routine implant placement and analyzed for comparison . In the socket management procedure , DFDBA was packed tightly into the socket and covered with an exp and ed polytetrafluoroethylene ( e-PTFE ) membrane . Primary closure was achieved in all cases . In the ridge regeneration procedure , cortical columns were placed in the ridge projecting outward approximately 3 mm to create and maintain space for DFDBA particles packed between them ; the columns were then covered by an e-PTFE membrane . Healing time ranged from 8 to 23 months . At the time of implant placement , bone cores ( 7 mm x 2 mm ) were harvested , fixed OUTPUT: After flapless extraction of teeth , and using a minimum healing period of 12 weeks as a temporal measure , xenografts and allografts result ed in the least loss of socket dimensions compared to alloplasts or sockets with no grafting . Histologic outcomes after a minimum of 12 weeks of healing showed that sockets grafted with alloplasts had the maximum amount of vital bone and the least amount of remnant graft material and remnant connective tissue . There is a limited but emerging body of evidence for the predictable regeneration of deficient buccal bone with socket grafting material s , need for barrier membranes , use of tissue engineering , and use of autogenous soft tissue grafts from the palate to cover the socket INPUT: OBJECTIVES The aim of the following study was to assess contour changes after socket preservation techniques . MATERIAL AND METHODS In five beagle dogs , the distal root of the third and fourth m and ibular premolars was extracted . The following treatments ( Tx ) were r and omly assigned for the extraction socket . Tx 1 : BioOss Collagen . Tx 2 : BioOss Collagen and a free soft tissue graft . Tx 3 : No treatment . Tx 4 : The internal buccal aspect was covered with an experimental collagen membrane , the extraction socket was filled with BioOss Collagen and the membrane folded on top of the graft . Impressions were obtained at baseline , 2 and 4 months after surgery . Bucco-lingual measurements were performed using digital imaging analysis . RESULTS All groups displayed contour shrinkage at the buccal aspect . Only the differences between the two test groups ( Tx 1 , Tx 2 ) and the control group ( Tx 3 ) were significant at the buccal aspect ( p < or = 0.001 ) . No measurements of the Tx 4 group could be performed . CONCLUSION Socket preservation techniques , used in the present experiment , were not able to entirely compensate for the alterations after tooth extraction . Yet , incorporation of BioOss Collagen seems to have the potential to limit but not avoid the post-operative contour shrinkage BACKGROUND Reduction of alveolar height and width after tooth extraction may present problems for implant placement , especially in the anterior maxilla where bone volume is important for biologic and esthetic reasons . Different graft material s have been proposed to minimize the reduction in ridge volume . The aim of this study was to compare radiographic and histomorphometric results of magnesium-enriched hydroxyapatite ( MHA ) and calcium sulfate ( CS ) grafts in fresh sockets after tooth extraction s. METHODS Forty-five fresh extraction sockets with three bone walls were selected in 15 patients . A split-mouth design was used : 15 sockets on the right side of the jaw received MHA , 15 sockets on the left side received CS , and 15 r and om unfilled sockets were considered the control ( C ) group . Intraoral digital radiographs were taken at baseline and at 3 months after graft material placement . At 3 months , cylinder bone sample s were obtained for histology and histomorphometry analysis . RESULTS The difference in mean radiographic vertical bone level from baseline to 3 months was -2.48 + /- 0.65 mm in the CS group , -0.48 + /- 0.21 mm in the MHA group , and -3.75 + /- 0.63 mm in the unfilled C group . Statistically significant differences ( P < 0.05 ) were found between CS and MHA groups and between MHA and C groups . Histologic examination revealed bone formation in all treated sites ; trabecular bone assessment did not differ among apical , mesial , and coronal portions of the specimens . Mean vital bone measurements for CS , MHA , and C groups were 45.0 % + /- 6.5 % , 40.0 % + /- 2.7 % , and 32.8 % + /- 5.8 % , respectively . Statistically significant differences ( P < 0.05 ) were found among all groups . Connective tissue percentages averaged 41.5 % + /- 6.7 % for the CS group , 41.3 % + /- 1.3 % for the MHA group , and 64.6 % + /- 6.8 % for the C group . Statistically significant differences ( P < 0.05 ) were found between CS and C groups and between MHA and C groups . The CS-grafted sockets showed 13.9 % + /- 3.4 % residual implant material , whereas the MHA-treated sockets showed 20.2 % + /- 3.2 % residual material . The difference between the groups was statistically significant ( P < 0.05 ) . CONCLUSIONS Radiographs revealed a greater reduction of alveolar ridge in the CS group than in the MHA group . Histologic examination showed more bone formation and faster resorption in the CS group and more residual implant material in the MHA group BACKGROUND The placement of different graft material s and /or the use of occlusive membranes to cover the extraction socket entrance are techniques aim ed at preserving/reducing alveolar ridge resorption . The use of grafting material s in fresh extraction sockets has , however , been question ed because particles of the grafted material have been found in alveolar sockets 6 - 9 months following their insertion . AIM The aims of the study were to ( i ) . evaluate whether alveolar ridge resorption following tooth extraction could be prevented or reduced by the application of a bioabsorbable polylactide-polyglycolide sponge used as a space filler , compared to natural healing by clot formation , and ( ii ) . evaluate histologically the amount and quality of bone tissue formed in the sockets , 6 months after the use of the bioabsorbable material . MATERIAL AND METHODS Thirty-six patients , undergoing periodontal therapy , participated in this study . All patients were scheduled for extraction of one or more compromised teeth . Following elevation of full-thickness flaps and extraction of teeth , measurements were taken to evaluate the distance between three l and marks ( mesio-buccal , mid-buccal , disto-buccal ) on individually prefabricated stents , and the alveolar crest . Twenty-six alveolar sockets ( test ) were filled with a bioabsorbable polylactide-polyglycolide acid sponge ( Fisiograft ) , while 13 sockets ( controls ) were allowed to heal without any filling material . The flaps were sutured with no attempt to achieve primary closure of the surgical wound . Re-entry for implant surgery was performed 6 months following the extraction s. Thirteen biopsies ( OUTPUT:
The potential benefit of socket preservation therapies was demonstrated result ing in significantly less vertical and horizontal contraction of the alveolar bone crest . The scientific evidence does not provide clear guidelines in regards to the type of bio material , or surgical procedure , although a significant positive effect of the flapped surgery was observed . There are no data available to draw conclusions on the consequences of such benefits on the long-term outcomes of implant therapy
MS2_dynamic_1_shot415
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: In a prospect i ve trial , 222 adults with low-back pain of at least 2 weeks ' duration in a Health Maintenance Organization ( HMO ) were r and omly assigned to usual care ( UC ) , a 4-hour back school psychoeducational session ( LBS ) , or the same back school plus a 1-year “ compliance package ” program design ed to encourage appropriate self-management for back pain ( CP ) . Sixty-four percent of LBS and CP subjects attended their back school sessions . Follow-up measurement of pain level ( using the Visual Analogue Scale ) , functional status ( using the Sickness Impact Profile ) , and various other indicators of health status showed no measurable effect of either treatment condition ( LBS or CP ) compared with UC at 3 , 6 , 12 , and 18 months after entry into the study . Initial disability resolved by 3 months in most patients , and a minority of subjects ( 10–15 % ) showed residual or recurrent functional Impairment 1 year after entry . Health care utilization tended to be slightly higher after intervention In the CP group . With or without follow-up encouragement , back school instructions given in a single 4-hour session had no measurable impact on the comfort or functional status of the majority of patients with new onset back pain in this HMO Design . R and omized prospect i ve study of the effects of three types of active therapy on back muscle function in chronic low back pain patients . Objectives . To quantify the effects of 3 months active therapy on strength , endurance , activation , and fatigability of the back entensor muscles . Summary of Background Data . Many studies have documented an association between chronic low back pain and diminished muscular performance capacity . Few studies have quantified the changes in these measures following interventions using objective measurement techniques or related them to changes in clinical outcome . Methods . A total of 148 individuals ( 57 % women ) with chronic low back pain ( age , 45.0 ± 10.0 years ; duration of low back pain , 10.9 ± 9.5 years ) were r and omized to a treatment that they attended for 3 months : active physiotherapy , muscle reconditioning on devices , or low-impact aerobics . Before and after therapy , assessment s were made of the following : trunk muscle strength ( in flexion , extension , lateral bending , and axial rotation ) , erector spinae activation ( maximal , and during forward bending movements ) , back extensor endurance ( Biering-S/orensen test ) , and erector spinae fatigability ( determined from changes in the median frequency of the surface electromyographic signal ) during isometric and dynamic tests . Results . A total of 132 of 148 patients ( 89 % ) completed the therapy . Isometric strength in each movement direction increased in all groups post-therapy ( P < 0.0008 ) , most notably in the devices group . Activation of the erector spinae during the extension tests also increased significantly in all groups and showed a weak , but significant , relationship with increased maximal strength ( P = 0.01 ) . Pretherapy 55 % of the subjects showed no relaxation of the back muscles at L5 when in the fully flexed position ; no changes were observed in any group post-therapy . Endurance time during the Biering-S/orensen test increased significantly post-therapy in all groups ( P = 0.0001 ) , but there were no significant changes in EMG-determined fatigability . Fatigability of the lumbar muscles at L5 ( EMG median frequency changes ) during the dynamic test increased post-therapy ( P = 0.0001 ) without group differences . Conclusion . Significant changes in muscle performance were observed in all three active therapy groups post-therapy , which appeared to be mainly due to changes in neural activation of the lumbar muscles and psychological changes concerning , for example , motivation or pain tolerance The purpose of this study was to assess the effects of two different treatment modalities on the rehabilitation process of chronic sacroiliac joint patients . The treatment modalities included spinal manipulative therapy given by a chiropractor and a program of back school therapy given by a physiotherapist . The rehabilitation process was assessed using clinical and biomechanical measures . It was found that back school therapy was a better treatment modality than the spinal manipulative therapy , according to the clinical measures of rehabilitation . Precisely the opposite result was found for the biomechanical measures This study investigated the effect of a back school rehabilitation program on lost work time , lost time cost , medical cost , and number of injuries in municipal employees . Seventy back-injured workers who participated in a 6-week back school were compared on the dependent variables with 70 r and omly selected back-injured city employees who had not participated in a back school . Back school participants demonstrated a significant decrease on all dependent variables . Back school participants had significantly fewer injuries in the 6-month postintervention period . No statistically significant differences were found between groups on the time and cost variables . Actual dollars saved in lost time and medical costs between groups was of practical value to the city . Study findings offer support for the back school as a cost-effective measure A clinical trial , aim ed at secondary prevention of low-back pain , was performed in 142 hospital employees reporting at least three annual episodes of this condition . Participants were r and omly assigned to one of three groups : a calisthenics program ( CAL ) for 3 months with biweekly sessions of flexion exercises , a back school program ( 5 sessions ) , and a control group . The effectiveness of the two intervention programs was evaluated over a 1-year period . Baseline preintervention data and evaluation at the end of 3 months of intervention and after an additional 6 months were collected . A monthly surveillance for the whole year showed a mean of 4.5 “ painful months ” in the CAL group versus 7.3 and 7.4 months in the back school and control groups , respectively ( P < 0.0001 ) . The superiority of the CAL group was achieved partly because of the significant increase in trunk forward flexion and to initial increment in abdominal muscle strength . The increased trunk flexion was associated with the rate of participation in the CAL OUTPUT: The results indicate that there is moderate evidence that back schools have better short-term effects than other treatments for chronic low back pain , and that there is moderate evidence that back schools in an occupational setting are more effective compared to ' placebo ' or waiting list controls . REVIEW ER 'S CONCLUSIONS Back schools may be effective for patients with recurrent and chronic low back pain in occupational setting s , but little is known about the cost-effectiveness of back schools INPUT: The purpose of this study was to assess the effects of two different treatment modalities on the rehabilitation process of chronic sacroiliac joint patients . The treatment modalities included spinal manipulative therapy given by a chiropractor and a program of back school therapy given by a physiotherapist . The rehabilitation process was assessed using clinical and biomechanical measures . It was found that back school therapy was a better treatment modality than the spinal manipulative therapy , according to the clinical measures of rehabilitation . Precisely the opposite result was found for the biomechanical measures A clinical trial , aim ed at secondary prevention of low-back pain , was performed in 142 hospital employees reporting at least three annual episodes of this condition . Participants were r and omly assigned to one of three groups : a calisthenics program ( CAL ) for 3 months with biweekly sessions of flexion exercises , a back school program ( 5 sessions ) , and a control group . The effectiveness of the two intervention programs was evaluated over a 1-year period . Baseline preintervention data and evaluation at the end of 3 months of intervention and after an additional 6 months were collected . A monthly surveillance for the whole year showed a mean of 4.5 “ painful months ” in the CAL group versus 7.3 and 7.4 months in the back school and control groups , respectively ( P < 0.0001 ) . The superiority of the CAL group was achieved partly because of the significant increase in trunk forward flexion and to initial increment in abdominal muscle strength . The increased trunk flexion was associated with the rate of participation in the CAL sessions . Further research is needed to answer the question of “ intensity versus type of exercise ” by comparing different intervention programs , with similar intensity Ninety-two chronic low back pain patients were r and omly allocated to two groups to evaluate the effectiveness of a back school compared with an exercise-only regimen according to specified outcome variables . The data from 78 patients with 7 years mean duration of symptoms was analyzed . Three assessment s were made : before treatment and 6 and 16 weeks after treatment . Changes in patients ' levels of pain , functional disability , and other related variables were compared in the two groups . Almost all variables showed an improvement at 6 weeks . At 16 weeks , functional disability and pain levels showed a significant difference . Back school patients continued to make an improvement . This method of managing low back pain makes maximal use of limited re sources and appears to be effective , especially in the longer term The long-term outcome results of inpatient and outpatient treatment of low back pain ( LBP ) were studied in 476 subjects ( aged 35 - 54 , 63 % men ) r and omly assigned to three study groups : in patients ( n = 157 ) , out patients ( n = 159 ) , and controls ( n = 160 ) . The study included changes in the severity of low back pain , grade and disability , compliance with self-care , data on disability pensions , and days of sickness allowance during a 2.5-year follow-up period . These variables were used as outcome criteria . Pain and disability had decreased significantly in the two treated groups up to the 3-month follow-up . LBP was still a little slighter in the in patients at the 1.5-year and 22-month follow-ups , but there were no significant differences between the groups in disability caused by LBP . The refresher programme carried out 1.5 years after the first one did not bring about as clear short-term improvement in pain and disability as the first treatment . During the whole 2.5-year follow-up compliance with self-care was better in the two treated groups , especially in the in patients . Days of sickness allowance had increased somewhat more in the controls than in the in patients during the follow-up . No differences between the groups were found in the number of disability pensions granted Because back pain is a widespread and costly condition that tends to recur , treatment must focus on both the amelioration of acute symptoms and prevention over the long term . This paper reports a longitudinal evaluation of a program from a community hospital that emphasizes both these aspects . One hundred twenty patients routinely admitted to this program were r and omly assigned to treatment and control groups . These groups were assessed for differences in demonstrated physical strength , mobility , body mechanics , and self-care knowledge , and in levels of self-reported exercise , anxiety , and pain . There were significant immediate gains on physical measures of fitness and in observed body mechanics ; patients also reported significant gains in physical capabilities at home and in leisure activities . Self-care knowledge also improved . When assessed one year later , original gains in physical strength and mobility were being maintained , and self-reported physical capabilities also remained high . Although demonstrated knowledge of correct body mechanics declined over this period , it was still significantly greater than before the program . In light of these results , we believe that outpatient programs like the one reported here merit careful consideration in an era of concern about rising costs for primary health care Study Design . Prospect i ve , r and omized trial . Objectives . To compare the McKenzie method of treatment of acute low back pain with patient education in “ mini back school ” after 5 years ; the 1-year results have already been published . Summary of Background Data . The 5-year results after the initial treatment are presented in this study of 89 subjects . Included in the study were 22 women and 67 men with an average age of 39.6 ± 10.5 years ( range 22–66 years ) . Methods . Sixty-two subjects ( 70 % ) were interviewed by telephone , while the remaining 27 subjects ( 30 % ) were examined and interviewed personally . Information of sick leave was obtained from the Swedish National Health Insurance Office . Results . The results showed that subjects who received treatment according to the McKenzie principle 5 years earlier had significantly less recurrences of pain and fewer were on sick leave compared with the subjects who received education in mini back school . The other variables did not show any statistically significant differences . Conclusions . The difference between the two treatments was much less after 5 years compared with the 1-year results BACKGROUND Low back injuries are common and costly , accounting for 15 to 25 percent of injuries covered by workers ' compensation and OUTPUT:
According to the conclusions of the review s there is limited to strong evidence for the effectiveness of back schools for chronic back pain . Summarizing the results of the given evidence based recommendations it is concluded that back schools at work sites and back schools with intensive training is effective . Eine Metaanalyse errechnet große Effekte für Verhaltensänderungen und Kenntnisgewinn , die and ere größere Effekte für Rückenschulen als Teil von umfassenden Rehabilitationsprogrammen , 2 der Expertenkommissionen sehen keine Evidenz für die Wirksamkeit von Rückenschulen , 3 sehen die Wirksamkeit bei akuten Beschwerden bzw .
MS2_dynamic_1_shot416
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: Objectives : To assess the effectiveness of multidisciplinary rehabilitation in the treatment of fibromyalgia in comparison to st and ard medical care . Methods : Seventy-nine men and women were r and omly assigned to one of two groups . The intervention group consisted of a rheumatologist and physical therapist intake and discharge , 18 group supervised exercise therapy sessions , 2 group pain and stress management lectures , 1 group education lecture , 1 group dietary lecture , and 2 massage therapy sessions . The control group consisted of st and ard medical care with the patients ' family physician . Outcome measures included self-perceived health status , pain-related disability , average pain intensity , depressed mood , days in pain , hours in pain , prescription and nonprescription medication usage , and work status . Outcomes were measured at the end of the 6-week intervention and at 15-month follow-up . Results : Thirty-five out of 43 patients from the intervention group and 36 out of 36 patients from the control group completed the study . There were no statistically significant differences between the 2 groups prior to intervention . Intention-to-treat analysis revealed that the intervention group , in comparison to the control group , experienced statistically significant changes at intervention completion in self-perceived health status , average pain intensity , pain related disability , depressed mood , days in pain , and hours in pain , but no significant differences in nonprescription drug use , prescription drug use , or work status . At 15 months , all health outcomes retained their significance except health status . Nonprescription and prescription drug use demonstrated significant reductions at 15 months . Binary logistic regression indicated that long-term changes in Pain Disability Index were influenced by long-term exercise adherence and income status . Conclusions : Positive health-related outcomes in this mostly unresponsive condition can be obtained with a low-cost , group multidisciplinary intervention in a community-based , non clinical setting Background Massage is increasingly used to manage chronic pain but its benefit has not been clearly established . The aim of the study is to determine the effectiveness of a single session of nurse-administered massage for the short term relief of chronic non-malignant pain and anxiety . Methods A r and omised controlled trial design was used , in which the patients were assigned to a massage or control group . The massage group received a 15 minute manual massage and the control group a 15 minute visit to talk about their pain . Adult patients attending a pain relief unit with a diagnosis of chronic pain whose pain was described as moderate or severe were eligible for the study . An observer blind to the patients ' treatment group carried out assessment s immediately before ( baseline ) , after treatment and 1 , 2 , 3 and 4 hours later . Pain was assessed using 100 mm visual analogue scale and the McGill Pain Question naire . Pain Relief was assessed using a five point verbal rating scale . Anxiety was assessed with the Spielberger short form State-Trait Anxiety Inventory . Results 101 patients were r and omised and evaluated , 50 in the massage and 51 in the control group . There were no statistically significant differences between the groups at baseline interview . Patients in the massage but not the control group had significantly less pain compared to baseline immediately after and one hour post treatment . 95 % confidence interval for the difference in mean pain reduction at one hour post treatment between the massage and control groups is 5.47 mm to 24.70 mm . Patients in the massage but not the control group had a statistically significant reduction in anxiety compared to baseline immediately after and at 1 hour post treatment . Conclusion Massage is effective in the short term for chronic pain of moderate to severe intensity . Trial Registration [ IS RCT N98406653 To evaluate the impact of music on opioid requirements and pain levels during renal lithotripsy using alfentanil patient-controlled analgesia ( PCA ) , we conducted a prospect i ve , blinded , r and omized controlled trial . Patients undergoing lithotripsy were instructed in PCA use and asked to rate their anxiety and select their preferred type of music . They were then premedicated with morphine and ketorolac and r and omly allocated into two groups . Group 1 ( n = 97 ) had music started 10 min before the procedure and maintained until 10 min after its conclusion . Group 2 ( n = 96 ) had music begun at the conclusion of lithotripsy and continued for 10 min . Pain intensity , alfentanil requirement , side effects , quality of analgesia , patient satisfaction , and acceptance of the technique were evaluated . Demographics , alfentanil requirement , pain levels , side effects , quality of analgesia , and patient satisfaction were similar in both groups . The addition of music did not provide any benefit . This result raises the possibility that some nonpharmacologic therapies have minimal impact in setting s where the painful stimulus is moderate to severe and adequate pharmacotherapy is available OBJECTIVE Studies have suggested that the Arthritis Self-Management Program ( ASMP ) course is effective at reducing arthritis pain and health care costs in volunteer participants . There have been no reports of trials of the ASMP in the context of primary care physicians ' practice s , where the potential for spreading the program may be greatest . We conducted a r and omized controlled trial of the ASMP course in a large primary care physician network . METHODS Patients with osteoarthritis , rheumatoid arthritis , or fibromyalgia were recruited for the study . Subjects in the intervention practice s received the 6 week course and those in the control practice s received only the ASMP book , without course . Disability , pain , self-efficacy , mental health , and satisfaction were measured using vali date d instruments at baseline and at 4 months . RESULTS One hundred thirteen patients were recruited for the ASMP course ( intervention ) and completed baseline and 4 month followup question naires . Eighty-four percent completed at least 4 of 6 classes . Seventy-four patients received the ASMP manual ( controls ) and completed both question naires . Patients OUTPUT: In the end , eight controlled trials were included The main results were : • Cognitive-behavioural and sensorial stimulation programs reduce perceived chronic pain . • Interventions based on psycho-education and music therapy programs reduce osteoarticular pain . • Magnetic therapy and guided imagery are interventions that may relieve chronic headache . • An intervention including a physical exercise program in incontinent elderly increases mobility but does not relieve pain , and may even worsen it . Other outcome measures showed an improvement in the quality of life ( sensorial stimulation and guided imagery ) , in depression , disability and empowerment ( music therapy ) and physical functioning ( program of psycho-education ) . INPUT: The purpose of this study was to compare the effects of aerobic training with a muscle-strengthening program in patients with fibromyalgia . Thirty women with fibromyalgia were r and omized to either an aerobic exercise ( AE ) program or a strengthening exercise ( SE ) program for 8 weeks . Outcome measures included the intensity of fibromyalgia-related symptoms , tender point count , fitness ( 6-min walk distance ) , hospital anxiety and depression ( HAD ) scale , and short-form health survey ( SF-36 ) . There were significant improvements in both groups regarding pain , sleep , fatigue , tender point count , and fitness after treatment . HAD-depression scores improved significantly in both groups while no significant change occurred in HAD-anxiety scores . Bodily pain subscale of SF-36 and physical component summary improved significantly in the AE group , whereas seven subscales of SF-36 , physical component summary , and mental component summary improved significantly in the SE group . When the groups were compared after treatment , there were no significant differences in pain , sleep , fatigue , tender point count , fitness , HAD scores , and SF-36 scores . AE and SE are similarly effective at improving symptoms , tender point count , fitness , depression , and quality of life in fibromyalgia Background Health and physical capacity are commonly associated with disease , age , and socioeconomic factors . The primary objective of this study was to investigate the degree to which physical capacity , defined as muscle strength and walking ability , is decreased in women with fibromyalgia ( FM ) , as compared to healthy women , who are matched for age and level of education . The secondary aim was to investigate whether muscle strength and walking ability are associated with age , symptom duration , activity limitations and , Body Mass Index ( BMI ) in women with FM and control subjects . Methods This controlled , cross-sectional , multi-center study comprised 118 women with FM and 93 age- and education-level-matched healthy women . The outcome measures were isometric knee-extension force , isometric elbow-flexion force , isometric h and -grip force , and walking ability . Differences between the groups were calculated , and for the women with FM analyses of correlations between the measures of physical capacity and variables were performed . Results The women with FM showed 20 % ( p < 0.001 ) lower isometric knee-extension force , 36 % ( p < 0.001 ) lower isometric elbow-flexion force , 34 % ( p < 0.001 ) lower isometric h and -grip force , and 16 % lower walking ability ( p < 0.001 ) , as compared to the healthy controls . All measures of muscle strength in women with FM showed significant weak to moderate relationship to symptom duration ( rs = − 0.23–0.32 ) and walking ability ( rs = 0.25–0.36 ) . Isometric knee-extension force correlated with activity limitations , as measured using the SF-36 Physical function subscale ( rs=0.23 , p = 0.011 ) . Conclusions Physical capacity was considerably decreased in the women with FM , as compared to the age- and education-level-matched control group . All measures of physical capacity showed a significant association with symptom duration . Knee-extension force and walking ability were significantly associated with activity limitations , age , and BMI . It seems important to address this problem and to target interventions to prevent decline in muscle strength . Assessment s of muscle strength and walking ability are easy to administer and should be routinely carried out in the clinical setting for women with FM.Trial registration Clinical Trials.gov identification number : NCT01226784 , Oct 21 , 2010 OBJECTIVE To test the hypothesis that autonomic modulation after resistance exercise ( RE ) would be reduced in women with fibromyalgia ( FM ) compared with controls . DESIGN Before-after trial . SETTING Testing occurred in a university setting . PARTICIPANTS Women with FM ( n=9 ) and healthy controls ( n=9 ) underwent testing before ( pre ) and 20 minutes after ( post ) RE . INTERVENTIONS Not applicable . MAIN OUTCOME MEASURES Normalized low-frequency ( LFnu ) and normalized high-frequency ( HFnu ) oscillations and the LFnu/HFnu ratio were indicative of sympathetic modulation , parasympathetic modulation , and sympathovagal balance , respectively . Baroreceptor reflex sensitivity ( BRS ) was also measured . RESULTS Variables were similar in both groups at rest . HFnu decreased in controls ( pre , 55.0+/-4.2 % ; post , 35.0+/-4.7 % ; P<.05 ) and increased in women with FM ( pre , 57.0+/-5.7 % ; post , 63.2+/-4.6 % ; P<.05 ) . LFnu increased in controls ( pre , 43.3+/-4.4 % ; post , 63.2+/-4.8 % ; P<.05 ) and decreased in women with FM ( pre , 41.8+/-5.6 % ; post , 35.6+/-4.7 % ; P<.05 ) . The LFnu/HFnu ratio increased in controls ( pre , 0.89+/-0.17 ; post , 2.43+/-0.64 ; P<.05 ) with no change in women with FM ( pre , 0.90+/-0.22 ; post , 0.64+/-0.13 ; P=.13 ) . BRS decreased in controls ( pre , 8.78+/-1.42 ms/mmHg ; post , 5.49+/-0.66 ms/mmHg ; P<.05 ) , but not in women with FM ( pre , 5.91+/-1.22 ms/mmHg ; post , 9.23+/-2.4 ms/mmHg ; P=.16 ) . CONCLUSIONS After acute RE , women with FM responded differently from controls , demonstrated by lower sympathetic and higher vagal modulation without altering BRS . These postexercise responses may be attributed OUTPUT:
Conclusion The main results included reduction in pain , fatigue , number of tender points , depression , and anxiety , with increased functional capacity and quality of life .
MS2_dynamic_1_shot417
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: Background Older people are at increased risk of drug-related problems ( DRPs ) caused by inappropriate use or underuse of medications which may be increased during care transitions . Objective To examine the effects of applying a vali date d prescribing appropriateness criteria -set during medication review in a cohort of older ( ≥65 years ) Australians at the time of discharge from hospital . Setting Private hospital and homes of older patients in Sydney , Australia . Methods Cognitively well English speaking patients aged 65 years or over taking five or more medications were recruited . A prescribing appropriateness criteria -set and SF-36 health-related quality of life health ( HRQoL ) survey were applied to all patients at discharge . Patients were then r and omly assigned to receive either usual care ( control , n = 91 ) or discharge medication counselling and a medication review by a clinical pharmacist ( intervention , n = 92 ) . Medication review recommendations were sent to the general practitioners of intervention group patients . All patients were followed up at 3 months post discharge , where the prescribing appropriateness criteria -set was reapplied and HRQoL survey repeated . Main outcome measures change in the number of prescribing appropriateness criteria met ; change in HRQoL ; number and causes of DRPS identified by medication review ; intervention patient medication recommendation implementation rates . Results There was no significant difference in the number of criteria applicable and met in intervention patients , compared to control patients , between follow-up and discharge ( 0.09 ≤ p ≤ 0.97 ) . While the difference between groups was positive at follow-up for SF-36 scores , the only domain that reached statistical significance was that for vitality ( p = 0.04 ) . Eighty-eight intervention patient medication review s identified 750 causes of DRPs ( 8.5 ± 2.7 per patient ) . No causes of DRPs were identified in four patients . Of these causes , 76.4 % ( 573/750 ) were identified by application of the prescribing appropriateness criteria -set . GPs implemented a relatively low number ( 42.4 % , 318/750 ) of recommendations . Conclusion Application of a prescribing appropriateness criteria -set during medication review in intervention patients did not increase the number of criteria met , nor result in a significant improvement in HRQoL. Higher recommendation implementation rates may require additional facilitators , including a higher quality of collaboration Aim : To measure the outcomes of a harmonised , structured pharmaceutical care programme provided to elderly patients by community pharmacists . Method : A r and omised , controlled , longitudinal , clinical trial with repeated measures was performed over an 18‐month period , involving community pharmacies ( 5 intervention and 5 control ) in Northern Irel and . Elderly , ambulatory patients ( ≥ 65 years ) , taking 4 or more prescribed medications were eligible for participation . Patients attending an intervention pharmacy received education on medical conditions , implementation of compliance strategies , rationalising of drug regimens and appropriate monitoring ; patients attending control sites received normal services . A battery of clinical , humanistic and economic outcomes were assessed . Results : A significantly higher proportion of intervention patients were compliant at the end of the 18‐month study and experienced fewer problems with medication compared to control patients ( P < 0.05 ) . There was little impact on quality of life and health care utilisation . Conclusions : Pharmaceutical care provision to community‐dwelling patients result ed in an improvement in medication compliance and evidence of cost‐savings . Future pharmaceutical care studies may benefit from a more focussed selective approach to data collection and outcomes measurement Abstract Objective : To determine whether a pharmacist can effectively review repeat prescriptions through consultations with elderly patients in general practice . Design : R and omised controlled trial of clinical medication review by a pharmacist against normal general practice review . Setting : Four general practice s. Participants : 1188 patients aged 65 or over who were receiving at least one repeat prescription and living in the community . Intervention : Patients were invited to a consultation at which the pharmacist review ed their medical conditions and current treatment . Main outcome measures : Number of changes to repeat prescriptions over one year , drug costs , and use of healthcare services . Results : 590 ( 97 % ) patients in the intervention group were review ed compared with 233 ( 44 % ) in the control group . Patients seen by the pharmacist were more likely to have changes made to their repeat prescriptions ( mean number of changes per patient 2.2 v 1.9 ; difference=0.31 , 95 % confidence interval 0.06 to 0.57 ; P=0.02 ) . Monthly drug costs rose in both groups over the year , but the rise was less in the intervention group ( mean difference £ 4.72 per 28 days , −£7.04 to -£2.41 ) ; equivalent to £ 61 per patient a year . Intervention patients had a smaller rise in the number of drugs prescribed ( 0.2 v 0.4 ; mean difference −0.2 , −0.4 to −0.1 ) . There was no evidence that review of treatment by the pharmacist affected practice consultation rates , outpatient consultations , hospital admissions , or death rate . Conclusions : A clinical pharmacist can conduct effective consultations with elderly patients in general practice to review their drugs . Such review results in significant changes in patients ' drugs and saves more than the cost of the intervention without affecting the workload of general practitioners . What is already known on this topic Review of patients on long term drug treatment is important but is done inadequately Evidence from the United States shows that pharmacists can improve patient care by review ing drug treatment What this study adds Consultations with a clinical pharmacist are an effective method of review ing the drug treatment of older patients Review by a pharmacist results in more drug changes and lower prescribing costs than normal care plus a much higher review rate Use of healthcare services by patients is not Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of OUTPUT: Overall , there was no significant difference in HRQoL and healthcare costs between pharmacist-provided medication review and usual care . WHAT IS NEW AND CONCLUSION Humanistic and economic outcomes of pharmacist-provided medication review were largely similar to those of usual care . INPUT: Background Since drug-related emergency department ( ED ) visits are common among older adults , the objectives of our study were to identify the frequency of drug-related problems ( DRPs ) among patients presenting to the ED with non-specific complaints ( NSC ) , such as generalized weakness and to evaluate responsible drug classes . Methods Delayed type cross-sectional diagnostic study with a prospect i ve 30 day follow-up in the ED of the University Hospital Basel , Switzerl and . From May 2007 until April 2009 , all non-trauma patients presenting to the ED with an Emergency Severity Index ( ESI ) of 2 or 3 were screened and included , if they presented with non-specific complaints . After having obtained complete 30-day follow-up , two outcome assessors review ed all available information , judged whether the initial presentation was a DRP and compared their judgment with the initial ED diagnosis . Acute morbidity ( “ serious condition ” ) was allocated to individual cases according to predefined criteria . Results The study population consisted of 633 patients with NSC . Median age was 81 years ( IQR 72/87 ) , and the mean Charlson comorbidity index was 2.5 ( IQR 1/4 ) . DRPs were identified in 77 of the 633 cases ( 12.2 % ) . At the initial assessment , only 40 % of the DRPs were correctly identified . 64 of the 77 identified DRPs ( 83 % ) fulfilled the criteria “ serious condition ” . Polypharmacy and certain drug classes ( thiazides , antidepressants , benzodiazepines , anticonvulsants ) were associated with DRPs . Conclusion Elderly patients with non-specific complaints need to be screened systematic ally for drug-related problems . Trial Registration Clinical Trials.gov : Trialists and epidemiologists often employ different terminology to refer to biases in r and omized trials and observational studies , even though many biases have a similar structure in both types of study . We use causal diagrams to represent the structure of biases , as described by Cochrane for r and omized trials , and provide a translation to the usual epidemiologic terms of confounding , selection bias , and measurement bias . This structural approach clarifies that an explicit description of the inferential goal -the intention-to-treat effect or the per- protocol effect-is necessary to assess risk of bias in the estimates . Being aware of each other 's terminologies will enhance communication between trialists and epidemiologists when considering key concepts and methods for causal inference Background Team based care has been used internationally to improve the delivery of best practice primary health care . The WentWest General Practice Pharmacist Project , involving the integration of pharmacists within general practice teams , was commissioned to improve medication management of general practice patients . A particular focus of the project was the performance of medication review to allow the detection and resolution of drug related problems ( DRPs ) . Objective The objectives of this 6-month study ( October 2016–March 2017 ) were to : ( 1 ) identify and classify the DRPs detected as a result of pharmacist activities within a general practice primary care setting . ( 2 ) compare the number of pharmacist recommendations and GP acceptance rates as a result of pharmacist patient consultations across multiple general practice sites . Setting 15 general practice primary care sites in Western Sydney NSW Australia . A multi-centre prospect i ve observational study conducted over a 6-month period from October 2016 to March 2017 . Main outcome measure Drug-related problems ( DRPs ) . Results Six pharmacists recorded the results from 493 patient consultations . The pharmacists identified 1124 DRPs and made 984 recommendations , of which 685 ( 70 % ) were recorded as accepted by the GP . Conclusion Pharmacists have a valuable role to play in the detection and resolution of DRP as part of the general practice team Background The magnitude of safety risks related to medications of the older adults has been evidence d by numerous studies , but less is known of how to manage and prevent these risks in different health care setting s. The aim of this study was to coordinate re sources for prospect i ve medication risk management of home care clients ≥ 65 years in primary care and to develop a study design for demonstrating effectiveness of the procedure . Methods Health care units involved in the study are from primary care in Lohja , Southern Finl and : home care ( 191 consented clients ) , the public healthcare center , and a private community pharmacy . System based risk management theory and action research method was applied to construct the collaborative procedure utilizing each profession ’s existing re sources in medication risk management of older home care clients . An inventory of clinical measures in usual clinical practice and systematic review of rigorous study design s was utilized in effectiveness study design . Discussion The new coordinated medication management model ( CoMM ) has the following 5 stages : 1 ) practical nurses are trained to identify clinical ly significant drug-related problems ( DRPs ) during home visits and report those to the clinical pharmacist . Clinical pharmacist prepares the cases for 2 ) an interprofessional triage meeting ( 50–70 cases/meeting of 2 h ) where decisions are made on further action , e.g. , more detailed medication review s , 3 ) community pharmacists conduct necessary medication review s and each patients ’ physician makes final decisions on medication changes needed . The final stages concern 4 ) implementation and 5 ) follow-up of medication changes . R and omized controlled trial ( RCT ) was developed to demonstrate the effectiveness of the procedure . The developed procedure is feasible for screening and review ing medications of a high number of older home care clients to identify clients with severe DRPs and provide interventions to solve them utilizing existing primary care re sources .Trial registration The study is registered in the Clinical Trials.gov ( NCT02545257 ) . Registration date September 9 2015 Abstract Background : Increased life expectancy is associated with an increased prevalence of chronic diseases and drug consumption . Changes often occur in the medication regimen after hospitalization . OUTPUT:
This review will provide an exhaustive view of medication management models that could be effective for polymedicated , home-dwelling older adults and will allow us to analyze their impact on managing and preventing MRPs .
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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: Background Impairment-based exercise programs have yielded only small to moderate benefits in reducing pain and improving function in people with knee osteoarthritis ( OA ) . It has previously been proposed that adding agility and perturbation training to exercise programs for people with knee OA may improve treatment effects for pain and function . Objective The purpose of this study was to examine the effectiveness of adding agility and perturbation techniques to st and ard exercise therapy compared with the st and ard exercise program alone for people with knee OA . Design This was a single-blinded r and omized controlled trial . Setting The study was conducted in the outpatient physical therapy clinic of a large , university-based health center . Participants One hundred eighty-three people with knee OA ( 122 women , 61 men ) participated . Interventions Participants were r and omly assigned to either a group that received agility and perturbation training with st and ard exercise therapy or a group that received only the st and ard exercise program . Measurements The outcome measures were self-reported knee pain and function , self-reported knee instability , a performance-based measure of function , and global rating of change . Results Although both groups exhibited improvement in self-reported function and in the global rating of change at the 2- , 6- , and 12-month follow-up periods , there were no differences between groups on these outcomes . There was no reduction in knee pain or improvement in performance-based function in either group . Limitations It is possible that more-intense application of the interventions or application of the interventions to participants with knee OA who were at greater risk for falling may have yielded additive effects of the agility and perturbation training approach . Conclusions Both intervention groups exhibited improvement in self-reported function and the global rating of change . Our results , however , did not support an additive effect of agility and perturbation training with st and ard exercise therapy in our sample of individuals with knee OA . Further study is needed to determine whether there are subgroups of individuals who might achieve an added benefit with this approach STUDY OBJECTIVES To underst and reasons for compliance and non-compliance with a home based exercise regimen by patients with osteoarthritis of the knee . DESIGN A qualitative study , nested within a r and omised controlled trial , examining the effectiveness of physiotherapy in reducing pain and increasing mobility in knee osteoarthritis . In the intervention arm , participants undertook a series of simple exercises and repositioning of the kneecap using tape . In depth interviews were conducted with a subset of participants in the intervention arm using open ended questions , guided by a topic schedule , to encourage patients to describe their experiences and reflect on why they did or did not comply with the physiotherapy . Interviews were audiotaped , fully transcribed and analysed thematically according to the method of constant comparison . A model explaining factors influencing compliance was developed . SETTING Patients were interviewed at home . The study was nested within a pragmatic r and omised controlled trial . PARTICIPANTS Twenty participants in the intervention arm of the r and omised trial were interviewed three months after they had completed the physiotherapy programme . Eight were interviewed again one year later . MAIN RESULTS Initial compliance was high because of loyalty to the physiotherapist . Reasoning underpinning continued compliance was more complex , involving willingness and ability to accommo date exercises within everyday life , the perceived severity of symptoms , attitudes towards arthritis and comorbidity and previous experiences of osteoarthritis . A necessary precondition for continued compliance was the perception that the physiotherapy was effective in ameliorating unpleasant symptoms . CONCLUSIONS Non-compliance with physiotherapy , as with drug therapies , is common . From the patient 's perspective , decisions about whether or not to comply are rational but often can not be predicted by therapists or research ers . Ultimately , this study suggests that health professionals need to underst and reasons for non-compliance if they are to provide supportive care and trialists should include qualitative research within trials whenever levels of compliance may have an impact on the effectiveness of the intervention In recent years quality of life instruments have been featured as primary outcomes in many r and omized trials . One of the challenges facing the investigator using such measures is determining the significance of any differences observed , and communicating that significance to clinicians who will be applying the trial results . We have developed an approach to elucidating the significance of changes in score in quality of life instruments by comparing them to global ratings of change . Using this approach we have established a plausible range within which the minimal clinical ly important difference ( MCID ) falls . In three studies in which instruments measuring dyspnea , fatigue , and emotional function in patients with chronic heart and lung disease were applied the MCID was represented by mean change in score of approximately 0.5 per item , when responses were presented on a seven point Likert scale . Furthermore , we have established ranges for changes in question naire scores that correspond to moderate and large changes in the domains of interest . This information will be useful in interpreting question naire scores , both in individuals and in groups of patients participating in controlled trials , and in the planning of new trials Background : In patients with knee osteoarthritis ( OA ) , there is a prominent loss in proprioception and kinesthesia sensation compared with control subjects of the same age and gender . Objectives : The aim of this study is the investigation of short-term clinical effects of kinesthesia and balance exercises in patients with knee OA . Methods : This 8-week study was conducted on 66 female patients with knee OA who were r and omized into 2 groups . The first group received kinesthesia and balance exercises ( such as retrowalking , walking on their toes , leaning to the sides , balance board exercises , minitrampoline exercises , plyometric exercises , and so on ) in addition to strengthening exercises . The second group received only strengthening exercises . Results : Statistically significant improvements were observed postexercise for both groups with respect to baseline for WOMAC , SF-36 Form , times for performing activities of daily living , isokinetic quadriceps muscle strength , and proprioceptive sensation levels . OUTPUT: Proprioceptive exercises are efficacious in the treatment of knee OA . There is some evidence to indicate the effectiveness of proprioceptive exercises compared to general strengthening exercises in functional outcomes INPUT: The purpose of this study was to determine the efficacy of a home-based kinesthesia , balance and agility ( KBA ) exercise program to improve symptoms among persons age ≥ 50 years with knee osteoarthritis ( OA ) . Forty-four persons were r and omly assigned to 8-weeks , 3 times per week KBA , resistance training ( RT ) , KBA + RT , or Control . KBA utilized walking agility exercises and single-leg static and dynamic balancing . RT used elastic resistance b and s for open chain lower extremity exercises . KBA + RT performed selected exercises from each technique . Control applied inert lotion daily . Outcomes included the OA specific WOMAC Index of Pain , Stiffness , and Physical Function ( PF ) , community activity level , exercise self-efficacy , self-report knee stability , and 15 m get up & go walk ( GUG ) . Thirty-three participants [ 70.7 ( SD 8.5 ) years ] completed the trial . Analysis of variance comparing baseline , mid-point , and follow-up measures revealed significant ( p < 0.05 ) improvements in WOMAC scores among KBA , RT , KBA + RT , and Control , with no differences between groups . However , Control WOMAC improvements peaked at mid-point , whereas improvement in the exercise conditions continued at 8-weeks . There were no significant changes in community activity level . Only Control improved exercise self-efficacy . Knee stability was improved in RT and Control . GUG improved in RT and KBA+RT . These results indicate that KBA , RT , or a combination of the two administered as home exercise programs are effective in improving symptoms and quality of life among persons with knee OA . Control results indicate a strong placebo effect in the short term . A combination of KBA and RT should be considered as part of the rehabilitation program , but KBA or RT alone may be appropriate for some patients . Studies with more statistical power are needed to confirm or refute these results . Patient presentation , preferences , costs , and convenience should be considered when choosing an exercise rehabilitation approach for persons with knee OA OBJECTIVE To compare the efficacy of aquatic exercise and a l and -based exercise programme vs control in patients with knee osteoarthritis . METHODS Primary outcome was change in pain , and in addition Knee Injury and Osteoarthritis Outcome Score question naire ( KOOS ) . St and ing balance and strength was also measured after and at 3-month follow-up . Seventy-nine patients ( 62 women ) , with a mean age of 68 years ( age range 40 - 89 years ) were r and omized to aquatic exercise ( n = 27 ) , l and -based exercise ( n = 25 ) or control ( n = 27 ) . RESULTS No effect was observed immediately after exercise cessation ( 8 weeks ) . At 3-month follow-up a reduction in pain was observed only in the l and -based exercise group compared with control ( -8.1 mm , ( 95 % confidence interval -15.4 to -0.4 ; p = 0.039 ) , but no differences between groups were observed for KOOS ; and no improvement following aquatic exercise . Eleven patients reported adverse events ( i.e. discomfort ) in l and -based exercise , while only 3 reported adverse events in the aquatic exercise . CONCLUSION Only l and -based exercise showed some improvement in pain and muscle strength compared with the control group , while no clinical benefits were detectable after aquatic exercise compared with the control group . However , aquatic exercise has significantly less adverse effects compared with a l and -based programme PURPOSE Individuals with osteoarthritis can experience difficulty walking and poor strength , possibly leading to falls and fractures . Exercise has been found to increase strength and bone mineral density . The purpose of this study was to determine the effects of 6 months of t'ai chi on knee muscle strength , bone mineral density , and fear of falling in older women with osteoarthritis . METHODS Eighty-two ( 82 ) women with osteoarthritis , recruited from outpatient clinics and community health centers , were r and omly assigned to either a t'ai chi group and took part in a t'ai chi program , or a control group . Of these , 30 subjects ( mean age = 63 years ) in the t'ai chi group and 35 ( mean age = 61 years ) in the control group completed post-test measures at 6 months . RESULTS After the 6-month study period , subjects in the t'ai chi program had significantly greater knee extensor endurance ( pre- to post-test mean increase = 36.4 W/kg , versus 1.1 W/kg for the controls ) , and significantly greater bone mineral density in the neck of the proximal femur ( mean change = 0.09 , versus -0.10 for the controls ) , Ward 's triangle ( mean change = 0.04 , versus -0.04 for the controls ) , and trochanter ( mean change = 0.07 , versus -0.05 for the controls ) than the controls . However , knee extensor and flexor strength did not differ significantly between the groups . The fear of falling during daily activities reduced significantly more in the t'ai chi group ( mean change = -2.40 , versus 0.66 for the controls ) . CONCLUSIONS T'ai chi increased knee extensor muscle endurance and bone mineral density in older women with osteoarthritis , and decreased their fear of falling during daily activities . Further study with long-term follow-up is needed to substantiate the role of t'ai chi exercise in the prevention of fall and its related fracture The aim of this study was to evaluate effects of electrical stimulation combined with continuous passive motion ( CPM – ES ) versus isometric exercise on symptoms , functional capacity , quality of life , muscle strength , knee and thigh circle measurements , and balance in knee osteoarthritis ( OA ) . This is a r and omized clinical trial . The study was done in Gulhane Military Medical Academy ( GMMA ) Rehabilitation Center . Forty patients with OUTPUT:
CONCLUSION strength training , Tai Chi and aerobics exercises improved balance and falls risk in older individuals with knee OA , while water-based exercises and light treatment did not significantly improve balance outcomes . Strength training , Tai Chi and aerobics exercises can therefore be recommended as falls prevention strategies for individuals with OA .
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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: BACKGROUND Patients with heart failure are a growing population within cardiac rehabilitation . The purpose of this study was to compare , through a single-centre , parallel-group , r and omized controlled trial , the effects of Nordic walking and st and ard cardiac rehabilitation care on functional capacity and other outcomes in patients with moderate to severe heart failure . METHODS Between 2008 and 2009 , 54 patients ( aged 62.4 ± 11.4 years ) with heart failure ( mean ejection fraction = 26.9 % ± 5.0 % ) were r and omly assigned to st and ard cardiac rehabilitation care ( n = 27 ) or Nordic walking ( n = 27 ) ; both groups performed 200 to 400 minutes of exercise per week for 12 weeks . The primary outcome , measured after 12 weeks , was functional capacity assessed by a 6-minute walk test ( 6MWT ) . RESULTS Compared with st and ard care , Nordic walking led to higher functional capacity ( Δ 125.6 ± 59.4 m vs Δ 57.0 ± 71.3 m travelled during 6MWT ; P = 0.001 ) , greater self-reported physical activity ( Δ 158.5 ± 118.5 minutes vs Δ 155.5 ± 125.6 minutes ; P = 0.049 ) , increased right grip strength ( Δ 2.3 ± 3.5 kg vs Δ 0.3 ± 3.1 kg ; P = 0.026 ) , and fewer depressive symptoms ( Hospital Anxiety and Depression Scale score = Δ -1.7 ± 2.4 vs Δ -0.8 ± 3.1 ; P = 0.014 ) . No significant differences were found for peak aerobic capacity , left-h and grip strength , body weight , waist circumference , or symptoms of anxiety . CONCLUSIONS Nordic walking was superior to st and ard cardiac rehabilitation care in improving functional capacity and other important outcomes in patients with heart failure . This exercise modality is a promising alternative for this population Background Exercise training has now become established practice in patients with chronic heart failure . Women are often under-represented in intervention studies compared to men . For this reason it was our aim to conduct a combined endurance and muscle strength training program to evaluate its effect on clinical performance data and health-related psychosocial factors in women and men . Methods One hundred and sixteen women , mean age 69 ± 9 years , body mass index ( BMI ) 25.8 ± 4.9 , and 169 men , mean age 66 ± 9 years , BMI 26.6 ± 3.6 underwent combined endurance/resistance training . The training program lasted 29 ± 7 days and comprised bicycle ergometer training , a 6-min walk test as a training unit and muscle strength training for the lower and upper extremities . Results Differences between women and men were found in clinical parameters . In particular , statistically significant differences were revealed between the women and men with regard to cardiopulmonary performance . Quality of life was significantly improved on discharge with regard to both physical and mental health , whereas anxiety and depression showed no significant alteration . Conclusion A specialized in-hospital program for women and men combining endurance/resistance training and education is feasible . But our program revealed a very low level of cardiopulmonary performance in women . Women need to be encouraged and motivated to participate in such programs Exercise is now considered an important component of management in chronic heart failure ( CHF ) , but little is known about central hemodynamic changes that occur during different exercise modalities in these patients . Seventeen patients ( ejection fraction 25 + /- 2 % ) undertook brachial artery and right heart catheterization and oxygen consumption assessment at rest , during submaximal and peak cycling ( Cyc ) , and during submaximal upper and lower limb resistance exercise . Cardiac output ( CO ) increased relative to baseline during peak Cyc ( P < 0.05 ) but did not change during submaximal Cyc or upper or lower limb exercise . Heart rate ( HR ) was lowest during upper limb exercise and progressively increased during lower limb exercise , submaximal Cyc , and peak Cyc , with significant differences between each of these ( P < 0.01 ) . Conversely , stroke volume ( SV ) decreased during submaximal Cyc and lower limb exercise and was lower during peak and submaximal Cyc and lower limb exercise than during upper limb exercise ( P < 0.05 ) . CHF patients are dependent on increases in HR to increase CO during exercise when SV may decline . Resistance exercise , performed at appropriate intensity , induces a similar hemodynamic burden to aerobic exercise in patients with CHF Background : In chronic heart failure ( CHF ) , cardiac cachexia is often associated with the terminal stage of this disease . In animal studies it has been demonstrated that myostatin , a key regulator of skeletal muscle mass , is elevated in advanced stages of this syndrome . Design : The aim of the present study was to investigate the expression of myostatin in patients with late stage CHF ( NYHA IIIb ) in comparison to healthy subjects . Furthermore the effects of physical exercise on myostatin were analyzed . Methods : Twenty-four patients were either r and omized to a sedentary control group ( CHF-S ) or exercise training ( CHF-E ) . At baseline and after 12 weeks mRNA and myostatin protein in the peripheral skeletal muscle as well as myostatin serum concentration were measured . Furthermore 12 age-matched healthy men were compared to all patients at baseline ( HC ) . Results : CHF patients showed a two-fold increase of myostatin mRNA ( p = 0.05 ) and a 1.7-fold ( p = 0.01 ) augmentation of protein content in skeletal muscle compared to healthy subjects . In late-stage CHF , exercise training led to a 36 % reduction of the mRNA and OUTPUT: Subgroup analysis revealed that AE reduced LVEDV ( − 10.21 ml ; P = 0.007 , I2 = 0 % ) , while RT and combined RT and AE had no effect on LVEDV compared with control participants . RT results in a greater gain in V̇O2$$ \dot{\mathrm{V}}{\mathrm{O}}_2 $ $ peak , and induces no deleterious effects on cardiac function in HF patients INPUT: PURPOSE We evaluated the value of resistance training on measures of physical performance in disabled older women with coronary heart disease ( CHD ) . METHODS The study intervention consisted of a 6-month program of resistance training in a r and omized controlled trial format . Training intensity was at 80 % of the single-repetition maximal lift . Control patients performed light yoga and breathing exercises . Study participants included 42 women with CHD , all > or= 65 yr of age and community dwelling . Subjects were screened by question naire to have low self-reported physical function . The primary study measurements related to the performance of 16 household activities of the Continuous Scale Physical Functional Performance test ( CSPFP ) . These ranged from dressing , to kitchen and cleaning activities , to carrying groceries and walking onto a bus with luggage , and a 6-min walk . Activities were measured in time to complete a task , weight carried during a task , or distance walked . Other measures included body composition , measures of aerobic fitness and strength , and question naire-based measures of physical function and depression score . RESULTS Study groups were similar at baseline by age , aerobic capacity , strength , body composition , and in performing the CSPFP . After conditioning , 13 of 16 measured activities were performed more rapidly , or with increased weight carried , compared with the control group ( all P < 0.05 ) . Maximal power for activities that involved weight-bearing over a distance , increased by 40 % ( P < 0.05 ) . CONCLUSIONS Disabled older women with CHD who participate in an intense resistance-training program improve physical capacity over a wide range of household physical activities . Benefits extend beyond strength-related activities , as endurance , balance , coordination , and flexibility all improved . Strength training should be considered an important component in the rehabilitation of older women with CHD Gremeaux V , Deley G , Duclay J , Antoine D , Hannequin A , Casillas JM : The 200-m fast-walk test compared with the 6-min walk test and the maximal cardiopulmonary test : A pilot study . Objective : The 200-m fast-walk test has been proposed as a high- intensity performance test in healthy , elderly subjects . Adaptation of low-risk coronary artery disease patients during this test were compared with those in a 6-min walk test and a maximal cardiopulmonary exercise test . Design : Thirty patients with stable coronary artery disease ( 51.9 ± 8.7 yrs ) , referred to the cardiac rehabilitation department , performed a cardiopulmonary exercise test , then a 200-m fast-walk test and a 6-min walk test in a r and om order , before and after the training period ( 6 wks , 3 days per week ) . Heart rate was monitored during each test . Peak workload of cardiopulmonary exercise test , distance walked on the 6-min walk test , and time to perform the 200-m fast-walk test were measured . A sub sample of ten patients performed the exercise test with gas exchange measurements , with ventilatory threshold determination . Results : All subjects completed walk tests without complaint or incidents . Compared with the cardiopulmonary exercise test , the cardiac relative intensity was higher during the 200-m fast-walk test than during the 6-min walk test , both before ( 89.6 % vs. 78.1 % of cardiopulmonary exercise test maximal heart rate ; P < 0.05 ) and after ( 83.8 % vs. 74.3 % ; P < 0.05 ) training . Among the sub sample of ten patients , the 200-m fast-walk test heart rate was significantly higher than the ventilatory threshold heart rate , which did not differ from the 6-min walk test heart rate . The 200-m fast-walk test time significantly decreased after training ( −9.1 % , P < 0.01 ) . Conclusion : In patients with coronary artery disease at low risk , the 200-m fast-walk test explores higher levels of cardiorespiratory capacity than the 6-min walk test . Thus , this could be a useful field test in complement to the cardiopulmonary exercise test to assess functional capacity improvement and up date training targets regularly during the course of high-intensity rehabilitation programs in this population The 6-minute walk test is used in clinical practice and clinical trials of lung diseases ; however , it is not clear whether replicate tests need to be performed to assess performance . Furthermore , little is known about the impact of walking course layout on test performance . We conducted 6-minute walks on 761 patients with severe emphysema ( mean + /- SD FEV1 % predicted = 26.3 + /- 7.2 ) who were participants in the National Emphysema Treatment Trial . Four hundred seventy participants had repeated walks on a separate day . The second test was improved by an average of 7.0 + /- 15.2 % ( 66.1 + /- 146 feet , p < 0.0001 , by paired t test ) , with an intraclass correlation coefficient of 0.88 between days . The course layout had an effect on the distance walked . Participants tested on continuous ( circular or oval ) courses had a 92.2-foot longer walking distance than those tested on straight ( out and back ) courses . Course length had no significant effect on walking distance . The training effect found in these patients with severe emphysema is less than in previous reports of patients with chronic obstructive pulmonary disease . Furthermore , the layout of the track may influence the 6-minute walk performance OBJECTIVE To estimate the minimal clinical ly important difference ( MCID ) for the 6-minute walk test ( 6MWT ) and the 200-m fast-walk test ( FWT ) in patients with coronary artery disease ( CAD ) during a cardiac rehabilitation program . DESIGN Prospect i ve study using distribution- and anchor-based methods . SETTING Out patients from a cardiac rehabilitation unit . PARTICIPANTS Stable patients with CAD ( N=81 ; 77 men ; mean±SD age , 58.1±8.7y OUTPUT:
Qualitative analysis indicated moderate evidence for repeatability of the 6MWT in patients undergoing cardiac rehabilitation , for a 2 % to 8 % learning effect between repeated 6MWTs , for a relationship between peak heart rate during the 6MWT and during cycle exercise at the ventilatory threshold , and for moderate-to-high correlation between the 6-minute walk distance and maximum metabolic equivalents achieved on symptom-limited exercise tests . Strong evidence suggests that the 6MWT is responsive to clinical change following cardiac rehabilitation .
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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: Background No proof of efficacy , in the form of a r and omized controlled trial ( RCT ) , exists to support pulsed radiofrequency ( PRF ) treatment of the dorsal root ganglion ( DRG ) for chronic lumbar radicular ( CLR ) pain . We determined the feasibility of a larger trial ( primary objective ) , and also explored the efficacy of PRF in decreasing pain on a visual analog scale ( VAS ) and improving the Oswestry Disability Index . Methods This was a single-center , placebo-controlled , triple-blinded RCT . Patients were r and omized to a placebo group ( needle placement ) or a treatment group ( PRF at 42 ° C for 120 seconds to the DRG ) . Patients were followed up for 3 months post procedure . Outcomes with regard to pain , Oswestry Disability Index score , and side effects were analyzed on an intention-to-treat basis . Results Over 15 months , 350 potential patients were identified and 56 were assessed for eligibility . Fifteen of them did not meet the selection criteria . Of the 41 eligible patients , 32 ( 78 % ) were recruited . One patient opted out before intervention . Three patients were lost to follow-up at 3 months . Mean VAS differences were not significantly different at 4 weeks ( −0.36 , 95 % confidence interval [ CI ] , −2.29 , 1.57 ) or at 3 months ( −0.76 , 95 % CI , −3.14 , 1.61 ) . The difference in mean Oswestry Disability Index score was also not significantly different at 4 weeks ( −2 % , 95 % CI , −14 % , 10 % ) or 3 months ( −7 % , 95 % CI , −21 % , 6 % ) . There were no major side effects . Six of 16 patients in the PRF group and three of 15 in the placebo group showed a > 50 % decrease in VAS score . Conclusion The recruitment rate was partially successful . At 3 months , the relative success of PRF-DRG was small . A large-scale trial to establish efficacy is not practically feasible considering the small effect size , which would necessitate recruitment of a challengingly large number of participants over a number of years . Until clear parameters for application of PRF are established , clinicians will need to use their individual judgment regarding its clinical applicability , given the present evidence Study Design . A prospect i ve double-blind r and omized trial in 28 patients . Objectives . To assess the clinical effect of percutaneous intradiscal radiofrequency thermocoagulation for reducing pain , functional disability , and physical impairment in patients with chronic discogenic low back pain . Summary of Background Data . Chronic discogenic low back pain is a challenging problem in western countries . A treatment option is radiofrequency heating of the affected disc . Its clinical efficacy has never been formally tested in a controlled trial . Methods . Twenty-eight patients with a history of at least 1 year of chronic low back pain were selected on the basis of a diagnostic anesthetization of the lower intervertebral discs . Only patients with one putative painful level were selected and r and omly assigned to one of two treatment groups . Each patient in the radiofrequency treatment group ( n = 13 ) received a 90-second 70 C lesion of the intervertebral disc . Patients in the control group ( n = 15 ) underwent the same procedure , but without use of radiofrequency current . Both the treating physician and the patients were blinded to the group assignment . Before treatment , physical impairment , rating of pain , the degree of disability , and quality of life were assessed by a blinded investigator . Results . Eight weeks after treatment , there was one success in the radiofrequency group ( n = 13 ) and two in the control group ( n = 15 ) . The adjusted and unadjusted odds ratio was 0.5 and 1.1 , respectively ( not significant ) . Also , visual analog scores for pain , global perceived effect , and the Oswestry disability scale showed no differences between the two groups . Conclusions . Percutaneous intradiscal radiofrequency thermocoagulation ( 90 seconds , 70 C ) is not effective in reducing chronic discogenic low back pain Background and aims Facet joint denervation is a frequently performed technique to treat facet joint syndrome . Most often this technique is used under fluoroscopic guidance implicating high radiation doses for both patients and surgeons . This prospect i ve study was performed to evaluate the effectiveness in reducing radiation dose during radiofrequency ablation therapy of the lumbar facet joints and to evaluate the feasibility and possibilities of the new real time image guidance system Sabre Source ™ . Material s and methods As much as 20 consecutive patients with radiofrequency ablation therapy of the facet joints L4 to S1 were included . Ten patients were treated by fluoroscopic control alone ; the following 10 patients were treated with the Sabre Source ™ image guidance system . A total of 40 thermal ablations to the facet joints were performed . Each patient was given one thermal ablation on both sides of the vertebral segment , either to the facet joints of L4–L5 or of L5–S1 . Pain , according to the visual analogue scale ( VAS ) , was documented before and 6 h after the intervention . Radiation dose , time of radiation and the number of shots needed to place the radiofrequency cannula were recorded . Results No complications occurred . Before therapy , the mean VAS in all patients was 7.6 ( range 6–10 ) . After therapy the mean VAS in all patients was 3.4 ( range 0–5 ) . Compared to the fluoroscopy-guided thermal ablation therapy the Sabre Source ™ system significantly reduced the number of fluoroscopy exposures ( reduction 23.53 % , p = 0.02 ) , the time of radiation exposure ( reduction 21.2 % , p = 0.03 ) and the mean entrance surface dose ( reduction 30.46 % , p = 0.01 ) . Conclusion The Sabre Source System reduces radiation expos OUTPUT: The review authors found no high- quality evidence suggesting that RF denervation provides pain relief for patients with CLBP . Similarly , we identified no convincing evidence to show that this treatment improves function . INPUT: Study Design . Prospect i ve longitudinal study with a minimum 2-year follow-up . Objective . To assess the long-term outcome of a group of patients with chronic discogenic low back pain who had failed to improve with comprehensive nonoperative care and who were subsequently treated with intradiscal electrothermal therapy ( IDET ) . Summary of Background Data . Previous reports of patient outcomes at 1 year after IDET have demonstrated statistically significant improvement . Methods . The study group comprised 58 patients with chronic symptoms of more than 6 months who failed to improve with nonoperative care and subsequently underwent IDET . VAS pain scores , SF-36 scores , and sitting tolerance times were collected pretreatment and at 6 , 12 , and 24 months . Results . Mean duration of pre-IDET symptoms was 60.7 months . The minimum follow-up at data collection was 24 months . The study group ( n = 58 ) demonstrated a significant improvement in pain as demonstrated by statistically significant improvement in VAS scores and bodily pain SF-36 scores . The IDET-treated group demonstrated a significant improvement in physical function as noted by statistically significant improvement in sitting tolerance times and physical function SF-36 scores . Bodily pain and physical function scores demonstrated significant improvement between the 1- and 2-year observation points . Additionally , quality of life improvement was demonstrated by a statistically significant improvement in all the SF-36 subscales . Conclusions . A cohort of patients with chronic discogenic low back pain who had failed to improve with comprehensive nonoperative care demonstrated a statistically significant improvement in pain , physical function , and quality of life at 2 years after IDET BACKGROUND Numerous pre clinical and clinical studies have reported on the use of platelet concentrates to promote tissue healing . The results in spinal fusion applications are limited and controversial . PURPOSE The purpose of the current prospect i ve clinical cohort study is to assess the effect of Autologous Growth Factors ( AGF ) on lumbar interbody fusion with specific attention paid to determination of clinical and radiographic outcomes . STUDY DESIGN / SETTING Prospect i ve clinical study PATIENT SAMPLE C and i date s for anterior-posterior lumbar fusion with diagnosis of degenerative disc disease and /or up to grade I spondylolytic spondylolisthesis based on positive provocative discography . OUTCOME MEASURES Clinical ( visual analogue pain scale/functional outcome assessment ) and radiographic outcomes ( fusion on computed tomography at 6 months and plain radiographs at 12 and 24 months ) . METHODS Thirty-seven patients were assigned to st and ard anterior-posterior interbody fusion L2-S1 ( single or two-level ) using iliac crest bone graft ( autograft group : 22 patients with 32 levels operated ) or allograft combined with autogenous growth factors ( AGF group : 15 patients with 25 levels operated ) . Radiographic outcomes were collected at 6 months postsurgery with computed tomography and at 12 and 24 months with plain radiographs . Pre- and postoperative clinical outcome measures included visual analog scores ( VAS ) for back and leg pain ( 0 - 10 ) , SF-36 scores , and Oswestry disability determination . Average clinical and radiographic follow-up for the autograft group was 24.3+/-5.6 months ( 12 - 36 months ) and AGF was 25.7+/-7.5 ( 6 - 40 months ) . RESULTS Fusion incorporation at each end plate was determined at 56 % in both autograft and AGF ( p = NS ) patients based on computed tomography at 6 months with minimal subsidence noted and no direct correlation between the incidence or degree of cage subsidence and bone graft technique . The 12- and 24-month radiographic results confirmed an 85 % arthrodesis rate for the autograft patients , whereas the AGF patients had an 89 % fusion rate ( p = NS ) . Clinical outcomes were similar for both groups and no significant differences were noted for pain or functional outcome improvements . CONCLUSIONS AGF combined with an allograft carrier is equivalent in radiographic and clinical outcomes to autograft in one- or two-level lumbar interbody fusion with supplemental posterior fixation and , thus , eliminates any morbidity from iliac crest bone graft harvesting . AGF combined with an appropriate carrier is a reasonable alternative to autograft and expensive bone induction technologies . Further research is still required to examine the optimum carriers , preparation and formulation , and platelet concentrations for this technology Study Design . A prospect i ve double-blind r and omized trial in 28 patients . Objectives . To assess the clinical effect of percutaneous intradiscal radiofrequency thermocoagulation for reducing pain , functional disability , and physical impairment in patients with chronic discogenic low back pain . Summary of Background Data . Chronic discogenic low back pain is a challenging problem in western countries . A treatment option is radiofrequency heating of the affected disc . Its clinical efficacy has never been formally tested in a controlled trial . Methods . Twenty-eight patients with a history of at least 1 year of chronic low back pain were selected on the basis of a diagnostic anesthetization of the lower intervertebral discs . Only patients with one putative painful level were selected and r and omly assigned to one of two treatment groups . Each patient in the radiofrequency treatment group ( n = 13 ) received a 90-second 70 C lesion of the intervertebral disc . Patients in the control group ( n = 15 ) underwent the same procedure , but without use of radiofrequency current . Both the treating physician and the patients were blinded to the group assignment . Before treatment , physical impairment , rating of pain , the degree of disability , and quality of life were assessed by a blinded investigator . Results . Eight weeks after treatment , there was one success in the radiofrequency group ( n = 13 ) and two in the control group ( n = 15 ) . The adjusted and unadjusted odds ratio was 0.5 and 1.1 , respectively OUTPUT:
RESULTS The results of this review confirm and help quantify the significant differences that existed in the terminology and all the areas of diagnosis and treatment of presumed discogenic pain . Our findings show that suspected discogenic pain , despite its extensive affirmation in the literature and enormous re sources regularly devoted to it , currently lacks clear diagnostic criteria and uniform treatment or terminology
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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: PURPOSE / OBJECTIVES To evaluate the effects of 10 weeks of aerobic exercise on depressive and anxiety symptoms and self-esteem of breast cancer survivors . DESIGN Experimental , crossover . SETTING Midwestern university town . SAMPLE Twenty-four breast cancer survivors ( mean time following surgery 41.8 months ; ranging from 1 to 99 months ) recruited via mail and cancer support groups . The mean age of the sample was 48.9 years . METHODS Subjects were assigned r and omly into exercise ( EX ) , exercise-plus-behavior modification ( EX + BM ) , and control groups . EX and EX + BM groups exercised aerobically four days/week at > or = 60 % of age-predicted maximum heart rate for 10 weeks . Data were collected pretest , post-test , and crossover ( 12 weeks following post-test ) . Because pretest or post-test scores showed no statistical differences between EX and EX + BM groups , data were combined to form one group . MAIN RESEARCH VARIABLES Aerobic exercise ( four days/ week ; 30 - 40 minutes/session ) , depression , ( Beck Depression inventory ) , anxiety ( Speilberger State-Trait Anxiety Inventory ) , and self-esteem ( Rosenberg Self-Esteem Inventory ) . FINDINGS Pre- to post-test analyses revealed that women who exercised had significantly less depression and state and trait anxiety over time compared to controls . After the crossover , the control group demonstrated comparable improvements in both depressive and state anxiety scores . Self-esteem did not change significantly . Subjects who received exercise recommendations from their physicians exercised significantly more than subjects who received no recommendation . CONCLUSIONS Mild to moderate aerobic exercise may be of therapeutic value to breast cancer survivors with respect to depressive and anxiety symptoms but not to self-esteem . A physician 's recommendation to exercise appears to be an important factor in a patient 's exercise adherence . IMPLICATION S FOR NURSING PRACTICE To Improve depressive and anxiety symptoms following breast cancer surgery , healthcare professionals should consider recommending mild to moderate exercise Goals of workProstate cancer patients receiving and rogen deprivation therapy ( ADT ) are vulnerable to a number of potentially debilitating side effects , which can significantly impact quality of life . The role of alternate therapies , such as physical activity ( PA ) , in attenuating these side effects is largely understudied for such a large population . Thus , the purpose of this study was to investigate the effects of PA intervention for men receiving ADT on PA behavior , quality of life , and fitness measures . Patients and methods One hundred participants were r and omized into an intervention ( n = 53 ) or a wait-list control group ( n = 47 ) , with 11 dropping out of the intervention group and 23 dropping out of the wait-list control group prior to post-testing . The intervention consisted of both an individually tailored home-based aerobic and light resistant training program and weekly group sessions . PA , quality of life , fitness , and physiological outcomes were assessed pre and post the 16-week intervention . Results Significant increases in PA , supported by changes in girth measures and blood pressure , support the beneficial impact of the intervention . Positive trends were also evident for depression and fatigue . However , due to the high dropout rate , these results must be interpreted with caution . Conclusions PA effectively attenuates many of the side effects of ADT and should be recommended to prostate survivors as an alternate therapy . Determining the maintenance of this behavior change will be important for underst and ing how the long-term benefits of increased activity levels may alleviate the late effects of ADT Background : Few studies have evaluated an individualized home-based exercise prescription during and after cancer treatment . Objective : The purpose of this study was to evaluate the effectiveness of a home-based exercise training intervention , the Pro-self Fatigue Control Program on the management of cancer-related fatigue . Interventions / Methods : Participants ( N = 119 ) were r and omized into 1 of 3 groups : group 1 received the exercise prescription throughout the study ; group 2 received their exercise prescription after completing cancer treatment ; and group 3 received usual care . Patients completed the Piper Fatigue Scale , General Sleep Disturbance Scale , Center for Epidemiological Studies -Depression Scale , and Worst Pain Intensity Scale . Results : All groups reported mild fatigue levels , sleep disturbance , and mild pain , but not depression . Using multilevel regression analysis , significant linear and quadratic trends were found for change in fatigue and pain ( ie , scores increased , then decreased over time ) . No group differences were found in the changing scores over time . A significant quadratic effect for the trajectory of sleep disturbance was found , but no group differences were detected over time . No significant time or group effects were found for depression . Conclusions : Our home-based exercise intervention had no effect on fatigue or related symptoms associated with cancer treatment . The optimal timing of exercise remains to be determined . Implication s for Practice : Clinicians need to be aware that some physical activity is better than none , and there is no harm in exercise as tolerated during cancer treatment . Further analysis is needed to examine the adherence to exercise . More frequent assessment s of fatigue , sleep disturbance , depression , and pain may capture the effect of exercise OBJECTIVE To determine the effect of exercise on quality of life in ( a ) a r and omized controlled trial of exercise among recently diagnosed breast cancer survivors undergoing adjuvant therapy and ( b ) a similar trial among post-treatment survivors . METHODS Fifty newly diagnosed breast cancer survivors were recruited through a hospital-based tumor registry and r and omized to a 6-month , home-based exercise program ( n=25 ) or a usual care group ( n=25 ) . In a separate trial , 75 post-treatment survivors were r and omized to a 6-month , supervised exercise intervention ( n=37 ) or to usual care ( n=38 ) . Participants in both studies completed measures OUTPUT: CONCLUSIONS Exercise has modest positive effects on depressive symptoms with larger effects for programs that were supervised or partially supervised , not conducted at home , and at least 30 minutes in duration . IMPACT Our results complement other studies showing that exercise is associated with reduced pain and fatigue and with improvements in quality of life among cancer survivors INPUT: PURPOSE / OBJECTIVES To evaluate the effects of 10 weeks of aerobic exercise on depressive and anxiety symptoms and self-esteem of breast cancer survivors . DESIGN Experimental , crossover . SETTING Midwestern university town . SAMPLE Twenty-four breast cancer survivors ( mean time following surgery 41.8 months ; ranging from 1 to 99 months ) recruited via mail and cancer support groups . The mean age of the sample was 48.9 years . METHODS Subjects were assigned r and omly into exercise ( EX ) , exercise-plus-behavior modification ( EX + BM ) , and control groups . EX and EX + BM groups exercised aerobically four days/week at > or = 60 % of age-predicted maximum heart rate for 10 weeks . Data were collected pretest , post-test , and crossover ( 12 weeks following post-test ) . Because pretest or post-test scores showed no statistical differences between EX and EX + BM groups , data were combined to form one group . MAIN RESEARCH VARIABLES Aerobic exercise ( four days/ week ; 30 - 40 minutes/session ) , depression , ( Beck Depression inventory ) , anxiety ( Speilberger State-Trait Anxiety Inventory ) , and self-esteem ( Rosenberg Self-Esteem Inventory ) . FINDINGS Pre- to post-test analyses revealed that women who exercised had significantly less depression and state and trait anxiety over time compared to controls . After the crossover , the control group demonstrated comparable improvements in both depressive and state anxiety scores . Self-esteem did not change significantly . Subjects who received exercise recommendations from their physicians exercised significantly more than subjects who received no recommendation . CONCLUSIONS Mild to moderate aerobic exercise may be of therapeutic value to breast cancer survivors with respect to depressive and anxiety symptoms but not to self-esteem . A physician 's recommendation to exercise appears to be an important factor in a patient 's exercise adherence . IMPLICATION S FOR NURSING PRACTICE To Improve depressive and anxiety symptoms following breast cancer surgery , healthcare professionals should consider recommending mild to moderate exercise PURPOSE / OBJECTIVES To investigate the feasibility of an exercise program patterned after a phase II cardiac rehabilitation program to improve selected physiologic and psychological parameters of health in patients with cancer . DESIGN Prospect i ve , repeated measures study . SETTING Two major military medical centers in the southwestern United States . SAMPLE 62 patients diagnosed with cancer within the previous two years . Ages ranged from 24 - 83 ( meanX = 59 ) . Half of the participants were male and half were female . Minorities made up 29 % of the sample . Participants had a wide range of cancer diagnoses and all stages of cancer . Fifteen subjects were undergoing treatment when they enrolled in the study . More than half of the subjects exercised prior to their cancer diagnoses , but fewer than half were able to resume an exercise routine following their cancer diagnoses . METHODS Subjects met two days each week for 12 weeks for exercise and education . MAIN RESEARCH VARIABLES Exercise tolerance as measured with a grade d exercise test , activity and sleep patterns as measured with a wrist actigraph , and quality of life ( QOL ) as measured with the Cancer Rehabilitation Evaluation System-Short Form . FINDINGS Significant improvements were observed over time in exercise tolerance , selected activity and sleep patterns , and QOL among the 46 ( 74 % ) subjects who completed the program . CONCLUSIONS Patients with various types and stages of cancer can safely exercise using a cardiac rehabilitation model and can realize significant improvements in exercise tolerance , selected activity and sleep patterns , and QOL . IMPLICATION S FOR NURSING Most people are aware that regular exercise is part of a healthy lifestyle . After cancer diagnosis and treatment , patients experience uncertainty regarding how to resume exercise or how to begin an exercise program as part of their rehabilitation . Participation in a structured exercise program can provide patients with a safe environment within which to exercise at an intensity appropriate to their individual needs PURPOSE S/ OBJECTIVES To test the hypothesis that women participating in a walking exercise program during radiation therapy treatment for breast cancer would demonstrate more adaptive responses as evidence d by higher levels of physical functioning and lower levels of symptom intensity than women who did not participate . DESIGN Experimental , two-group pretest , post-test . SETTING Two university teaching hospital outpatient radiation therapy departments . SAMPLE 46 women beginning a six-week program of radiation therapy for early stage breast cancer . METHODS Following r and om assignment , subjects in the exercise group maintained an individualized , self-paced , home-based walking exercise program throughout treatment . The control group received usual care . Dependent variables were measured prior to and at the end of radiation therapy . In addition , symptoms were assessed at the end of three weeks of treatment . MAIN RESEARCH VARIABLES Participation in the walking exercise program , physical functioning fatigue , emotional distress , and difficulty sleeping . FINDINGS Hypothesis testing by multivariate analysis of covariance , with pretest scores as covariates , indicated significant differences between groups on outcome measures ( p < 0.001 ) . The exercise group scored significantly higher than the usual care group on physical functioning ( p = 0.003 ) and symptom intensity , particularly fatigue , anxiety , and difficulty sleeping . Fatigue was the most frequent and intense subjective symptom reported . CONCLUSIONS A self-paced , home-based walking exercise program can help manage symptoms and improve physical functioning during radiation therapy . IMPLICATION S FOR NURSING PRACTICE Nurse-prescribed and -monitored exercise is an effective , convenient , and low-cost self-care activity that reduces symptoms and facilitates adaptation to breast cancer diagnosis and treatment PURPOSE / OBJECTIVES To examine the effects of a comprehensive rehabilitation program on facilitating physical and psychosocial adaptation of women with breast cancer who are receiving adjuvant chemotherapy . DESIGN Experimental . SETTING Breast evaluation clinics of two OUTPUT:
There is evidence that exercise , such as low intensity aerobics walking , Tai Chi , or cycling , results in an overall decrease in fatigue levels over the course of cancer treatment . Additionally , there is evidence that regular physical activity or exercise can decrease emotional stress , blood pressure , the duration of neutropenia , thrombocytopenia , and pain . Exercise also has been shown to increase quality of life and improve the maximal oxygen uptake during exertion , sleep patterns , and cognition .
MS2_dynamic_1_shot422
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: OBJECTIVE To investigate the efficacy of patellar taping on pain control , patellar alignment , and neuromuscular control ( ie , vastus medialis oblique activation , knee extensor moment , etc ) in subjects with patellofemoral pain syndrome . DATA SOURCES We search ed MEDLINE , SPORT Discus , PEDro , and CINAHL through December 2004 , using the key words patellar taping , therapeutic taping , McConnell taping , taping , chronic injury , patellofemoral pain , and knee . STUDY SELECTION Criteria for inclusion criteria were studies that exclusively recruited patients diagnosed with patellofemoral pain syndrome or anterior knee pain and outcome measures specific to pain reduction , neuromuscular control , and patellar positioning . DATA EXTRACTION We identified and review ed 16 studies with an average PEDro score of 4.25/10 . Articles were divided into 3 categories based on primary outcome measures : 4 r and omized controlled trials on treatment methods and pain , 9 studies on neuromuscular control , and 3 on patellar positioning . DATA SYNTHESIS Although patellar taping seems to reduce pain and improve function in people with patellofemoral pain syndrome during activities of daily living and rehabilitation exercise , strong evidence to identify the underlying mechanisms is still not available BACKGROUND AND PURPOSE Quadriceps strengthening , quadriceps stretching and patellar taping are commonly prescribed together for patellofemoral pain patients . This study aim ed to examine the effectiveness of each of these techniques in isolation for one week and in combination for one week . METHODS A prospect i ve double-blind r and omized control study was design ed involving 41 subjects with 60 knees diagnosed with patellofemoral pain . The knees were r and omized in onto one of four groups ( n = 15 ) : infrapatellar taping , quadriceps strengthening , quadriceps stretching and control . The taping was worn continually for the week ; the strengthening group followed a programme of non-weight-bearing terminal range quadriceps exercises , the stretching group performed rectus femoris stretches . The control group did not receive treatment . All subjects received advice . Seven pre- and post-treatment measures included isokinetic quadriceps strength , quadriceps length , pain measured during four activities and maximum eccentric , posturally controlled , pain-free knee flexion angle during a step-down . Results showed significant changes over time ( p < 0.01 ) in two out of seven measures for the taping group , in five out of seven for the strengthening group and five out of seven for the stretching group and none in the control group . When the three modalities were combined for one week , ( n = 60 ) all seven measures improved significantly ( p < 0.01 ) . CONCLUSION In isolation , quadriceps stretching and quadriceps strengthening result ed in more improvements than taping . Combining these treatments is recommended as the initial approach to treating patellofemoral pain but further individualized more functional , global treatment is essential Abstract Although patellar taping has been shown to reduce pain in participants with patellofemoral pain syndrome , the mechanisms of pain reduction have not completely been established following its application . The purpose of this study was to evaluate EMG activity of vastus medialis and vastus lateralis following the application of patellar taping during a functional single leg squat . Both vastus medialis obliquus – vastus lateralis onset and vastus medialis obliquus/vastus lateralis amplitude of 18 participants with patellofemoral pain syndrome and 18 healthy participants as controls were measured using an EMG unit . This procedure was performed on the affected knee of participants with patellofemoral pain syndrome , before , during , and after patellar taping during unilateral squatting . The same procedure was also performed on the unaffected knees of both groups . The mean values of vastus medialis obliquus – vastus lateralis onset prior to taping ( 2.54 ms , s = 4.35 ) were decreased significantly following an immediate application of tape ( −3.22 ms , s = 3.45 ) and after a prolonged period of taping ( −6.00 ms , s = 3.40 s ) ( P < 0.05 ) . There was also a significant difference between the mean values of vastus medialis obliquus – vastus lateralis onset among controls ( −2.03 ms , s = 6.04 ) and participants with patellofemoral pain syndrome prior to taping ( P < 0.05 ) . However , there were no significant difference between the ranked values of vastus medialis obliquus/vastus lateralis amplitude of the affected and unaffected knees of participants with patellofemoral pain syndrome and controls during different conditions of taping ( P > 0.05 ) . Decreased values of vastus medialis obliquus – vastus lateralis onset may contribute to patellar realignment and explain the mechanism of pain reduction following patellar taping in participants with patellofemoral pain syndrome Background Since knee complaints are common among athletes and are frequently presented in general practice , it is of interest to investigate the type of knee complaints represented in general practice of athletes in comparison with those of non-athletes . Therefore , the aim of this study is to investigate the differences in type of knee complaints between sport participants , in this study defined as athletes , and non-sport participants , defined as non-athletes , presenting in general practice . Further , differences in the initial policy of the GP , medical consumption , and outcome at one-year follow-up were also investigated . Methods Patients consulting their GP for a new episode of knee complaints were invited to participate in this prospect i ve cohort study . From the total HONEUR knee cohort population ( n = 1068 ) we extracted patients who were athletes ( n = 421 ) or non-athletes ( n = 388 ) . Results The results showed that acute distortions of the knee were significantly more diagnosed in athletes than in non-athletes ( p = 0.04 ) . Further , more athlet OUTPUT: There is moderate evidence that ( 1 ) tailored ( customised to the patient to control lateral tilt , glide and spin ) and untailored patellar taping provides immediate pain reduction of large and small effect , respectively and ( 2 ) tailored patellar taping promotes earlier onset of vastus medialis oblique ( VMO ) contraction ( relative to vastus lateralis contraction ) . There is limited evidence that ( 1 ) tailored patellar taping combined with exercise provides superior pain reduction compared to exercise alone at 4 weeks , ( 2 ) untailored patellar taping added to exercise at 3 - 12 months has no benefit and ( 3 ) tailored patellar taping promotes increased internal knee extension moments . CONCLUSIONS Tailoring patellar taping application ( ie , to control lateral tilt , glide and spin ) to optimise pain reduction is important for efficacy . Possible mechanisms behind patellar taping efficacy include earlier VMO onset and improved knee function capacity ( ie , ability to tolerate greater internal knee extension moments ) INPUT: OBJECTIVE To investigate the efficacy of patellar taping on pain control , patellar alignment , and neuromuscular control ( ie , vastus medialis oblique activation , knee extensor moment , etc ) in subjects with patellofemoral pain syndrome . DATA SOURCES We search ed MEDLINE , SPORT Discus , PEDro , and CINAHL through December 2004 , using the key words patellar taping , therapeutic taping , McConnell taping , taping , chronic injury , patellofemoral pain , and knee . STUDY SELECTION Criteria for inclusion criteria were studies that exclusively recruited patients diagnosed with patellofemoral pain syndrome or anterior knee pain and outcome measures specific to pain reduction , neuromuscular control , and patellar positioning . DATA EXTRACTION We identified and review ed 16 studies with an average PEDro score of 4.25/10 . Articles were divided into 3 categories based on primary outcome measures : 4 r and omized controlled trials on treatment methods and pain , 9 studies on neuromuscular control , and 3 on patellar positioning . DATA SYNTHESIS Although patellar taping seems to reduce pain and improve function in people with patellofemoral pain syndrome during activities of daily living and rehabilitation exercise , strong evidence to identify the underlying mechanisms is still not available Objectives Describe proportions of individuals with patellofemoral pain ( PFP ) with an unfavourable recovery over 12 months ; identify clinical predictors of poor recovery at 3 and 12 months ; and determine baseline values of predictors that identify those with poor 12-month prognosis . Methods An observational analysis utilised data from 310 individuals with PFP enrolled in two r and omised clinical trials . Thirteen baseline variables ( participant , PFP , study characteristics ) were investigated for their prognostic ability . Pain , function and global recovery were measured at 3 and 12 months . Multivariate backward stepwise regression analyses ( treatment-adjusted , p<0.10 ) were performed for each follow-up measure . Receiver operator characteristic curves identified cut-points associated with unfavourable recovery at 12 months . Results 55 % and 40 % of participants had an unfavourable recovery at 3 and 12 months , respectively . Longer baseline pain duration was significantly associated with poor 3-month and 12-month recovery on measures of pain severity ( β 11.36 to 24.94 ) , Anterior Knee Pain ( AKP ) Scale ( −4.44 to −11.33 ) and global recovery ( OR : 2.32 to 6.11 ) . Greater baseline pain severity and lower AKP Scale score were significantly associated with poor recovery on multiple measures ( p<0.05 ) . Baseline duration > 2 months and AKP Scale score < 70/100 were associated with unfavourable 12-month recovery . Conclusions A substantial number of individuals with PFP have an unfavourable recovery over 12 months , irrespective of intervention . Knee pain duration > 2 months is the most consistent prognostic indicator , followed by AKP Scale score < 70 . Sports medicine practitioners should utilise interventions with known efficacy in reducing PFP , and promote early intervention to maximise prognosis . Trial registration Australian study : Australian Clinical Trials Registry ( ACTRN012605000463673 ) , Clinical Trials.gov ( NCT00118521 ) ; Dutch study : International St and ard R and omised Controlled Trial Number Register ( IS RCT N83938749 Purpose There is research evidence which supports the effectiveness of exercise in reducing pain and increasing function in patients with patellofemoral pain syndrome . However , what is unclear are the parameters underpinning this intervention . This has led to uncertainty when operationalizing exercises for patients with patellofemoral pain syndrome in clinical practice . The aim of this review was to evaluate the parameters of exercise programs reported in primary research , to provide clinicians with evidence -based recommendations for exercise prescription for patellofemoral pain . Methods A systematic review of r and omized controlled trials was undertaken . Only trials that identified exercise to be effective in treating patellofemoral pain were included . Appropriate data bases and reference lists were search ed using established keywords . Data relating to common exercise parameters such as the type of exercise , length , and frequency of intervention , intensity , repetitions , sets , and specific technique were extracted , along with details of co- interventions that may have been used . Results A total of ten r and omized controlled trials were included in this review and from these trials 14 interventions arms were evaluated . All 14 interventions focused on active exercises , all but two of which also included a passive stretching component . The current body of evidence demonstrates positive results with exercise interventions such as knee extension , squats , stationary cycling , static quadriceps , active straight leg raise , leg press , and step-up and down exercises for patients with patellofemoral pain syndrome . A progressive regime of daily exercises of two to four sets of ten or more repetitions over an intervention period of 6 weeks or more , combined with exercises to address flexibility of the lower limb musculature was commonly used . Conclusion Currently , the primary research on this topic supports the use of closed kinetic chain , strengthening exercises for musculature of the lower limb , combined with flexibility options . The current evidence base supports a prescription of daily exercises of two – four sets of ten or more repetitions over a period of 6 weeks or more Data regarding validity of clinical and radiographic findings in diagnosing patellofemoral pain syndrome are inconclusive . We prospect ively assessed how sensitive and specific key patellofemoral physical examination tests are , and evaluated the prevalence of physical examination and radiographic findings . Sixty-one infantry soldiers with patellofemoral pain syndrome and 25 control subjects were evaluated . The sensitivity of the patellar tilt , active instability , patella alta , and apprehension OUTPUT:
Of the functional tests , squatting demonstrated the highest sensitivity . Other useful tests include pain during stair climbing and prolonged sitting . Conclusion A diagnostic checklist is useful as it provides a structured method for diagnosing AKP in a clinical setting .
MS2_dynamic_1_shot423
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: Background Preliminary studies suggest that physical exercise interventions can improve physical fitness , fatigue and quality of life in cancer patients after completion of chemotherapy . Additional research is needed to rigorously test the effects of exercise programmes among cancer patients and to determine optimal training intensity accordingly . The present paper presents the design of a r and omized controlled trial evaluating the effectiveness and cost-effectiveness of a high intensity exercise programme compared to a low-to-moderate intensity exercise programme and a waiting list control group on physical fitness and fatigue as primary outcomes . Methods After baseline measurements , cancer patients who completed chemotherapy are r and omly assigned to either a 12-week high intensity exercise programme or a low-to-moderate intensity exercise programme . Next , patients from both groups are r and omly assigned to immediate training or a waiting list ( i.e. waiting list control group ) . After 12 weeks , patients of the waiting list control group start with the exercise programme they have been allocated to . Both interventions consist of equal bouts of resistance and endurance interval exercises with the same frequency and duration , but differ in training intensity . Additionally , patients of both exercise programmes are counselled to improve compliance and achieve and maintain an active lifestyle , tailored to their individual preferences and capabilities . Measurements will be performed at baseline ( t = 0 ) , 12 weeks after r and omization ( t = 1 ) , and 64 weeks after r and omization ( t = 2 ) . The primary outcome measures are cardiorespiratory fitness and muscle strength assessed by means of objective performance indicators , and self-reported fatigue . Secondary outcome measures include health-related quality of life , self-reported physical activity , daily functioning , body composition , mood and sleep disturbances , and return to work . In addition , compliance and satisfaction with the interventions will be evaluated . Potential moderation by pre- and post-illness lifestyle , health and exercise-related attitudes , beliefs and motivation will also be assessed . Finally , the cost-effectiveness of both exercise interventions will be evaluated . Discussion This r and omized controlled trial will be a rigorous test of effects of exercise programmes for cancer patients after chemotherapy , aim ing to contribute to evidence -based practice in cancer rehabilitation programmes . Trial registration This study is registered at the Netherl and s Trial Register ( NTR2153 Background : Substantial numbers of cancer patients use complementary medicine therapies , even without a supportive evidence base . This study aim ed to evaluate in a r and omized controlled trial , the use of Medical Qigong ( MQ ) compared with usual care to improve the quality of life ( QOL ) of cancer patients . Patients and methods : One hundred and sixty-two patients with a range of cancers were recruited . QOL and fatigue were measured by Functional Assessment of Cancer Therapy — General and Functional Assessment of Cancer Therapy — Fatigue , respectively , and mood status by Profile of Mood State . The inflammatory marker serum C-reactive protein ( CRP ) was monitored serially . Results : Regression analysis indicated that the MQ group significantly improved overall QOL ( t144 = −5.761 , P < 0.001 ) , fatigue ( t153 = −5.621 , P < 0.001 ) , mood disturbance ( t122 = 2.346 , P = 0.021 ) and inflammation ( CRP ) ( t99 = 2.042 , P < 0.044 ) compared with usual care after controlling for baseline variables . Conclusions : This study indicates that MQ can improve cancer patients ’ overall QOL and mood status and reduce specific side-effects of treatment . It may also produce physical benefits in the long term through reduced inflammation Introduction Numerous primary studies and several review papers have highlighted delayed physical and psychological recovery for survivors of critical illness , often beyond 6 months after discharge . This r and omized controlled trial with blinded assessment aims to test the effects of an 8-week , home-based , individually tailored physical rehabilitation programme on physical and psychological recovery for survivors of a critical illness after discharge from hospital . Method Participants are survivors of a critical illness discharged from nine intensive care units ( ICUs ) in Australia , who are aged 18 years or older , in an ICU longer than 48 hours , discharged home to self-care or carer ( non-institutional care ) , able to participate in physical rehabilitation , and within the hospitals ' local geographical areas for home visits . The study is based in participants ' home environments . Blinded assessment s at weeks 1 , 8 and 26 after hospital discharge examine physical functioning , exercise capacity , health-related quality of life and psychological well being . The intervention is grade d , individualized endurance and strength training prescribed by a pulmonary rehabilitation physiotherapist over an 8-week period , with three home visits , five follow-up phone calls , and a printed exercise manual supporting the training . Initial focus is on lower limb exercises and walking , with warm-up stretches , and progresses to the addition of core stabilization and upper limb exercises . Results The burden of a critical illness is well documented . This novel study will determine whether a home-based physical rehabilitation programme improves the recovery trajectory for survivors of critical illness . The projected sample size of 200 patients aims to detect a clinical ly important 10 % improvement in physical functioning . The study will also examine whether other important physical and psychological measures are improved . Conclusion This multicentre , r and omized controlled trial will examine outcomes that are meaningful to patients , their family and society , namely functional ability and well being . The study will also target a health problem that is likely to increase as the population ages . If the programme is effective , it will provide a model that can be easily adapted and adopted by existing primary care or community services to improve the recovery of individuals following critical illness BACKGROUND Anemia in patients with solid tumors is a common problem that is associated with impaired exercise capacity , increased fatigue , and lower quality of life ( QoL ) . Erythropoiesis-stimulating agents ( ESAs ) have been shown to improve these outcomes ; however , OUTPUT: HRQoL and its domains were measured using a wide range of measures .The results suggested that exercise compared with control has a positive impact on HRQoL and certain HRQoL domains . No conclusions can be drawn regarding the effects of exercise interventions on HRQoL domains of cognitive function , physical functioning , general health perspective , role function , and spirituality . This systematic review indicates that exercise may have beneficial effects on HRQoL and certain HRQoL domains including cancer-specific concerns ( e.g. breast cancer ) , body image/self-esteem , emotional well-being , sexuality , sleep disturbance , social functioning , anxiety , fatigue , and pain at varying follow-up periods . INPUT: Background Patients with acute leukemia experience a substantial symptom burden and are at risk of developing infections throughout the course of repeated cycles of intensive chemotherapy . Physical activity in recent years has been a strategy for rehabilitation in cancer patients to remedy disease and treatment related symptoms and side effects . To date , there are no clinical practice exercise guidelines for patients with acute leukemia undergoing induction and consolidation chemotherapy . A r and omized controlled trial is needed to determine if patients with acute leukemia can benefit by a structured and supervised counseling and exercise program . Methods / design This paper presents the study protocol : Patient Activation through Counseling and Exercise – Acute Leukemia ( PACE-AL ) trial , a two center , r and omized controlled trial of 70 patients with acute leukemia ( 35 patients / study arm ) following induction chemotherapy in the outpatient setting . Eligible patients will be r and omized to usual care or to the 12 week exercise and counseling program . The intervention includes 3 hours + 30 minutes per week of supervised and structured aerobic training ( moderate to high intensity 70 - 80 % ) on an ergometer cycle , strength exercises using h and weights and relaxation exercise . Individual health counseling sessions include a self directed home walk program with a step counter . The primary endpoint is functional performance/exercise capacity ( 6 minute walk distance ) . The secondary endpoints are submaximal VO2 max test , sit to st and and bicep curl test , physical activity levels , patient reported outcomes ( quality of life , anxiety and depression , symptom prevalence , intensity and interference ) . Evaluation of clinical outcomes will be explored including incidence of infection , hospitalization days , body mass index , time to recurrence and survival . Qualitative exploration of patients ’ health behavior and experiences . Discussion PACE-AL will provide evidence of the effect of exercise and health promotion counseling on functional and physical capacity , the symptom burden and quality of life in patients with acute leukemia during out patient management . The results will inform clinical practice exercise guidelines and rehabilitation programs for patients undergoing treatment for acute leukemia . Optimizing the treatment and care pathway may ease the transition for patients from illness to the resumption of everyday activities . Trial registration Clinical Trials.gov Identifier : NCT01404520 Background : Despite thous and s of papers , the value of quality of life ( QoL ) in curing disease remains uncertain . Until now , we lacked tools for the diagnosis and specific treatment of diseased QoL. We approached this problem stepwise by theory building , modelling , an exploratory trial and now a definitive r and omised controlled trial ( RCT ) in breast cancer , whose results we report here . Methods : In all , 200 representative Bavarian primary breast cancer patients were recruited by five hospitals and treated by 146 care professionals . Patients were r and omised to either ( 1 ) a novel care pathway including diagnosis of ‘ diseased ’ QoL ( any QoL measure below 50 points ) using a QoL profile and expert report sent to the patient 's coordinating practitioner , who arranged QoL therapy consisting of up to five st and ardised treatments for specific QoL defects or ( 2 ) st and ard postoperative care adhering to the German national guideline for breast cancer . The primary end point was the proportion of patients in each group with diseased QoL 6 months after surgery . Patients were blinded to their allocated group . Results : At 0 and 3 months after surgery , diseased QoL was diagnosed in 70 % of patients . The QoL pathway reduced rates of diseased QoL to 56 % at 6 months , especially in emotion and coping , compared with 71 % in controls ( P=0.048 ) . Relative risk reduction was 21 % ( 95 % confidence interval ( CI ) : 0–37 ) , absolute risk reduction 15 % ( 95 % CI : 0.3–29 ) , number needed to treat (NNT)=7 ( 95 % CI : 3–37 ) . When QoL therapy finished after successful treatment , diseased QoL often returned again , indicating good responsiveness of the QoL pathway . Conclusion : A three-component outcome system including clinician-derived objective , patient-reported subjective end points and qualitative analysis of clinical relevance was developed in the last 10 years for cancer as a complex intervention . A separate QoL pathway was implemented for the diagnosis and treatment of diseased QoL and its effectiveness tested in a community-based , pragmatic , definitive RCT . While the pathway was active , it was effective with an NNT of 7 PURPOSE The aims of this pilot study were the following : 1 ) to examine patterns of adherence to a brisk walking program in women receiving adjuvant chemotherapy or radiation therapy for newly diagnosed breast cancer using a prospect i ve , r and omized , controlled experimental design ; 2 ) to examine the influence of disease symptoms and treatment side effects on exercise levels ; and 3 ) to suggest methods that may improve future clinical trials of moderate-intensity exercise in similar population s. DESCRIPTION OF STUDY Fifty-two patients with newly diagnosed breast cancer were r and omly assigned to one of two treatment arms : usual care or usual care plus exercise . Those assigned to the exercise group received a st and ardized , self-administered , home-based brisk walking intervention in addition to usual care . Each day subjects completed self-report diary forms that elicited information about activity levels , and the occurrence of symptoms and side effects during cancer treatment . RESULTS Analyses of self-reported daily activity levels revealed a diffusion of treatment effect . Fifty percent of the usual-care group reported maintaining or increasing their physical activity to a moderate-intensity level , while 33 % of the exercise group did not exercise at the prescribed levels . Analyses of self-reported disease symptoms and treatment side effects did not reveal clinical ly meaningful differences between the two groups . CLINICAL IMPLICATION S The results of this study suggest that women who exercised regularly before receiving a breast cancer diagnosis attempted to maintain their exercise programs OUTPUT:
Interventions to promote exercise in cancer survivors who report better levels of adherence share some common behaviour change techniques . These involve setting programme goals , prompting practise and self-monitoring and encouraging participants to attempt to generalise behaviours learned in supervised exercise environments to other , non-supervised context s. However , expecting most sedentary survivors to achieve current guideline recommendations of at least 150 minutes per week of aerobic exercise is likely to be unrealistic .
MS2_dynamic_1_shot424
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: The effect of pharmaceutical care on the prevention , detection , and resolution of medication-related problems in high-risk patients in a rural community was studied . Adult patients who received care at clinics in a medically underserved area of Alabama and who were identified as being at high risk of medication-related adverse events were r and omly assigned to a control group or an intervention group . The control group received st and ard medical care , and the intervention group received pharmaceutical care , including a medical record review , a medication history review , pharmacotherapeutic evaluation , and patient medication education and monitoring over a one-year period . A total of 69 patients completed the study ( 33 in the intervention group and 36 in the control group ) . The percentage of patients responding to hypertension , diabetes , dyslipidemia , and anticoagulation therapy increased significantly in the intervention group and declined in the control group . Ratings for inappropriate prescribing improved in all 10 domains evaluated in the intervention group but worsened in 5 domains in the control group . There were no significant differences between the groups at 12 months in health-related quality of life or medication misadventures . Medication compliance scores improved in the intervention group but not in the control group . Medication knowledge increased in the intervention group and decreased in the control group . Pharmaceutical care in a rural , community-based setting appeared to reduce inappropriate prescribing , enhance disease management , and improve medication compliance and knowledge without adversely affecting health-related quality of life Aim : To measure the outcomes of a harmonised , structured pharmaceutical care programme provided to elderly patients by community pharmacists . Method : A r and omised , controlled , longitudinal , clinical trial with repeated measures was performed over an 18‐month period , involving community pharmacies ( 5 intervention and 5 control ) in Northern Irel and . Elderly , ambulatory patients ( ≥ 65 years ) , taking 4 or more prescribed medications were eligible for participation . Patients attending an intervention pharmacy received education on medical conditions , implementation of compliance strategies , rationalising of drug regimens and appropriate monitoring ; patients attending control sites received normal services . A battery of clinical , humanistic and economic outcomes were assessed . Results : A significantly higher proportion of intervention patients were compliant at the end of the 18‐month study and experienced fewer problems with medication compared to control patients ( P < 0.05 ) . There was little impact on quality of life and health care utilisation . Conclusions : Pharmaceutical care provision to community‐dwelling patients result ed in an improvement in medication compliance and evidence of cost‐savings . Future pharmaceutical care studies may benefit from a more focussed selective approach to data collection and outcomes measurement Abstract Objective To investigate the effects of compliance and periodic telephone counselling by a pharmacist on mortality in patients receiving polypharmacy . Design Two year r and omised controlled trial . Setting Hospital medical clinic . Participants 502 of 1011 patients receiving five or more drugs for chronic disease found to be non-compliant at the screening visit were invited for r and omisation to either the telephone counselling group ( n = 219 ) or control group ( n = 223 ) at enrolment 12 - 16 weeks later . Main outcome measures Primary outcome was all cause mortality in r and omised patients . Associations between compliance and mortality in the entire cohort of 1011 patients were also examined . Patients were defined as compliant with a drug if they took 80 - 120 % of the prescribed daily dose . To calculate a compliance score for the whole treatment regimen , the number of drugs that the patient was fully compliant with was divided by the total number of prescribed drugs and expressed as a percentage . Only patients who complied with all recommended drugs were considered compliant ( 100 % score ) . Results 60 of the 502 eligible patients defaulted and only 442 patients were r and omised . After two years , 31 ( 52 % ) of the defaulters had died , 38 ( 17 % ) of the control group had died , and 25 ( 11 % ) of the intervention group had died . After adjustment for confounders , telephone counselling was associated with a 41 % reduction in the risk of death ( relative risk 0.59 , 95 % confidence interval 0.35 to 0.97 ; P = 0.039 ) . The number needed to treat to prevent one death at two years was 16 . Other predictors included old age , living alone , rate of admission to hospital , compliance score , number of drugs for chronic disease , and non-treatment with lipid lowering drugs at screening visit . In the cohort of 1011 patients , the adjusted relative risk for death was 1.61 ( 1.05 to 2.48 ; P = 0.029 ) and 2.87 ( 1.80 to 2.57 ; P < 0.001 ) in patients with compliance scores of 34 - 66 % and 0 - 33 % , respectively , compared with those who had a compliance score of 67 % or more . Conclusion In patients receiving polypharmacy , poor compliance was associated with increased mortality . Periodic telephone counselling by a pharmacist improved compliance and reduced mortality . Trial registration International St and ard R and omised Controlled Trial Number Register : S RCT N48076318 OBJECTIVE To compare patients ' adherence to therapy , expectations , satisfaction with pharmacy services , and health-related quality of life ( HRQOL ) after the provision of pharmaceutical care with those of patients who received traditional pharmacy care . DESIGN R and omized controlled cluster design . SETTING Sixteen community pharmacies in Alberta , Canada . PATIENTS AND OTHER PARTICIPANTS Ambulatory elderly ( > or = 65 years of age ) patients covered under Alberta Health & Wellness 's senior drug benefit plan and who OUTPUT: : The evidence from this review does not clearly support one single intervention to optimize medication adherence in older patients . INPUT: The effect of pharmaceutical care on the prevention , detection , and resolution of medication-related problems in high-risk patients in a rural community was studied . Adult patients who received care at clinics in a medically underserved area of Alabama and who were identified as being at high risk of medication-related adverse events were r and omly assigned to a control group or an intervention group . The control group received st and ard medical care , and the intervention group received pharmaceutical care , including a medical record review , a medication history review , pharmacotherapeutic evaluation , and patient medication education and monitoring over a one-year period . A total of 69 patients completed the study ( 33 in the intervention group and 36 in the control group ) . The percentage of patients responding to hypertension , diabetes , dyslipidemia , and anticoagulation therapy increased significantly in the intervention group and declined in the control group . Ratings for inappropriate prescribing improved in all 10 domains evaluated in the intervention group but worsened in 5 domains in the control group . There were no significant differences between the groups at 12 months in health-related quality of life or medication misadventures . Medication compliance scores improved in the intervention group but not in the control group . Medication knowledge increased in the intervention group and decreased in the control group . Pharmaceutical care in a rural , community-based setting appeared to reduce inappropriate prescribing , enhance disease management , and improve medication compliance and knowledge without adversely affecting health-related quality of life BACKGROUND Pharmacists have been shown to positively impact the outcomes of care for treatment of many different kinds of disease states . In particular , pharmacist-run lipid clinics have enjoyed varying degrees of success , depending on the outcome assessed . At our hospital , when a patient is transferred to the pharmacist-coordinated lipid clinic , the primary care pharmacist is responsible for ordering and interpreting labs and prescribing and monitoring lipid-altering therapy . OBJECTIVE This study was design ed to assess if there is a statistically significant difference between the magnitude of serum cholesterol reduction for patients receiving lipid-altering pharmacotherapy when clinical ly trained pharmacists are actively prescribing and adjusting the drug therapy compared to other health care practitioners ( usual care ) . METHODS Patient records from the hospital computer data bases were retrospectively and r and omly selected for analysis . Following evaluation for inclusion s and exclusions , 41 patient records remained for statistical analysis for the cohort group , and 47 records remained from the group of patients managed by a clinical pharmacist . RESULTS Management of dyslipidemia by a clinical pharmacist was associated with a significant reduction in overall mean low-density lipoprotein ( LDL , 18.5 % ) compared to the cohort that did not have a clinical pharmacist as the primary manager of dyslipidemia ( 6.5 % , P=0.049 ) . This suggests improved clinical outcomes , defined as greater LDL reduction , when clinical pharmacists participate in lipid management , including drug prescribing . The magnitude reduction in LDL was found to be related to the number of clinical pharmacy visits ( 11.4 % for 1 visit , 23.2 % for 2 visits , and 23.7 % for > 3 visits ) , compared to the usual care group ( -11.0 % , 18.0 % , and 7.4 % ; statistically significant , P=0.038 , for > 3 visits only ) . These results occurred even though the group of dyslipidemic patients managed primarily by a clinical pharmacist contained a statistically greater number of patients with 2 or more risk factors and high-density lipoprotein ( HDL ) levels less than 40 mg/dL. CONCLUSION Interdisciplinary medical teams that include clinical pharmacists who are actively prescribing and adjusting lipid drug therapy may achieve greater reductions in LDL for patients who have been assessed with multiple risk factors compared to patients managed without clinical pharmacists . Active participation by clinical pharmacists in lipid management for patients with elevated LDL result ed in improved treatment success as measured by the magnitude reduction in LDL . The reduction in LDL was between 5 % and 22 % per visit greater for patients being treated by clinical pharmacists versus usual care , even in a patient population with more risk factors . These intermediate outcomes may translate into long-term outcomes in fewer cardiovascular events , improved quality of life for patients with dyslipidemia , and lower costs associated with sequelae of dyslipidemias OBJECTIVES To identify patients at risk for coronary artery disease ( CAD ) through a search of a community pharmacy 's prescription data base , to screen and identify patients with elevated cholesterol and at risk for CAD , to enroll patients in a pharmacist-directed lipid management program , and to evaluate selected clinical and humanistic outcomes . DESIGN R and omized , pretest-posttest control groups . SETTING Independent community pharmacy in a suburban metropolitan area . PATIENTS 51 patients who were not at National Cholesterol Education Program low-density lipoprotein cholesterol ( LDL-C ) or defined triglyceride goals and who met inclusion criteria . INTERVENTION Pharmacist-directed lipid management program . MAIN OUTCOME MEASURES Clinical outcome measures included total cholesterol , LDL-C , high-density lipoprotein cholesterol ( HDL-C ) , and triglyceride levels ; achievement of LDL-C goal ; and risk factor prediction scores . Humanistic outcome measures included patient satisfaction with pharmaceutical care and patient knowledge of hyperlipidemia . RESULTS LDL-C was decreased in the pharmacist intervention group ( n = 25 ) , compared with an increase in the control group at study end . HDL-C levels increased and triglyceride levels decreased in both groups . Of treatment group patients , 32 % achieved their cholesterol goals , compared with 15 % of control group patients . Risk OUTPUT:
A clinical ly relevant but not statistically significant reduction in triglycerides was found . No impact on HDL-C levels was found . Patients ' adherence to pharmacotherapeutic regimens and quality of life were considered possibly not sensitive and possibly sensitive to pharmacist interventions , respectively . Total cholesterol is sensitive to pharmacist interventions , while LDL-C and triglyceride levels are possibly sensitive to those interventions .
MS2_dynamic_1_shot425
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: OBJECTIVE To compare training and follow-up effects of combined aerobic and strength training versus aerobic-only training on cognitive and motor function in institutionalized patients with dementia and to explore whether improved motor function mediates improved cognitive function . METHODS Using a 9-week , parallel , three-group , single-blind , r and omized , controlled trial with a follow-up assessment at week 18 , we assessed 109 patients with dementia ( age 85.5 ± 5.1 years ) in a psycho-geriatric nursing home . Each 9-week intervention consisted of 36 , 30-minute sessions . A combined group ( N = 37 ) received and completed two strength and two walking sessions per week , an aerobic group ( N = 36 ) completed four walking sessions , and a social group ( N = 36 ) completed four social visits per week . Cognitive and motor functions were assessed at baseline , after the 9-week intervention , and after a consecutive 9 weeks of usual care . RESULTS Baseline corrected post-test scores in the combined versus the social group were higher for global cognition , visual memory , verbal memory , executive function , walking endurance , leg muscle strength , and balance . Aerobic versus social group scores were higher for executive function . Follow-up effects reversed toward baseline values . Motor improvement did not significantly mediate cognitive improvement . CONCLUSION Compared with a nonexercise control group , a combination of aerobic and strength training is more effective than aerobic-only training in slowing cognitive and motor decline in patients with dementia . No mediating effects between improvements in cognitive function via improved motor function were found . Future research into the underlying mechanistic associations is needed OBJECTIVES To determine the independent and combined effects of progressive resistance muscle strength training ( PRMST ) and megestrol acetate ( MA ) on strength , muscle mass , and function in older recuperative care patients . DESIGN Double-blind , r and omized , controlled intervention using a two-by-two factorial design and conducted between 1999 and 2001 . SETTING University-affiliated Department of Veterans Affairs hospital . PARTICIPANTS Twenty-nine patients ( mean age 79.4 + /- 7.4 , 90 % white ) aged 65 and older and had recent functional decline . INTERVENTIONS After r and omization to one of four treatment groups ( low-resistance exercises plus 800 mg per day of MA or a placebo or high-intensity PRMST plus 800 mg/d of MA or placebo ) , subjects received training and the drug or placebo for 12 weeks . MEASUREMENTS Change in muscle strength , mid-thigh muscle area , and aggregate functional performance score as assessed using analysis of covariance . RESULTS Five subjects withdrew from the study before its completion . Based on intent-to-treat analyses , subjects who received high-intensity PRMST and placebo experienced the greatest strength gains . The addition of MA was associated with worse outcomes than with high-intensity exercise training alone , especially with regard to the leg exercises . Post hoc analysis demonstrated that subjects who received high-intensity PRMST and placebo experienced significantly greater percentage increases in leg strength than subjects in either of the MA treatment groups ( P<.05 for each comparison ) . There was also a significant negative effect of MA on physical function . In general , subjects who received MA experienced a deterioration in aggregate physical function scores , whereas the remaining subjects improved ( -0.80+/-0.40 vs 0.48+/-0.41 , P=.04 ) . There was not a significant interaction between exercise and MA for any outcome . CONCLUSION High-intensity PRMST is a safe and well-tolerated exercise regimen for frail elderly patients . The addition of MA appears to blunt the beneficial effects of PRMST , result ing in less muscle strength and functional performance gains OBJECTIVES To examine the effects of exercise training on cognitive function in individuals at risk of or diagnosed with Alzheimer 's disease ( AD ) . DESIGN Meta- analysis . SETTING PubMed , Scopus , Clinical Trials.gov , and ProQuest were search ed from inception until August 1 , 2017 . PARTICIPANTS Nineteen studies with 23 interventions including 1,145 subjects with a mean age of 77.0 ± 7.5 were included . Most subjects were at risk of AD because they had mild cognitive impairment ( 64 % ) or a parent diagnosed with AD ( 1 % ) , and 35 % presented with AD . INTERVENTION Controlled studies that included an exercise-only intervention and a nondiet , nonexercise control group and reported pre- and post-intervention cognitive function measurements . MEASUREMENTS Cognitive function before and after the intervention and features of the exercise intervention . RESULTS Exercise interventions were performed 3.4 ± 1.4 days per week at moderate intensity ( 3.7 ± 0.6 metabolic equivalents ) for 45.2 ± 17.0 minutes per session for 18.6 ± 10.0 weeks and consisted primarily of aerobic exercise ( 65 % ) . Overall , there was a modest favorable effect of exercise on cognitive function ( d+ = 0.47 , 95 % confidence interval ( CI ) = 0.26 - 0.68 ) . Within-group analyses revealed that exercise improved cognitive function ( d+w = 0.20 , 95 % CI = 0.11 - 0.28 ) , whereas cognitive function declined in the control group ( d+w = -0.18 , 95 % CI = -0.36 to 0.00 ) . Aerobic exercise had a moderate favorable effect on cognitive function ( d+w = 0.65 , 95 % CI = 0.35 - 0.95 ) , but other exercise types did not ( d+w = 0.19 , 95 % CI = -0.06 - 0.43 ) . OUTPUT: Compared to usual care or social activities , seated exercise had a large positive effect on cognition ( SMD 1.20 , 95 % confidence interval 0.25 , 2.16 ) with smaller effects on strength , spinal flexion , activity , depression and quality of life . There was no effect on balance or mobility . There were no positive effects when seated exercise was compared to weight-bearing and functional exercise . CONCLUSION Seated exercise has a positive effect on cognition and is also of some benefit for older adults who are unable to exercise in upright positions INPUT: OBJECTIVES To determine the independent and combined effects of progressive resistance muscle strength training ( PRMST ) and megestrol acetate ( MA ) on strength , muscle mass , and function in older recuperative care patients . DESIGN Double-blind , r and omized , controlled intervention using a two-by-two factorial design and conducted between 1999 and 2001 . SETTING University-affiliated Department of Veterans Affairs hospital . PARTICIPANTS Twenty-nine patients ( mean age 79.4 + /- 7.4 , 90 % white ) aged 65 and older and had recent functional decline . INTERVENTIONS After r and omization to one of four treatment groups ( low-resistance exercises plus 800 mg per day of MA or a placebo or high-intensity PRMST plus 800 mg/d of MA or placebo ) , subjects received training and the drug or placebo for 12 weeks . MEASUREMENTS Change in muscle strength , mid-thigh muscle area , and aggregate functional performance score as assessed using analysis of covariance . RESULTS Five subjects withdrew from the study before its completion . Based on intent-to-treat analyses , subjects who received high-intensity PRMST and placebo experienced the greatest strength gains . The addition of MA was associated with worse outcomes than with high-intensity exercise training alone , especially with regard to the leg exercises . Post hoc analysis demonstrated that subjects who received high-intensity PRMST and placebo experienced significantly greater percentage increases in leg strength than subjects in either of the MA treatment groups ( P<.05 for each comparison ) . There was also a significant negative effect of MA on physical function . In general , subjects who received MA experienced a deterioration in aggregate physical function scores , whereas the remaining subjects improved ( -0.80+/-0.40 vs 0.48+/-0.41 , P=.04 ) . There was not a significant interaction between exercise and MA for any outcome . CONCLUSION High-intensity PRMST is a safe and well-tolerated exercise regimen for frail elderly patients . The addition of MA appears to blunt the beneficial effects of PRMST , result ing in less muscle strength and functional performance gains OBJECTIVE To evaluate the effects of two exercise approaches , Tai Chi ( TC ) and computerized balance training ( BT ) , on specified primary outcomes ( biomedical , functional , and psychosocial indicators of frailty ) and secondary outcomes ( occurrence of falls ) . DESIGN The Atlanta FICSIT ( Frailty and Injuries : Cooperative Studies of Intervention Techniques ) , a prospect i ve , r and omized , controlled clinical trial with three arms ( TC , BT , and education [ ED ] . Intervention length was 15 weeks , with primary outcomes measured before and after intervention and at 4-month follow-up . Falls were monitored continuously throughout the study . SETTING Persons aged 70 and older living in the community . PARTICIPANTS A total of 200 participants , 162 women and 38 men ; mean age was 76.2 . MEASUREMENTS Biomedical ( strength , flexibility , cardiovascular endurance , body composition ) , functional ( IADL ) , and psychosocial well-being ( CES-D scale , fear of falling question naire , self-perception of present and future health , mastery index , perceived quality of sleep , and intrusiveness ) variables . RESULTS Grip strength declined in all groups , and lower extremity range of motion showed limited but statistically significant changes . Lowered blood pressure before and after a 12-minute walk was seen following TC participation . Fear of falling responses and intrusiveness responses were reduced after the TC intervention compared with the ED group ( P = .046 and P = .058 , respectively ) . After adjusting for fall risk factors , TC was found to reduce the risk of multiple falls by 47.5 % . CONCLUSIONS A moderate TC intervention can impact favorably on defined biomedical and psychosocial indices of frailty . This intervention can also have favorable effects upon the occurrence of falls . Tai Chi warrants further study as an exercise treatment to improve the health of older people OBJECTIVE To determine the safety and efficacy of an exercise protocol design ed to improve strength , mobility , and balance and to reduce subsequent falls in geriatric patients with a history of injurious falls . DESIGN A r and omized controlled 3-month intervention trial , with an additional 3-month follow-up . SETTING Out-patient geriatric rehabilitation unit . PARTICIPANTS Fifty-seven female geriatric patients ( mean age 82 + /- 4.8 years ; range 75 - 90 ) admitted to acute care or inpatient rehabilitation with a history of recurrent or injurious falls including patients with acute fall-related fracture . INTERVENTION Ambulatory training of strength , functional performance , and balance 3 times per week for 3 months . Patients of the control group attended a placebo group 3 times a week for 3 months . Both groups received an identical physiotherapeutic treatment 2 times a week , in which strengthening and balance training were excluded . MEASUREMENTS Strength , functional ability , motor function , psychological parameters , and fall rates were assessed by st and ardized protocol s at the beginning ( T1 ) and the end ( T2 ) of intervention . Patients were followed up for 3 months after the intervention ( T3 ) . RESULTS No training-related medical problems occurred in the study group . Forty-five patients ( 79 % ) completed all assessment s after the intervention and follow-up period . Adherence was excellent in both groups ( intervention 85.4 + /- 27.8 % vs control 84.2 + /- 29.3 % ) . The patients in the intervention group increased strength , functional motor performance , and balance significantly . Fall-related behavioral and emotional restrictions were reduced significantly . Improvements persisted during the 3-month follow-up with only moderate losses . For patients of the control group , no change in strength , functional performance , or emotional status could be documented during intervention and follow-up . Fall incidence was OUTPUT:
The multi-component exercise intervention composed by strength , endurance and balance training seems to be the best strategy to improve rate of falls , gait ability , balance , and strength performance in physically frail older adults
MS2_dynamic_1_shot426
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: The effect on serum high density lipoprotein subfractions of a low fat diet with a high ratio of polyunsaturated-to-saturated fatty acids was studied in 38 middle-aged volunteers ( 19 men and 19 women ) in North Karelia , Finl and . The mean serum HDL2 cholesterol decreased from 32 + /- 2 mg/dl ( mean + /- SE ) to 28 + /- 2 mg/dl ( p less than 0.001 ) during the experimental diet and returned to 33 + /- 2 mg/dl ( p less than 0.001 ) after a return to the original diet . No changes were observed in the concentration of HDL3 cholesterol . A highly significant decrease was observed in serum apoprotein A-I concentration , but not in apoprotein A-II concentration during the experimental diet . It is concluded that a low-fat , high-P/S ratio diet lowers LDL and HDL2 cholesterol in healthy volunteers , but does not influence the level of HDL3 subfraction The Minnesota Coronary Survey was a 4.5-year , open enrollment , single end-time , double-blind , r and omized clinical trial that was conducted In six Minnesota state mental hospitals and one nursing home . It Involved 4393 Institutionalized men and 4664 Institutionalized women . The trial compared the effects of a 39 % fat control diet ( 18 % saturated fat , 5 % polyunsaturated fat , 16 % monounsaturated fat , 446 mg dietary cholesterol per day ) with a 38 % fat treatment diet ( 9 % saturated fat , 15 % polyunsaturated fat , 14 % monounsaturated fat , 166 mg dietary cholesterol per day ) on serum cholesterol levels and the Incidence of myocardlal Infa rct ions , sudden deaths , and all-cause mortality . The mean duration of time on the diets was 384 days , with 1568 subjects consuming the diet for over 2 years . The mean serum cholesterol level In the pre-admission period was 207 mg/dl , falling to 175 mg/dl in the treatment group and 203 mg/dl In the control group . For the entire study population , no differences between the treatment and control groups were observed for cardiovascular events , cardiovascular deaths , or total mortality . A favorable trend for all these end-points occurred In some younger age groups It has been suggested that alpha-tocopherol , a safe and effective antioxidant , be used in clinical trials to evaluate the ability of antioxidant therapy to inhibit atherosclerosis . Recent reports , however , have raised the possibility that there may be greater enrichment of plasma low density lipoprotein ( LDL ) in alpha-tocopherol result ing from the use of the naturally occurring RRR-alpha-tocopherol isomer compared with the other isomers present in the synthetic racemic form of alpha-tocopherol . Therefore , we fed equal dosages ( 1,600 mg/day ) of the two forms of vitamin E to 16 men and women for 8 weeks and compared the effects of this supplementation on the susceptibility of isolated lipoproteins to oxidation . Neither form of vitamin E had appreciable effects on lipid or lipoprotein levels . alpha-Tocopherol levels in LDL increased at a similar rate in both groups and were nearly twofold higher than baseline levels by the end of the study . The susceptibility of LDL to oxidation was measured by formation of conjugated dienes , lipid peroxides , and thiobarbituric acid-reactive substances , as well as by macrophage degradation of LDL exposed to oxidizing conditions in vitro . The susceptibility of LDL to oxidation was decreased in both vitamin E groups compared with the baseline value , and this reduction occurred to a similar extent in both vitamin E-supplemented groups . alpha-Tocopherol levels in LDL also strongly correlated with all measures of LDL oxidation . This study demonstrates that , at this dosage , supplementation with either the natural or synthetic form of alpha-tocopherol provided equal antioxidant protection to LDL The effects of high oleic acid rapeseed oil compared with polyunsaturated fats on serum lipoprotein levels are largely unknown . Therefore , we fed 30 women and 29 men a baseline diet rich in saturated fat , which was followed by a diet rich in high oleic and low erucic acid rapeseed oil ( total energy content of fat , 38 % ; saturates , 12.4 % ; monounsaturates , 16 % ; n-6 polyunsaturates , 6 % ; and n-3 polyunsaturates , 2 % ) and one rich in sunflower oil ( total energy content of fat , 38 % ; saturates , 12.7 % ; monounsaturates , 10 % ; n-6 polyunsaturates , 13 % ; and n-3 polyunsaturates , 0 % ) . The oils were incorporated into mixed natural diets that were dispensed in a r and om order for 3.5 weeks each in a blinded crossover design . The diet composition was confirmed by analysis of duplicate diets . Both test diets reduced serum total cholesterol ( TC ) and low density lipoprotein ( LDL ) cholesterol levels from baseline , the monounsaturated rapeseed oil diet more than the polyunsaturated sunflower oil diet ( TC : -15 % versus -12 % , p less than 0.01 ; LDL cholesterol : -23 % versus -17 % , p less than 0.01 ) . Very low density lipoprotein ( VLDL ) cholesterol and total , VLDL , and LDL triglyceride levels were lower during the sunflower oil diet compared with the rapese OUTPUT: No significant difference was noted for the majority of secondary outcomes for any of the planned comparisons . INPUT: We have compared the effects of partially hydrogenated fish oil ( PHFO-diet ) , partially hydrogenated soybean oil ( PHSO-diet ) , and butterfat ( butter-diet ) on serum lipids and lipoprotein[a ] in 31 young men . The three test margarines , which contributed 78 % of total fat in the diets , were produced from 70 % of butterfat , PHSO , or PHFO , each with 30 % of soybean oil . Fat provided about 35 % of energy , and trans fatty acids 0.9 % , 8.5 % , and 8.0 % of energy in the butter- , the PHSO- , and the PHFO-diet , respectively . Dietary cholesterol was balanced by the addition of dried egg powder to the PHSO- and the butter-diet ; thus all diets contained 420 mg dietary cholesterol per 10 MJ per day . The subjects consumed all three test diets for 19 - 21 days in a r and om order ( crossover design ) . The serum levels of total and LDL-cholesterol were significantly elevated on the PHFO-diet ( mean values 5.42 and 3.94 mmol/L , respectively ) compared to the PHSO-diet ( 5.11 and 3.58 mmol/L , respectively ) but not different from those on the butter-diet ( 5.32 and 3.81 mmol/L , respectively ) . LDL-cholesterol was significantly reduced on the PHSO-diet compared to the butter-diet . The level of HDL-cholesterol was significantly lower on the PHFO-diet ( 0.98 mmol/L ) when compared to the butter-diet ( 1.05 mmol/L ) and with border-line significance compared to the PHSO-diet ( 1.05 mmol/L ) . The ratio of LDL- to HDL-cholesterol was significantly higher on the PHFO-diet ( 4.20 ) when compared to both other test diets ( 3.85 and 3.65 , respectively ) . No significant differences in triglyceride values were observed . Lp[a ] increased and apoA-I decreased significantly after consumption of both the PHSO-diet and the PHFO-diet , compared to the butter-diet . In conclusion , our results indicate that consumption of PHFO may unfavorably affect lipid risk indicators for coronary heart disease at least to the same extent as butterfat . To what extent the observed effects are due to the content of monoene trans , diene trans , or to the long chain saturated fatty acids in PHFO remains to be eluci date Background / Objectives : The objective of this study was to evaluate the impact of three specific ruminant ( R ) milk fats result ing from modification of the cow 's diet on cardiovascular risk factors in healthy volunteers . R-milk fats were characterized by increased content in total trans fatty acids ( R-TFAs ) and parallel decrease in saturated fatty acids (SFAs).Subjects/ Methods : A total of 111 healthy , normolipemic men and women have been recruited for a monocentric , r and omized , double-blind and parallel intervention , 4-week controlled study . Volunteers consumed three experimental products ( butter , dessert cream and cookies ) made with one of the three specific milk fats ( 55 g fat per day ) . During the first week ( run-in period ) , the subjects consumed on a daily basis dairy products containing 72 % SFA/2.85 % R-TFA ( called ‘ L0 ’ ) . For the next 3 weeks of the study ( intervention period ) , the first group continued to consume L0 products . The second group received dairy products containing 63.3 % SFA/4.06 % R-TFA ( called ‘ L4 ’ ) , and the third group received dairy products containing 56.6 % SFA/12.16 % R-TFA ( called ‘ L9 ’ ) . Results : Plasma concentrations of high-density lipoprotein (HDL)-cholesterol were not significantly altered by either diet ( P=0.38 ) . Compared to L0 diet , L4 diet contributed to reduce low-density lipoprotein (LDL)-cholesterol ( −0.14±0.38 mmol/l , P=0.04 ) , total cholesterol ( −0.13±0.50 mmol/l , P=0.04 ) , LDL-cholesterol/HDL-cholesterol ( −0.14±0.36 , P=0.03 ) and total cholesterol/HDL-cholesterol ( −0.18±0.44 , P=0.02 ) . Conclusions : Different milk fat profiles can change cardiovascular plasma parameters in human healthy volunteers . A limited increase of the R-TFA/SFA ratio in dairy products is associated with an improvement in some cardiovascular risk factors . However , a further increase in R-TFA/SFA ratio has no additional benefit Fatty acid profile of milk fat can be modified by cow feeding strategies . Our aim was postpr and ially and after 4 wk to compare the effect of a modified milk fat ( M diet ) [ with 16 % of the cholesterolemic saturated fatty acid ( C12–16 ) replaced by mainly oleic and stearic acids ] with the effect of D diet , including a conventional Danish milk fat on plasma lipids and lipoproteins . A side effect of the cow feeding regime was a 5 % ( w/w ) increase in trans fatty acid in M diet . Eighteen subjects were fed for two periods of 4 wk strictly controlled isoenergetic test diets with 40 % of energy from total fat and the same content of dietary cholesterol in a r and omized study with cross-over design . Contrary OUTPUT:
We found no relationship between R-TFA intake levels of up to 4.19 % of daily energy intake ( EI ) and changes in cardiovascular risk factors such as TC : HDL-C and LDL-cholesterol (LDL-C):HDL-C ratios . In addition , a multivariate regression analysis that included other dietary variables , as well as subject baseline characteristics , confirmed that doses of R-TFA did not significantly influence the changes in the lipid ratio . Our findings showed that doses of R-TFA did not influence the changes in the ratios of plasma TC : HDL-C and LDL-C : HDL-C. These data suggest that TFA from natural sources , at least at the current levels of intake and up to 4.19 % EI , have no adverse effects on these key CVD risk markers in healthy people
MS2_dynamic_1_shot427
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: Background Prevalence of type 2 diabetes ( T2D ) is increasing worldwide . T2D prevention by lifestyle intervention is effective . Pragmatic scalable interventions are needed , with evidence to efficiently target and monitor such interventions . We report pooled analyses of data from three European trial cohorts : to analyse T2D incidence , sustained weight loss and utility of risk predictors . Methods We analysed data on 749 adults with impaired glucose tolerance ( 278 men and 471 women , mean age 56 years , mean BMI 31 kgm−2 ) recruited between 1993 and 2003 , and r and omised to intensive lifestyle intervention ( I ) or lifestyle advice control ( C ) . The intervention aim ed to increase physical activity , modify diet , and promote weight loss≥5 % . Using Cox-regression survival analysis , we assessed T2D incidence and the impact on T2D incidence of sustained weight loss , and of baseline cut-point values of FINDRISC score , fasting plasma glucose ( FPG ) , and HbA1c . Results Mean follow-up duration was 3.1 years . T2D was diagnosed in 139 participants ( I = 45/379 , C = 94/370 ) . Cumulative T2D incidence was 57 % lower in the intervention compared with the control group ( HR 0.42 ( 95 % CI 0.29 to 0.60 ) P<0.001 ) . Participants with ≥5 % weight loss at one year had 65 % lower T2D incidence ( HR 0.35 ( 95 % CI 0.22 to 0.56 ) P<0.001 ) ; maintaining ≥5 % weight loss for two and three years further reduced T2D incidence . Recommended cut-points to identify those at high risk for T2D would have identified different proportions of European Diabetes Prevention Study ( EDIPS ) participants with similar hazard-ratios for intervention effect . Conclusions Pooled analysis of EDIPS trial data reinforces evidence for T2D prevention by lifestyle intervention . Analysis showed the preventive effect of ≥5 % weight loss , especially if maintained long term , which has utility for intervention monitoring . Analysis of proposed cut-points demonstrates difficulties in balancing risk and benefit , to efficiently target interventions and suggests evidence is needed to define clinical policy . Trial registration s The Finnish Diabetes Prevention study , Helsinki , Finl and : Clinical Trials.gov ; NCT00518167 The SLIM diabetes prevention study , Maastricht , The Netherl and s : Clinical Trials.gov ; NCT00381186 The EDIPS-Newcastle diabetes prevention study , Newcastle upon Tyne , UK : International St and ard R and omised Controlled Trial Number ; IS RCT N15670600 OBJECTIVE Changing dietary and physical activity habits has the potential to postpone or prevent the development of type 2 diabetes . However , it needs to be assessed whether moderate interventions , in agreement with current guidelines for the general population , are effective . We evaluated the impact of a 2-year combined diet and physical activity intervention program on glucose tolerance in Dutch subjects at increased risk for developing diabetes . RESEARCH METHODS AND PROCEDURES Subjects with glucose intolerance were r and omly assigned to either the lifestyle intervention group ( INT ) or control group ( CON ) . The INT received regular dietary advice and was stimulated to increase their physical activity . The CON received a brief leaflet about healthy diet and increased physical activity . Primary outcome measure was the change in glucose tolerance . RESULTS In total , 88 subjects completed 2 years of intervention ( 40 subjects in the INT , 48 subjects in the CON , mean BMI 29.4 kg/m2 ) . Subjects in the INT reduced their body weight , waist circumference , and ( saturated ) fat intake and improved their aerobic capacity . Two-hour plasma glucose concentration declined from 8.7 to 8.0 mM in the INT and rose from 8.6 to 9.4 mM in the CON ( p < 0.01 ) . Subjects adherent to both the diet and exercise intervention showed the largest reduction in 2-hour glucose levels . DISCUSSION Our results showed that a lifestyle intervention program according to general recommendations improves glucose tolerance , even in a less obese and more physical active population . Furthermore , our results underscore the importance of combining diet and physical activity to improve glucose tolerance and insulin resistance OBJECTIVE To test the effects of two Mediterranean diet ( MedDiet ) interventions versus a low-fat diet on incidence of diabetes . RESEARCH DESIGN AND METHODS This was a three-arm r and omized trial in 418 nondiabetic subjects aged 55–80 years recruited in one center ( PREDIMED-Reus , northeastern Spain ) of the Prevención con Dieta Mediterránea [ PREDIMED ] study , a large nutrition intervention trial for primary cardiovascular prevention in individuals at high cardiovascular risk . Participants were r and omly assigned to education on a low-fat diet ( control group ) or to one of two MedDiets , supplemented with either free virgin olive oil ( 1 liter/week ) or nuts ( 30 g/day ) . Diets were ad libitum , and no advice on physical activity was given . The main outcome was diabetes incidence diagnosed by the 2009 American Diabetes Association criteria . RESULTS After a median follow-up of 4.0 years , diabetes incidence was 10.1 % ( 95 % CI 5.1–15.1 ) , 11.0 % ( 5.9–16.1 ) , and 17. OUTPUT: We conclude that T2D is preventable by changing lifestyle and the risk reduction is sustained for many years after the active intervention ( high certainty of evidence ) . There is limited or insufficient data to show that prevention of T2D by lifestyle changes results in a lower risk of cardiovascular and microvascular complications INPUT: Background Colorectal cancer ( CRC ) is the third most commonly diagnosed cancer and the second highest cause of cancer death in the UK . Most cases occur in people over 50 years and CRC often co-exists with other lifestyle related disorders including obesity , type 2 diabetes mellitus ( T2DM ) and cardiovascular disease ( CVD ) . These diseases share risk factors related to the metabolic syndrome including large body size , abnormal lipids and markers of insulin resistance indicating common aetiological pathways . Methods / Design This 3 year study will be a two-arm , multicentre , r and omised controlled trial comparing the BeWEL lifestyle ( diet , physical activity and behaviour change ) programme against usual care . The pre-trial development will take 6 months and participants will be recruited over a 12 month period and undertake the intervention and follow up for 12 months ( total 24 months recruitment and intervention implementation ) with a further 6 months for data collection , analysis and interpretation . Four hundred and fifty two participants who have had a colorectal adenoma detected and removed ( through the national colorectal screening programme ) will provide 80 % power to detect a weight loss of 7 % over 12 months . Primary outcomes are changes in body weight and waist circumference . Secondary outcomes will include cardiovascular risk factors , psycho-social measures and intervention costs . Discussion The results from this study will enhance the evidence base for lifestyle change in patients at higher risk of chronic disease including obesity related cancers . International St and ard R and omised Controlled Trials No : IS RCT BACKGROUND Since the Diabetes Prevention Project ( DPP ) demonstrated that lifestyle weight-loss interventions can reduce the incidence of diabetes by 58 % , several studies have translated the DPP methods to public health-friendly context s. Although these studies have demonstrated short-term effects , no study to date has examined the impact of a translated DPP intervention on blood glucose and adiposity beyond 12 months of follow-up . PURPOSE To examine the impact of a 24-month , community-based diabetes prevention program on fasting blood glucose , insulin , insulin resistance as well as body weight , waist circumference , and BMI in the second year of follow-up . DESIGN An RCT comparing a 24-month lifestyle weight-loss program ( LWL ) to an enhanced usual care condition ( UCC ) in participants with prediabetes ( fasting blood glucose=95 - 125 mg/dL ) . Data were collected in 2007 - 2011 ; analyses were conducted in 2011 - 2012 . SETTING / PARTICIPANTS 301 participants with prediabetes were r and omized ; 261 completed the study . The intervention was held in community-based sites . INTERVENTION The LWL program was led by community health workers and sought to induce 7 % weight loss at 6 months that would be maintained over time through decreased caloric intake and increased physical activity . The UCC received two visits with a registered dietitian and a monthly newsletter . MAIN OUTCOME MEASURES The main measures were fasting blood glucose , insulin , insulin resistance , body weight , waist circumference , and BMI . RESULTS Intent-to-treat analyses of between-group differences in the average of 18- and 24-month measures of outcomes ( controlling for baseline values ) revealed that the LWL participants experienced greater decreases in fasting glucose ( -4.35 mg/dL ) ; insulin ( -3.01 μU/ml ) ; insulin resistance ( -0.97 ) ; body weight ( -4.19 kg ) ; waist circumference ( -3.23 cm ) ; and BMI ( -1.40 ) , all p-values < 0.01 . CONCLUSIONS A diabetes prevention program administered through an existing community-based system and delivered by community health workers is effective at inducing significant long-term reductions in metabolic indicators and adiposity Aims /hypothesis . The World Health Organisation Consultation recommended new diagnostic criteria for diabetes mellitus including : lowering of the diagnostic fasting plasma glucose to 7.0 mmol/l and introduction of a new category : impaired fasting glycaemia . The diagnostic 2-h glucose concentrations for diabetes and for impaired glucose tolerance were unchanged . This study identifies fasting plasma glucose concentrations predicting a diabetic 2-h plasma glucose of 11.1 mmol/l or more , analyses the sensitivity and specificity of different screening strategies for diabetes and describes the cardiovascular risk profile in people with impaired fasting glycaemia . Methods . European population based studies ( n = 17 ) or large , representative sample s of employees ( n = 3 ) with both fasting and 2-h post load glucose concentrations following 75-g oral glucose tolerance tests were included ( 18 918 men and 10 190 women ) . The Icel and study ( 8881 men and 9407 women ) is presented separately as a 50-g glucose load was used . Results . The fasting plasma glucose predicting a 2-h plasma glucose of 11.1 mmol/l or more with optimal sensitivity and specificity was a ) 5.8 mmol/l in women and 6.4 mmol/l in men ; b ) independent of age ; c ) increased with obesity . Fasting plasma glucose of 7.0/7.8 mmol/l or more predicted a diabetic 2-h plasma glucose with sensitivities of 49.0/29.8 % and specificities of 98.2/99.7 % , respectively . Conclusion /interpretation . If fasting glucose is used alone , the 31 % of diabetic subjects with a OUTPUT:
Similar effects also appeared in SBP and DBP categories regardless of follow-up duration . PA+D interventions had larger improvement effects on CVD risk factors than PA alone interventions . In adults without IGT or diabetes , lifestyle interventions result ed in significant improvements in SBP , DBP , TC , LDL-C , HDL-C , and TG , and might further reduce CVD risk
MS2_dynamic_1_shot428
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: BACKGROUND The effects of a carbohydrate-restricted diet on weight loss and risk factors for atherosclerosis have been incompletely assessed . METHODS We r and omly assigned 132 severely obese subjects ( including 77 blacks and 23 women ) with a mean body-mass index of 43 and a high prevalence of diabetes ( 39 percent ) or the metabolic syndrome ( 43 percent ) to a carbohydrate-restricted ( low-carbohydrate ) diet or a calorie- and fat-restricted ( low-fat ) diet . RESULTS Seventy-nine subjects completed the six-month study . An analysis including all subjects , with the last observation carried forward for those who dropped out , showed that subjects on the low-carbohydrate diet lost more weight than those on the low-fat diet ( mean [ + /-SD ] , -5.8+/-8.6 kg vs. -1.9+/-4.2 kg ; P=0.002 ) and had greater decreases in triglyceride levels ( mean , -20+/-43 percent vs. -4+/-31 percent ; P=0.001 ) , irrespective of the use or nonuse of hypoglycemic or lipid-lowering medications . Insulin sensitivity , measured only in subjects without diabetes , also improved more among subjects on the low-carbohydrate diet ( 6+/-9 percent vs. -3+/-8 percent , P=0.01 ) . The amount of weight lost ( P<0.001 ) and assignment to the low-carbohydrate diet ( P=0.01 ) were independent predictors of improvement in triglyceride levels and insulin sensitivity . CONCLUSIONS Severely obese subjects with a high prevalence of diabetes or the metabolic syndrome lost more weight during six months on a carbohydrate-restricted diet than on a calorie- and fat-restricted diet , with a relative improvement in insulin sensitivity and triglyceride levels , even after adjustment for the amount of weight lost . This finding should be interpreted with caution , given the small magnitude of overall and between-group differences in weight loss in these markedly obese subjects and the short duration of the study . Future studies evaluating long-term cardiovascular outcomes are needed before a carbohydrate-restricted diet can be endorsed Context In 2003 , the authors reported that severely obese adults lost more weight and had better serum lipid patterns after 6 months of a low-carbohydrate diet rather than a conventional low-fat diet . Contribution After 1 year , these same patients still had more favorable triglyceride and high-density lipoprotein cholesterol levels on the low-carbohydrate diet than on the conventional diet . However , weight loss and the other metabolic parameters were similar in the 2 diet groups . Caution s The effect of the modest improvements in high-density lipoprotein cholesterol and triglyceride levels on the development of diabetes and cardiovascular disease is unknown . The Editors The prevalence of obesity and its associated metabolic abnormalities has increased markedly over the past 2 decades ( 1 , 2 ) . Although guidelines to follow a highcomplex carbohydrate , low-fat , energy-deficient diet to achieve weight loss are generally accepted ( 3 ) , considerable public interest has focused on low-carbohydrate diets ( 4 ) . We recently reported that persons with severe obesity lost more weight and had greater improvements in triglyceride levels , insulin sensitivity , and glycemic control after 6 months of a low-carbohydrate diet as compared with a conventional weight loss diet based on calorie and fat restriction ( 5 ) . However , these findings were preliminary because of the short duration of that study ( 6 ) . A simultaneously published study by Foster and colleagues suggested that persons on a low-carbohydrate diet tended to regain weight by 1 year ( 7 ) . These findings were limited , however , because few participants completed the study and because the study used a self-help approach , which is less effective than direct counseling for maintaining weight loss ( 8) . Foster and colleagues also excluded persons with diabetes , which is highly prevalent in the obese population . During the development of this study , we decided to analyze and report preliminary results at 6 months and final results at 1 year . We thought that the short-term results would be important , given the high-risk nature of our study sample , but that long-term outcomes would provide more information about the sustainability of any diet-related outcomes . We now report our findings 1 year after r and omization to a low-carbohydrate diet versus a low-fat weight loss diet ( conventional diet ) in severely obese adults with a high prevalence of diabetes or the metabolic syndrome . Methods Study Participants The study design has been previously described ( 5 ) . Participants were recruited from the outpatient practice s of the Philadelphia Veterans Affairs Medical Center and included persons 18 years of age and older with a body mass index ( BMI ) of 35 kg/m2 or greater . The exclusion criteria were a serum creatinine level greater than 133 mol/L ( > 1.5 mg/dL ) , hepatic disease , severe life-limiting medical illness , inability to self-monitor glucose levels , or active use of a weight loss program or weight loss medication . Between May 2001 and November 2001 , 132 persons were r and omly assigned to either a low-carbohydrate diet ( n = 64 ) or a conventional diet ( n = 68 ) . The Institutional Review Committee at the Philadelphia Veterans Affairs Medical Center approved the study , and all participants provided written informed consent . Interventions Diet groups met in weekly counseling sessions for 4 weeks , followed by 11 monthly sessions . Participants on the low-carbohydrate diet were instructed only to OUTPUT: Comprehensive and intensive behavioral interventions can result in clinical ly significant , albeit modest , weight loss in this obese sub population but may not result significant improvements in other cardiometabolic risk factors . INPUT: BACKGROUND The effects of a carbohydrate-restricted diet on weight loss and risk factors for atherosclerosis have been incompletely assessed . METHODS We r and omly assigned 132 severely obese subjects ( including 77 blacks and 23 women ) with a mean body-mass index of 43 and a high prevalence of diabetes ( 39 percent ) or the metabolic syndrome ( 43 percent ) to a carbohydrate-restricted ( low-carbohydrate ) diet or a calorie- and fat-restricted ( low-fat ) diet . RESULTS Seventy-nine subjects completed the six-month study . An analysis including all subjects , with the last observation carried forward for those who dropped out , showed that subjects on the low-carbohydrate diet lost more weight than those on the low-fat diet ( mean [ + /-SD ] , -5.8+/-8.6 kg vs. -1.9+/-4.2 kg ; P=0.002 ) and had greater decreases in triglyceride levels ( mean , -20+/-43 percent vs. -4+/-31 percent ; P=0.001 ) , irrespective of the use or nonuse of hypoglycemic or lipid-lowering medications . Insulin sensitivity , measured only in subjects without diabetes , also improved more among subjects on the low-carbohydrate diet ( 6+/-9 percent vs. -3+/-8 percent , P=0.01 ) . The amount of weight lost ( P<0.001 ) and assignment to the low-carbohydrate diet ( P=0.01 ) were independent predictors of improvement in triglyceride levels and insulin sensitivity . CONCLUSIONS Severely obese subjects with a high prevalence of diabetes or the metabolic syndrome lost more weight during six months on a carbohydrate-restricted diet than on a calorie- and fat-restricted diet , with a relative improvement in insulin sensitivity and triglyceride levels , even after adjustment for the amount of weight lost . This finding should be interpreted with caution , given the small magnitude of overall and between-group differences in weight loss in these markedly obese subjects and the short duration of the study . Future studies evaluating long-term cardiovascular outcomes are needed before a carbohydrate-restricted diet can be endorsed UNLABELLED Weight loss and resolution of comorbidities is well established after modern bariatric procedures , however chronology of glyco-lipidic biochemical response is still debated . OBJECTIVE Aim ing to analyze this variable as well as its correlation with food amount and composition , a prospect i ve study was design ed . METHODOLOGY Eighty consecutive patients undergoing Roux-en-Y gastric bypass were investigated every three months until one year after surgery . Females only were accepted and variables included general and nutritional course as well as glucose and lipid measurements . Energy intake was documented including percentage of macronutrients in the diet . RESULTS Surgery was successful with about 71 % excess body weight loss at the end of the first year . Mean energy intake on the 4 postoperative quarters was respectively 519.6 + /- 306.6 , 836.0 + /- 407.9 , 702.1 + /- 313.1 and 868.8 + /- 342.8 kcal/day ( mean + /- SD ) . Fat intake was initially low but reached 34.1 + /- 7.9 % of total calories at final measurement . Blood glucose and lipid fractions tended to be borderline or abnormal preoperatively , and favorably changed by 12 months . Consumption of glucose- and lipid-lowering medication significantly diminished , but each of these was still necessary in 6.3 % of the group . Correlation between body mass index and also calorie intake versus glucose and lipid measurements was highly significant ( P = 0.000 ) . CONCLUSIONS 1 ) Energy intake after operation was very low ; 2 ) Weight loss proceeded rapidly and correlated with meal pattern ; 3 ) Improvement of glucose and lipid tests was adequate but took several quarters to normalize ; 4 ) Decreased requirements for glucose- and lipid-lowering medication was significant but not absolute ; 4 ) Fat percentage of total calories exceeded 30 % at the end of the observation period , despite recommendations to the contrary Objective Dietary carbohydrate is the major determinant of postpr and ial glucose levels , and several clinical studies have shown that low-carbohydrate diets improve glycemic control . In this study , we tested the hypothesis that a diet lower in carbohydrate would lead to greater improvement in glycemic control over a 24-week period in patients with obesity and type 2 diabetes mellitus . Research design and methods Eighty-four community volunteers with obesity and type 2 diabetes were r and omized to either a low-carbohydrate , ketogenic diet ( < 20 g of carbohydrate daily ; LCKD ) or a low-glycemic , reduced-calorie diet ( 500 kcal/day deficit from weight maintenance diet ; LGID ) . Both groups received group meetings , nutritional supplementation , and an exercise recommendation . The main outcome was glycemic control , measured by hemoglobin A1c . Results Forty-nine ( 58.3 % ) participants completed the study . Both interventions led to improvements in hemoglobin A1c , fasting glucose , fasting insulin , and weight loss . The LCKD group had greater improvements in hemoglobin A1c ( -1.5 % vs. -0.5 % , p = 0.03 ) , body weight ( -11.1 kg vs. -6.9 kg , p = 0.008 ) , and high density lipoprotein cholesterol ( + OUTPUT:
The longest trial intervention studies did not show a difference in weight change . This review shows that there are no consistent differences in weight and A1C changes over the long-term treatment with LCD and LFD , UCD or LGID
MS2_dynamic_1_shot429
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: Background The use of Internet-based question naires for collection of data to evaluate patient education and other interventions has increased in recent years . Many self-report instruments have been vali date d using paper- and -pencil versions , but we can not assume that the psychometric properties of an Internet-based version will be identical . Objectives To look at similarities and differences between the Internet versions and the paper- and -pencil versions of 16 existing self-report instruments useful in evaluation of patient interventions . Methods Participants were recruited via the Internet and volunteered to participate ( N=397 ) , after which they were r and omly assigned to fill out question naires online or via mailed paper- and -pencil versions . The self-report instruments measured were overall health , health distress , practice mental stress management , Health Assessment Question naire ( HAQ ) disability , illness intrusiveness , activity limitations , visual numeric for pain , visual numeric for shortness of breath , visual numeric for fatigue , self-efficacy for managing disease , aerobic exercise , stretching and strengthening exercise , visits to MD , hospitalizations , hospital days , and emergency room visits . Means , ranges , and confidence intervals are given for each instrument within each type of question naire . The results from the two question naires were compared using both parametric and non-parametric tests . Reliability tests were given for multi-item instruments . A separate sample ( N=30 ) filled out identical question naires over the Internet within a few days and correlations were used to assess test-retest reliability . Results Out of 16 instruments , none showed significant differences when the appropriate tests were used . Construct reliability was similar within each type of question naire , and Internet test-retest reliability was high . Internet question naires required less follow-up to achieve a slightly ( non-significant ) higher completion rate compared to mailed question naires . Conclusions Among a convenience sample recruited via the Internet , results from those r and omly assigned to Internet participation were at least as good as , if not better than , among those assigned mailed question naires , with less recruitment effort required . The instruments administered via the Internet appear to be reliable , and to be answered similarly to the way they are answered when they are administered via traditional mailed paper question naires & NA ; Electronic question naires for pain assessment are becoming increasingly popular . There have been no published reports to establish the equivalence or psychometric properties of common pain question naires administered via desktop computers . This study compared responses to paper ( P ) and touch screen electronic ( E ) versions of the Short‐Form McGill Pain Question naire ( SF‐MPQ ) and Pain Disability Index ( PDI ) , while examining the role of computer anxiety and experience , and evaluating patient acceptance . In a r and omized , crossover design 189 chronic pain patients completed P and E versions of the SF‐MPQ and PDI , and self‐ratings of anxiety , experience , relative ease and preference . Psychometric properties were highly similar for P and E question naires . For the SF‐MPQ , 60 % or more of subjects gave equivalent responses on individual descriptors and PPI scale , with 80 % rating within ±1 point for an 11‐point VAS . Correlations for the SF‐MPQ scales ranged from 0.68 to 0.84 . For the PDI , 60 % or more of subjects responded within ±1 point on individual questions , and the total score correlation was 0.67 . Comparison of mean difference scores revealed no significant differences between modes for any of the question naire items or scores . Anxiety and experience scores showed no significant associations through correlations and high/low comparisons . Although nearly half of subjects reported no computer training , anxiety ratings were low , and considerably more subjects rated the E question naires as easier and preferred . Findings are consistent with test‐retest reliability data , and support the validity and acceptance of electronic versions of the SF‐MPQ and PDI Background While modern electronic data collection methods ( e.g. , computer touch-screen or web-based ) hold much promise , most current studies continue to make use of more traditional data collection techniques , including paper- and -pencil administration and telephone interviews . The present r and omized trial investigated the measurement properties of the EORTC QLQ-C30 under three different modes of administration ( MOA 's ) . Methods A heterogeneous sample of 314 cancer patients undergoing treatment at a specialized treatment center in Amsterdam were r and omized to one of three MOA 's for the QLQ-C30 : paper- and -pencil at home via the mail , telephone interview , and paper- and -pencil at the hospital clinic . Group differences in internal consistency reliabilities ( Cronbach 's alpha coefficient ) for the scale scores were compared . Differences in mean scale scores were also compared by means of ANOVA , with adjustment for potential confounders . Results Only one statistically significant , yet minor , difference in Cronbach 's alpha between the MOA groups was observed for the Role Functioning scale ( all 3 alphas > 0.80 ) . Significant differences in group means -after adjustment- were found for the Emotional Functioning ( EF ) scale . Patients completing the written question naire at home had significantly lower levels of EF as compared to those interviewed via the telephone ; EF scores of those completing the question naire at the clinic fell in-between those of the other two groups . These differences , however , were small in magnitude . Conclusions MOA had little effect on the reliability or the mean scores of the EORTC QLQ-C30 , with the possible exception of the EF scale Background The most commonly used survey methods are self-administered question naires , telephone interviews , and a mixture of both . But until now evidence out of r and omised controlled trials as to whether patient responses differ depending on the survey mode is lacking . Therefore this study assessed whether patient responses to surveys depend on the mode of survey administration . The comparison was between mailed , self-administered question naires and telephone interviews . Methods A four-armed , r and omised controlled two-period change-over design . Each patient responded to the same survey twice , once in written form and once by telephone interview , separated by at least a fortnight . The study was conducted in 2003/2004 in Germany . 1087 patients taking part in the German Acupuncture Trials ( G OUTPUT: No evidence of bias was found for : ( 1 ) paper versus electronic self-complete ; and ( 2 ) self-complete versus assisted MOA . Heterogeneity for paper versus electronic comparison was explained by type of construct ( i.e. physical vs. psychological ) . Heterogeneity for self-completion versus assisted modes was in part explained by setting ( clinic vs. home ) ; the largest bias was introduced when assisted completion occurred in the clinic and follow-up was by self-completion ( either electronic or paper ) in the home . Conclusions Self-complete paper and electronic MOA can be used interchangeably for research in clinic and home setting s. Self-completion and assisted completion produce equivalent scores overall , although heterogeneity may be induced by setting . INPUT: Although the Insomnia Severity Index ( ISI ) is already administered online , this frequently used instrument has not been vali date d for Web delivery . This study compares online and paper- and -pencil ISI versions completed by participants in a r and omized controlled trial testing an Internet-delivered intervention for insomnia . Forty-three adults with insomnia completed both ISI versions during pre- ( Assessment 1 ) and post-intervention ( Assessment 2 ) . Correlations between total scores of both versions were significant ( rs ≥ .98 , ps < .001 ) . For both ISI versions , internal consistency was acceptable ( Assessment 1 , α = .61 ; Assessment 2 , α ≥ .88 ) . Among participants not receiving the parent study intervention , correlations between 1 format at Assessment 1 and the alternative format at Assessment 2 were generally significant ( rs = .26–.82 ) . Together , findings suggest the ISI can be delivered online Background Low response rates among surgeons can threaten the validity of surveys . Internet technologies may reduce the time , effort , and financial re sources needed to conduct surveys . Objective We investigated whether using Web-based technology could increase the response rates to an international survey . Methods We solicited opinions from the 442 surgeon – members of the Orthopaedic Trauma Association regarding the treatment of femoral neck fractures . We developed a self-administered question naire after conducting a literature review , focus groups , and key informant interviews , for which we used sampling to redundancy techniques . We administered an Internet version of the question naire on a Web site , as well as a paper version , which looked similar to the Internet version and which had identical content . Only those in our sample could access the Web site . We alternately assigned the participants to receive the survey by mail ( n=221 ) or an email invitation to participate on the Internet ( n=221 ) . Non-respondents in the mail arm received up to three additional copies of the survey , while non-respondents in the Internet arm received up to three additional requests , including a final mailed copy . All participants in the Internet arm had an opportunity to request an emailed Portable Document Format ( PDF ) version . Results The Internet arm demonstrated a lower response rate ( 99/221 , 45 % ) than the mail question naire arm ( 128/221 , 58 % ) ( absolute difference 13 % , 95 % confidence interval 4%-22 % , P<0.01 ) . Conclusions Our Internet-based survey to surgeons result ed in a significantly lower response rate than a traditional mailed survey . Research ers should not assume that the widespread availability and potential ease of Internet-based surveys will translate into higher response rates Background When evaluating hearing rehabilitation , it is reasonable to use self-report question naires as outcome measure . Question naires used in audiological research are developed and vali date d for the paper- and -pencil format . As computer and Internet use is increasing , st and ardized question naires used in the audiological context should be evaluated to determine the viability of the online administration format . The aim of this study was to compare administration of question naires online versus paper- and pencil of four st and ardised question naires used in hearing research and clinic . We included the Hearing H and icap Inventory for the Elderly ( HHIE ) , the International Outcome Inventory for Hearing Aids ( IOI-HA ) , Satisfaction with Amplification in Daily Life ( SADL ) , and the Hospital Anxiety and Depression Scale ( HADS ) . Methods A cross-over design was used by r and omly letting the participants complete the question naires either online or on paper . After 3 weeks the participants filled out the same question naires again but in the other format . A total of 65 hearing-aid users were recruited from a hearing clinic to participate on a voluntary basis and of these 53 completed both versions of the question naires . Results A significant main effect of format was found on the HHIE ( p < 0.001 ) , with participants reporting higher scores on the online format than in the paper format . There was no interaction effect . For the other question naires were no significant main or interaction effects of format . Significant correlations between the two ways of presenting the measures was found for all question naires ( p<0.05 ) . The results from reliability tests showed Cronbachs α ’s above .70 for all four question naires and differences in Cronbachs α between administration formats were negligible . Conclusions For three of the four included question naires the participants ’ scores remained consistent across administrations and formats . For the fourth included question naire ( HHIE ) a significant difference of format with a small effect size was found . The relevance of the difference in scores between the formats depends on which context the question naire is used in . On balance , it is recommended that the administration format remain stable across assessment points It has been argued that behavior on the Internet differs from similar behavior in the “ real world ” ( Joinson , 1998a ) . In the present study , participants completed measures of self-consciousness , social anxiety , self-esteem , and social desirability , using either the World-Wide Web ( WWW ) or pen and paper , and were assigned to either an anonymous or a nonanonymous condition . It was found that people reported lower social anxiety and social desirability and higher self-esteem when they were anonymous than when they were nonanonymous . Furthermore , participants also reported lower social anxiety and social desirability when they were using the Internet than when they were using paper-based methods . Contrast analyses supported the prediction that participants using the WWW anonymously would show the lowest levels of social desirability , whereas participants answering with pen and paper nonanonymously would score highest on the same measure . Implication s for the use of the Internet for the collection of psychological data are discussed This study examines whether the Internet-based question naire is psychometrically equivalent to the paper-based question naire . A r and om sample of 2,400 teachers in Taiwan was divided into experimental and control groups . The experimental group was invited to complete the electronic form of the Chinese version of Center for Epidemiologic Studies Depression Scale ( CES-D ) placed on the Internet , whereas the control group was invited to complete the paper- OUTPUT:
When digital versions of self-report symptom scales are compared to pen and paper versions , most scales show high interformat reliability . This supports the reliability of results obtained in psychotherapy research on the Internet and the comparability of the results to traditional psychotherapy research .
MS2_dynamic_1_shot430
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: Aims /hypothesisLow 25-hydroxyvitamin D levels predict future cardiovascular events and are common in patients with type 2 diabetes . We compared the effect of 100,000 and 200,000 IU doses of vitamin D3 on endothelial function , blood pressure and markers of glycaemic control in patients with type 2 diabetes . Methods This was a r and omised , parallel group , placebo-controlled trial . Patients with type 2 diabetes and baseline 25-hydroxyvitamin D levels < 100 nmol/l were enrolled from community and hospital-based diabetes clinics . Participants were assessed in a university department of clinical pharmacology and received a single oral dose of placebo or vitamin D3 ( 100,000 IU or 200,000 IU ) at baseline , r and omly allocated via numbered bottles prepared offsite ; participants and investigators were both blinded to treatment allocation . Endothelial function , office blood pressure , B-type natriuretic peptide , insulin resistance and glycosylated haemoglobin were measured at baseline , and at 8 and 16 weeks . Results We r and omised 61 participants to the three groups ( placebo 22 , 100,000 IU vitamin D3 19 , 200,000 IU vitamin D3 20 ) . There was no significant difference in the primary outcome of endothelial function at 8 weeks ( placebo 5.2 % , n = 22 ; 100,000 IU 4.3 % , n = 19 ; 200,000 IU 4.9 % , n = 17 ) or at 16 weeks . Insulin resistance and glycosylated haemoglobin did not improve with either dose of vitamin D3 . On covariate analysis , systolic blood pressure was significantly lower in both treatment arms than in the placebo group at 8 weeks ( placebo 146.4 mmHg , 100,000 IU 141.4 mmHg [ p = 0.04 vs placebo ] , 200,000 IU 136.8 mmHg [ p = 0.03 vs placebo ] ) . B-type natriuretic peptide levels were significantly lower in the 200,000 IU group by 16 weeks ( placebo 34 pg/ml , 200,000 IU 21 pg/ml , p = 0.02 ) . No significant excess of adverse effects was noted in the treatment arms . Conclusions /interpretationHigh-dose vitamin D3 improved systolic blood pressure and B-type natriuretic peptide levels , but not endothelial function , insulin resistance or glycosylated haemoglobin in patients with type 2 diabetes . Trial registration IS RCT N50587697 ( www.controlled-trials.com ) Funding Diabetes UK , grant number 06/0003429 . M. D. Witham is funded by a Scottish Government NES/CSO Clinician Scientist Award BACKGROUND Adequate calcium intake can have a favorable effect on some metabolic variables . OBJECTIVE The objective of the study was to determine the effects of daily calcium intake and of supplementation with calcium and vitamin D ( calcium+D ) during a weight-loss intervention on blood pressures , plasma lipid and lipoprotein concentrations , and glucose and insulin concentrations in low calcium consumers . DESIGN Healthy , overweight or obese women ( n = 63 ) with a daily calcium intake of < 800 mg/d were r and omly assigned in a double-blind manner to 1 of 2 groups : the group consuming 2 tablets/d of a calcium + vitamin D supplement ( 600 mg elemental calcium and 200 IU vitamin D/tablet ) or the group consuming placebo ; both groups observed a 700 kcal/d energy restriction . These 63 women then completed a 15-wk weight-loss intervention . RESULTS Initial daily calcium intake was significantly correlated with plasma HDL cholesterol ( r = 0.41 , P < 0.001 ) and with 2-h postload glycemia ( r = -0.29 , P < 0.05 ) during an oral-glucose-tolerance test , independent of fat mass and waist circumference . After the 15-wk intervention , significantly greater decreases in total : LDL and LDL : HDL ( P < 0.01 for both ) and of LDL cholesterol ( P < 0.05 ) were observed in the calcium+D group than in the placebo group . The differences in total : HDL and LDL : HDL were independent of changes in fat mass and in waist circumference . A tendency for more beneficial changes in HDL cholesterol , triacylglycerol , and total cholesterol was also observed in the calcium+D group ( P = 0.08 ) . CONCLUSION Consumption of calcium+D during a weight-loss intervention enhanced the beneficial effect of body weight loss on the lipid and lipoprotein profile in overweight or obese women with usual low daily calcium intake BACKGROUND Indirect evidence suggests that optimal vitamin D status is achieved with a serum 25-hydroxyvitamin D [ 25(OH)D ] concentration > 75 nmol/L. OBJECTIVE We aim ed to determine the intake of vitamin D(3 ) needed to raise serum 25(OH)D to > 75 nmol/L. DESIGN The design was a 6-mo , prospect i ve , r and omized , double-blinded , double-dummy , placebo-controlled study of vitamin D(3 ) supplementation . Serum 25(OH OUTPUT: Combining all studies , no significant improvement was seen in fasting glucose , HbA(1c ) or insulin resistance in those treated with vitamin D compared with placebo . No effect was seen on glycated haemoglobin in patients with diabetes and no differences were seen for any outcome in patients with normal fasting glucose . Insufficient data were available to draw conclusions regarding micro- or macrovascular events ; two trials failed to show a reduction in new cases of diabetes in patients treated with vitamin D. CONCLUSIONS There is currently insufficient evidence of beneficial effect to recommend vitamin D supplementation as a means of improving glycaemia or insulin resistance in patients with diabetes , normal fasting glucose or impaired glucose tolerance INPUT: BACKGROUND Low serum concentrations of 25-hydroxyvitamin D [ 25(OH)D ] have been associated with impaired glucose tolerance and diabetes . OBJECTIVE This study aim ed to compare the effects of daily intake of vitamin D- or vitamin D(3 ) + calcium-fortified yogurt drink on glycemic status in subjects with type 2 diabetes ( T2D ) . DESIGN Ninety diabetic subjects were r and omly allocated to 3 groups to consume plain yogurt drink ( PY ; containing no vitamin D and 150 mg Ca/250 mL ) , vitamin D-fortified yogurt drink ( DY ; containing 500 IU vitamin D(3 ) and 150 mg Ca/250 mL ) , or vitamin D + calcium-fortified yogurt drink ( DCY ; containing 500 IU vitamin D(3 ) and 250 mg Ca/250 mL ) twice per day for 12 wk . Fasting serum glucose ( FSG ) , glycated hemoglobin ( Hb A(1c ) ) , homeostasis model assessment of insulin resistance ( HOMA-IR ) , serum lipid profile , and percentage fat mass ( FM ) were assessed before ( baseline ) and after the intervention . RESULTS In both the DY and DCY groups , mean serum 25(OH)D(3 ) improved ( + 32.8 ± 28.4 and + 28.8 ± 16.1 nmol/L , respectively ; P < 0.001 for both ) , but FSG [ -12.9 ± 33.7 mg/dL ( P = 0.015 ) and -9.6 ± 46.9 mg/dL ( P = 0.035 ) ] , Hb A(1c ) [ -0.4 ± 1.2 % ( P < 0.001 ) and -0.4 ± 1.9 % ( P < 0.001 ) ] , HOMA-IR [ -0.6 ± 1.4 ( P = 0.001 ) and -0.6 ± 3.2 ( P < 0.001 ) ] , waist circumference ( -3.6 ± 2.7 and -2.9 ± 3.3 ; P < 0.001 for both ) , and body mass index [ in kg/m(2 ) ; -0.9 ± 0.6 ( P < 0.001 ) and -0.4 ± 0.7 ( P = 0.005 ) ] decreased significantly more than in the PY group . An inverse correlation was observed between changes in serum 25(OH)D(3 ) and FSG ( r = -0.208 , P = 0.049 ) , FM ( r = -0.219 , P = 0.038 ) , and HOMA-IR ( r = -0.219 , P = 0.005 ) . CONCLUSION Daily intake of a vitamin D-fortified yogurt drink , either with or without added calcium , improved glycemic status in T2D patients . This trial was registered at clinical trials.gov as NCT01229891 This study aim ed to investigate the effects of daily intake of vitamin D-fortified yogurt drink ( doogh ) on central obesity indicators in subjects with type 2 diabetes ( T2D ) and the possible modulation of this effect by vitamin D receptor ( VDR ) Cdx-2 genotypes . A total of sixty T2D subjects were r and omly allocated to two groups to receive either plain doogh ( PD ; n 29 , containing 170 mg Ca and no vitamin D/250 ml ) or vitamin D3-fortified doogh ( FD ; n 31 , containing 170 mg Ca and 12·5 μg/250 ml ) twice a day for 12 weeks . 25-hydroxyvitamin D ( 25(OH)D ) , glycaemic as well as adiposity indicators were evaluated before and after the intervention . VDR-Cdx-2 genotypes in extended number of T2D subjects in the FD group ( n 60 ) were determined as AA , GA and GG . After 12 weeks , in FD compared with PD , serum 25(OH)D increased ( + 35·4 v. -4·8 nmol/l ; P<0·001 ) and mean changes of waist circumference ( WC ; -1·3 v. + 1·6 cm ; P=0·02 ) , body fat mass ( FM ; -1·9 v. + 0·60 % ; P=0·008 ) , truncal fat ( TF ; -1·1 v. 0·13 % ; P=0·003 ) and visceral adipose tissue ( -0·80 v. + 0·37 AU ; P<0·001 ) decreased significantly . Circulating 25(OH)D was raised only in the AA group ( 34·8 nmo/l in AA group v. -6·4 nmol/l in AG and -1·6 nmol/l in GG groups ; P<0·001 ) , which was accompanied by a significant decrease in changes of WC ( P=0·004 ) , FM% ( P=0·01 ) and TF% ( P<0·001 ) in the AA genotype . Daily intake of vitamin D-FD for 12 weeks improved the central obesity indices in T2D subjects , and the improvement was more pronounced in the carriers of the AA genotype of VDR-Cdx-2 Background : Peripheral neuropathy is a common complaint of diabetes . This study aim ed to determine the effects of 12 weeks combined training with Vitamin D supplement on improvement of sensory-mot OUTPUT:
This meta- analysis suggests that vitamin D supplementation improves indices of glycemic control ( FBG , HOMA-IR , and HbA1C ) in patients with diabetes mellitus . Hence , vitamin D supplements may be of potential therapeutic value in diabetic patients , as an adjuvant therapy along with other treatments
MS2_dynamic_1_shot431
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: Objective : To prospect ively compare the functional outcome associated with cemented and uncemented hemiarthroplasty . Design : Prospect i ve r and omized control trial . Setting : University-affiliated level 1 trauma center . Patients / Participants : All individuals design ated for hemiarthroplasty , older than 55 years , with a nonpathologic displaced femoral neck fracture and the ability to ambulate 10 feet independently before injury [ 269 patients ( 274 hips ) presented with displaced femoral neck fracture , 130 patients ( 48.3 % ) enrolled , and 5 patients ( 3.8 % ) withdrew ] . Intervention : Hip hemiarthroplasty with a cemented femoral prosthesis ( VerSys LD/Fx ; Zimmer , Warsaw , IN ) or an uncemented component ( VerSys Beaded FullCoat ; Zimmer , Warsaw , IN ) . Main Outcome Measures : Instrumental Activities of Daily Living and Physical Activities of Daily Living scales ( Older Americans Re sources and Services Instrument ) and the Energy/Fatigue Scale . Results : No statistically significant differences were present in the groups ' preoperative or intraoperative characteristics , including American Society of Anesthesiologists grade , operative time , anesthesia time , use of perioperative & bgr;-blockers , estimated blood loss , or the rate of intraoperative fracture . Postoperatively , no difference was found in hemoglobin level , transfusion rate , discharge disposition , or acute complication rate . At 30-day , 60-day , and 1-year follow-ups , no clinical ly or statistically significant differences were found in mortality , disposition , need for assistance with ambulation , Older Americans Re sources and Services Activities of Daily Living subscales , or the Energy/Fatigue Scale . Conclusions : In the treatment of nonpathologic displaced femoral neck fractures , the use of cemented and uncemented femoral components is associated with similar functional outcome at 1 year . Practitioners may inform their clinical decisions using these equally good results . Level of Evidence : Therapeutic Level II . See page 128 for a complete description of levels of evidence Hip hemiarthroplasties are frequently performed for displaced femoral neck fractures . The purpose of this study was to identify the costs associated with cementless and cemented hemiarthroplasties , compare operative times , and identify complications . The hypothesis was that cementless hemiarthroplasties cost less than cemented hemiarthroplasties , require less operative time , and have fewer perioperative complications . A retrospective review was conducted of 2 surgeons ' patients admitted for displaced femoral neck fractures between 2006 and 2010 . Group 1 included 45 patients who underwent monopolar hemiarthroplasties with cementless femoral components via a st and ard posterior approach by a single surgeon . Group 2 included 49 patients who underwent monopolar hemiarthroplasties with cemented femoral components via a modified lateral approach by a single surgeon . Surgical and anesthesia times and the cost of implants and accessories were recorded . The cost for cementless components was $ 3275.60 ( femoral stem , $ 2800 ; monopolar head , $ 400 ; sleeve , $ 75.60 ) , whereas the cost of cemented components was $ 3694.47 ( femoral stem , $ 1800 ; monopolar head , $ 400 ; sleeve , $ 75.60 , 3 Simplex with tobramycin cement packets , $ 1221 ; cement mixer/irrigator with tip/ central izer and plug/pressurizer , $ 197.87 ) , a cost savings of 12.7 % ( $ 418.87 ) . Operative time was significantly reduced in group 1 vs group 2 ( mean , 32.9 vs 56.1 minutes , respectively ; P<.01 ) . Anesthesia time was also significantly reduced in group 1 ( mean , 82.3 vs 102.9 minutes , respectively ; P<.01 ) . The difference in mean anesthetic times demonstrates an overall cost savings of 18.6 % , or $ 1161.30 . No difference in complications was noted between the groups perioperatively . Regional cost variances , vendor-hospital contracts , and surgeons ' operative times are factors that may influence cost savings . This study demonstrates significantly lower operative and anesthetic times and observable cost savings with cementless femoral implants Background Displaced femoral neck fractures usually are treated with hemiarthroplasty . However , the degree to which the design of the implant used ( cemented or uncemented ) affects the outcome is not known and may be therapeutically important . Questions / purpose sIn this r and omized controlled trial , we sought to compare cemented with cementless fixation in bipolar hemiarthroplasties at 5 years in terms of ( 1 ) Harris hip scores ; ( 2 ) femoral fractures ; ( 3 ) overall health outcomes using the Barthel Index and EQ-5D scores ; and ( 4 ) complications , reoperations , and mortality since our earlier report on this cohort at 1-year followup . Methods We present followup at a median of 5 years after surgery ( range , 56–65 months ) from a r and omized trial comparing a cemented hemiarthroplasty ( 112 hips ) with an uncemented , hydroxyapatite-coated hemiarthroplasty ( 108 hips ) , both with a bipolar head . Results were previously reported at 1-year followup . Harris hip scores , Barthel Index , and EQ-5D scores were assessed by one research nurse and one orthopaedic surgeon . Complications and reoperations were determined by chart review and radiographs examined by OUTPUT: There was no statistically significant difference for any other outcome between the two methods of fixation . Conclusion In hemiarthroplasty of the hip using current generation stems , cemented stems result in fewer implant‐related complications and similar mortality compared with cementless stems INPUT: Background The aim of this study is to compare the functional midterm outcome of stemless shoulder prostheses with st and ard anatomical stemmed shoulder prostheses and to show that the STEMLESS results are comparable to the STEMMED with respect to active maximum range of shoulder motion ( ROM ) and Constant score ( CS ) . Methods Seventeen patients underwent total shoulder arthroplasty ( TSA ) in 25 shoulder joints . Stemless TSA was performed in 12 shoulder joints ( group STEMLESS ) , third-generation stemmed TSA in 13 shoulder joints ( group STEMMED ) . Functional results were documented using the CS . 3D-motion- analysis using the Heidelberg upper extremity model ( HUX ) was conducted to measure active maximum ( ROM ) . Results The group STEMLESS achieved a CS of 67.9 ( SD 12.0 ) points and the group STEMMED of 70.2 ( SD 5.8 points ) without significant difference between the groups ( p = 0.925 ) . The maximum ROM of the group STEMLESS , ascertained by 3-D-motion- analysis , was in forward flexion 125.5 ° ( SD 17.2 ° ) , in extension 49.4 ° ( SD 13.8 ° ) , in abduction 126.2 ° ( SD 28.5 ° ) and in external rotation 40.3 ° ( SD 13.9 ° ) . The maximum ROM of the group STEMMED , also ascertained by 3-D-motion analysis , was in forward flexion 135.0 ° ( SD 16.8 ° ) , in extension 47.2 ° ( SD 11.5 ° ) , in abduction 136.3 ° ( SD 24.2 ° ) and in external rotation 40.1 ° ( SD 12.2 ° ) . The maximum ROM of the STEMLESS group was lower in forward flexion and abduction , higher in extension and almost identical in external rotation . But there was no significant difference ( forward flexion p = 0.174 , extension p = 0.470 , abduction p = 0.345 , external rotation p = 0.978 ) . Conclusion Both types of shoulder prostheses achieve a similar and good active ROM and similar results in CS.Trial registration DRKS00013166 , retrospectively registered , Background Stemless shoulder arthroplasty is a fairly new concept . Clinical and radiological follow-up is essential to prove implant safety and concept . This prospect i ve single-centre study was performed to evaluate the influence of radiological changes on clinical mid-term outcome following stemless humeral head replacement with hollow screw fixation . Methods Short- and mid-term radiological and clinical evaluations were performed in 73 consecutive shoulders treated mainly for idiopathic and posttraumatic osteoarthritis with stemless humeral head arthroplasty including 40 hemi- ( HSA ) and 33 total shoulder arthroplasties ( TSA ) . Operating times of stemless implantations were compared to 110 stemmed anatomical shoulder prostheses . Appearances of humeral radiolucencies or radiological signs of osteolysis or stress shielding were assessed on st and ardized radiographs . Patients ’ clinical outcome was evaluated using the Constant score and patients ’ satisfaction was documented . Results Radiological changes , detected in 37.0 % , did not affect clinical outcome . Constant scores significantly improved from baseline to short and mid-term follow-up ( p < 0.001 ) . The majority of patients ( 96.2 % ) were satisfied with the procedure . No loosening of the humeral head component was detected during a mean follow-up of 58 months . Operating times were significantly shorter with stemless compared to stemmed implants ( p < 0.001 ) . Conclusions Clinical mid-term outcome after stemless humeral head replacement was not affected by radiological changes . Trial registration The institutional review board ( St. Vincent Hospital Vienna ; 201212_EK01 ; date of issue : 11.12.2012 ) approved the study . The trial was registered at Clinical Trials.gov ( NCT02754024 ) . Retrospective registration BACKGROUND Several stemless shoulder implants are available on the market , but only a few studies have presented results with sufficient mid- to long-term follow-up . The present study evaluated clinical and radiologic outcomes 9 years after anatomic stemless shoulder replacement . METHODS This is a prospect i ve cohort study evaluating the stemless shoulder prosthesis since 2005 . Anatomic stemless shoulder replacement using a single prosthesis was performed in 49 shoulders ; 17 underwent total shoulder replacement , and 32 underwent hemiarthroplasty . Forty-three patients were clinical ly and radiologically monitored after a mean of 9 years ( range , 90 - 127 months ; follow-up rate , 88 % ) . The indications for shoulder replacement were primary osteoarthritis in 7 shoulders , post-traumatic in 24 , instability in 7 , cuff tear arthropathy in 2 , postinfectious arthritis in 1 , and revision arthroplasty in 2 . RESULTS The Constant-Murley Score improved significantly from 52 % to 79 % ( P < .0001 ) . The active range of motion also increased significantly for flexion from 101 ° to 118 ° ( P = .022 ) , for abduction from 79 ° to 105 ° ( P = .02 ) , and for external rotation from 21 ° to 43 ° ( P < .0001 ) . Radiologic evaluation revealed incomplete radiolucency in 1 patient without clinical significance or further intervention . No revision caused by loosening or countersinking of the humeral implant was observed . CONCLUSIONS The 9-year outcome after stemless shoulder replacement is OUTPUT:
Stemless anatomic TSA result ed in similar functional outcomes and complication rates to stemmed TSA with decreased operative time and lower blood loss .
MS2_dynamic_1_shot432
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: ABSTRACT Lifestyle interventions can prevent diabetes through weight loss , but they are rarely translated for use in underserved communities . The aim of this study was to describe how a community – academic partnership formed and developed a program to address local health disparities by developing a low-cost , culturally and economically appropriate , peer-led community-based diabetes prevention program . Using a participatory approach , the partnership chose to focus on diabetes prevention , and co-developed all intervention , recruitment , research , and evaluation strategies . The partnership 's philosophy to maintain high clinical and scientific st and ards paired with their ability to represent and engage the community facilitated the development of a r and omized controlled trial that achieved statistically significant and sustained weight loss , and the recruitment of a largely Spanish-speaking , low income , uninsured population . The success of this intervention lies in the partnership 's commitment to the community , co-ownership of research , and a careful balance between academic rigor and community engagement and relevance BACKGROUND Since the Diabetes Prevention Project ( DPP ) demonstrated that lifestyle weight-loss interventions can reduce the incidence of diabetes by 58 % , several studies have translated the DPP methods to public health-friendly context s. Although these studies have demonstrated short-term effects , no study to date has examined the impact of a translated DPP intervention on blood glucose and adiposity beyond 12 months of follow-up . PURPOSE To examine the impact of a 24-month , community-based diabetes prevention program on fasting blood glucose , insulin , insulin resistance as well as body weight , waist circumference , and BMI in the second year of follow-up . DESIGN An RCT comparing a 24-month lifestyle weight-loss program ( LWL ) to an enhanced usual care condition ( UCC ) in participants with prediabetes ( fasting blood glucose=95 - 125 mg/dL ) . Data were collected in 2007 - 2011 ; analyses were conducted in 2011 - 2012 . SETTING / PARTICIPANTS 301 participants with prediabetes were r and omized ; 261 completed the study . The intervention was held in community-based sites . INTERVENTION The LWL program was led by community health workers and sought to induce 7 % weight loss at 6 months that would be maintained over time through decreased caloric intake and increased physical activity . The UCC received two visits with a registered dietitian and a monthly newsletter . MAIN OUTCOME MEASURES The main measures were fasting blood glucose , insulin , insulin resistance , body weight , waist circumference , and BMI . RESULTS Intent-to-treat analyses of between-group differences in the average of 18- and 24-month measures of outcomes ( controlling for baseline values ) revealed that the LWL participants experienced greater decreases in fasting glucose ( -4.35 mg/dL ) ; insulin ( -3.01 μU/ml ) ; insulin resistance ( -0.97 ) ; body weight ( -4.19 kg ) ; waist circumference ( -3.23 cm ) ; and BMI ( -1.40 ) , all p-values < 0.01 . CONCLUSIONS A diabetes prevention program administered through an existing community-based system and delivered by community health workers is effective at inducing significant long-term reductions in metabolic indicators and adiposity Purpose The objective was to take prevention from the clinic to the community by including a high-risk group and working with the community to tailor , enhance , deliver , and evaluate a community-based version of the Diabetes Prevention Program ’s ( DPP ) clinic-based lifestyle intervention . Methods This was a nonr and omized prospect i ve study using a single-group design . Study eligibility included a screening glucose value in the normal to prediabetes range with no current diagnosis of diabetes , overweight , not pregnant nor planning to become pregnant during study period , aged 18 to 65 , Latino , living in the study target communities , and no reported medical restrictions related to the program goals . A total of 69 individuals participated . The Healthy Living Program ( HLP ) was based on the DPP ’s 1-year intensive lifestyle program , was tailored and enhanced for a Latino community , and was delivered by community health workers . Anthropometric and paper and pencil measures were administered to examine program outcome at 6 months and 12 months . Results In general , results indicate statistically significant improvements in anthropometrics and many behavioral outcomes , particularly at 6 months . Participants demonstrated forward movement through the stages of change during the program . Conclusions Results support the effectiveness of the intervention and show that delivery of the translated version of the DPP ’s lifestyle intervention in the community by community residents holds promise as one strategy to reach people at increased risk of developing diabetes . Use of this translation model , including collaboration with community health workers , offers diabetes educators an opportunity to extend their reach into underserved communities Introduction Hispanics are at increased risk of developing type 2 diabetes . Lifestyle interventions are effective in preventing diabetes and restoring glucose regulation . Methods We recruited Hispanic men and women ( N = 320 ) who were residents of the Lower Yakima Valley , Washington , aged 18 years or older with hemoglobin A1c ( HbA1c ) levels higher than 6 % to a parallel 2-arm r and omized-controlled trial conducted from 2008 through 2012 . The trial compared participants in the intervention arm , who received an immediate educational curriculum ( n = 166 ) , to participants in the control arm , who received a delayed educational curriculum ( n = 154 ) . The home-based curriculum consisted of 5 sessions led by community health workers and was design ed to inform participants about diabetes , diabetes treatment , and healthy dietary and physical activity behaviors . Participants were r and omly assigned to the intervention and control arms , and analysts were OUTPUT: Overall the training was culturally sensitive and /or appropriate , covering topics such as the importance of good nutrition and the benefits of increased physical activity , communication and leadership . CHWs delivered a variety of interventions and also screened or recruited participants . The shared culture and language between CHWs and participants likely contributed to better programme implementation and successful outcomes . The complexity of DPPs and the diverse CHW roles preclude attributing specific outcomes to CHW involvement . INPUT: BACKGROUND The Diabetes Prevention Program ( DPP ) found that an intensive lifestyle intervention can reduce the development of diabetes by more than half in adults with prediabetes , but there is little information about the feasibility of offering such an intervention in community setting s. This study evaluated the delivery of a group-based DPP lifestyle intervention in partnership with the YMCA . METHODS This pilot cluster-r and omized trial was design ed to compare group-based DPP lifestyle intervention delivery by the YMCA to brief counseling alone ( control ) in adults who attended a diabetes risk-screening event at one of two semi-urban YMCA facilities and who had a BMI > or=24 kg/m2 , > or=2 diabetes risk factors , and a r and om capillary blood glucose of 110 - 199 mg/dL. Multivariate regression was used to compare between-group differences in changes in body weight , blood pressures , HbA1c , total cholesterol , and HDL-cholesterol after 6 and 12 months . RESULTS Among 92 participants , controls were more often women ( 61 % vs 50 % ) and of nonwhite race ( 29 % vs 7 % ) . After 6 months , body weight decreased by 6.0 % ( 95 % CI=4.7 , 7.3 ) in intervention participants and 2.0 % ( 95 % CI=0.6 , 3.3 ) in controls ( p<0.001 ; difference between groups ) . Intervention participants also had greater changes in total cholesterol ( -22 mg/dL vs + 6 mg/dL controls ; p<0.001 ) . These differences were sustained after 12 months , and adjustment for differences in race and gender did not alter these findings . With only two matched YMCA sites , it was not possible to adjust for potential clustering by site . CONCLUSIONS The YMCA may be a promising channel for wide-scale dissemination of a low-cost approach to lifestyle diabetes prevention Purpose The objective was to take prevention from the clinic to the community by including a high-risk group and working with the community to tailor , enhance , deliver , and evaluate a community-based version of the Diabetes Prevention Program ’s ( DPP ) clinic-based lifestyle intervention . Methods This was a nonr and omized prospect i ve study using a single-group design . Study eligibility included a screening glucose value in the normal to prediabetes range with no current diagnosis of diabetes , overweight , not pregnant nor planning to become pregnant during study period , aged 18 to 65 , Latino , living in the study target communities , and no reported medical restrictions related to the program goals . A total of 69 individuals participated . The Healthy Living Program ( HLP ) was based on the DPP ’s 1-year intensive lifestyle program , was tailored and enhanced for a Latino community , and was delivered by community health workers . Anthropometric and paper and pencil measures were administered to examine program outcome at 6 months and 12 months . Results In general , results indicate statistically significant improvements in anthropometrics and many behavioral outcomes , particularly at 6 months . Participants demonstrated forward movement through the stages of change during the program . Conclusions Results support the effectiveness of the intervention and show that delivery of the translated version of the DPP ’s lifestyle intervention in the community by community residents holds promise as one strategy to reach people at increased risk of developing diabetes . Use of this translation model , including collaboration with community health workers , offers diabetes educators an opportunity to extend their reach into underserved communities Asian Americans experience diabetes at a higher rate than non-Hispanic whites . Diabetes prevention programs using lifestyle interventions have been shown to produce beneficial results , yet there have been no culturally-tailored programs for diabetes prevention in the Korean community . We explore the impact and feasibility of a pilot Community Health Worker ( CHW ) intervention to improve health behaviors and promote diabetes prevention among Korean Americans using a r and omized controlled trial . Between 2011 and 2012 , a total of 48 Korean Americans at risk for diabetes living in New York City ( NYC ) participated in the intervention . Participants were allocated to treatment or control groups . A community-based participatory research approach guided development of the intervention , which consisted of 6 workshops held by CHWs on diabetes prevention , nutrition , physical activity , diabetes complications , stress and family support , and access to health care . Changes over 6 months were examined for clinical measurements ( weight , BMI , waist circumference , blood pressure , glucose , and cholesterol ) ; health behaviors ( physical activity , nutrition , food behaviors , diabetes knowledge , self-efficacy , and mental health ) ; and health access ( insurance and self-reported health ) . In this small pilot study , changes were seen in weight , waist circumference , diastolic blood pressure , physical activity nutrition , diabetes knowledge , and mental health . Qualitative findings provide additional context ual information that inform ways in which CHWs may influence health outcomes . These findings demonstrate that a diabetes prevention program can be successful among a Korean American population in NYC , and important insight is provided for ways that programs can be tailored to meet the needs of vulnerable population Prevention of type 2 diabetes by intensive lifestyle intervention design ed to achieve and maintain ideal body weight was assessed in subjects with impaired glucose tolerance ( IGT ) . Male subjects with IGT recruited from health-screening examinees were r and omly assigned in a 4:1 ratio to a st and ard intervention group ( control group ) and intensive intervention group ( intervention group ) . The final numbers of subjects were 356 and 102 , respectively . The subjects in the control group and in the intervention group were advised to maintain body mass index ( BMI ) of < 24.0 kg/m2 and of < 22.0 kg/m2 , respectively , by diet and exercise . In the intervention group , detailed instructions on lifestyle were repeated every OUTPUT:
Findings are subject to incomplete reporting and heterogeneity of studies included , and confounding because most included studies used pre-post study design s. CONCLUSIONS DPP lifestyle modification programs achieved clinical ly meaningful weight and cardiometabolic health improvements . Together , these data suggest that additional value is gained from these programs , reinforcing that they are likely very cost-effective
MS2_dynamic_1_shot433
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: PURPOSE This study 's purpose was to test silver diammine fluoride ( SDF ) in arresting incipient occlusal caries in erupting permanent first molars and to compare it with other approaches . METHODS Sixty-six first erupting permanent molars were r and omly divided into 3 groups : cross tooth-brushing technique ( CTT ) , application of SDF , and glass ionomer fissure sealant ( GIC ) . The clinical procedures were conducted by the same dentist . Teeth were assessed clinical ly by 1 blinded examiner using visual inspection at baseline and after 3 , 6 , 12 , 18 , and 30 months and radiographically at 6- , 12- , and 30-month follow-up evaluations . The Kruskall-Wallis test was used to compare noninvasive treatments , and the Friedman test was performed to evaluate differences for each group during different follow-up periods . RESULTS A reduced number of active caries lesions was noted in all groups . After 3 and 6 months , SDF showed a significantly greater capacity for arresting caries lesions than CTT and GIC . At 18- and 30-month evaluations , no differences were observed among the 3 groups . All groups showed differences between baseline and all follow-up re-examinations . CONCLUSIONS All the tested techniques are equally efficient in controlling initial occlusal caries in erupting permanent first molars after 30-months of follow-up Glass ionomer cements possess several properties that support their consideration in a wide variety of clinical applications including Pit and fissure sealants . The aim of this study was to compare and evaluate Fuji III and Fuji VII glass ionomer sealants in terms of retention , caries incidence and salivary fluoride release between two groups of children aged 6 and -8 years respectively . One hundred and ten first permanent molars were sealed and the clinical evaluation showed no incidence of caries . There was partial or complete retention of the sealant in 80 % of the treated teeth in both groups at the one-year evaluation . Irrespective of the sealant used , the pattern of fluoride release remained consistent , with an initial high fluoride release followed by low prolonged leakage before returning to baseline value at the end of one year Background Occlusal surfaces of erupting and newly erupted permanent molars are particularly susceptible to caries . The objective of the study was to assess and compare the effect of a single application of 38 % SDF with ART sealants and no treatment in preventing dentinal ( D3 ) caries lesions on occlusal surfaces of permanent first molars of school children who participated in a daily school-based toothbrushing program with fluoride toothpaste . Methods The prospect i ve community clinical trial in the Philippines was conducted over a period of 18 months and included 704 six- to eight-year-old school children in eight public elementary schools with a daily school-based fluoride toothpaste brushing program . Children were r and omly assigned for SDF application or ART sealant treatment . Children from two of the eight schools did not receive SDF or ART sealant treatment and served as controls . SDF or ART sealant treatment was applied on sound occlusal surfaces of permanent first molars . Surfaces that were originally defined as sound at baseline but which changed to dentinal ( D3 ) caries lesions were defined as surfaces with new caries ( caries increment ) . Non-compliance to the daily toothbrushing program in three schools offered the opportunity to analyze the caries preventive effect of SDF and sealants separately in fluoride toothpaste brushing and in non-toothbrushing children . Results In the brushing group , caries increment in the SDF treatment group was comparable with the non-treatment group but caries increment in the sealant group was lower than in the non-treatment group with a statistically significant lower hazard ratio of 0.12 ( 0.02 - 0.61 ) . In the non-brushing group , caries increment in the SDF treatment group and the sealant group was lower than the non-treatment group but the hazard ratio was only statistically significant for the sealant group ( HR 0.33 ; 0.20 - 0.54 ) . Caries increment was lower in toothbrushing children than in non-toothbrushing children . Hazard ratios reached statistical significance for the non-treated children ( HR 0.43 ; 0.21 - 0.87 ) and the sealant-treated children ( HR 0.15 ; 0.03 - 0.072 ) . Conclusions A one-time application of 38 % SDF on the occlusal surfaces of permanent first molars of six- to eight-year-old children is not an effective method to prevent dentinal ( D3 ) caries lesions . ART sealants significantly reduced the onset of caries over a period of 18 months . Trial registration numberGerman Clinical Trial Register The aim of the present study was to compare intraindividually a type III fissure-sealant , glass ionomer cement with a resin-based sealant . One hundred and forty-eight first permanent molars were sealed in forty-seven children . After three years 20.8 percent of the resin and 34.7 percent of the glass ionomer cement sealants were partially lost , and 0 percent and 37.5 percent , respectively , were totally lost . One tooth ( 1.4 percent ) in the glass ionomer cement group and three teeth ( 4.2 percent ) in the resin group developed caries OBJECTIVES A split-mouth r and omized clinical trial was carried out to assess the effectiveness of a school-based dental sealant ( SBDS ) program for French children from low-income background s. The secondary objectives were to determine the effectiveness of the program according to the baseline individual caries risk ( ICR ) and to assess the sealant retention . METHODS The study included 276 pupils from Nice . The sealing was performed in the first or second grade s. The permanent first molars were r and omized into two groups : one received resin-based sealant and the other OUTPUT: Resin-based sealants applied on occlusal surfaces of permanent molars are effective for preventing caries in children and adolescents . Similar benefit was seen at timepoints up to 48 months ; after longer follow-up , the quantity and quality of evidence was reduced . There was insufficient evidence to judge the effectiveness of glass ionomer sealant or the relative effectiveness of different types of sealants . INPUT: Background Occlusal surfaces of erupting and newly erupted permanent molars are particularly susceptible to caries . The objective of the study was to assess and compare the effect of a single application of 38 % SDF with ART sealants and no treatment in preventing dentinal ( D3 ) caries lesions on occlusal surfaces of permanent first molars of school children who participated in a daily school-based toothbrushing program with fluoride toothpaste . Methods The prospect i ve community clinical trial in the Philippines was conducted over a period of 18 months and included 704 six- to eight-year-old school children in eight public elementary schools with a daily school-based fluoride toothpaste brushing program . Children were r and omly assigned for SDF application or ART sealant treatment . Children from two of the eight schools did not receive SDF or ART sealant treatment and served as controls . SDF or ART sealant treatment was applied on sound occlusal surfaces of permanent first molars . Surfaces that were originally defined as sound at baseline but which changed to dentinal ( D3 ) caries lesions were defined as surfaces with new caries ( caries increment ) . Non-compliance to the daily toothbrushing program in three schools offered the opportunity to analyze the caries preventive effect of SDF and sealants separately in fluoride toothpaste brushing and in non-toothbrushing children . Results In the brushing group , caries increment in the SDF treatment group was comparable with the non-treatment group but caries increment in the sealant group was lower than in the non-treatment group with a statistically significant lower hazard ratio of 0.12 ( 0.02 - 0.61 ) . In the non-brushing group , caries increment in the SDF treatment group and the sealant group was lower than the non-treatment group but the hazard ratio was only statistically significant for the sealant group ( HR 0.33 ; 0.20 - 0.54 ) . Caries increment was lower in toothbrushing children than in non-toothbrushing children . Hazard ratios reached statistical significance for the non-treated children ( HR 0.43 ; 0.21 - 0.87 ) and the sealant-treated children ( HR 0.15 ; 0.03 - 0.072 ) . Conclusions A one-time application of 38 % SDF on the occlusal surfaces of permanent first molars of six- to eight-year-old children is not an effective method to prevent dentinal ( D3 ) caries lesions . ART sealants significantly reduced the onset of caries over a period of 18 months . Trial registration numberGerman Clinical Trial Register BACKGROUND Failed restorations in primary teeth are not always re-restored . Is re-restoration not required anymore ? OBJECTIVE To compare survival rates of primary molars with intact and defective amalgam and ART restorations . METHODS A total of 649 restored primary molars , of which 162 were assessed with defective restorations for mechanical reasons , from a cluster-r and omised controlled clinical trial , were followed up over a period of 3.5 years . Restored primary molars , extracted because of dental sepsis or toothache , were considered a failure . Primary molars with defective restorations were followed up from the time they were assessed defective . Data were analysed using PHREG model with frailty correction , Wald test , t-test , and jackknife procedure . RESULTS The survival rate of primary molars with intact restorations ( 96.3 % ) was statistically significantly higher than that of primary molars with defective restorations ( 75.9 % ) over a 3-year period ( P < 0.0001 ) . Neither the effect of treatment protocol ( amalgam or ART ) ( P = 0.05 ) nor the type of surface ( single or multiple ) ( P = 0.73 ) was observed with respect to the survival rate of restored primary molars . CONCLUSIONS Survival rates for primary molars with intact and defective amalgam and ART restorations were high . The 3-year survival rate of primary molars with intact restorations was significantly higher than that of primary molars with defective restorations Clinical trials are normally performed with well-known br and s of glass ionomer cement ( GIC ) , but the cost of these material s is high for public healthcare in less-affluent communities . Given the need to research cheaper material s , it seems pertinent to investigate the retention rate of a low-cost GIC applied as atraumatic restorative treatment ( ART ) sealants in two centers in Brazil . Four hundred and thirty-seven 6-to-8-year-old schoolchildren were selected in two cities in Brazil . The children were r and omly divided into two groups , according to the tested GIC applied in the first permanent molars . The retention rate was evaluated after 3 , 6 and 12 months . Kaplan-Meier survival analysis and the log-rank test were performed . The variables were tested for association with sealant longevity , using logistic regression analyses ( α = 5 % ) . The retention rate of sealants after 12 months was 19.1 % . The high-cost GIC br and presented a 2-fold-more-likely-to-survive rate than the low-cost br and ( p < 0.001 ) . Significant difference was also found between the cities where the treatments were performed , in that Barueri presented a higher sealant survival rate than Recife ( p < 0.001 ) . The retention rate of a low-cost GIC sealant br and was markedly lower than that of a well-known GIC sealant br and Objectives This study aim ed to test the hypothesis that there is no difference in the survival rates of molars treated according to the conventional restorative treatment ( CRT ) using amalgam , atraumatic restorative treatment ( ART ) using high-viscosity glass ionomer , and ultraconservative treatment ( UCT ) protocol after 3.5 years . Material s and methods Cavitated primary molars were treated according to CRT , OUTPUT:
Conclusions ART single-surface restorations presented high survival percentages in both primary and permanent posterior teeth , whilst ART multiple-surface restorations presented lower survival percentages . ART sealants presented a high-caries-preventive effect . Clinical relevance ART is an effective evidence -based option for treating and preventing carious lesions in primary and permanent posterior teeth
MS2_dynamic_1_shot434
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: Purpose To evaluate the efficacy and safety of adalimumab in patients with non-radiographic axial spondyloarthritis ( nr-axSpA ) . Methods Patients fulfilled Assessment of Spondyloarthritis international Society ( ASAS ) criteria for axial spondyloarthritis , had a Bath Ankylosing Spondylitis Disease Activity Index ( BASDAI ) score of ≥ 4 , total back pain score of ≥ 4 ( 10 cm visual analogue scale ) and inadequate response , intolerance or contraindication to non-steroidal anti-inflammatory drugs ( NSAIDs ) ; patients fulfilling modified New York criteria for ankylosing spondylitis were excluded . Patients were r and omised to adalimumab ( N=91 ) or placebo ( N=94 ) . The primary endpoint was the percentage of patients achieving ASAS40 at week 12 . Efficacy assessment s included BASDAI and Ankylosing Spondylitis Disease Activity Score ( ASDAS ) . MRI was performed at baseline and week 12 and scored using the Spondyloarthritis Research Consortium of Canada ( SPARCC ) index . Results Significantly more patients in the adalimumab group achieved ASAS40 at week 12 compared with patients in the placebo group ( 36 % vs 15 % , p<0.001 ) . Significant clinical improvements based on other ASAS responses , ASDAS and BASDAI were also detected at week 12 with adalimumab treatment , as were improvements in quality of life measures . Inflammation in the spine and sacroiliac joints on MRI significantly decreased after 12 weeks of adalimumab treatment . Shorter disease duration , younger age , elevated baseline C-reactive protein or higher SPARCC MRI sacroiliac joint scores were associated with better week 12 responses to adalimumab . The safety profile was consistent with what is known for adalimumab in ankylosing spondylitis and other diseases . Conclusions In patients with nr-axSpA , adalimumab treatment result ed in effective control of disease activity , decreased inflammation and improved quality of life compared with placebo . Results from ABILITY-1 suggest that adalimumab has a positive benefit – risk profile in active nr-axSpA patients with inadequate response to NSAIDs OBJECTIVE To compare the performance of whole-body magnetic resonance imaging ( MRI ) versus conventional MRI in assessing acute inflammatory lesions of the sacroiliac ( SI ) joints in patients with established and active spondylarthritis ( SpA ) using the Spondyloarthritis Research Consortium of Canada ( SPARCC ) MRI index . This study is validating whole-body MRI against the current MRI st and ard for assessing active inflammatory lesions of the SI joints in patients with SpA. METHODS Thirty-two SpA patients with clinical ly active disease ( Bath Ankylosing Spondylitis Disease Activity Index score > /=4 ) fulfilling the modified New York criteria were scanned by whole-body and conventional MRI of the SI joints . The MRIs were scored independently in r and om order by 3 readers blinded to patient identity . Active inflammatory lesions of the SI joints were recorded on a Web-based SPARCC index . Pearson 's correlation coefficients were used to compare scores for whole-body and conventional MRI for each reader , whereas intraclass correlation coefficients ( ICCs ) were used to compare interobserver reliability . RESULTS The Pearson 's correlation coefficients between whole-body and conventional MRI per rater were 0.94 , 0.87 , and 0.93 . The mean sum scores for conventional versus whole-body MRI were statistically significantly higher for all 3 readers , although all patients showing inflammatory lesions on conventional MRI also demonstrated them on whole-body MRI . The ICCs(2,1 ) were 0.69 , 0.78 , and 0.95 for conventional MRI , and 0.79 , 0.85 , and 0.96 for whole-body MRI for the 3 possible reader pairs . CONCLUSION Whole-body and conventional MRI scores show a strong correlation and comparable reliability for the detection of inflammatory lesions of the SI joints Objective : To examine the efficacy and safety of infliximab combined with methotrexate compared with methotrexate alone in the treatment of ankylosing spondylitis ( AS ) using MRI and DXA to monitor its impact on bone . Methods : In this single centre study 42 subjects with active AS were treated with methotrexate and were r and omly assigned , in a ratio of 2:1 , to receive five infusions of either 5 mg/kg infliximab or placebo over 30 weeks . The primary outcome was improvement in disease activity as shown by the BASDAI at week 30 . MRI was used to assess the effect of treatments on sacroiliac and spinal enthesitis/osteitis and DXA to monitor bone mineral density . Results : Both therapeutic agents were well tolerated with no dropouts due to adverse events . A significantly greater improvement in mean BASDAI score was seen in the infliximab arm at week 10 ( p = 0.017 ) than in the placebo arm , but this was not maintained by week 30 ( p = 0.195 ) , 8 weeks after the last infusion , at which stage disease flares were reported by some subjects . MRI showed that the mean number of lesions resolving for each subject from week 0 to week 30 was significantly greater in the combination group than in the methotrexate monotherapy group ( p = 0.016 ) . Conclusions : Infliximab in combination with methotrexate was a safe and efficacious treatment in AS over 6 months and was associated with significant regression in enthesitis/osteitis as determined by MRI . However , disease flares were reported 8 weeks after the last infusion , indicating that addition of methotrexate failed to extend the inflixim OUTPUT: These are the first recommendations which encompass the entire spectrum of SpA and evaluate the full role of all commonly used imaging modalities . INPUT: Objective : A double blind , r and omised , placebo controlled study to evaluate the safety and efficacy of etanercept to treat adult patients with ankylosing spondylitis ( AS ) . Methods : Adult patients with AS at 14 European sites were r and omly assigned to 25 mg injections of etanercept or placebo twice weekly for 12 weeks . The primary efficacy end point was an improvement of at least 20 % in patient reported symptoms , based on the multicomponent Assessment s in Ankylosing Spondylitis ( ASAS ) response criteria ( ASAS 20 ) . Secondary end points included ASAS 50 and ASAS 70 responses and improved scores on individual components of ASAS , the Bath Ankylosing Spondylitis Disease Activity Index ( BASDAI ) , acute phase reactants , and spinal mobility tests . Safety was evaluated during scheduled visits . Results : Of 84 patients enrolled , 45 received etanercept and 39 received placebo . Significantly more etanercept patients than placebo patients responded at the ASAS 20 level as early as week 2 , and sustained differences were evident up to week 12 . Significantly more etanercept patients reported ASAS 50 responses at all times and ASAS 70 responses at weeks 2 , 4 , and 8 ; reported lower composite and fatigue BASDAI scores ; had lower acute phase reactant levels ; and had improved spinal flexion . Etanercept was well tolerated . Most adverse events were mild to moderate ; the only between-group difference was injection site reactions , which occurred significantly more often in etanercept patients . Conclusions : Etanercept is a well tolerated and effective treatment for reducing clinical symptoms and signs of AS Objectives Patients with advanced ankylosing spondylitis ( AS ) experience disability because of reduced spinal mobility and pulmonary function impairment . This placebo-controlled study evaluated the effect of etanercept ( ETN ) in patients with advanced AS . Methods A multicentre r and omised double-blind placebo-controlled trial of 12 weeks ' duration was performed . Patients had definite ( modified New York criteria ) , active ( Bath AS Disease Activity Index ( BASDAI ) ≥40 ) , severe ( radiological intervertebral bridges ) AS refractory to non-steroidal anti-inflammatory drugs and were antitumour necrosis factor naive . They were treated with ETN 50 mg once weekly or identical placebo ( PBO ) . Results Of the 95 patients screened , 82 were r and omised to receive ETN ( n=39 ) or PBO ( n=43 ) . At baseline the disease was active ( mean BASDAI 61.0±13.4 , C reactive protein ( CRP ) 20.7±25.5 mg/l ) and severe ( mean Bath AS Metrology Index ( BASMI ) 5.7±1.3 , mSASSS 36.5±20.5 ) ; forced pulmonary vital capacity ( FVC ) was 3.3±0.7 l. Improvement in BASDAI ( normalised net incremental area under the curve between baseline and week 12 , primary end point ) was significantly greater in the ETN group than in the PBO group ( −19.8±16.5 vs −11.0±16.4 , p=0.019 ) . Moreover , at week 12 , ETN gave better results than PBO for the BASDAI ( −26.4±19.7 vs −14.4±19.7 ; p=0.008 ) , total back pain ( −29.2±24.0 vs −14.9±24.0 ; p=0.010 ) , BASFI ( −21.7±17.6 vs −10.1±17.6 ; p=0.004 ) , BASMI ( −0.6±0.6 vs −0.2±0.6 ; p=0.011 ) , CRP level ( −15.7±14.2 vs −1.3±14.2 ; p<0.001 ) and FVC ( + 160±280 ml vs −20±280 ml ; p=0.006 ) . Conclusions ETN has short-term efficacy for patients with advanced AS , as was previously reported for less advanced disease . The efficacy is observed for the main symptoms ( pain ) and on markers of inflammation ( CRP ) , as well as disease severity in terms of spinal mobility and pulmonary function BACKGROUND Etanercept , a tumour-necrosis-factor inhibitor , has shown efficacy in the treatment of rheumatoid arthritis . Psoriatic arthritis and psoriasis are disease states in which tumour necrosis factor , a proinflammatory cytokine , is present in increased concentrations in joints and in the skin . Therefore , psoriatic arthritis and psoriasis may be appropriate therapeutic targets for etanercept . METHODS This r and omised , double-blind , placebo-controlled , 12 week study assessed the efficacy and safety of etanercept ( 25 mg twice-weekly subcutaneous injections ) or placebo in 60 patients with psoriatic arthritis and psoriasis . Psoriatic arthritis endpoints included the proportion of patients who met the Psoriatic Arthritis Response Criteria ( PsARC ) and who met the American College of Rheumatology preliminary criteria for improvement ( ACR20 ) . Psoriasis endpoints included improvement in the psoriasis area and severity index ( PASI ) and improvement in prospect ively-identified individual target lesions . FINDINGS In this 12 week study , 26 ( 87 % ) of etanercept-treated patients met the PsARC , compared with seven ( 23 % ) of placebo-controlled patients . The ARC20 was achieved by 2 OUTPUT:
This meta- analysis shows that ETN monotherapy is effective in improving physical function and reducing disease activity in patients with AS . Compared with SSZ , ETN markedly decreased the BASDAI and CRP levels .
MS2_dynamic_1_shot435
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: Objectives To test the inter-rater reliability of the RoB tool applied to Physical Therapy ( PT ) trials by comparing ratings from Cochrane review authors with those of blinded external review ers . Methods R and omized controlled trials ( RCTs ) in PT were identified by search ing the Cochrane Data base of Systematic Review s for meta- analysis of PT interventions . RoB assessment s were conducted independently by 2 review ers blinded to the RoB ratings reported in the Cochrane review s. Data on RoB assessment s from Cochrane review s and other characteristics of review s and trials were extracted . Consensus assessment s between the two review ers were then compared with the RoB ratings from the Cochrane review s. Agreement between Cochrane and blinded external review ers was assessed using weighted kappa ( κ ) . Results In total , 109 trials included in 17 Cochrane review s were assessed . Inter-rater reliability on the overall RoB assessment between Cochrane review authors and blinded external review ers was poor ( κ = 0.02 , 95%CI : −0.06 , 0.06 ] ) . Inter-rater reliability on individual domains of the RoB tool was poor ( median κ = 0.19 ) , ranging from κ = −0.04 ( “ Other bias ” ) to κ = 0.62 ( “ Sequence generation ” ) . There was also no agreement ( κ = −0.29 , 95%CI : −0.81 , 0.35 ] ) in the overall RoB assessment at the meta- analysis level . Conclusions Risk of bias assessment s of RCTs using the RoB tool are not consistent across different research groups . Poor agreement was not only demonstrated at the trial level but also at the meta- analysis level . Results have implication s for decision making since different recommendations can be reached depending on the group analyzing the evidence . Improved guidelines to consistently apply the RoB tool and revisions to the tool for different health areas are needed Objective : The aim of this study was to develop and evaluate a pedagogical tool to enhance the underst and ing of a checklist that evaluates reports of nonpharmacological trials ( CLEAR NPT ) . Design : Paired r and omised controlled trial . Participants : Clinicians and systematic review ers . Interventions : We developed an Internet-based computer learning system ( ICLS ) . This pedagogical tool used many examples from published r and omised controlled trials to demonstrate the main coding difficulties encountered when using this checklist . R and omised participants received either a specific Web-based training with the ICLS ( intervention group ) or no specific training . Outcome measures : The primary outcome was the rate of correct answers compared to a criterion st and ard for coding a report of r and omised controlled trials with the CLEAR NPT . Results : Between April and June 2006 , 78 participants were r and omly assigned to receive training with the ICLS ( 39 ) or no training ( 39 ) . Participants trained by the ICLS did not differ from the control group in performance on the CLEAR NPT . The mean paired difference and corresponding 95 % confidence interval was 0.5 ( −5.1 to 6.1 ) . The rate of correct answers did not differ between the two groups regardless of the CLEAR NPT item . Combining both groups , the rate of correct answers was high or items related to allocation sequence ( 79.5 % ) , description of the intervention ( 82.0 % ) , blinding of patients ( 79.5 % ) , and follow-up schedule ( 83.3 % ) . The rate of correct answers was low for items related to allocation concealment ( 46.1 % ) , co- interventions ( 30.3 % ) , blinding of outcome assessors ( 53.8 % ) , specific measures to avoid ascertainment bias ( 28.6 % ) , and intention-to-treat analysis ( 60.2 % ) . Conclusions : Although we showed no difference in effect between the intervention and control groups , our results highlight the gap in knowledge and urgency for education on important aspects of trial conduct UNLABELLED We describe our experience of using a modified version of the Cochrane risk of bias ( RoB ) tool for r and omised and non-r and omised comparative studies . OBJECTIVES To assess time to complete RoB assessment . To assess inter-rater agreement . To explore the association between RoB and treatment effect size METHODS Cochrane risk of bias assessment was performed on a sample of full text primary reports included in a systematic review comparing operative techniques for radical prostatectomy . Inter-rater agreement was assessed using the kappa statistic . RESULTS Twenty-four studies were judged as high overall RoB , 13 were judged as low RoB and 11 were unclear . The weighted Kappa value was 0.35 indicating fair agreement . The median ( range ) time taken to rate each study was 30 min ( 10 - 49 ) . The effect estimate for all studies was 0.61 ( 95 % credible interval ( CrI ) 0.46 - 0.83 ) and 0.73 ( 95 % CrI 0.29 - 1.75 ) for low risk studies . CONCLUSIONS Although the process was time consuming , using a modified version of the RoB tool proved useful for demonstrating conservative effect estimates . That we only achieved a fair agreement between review ers demonstrates the urgent need for further validation to improve inter-rater agreement . We suggest additional RoB levels could improve inter-rater reliability Overwhelming evidence shows the quality of reporting of r and omised controlled trials ( RCTs ) is not optimal . Without transparent reporting , readers can not judge the reliability and validity of trial findings nor extract information for systematic review s. Recent method ological analyses indicate that inadequate reporting and design are associated with biased estimates of treatment effects . Such systematic error is seriously damaging to RCTs , which are considered the gold st and ard for evaluating interventions because of their ability to minimise or avoid bias . A group of scientists and editors developed the CONSORT ( Consoli date d St and ards of Reporting Trials ) OUTPUT: For quality appraisal , studies supported intensive training , piloting quality assessment tools , providing decision rules for poorly reported studies , contacting authors , and using structured tools if different study design s are included . INPUT: BACKGROUND The Cochrane Collaboration is strongly encouraging the use of a newly developed tool , the Cochrane Collaboration Risk of Bias Tool ( CCRBT ) , for all review groups . However , the psychometric properties of this tool to date have yet to be described . Thus , the objective of this study was to add information about psychometric properties of the CCRBT including inter-rater reliability and concurrent validity , in comparison with the Effective Public Health Practice Project Quality Assessment Tool ( EPHPP ) . METHODS Both tools were used to assess the method ological quality of 20 r and omized controlled trials included in our systematic review of the effectiveness of knowledge translation interventions to improve the management of cancer pain . Each study assessment was completed independently by two review ers using each tool . We analysed the inter-rater reliability of each tool 's individual domains , as well as final grade assigned to each study . RESULTS The EPHPP had fair inter-rater agreement for individual domains and excellent agreement for the final grade . In contrast , the CCRBT had slight inter-rater agreement for individual domains and fair inter-rater agreement for final grade . Of interest , no agreement between the two tools was evident in their final grade assigned to each study . Although both tools were developed to assess ' quality of the evidence ' , they appear to measure different constructs . CONCLUSIONS Both tools performed quite differently when evaluating the risk of bias or method ological quality of studies in knowledge translation interventions for cancer pain . The newly introduced CCRBT assigned these studies a higher risk of bias . Its psychometric properties need to be more thoroughly vali date d , in a range of research fields , to underst and fully how to interpret results from its application Context Obesity is a major public health problem in North America , particularly in Aboriginal people . Objective To determine if a household-based lifestyle intervention is effective at reducing energy intake and increasing physical activity among Aboriginal families after 6 months . Design , Participants , and InterventionR and omized , open trial of 57 Aboriginal households recruited between May 2004 and April 2005 from the Six Nations Reserve in Ohsweken , Canada . Aboriginal Health Counsellors made regular home visits to assist families in setting dietary and physical activity goals . Additional interventions included provision of filtered water , a physical activity program for children , and educational events about healthy lifestyles . Results 57 households involving 174 individuals were r and omized to intervention or usual care . Intervention households decreased consumption of fats , oils and sweets compared to usual care households ( -4.9 servings per day vs. -3 servings/day , p=0.006 ) , and this was associated with a reduction in trans fatty acids ( -0.2 vs. + 0.6 grams/day , p=0.02 ) . Water consumption increased ( + 0.3 vs. -0.1 servings/day , p<0.04 ) and soda pop consumption decreased ( -0.3 vs. -0.1 servings/day , p=0.02 ) in intervention households compared to usual care . A trend toward increased knowledge about healthy dietary practice s in children , increased leisure-time activity and decreased sedentary behaviours was observed , although these differences were not statistically significant . Conclusion A household-based intervention is associated with some positive changes in dietary practice s and activity patterns . A larger and longer-term intervention which addresses both individual change and structural barriers in the community is needed . Résumé Context eL’obésité est un problème de santé publique majeur en Amérique du Nord , particulièrement chez les Autochtones . ObjectifDéterminer si une intervention de modification du mode de vie centrée sur les ménages parvient à réduire l’apport énergétique et à accroître l’activité physique dans des familles autochtones au bout de six mois . Méthode , participants et interventionEssai ouvert aléatoire auprès de 57 ménages autochtones recrutés entre mai 2004 et avril 2005 dans la réserve des Six-Nations à Ohsweken ( Ontario ) , au Canada . Des conseillers en santé autochtone ont fait des visites à domicile périodiques pour aider les familles à se fixer des objectifs de saine alimentation et d’activité physique . D’autres mesures ont aussi été instaurées : on a fourni de l’eau filtrée aux ménages , offert un programme d’activité physique aux enfants et organisé des activités de sensibilisation aux modes de vie sains . RésultatsLes 57 ménages ( 174 personnes ) ont été répartis aléatoirement en deux groupes , l’un recevant les mesures d’intervention et l’autre , les soins habituels . Les ménages recevant les mesures d’intervention ont diminué leur consommation de matières grasses , d’huile et de sucreries par rapport aux ménages recevant les soins habituels ( -4,9 portions/jour contre -3 portions/jour , p=0,006 ) , et cette diminution était associée à une baisse de la consommation d’acides gras trans ( -0,2 contre + 0,6 g/jour , p=0,02 ) . Par ailleurs , leur consommation d’eau a augmenté ( + 0,3 contre -0,1 portion/jour , p<0,04 ) , et leur consommation de boissons gazeuses a diminué ( -0,3 contre -0,1 portion/jour , p=0,02 ) . Nous avons aussi observé une amélioration des connaissances des enfants sur la saine alimentation , une augmentation de l’activité pendant les temps libres et une diminution des comportements sédentaires , mais ces changements n’étaient pas significatifs . Conclusion Une intervention centrée sur les ménages est associée à certains changements positifs dans l’alimentation et l’activité physique . Il faudrait élargir et prolonger l’initiative , en tenant compte à la fois des changements individuels et des obstacles OUTPUT:
There is limited evidence and a lack of robust interventions that examine the impacts of physical activity on health and fitness status in the Canadian Indigenous population . Vali date d , culturally relevant tools for measuring physical activity may aid in program evaluation and focused educational material s could better support population health initiatives .
MS2_dynamic_1_shot436
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: Background : Sepsis is a leading cause of neonatal morbidity and mortality . Clinical suspicion may lead to overuse of antibiotics . The objective of this study was to assess the epidemiology of early-onset sepsis ( EOS ) and antibiotic exposure during the first week of life in Norwegian term infants . Methods : This is a nationwide population -based study from the Norwegian Neonatal Network . During the 3-year study period ( 2009–2011 ) , 20 of Norway ’s 21 neonatal units prospect ively collected data . Among 168,877 live-born ( LB ) term infants born during the study period , 10,175 ( 6.0 % ) infants were hospitalized in the first week of life and included in the study . Results : There were 91 cases of culture-confirmed EOS ( 0.54 per 1000 LB ) and 1447 cases classified as culture-negative EOS ( 8.57 per 1000 LB ) . The majority of culture-confirmed EOS cases were caused by Gram-positives ( 83/91 ; 91 % ) , most commonly group B streptococci ( 0.31 per 1000 LB ) . Intravenous antibiotics were administered to 3964 infants ; 39 % of all admissions and 2.3 % of all LB term infants . Empiric therapy consisted of an aminoglycoside and either benzylpenicillin or ampicillin in 95 % of the cases . The median ( interquartile range ) treatment duration was 8 ( 7–10 ) days for culture-confirmed EOS and 6 ( 5–7 ) days for culture-negative EOS . There was 1 EOS-attributable death ( group B streptococcal EOS ) during the study period . Conclusions : In this registry-based study , the incidence of culture-confirmed EOS was in line with previous international reports and the mortality was very low . A large proportion of infants without infection were treated with antibiotics . Measures should be taken to spare neonates unnecessary antibiotic treatment BACKGROUND OF THE STUDY Neonates at risk for early-onset sepsis are started on antibiotics empirically . Antibiotic resistance to conventionally used antibiotics is increasingly being reported . Antenatal maternal antibiotic exposure in this setting contributes to low yield on blood culture drawn at birth , limiting the planning of antibiotics based on culture reports . A head-to-head comparison for selecting the appropriate antibiotic is one strategy . OBJECTIVES To compare monotherapy with amikacin against piperacillin-tazobactum as an empirical therapy in neonates at risk for early-onset sepsis . DESIGN R and omized open-label controlled trial with stratification and block r and omization . SETTING S Tertiary care neonatal unit in India PARTICIPANTS All consecutive inborn neonates delivered between 01 May 2009 and 30 April 2011 who were ≥28 week gestation and /or ≥1000 g birth weight with risk factors for early-onset sepsis . INTERVENTION R and omized to receive either amikacin or piperacillin-tazobactum , after stratifying as asymptomatic or symptomatic within 1 h of birth . PRIMARY OUTCOME Incidence of treatment failure to the allocated antibiotic defined as blood culture isolate reported resistant to the allocated antibiotic or progression of the illness , necessitating a change of antibiotic . RESULTS Of 204 eligible cases , 187 were enrolled . Seventeen babies were excluded . A total of 128 neonates were stratified as asymptomatic and 59 as symptomatic . In all , 64 of the asymptomatic cases received amikacin and 64 received piperacillin-tazobactum , while 29 symptomatic babies received amikacin and 30 received piperacillin-tazobactum . Five babies had blood culture-positive sepsis , and 28 babies had strong suspicion of sepsis . There was no difference in the treatment failure in the amikacin group ( 3 of 93 ; 3.2 % ) compared with piperacillin-tazobactum group ( 2 of 94 ; 2.1 % ) ( p > 0.01 ) and no difference in the incidence of second infection , fungal sepsis and all-cause mortality at day 7 and 28 between the two study groups ( p > 0.01 ) . CONCLUSIONS Monotherapy with amikacin as an empirical antibiotic did not result in a higher incidence of treatment failure in neonates at risk for early-onset sepsis as compared with piperacillin-tazobactum . Both antibiotics were effective in management of babies with early-onset sepsis Yeasts may gain entry into the blood via routes such as intubation , intravenous catheterization or by direct persorption from the gut . The latter route becomes important when the numbers of commensal yeasts in the gut exceeds a threshold which may vary between animal species . In a prospect i ve study utilizing serial , twice weekly quantitative stool cultures during the first 6 weeks of life of 40 very low birth weight infants , we found a threshold of 8 x 10(6 ) C and ida colony-forming units/gram of stool . Beyond this threshold 50 % of the infants developed gastrointestinal symptoms and 28.5 % developed systemic sepsis within 1 to 3 weeks of heavy colonization . The gastrointestinal colonization rate was 62.5 % ( 25/40 ) with 66 % having C and ida colony-forming units greater than 8 x 10(6)/g stool A comparative study of bowel colonisation and OUTPUT: Conclusions Prolonged antibiotic exposure in uninfected preterm infants is associated with an increased risk of NEC and /or death , and broad-spectrum antibiotic exposure is associated with an increased risk of IFI INPUT: Alimentary kanamycin , 15 mg/kg/day , was given as prophylaxis for neonatal necrotizing enterocolitis in a prospect i ve study . Newborn infants of less than 1,500 gm birth weight who survived until initiation of alimentary nutrition at the University of Florida Neonatal Intensive Care Unit were admitted to a control or study group based on the last digit of the hospital number . Alimentary kanamycin was not absorbed ; all blood levels determined were less than 0.5 μg/ml . The two groups had similar gestational ages , birth weights , severity of neonatal illness , and frequency of therapeutic procedures . In the study group of 35 infants , none developed neonatal necrotizing enterocolitis , whereas five cases occurred in the 40 control infants ( p=0.038 ) AIMS To evaluate the effectiveness of oral vancomycin in the prophylaxis of necrotising enterocolitis in preterm , very low birthweight infants . METHODS A prospect i ve , double blind , r and omised , placebo controlled study in a tertiary referral centre of a university teaching hospital was conducted on 140 very low birthweight infants consecutively admitted to the neonatal unit . The babies were r and omly allocated to receive oral vancomycin ( 15 mg/kg every 8 hours for 7 days ) or an equivalent volume of placebo solution . Prophylaxis was started 24 hours before the start of oral feeds . All suspected cases of necrotising enterocolitis were investigated with a full sepsis screen and serial abdominal radiographs . Necrotising enterocolitis was diagnosed and staged according to modified Bell ’s criteria . RESULTS Nine of 71 infants receiving oral vancomycin and 19 of 69 infants receiving the placebo solution developed necrotising enterocolitis ( p=0.035 ) . Infants with necrotising enterocolitis were associated with a significant increase in mortality ( p=0.026 ) and longer duration of hospital stay ( p = 0.002 ) . CONCLUSIONS Prophylactic oral vancomycin conferred protection against necrotising enterocolitis in preterm , very low birthweight infants and was associated with a 50 % reduction in the incidence . However , widespread implementation of this preventive measure is not recommended , as it would only be effective in necrotising enterocolitis caused by Gram positive organisms and could increase the danger of the emergence of vancomycin resistant or dependent organisms . Its use should be restricted to a high prevalence nursery for a short and well defined period in a selected group of high risk patients The value of prophylactic oral gentamicin sulfate therapy in the prevention of necrotizing enterocolitis ( NEC ) was evaluated in a group of 42 high-risk neonates over a four-month period in a r and omized , double-blind controlled trial . Twenty babies in the treatment group received 2.5 mg/kg of gentamicin sulfate every six hours for one week after birth , and 22 babies received dextrose- and -water placebo in an equivalently small volume . None of the 20 gentamicin-treated babies developed NEC . Four of the control babies did . Two of these babies died , and their diagnosis was pathologically confirmed . This difference in the incidence of NEC between the treatment and control group was significant at the .05 level . These results support the prophylactic use of orally given gentamicin for selected babies at high risk for NEC , particularly those born prematurely and those who have a history of perinatal asphyxia or umbilical artery catheterization or both . Continued surveillance for changes in antimicrobial sensitivity patterns is recommended A comparative study of bowel colonisation and incidence of necrotising enterocolitis in neonates admitted to an intensive care unit is reported . Neonates of less than 33 weeks gestational age requiring mechanical ventilation for respiratory distress syndrome were r and omised during the first week of life to receive either vancomycin and aztreonam or vancomycin and gentamicin for episodes of suspected sepsis after the first week of life . A higher proportion of neonates who received vancomycin and gentamicin had faecal colonisation with enterobacteriaceae at the end of the second , third , and fourth weeks of life . Treatment with vancomycin and aztreonam was associated with a rapid quantitative reduction in faecal colonisation with enterobacteriaceae , whereas there was no quantitative reduction in colonisation with enterobacteriaceae associated with treatment with vancomycin and gentamicin . There were no differences between the two groups in faecal colonisation with anaerobes , Enterococcus sp , Staphylococcus sp , or yeasts . Six ( 14.6 % ) of 41 who received vancomycin and gentamicin compared with 0 of 40 who received vancomycin and aztreonam subsequently developed necrotising enterocolitis We conducted a prospect i ve r and omized trial to compare the efficacy of oral gentamicin versus oral IgA‐IgG for the prophylaxis of necrotizing enterocolitis ( NEC ) ; 200 newborns considered at high risk for NEC were assigned to group A ( oral IgA‐IgG , n= 100 ) or group B ( oral Gentamicin , n= 100 ) . NEC was diagnosed in 13 cases in group A and in 1 case in group B between the 3rd and 16th days of life . Surgical treatment was necessary in 3 cases ( 2 in group A ) . All infants survived . We conclude that oral gentamicin is more effective than oral IgA‐IgG in the prevention of NEC in infants at high risk To evaluate the effects of oral kanamycin prophylaxis for necrotizing enterocolitis on stool OUTPUT:
REVIEW ER 'S CONCLUSIONS Evidence suggests that oral antibiotics reduce the incidence of NEC in low birth weight infants .
MS2_dynamic_1_shot437
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: Background Chronic obstructive pulmonary disease ( COPD ) is a health problem that is becoming increasingly attended-to in Primary Care ( PC ) . However , there is a scarcity of health-care programs and studies exploring the implementation of Clinical Practice Guidelines ( CPG ) . The principal objective of the present study is to evaluate the effectiveness of a combined strategy directed towards health-care professionals and patients to improve the grade of clinical control and the quality -of-life ( QoL ) of the patients via a feedback on their state-of-health . A training plan for the health-care professionals is based on CPG and health education . Method / Design Multi-centred , before-after , quasi experimental , prospect i ve study involving an intervention group and a control group of individuals followed-up for 12 months . The patients receive attention from urban and semi-urban Primary Care Centres ( PCC ) within the administrative area of the Costa de Ponent ( near Barcelona ) . All the pacients corresponding to the PCC of one sub-area were assigned to the intervention group and patients from the rest of sub- areas to the group control . The intervention includes providing data to the health-care professionals ( clinician/nurse ) derived from a clinical history and an interview . A course of training focused on aspects of CPG , motivational interview and health education ( tobacco , inhalers , diet , physical exercise , physiotherapy ) . The sample r and om includes a total of 801 patients ( ≥ 40 years of age ) , recorded as having COPD , receiving attention in the PCC or at home , who have had at least one clinical visit , and who provided written informed consent to participation in the study . Data collected include socio-demographic characteristics , drug treatment , exacerbations and hospital admissions , evaluation of inhaler use , tobacco consumption and life-style and health-care re sources consumed . The main endpoints are dyspnoea , according to the modified scale of the Medical Research Council ( MRC ) and the QoL , evaluated with the St George 's Respiratory Question naire ( SGRQ ) . The variables are obtained at the start and the end of the intervention . Information from follow-up visits focuses on the changes in life-style activities of the patient . Discussion This study is conducted with the objective of generating evidence that shows that implementation of awareness programs directed towards health-care professionals as well as patients in the context of PC can produce an increase in the QoL and a decrease in the disease exacerbation , compared to st and ard clinical practice .Trial Registration Clinical Trials.gov Identifier : NCT00922545 Abstract Objective : To evaluate the use of a computerised support system for decision making for implementing evidence based clinical guidelines for the management of asthma and angina in adults in primary care . Design : A before and after pragmatic cluster r and omised controlled trial utilising a two by two incomplete block design . Setting : 60 general practice s in north east Engl and . Participants : General practitioners and practice nurses in the study practice s and their patients aged 18 or over with angina or asthma . Main outcome measures : Adherence to the guidelines , based on review of case notes and patient reported generic and condition specific outcome measures . Results : The computerised decision support system had no significant effect on consultation rates , process of care measures ( including prescribing ) , or any patient reported outcomes for either condition . Levels of use of the software were low . Conclusions : No effect was found of computerised evidence based guidelines on the management of asthma or angina in adults in primary care . This was probably due to low levels of use of the software , despite the system being optimised as far as was technically possible . Even if the technical problems of producing a system that fully supports the management of chronic disease were solved , there remains the challenge of integrating the systems into clinical encounters where busy practitioners manage patients with complex , multiple conditions OBJECTIVE To assess the effects of a facilitator enhanced multifaceted intervention to implement a locally adapted guideline on the shared care for people with type 2 diabetes . METHODS During 1 year a cluster-r and omized trial was performed in 30 general practice s. In the intervention group , nurse facilitators enhanced guideline implementation by analysing barriers to change , introducing structured care , training practice staff and giving performance feedback . Targets for HbA1c% , systolic blood pressure as well as indications for angiotensin converting enzyme/angiotensin receptor blocking agent prescription differed from the national guidelines . In the control group , GPs were asked to continue the care for people with diabetes as usually . Generalized estimating equations were used to control for the clustered design of the study . RESULTS In the intervention group , more people were seen on a 3-monthly basis ( 88 % versus 69 % , P < 0.001 ) and more blood pressure and bodyweight measurements were performed every 3 months ( blood pressure 83 % versus 66 % , P < 0.001 and bodyweight 78.9 % versus 48.5 % , P < 0.001 ) . Apart from a marginal difference in mean cholesterol , differences in HbA1c% , blood pressure , body mass index and treatment satisfaction were not significant . CONCLUSION Multifaceted implementation of locally adapted shared care guidelines did improve the process of diabetes care but hardly changed intermediate outcomes . In the short term , local adaptation of shared care guidelines does not improve the cardiovascular risks of people with type 2 diabetes BACKGROUND Good blood pressure ( BP ) control reduces the risk of complications in people with type 2 diabetes , yet many do not achieve this . Guidelines for managing hypertension recommend increasing antihypertensive medications until control is achieved , but the effect of such recommendations in routine primary care is unknown . AIM To evaluate the effectiveness of a BP treatment algorithm in primary care patients with type 2 diabetes . DESIGN OF STUDY A cluster r and omised controlled trial of 1534 patients with type 2 diabetes . SETTING Forty-two practice s in Nottingham , UK . METHOD Practice s were r and omised to continue usual care or to use a treatment algorithm design ed so that OUTPUT: Moreover , the results are not consistent in showing which strategy is the most appropriate to facilitate their implementation . INPUT: OBJECTIVE Development of these guidelines is m and ated by the American Association of Clinical Endocrinologists ( AACE ) Board of Directors and the American College of Endocrinology ( ACE ) Board of Trustees and adheres to published AACE protocol s for the st and ardized production of clinical practice guidelines ( CPGs ) . METHODS Recommendations are based on diligent review of clinical evidence with transparent incorporation of subjective factors . RESULTS There are 9 broad clinical questions with 123 recommendation numbers that include 160 specific statements ( 85 [ 53.1 % ] strong [ Grade A ] ; 48 [ 30.0 % ] intermediate [ Grade B ] , and 11 [ 6.9 % ] weak [ Grade C ] , with 16 [ 10.0 % ] based on expert opinion [ Grade D ] ) that build a comprehensive medical care plan for obesity . There were 133 ( 83.1 % ) statements based on strong ( best evidence level [ BEL ] 1 = 79 [ 49.4 % ] ) or intermediate ( BEL 2 = 54 [ 33.7 % ] ) levels of scientific substantiation . There were 34 ( 23.6 % ) evidence -based recommendation grade s ( Grade s A-C = 144 ) that were adjusted based on subjective factors . Among the 1,790 reference citations used in this CPG , 524 ( 29.3 % ) were based on strong ( evidence level [ EL ] 1 ) , 605 ( 33.8 % ) were based on intermediate ( EL 2 ) , and 308 ( 17.2 % ) were based on weak ( EL 3 ) scientific studies , with 353 ( 19.7 % ) based on review s and opinions ( EL 4 ) . CONCLUSION The final recommendations recognize that obesity is a complex , adiposity-based chronic disease , where management targets both weight-related complications and adiposity to improve overall health and quality of life . The detailed evidence -based recommendations allow for nuanced clinical decision-making that addresses real-world medical care of patients with obesity , including screening , diagnosis , evaluation , selection of therapy , treatment goals , and individualization of care . The goal is to facilitate high- quality care of patients with obesity and provide a rational , scientific approach to management that optimizes health outcomes and safety . ABBREVIATIONS A1C = hemoglobin A1c AACE = American Association of Clinical Endocrinologists ACE = American College of Endocrinology ACSM = American College of Sports Medicine ADA = American Diabetes Association ADAPT = Arthritis , Diet , and Activity Promotion Trial ADHD = attention-deficit hyperactivity disorder AHA = American Heart Association AHEAD = Action for Health in Diabetes AHI = apnea-hypopnea index ALT = alanine aminotransferase AMA = American Medical Association ARB = angiotensin receptor blocker ART = assisted reproductive technology AUC = area under the curve BDI = Beck Depression Inventory BED = binge eating disorder BEL = best evidence level BLOOM = Behavioral Modification and Lorcaserin for Overweight and Obesity Management BLOSSOM = Behavioral Modification and Lorcaserin Second Study for Obesity Management BMI = body mass index BP = blood pressure C-SSRS = Columbia Suicidality Severity Rating Scale CAD = coronary artery disease CARDIA = Coronary Artery Risk Development in Young Adults CBT = cognitive behavioral therapy CCO = Consensus Conference on Obesity CHF = congestive heart failure CHO = carbohydrate CI = confidence interval COR-I = Contrave Obesity Research I CPG = clinical practice guideline CV = cardiovascular CVD = cardiovascular disease DASH = Dietary Approaches to Stop Hypertension DBP = diastolic blood pressure DEXA = dual-energy X-ray absorptiometry DPP = Diabetes Prevention Program DSE = diabetes support and education EL = evidence level ED = erectile dysfunction ER = extended release EWL = excess weight loss FDA = Food and Drug Administration FDG = 18F-fluorodeoxyglucose GABA = gamma-aminobutyric acid GERD = gastroesophageal reflux disease GI = gastrointestinal GLP-1 = glucagon-like peptide 1 HADS = Hospital Anxiety and Depression Scale HDL-c = high-density lipoprotein cholesterol HR = hazard ratio HTN = hypertension HUNT = Nord-Trøndelag Health Study ICSI = intracytoplasmic sperm injection IFG = impaired fasting glucose IGT = impaired glucose tolerance ILI = intensive lifestyle intervention IVF = in vitro fertilization LAGB = laparoscopic adjustable gastric b and ing LDL-c = low-density lipoprotein cholesterol LES = lower esophageal sphincter LSG = laparoscopic sleeve gastrectomy LV = left ventricle LVH = left ventricular hypertrophy LVBG = laparoscopic vertical b and ed gastroplasty MACE = major adverse cardiovascular events MAOI = monoamine oxidase inhibitor MI = myocardial infa rct ion MN RCT = meta- analysis of non-r and omized prospect i ve or case-controlled trials MRI = magnetic resonance imaging MUFA = monounsaturated fatty acid NAFLD = nonalcoholic fatty liver disease NASH = nonalcoholic steatohepatitis NES = night eating syndrome NHANES = National Health and Nutrition Examination Surveys NHLBI = National Heart , Lung , and Blood Institute NHS = Nurses ' Health Study NICE = National Institute for Health and Care Excellence OA = osteoarthritis OGTT = oral OUTPUT:
4 ) Conclusions : The analysis of the information here reported sheds light for the design of future clinical trials in adults with MS . The best anthropometric parameters and units of measurement to monitor the interventions are related to dietary and physical exercise interventions .
MS2_dynamic_1_shot438
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: Background Supporting 21st century health care and the practice of evidence -based medicine ( EBM ) requires ubiquitous access to clinical information and to knowledge-based re sources to answer clinical questions . Many questions go unanswered , however , due to lack of skills in formulating questions , crafting effective search strategies , and accessing data bases to identify best levels of evidence . Methods This r and omized trial was design ed as a pilot study to measure the relevancy of search results using three different interfaces for the PubMed search system . Two of the search interfaces utilized a specific framework called PICO , which was design ed to focus clinical questions and to prompt for publication type or type of question asked . The third interface was the st and ard PubMed interface readily available on the Web . Study subjects were recruited from interns and residents on an inpatient general medicine rotation at an academic medical center in the US . Thirty-one subjects were r and omized to one of the three interfaces , given 3 clinical questions , and asked to search PubMed for a set of relevant articles that would provide an answer for each question . The success of the search results was determined by a precision score , which compared the number of relevant or gold st and ard articles retrieved in a result set to the total number of articles retrieved in that set . Results Participants using the PICO templates ( Protocol A or Protocol B ) had higher precision scores for each question than the participants who used Protocol C , the st and ard PubMed Web interface . ( Question 1 : A = 35 % , B = 28 % , C = 20 % ; Question 2 : A = 5 % , B = 6 % , C = 4 % ; Question 3 : A = 1 % , B = 0 % , C = 0 % ) 95 % confidence intervals were calculated for the precision for each question using a lower boundary of zero . However , the 95 % confidence limits were overlapping , suggesting no statistical difference between the groups . Conclusion Due to the small number of search es for each arm , this pilot study could not demonstrate a statistically significant difference between the search protocol s. However there was a trend towards higher precision that needs to be investigated in a larger study to determine if PICO can improve the relevancy of search results OBJECTIVE To examine the long-term effects of an intervention combining teacher training , parent education , and social competence training for children during the elementary grade s on adolescent health-risk behaviors at age 18 years . DESIGN Nonr and omized controlled trial with follow-up 6 years after intervention . SETTING Public elementary schools serving high-crime areas in Seattle , Wash. PARTICIPANTS Of the fifth- grade students enrolled in participating schools , 643 ( 76 % ) were given written parental consent for the longitudinal study and 598 ( 93 % ) were followed up and interviewed at age 18 years . INTERVENTIONS A full intervention provided in grade s 1 through 6 of 5 days of in-service training for teachers each intervention year , developmentally appropriate parenting classes offered to parents when children were in grade s 1 through 3 and 5 through 6 , and developmentally adjusted social competence training for children in grade s 1 and 6 . A late intervention , provided in grade s 5 and 6 only , paralleled the full intervention at these grade s. MAIN OUTCOME MEASURES Self-reported violent and nonviolent crime , substance use , sexual activity , pregnancy , bonding to school , school achievement , grade repetition and school dropout , suspension and /or expulsion , and school misbehavior ; delinquency charges from court records ; grade point average ; California Achievement Test scores : and disciplinary action reports from school records . RESULTS Fewer students receiving full intervention than control students reported violent delinquent acts ( 48.3 % vs 59.7 % ; P=.04 ) , heavy drinking ( 15.4 % vs 25.6 % ; P=.04 ) , sexual intercourse ( 72.1 % vs 83.0 % ; P=.02 ) , having multiple sex partners ( 49.7 % vs 61.5 % ; P=.04 ) , and pregnancy or causing pregnancy ( 17.1 % vs 26.4 % ; P=.06 ) by age 18 years . The full intervention student group reported more commitment ( P=.03 ) and attachment ( P=.006 ) to school , better academic achievement ( P=.01 ) , and less school misbehavior ( P=.02 ) than control students . Late intervention in grade s 5 and 6 only did not significantly affect health-risk behaviors in adolescence . CONCLUSIONS A package of interventions with teachers , parents , and children provided throughout the elementary grade s can have enduring effects in reducing violent behavior , heavy drinking , and sexual intercourse by age 18 years among multiethnic urban children . Results are consistent with the theoretical model guiding the intervention and support efforts to reduce health-risk behaviors through universal interventions in selected communities or schools serving high-crime neighborhoods PURPOSE The purpose of this investigation was to assess the School-Based Adolescent Health Care Program , which provided comprehensive health-related services in 24 school-based health centers . METHODS The outcomes evaluation compared a cohort of students attending 19 participating schools and a national sample of urban youths , using logit models to control for observed differences between the two groups of youths . Outcome measures included self-reports concerning health center utilization , use of other health care providers , knowledge of key health facts , substance use , sexual activity , contraceptive use , pregnancies and births , and health status . RESULTS The health centers increased students ' access to health care and improved their health knowledge . However , the estimated impacts on health status and risky behaviors were inconsistent , and most were small and not statistically significant . CONCLUSIONS School-based health centers can increase students ' health knowledge and access to health-related services , but more intensive or different services are needed if they are to significantly reduce risk-taking behaviors OBJECTIVES A theory-based curriculum design ed to delay the onset of intercourse and increase use of condoms was implemented in the classrooms of six Los Angeles middle schools . METHODS The curriculum activities were very interactive , emphasized skill building , and were implemented OUTPUT: Identified evidence indicated no consistent difference in rates of pregnancies between intervention recipients and controls INPUT: Background Supporting 21st century health care and the practice of evidence -based medicine ( EBM ) requires ubiquitous access to clinical information and to knowledge-based re sources to answer clinical questions . Many questions go unanswered , however , due to lack of skills in formulating questions , crafting effective search strategies , and accessing data bases to identify best levels of evidence . Methods This r and omized trial was design ed as a pilot study to measure the relevancy of search results using three different interfaces for the PubMed search system . Two of the search interfaces utilized a specific framework called PICO , which was design ed to focus clinical questions and to prompt for publication type or type of question asked . The third interface was the st and ard PubMed interface readily available on the Web . Study subjects were recruited from interns and residents on an inpatient general medicine rotation at an academic medical center in the US . Thirty-one subjects were r and omized to one of the three interfaces , given 3 clinical questions , and asked to search PubMed for a set of relevant articles that would provide an answer for each question . The success of the search results was determined by a precision score , which compared the number of relevant or gold st and ard articles retrieved in a result set to the total number of articles retrieved in that set . Results Participants using the PICO templates ( Protocol A or Protocol B ) had higher precision scores for each question than the participants who used Protocol C , the st and ard PubMed Web interface . ( Question 1 : A = 35 % , B = 28 % , C = 20 % ; Question 2 : A = 5 % , B = 6 % , C = 4 % ; Question 3 : A = 1 % , B = 0 % , C = 0 % ) 95 % confidence intervals were calculated for the precision for each question using a lower boundary of zero . However , the 95 % confidence limits were overlapping , suggesting no statistical difference between the groups . Conclusion Due to the small number of search es for each arm , this pilot study could not demonstrate a statistically significant difference between the search protocol s. However there was a trend towards higher precision that needs to be investigated in a larger study to determine if PICO can improve the relevancy of search results The study was aim ed to test whether zinc supplementation , if initiated early , can prevent stunting and promote optimum body composition in full term infants . For this , full term pregnant women from low income urban community were enrolled and were followed-up for 24 months postpartum . Body mass index ( BMI ) was calculated from maternal weight and height that were collected one month after delivery . Infants ' weight , and length , head , chest and mid upper arm circumferences and skin fold thicknesses at triceps , biceps and subscapular area were collected at baseline ( before r and omization ) and once in three months up till 24 months . Three hundred and twenty four infants were r and omized and allocated to zinc ( 163 ) or placebo ( 161 ) groups respectively . Supplementation of zinc was initiated from 4 months of age and continued till children attained 18 months . The control ( placebo ) group of children received riboflavin 0.5 mg/day , whereas the intervention ( zinc ) group received 5 mg zinc plus riboflavin 0.5 mg/day . When infants were 18 months old , dietary intakes ( in 78 children ) were calculated by 24 hour diet recall method and hemoglobin , zinc , copper and vitamin A were quantified in blood sample s collected from 70 children . The results showed prevalence of undernutrition ( body mass index < 18.5 ) in 37 % of the mothers . Mean±SD calorie consumption and zinc intakes from diets in infants were 590±282.8 Kcal/day and 0.97±0.608 mg/day respectively . Multiple linear regression models demonstrated maternal weight as a strong predictor of infants ' weight and length at 18 months of age . As expected , diarrhea duration impacted infants ' linear growth and weight gain adversely . Zinc supplementation for a mean period of 190 days , starting from 4 months up to 18 months of age , in full term normal infants , consuming an average energy of 590 Kcal/day , had significant effect on the skin fold thicknesses , but not on their linear growth . Trial Registration Clinical Trail Registration India ( CTRI ) Apparently healthy preschool children ( 46 boys , 52 girls ) aged 27 - 50 mo from low socioeconomic conditions who attended daycare centers in Santiago participated in a 14-mo long double-blind zinc supplementation trial . Unlike most previous studies , no additional inclusion criteria such as short stature or slow growth rate were considered . Subjects were pair matched according to sex and age and r and omly assigned to two experimental groups : the supplemented group , which received 10 mg Zn/d , and the placebo group . Selected anthropometric , clinical , dietary , biochemical , and functional indexes were determined at the beginning of the study and after 6 and 14 mo of intervention . Actual dietary zinc intake was 66 % of the recommended dietary allowance . Height gain after 14 mo was on average 0.5 cm higher in the supplemented group ( P = 0.10 ) . The response , however , was different between sexes . Boys from the supplemented group gained 0.9 cm more than those in the placebo group ( P = 0.045 ) . No effect was seen in girls . Although no significant differences were observed in the rest of the variables studied , trends ( 0.05 < P < 0.10 ) in the supplemented group compared with the placebo group for increased midarm muscle area in boys , improved response to tuberculin , and reduced rates of parasite reinfestation were noted . We conclude that in preschool children of low socioeconomic status , zinc is a limiting factor in the expression of growth potential BACKGROUND Poor growth and delayed maturation in children with sickle cell disease ( SCD ) may be due , in part , to mild zinc deficiency . OBJECTIVE The objective was to determine OUTPUT:
Zn supplementation was associated with increased fat-free mass among stunted children . Due to the use of anthropometry when determining body composition , a majority of the studies could not accurately address whether alterations in the fat and /or fat-free mass components of the body were responsible for the observed changes in body composition . The effect of Zn supplementation on body composition is not consistent but may modify fat-free mass among children with pre-existing growth failure
MS2_dynamic_1_shot439
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: Depressed out patients ( n = 51 ) resistant to treatment with maprotiline were treated in a blind , r and omized , single-centre study , for 6 weeks with either the reversible and selective monoamine oxidase A-inhibitor ( MAO-A-I ) , brofaromine or lithium addition to maprotiline . The Hamilton Rating Scale for Depression was scored by an independent rater before and after the 6 week treatment period . No significant differences in efficacy were found between the two treatment regimes . In the patients who completed the trial , brofaromine was well tolerated with the exception of insomnia . Anticholinergic effects as well as thyroid dysfunctions ( 17 out of 20 ) were more frequent in the maprotiline/lithium group This open , prospect i ve study investigated the efficacy of lithium augmentation in elderly patients who had failed to respond to a 6-week course of antidepressant medication . Twenty-one patients ( age range , 64 to 88 years ) with DSM-III-R unipolar , nonpsychotic major depression refractory to a 6-week course of nortriptyline , fluoxetine , or phenelzine underwent a minimum of 2 weeks of lithium augmentation . Five patients had a complete response , 3 had a partial response , and 13 did not respond . Half of the patients developed dose-limiting side effects , most commonly neuromuscular or neurologic . Patients developing side effects were significantly older ( p = 0.05 ) , and there was a tendency for side effects to occur more frequently in patients treated with fluoxetine . The rate of response to lithium augmentation in this elderly population was lower than that reported for most open and controlled studies in younger patients . Possible reasons for this are discussed Thirty-four patients with tricyclic-resistant depressive illness took part in a nine-week , double-blind , placebo-controlled trial of lithium augmentation . In addition to the maximum tolerated doses of their tricyclic antidepressant , the experimental group ( n = 16 ) received 250 mg lithium daily for three weeks , followed by 750 mg lithium daily for six weeks , while the controls ( n = 18 ) received placebo for three weeks followed by three weeks each of 250 mg lithium daily and 750 mg lithium daily . There was no significant difference between placebo and 250 mg lithium for weeks 0 - 3 of the trial . However , there was a significantly greater improvement on the MADRS for weeks 3 - 6 for those subjects on 750 mg lithium than for those on 250 mg lithium . In addition , using a 50 % fall in the HRSD as a criterion of drug responsiveness , 22 % responded to placebo , 18 % to 250 mg lithium , and 44 % to 750 mg lithium . Thus , lithium in normal , but not in low , dose has a significant antidepressant effect in TCA-resistant depression . Further controlled studies using lithium in normal dose in trials which have a greater duration of placebo exposure are required to confirm the lithium augmentation effect Resistance to antidepressant therapy is a common clinical problem in the treatment of affective disorders . Adjunctive low dose lithium is a promising strategy based on biochemical models and encouraging clinical trials . After a mean duration of 9.2 months of conventional therapy , 16 healthy patients with treatment-resistant depression were treated for a minimum of 2 weeks with either adjunctive lithium or placebo using a double-blind design . We found no difference between the two groups in rate or degree of response . The two most dramatic responses occurred in patients treated with placebo , although 50 % of patients treated with lithium had at least a partial response . The number of patients studied was clearly inadequate to avoid a type 2 error . The cumulative response rate reported in the literature of greater than 60 % , however , suggests that lithium is indeed an effective adjunct in some patients with treatment-resistant depression . Our patients differed from those in other studies in that they were treated with a lower dose of lithium , the duration of conventional antidepressant therapy was longer , and , finally , they were less depressed and possibly depressed for a longer period . These differences may explain the comparable lithium and placebo responses in this study OBJECTIVE Use of lithium to augment antidepressant medication has been shown to be beneficial in the acute treatment of depression . The authors examined the efficacy of lithium augmentation in the continuation treatment of unipolar major depressive disorder . METHOD Thirty patients with a refractory major depressive episode who had responded to acute lithium augmentation during an open 6-week study participated in a r and omized , parallel-group , double-blind , placebo-controlled trial of lithium augmentation during continuation treatment . After a 2 - 4-week stabilization period following remission , patients were r and omly assigned to receive either lithium or placebo for a 4-month period . Antidepressant medication was continued throughout the study . RESULTS Relapses ( including one suicide ) occurred in seven ( 47 % ) of the 15 patients who received placebo in addition to antidepressants . None ( 0 % ) of the 14 patients who received lithium augmentation with antidepressants suffered a relapse during the double-blind phase of the study . Five of the seven relapsing patients in the placebo group developed a depressive episode , and the other two experienced a manic episode . CONCLUSIONS Lithium augmentation in the continuation phase of treatment of unipolar major depressive disorder effectively protects patients against a relapse . Patients who respond to lithium augmentation should be maintained on lithium augmentation for a minimum of 6 months or even longer The authors conducted an open-label study of the efficacy and tolerability of venlafaxine and of lithium augmentation in out patients with depression who were not responding to venlafaxine . Out patients aged OUTPUT: Animal studies offer robust evidence that lithium augmentation increases 5-HT neurotransmission , possibly by a synergistic action of lithium and the antidepressant on brain 5-HT pathways . Conclusions : Augmentation of antidepressants with lithium is the best-documented augmentation therapy in the treatment of refractory depression . Emerging data from animal studies suggest that the 5-HTergic system is involved in the augmentatory effect of lithium INPUT: Prolactin ( PRL ) and Cortisol ( CORT ) responses to d , l-fenfluramine ( FEN ) challenge ( 60 mg ) were examined in patients with affective disorders on two occasions under euthymic conditions : drug-free before admission to prophylactic treatment and after about 9 months of medication with lithium or carbamazepine . Response to treatment was assessed by a complex algorithm using continuous ratings in outpatient clinic over a period of 2 years . In general , treatment result ed in a delayed and diminished CORT release ( n.s . ) ; subgroup analysis revealed an attenuated CORT response ( P < 0.05 ) in responders , whereas nonresponders showed no change in CORT secretion pattern except an enhanced CORT baseline value ( P < 0.05 ) . Cross-sectional comparison of responders with nonresponders under medication yielded a trend for greater CORT stimulation in nonresponders . This result was not affected by FEN/NorFEN or lithium/carbamazepine serum levels , baseline CORT values , age , sex , diagnostic distribution , number of appointments to the outpatient clinic or duration of medication at the time of FEN test session . Before onset of prophylactic medication responders and nonresponders could not be discriminated significantly regarding stimulated hormone release , probably due to the small sample size ( n = 17 ) . CORT response to FEN was increased in drugfree unipolar patients compared to bipolar ( P < 0.05 ) and to schizoaffective patients ( P < 0.1 ) . In accordance with its well-documented presynaptic 5-HT-agonistic action lithium medication result ed in a significantly greater increase in CORT release than carbamazepine ( P < 0.05 ) . Evaluation of PRL stimulation showed patterns of secretion quite similar to those of CORT , without reaching statistical significance in most cases . Perhaps due to method ological differences in assessing treatment response , these data do not confirm former results , which supposed an enhanced 5-HT net activity in long-term prophylactic lithium treatment . Because of high interindividual variances of hormone parameters , the FEN-test procedure is not a useful tool for the prediction of therapeutical outcome in terms of clinical routine use . Relations of stimulated hormone response as a marker of central serotoninergic activity and clinical outcome are discussed Relapse rates of the first 35 unipolar and bipolar II manic-depressive patients who entered the controlled phase of a continuing evaluation of the prophylactic value of lithium alone or in combination with imipramine were analyzed . Lithium had a prophylactic effect in unipolar patients and possibly in bipolar II patients . Imipramine did not have a prophylactic effect in either group of patients In two r and omized double-blind controlled trials on 63 depressed female in- patients subject to recurrent affective disorder ( bipolar and unipolar manic-depressive psychosis ) lithium was shown to have major acute antidepressant effects . At the end of three weeks lithium produced more uniform improvement than did imipramine ; lithium in combination with tryptophan ( in the form of Optimax ) was superior to tryptophan alone -- the latter drug having no discernible antidepressant activity in this group of patients . Lithium did not produce an antidepressant effect until the second and third week of both trials Abstract The prophylactic effect of lithium was studied in a group of sixty-five patients with recurrent affective disorders in four centres . Patients were r and omly allocated to lithium or identical-looking placebo tablets for periods of up to 112 weeks . In addition , patients received any further medication or treatment which the psychiatrist in charge of the case thought was necessary . Patients receiving lithium had very significantly less affective illness than patients receiving placebo tablets , whether this was measured by time spent as an inpatient or by the duration of outpatient episodes . The amount of antidepressant or of antimanic medication prescribed was also significantly less in the lithium group . No patient on lithium was given electroconvulsive therapy ( E.C.T. ) , whereas 43 % of the placebo group received one or more courses of E.C.T. A global rating was made independently by two assessors who did not know whether the patient was in the lithium or in the placebo group . These assessors , the psychiatrist in charge of the case and a psychiatric social worker , showed a very high concordance in their ratings . 86 % of patients on lithium were rated as showing little or no affective disorders ( global rating 1 and 2 ) during the trial , as compared to only 8 % of the placebo group . Only 11 % of the lithium group was rated as unchanged or worse than during the 2 years previous to the trial , as compared with 75 % of the placebo group . Lithium seemed to be as effective in patients with unipolar recurrent depressive illness as in patients with both mania and depression Depressed out patients ( n = 51 ) resistant to treatment with maprotiline were treated in a blind , r and omized , single-centre study , for 6 weeks with either the reversible and selective monoamine oxidase A-inhibitor ( MAO-A-I ) , brofaromine or lithium addition to maprotiline . The Hamilton Rating Scale for Depression was scored by an independent rater before and after the 6 week treatment period . No significant differences in efficacy were found between the two treatment regimes . In the patients who completed the trial , brofaromine was well tolerated with the exception of insomnia . Anticholinergic effects as well as thyroid dysfunctions ( 17 out of 20 ) were more frequent in the maprotiline/lithium group The authors compared rates of new episodes in a sample of 64 unipolar subjects treated with fluvoxamine ( n = 32 ) and lithium ( n = 32 ) during a follow-up period of 24 months . Unipolar patients on l OUTPUT:
There were no other statistically significant differences between lithium and antidepressants according to all other outcomes considered . AUTHORS ' CONCLUSIONS There was adequate efficacy evidence for lithium or antidepressants preventing relapse in unipolar affective disorder , however their relative efficacy was unknown .
MS2_dynamic_1_shot440
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: Background In many but not in all neuropsychological studies buprenorphine-treated opioid-dependent patients have shown fewer cognitive deficits than patients treated with methadone . In order to examine if hypothesized cognitive advantage of buprenorphine in relation to methadone is seen in clinical patients we did a neuropsychological follow-up study in unselected sample of buprenorphine- vs. methadone-treated patients . Methods In part I of the study fourteen buprenorphine-treated and 12 methadone-treated patients were tested by cognitive tests within two months ( T1 ) , 6 - 9 months ( T2 ) , and 12 - 17 months ( T3 ) from the start of opioid substitution treatment . Fourteen healthy controls were examined at similar intervals . Benzodiazepine and other psychoactive comedications were common among the patients . Test results were analyzed with repeated measures analysis of variance and planned contrasts . In part II of the study the patient sample was extended to include 36 patients at T2 and T3 . Correlations between cognitive functioning and medication , substance abuse , or demographic variables were then analyzed . Results In part I methadone patients were inferior to healthy controls tests in all tests measuring attention , working memory , or verbal memory . Buprenorphine patients were inferior to healthy controls in the first working memory task , the Paced Auditory Serial Addition Task and verbal memory . In the second working memory task , the Letter-Number Sequencing , their performance improved between T2 and T3 . In part II only group membership ( buprenorphine vs. methadone ) correlated significantly with attention performance and improvement in the Letter-Number Sequencing . High frequency of substance abuse in the past month was associated with poor performance in the Letter-Number Sequencing . Conclusions The results underline the differences between non-r and omized and r and omized studies comparing cognitive performance in opioid substitution treated patients ( fewer deficits in buprenorphine patients vs. no difference between buprenorphine and methadone patients , respectively ) . Possible reasons for this are discussed Background Because pain often signals the occurrence of potential tissue damage , a nociceptive stimulus has the capacity to involuntarily capture attention and take priority over other sensory inputs . Whether distraction by nociception actually occurs may depend upon the cognitive characteristics of the ongoing activities . The present study tested the role of working memory in controlling the attentional capture by nociception . Methodology and Principal Findings Participants performed visual discrimination and matching tasks in which visual targets were shortly preceded by a tactile distracter . The two tasks were chosen because of the different effects the involvement of working memory produces on performance , in order to dissociate the specific role of working memory in the control of attention from the effect of general re source dem and s. Occasionally ( i.e. 17 % of the trials ) , tactile distracters were replaced by a novel nociceptive stimulus in order to distract participants from the visual tasks . Indeed , in the control conditions ( no working memory ) , reaction times to visual targets were increased when the target was preceded by a novel nociceptive distracter as compared to the target preceded by a frequent tactile distracter , suggesting attentional capture by the novel nociceptive stimulus . However , when the task required an active rehearsal of the visual target in working memory , the novel nociceptive stimulus no longer induced a lengthening of reaction times to visual targets , indicating a reduction of the distraction produced by the novel nociceptive stimulus . This effect was independent of the overall task dem and s. Conclusion and Significance Loading working memory with pain-unrelated information may reduce the ability of nociceptive input to involuntarily capture attention , and shields cognitive processing from nociceptive distraction . An efficient control of attention over pain is best guaranteed by the ability to maintain active goal priorities during achievement of cognitive activities and to keep pain-related information out of task setting OBJECTIVE The present study examines the possibility that a chronic pain condition , such as fibromyalgia , was associated with deficits in decision making and associative learning . METHODS Fifteen patients with fibromyalgia ( aged 42 - 59 years ) and 15 healthy controls ( aged 39 - 61 years ) participated in the experiment . Subjects completed anxiety ( STAI ) and depression ( BDI ) question naires , as well as st and ardized neuropsychological tests ( Stroop and WAIS subscales ) . In addition , an emotional decision-making task ( Iowa Gambling Task ) and a conditional associative learning task ( CALT ) were administered to all participants . RESULTS Results indicated that fibromyalgia had a poorer performance than healthy controls in both tasks , showing more perseveration errors in the learning task , and more disadvantageous decisions , as well as a more r and om behavior in the gambling task . Moreover , we observed that poor performance on the associative learning task was mediated by depression , whereas performance on the gambling task was not influenced by depression . No group differences were found on the st and ardized neuropsychological tests . CONCLUSION These findings indicate that pain and depressive symptoms in fibromyalgia might lead to significant deficits in emotionally charged cognitive tasks . Furthermore , it suggests that chronic pain might impose a high cost on executive control , undermining mainly affective processes involved in learning , memory , attention , and decision-making The aim of the study was to investigate the influence of pain , sedation , pain medications and socio-demographics on cognitive functioning in chronic non-malignant pain patients . Chronic non-malignant pain patients ( N=91 ) treated in a multidisciplinary pain centre were compared with age and sex matched healthy volunteers ( N=64 ) . Furthermore four subgroups of patients were examined : Group 1 ( N=21 ) received no pain medications , group 2 ( N=19 ) were in long-term oral opioid treatment , group 3 ( N=18 ) were treated with antidepressants and /or anticonvulsants and group 4 ( N=33 ) were treated with a OUTPUT: High heterogeneity within the field was found with the inclusion of 24 papers using 21 different working memory tests encompassing 9 different working memory constructs and 9 different chronic pain population s. Notwithst and ing high heterogeneity , pooled results from behavioural outcomes reflected a consistent , significant moderate effect in favour of better performance by healthy controls and , with the exception of one study , pooled results from physiological outcomes reflected no evidence for an effect . INPUT: Abstract . Rationale : Methadone is the most widespread pharmacological treatment for opiate dependency but relatively little is known of its effects on cognitive and psychomotor functioning , drug craving and mood . Objective : The present study aim ed to assess the acute effects of methadone in patients admitted to an opiate detoxification programme . Methods : Patients were r and omly allocated to one of two groups who received either 50 % or 100 % of their daily stabilisation dose , and a placebo , in a double-blind , cross-over design . Twenty patients completed the study , all were assessed pre- and post-drug on 2 separate testing days . Results : Performance on a task tapping episodic memory ( delayed recall of a prose passage ) was significantly impaired following the 100 % daily dose of methadone . Methadone treatment had no effect on craving or mood . Patients were unable to distinguish between methadone and placebo treatments . Conclusions : A single dose of methadone can induce episodic memory impairment in patients who have a history of heroin use averaging more than 10 years . Such impairment can be avoided by giving methadone in divided doses This study tested whether opiate dependence , tobacco smoking , or their combination accompanied impaired performance on the gambling task ( GT ) , which tests decision-making . GT previously detected impairments in patients with lesions of the ventromedial prefrontal cortex and in substance abusers . Four groups were matched on demographic characteristics and intelligence : methadone-maintained smokers ( n = 9 ) and nonsmokers ( n = 9 ) , and control ( i.e. , not opiate-dependent ) smokers ( n = 9 ) and nonsmokers ( n = 10 ) . The Wisconsin Card Sorting Task ( WCST ) was administered to test whether differences in GT performance reflected generalized deficits in prefrontal cortical function . While there were no significant group differences on the WCST , groups differed significantly on GT performance ( F(3,31 ) = 2.95 , P = 0.048 ) , controlling for depressive symptom ratings and childhood attention deficit hyperactivity disorder . Methadone-maintained smokers ( but not nonsmokers ) performed more poorly than either of the two control groups ( P = 0.007 versus smokers ; P = 0.024 versus nonsmokers ) . In a planned analysis of methadone-maintained subjects , smokers scored more poorly on GT than nonsmokers ( F(1,18 ) = 5.64 , P = 0.032 ) and had more treatment failures ( 67 % heroin use during the last 30 days versus 20 % ) . The findings suggest that among opiate-dependent individuals , tobacco smoking may be a marker for a more severe form of substance abuse disorder , reflecting impaired decision-making , as modeled by GT Reinforcing properties of psychoactive substances are considered to be critically involved in the development and maintenance of substance dependence . While accumulating evidence suggests that the sensitivity to reinforcement values may generally be altered in chronic substance users , relatively little is known about the influence reinforcing feedback exerts on ongoing decision-making in these individuals . Decision-making was investigated using the Cambridge Risk Task , in which there is a conflict between an unlikely large reward option and a likely small reward option . Responses on a given trial were analyzed with respect to the outcome on the previous trial , providing a measure of the impact of prior feedback in modulating behavior . Five different groups were compared : ( i ) chronic amphetamine users , ( ii ) chronic opiate users in methadone maintenance treatment ( MMT ) , ( iii ) chronic users of illicit heroin , ( iv ) ex-drug users who had been long-term amphetamine / opiate users but were abstinent from all drugs of abuse for at least 1 year and ( v ) matched controls without a history of illicit substance use . Contrary to our predictions , choice preference was modified in response to feedback only in opiate users enrolled in MMT . Following a loss , the MMT opiate group chose the likely small reward option significantly less frequently than controls and heroin users . Our results suggest that different opiates are associated with distinctive behavioral responses to feedback . These findings are discussed with respect to the different mechanisms of action of heroin and methadone AIMS To assess the influence of methadone and buprenorphine maintenance treatment on the driving aptitude of opioid-dependent patients . DESIGN Prospect i ve , open label , outpatient maintenance , single-blind ( investigator ) study . PARTICIPANTS AND SETTING Thirty opioid-dependent patients maintained on either methadone or buprenorphine were recruited from the drug-addiction outpatient clinic in Vienna . MEASUREMENTS The traffic-relevant performance dimensions of the participants were assessed 22 h after receiving synthetic opioid maintenance therapy , by a series of seven tests constituting the Act & React Test System ( ART ) 2020 St and ard test battery , developed by the Austrian Road Safety Board ( ARSB ) . To test for additional consumption of illicit substances , blood and urine sample s were taken at the beginning of the tests . FINDINGS The patient group only differed from control subjects in two of the ART 2020 St and ard tests . During a task to test the subject 's attention under monotonous circumstances ( Q1 test ) , patients had a significantly greater number of reactions ( p = 0.027 ) and a significantly higher percentage of incorrect reactions than control subjects . When driving in a dynamic environment ( DR2 test ) patients had a significantly longer mean decision time ( p = 0.029 ) and mean reaction time ( p = 0.009 ) compared with control subjects . Interestingly , when separated into treatment groups , the mean decision and reaction times of buprenorphine-maintained patients in the DR2 test did not differ from controls , whereas patients maintained on methadone showed significantly prolonged mean decision ( p = OUTPUT:
HighlightsA broad range of domains of neuropsychological performance are significantly impaired in studies which have compared methadone population s with the healthy controls . However low power , poor quality and heterogenous population s limit the interpretation of these results .Short term ( less than 1 year ) abstinent groups , when compared with methadone groups , still exhibited cognitive impairments but results are inconclusive . It is still not clear what the role of global sedative effects of opioids such as methadone have on cognitive impairment . Only higher quality longitudinal studies using ecologically valid cognitive tests , in well‐defined population groups can address this question .Methadone population s present with a broad range of neuropsychological impairment when compared with healthy controls . Results : Data from a total cohort of 1063 CM , 412 AP and 879 HP participants , from 23 independent studies indicate global impairments in neurocognitive function in CM relative to HP participants . Conclusion : Method ological issues such as small sample sizes , heterogeneity and poor quality limited the interpretation of the results and does not address whether the observed impairments reflect co‐morbid functioning , methadone‐related sedation and /or other factors .
MS2_dynamic_1_shot441
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: Background The prevalence of micronutrient deficiencies is higher in obese individuals compared to normal-weight people , probably because of inadequate eating habits but also due to increased dem and s among overweight persons , which are underestimated by dietary reference intakes ( DRI ) intended for the general population . We therefore evaluated the dietary micronutrient intake in obese individuals compared to a reference population and DRI recommendations . Furthermore , we determined the micronutrient status in obese subjects undergoing a st and ardized DRI-covering low-calorie formula diet to analyze if the DRI meet the micronutrient requirements of obese individuals . Methods In 104 subjects baseline micronutrient intake was determined by dietary record collection . A r and omly assigned subgroup of subjects ( n = 32 ) underwent a st and ardized DRI-covering low-calorie formula diet over a period of three months . Pre- and post-interventional intracellular micronutrient status in buccal mucosa cells ( BMC ) was analyzed , as well as additional micronutrient serum concentrations in 14 of the subjects . Results Prior to dietetic intervention , nutrition was calorie-rich and micronutrient-poor . Baseline deficiencies in serum concentrations were observed for 25-hydroxyvitamin-D , vitamin C , selenium , iron , as well as ß-carotene , vitamin C , and lycopene in BMC . After a three-month period of formula diet even more subjects had reduced micronutrient levels of vitamin C ( serum , BMC ) , zinc , and lycopene . There was a significant negative correlation between lipophilic serum vitamin concentrations and body fat , as well as between iron and C-reactive protein . Conclusions The present pilot study shows that micronutrient deficiency occurring in obese individuals is not corrected by protein-rich formula diet containing vitamins and minerals according to DRI . In contrast , micronutrient levels remain low or become even lower , which might be explained by insufficient intake , increased dem and and unbalanced dispersal of lipophilic compounds in the body . Trial registration The study was registered at Clinical Trials.gov ( NCT01344525 ) . The study protocol comprises only a part of the approved trial protocol Context : Common concerns when using low-calorie diets as a treatment for obesity are the reduction in fat-free mass , mostly muscular mass , that occurs together with the fat mass ( FM ) loss , and determining the best method ologies to evaluate body composition changes . Objective : This study aim ed to evaluate the very-low-calorie ketogenic ( VLCK ) diet-induced changes in body composition of obese patients and to compare 3 different method ologies used to evaluate those changes . Design : Twenty obese patients followed a VLCK diet for 4 months . Body composition assessment was performed by dual-energy X-ray absorptiometry ( DXA ) , multifrequency bioelectrical impedance ( MF-BIA ) , and air displacement plethysmography ( ADP ) techniques . Muscular strength was also assessed . Measurements were performed at 4 points matched with the ketotic phases ( basal , maximum ketosis , ketosis declining , and out of ketosis ) . Results : After 4 months the VLCK diet induced a −20.2 ± 4.5 kg weight loss , at expenses of reductions in fat mass ( FM ) of −16.5 ± 5.1 kg ( DXA ) , −18.2 ± 5.8 kg ( MF-BIA ) , and −17.7 ± 9.9 kg ( ADP ) . A substantial decrease was also observed in the visceral FM . The mild but marked reduction in fat-free mass occurred at maximum ketosis , primarily as a result of changes in total body water , and was recovered thereafter . No changes in muscle strength were observed . A strong correlation was evidence d between the 3 methods of assessing body composition . Conclusion : The VLCK diet-induced weight loss was mainly at the expense of FM and visceral mass ; muscle mass and strength were preserved . Of the 3 body composition techniques used , the MF-BIA method seems more convenient in the clinical setting OBJECTIVE Obesity plays a relevant pathophysiological role in the development of health problems , arising as result of complex interaction of genetic , nutritional and metabolic factors . We conducted a dietary intervention case-control r and omized trial , to compare the effectiveness on body composition of two nutritional protocol s : a very-low-carbohydrate ketogenic diet ( VLCKD ) , integrated by an aminoacid supplement with whey protein , and very low restricted-calorie diet ( VLCD ) . PATIENTS AND METHODS The clinical study was conducted with a r and omized case-control in which twenty-five healthy subjects gave informed consent to participate in the interventional study and were evaluated for their health and nutritional status , by anthropometric , and body composition evaluation . RESULTS The results of this pilot study show that a diet low in carbohydrates , associated with a decreased caloric intake , is effective in weight loss . After VLCKD , versus VLCD , no significant differences in body lean of the trunk , body lean distribution ( and roid and gynoid ) , total body lean were observed ( p > 0.05 ) . After VLCKD , no increasing of sarcopenia frequency , according ASSMI , was observed . DISCUSSION Many studies have shown the effectiveness of the ketogenic diet on weight loss ; even if not know how to work effectively , as some research ers believe that the weight loss is due to reduced calorie intake , satiety could also be induced by the effect of the proteins , rather than the low-carbohydrates . CONCLUSIONS Our pilot study showed that a VLCKD was highly effective in terms of body weight reduction without to induce lean body mass loss , preventing the risk of sarcopenia . Further clinical trials are needed on a larger population and long-term OUTPUT: No changes in LDL cholesterol , HDL cholesterol , serum creatinine , serum uric acid and serum potassium were found . The present review supports the use of VLCKD as an effective strategy for the management of overweight and obesity . INPUT: Background The prevalence of micronutrient deficiencies is higher in obese individuals compared to normal-weight people , probably because of inadequate eating habits but also due to increased dem and s among overweight persons , which are underestimated by dietary reference intakes ( DRI ) intended for the general population . We therefore evaluated the dietary micronutrient intake in obese individuals compared to a reference population and DRI recommendations . Furthermore , we determined the micronutrient status in obese subjects undergoing a st and ardized DRI-covering low-calorie formula diet to analyze if the DRI meet the micronutrient requirements of obese individuals . Methods In 104 subjects baseline micronutrient intake was determined by dietary record collection . A r and omly assigned subgroup of subjects ( n = 32 ) underwent a st and ardized DRI-covering low-calorie formula diet over a period of three months . Pre- and post-interventional intracellular micronutrient status in buccal mucosa cells ( BMC ) was analyzed , as well as additional micronutrient serum concentrations in 14 of the subjects . Results Prior to dietetic intervention , nutrition was calorie-rich and micronutrient-poor . Baseline deficiencies in serum concentrations were observed for 25-hydroxyvitamin-D , vitamin C , selenium , iron , as well as ß-carotene , vitamin C , and lycopene in BMC . After a three-month period of formula diet even more subjects had reduced micronutrient levels of vitamin C ( serum , BMC ) , zinc , and lycopene . There was a significant negative correlation between lipophilic serum vitamin concentrations and body fat , as well as between iron and C-reactive protein . Conclusions The present pilot study shows that micronutrient deficiency occurring in obese individuals is not corrected by protein-rich formula diet containing vitamins and minerals according to DRI . In contrast , micronutrient levels remain low or become even lower , which might be explained by insufficient intake , increased dem and and unbalanced dispersal of lipophilic compounds in the body . Trial registration The study was registered at Clinical Trials.gov ( NCT01344525 ) . The study protocol comprises only a part of the approved trial protocol BACKGROUND Weight loss is associated with bone loss , but this has not been examined in overweight premenopausal women . OBJECTIVE The aim of this study was to assess whether overweight premenopausal women lose bone with moderate weight loss at recommended or higher than recommended calcium intakes . DESIGN Overweight premenopausal women [ n = 44 ; x ( + /-SD ) age : 38 + /- 6.4 y ; body mass index ( BMI ): 27.7 + /- 2.1 kg/m(2 ) ] were r and omly assigned to either a normal ( 1 g/d ) or high ( 1.8 g/d ) calcium intake during 6 mo of energy restriction [ weight loss ( WL ) groups ] or were recruited for weight maintenance at 1 g Ca/d intake . Regional bone mineral density and content were measured by dual-energy X-ray absorptiometry , and markers of bone turnover were measured before and after weight loss . True fractional calcium absorption ( TFCA ) was measured at baseline and during caloric restriction by using a dual-stable calcium isotope method . RESULTS The WL groups lost 7.2 + /- 3.3 % of initial body weight . No significant decrease in BMD or rise in bone turnover was observed with weight loss at normal or high calcium intake . The group that consumed high calcium showed a strong relation ( r = 0.71 ) between increased femoral neck bone mineral density and increased serum 25-hydroxyvitamin D. No significant effect of weight loss on TFCA was observed , and the total calcium absorbed was adequate at 238 + /- 81 and 310 + /- 91 mg/d for the normal- and high-calcium WL groups , respectively . CONCLUSION Overweight premenopausal women do not lose bone during weight loss at the recommended calcium intake , which may be explained by sufficient amounts of absorbed calcium BACKGROUND Overweight and obesity are increasing in young adults . However , moderate energy restriction aim ed at lowering body weight may promote bone turnover and bone loss . Inclusion of fish or fish oils in a weight-loss diet may attenuate these adverse skeletal effects . OBJECTIVE We examined the effects of incorporating fish or fish oil into an energy-restricted diet on bone turnover markers in young overweight adults . DESIGN While following a strict hypoenergetic ( -30 % relative to estimated requirements ) diet for 8 wk , 276 overweight men and women [ body mass index ( in kg/m(2 ) ) : 27.5 - 32.5 ; age : 20 - 40 y ) were r and omly assigned to 1 of 4 dietary groups : sunflower-oil capsules ( 3 g/d ; control ) , cod ( 3 x 150 g/wk ) , salmon ( 3 x 150 g/wk ) , and fish-oil capsules ( 3 g/d ) . Body weight , bone biomarkers , and 25-hydroxyvitamin D were measured at baseline and endpoint . Data were analyzed with repeated- measures analysis of variance and general linear models . RESULTS The mean ( + /-SD ) weight loss was 5.14 + /- 3.0 kg ( 5.8 % + /- 3.2 % body weight ) during the 8 wk in the 4 dietary groups combined . Urinary N-telopeptides of type I collagen and serum C-terminal telopeptide of type I collagen increased ( P < 0.05 ) , whereas serum osteocalcin ( but not bone-specific alkaline ph OUTPUT:
Collectively , these outcomes support a volumetric dilution of vitamin D. The slopes of the respective regression lines , however , indicate a smaller increase in 25OHD than would be expected from a direct mobilization of stores into the circulation . Hence , sequestration of 25OHD and its conversion to inactive metabolites would also play a role .
MS2_dynamic_1_shot442
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: OBJECTIVE To study the effectiveness of luteinising hormone releasing hormone ( LHRH ) analogues in improving final height in girls affected by early puberty . PATIENTS Forty six consecutive girls with onset of puberty aged 7.5–8.5 years r and omly divided into two groups : one treated with 3.75 mg triptorelin intramuscularly every four weeks ( group 1 ) ; and the other with no treatment ( group 2 ) . RESULTS Mean ( SD ) chronological age at onset of menarche was significantly higher in group 1 than in group 2 ( 11.9 ( 1.0 ) v 10.8 ( 0.7 ) years ) . However , mean ( SD ) height at menarche ( 152.7 (7.2)v 152.5 ( 5.7 ) cm ) and mean ( SD ) growth after menarche ( 4.9 ( 3.0 ) v 5.4 ( 2.2 ) cm ) were similar in both groups . The mean ( SD ) final height was similar in the two groups ( group 1 , 158.1 ( 6.2 ) cm ; group 2 , 158.6 ( 6.0 ) cm ) and not significantly different from target height . Fourteen of 20 patients in group 1 and 12 of 18 patients in group 2 showed final height equal to or higher than target height . Final heights of girls with poor initial height prognosis were significantly lower than those of girls with good prognosis , but in patients with the same initial height prognosis , both groups showed final heights similar and not significantly different from their target heights . CONCLUSIONS LHRH analogue has no apparent effect on final height in subjects with onset of puberty between 7.5 and 8.5 years Early and fast puberty ( EFP ) in girls , defined as pubertal onset at age 8 - 9 yr , with an accelerated course , may cause compromised final height ( FHt ) and psychosocial distress . Treatment with a gonadotropin-suppressive agent is controversial , because the improvement in FHt is equivocal and there may be risk of obesity . We analyzed the data of 126 girls with EFP : 63 treated with GnRH analog ( GnRHA ) since Tanner stage 3 , for 2 - 4 yr ; and 63 untreated . Age at onset of puberty ; accelerated time of transition from Tanner stage 2 to 3 ( < 1.3 yr ) ; and clinical , hormonal and sonographic findings were similar in the 2 groups . The girls given GnRHA treatment had a significantly prolonged pubertal course , compared with the accelerated course in the untreated girls ( 4.7 + /- 0.4 vs. 2.45 + /- 0.4 yr , P < 0.001 ) . After therapy , they reached Tanner stages 4 and 5 and FHt at a significantly older age than the untreated group ( P < 0.001 ) , and their menarche was delayed ( 12.8 + /- 0.6 vs. 10.8 + /- 0.5 yr , P < 0.001 ) . However , the different pace of puberty in the 2 groups did not change the total pubertal growth and the bone maturation rate . The Ht gain from Tanner stage 3 to 4 ( 10.4 + /- 2.7 vs. 11.2 + /- 3.1 cm ) and from Tanner stage 4 to FHt ( 8.2 + /- 2.7 vs. 8.8 + /- 3.6 cm ) was similar in the treated and untreated girls , as were absolute Ht and bone age at each pubertal stage . The weight gain of the treated girls was more pronounced during treatment ( P = 0.0016 ) , but it was arrested after discontinuation of therapy ; and by the time FHt was reached , the body mass index was similar in the 2 groups . The treated and untreated girls achieved a similar mean FHt , which was not significantly different from their respective mean target Ht ( THt ) . Individual analysis revealed that 70 % of the treated girls and 67 % of the untreated girls attained their THt range ( THt + /- 0.5 SD ) or surpassed it . In conclusion , treatment with GnRHA affected only the pace of EFP . The similar Ht gain and bone maturation rate at each pubertal stage in the treated and untreated girls may suggest that the total pubertal growth is not dependent on pubertal duration and pace and is probably determined already at the onset of the normal pubertal development . The treatment did not compromise the FHt and did not cause long-lasting obesity . Therefore , GnRHA therapy may be suggested for use in girls who have psychosocial difficulties in coping with EFP Twenty-two girls affected by sexual precocity with impaired final height prognosis were followed until they achieved final height . Twelve of them were treated with an intranasal (D-Ser6)-gonadotrophin-releasing hormone ( GnRH ) analogue ( buserelin ) administered at a mean dose of 25 micrograms/kg/day ( range 20 - 32 ) for a mean period of 14 months ( range 8 - 18 ) . Ten girls refused treatment . Mean final height of the treated girls was 157.3 + /- 8.2 cm , significantly ( p = 0.03 ) higher than the 149.7 + /- 5.5 cm of untreated patients . Treated girls surpassed midparental height ( + 1.7 cm ) while untreated girls reached the lower part of target zone ( -3.5 cm ) . Our data suggest that intranasal buserelin treatment preserves final height in girls with sexual precocity and initially impaired height prognosis Objective : To investigate the effects of treatment with gonadotropin-releasing hormone analog ( GnRHa ) on final height in girls who OUTPUT: Conclusion We found no evidence from controlled experimental and observational studies that compared with no treatment , the use of GnRH analogs improved AH in girls with EP INPUT: GH , 0.1 IU/kg/day 6 days/week , was given to 30 early pubertal short patients for 3 years . There were 16 males , aged 14.4 + /- 0.8 years , and 14 females , aged 12.2 + /- 1.2 years , at pubertal stage 2 or 3 with slow growth ( 4.2 + /- 1.2 cm/year ) and no detected GH insufficiency or other cause for short stature . They were r and omized in 2 groups : group A with GH alone , and group B with GH and a gonadotropin-releasing hormone agonist during the first 2 years . 28 of the 30 patients completed 3 years of treatment . The annual growth rate increased during the 1st year in both groups and sexes , the increase being significant ( p < 0.01 ) in group A only . Patients of group A kept an improved growth velocity in the 2nd year , then returned to pretreatment growth rate in the 3rd year , while completing their sexual development and bone maturation . Their height , expressed as st and ard deviation score ( SDS ) for bone age , improved in the first 2 years , but decreased thereafter . Group B patients returned to pretreatment growth velocity in the 2nd year , and had no significant improvement in growth rate in the 3rd year with GH alone . Their bone maturation , slow when on the GnRH agonist , accelerated when sexual development resumed . At the end of the 3 years , height , expressed as SDS for age , improved in group A from -2.5 + /- 0.6 to -1.5 + /- 0.4 in males ( p < 0.05 ) and from -2.8 + /- 0.5 to -2.1 + /- 0.9 in females ( NS ) . ( ABSTRACT TRUNCATED AT 250 WORDS Short-term administration of human growth hormone to children with idiopathic short stature can improve mean growth rate and predicted adult height . It is yet unknown whether therapy would alter pubertal development or affect final height . Three-year treatment results in a group of children with idiopathic short stature are reported . For year 1 of the study , 121 prepubertal children were r and omly selected to receive somatotropin , 0.3 mg/kg per week , administered subcutaneously three times weekly ( n = 63 ) , or to be nontreatment control subjects ( n = 58 ) . After 1 year , all subjects were again r and omly selected to receive either three-times-weekly or daily dosing at the same total dose . For the 92 subjects who completed 36 months of treatment , mean growth rate increased from a mean of 4.6 cm/yr before treatment to a mean of 8.0 cm/yr in the first year of treatment . Daily dosing result ed in a significantly faster mean growth rate ( 9.0 cm/yr ) than three-times-weekly dosing ( 7.8 cm/yr ) ( p = 0.0005 ) . Mean growth rates were 7.6 and 7.2 cm/yr during years 2 and 3 , respectively , and did not differ by dosing group . Mean st and ardized height for all subjects improved from -2.7 to -1.6 after 3 years . When the growth rate was st and ardized for bone age , however , subjects who remained prepubertal had a significantly greater gain in mean height SD score than subjects who became pubertal during that 3-year period ( p < 0.02 ) . Mean st and ardized Bayley-Pinneau predicted adult height SD score increased from -2.7 to -1.6 and was independent of the timing of pubertal onset , but for individuals this score was more variable . Year-1 growth response , expressed as growth rate or change in height SD score , was the best predictor of growth in subsequent years . Responses to therapy could not be reliably predicted from baseline anthropometric variables , plasma insulin-like growth factor I SD score , growth hormone levels . Final height assessment will be needed to determine the ultimate benefit of therapy GH is often used to treat children with idiopathic short stature despite the lack of definitive , long-term studies of efficacy . We performed a r and omized , double-blind , placebo-controlled trial to determine the effect of GH on adult height in peripubertal children . Subjects ( n = 68 ; 53 males and 15 females ) , 9 - 16 yr old , with marked , idiopathic short stature [ height or predicted height < or = -2.5 sd score ( SDS ) ] received either GH ( 0.074 mg/kg ) or placebo sc three times per week until they were near adult height . At study termination , adult height measurements were available for 33 patients after mean treatment duration of 4.4 yr . Adult height was greater in the GH-treated group ( -1.81 + /- 0.11 SDS , least squares mean + /- sem ) than in the placebo-treated group ( -2.32 + /- 0.17 SDS ) by 0.51 SDS ( 3.7 cm ; P < 0.02 ; 95 % confidence interval , 0.10 - 0.92 SDS ) . A similar GH effect was demonstrated in terms of adult height SDS minus baseline height SDS and adult height SDS minus baseline predicted height SDS . Modified intent-to-treat analysis in 62 patients treated for at least 6 months indicated a similar GH effect on last observed height SDS ( 0.52 SDS ; 3.8 cm ; P < 0.001 ; 95 % confidence interval , 0.22 - 0.82 SDS ) and no important dropout bias . In conclusion , GH treatment increases adult height in peripubertal children with marked idiopathic short stature ABSTRACT . Overnight physiological growth hormone ( GH ) secretion was evaluated in 95 short , prepubertal children ( 73 boys OUTPUT:
GH therapy can increase short-term growth and improve ( near ) final height . Increases in height are such that treated individuals remain relatively short when compared with peers of normal stature .
MS2_dynamic_1_shot443
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: OBJECTIVE Effects of pump treatment vs. four times daily injections were explored in children with diabetes with regard to quality of life and impact of disease as well as adverse effects and parameters of metabolic control . METHODS An open , parallel , r and omized controlled prospect i ve comparative study lasting 14 months was completed by 38 type 1 children with diabetes ( age 4 - 16 yr ) following a 3.5-months run-in phase . St and ardized quality -of-life Pediatric Quality of life Inventory ( PedsQL ) and impact of disease scores were obtained every 3.5 months as well as regular medical parameters . Parallel treatment group data and longitudinal within-patient data were analysed for each treatment modality . RESULTS Within-patient comparisons of the two treatment modalities showed significant improvement in PedsQL and impact scores after pump treatment . Treatment group comparisons did not show significant improvement . Pump treatment result ed in decreased symptomatic hypoglycaemia and lowered haemoglobin A1c by 0.22 % after run in . CONCLUSIONS Within-patient comparison suggests that metabolic control , frequency of severe hypoglycaemia ( a threefold decrease ) , quality of life and impact of disease scores are improved by pump treatment in comparison to regular treatment with four daily insulin injections BACKGROUND The management of diabetes in preschool children poses unique difficulties for both the families and the medical team . OBJECTIVE To test the feasibility and safety of insulin pump therapy in the 1 - 6 year age group in order to improve quality of life and metabolic control . METHODS The study group comprised 15 type 1 diabetic children aged 1 - 6 years old ( mean + /- SD , 3.8 + /- 1.2 years ) from three diabetes centers . Insulin pump therapy was applied for 12 months . Data , including insulin dose , hemoglobin A1c , hypoglycemic events , as well as scores on the Diabetes Quality of Life Measure Question naire and the Diabetes Treatment Satisfaction Question naire , were collected and compared with the multiple daily injection treatment prior to entry into the study , RESULTS HbA1c was measured at the beginning of the study and at 2 , 4 , 8 and 12 months later ; the respective levels ( mean + /- SD ) were 8.82 + /- 0.98 , 8.45 + /- 1.05 , 8.37 + /- 0.85 , 8.32 + /- 0.71 , 8.18 + /- 0.90 % . HbA1c measurements after 12 months were significantly lower than at the beginning of the study ( P < 0.05 ) . There were no significant differences in insulin dose and the total number of hypoglycemic events . In both the DQOL and DTSQ scales there were significant differences in scores in favor of the insulin pump period ( 43.7 + /- 8.0 versus 33.7 + /- 7.9 , P < 0.001 ; and 10.9 + /- 2.3 versus 14.5 + /- 2.3 , P < 0.001 ) , respectively . CONCLUSIONS For very young diabetic children , insulin pump therapy improves quality of life and is feasible and safe . It should be considered as an optional mode of therapy for this age group OBJECTIVE Our goals were to determine if continuous subcutaneous insulin infusion ( CSII ) , compared with those continuing multiple daily injections ( MDIs ) , can be safely used in young children , if those on CSII will have superior glycemic control , if subjects using CSII will have less hypoglycemia for their level of control , and if families using CSII will report an improved quality of life . RESEARCH DESIGN AND METHODS We conducted a r and omized 1-year feasibility trial comparing CSII with continuing MDIs in preschool children with a history of type 1 diabetes for at least 6 months ' duration . Prospect i ve outcomes included measures of overall glycemic control ( HbA1c and continuous glucose monitoring system ) , the incidence of severe hypoglycemia and diabetic ketoacidosis , the percent of glucose values below 3.9 mmol/l , and the parents ' report of quality of life . RESULTS The 19 subjects ' ages ranged from 1.7 to 6.1 ( mean 3.6 ) years , duration of diabetes ranged from 0.6 to 2.6 ( mean 1.4 ) years , and baseline HbA1c ranged from 6.7 to 9.6 % ( mean 7.9 % ) . Seven subjects were male . Nine subjects were r and omized to start CSII and 10 to continue on MDI . All baseline characteristics were well balanced . Overall metabolic control , diabetes quality of life , and the incidence of hypoglycemia were similar in the two groups . No subject had diabetic ketoacidosis , while one subject in each group had an episode of severe hypoglycemia . No CSII subject discontinued using the pump during or after the study . CONCLUSIONS CSII can be a safe and effective method to deliver insulin in young children BACKGROUND The Cochrane Collaboration is strongly encouraging the use of a newly developed tool , the Cochrane Collaboration Risk of Bias Tool ( CCRBT ) , for all review groups . However , the psychometric properties of this tool to date have yet to be described . Thus , the objective of this study was to add information about psychometric properties of the CCRBT including inter-rater reliability and concurrent validity , in comparison with the Effective Public Health Practice Project Quality Assessment Tool ( EPHPP ) . METHODS Both tools were used to assess the method ological quality of 20 r and omized controlled trials included in our systematic review of the effectiveness of knowledge translation interventions to improve the management of cancer pain . Each study assessment was completed independently by two OUTPUT: RESULTS QoL and glycaemic control was significantly better in CSII subjects at baseline and follow-up . No significant differences in adverse events were found between study groups . No significant changes over time could be shown for either QoL or glycaemic control . CONCLUSION CSII proved to provide similar or slightly better outcomes in all analysed fields . This is consistent with previous research . INPUT: BACKGROUND Conventional insulin therapy requires patients with Type 1 diabetes to adhere to rigid dietary and insulin injection practice s. Recent trends towards flexible intensive insulin therapy enable patients to match insulin to dietary intake and lifestyle ; however , little work has examined patients ' experiences of incorporating these practice s into real-life context s. This qualitative longitudinal study explored patients ' experiences of using flexible intensive insulin therapy to help inform the development of effective long-term support . METHODS Semi-structured interviews were conducted with 30 adult patients with Type 1 diabetes following participation in a structured education programme on using flexible intensive insulin therapy , and 6 and 12 months post-course . Longitudinal data analysis used an inductive , thematic approach . RESULTS Patients consistently reported feeling committed to and wanting to sustain flexible intensive insulin therapy . This regimen was seen as a logical and effective method of self-management , as patients experienced improved blood glucose readings and /or reported feeling better . Implementing and sustaining flexible intensive insulin therapy was enhanced when patients had stable routines , with more challenges reported by those working irregular hours and during weekends/holidays . Some patients re-crafted their lives to make this approach work for them ; for instance , by creating dietary routines or adjusting dietary choices . CONCLUSIONS Clinical data have shown that flexible intensive insulin therapy can lead to improvement in glycaemic control . This study , drawing on patients ' perspectives , provides further endorsement for flexible intensive insulin therapy by demonstrating patients ' liking of , and their motivation to sustain , this approach over time . To help patients implement and sustain flexible intensive insulin therapy , follow-up support should encourage them to identify routines to better integrate this regimen into their lives BACKGROUND Insulin is generally administered to people with type 1 diabetes mellitus ( T1DM ) using multiple daily injections ( MDIs ) , but can also be delivered using infusion pumps . In the UK , pumps are recommended for patients with the greatest need and adult use is less than in comparable countries . Previous trials have been small , of short duration and have failed to control for training in insulin adjustment . OBJECTIVE To assess the clinical effectiveness and cost-effectiveness of pump therapy compared with MDI for adults with T1DM , with both groups receiving equivalent structured training in flexible insulin therapy . DESIGN Pragmatic , multicentre , open-label , parallel-group cluster r and omised controlled trial , including economic and psychosocial evaluations . After participants were assigned a group training course , courses were r and omly allocated in pairs to either pump or MDI . SETTING Eight secondary care diabetes centres in the UK . PARTICIPANTS Adults with T1DM for > 12 months , willing to undertake intensive insulin therapy , with no preference for pump or MDI , or a clinical indication for pumps . INTERVENTIONS Pump or MDI structured training in flexible insulin therapy , followed up for 2 years . MDI participants used insulin analogues . Pump participants used a Medtronic Paradigm ® VeoTM ( Medtronic , Watford , UK ) with insulin aspart ( NovoRapid , Novo Nordisk , Gatwick , UK ) . MAIN OUTCOME MEASURES Primary outcome - change in glycated haemoglobin ( HbA1c ) at 2 years in participants whose baseline HbA1c was ≥ 7.5 % ( 58 mmol/mol ) . Key secondary outcome - proportion of participants with HbA1c ≤ 7.5 % at 2 years . Other outcomes at 6 , 12 and 24 months - moderate and severe hypoglycaemia ; insulin dose ; body weight ; proteinuria ; diabetic ketoacidosis ; quality of life ( QoL ) ; fear of hypoglycaemia ; treatment satisfaction ; emotional well-being ; qualitative interviews with participants and staff ( 2 weeks ) , and participants ( 6 months ) ; and ICERs in trial and modelled estimates of cost-effectiveness . RESULTS We r and omised 46 courses comprising 317 participants : 267 attended a Dose Adjustment For Normal Eating course ( 132 pump ; 135 MDI ) ; 260 were included in the intention-to-treat analysis , of which 235 ( 119 pump ; 116 MDI ) had baseline HbA1c of ≥ 7.5 % . HbA1c and severe hypoglycaemia improved in both groups . The drop in HbA1c% at 2 years was 0.85 on pump and 0.42 on MDI . The mean difference ( MD ) in HbA1c change at 2 years , at which the baseline HbA1c was ≥ 7.5 % , was -0.24 % [ 95 % confidence interval ( CI ) -0.53 % to 0.05 % ] in favour of the pump ( p = 0.098 ) . The per- protocol analysis showed a MD in change of -0.36 % ( 95 % CI -0.64 % to -0.07 % ) favouring pumps ( p = 0.015 ) . Pumps were not cost-effective in the base case and all of the sensitivity analyses . The pump group had greater improvement in diabetes-specific QoL diet restrictions , daily hassle plus treatment satisfaction , statistically significant at 12 and 24 months and supported by qualitative interviews . LIMITATION Blinding of pump therapy was not possible , although an objective primary outcome was used . CONCLUSION Adding pump therapy to structured training in flexible insulin therapy did not significantly enhance glycaemic control or psychosocial outcomes in adults with T1DM . RESEARCH PRIORITY To underst and why few patients achieve a HbA1c of < 7.5 % , particularly as glycaemic control is worse in OUTPUT:
This model outlines the challenges participants encounter in maintaining diabetes self-management practice s after attending structured education , and describes how participants try to address these barriers by adapting , simplifying or personalising the self-management approaches they have learned . Conclusions This meta-ethnography highlights how providing skills training using structured education to people with type 1 diabetes does not necessarily result in participants adopting and sustaining recommended changes in behaviour .
MS2_dynamic_1_shot444
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: BACKGROUND There is great heterogeneity of clinical presentation and outcome in paediatric depression . AIMS To identify which clinical and environmental risk factors at baseline and during treatment predicted major depression at 28-week follow-up in a sample of adolescents with depression . METHOD One hundred and ninety-two British adolescents with unipolar major depression were enrolled in a r and omised controlled trial ( the Adolescent Depression Antidepressants and Psychotherapy Trial , ADAPT ) . Participants were treated for 28 weeks with routine psychosocial care and selective serotonin reuptake inhibitors ( SSRIs ) , with half also receiving cognitive-behavioural therapy ( CBT ) . Full clinical and demographic assessment was carried out at baseline and 28 weeks . RESULTS Depression at 28 weeks was predicted by the additive effects of severity , obsessive-compulsive disorder and suicidal ideation at entry together with presence of at least one disappointing life event over the follow-up period . CONCLUSIONS Clinicians should assess for severity , suicidality and comorbid obsessive-compulsive disorder at presentation and should monitor closely for subsequent life events during treatment OBJECTIVE Open-label trials with the selective serotonin reuptake inhibitor citalopram suggest that this agent is effective and safe for the treatment of depressive symptoms in children and adolescents . The current study investigated the efficacy and safety of citalopram compared with placebo in the treatment of pediatric patients with major depression . METHOD An 8-week , r and omized , double-blind , placebo-controlled study compared the safety and efficacy of citalopram with placebo in the treatment of children ( ages 7 - 11 ) and adolescents ( ages 12 - 17 ) with major depressive disorder . Diagnosis was established with the Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version . Patients ( N=174 ) were treated initially with placebo or 20 mg/day of citalopram , with an option to increase the dose to 40 mg/day at week 4 if clinical ly indicated . The primary outcome measure was score on the Children 's Depression Rating Scale-Revised ; the response criterion was defined as a score of < or = 28 . RESULTS The overall mean citalopram dose was approximately 24 mg/day . Mean Children 's Depression Rating Scale-Revised scores decreased significantly more from baseline in the citalopram treatment group than in the placebo treatment group , beginning at week 1 and continuing at every observation point to the end of the study ( effect size=2.9 ) . The difference in response rate at week 8 between placebo ( 24 % ) and citalopram ( 36 % ) also was statistically significant . Citalopram treatment was well tolerated . Rates of discontinuation due to adverse events were comparable in the placebo and citalopram groups ( 5.9 % versus 5.6 % , respectively ) . Rhinitis , nausea , and abdominal pain were the only adverse events to occur with a frequency exceeding 10 % in either treatment group . CONCLUSIONS In this population of children and adolescents , treatment with citalopram reduced depressive symptoms to a significantly greater extent than placebo treatment and was well tolerated OBJECTIVE To compare paroxetine with placebo and imipramine with placebo for the treatment of adolescent depression . METHOD After a 7- to 14-day screening period , 275 adolescents with major depression began 8 weeks of double-blind paroxetine ( 20 - 40 mg ) , imipramine ( gradual upward titration to 200 - 300 mg ) , or placebo . The two primary outcome measures were endpoint response ( Hamilton Rating Scale for Depression [ HAM-D ] score < or = 8 or > or = 50 % reduction in baseline HAM-D ) and change from baseline HAM-D score . Other depression-related variables were ( 1 ) HAM-D depressed mood item ; ( 2 ) depression item of the Schedule for Affective Disorders and Schizophrenia for Adolescents-Lifetime version ( K-SADS-L ) ; ( 3 ) Clinical Global Impression ( CGI ) improvement scores of 1 or 2 ; ( 4 ) nine-item depression subscale of K-SADS-L ; and ( 5 ) mean CGI improvement scores . RESULTS Paroxetine demonstrated significantly greater improvement compared with placebo in HAM-D total score < or = 8 , HAM-D depressed mood item , K-SADS-L depressed mood item , and CGI score of 1 or 2 . The response to imipramine was not significantly different from placebo for any measure . Neither paroxetine nor imipramine differed significantly from placebo on parent- or self-rating measures . Withdrawal rates for adverse effects were 9.7 % and 6.9 % for paroxetine and placebo , respectively . Of 31.5 % of subjects stopping imipramine therapy because of adverse effects , nearly one third did so because of adverse cardiovascular effects . CONCLUSIONS Paroxetine is generally well tolerated and effective for major depression in adolescents OBJECTIVE To examine the course of depression during the treatment of adolescents with depression who had recently attempted suicide . METHOD Adolescents ( N = 124 ) , ages 12 to 18 years , with a 90-day history of suicide attempt , a current diagnosis of depressive disorder ( 96.0 % had major depressive disorder ) , and a Children 's Depression Rating Scale-Revised ( CDRS-R ) score of 36 or higher , entered a 6-month treatment with antidepressant medication , cognitive-behavioral therapy focused on suicide prevention , or their combination ( Com OUTPUT: The adverse effects most associated with dropout were attempted suicide followed by mania , skin rash , and headache . Problems relating to clinical trials and family arbitration were also related with dropout . Selective serotonin reuptake inhibitors were linked to the lowest prevalence , probably due to fewer perceived problems with related adverse effects and higher efficacy in adolescents . Cognitive-behavioral therapy combined with pharmacotherapy produced a lower nonadherence prevalence ; this approach can be an alternative to avoid dropouts and relapse . INPUT: BACKGROUND Obsessive-compulsive disorder ( OCD ) often starts in childhood and adolescence and can be a chronic disorder with high persistence rates . There are few prospect i ve long-term follow-up studies . AIMS To follow up young people with OCD to clarify persistence rates and relevant predictors , presence of other psychiatric disorders , functional impairment , service utilisation and perceived treatment needs . METHOD All young people with OCD assessed over 9 years at the National and Specialist Paediatric OCD clinic , Maudsley Hospital , London , were included . Sixty-one per cent ( 142 of 222 ) of all contactable young people and parents completed computerised diagnostic interviews and question naires . RESULTS We found a persistence rate of OCD of 41 % ; 40 % of participants had a psychiatric diagnosis other than OCD at follow-up . The main predictor for persistent OCD was duration of illness at assessment . High levels of baseline psychopathology predicted other psychiatric disorders at follow-up . Functional impairment and quality of life were mildly to moderately affected . Approximately 50 % of participants were still receiving treatment and about 50 % felt a need for further treatment . CONCLUSIONS This study confirms that paediatric OCD can be a chronic condition that persists into adulthood . Early recognition and treatment might prevent chronicity . Important challenges for services are ensuring adequate treatment and a smooth transition from child to adult services Expert guidelines recommend cognitive-behavior therapy ( CBT ) as a first-line treatment in pediatric obsessive – compulsive disorder ( OCD ) and the addition of selective serotonin reuptake inhibitors when CBT is not effective . However , the recommendations for CBT non-responders are not supported by empirical data . Our objective was to investigate the effectiveness of sertraline ( SRT ) versus continued CBT in children and adolescents that did not respond to an initial course of CBT . R and omized controlled trial conducted in five sites in Denmark , Sweden and Norway , 54 children and adolescents , age 7–17 years , with DSM-IV primary OCD were r and omized to SRT or continued CBT for 16 weeks . These participants had been classified as non-responders to CBT following 14 weekly sessions . Primary outcomes were the CY-BOCS total score and clinical response ( CY-BOCS < 16 ) . The study was a part of the Nordic Long-Term OCD Treatment Study ( NordLOTS ) . Intent-to-treat sample included 50 participants , mean age 14.0 ( SD = 2.7 ) and 48 % ( n = 24 ) males . Twenty-one of 28 participants ( 75 % ) completed continued CBT and 15 of 22 participants ( 69.2 % ) completed SRT . Planned pairwise comparison of the CY-BOCS total score did not reveal a significant difference between the treatments ( p = .351 ) , the response rate was 50.0 % in the CBT group and 45.4 % in the SRT group . The multivariate χ2 test suggested that there were no statistically significant differences between groups ( p = .727 ) . Within-group effect sizes were large and significant across both treatments . These large within-group effect sizes suggest that continued treatment for CBT non-responders is beneficial . However , there was no significant between-group differences in SRT or continued CBT at post-treatment OBJECTIVE This article describes the long-term effects of augmenting serotonin reuptake inhibitors ( SRIs ) with exposure and ritual prevention or stress management training in patients with DSM-IV obsessive-compulsive disorder ( OCD ) . METHOD Between November 2000 and November 2006 , 111 OCD patients from 2 academic outpatient centers with partial SRI response were r and omized to the addition of exposure and ritual prevention or stress management training , delivered twice weekly for 8 weeks ( acute phase ) ; 108 began treatment . Responders ( 38 of 52 in the exposure and ritual prevention condition , 11 of 52 in the stress management training condition ) entered a 24-week maintenance phase . The Yale-Brown Obsessive Compulsive Scale ( YBOCS ) was the primary outcome measure . RESULTS After 24 weeks , patients r and omized to and receiving exposure and ritual prevention versus stress management training had significantly better outcomes ( mean YBOCS scores of 14.69 and 21.37 , respectively ; t = 2.88 , P = .005 ) , higher response rates ( decrease in YBOCS scores ≥ 25 % : 40.7 % vs 9.3 % , Fisher exact test P < .001 ) , and higher rates of excellent response ( YBOCS score ≤ 12 : 24.1 % vs 5.6 % , Fisher exact test P = .01 ) . During the maintenance phase , the slope of change in YBOCS scores was not significant in either condition ( all P values ≥ .55 ) , with no difference between exposure and ritual prevention and stress management training ( P > .74 ) . Better outcome was associated with baseline variables : lower YBOCS scores , higher quality of life , fewer comorbid Axis I diagnoses , and male sex . CONCLUSIONS Augmenting SRIs with exposure and ritual prevention versus stress management training leads to better outcome after acute treatment and 24 weeks later . Maintenance outcome , however , was primarily a function of OCD severity at entrance . Greater improvement during the acute phase influences how well patients maintain their gains , regardless of treatment condition Rigorously design ed clinical trials have demonstrated the efficacy and safety of fluoxetine in adults with major depressive disorder and obsessive-compulsive disorder ( OCD ) but not in patients below 18 years old . This report describes a r and omized , double-blind , placebo-controlled , fixed-dose ( 20 OUTPUT:
Using the Cochrane methodology , and as measures of effect size mean difference and Hedge 's g , SRIs proved to be superior to drug placebo , with a modest effect size . From direct comparisons of CBT and SRI treatments , we conclude that CBT has the superior efficacy . COMBO versus CBT shows that SRI treatment adds little to concomitant CBT , while COMBO shows favourable outcome versus SRI alone . In pre-trial partial treatment responders , those who failed a SRI had better outcome from adding CBT as compared to continuing a SRI . Those who failed CBT treatment did as well with continued CBT as with switching to a SRI .
MS2_dynamic_1_shot445
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: Background Gut microbiota is now known to control glucose metabolism . Previous studies have shown that probiotics and prebiotics may improve glucose metabolism , but their effects have not been studied in combination with drug therapy . The aim of this study was to investigate whether probiotics and prebiotics combined with drug therapy affect diabetic outcomes . Methods Two different study design s were used to test gut microbiota modulating treatments with metformin ( MET ) or sitagliptin ( SITA ) in male C57Bl/6J mice . In Design 1 , diabetes was induced with four-week feeding with a ketogenic , 72 kcal% fat diet with virtually no carbohydrates . Mice were then r and omly divided into four groups ( n = 10 in each group ) : ( 1 ) vehicle , ( 2 ) Bifidobacterium animalis ssp . lactis 420 ( B420 ) ( 109 CFU/day ) , ( 3 ) MET ( 2 mg/mL in drinking water ) , or ( 4 ) MET + B420 ( same doses as in the MET and B420 groups ) . After another 4 weeks , glucose metabolism was assessed with a glucose tolerance test . Fasting glucose , fasting insulin and HOMA-IR were also assessed . In Design 2 , mice were fed the same 72 kcal% fat diet to induce diabetes , but they were simultaneously treated within their respective groups ( n = 8 in each group ) : ( 1 ) non-diabetic healthy control , ( 2 ) vehicle , ( 3 ) SITA [ 3 mg/(kg*day ) ] ( 4 ) SITA with prebiotic polydextrose ( PDX ) ( 0.25 g/day ) , ( 5 ) SITA with B420 ( 109 CFU/day ) , and ( 6 ) SITA + PDX + B420 . Glucose metabolism was assessed at 4 weeks , and weight development was monitored for 6 weeks . Results In Design 1 , with low-dose metformin , mice treated with B420 had a significantly lower glycemic response ( area under the curve ) ( factorial experiment , P = 0.002 ) and plasma glucose concentration ( P = 0.02 ) compared to mice not treated with B420 . In Design 2 , SITA + PDX reduced glycaemia in the oral glucose tolerance test significantly more than SITA only ( area under the curve reduced 28 % , P < 0.0001 ) . In addition , B420 , PDX or B420+PDX , together with SITA , further decreased fasting glucose concentrations compared to SITA only ( −19.5 , −40 and −49 % , respectively , P < 0.01 for each comparison ) . The effect of PDX may be due to its ability to increase portal vein GLP-1 concentrations together with SITA ( P = 0.0001 compared to vehicle ) whereas SITA alone had no statistically significant effect compared to vehicle ( P = 0.14 ) . Conclusions This study proposes that combining probiotics and /or prebiotics with antidiabetic drugs improves glycemic control and insulin sensitivity in mice . Mechanisms could be related to incretin secretion Background Recently , the relationship between gut microbiota and obesity has been highlighted . The present r and omized , double-blind , placebo-controlled study aim ed to evaluate the efficacy of transglucosidase ( TGD ) in modulating blood glucose levels and body weight gain in patients with type 2 diabetes mellitus ( T2DM ) and to clarify the underlying mechanism by analyzing the gut microbiota of T2DM patients . Methods This study included 60 patients who received placebo or TGD orally ( 300 or 900 mg/day ) for 12 weeks , and blood and fecal sample s were collected before and after 12 weeks . Comparisons of fecal bacterial communities were performed before and after the TGD treatment and were performed between T2DM patients and 10 healthy individuals , using the terminal-restriction fragment length polymorphism analysis . Results The Clostridium cluster IV and subcluster XIVa components were significantly decreased , whereas the Lactobacillales and Bifidobacterium population s significantly increased in the T2DM patients compared with the healthy individuals . By dendrogram analysis , most of the healthy individuals ( 6/10 ) and T2DM patients ( 45/60 ) were classified into cluster I , indicating no significant difference in fecal bacterial communities between the healthy individuals and the T2DM patients . In the placebo and TGD groups , the bacterial communities were generally similar before and after the treatment . However , after 12 weeks of TGD therapy , the Bacteroidetes-to-Firmicutes ratio in the TGD groups significantly increased and was significantly higher compared with that in the placebo group , indicating that TGD improved the growth of the fecal bacterial communities in the T2DM patients . Conclusions Therefore , TGD treatment decreased blood glucose levels and prevented body weight gain in the T2DM patients by inducing the production of oligosaccharides in the alimentary tract and modulating gut microbiota composition . Trial registration UMIN-CTR A high-fat diet ( HFD ) induces obesity and the associated increases in blood glucose and inflammation through changes in gut microbiota , endotoxemia , and increased gut permeability . To counteract this , research ers have suggested that the use of probiotics that suppress production of proinflammatory lipopolysaccharide ( LPS ) . Here , we tested whether Lactobacillus sakei OK67 , which inhibits gut microbiota LPS production selected from among the lactic acid bacteria isolated from kimchi , exerted antihypoglycemic or anti-inflammatory effects in HFD-f OUTPUT: Among the commonly reported findings , the genera of Bifidobacterium , Bacteroides , Faecalibacterium , Akkermansia and Roseburia were negatively associated with T2D , while the genera of Ruminococcus , Fusobacterium , and Blautia were positively associated with T2D . INPUT: BACKGROUND & AIMS Type 2 diabetes has been associated with dysbiosis and one of the possible routes to restore a healthy gut microbiota is by the regular ingestion of probiotics . We aim ed to investigate the effects of probiotics on glycemic control , lipid profile , inflammation , oxidative stress and short chain fatty acids in T2D . METHODS In a double-blind , r and omized , placebo-controlled trial , 50 volunteers consumed daily 120 g/d of fermented milk for 6 wk . Participants were assigned into two groups : probiotic group , consuming fermented milk containing Lactobacillus acidophilus La-5 and Bifidobacterium animalis subsp lactis BB-12 ( 109 colony-forming units/d , each ) and control group , consuming conventional fermented milk . Anthropometric measurements , body composition , fasting blood and faecal sample s were taken at baseline and after 6 wk . RESULTS 45 subjects out of 50 ( 90 % ) completed follow-up . After 6 wk , there was a significant decrease in fructosamine levels ( -9.91 mmol/L ; p = 0.04 ) and hemoglobin A1c tended to be lower ( -0.67 % ; p=0.06 ) in probiotic group . TNF-α and resistin were significantly reduced in probiotic and control groups ( -1.5 and -1.3 pg/mL , -.1 and -2.8 ng/mL , respectively ) , while IL-10 was significantly reduced ( - 0.65 pg/mL ; p < 0.001 ) only in the control group . Fecal acetic acid was increased in both groups ( 0.58 and 0.59 % in probiotic and control groups , respectively ; p < 0.01 ) . There was a significant difference between groups concerning mean changes of HbA1c ( + 0.31 for control group vs -0.65 for probiotic group ; p=0.02 ) , total cholesterol ( + 0.55 for control group vs -0.15 for probiotic group ; p=0.04 ) and LDL-cholesterol ( + 0.36 for control group vs -0.20 for probiotic group p=0.03 ) . CONCLUSIONS Probiotic consumption improved the glycemic control in T2D subjects , however , the intake of fermented milk seems to be involved with others metabolic changes , such as decrease in inflammatory cytokines ( TNF-α and resistin ) and increase in the acetic acid Microbial modulation of diabetes Short-chain fatty acids ( SCFAs ) are produced by various human gut microbes . SCFAs act as an energy source to the colonic epithelium and are also sensed by host signaling pathways that modulate appetite and inflammation . Deficiency of gut SCFAs is associated with type 2 diabetes . Zhao et al. found that adopting a high-fiber diet promoted the growth of SCFA-producing organisms in diabetic humans . The high-fiber diet induced changes in the entire gut microbe community and correlated with elevated levels of glucagon-like peptide-1 , a decline in acetylated hemoglobin levels , and improved blood-glucose regulation . Science , this issue p. 1151 Increasing dietary fiber intake increases the abundance of short-chain fatty acid – producing gut microbes and relieves diabetes . The gut microbiota benefits humans via short-chain fatty acid ( SCFA ) production from carbohydrate fermentation , and deficiency in SCFA production is associated with type 2 diabetes mellitus ( T2DM ) . We conducted a r and omized clinical study of specifically design ed isoenergetic diets , together with fecal shotgun metagenomics , to show that a select group of SCFA-producing strains was promoted by dietary fibers and that most other potential producers were either diminished or unchanged in patients with T2DM . When the fiber-promoted SCFA producers were present in greater diversity and abundance , participants had better improvement in hemoglobin A1c levels , partly via increased glucagon-like peptide-1 production . Promotion of these positive responders diminished producers of metabolically detrimental compounds such as indole and hydrogen sulfide . Targeted restoration of these SCFA producers may present a novel ecological approach for managing T2DM Aim Evidence of a possible connection between gut microbiota and several physiological processes linked to type 2 diabetes is increasing . However , the effect of multi-strain probiotics in people with type 2 diabetes remains unclear . This study investigated the effect of multi-strain microbial cell preparation — also refers to multi-strain probiotics — on glycemic control and other diabetes-related outcomes in people with type 2 diabetes . Design A r and omized , double-blind , parallel-group , controlled clinical trial . Setting Diabetes clinic of a teaching hospital in Kuala Lumpur , Malaysia . Participants A total of 136 participants with type 2 diabetes , aged 30–70 years , were recruited and r and omly assigned to receive either probiotics ( n = 68 ) or placebo ( n = 68 ) for 12 weeks . Outcomes Primary outcomes were glycemic control-related parameters , and secondary outcomes were anthropomorphic variables , lipid profile , blood pressure and high-sensitivity C-reactive protein . The Lactobacillus and Bifidobacterium quantities were measured before and after intervention as an indicator of successful passage of the supplement through gastrointestinal tract . Statistical analysis Intention-to-treat ( ITT ) analysis was performed on all participants , while per- protocol ( PP ) analysis was performed on those participants who had successfully completed the trial with good compliance rate . Results With respect to primary outcomes , glycated hemoglobin decreased by 0.1 OUTPUT:
The results of this systematic review and meta‐ analysis suggest that probiotic and synbiotic supplementation may help to improve biomarkers of inflammation and oxidative stress in diabetic patients .
MS2_dynamic_1_shot446
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: In a prospect i ve , r and omized , comparative study , patients undergoing elective major colorectal surgery received four six-hour doses of either sulbactam ( a β-lactamase inhibitor ) with ampicillin ( 1 gm with 1 gm ) , or cefoxitin ( 2 gm ) commencing at induction of anesthesia . The groups were well matched for age , sex , diagnosis , and surgical procedures . Three patients in the sulbactam group ( N=44 ) , and four in the cefoxitin group ( N=48 ) developed significant would sepsis . Minor wound sepsis occurred in an additional four sulbactam patients , and in five cefoxitin patients . There was no difference between the groups in deep sepsis or anastomotic leak rates ( sulbactam , four patients ; cefoxitin , seven patients ) . No serious side effects were recorded in either group . These results suggest that sulbactam combined with ampicillin provides a safe , effective alternative to cefoxitin for prophylaxis in colorectal surgery Although perioperative antibiotic cover reduces the incidence of septic complications associated with abdominal surgery , the optimum duration of antibiotic exposure is open to question . This clinical trial compared the efficacy of a single dose of moxalactam ( 1 g intravenously ) with an extended course of moxalactam ( 1 g intravenously for eight doses ) in 1027 patients undergoing contaminated abdominal surgery . The wound infection rate was 5.4 % ( 28/519 ) for the single-dose schedule and 6.1 % ( 31/508 ) for the extended-cover regimen ( the respective 95 % confidence intervals being 3.6 % to 7.7 % and 4.2 % to 8.6 % ) . Over 80 % of all patients undergoing abdominal surgery during the period of study were entered into the trial . There was no significant difference in the incidence of other complications between the two groups under study . It is concluded that a single dose of moxalactam is as effective as a 48-hour course when attempting to prevent infection after contaminated abdominal surgery A r and omized trial including 294 patients was performed to evaluate the prophylactic effect of singlevs . multiple doses of antibiotics in elective colorectal surgery . All patients received 1.5 g metronidazole and 3.0 g ampicillin peroperatively and were r and omized to : 1 ) no further prophylactic antibiotic treatment , or 2 ) ampicillin 1 g × 3 and metronidazole 0.5 g × 3 given intravenously during the second and third postoperative days . Deep wound infection was seen in 9/149 ( 6 percent ) receiving a single dose and in 8/145 ( 6 percent ) receiving multiple doses . no differences were found in the two groups between frequencies of anastomotic dehiscences , intra-abdominal abscesses , sepsis , and pulmonary infections . the two groups were similar according to distribution of sex , age , diagnosis , and type of surgery . A single peroperative dose of metronidazole and ampicillin is a simple and satisfactory antibiotic prophylaxis in elective colorectal surgery Summary Due to the high incidence of infective complications following colorectal surgery , prophylactic application of systemic antibiotics is required . In a prospect i ve , r and omised study of 34 patients who underwent elective colorectal surgery , it was found that a single 1 g dose of cefotaxime was as effective as three doses in controlling post-operative infections . Both groups received 500 mg metronidazole i.v . every 12 h for 72 h , with the first dose administered immediately prior to surgery . The results indicate that prophylactic cefotaxime and metronidazole are effective in reducing the incidence of septic complications following colorectal surgery ; nevertheless , a study with a larger number of patients is needed to reach a definitive conclusion .ZusammenfassungKolorektale Operationen sind durch eine hohe Inzidenz an infektiösen Komplikationen belastet ; eine systemische Antibiotikaprophylaxe ist daher erforderlich . In einer prospektiven , r and omisierten Studie wurden zwei Cefotaxim-Prophylaxeregime — die i.v . Gabe einer Einzeldosis von 1 g Cefotaxim bei gleichzeitiger Injektion von 500 mg Metronidazol kurz vor Beginn der Operation — und drei Einzelgaben von 1 g Cefotaxim — verglichen . In beiden Fällen wurde Metronidazol mit der ersten Dosis gegeben und in 12-stündlichen Abständen bis 72 Stunden postoperativ wiederholt . Die noch nicht abgeschlossene Studie umfaßt bisher 34 Patienten , bei denen ein elektiver kolorektaler Eingriff vorgenommen wurde . Das Prophylaxeregime mit Cefotaxim und Metronidazol erwies sich — sowohl bei der Einzel- wie der Dreifach-Dosierung von Cefotaxim — als wirksame Method e , infektiöse Komplikationen bei kolorektalen Eingriffen zu verhüten . Ein abschließendes Urteil ist erst mit einer umfangreichen Patientenzahl möglich To assess the suitability of latamoxef ( moxalactam ) as single agent chemoprophylaxis in elective colorectal surgery , 120 consecutive patients were r and omized to receive latamoxef ( L ) 1 g or cephazolin 1 g and metronidazole 500 mg ( CM ) administered intravenously at induction of anaesthesia and 6 and 12 h postoperatively . The groups were well matched for age , sex , pathology and procedures . Serum and tissue levels of latamoxef were well above the MIC OUTPUT: The results confirm that the use of antimicrobial prophylaxis is effective for the prevention of surgical wound infection after colorectal surgery . There was no significant difference in the rate of surgical wound infections between many different regimens . However , certain regimens appear to be inadequate ( e.g. metronidazole alone , doxycycline alone , piperacillin alone , oral neomycin plus erythromycin on the day before operation ) . INPUT: Background Intra-abdominal infections are one of the most common infections encountered by a general surgeon . However , despite this prevalence , st and ardized guidelines outlining the proper use of antibiotic therapy are poorly defined due to a lack of clinical trials investigating the ideal duration of antibiotic treatment . The aim of this study is to compare the efficacy and safety of a three-day treatment regimen of Ampicillin-Sulbactam to that of a three-day regimen of Ertapenem in patients with localized peritonitis ranging from mild to moderate severity . Methods This study is a prospect i ve , multi-center , r and omized investigation performed in the Department of General , Emergency , and Transplant Surgery of St. Orsola-Malpighi University Hospital in Bologna , Italy . Discrete data were analyzed using the Chi-squared and Fisher exact tests . Differences between the two study groups were considered statistically significant for p-values less than 0.05 . Results 71 patients were treated with Ertapenem and 71 patients were treated with Ampicillin-Sulbactam . The two groups were comparable in terms of age and gender as well as the site of abdominal infection . Post-operative infection was identified in 12 patients : 10 with wound infections and 2 with intra-abdominal infections . In the Ertapenem group , 69 of the 71 patients ( 97 % ) were treated successfully , while the therapy failed in 2 cases ( 3 % ) . Therapy failures were more frequent in the Unasyn group , amounting to 10 of 71 cases ( p = 0.03 ) . Conclusion According to these preliminary findings , the authors conclude that a three-day Ertapenem treatment regimen is the most effective antibiotic therapy for patients with localized intra-abdominal infections ranging from mild to moderate severity . Trial registration Trial registration : Clinical Trials.gov : OBJECTIVE The aim of this study was to evaluate the feasibility and safety of nonoperative treatment of acute nonperforated appendicitis with antibiotics in children . METHODS A pilot r and omized controlled trial was performed comparing nonoperative treatment with antibiotics versus surgery for acute appendicitis in children . Patients with imaging-confirmed acute nonperforated appendicitis who would normally have had emergency appendectomy were r and omized either to treatment with antibiotics or to surgery . Follow-up was for 1 year . RESULTS Fifty patients were enrolled ; 26 were r and omized to surgery and 24 to nonoperative treatment with antibiotics . All children in the surgery group had histopathologically confirmed acute appendicitis , and there were no significant complications in this group . Two of 24 patients in the nonoperative treatment group had appendectomy within the time of primary antibiotic treatment and 1 patient after 9 months for recurrent acute appendicitis . Another 6 patients have had an appendectomy due to recurrent abdominal pain ( n = 5 ) or parental wish ( n = 1 ) during the follow-up period ; none of these 6 patients had evidence of appendicitis on histopathological examination . CONCLUSIONS Twenty-two of 24 patients ( 92 % ) treated with antibiotics had initial resolution of symptoms . Of these 22 , only 1 patient ( 5 % ) had recurrence of acute appendicitis during follow-up . Overall , 62 % of patients have not had an appendectomy during the follow-up period . This pilot trial suggests that nonoperative treatment of acute appendicitis in children is feasible and safe and that further investigation of nonoperative treatment is warranted BACKGROUND In this prospect i ve study , operative and nonoperative management of acute appendicitis were evaluated regarding their safety and cost effectiveness . METHODS Two hundred ninety patients presenting to our Emergency Department between March 2005 and March 2006 with acute appendicitis were included in this prospect i ve study . Nonoperative medical therapy was performed in 107 patients ( Group 1 ) , and 183 patients were treated surgically ( Group 2 ) . Routine follow-up controls were done on the 10th day , at the 3rd and 6th months and at the first year after discharge in Group 1 . Both groups were compared regarding age , gender , mean hospital stay , modified Alvarado score , morbidity , mortality , and cost effectiveness . RESULTS The male/female ratio of Groups 1 and 2 were 65/42 ( mean age : 30.98+/-1.30 ) and 125/58 ( mean age : 26.25+/-0.79 ) , respectively . In Group 1 , 19 patients were operated . Operation indications were resistance to therapy , patient 's request , and operation in another hospital . Although the mean hospital stay of Group 1 was statistically significantly longer than Group 2 , the mean cost of the therapy was $ 559 in Group 2 and $ 433 in Group 1 . Morbidity rates were similar , with no mortality in either group . CONCLUSION With its high success rate and cost effectiveness , medical treatment seems to be a good alternative to the gold st and ard therapy of surgery in management of acute appendicitis The editors of the Journal of Gastrointestinal Surgery as well as the SSAT Board of Directors have retracted the article Malik , A.A. & Bari , S.U. Conservative management of acute appendicitis . J Gastrointest . Surg 13 , 966–970 ( 2009 ) since significant portions of the article were published earlier in the following articles : Eriksson , S. & Granstrom , L. R and omized controlled trial of appendectomy versus antibiotic therapy for acute appendicitis . Br J Surg 82 , 166–169 ( 1995 ) . Horton , M.D. , Counter , S OUTPUT:
With significantly higher efficacy and low complication rates , appendectomy remains the most effective treatment for patients with uncomplicated AA .
MS2_dynamic_1_shot447
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: BACKGROUND AND PURPOSE Controversy exists about the effectiveness of physical therapy after arthroscopic partial meniscectomy . This r and omized controlled trial evaluated the effectiveness of supervised physical therapy with a home program versus a home program alone . SUBJECTS Eighty-four patients ( 86 % males ; overall mean age=39 years , SD=9 , range=21 - 58 ; female mean age=39 years , SD=9 , range=24 - 58 ; male mean age=40 , SD=9 , range=21 - 58 ) who underwent an uncomplicated arthroscopic partial meniscectomy participated . METHODS Subjects were r and omly assigned to either a group who received 6 weeks of supervised physical therapy with a home program or a group who received only a home program . Blinded test sessions were conducted 5 and 50 days after surgery . Outcome measures were : ( 1 ) Hughston Clinic question naire , ( 2 ) Medical Outcomes Study 36-Item Short-Form Health Survey ( SF-36 ) and EuroQol EQ-5D ( EQ-5D ) question naires , ( 3 ) number of days to return to work after surgery divided by the Factor Occupational Rating System score , ( 4 ) kinematic analysis of knee function during level walking and stair use , and ( 5 ) horizontal and vertical hops . RESULTS No differences between groups were found for any of the outcomes measured . DISCUSSION AND CONCLUSION The results indicate that the supervised physical therapy used in this study is not beneficial for patients in the early period after uncomplicated arthroscopic partial meniscectomy Abstract To evaluate the effect of physiotherapy after partial arthroscopic meniscectomy , we performed a prospect i ve , r and omised and partially blinded study . This pilot study was performed from October 1996 to June 1997 . The control group received the st and ard treatment , consisting of verbal and written advice and exercises . The physiotherapy group performed exercises according to a dynamic protocol under the supervision of a physiotherapist . During a 3-week period , nine treatment sessions were given of 30 min each . Twenty patients , who had undergone arthroscopic meniscectomy without any other pathology of the knee , were r and omised into two groups of ten patients each . The effects of therapy were evaluated by a blinded observer . We measured the distance and height of one-leg jumps ( hops ) , the VAS pain scale , the Tegner and Lysholm scores and the SARS/FORS score . Recovery and satisfaction with the treatment were also evaluated . The effect measurements were performed at 7 ( T1 ) , 14 ( T2 ) , 21 ( T3 ) and 28 days ( T4 ) following surgery . Statistical analysis was performed with the Student ’s t-test . The physiotherapy group showed significantly better results than the control group regarding the SARS score , the hop test and the distance jumps . Moreover , the measurements showed clear progression in favour of the physiotherapy group . In conclusion , exercising under the supervision of a physiotherapist led to high patient satisfaction and good functional rehabilitation after partial arthroscopic meniscectomy In a r and omised controlled trial comparing the outcome of two groups of men aged 16 - 45 one group received outpatient physiotherapy after medial meniscectomy and the other did not . In clinical aspects of knee function there was no significant difference between the test group and control group measured at specified intervals up to 26 weeks postoperatively . Similarly , there was no significant difference between the groups in the time taken to return to work or in the mean fall in take-home pay as a result of meniscectomy . The mean cost per patient of providing outpatient physiotherapy in the test group was 23 pounds at 1976 prices . Thus the least costly way of returning male patients aged 16 - 45 to activity is by not providing routine outpatient physiotherapy after medial meniscectomy . Further r and omised controlled trials are , however , required to determine the value of physiotherapy in other age groups and other conditions We evaluated the outcome of and compared two rehabilitation programs ( clinic-based versus home ) after a mid-third patellar autograft reconstruction of the anterior cruciate ligament . Thirty-seven patients ( 28 male , 9 female ; average age , 24.1 years ) completed the study . Fifteen of these patients received clinic-based rehabilitation ( three visits per week for 6 weeks prescribed ) , and 22 patients received home-based physical therapy ( number of visits determined by patient response ) . Knee ROM , Lysholm , Visual Analogy Scale , ( VAS ) pain rating , hop test , KT-1000 , and Sickness Impact Profile ( SIP ) were evaluated preoperatively and postoperatively . All patients reported good satisfaction with the function of their knee at average follow-up of 21.6 months ( range , 12 to 48 ) . Patients managed by home rehabilitation averaged 2.85 visits as compared with 14.2 for clinic-centered patient ( P < .05 ) . There were no differences in functional or subjective outcomes in the different postoperative rehabilitation regimens , with both groups reporting high satisfaction and improved quality of life . Cost savings in the home rehabilitation group were significant One hundred sixty patients ( mean age , 68 ± 8 years ) having primary total knee arthroplasty were assigned r and omly to two rehabilitation programs : ( 1 ) clinic-based rehabilitation provided by outpatient physical therapists ; or ( 2 ) home-based rehabilitation monitored by periodic telephone calls from a physical therapist . Both rehabilitation programs emphasized a common home exercise program . Before surgery , and at 12 and 52 weeks after surgery , no statistically significant differences were observed between the clinic- and the home-based groups on any of the following measures : ( 1 ) total score on the Knee Society clinical rating scale ; ( 2 ) total score on the Western Ontario and Mc OUTPUT: GROWING POINTS Supervision and location does not seem to directly determine the final outcomes . INPUT: BACKGROUND AND PURPOSE Controversy exists about the effectiveness of physical therapy after arthroscopic partial meniscectomy . This r and omized controlled trial evaluated the effectiveness of supervised physical therapy with a home program versus a home program alone . SUBJECTS Eighty-four patients ( 86 % males ; overall mean age=39 years , SD=9 , range=21 - 58 ; female mean age=39 years , SD=9 , range=24 - 58 ; male mean age=40 , SD=9 , range=21 - 58 ) who underwent an uncomplicated arthroscopic partial meniscectomy participated . METHODS Subjects were r and omly assigned to either a group who received 6 weeks of supervised physical therapy with a home program or a group who received only a home program . Blinded test sessions were conducted 5 and 50 days after surgery . Outcome measures were : ( 1 ) Hughston Clinic question naire , ( 2 ) Medical Outcomes Study 36-Item Short-Form Health Survey ( SF-36 ) and EuroQol EQ-5D ( EQ-5D ) question naires , ( 3 ) number of days to return to work after surgery divided by the Factor Occupational Rating System score , ( 4 ) kinematic analysis of knee function during level walking and stair use , and ( 5 ) horizontal and vertical hops . RESULTS No differences between groups were found for any of the outcomes measured . DISCUSSION AND CONCLUSION The results indicate that the supervised physical therapy used in this study is not beneficial for patients in the early period after uncomplicated arthroscopic partial meniscectomy Abstract To evaluate the effect of physiotherapy after partial arthroscopic meniscectomy , we performed a prospect i ve , r and omised and partially blinded study . This pilot study was performed from October 1996 to June 1997 . The control group received the st and ard treatment , consisting of verbal and written advice and exercises . The physiotherapy group performed exercises according to a dynamic protocol under the supervision of a physiotherapist . During a 3-week period , nine treatment sessions were given of 30 min each . Twenty patients , who had undergone arthroscopic meniscectomy without any other pathology of the knee , were r and omised into two groups of ten patients each . The effects of therapy were evaluated by a blinded observer . We measured the distance and height of one-leg jumps ( hops ) , the VAS pain scale , the Tegner and Lysholm scores and the SARS/FORS score . Recovery and satisfaction with the treatment were also evaluated . The effect measurements were performed at 7 ( T1 ) , 14 ( T2 ) , 21 ( T3 ) and 28 days ( T4 ) following surgery . Statistical analysis was performed with the Student ’s t-test . The physiotherapy group showed significantly better results than the control group regarding the SARS score , the hop test and the distance jumps . Moreover , the measurements showed clear progression in favour of the physiotherapy group . In conclusion , exercising under the supervision of a physiotherapist led to high patient satisfaction and good functional rehabilitation after partial arthroscopic meniscectomy In a r and omised controlled trial comparing the outcome of two groups of men aged 16 - 45 one group received outpatient physiotherapy after medial meniscectomy and the other did not . In clinical aspects of knee function there was no significant difference between the test group and control group measured at specified intervals up to 26 weeks postoperatively . Similarly , there was no significant difference between the groups in the time taken to return to work or in the mean fall in take-home pay as a result of meniscectomy . The mean cost per patient of providing outpatient physiotherapy in the test group was 23 pounds at 1976 prices . Thus the least costly way of returning male patients aged 16 - 45 to activity is by not providing routine outpatient physiotherapy after medial meniscectomy . Further r and omised controlled trials are , however , required to determine the value of physiotherapy in other age groups and other conditions We evaluated the outcome of and compared two rehabilitation programs ( clinic-based versus home ) after a mid-third patellar autograft reconstruction of the anterior cruciate ligament . Thirty-seven patients ( 28 male , 9 female ; average age , 24.1 years ) completed the study . Fifteen of these patients received clinic-based rehabilitation ( three visits per week for 6 weeks prescribed ) , and 22 patients received home-based physical therapy ( number of visits determined by patient response ) . Knee ROM , Lysholm , Visual Analogy Scale , ( VAS ) pain rating , hop test , KT-1000 , and Sickness Impact Profile ( SIP ) were evaluated preoperatively and postoperatively . All patients reported good satisfaction with the function of their knee at average follow-up of 21.6 months ( range , 12 to 48 ) . Patients managed by home rehabilitation averaged 2.85 visits as compared with 14.2 for clinic-centered patient ( P < .05 ) . There were no differences in functional or subjective outcomes in the different postoperative rehabilitation regimens , with both groups reporting high satisfaction and improved quality of life . Cost savings in the home rehabilitation group were significant One hundred sixty patients ( mean age , 68 ± 8 years ) having primary total knee arthroplasty were assigned r and omly to two rehabilitation programs : ( 1 ) clinic-based rehabilitation provided by outpatient physical therapists ; or ( 2 ) home-based rehabilitation monitored by periodic telephone calls from a physical therapist . Both rehabilitation programs emphasized a common home exercise program . Before surgery , and at 12 and 52 weeks after surgery , no statistically significant differences were observed between the clinic- and the home-based groups on any of the following measures : ( 1 ) total score on the Knee Society clinical rating scale ; ( 2 ) total score on the Western Ontario and Mc OUTPUT:
In select young and healthy population with few co morbidities supervised physical therapy is no more beneficial than a home exercise program following relatively simple knee surgical procedures ( arthroscopic meniscetomy ) .
MS2_dynamic_1_shot448
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: OBJECTIVE To study the natural history of peripheral joint osteoarthritis ( OA ) and assess its impact over eight years in a prospect i ve study of 500 patients . METHODS 500 consecutive patients with peripheral joint OA were recruited from a hospital-based rheumatology clinic . All were invited for review 3 and 8 years after entry . Joint sites involved , pain severity , change in index joints , global change in the condition , use of medication , surgery and walking aids were all recorded at each visit , and after eight years disability was assessed by the health assessment question naire ( HAQ ) and anxiety and depression by the Hospital anxiety and depression scale ( HAD ) . RESULTS At eight-year review , 349 patients were seen : 90 % of those remaining alive . Outcome was heterogeneous . Sixty patients ( 17.2 % ) reported worsening in all three subjective parameters ( pain , index joint and global change ) compared with 22 ( 6.3 % ) who improved in all three parameters . Using this definition of worsening or improvement , strong baseline predictors of clinical outcome did not emerge . For further description , the group was split according to the index joint sites involved at entry to the study , there being 111 with knee OA alone , 87 with h and and knee OA , 72 with h and disease alone , and 29 with hip disease alone . Forty-four percent of those with lone h and disease at entry had acquired significant knee or hip OA 8 years later . The mean HAQ and HAD scores at 8 years were high , especially in those with knee disease , indicating significant disability as a result of the disease . Those with knee or knee and h and disease had the worst outcome in all parameters recorded . The data showed a general decrease in use of NSAIDs over the eight years , but an increase in utilization of analgesics , surgery ( especially for hip disease ) and walking aids . CONCLUSIONS Patients with peripheral joint OA of sufficient severity to lead to hospital referral have a heterogeneous , but generally bad outcome over 8 years , the disease result ing in high levels of physical disability , anxiety and depression , with a high level of utilization of healthcare re sources , including joint replacement , drugs and walking aids . The results were consistent with previous suggestions that peripheral joint OA in older people is characterized by the slow acquisition of new joint sites . Progression and outcome may depend on a complex set of psychosocial factors , as well as biological ones INTRODUCTION To evaluate the efficacy of a self-management support program including a 6 week self-management course , individualised phone support and goal setting in osteoarthritis patients on a waiting list for arthroplasty surgery . METHOD R and omised controlled trial of 152 public hospital out patients awaiting hip or knee replacement surgery who were not classified as requiring urgent surgery . Participants were r and omised to a self-management program or to usual care . The primary outcome was change in the Health Education Intervention Question naire ( HeiQ ) from r and omisation to 6 month follow-up . Quality of life and depressive symptoms were also measured . Changes in pain and function were assessed using the Western Ontario and McMaster Universities ( WOMAC ) Arthritis Index . RESULTS At 6 month follow-up , health-directed behaviour was significantly greater in the intervention [ mean 4.29 , 95 % confidence interval ( CI ) 3.99 - 4.58 ] than the control ( mean 3.81 , 95 % CI 3.52 - 4.09 ; P=0.017 ) . There was also a significant effect on skill and technique acquisition for the intervention ( mean 4.37 , 95 % CI 4.19 - 4.55 ) in comparison to control ( mean 4.11 , 95 % CI 3.93 - 4.29 ; P=0.036 ) . There was no significant effect of the intervention on the remaining HeiQ subscales , WOMAC pain or disability , quality of life or depressive symptoms . DISCUSSION The arthritis self-management program improved health-directed behaviours , skill acquisition and stiffness in patients on a joint replacement waiting list , although the observed effects were of modest size ( Cohen 's d between 0.36 and 0.42 ) . There was no significant effect on pain , function or quality of life in the short term . Self-management programs can assist in maintaining health behaviours ( particularly walking ) in this patient group . Further research is needed to assess their impact on quality of life and over longer periods Background This study examined the impact of a home-based self-management intervention for housebound older adults with arthritis on the adoption of health behaviors . The moderating role of socio-demographic , psychological , and physical characteristics in the process of behavior change was also investigated . Methods Participants were 113 older adult women ( n = 102 ) and men ( n = 11 ) with osteoarthritis ( OA ) or rheumatoid arthritis ( RA ) who were r and omly assigned to experimental ( n = 68 ) or wait list control ( n = 45 ) groups . Participants were interviewed using st and ardized question naires at baseline , pre-intervention , and post-intervention . Results Adjusted multilevel modeling analyses indicated that from pre to post intervention , experimental participants significantly increased their weekly frequency of exercise and relaxation activities . Socioeconomic status and depression played a moderating role in this change for exercise with larger effects occurring among more privileged , non-depressed participants . Conclusion We conclude that a self-management intervention can successfully improve involvement in exercise and relaxation among housebound older adults with arthritis There is limited underst and ing of how comorbid health conditions affect osteoarthritis (OA)-related outcomes . This study examined associations of different comorbidity measures with baseline OA-related patient-reported outcomes ( PROs ) among patients with hip and knee OA . Data were from patients ( N = 300 , 9 % female OUTPUT: Patients with OA diagnosed with these comorbidities experienced more pain , had frequent hospital visits , took more medication , and reported less optimal outcomes . Anxiety and depression adversely impact the QoL of patients with OA . INPUT: OBJECTIVE To develop preliminary criteria for inactive disease and clinical remission for select categories of juvenile idiopathic arthritis ( JIA ) , and to decide what such clinical states should predict in terms of probability of disease recurrence . METHODS A Delphi serial question naire consensus-formation approach was used initially to gather criteria in use by pediatric rheumatologists ( PR ) for defining clinical remission in oligoarticular ( persistent and extended ) , rheumatoid factor ( RF ) positive and negative polyarticular , and systemic JIA . Results from sequential question naires provided an agenda for a nominal group technique ( NGT ) conference to reach consensus on unresolved questions . RESULTS One hundred and thirty PR from 34 countries responded to the question naires and 20 PR from 9 countries attended the conference . Draft criteria for inactive disease include the following : no active arthritis ; no fever , rash , serositis , splenomegaly , or generalized lymphadenopathy attributable to JIA ; no active uveitis ; normal erythrocyte sedimentation rate or C-reactive protein ; and a physician 's global assessment of disease activity rated at the best score possible for the instrument used . According to consensus vote , 6 continuous months of inactive disease on medication defines clinical remission on medication , while 12 months of inactive disease off all anti-arthritis ( and anti-uveitis ) medications defines clinical remission off medication . The finalized criteria for remission off medication ideally should predict that a patient has < /= 20 % probability of disease recurrence within the next 5 years . CONCLUSION Using consensus formation techniques , we formulated preliminary criteria for inactive disease and clinical remission on and off medication for use in select categories of JIA . Retrospective validation is in progress ; prospect i ve validation will follow . Future efforts will include other categories of JIA OBJECTIVE To determine the reliability of formal exercise testing and the reliability of functional and activity question naires in children with juvenile idiopathic arthritis ( JIA ) . METHODS Children with JIA of any subtype ages 8 - 16 years who were recruited to a r and omized trial comparing different exercise therapies participated in 2 preintervention sessions of exercise testing 2 - 6 weeks apart . Exercise testing included 1 ) submaximal oxygen uptake ( VO(2submax ) ) , 2 ) peak VO(2 ) ( VO(2peak ) ) , and 3 ) anaerobic power using modified Wingate tests ( W(ant ) ) . Two physical function question naires ( the Childhood Health Assessment Question naire [ C-HAQ ] and Revised Activity Scale for Kids [ ASK ] ) and 1 daily physical activity question naire ( the Habitual Activity Estimation Scale [ HAES ] ) were also completed at these times . Test-retest reliability was assessed using type 3 , intrarater intraclass correlation coefficient ( ICC(3,1 ) ) and Bl and and Altman plots were used to determine limits of agreement . RESULTS Data were available for 74 patients ( 58 girls ) . VO(2submax ) , VO(2peak ) , and W(ant ) demonstrated high reliability ( ICC(3,1 ) 0.82 , 0.91 , and 0.94 , respectively ) . C-HAQ and ASK question naires also had very high reliability ( ICC(3,1 ) 0.82 and 0.91 , respectively ) . The HAES demonstrated low reliability for total activity score ( ICC(3,1 ) 0.15 ) and moderate reliability when the number of very active hours was analyzed separately ( ICC(3,1 ) 0.59 ) . CONCLUSION Results of this investigation suggest that exercise testing and functional question naires in children with JIA are consistent and reliable . Reliability of the HAES total score was poor , but moderate when the very active hours subscale score was used OBJECTIVE To develop preliminary criteria for defining disease flare in patients with polyarticular-course juvenile rheumatoid arthritis ( JRA ) . METHODS Data from a r and omized clinical trial of etanercept in JRA ( 51 patients ) and the 6 core response variables ( CRV ) for JRA were used to derive flare definitions . The criterion st and ard of flare was treatment with placebo . C and i date flare definitions were assessed by receiver-operator characteristic ( ROC ) curve properties and other statistics for diagnostic tests . RESULTS Of the possible flare definitions tested with acceptable statistical properties , the one that seemed to be the most useful was worsening in any 2/6 CRV by > or = 40 % without improvement in more than 1 of the remaining CRV by > or = 30 % . Two other superior flare definitions were ( 1 ) worsening in 3/6 CRV by > or = 30 % and ( 2 ) any worsening of the Childhood Health Assessment Question naire , worsening of erythrocyte sedimentation rate by > or = 30 % and worsening of the active joint count by > or = 10 % . CONCLUSIONS CRV are useful for defining flare in JRA . Worsening in any 2/6 CRV by > or = 40 % without concomitant improvement of more than one of the remaining CRV by > or = 30 % appears to be the most suitable preliminary flare definition . Because the proposed flare criteria were derived from a small number of patients , it is essential to perform more definitive testing of this and several alternative flare definitions in larger patient population The aim of this 12-month prospect i ve study was to compare reports describing the health-related quality of life ( HRQL ) of children with Juvenile idiopathic arthritis ( JIA ) obtained from parents and children , to investigate the extent to which the children ’s HRQL changed over a 12-month period , and to describe the relationship between children ’s HRQL , and their experience of pain and use of pain coping strategies . Fifty-four children aged 8–18 years with JIA and their parents completed st OUTPUT:
The Childhood Health Assessment Question naire ( C-HAQ ) was the most extensively studied instrument and had high reliability , but only moderate correlations with other indices of disease activity and poor responsiveness to change in disease status . The physician global assessment of disease activity ( PGA ) and articular indices had the strongest association with disease activity and were the most responsive to change . Measures of psychosocial function and quality of life were moderately associated with measures of disease activity , but were less responsive to changes in disease status . In children with JIA , no single instrument was superior in reliability or validity or in describing the impact of JIA . Although the C-HAQ has been extensively evaluated , the PGA and articular indices appear to have the highest responsiveness to change and , therefore , the highest potential for detecting important differences in treatment response
MS2_dynamic_1_shot449
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: OBJECTIVES To inform the debate over whether human sleep can be chronically reduced without consequences , we conducted a dose-response chronic sleep restriction experiment in which waking neurobehavioral and sleep physiological functions were monitored and compared to those for total sleep deprivation . DESIGN The chronic sleep restriction experiment involved r and omization to one of three sleep doses ( 4 h , 6 h , or 8 h time in bed per night ) , which were maintained for 14 consecutive days . The total sleep deprivation experiment involved 3 nights without sleep ( 0 h time in bed ) . Each study also involved 3 baseline ( pre-deprivation ) days and 3 recovery days . SETTING Both experiments were conducted under st and ardized laboratory conditions with continuous behavioral , physiological and medical monitoring . PARTICIPANTS A total of n = 48 healthy adults ( ages 21 - 38 ) participated in the experiments . INTERVENTIONS Noctumal sleep periods were restricted to 8 h , 6 h or 4 h per day for 14 days , or to 0 h for 3 days . All other sleep was prohibited . RESULTS Chronic restriction of sleep periods to 4 h or 6 h per night over 14 consecutive days result ed in significant cumulative , dose-dependent deficits in cognitive performance on all tasks . Subjective sleepiness ratings showed an acute response to sleep restriction but only small further increases on subsequent days , and did not significantly differentiate the 6 h and 4 h conditions . Polysomnographic variables and delta power in the non-REM sleep EEG-a putative marker of sleep homeostasis -- displayed an acute response to sleep restriction with negligible further changes across the 14 restricted nights . Comparison of chronic sleep restriction to total sleep deprivation showed that the latter result ed in disproportionately large waking neurobehavioral and sleep delta power responses relative to how much sleep was lost . A statistical model revealed that , regardless of the mode of sleep deprivation , lapses in behavioral alertness were near-linearly related to the cumulative duration of wakefulness in excess of 15.84 h ( s.e . 0.73 h ) . CONCLUSIONS Since chronic restriction of sleep to 6 h or less per night produced cognitive performance deficits equivalent to up to 2 nights of total sleep deprivation , it appears that even relatively moderate sleep restriction can seriously impair waking neurobehavioral functions in healthy adults . Sleepiness ratings suggest that subjects were largely unaware of these increasing cognitive deficits , which may explain why the impact of chronic sleep restriction on waking cognitive functions is often assumed to be benign . Physiological sleep responses to chronic restriction did not mirror waking neurobehavioral responses , but cumulative wakefulness in excess of a 15.84 h predicted performance lapses across all four experimental conditions . This suggests that sleep debt is perhaps best understood as result ing in additional wakefulness that has a neurobiological " cost " which accumulates over time STUDY OBJECTIVES To investigate whether sleep restriction therapy ( SRT ) is associated with reduced objective total sleep time ( TST ) , increased daytime somnolence , and impaired vigilance . DESIGN Within-subject , noncontrolled treatment investigation . SETTING Sleep research laboratory . PARTICIPANTS Sixteen patients [ 10 female , mean age = 47.1 ( 10.8 ) y ] with well-defined psychophysiological insomnia ( PI ) , reporting TST ≤ 6 h. INTERVENTIONS Patients were treated with single-component SRT over a 4-w protocol , sleeping in the laboratory for 2 nights prior to treatment initiation and for 3 nights ( SRT night 1 , 8 , 22 ) during the acute interventional phase . The psychomotor vigilance task ( PVT ) was completed at seven defined time points [ day 0 ( baseline ) , day 1,7,8,21,22 ( acute treatment ) and day 84 ( 3 mo ) ] . The Epworth Sleepiness Scale ( ESS ) was completed at baseline , w 1 - 4 , and 3 mo . MEASUREMENT AND RESULTS Subjective sleep outcomes and global insomnia severity significantly improved before and after SRT . There was , however , a robust decrease in PSG-defined TST during acute implementation of SRT , by an average of 91 min on night 1 , 78 min on night 8 , and 69 min on night 22 , relative to baseline ( P < 0.001 ; effect size range = 1.60 - 1.80 ) . During SRT , PVT lapses were significantly increased from baseline ( at three of five assessment points , all P < 0.05 ; effect size range = 0.69 - 0.78 ) , returning to baseline levels by 3 mo ( P = 0.43 ) . A similar pattern was observed for RT , with RTs slowing during acute treatment ( at four of five assessment points , all P < 0.05 ; effect size range = 0.57 - 0.89 ) and returning to pretreatment levels at 3 mo ( P = 0.78 ) . ESS scores were increased at w 1 , 2 , and 3 ( relative to baseline ; all P < 0.05 ) ; by 3 mo , sleepiness had returned to baseline ( normative ) levels ( P = 0.65 ) . CONCLUSION For the first time we show that acute sleep restriction therapy is associated with reduced objective total sleep time , increased daytime sleepiness , and objective performance impairment . Our data have important implication s for implementation guidelines around the safe and effective delivery of cognitive behavioral therapy for insomnia This study compared the accuracy of reporting adherence to sleep instructions in participants who were informed that adherence would be verified with an actigraph ( aware group ) to participants not informed the actigraph would be used to assess adherence ( unaware of group ) . Participants were college students ( N = 68 ) , who were screened for psychiatric or sleep disorders or extremes in circadian tendency . The UG had later actigraph estimates of OUTPUT: We found sleep diaries , polysomnography ( PSG ) , and clinical screening examinations to be widely used with both control subjects and insomnia participants . However , there are differences between research groups in the precise definitions applied to the components of normal sleep . INPUT: Study Objectives Napping is a useful countermeasure to the negative effects of acute sleep loss on alertness . The efficacy of naps to recover from chronic sleep loss is less well understood . Methods Following 2 baseline nights ( 10 hours ' time-in-bed ) , participants were restricted to 7 nights of 5-hour sleep opportunity . Ten adults participated in the No-Nap condition , and a further 9 were assigned to a Nap condition with a daily 45-minute nap opportunity at 1300 h. Sleepiness was assessed using the multiple sleep latency test and a visual analogue scale at 2-hour intervals . Both objective and subjective indexes of sleepiness were normalized within subject as a difference from those at baseline prior to sleep restriction . Mixed-effects models examined how the daytime nap opportunity altered sleepiness across the day and across the protocol . Results Short daytime naps attenuated sleepiness due to chronic sleep restriction for up to 6 - 8 hours after the nap . Benefits of the nap did not extend late into evening . Subjective sleepiness demonstrated a similar short-lived benefit that emerged later in the day when objective sleepiness already returned to pre-nap levels . Neither measure showed a benefit of the nap the following morning after the subsequent restriction night . Conclusions These data indicate a short daytime nap may attenuate sleepiness in chronic sleep restriction , yet subjective and objective benefits emerge at different time scales . Because neither measure showed a benefit the next day , the current study underscores the need for careful consideration before naps are used as routine counter measures to chronic sleep loss Background The epidemiology of sports-related concussion is not well-described in the literature . This paper presents a descriptive epidemiology of concussion in seven high school and collegiate sports . Methods We used the data from Concussion Prevention Initiative ( CPI ) , which enrolled 8905 athletes at 210 high schools and 26 colleges in a prospect i ve cohort study of 7 sports ( football , men ’s and women ’s soccer , men ’s and women ’s lacrosse , and men ’s and women ’s ice hockey ) between 1999 and 2001 . Injury risks and injury rates were used to characterize the incidence of concussion , and changes in symptoms over time were described . Results A total of 375 concussions were observed . The incidence of concussion was highest in football , followed by women ’s lacrosse , men ’s lacrosse , men ’s soccer , and women ’s soccer ( only 10 ice hockey teams were included , too few to quantify incidence ) . The rate of incident concussion was strongly associated with history of concussion in the previous 24 months ( rate ratio = 5.5 ; 95 % CI : 3.9 , 7.8 , for 2 or more concussions relative to no previous concussion ) . The most common symptoms at time of injury were headache ( 87 % ) , balance problems/dizziness ( 77 % ) , and feeling “ in a fog ” ( 62 % ) . Loss of consciousness and amnesia were present in relatively few cases ( 9 and 30 % ) . The most common mechanism of injury was collision with another player . Conclusions Sports-related concussions present with a diverse range of symptoms and are associated with previous concussion history OBJECTIVES To inform the debate over whether human sleep can be chronically reduced without consequences , we conducted a dose-response chronic sleep restriction experiment in which waking neurobehavioral and sleep physiological functions were monitored and compared to those for total sleep deprivation . DESIGN The chronic sleep restriction experiment involved r and omization to one of three sleep doses ( 4 h , 6 h , or 8 h time in bed per night ) , which were maintained for 14 consecutive days . The total sleep deprivation experiment involved 3 nights without sleep ( 0 h time in bed ) . Each study also involved 3 baseline ( pre-deprivation ) days and 3 recovery days . SETTING Both experiments were conducted under st and ardized laboratory conditions with continuous behavioral , physiological and medical monitoring . PARTICIPANTS A total of n = 48 healthy adults ( ages 21 - 38 ) participated in the experiments . INTERVENTIONS Noctumal sleep periods were restricted to 8 h , 6 h or 4 h per day for 14 days , or to 0 h for 3 days . All other sleep was prohibited . RESULTS Chronic restriction of sleep periods to 4 h or 6 h per night over 14 consecutive days result ed in significant cumulative , dose-dependent deficits in cognitive performance on all tasks . Subjective sleepiness ratings showed an acute response to sleep restriction but only small further increases on subsequent days , and did not significantly differentiate the 6 h and 4 h conditions . Polysomnographic variables and delta power in the non-REM sleep EEG-a putative marker of sleep homeostasis -- displayed an acute response to sleep restriction with negligible further changes across the 14 restricted nights . Comparison of chronic sleep restriction to total sleep deprivation showed that the latter result ed in disproportionately large waking neurobehavioral and sleep delta power responses relative to how much sleep was lost . A statistical model revealed that , regardless of the mode of sleep deprivation , lapses in behavioral alertness were near-linearly related to the cumulative duration of wakefulness in excess of 15.84 h ( s.e . 0.73 h ) . CONCLUSIONS Since chronic restriction of sleep to 6 h or less per night produced cognitive performance deficits equivalent to up to 2 nights of total sleep deprivation , it appears that even relatively moderate sleep restriction can seriously impair waking neurobehavioral functions in healthy adults . Sleepiness ratings suggest that subjects were largely unaware of these increasing cognitive deficits , which may explain why the impact of chronic sleep restriction on waking cognitive functions is often assumed to be benign . Physiological sleep responses to chronic restriction did not mirror waking neurobehavioral responses , but cumulative wakefulness in excess of a 15.84 h predicted performance lapses across all four experimental conditions . This suggests that sleep debt is perhaps best understood as result ing in additional wakeful OUTPUT:
Conclusions : Chronic lack of sleep in adolescents is associated with greater risk of sports and musculoskeletal injuries . Current evidence can not yet definitively determine the effect of acute lack of sleep on injury rates .
MS2_dynamic_1_shot450
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: BACKGROUND Changes in gut microbiota induced by bariatric surgery have been associated with metabolic benefits . OBJECTIVES Our aim was to identify specific gut microbiota that may contribute to the improvement of type 2 diabetes ( T2D ) after Roux-en-Y gastric bypass ( RYGB ) . SETTING Laboratories of Shanghai Diabetes Institute and Shanghai Sixth People 's Hospital . METHODS Diabetic rats induced via a high-fat diet and low-dose streptozotocin administration were r and omized to RYGB or sham surgery , and stool sample s were collected at baseline and at postoperative week 8 . The fecal microbiota was profiled using 16S ribosomal RNA gene sequencing . Additionally , we performed a case-control study of the gut microbial community profiles of T2D patients compared with those of healthy individuals via 16S ribosomal RNA gene sequencing of mucosal-luminal interface sample s collected from the ascending colon during colonoscopy . RESULTS RYGB significantly reduced the weight and improved glucose tolerance and insulin sensitivity in diabetic rats . Principal coordinate analysis showed that RYGB caused marked alterations in the gut microbiota . The RYGB group was postoperatively enriched for Bacteroidetes , Proteobacteria , Fusobacteria , and Actinobacteria , whereas the sham surgery group was enriched for Firmicutes and Verrucomicrobia . Based on the gut microbial patterns in the T2D patients , we found that the family Coriobacteriaceae within Actinobacteria might contribute to the beneficial effects of RYGB on T2D . CONCLUSIONS RYGB significantly improves glucose metabolism and alters the gut microbiota . Moreover , the family Coriobacteriaceae may partly mediate the beneficial effects of RYGB on T2D and thus possibly contribute to the development of novel bacteria-based therapeutic approaches Background and Objectives Bariatric surgery improves metabolic diseases and alters the intestinal microbiota in animals and humans , but different procedures reportedly have different impacts on the intestinal microbiota . We developed laparoscopic sleeve gastrectomy with duodenojejunal bypass ( LSG-DJB ) as an alternative to laparoscopic Roux-en-Y gastric bypass ( LRYGB ) in addition to laparoscopic sleeve gastrectomy ( LSG ) for Japanese patients with obesity . We investigated the precise change in the intestinal microbiota induced by these procedures in the present study . Methods A prospect i ve observational study of 44 Japanese patients with obesity was conducted [ 22 patients underwent LSG , 18 underwent LSG-DJB , and 4 underwent laparoscopic adjustable gastric b and ing ( LAGB ) ] . The patients ’ clinical parameters and intestinal microbiota were investigated before and for 6 months after surgery . The microbiota was analyzed by a 16S rDNA method . Results LSG and LSG-DJB significantly improved the metabolic disorders in the patients with obesity . The proportion of the phylum Bacteroidetes and order Lactobacillales increased significantly in the LSG group , and that of the order Enterobacteriales increased significantly in the LSG-DJB group . Conclusions LSG and LSG-DJB improved obesity and type 2 diabetes in Japanese patients with obesity , but the impact of LSG-DJB on the intestinal microbiota differed from that of LSG . This difference in the impact on the intestinal environment could explain the different efficacies of LSG and LSG-DJB in terms of their ability to resolve metabolic disorders in the clinical setting BACKGROUND Changes in the gut microbiome following bariatric surgery have been causally linked to metabolic benefits . OBJECTIVES We sought to characterize and assess the stability of gut microbiome shifts following sleeve gastrectomy ( SG ) . SETTING University laboratories . METHODS Diet-induced obese mice were r and omized to SG or sham surgery . Mice were housed individually or cohoused such that one SG mouse was housed with one weight-matched , sham-operated mouse . Fecal sample s were collected before and on postoperative days 7 and 28 . Bacterial composition in feces was characterized by using next-generation Illumina sequencing of 16 S rRNA . RESULTS SG mice lost more weight and were more insulin sensitive than sham mice independent of housing status ( P<.05 ) . One week following surgery , fecal sample s from all mice showed shifts in the microbiome that only persisted in SG-operated mice . Cohousing did not alter the microbial composition of SG-operated mice . Cohoused sham-operated mice showed a unique shift in microbial composition on postoperative day 28 that differed from individually housed , sham-operated mice ( P<.001 ) . Cohousing did not affect metabolic outcomes of either SG or sham surgeries . CONCLUSION SG results in acute and sustained shifts in the gut microbiome . SG associated shifts are not altered by reexposure to obesity-associated gut microbiota Background Roux-en-Y gastric bypass ( RYGB ) is an effective means to achieve sustained weight loss for morbidly obese individuals . Besides rapid weight reduction , patients achieve major improvements of insulin sensitivity and glucose homeostasis . Dysbiosis of gut microbiota has been associated with obesity and some of its co-morbidities , like type 2 diabetes , and major changes of gut microbial communities have been hypothesized to mediate part of the beneficial metabolic effects observed after RYGB . Here we describe changes in gut microbial taxonomic composition and functional potential following RYGB . Methods We recruited 13 morbidly OUTPUT: Roux-n-Y gastric bypass caused more alterations in gut microbial composition in comparison with sleeve gastrectomy . INPUT: Context A majority of women with polycystic ovary syndrome ( PCOS ) have metabolic abnormalities that result in an increased risk of developing type 2 diabetes and heart disease . Correlative studies have shown an association between changes in the gut microbiome and metabolic disorders . Two recent studies reported a decrease in α diversity of the gut microbiome in women with PCOS compared with healthy women . Objective We investigated whether changes in the gut microbiome correlated with specific clinical parameters in women with PCOS compared with healthy women . We also investigated whether there were changes in the gut microbiome in women with polycystic ovarian morphology ( PCOM ) who lacked the other diagnostic criteria of PCOS . Participants Subjects were recruited at the Poznan University of Medical Sciences . Fecal microbial diversity profiles of healthy women ( n = 48 ) , women with PCOM ( n = 42 ) , and women diagnosed with PCOS using the Rotterdam criteria ( n = 73 ) were analyzed using 16S ribosomal RNA gene sequencing . Results Lower α diversity was observed in women with PCOS compared with healthy women . Women with PCOM had a change in α diversity that was intermediate between that of the other two groups . Regression analyses showed that hyper and rogenism , total testosterone , and hirsutism were negatively correlated with α diversity . Permutational multivariate analysis of variance in UniFrac distances showed that hyper and rogenism was also correlated with β diversity . A r and om forest identified bacteria that discriminated between healthy women and women with PCOS . Conclusion These results suggest that hyper and rogenism may play a critical role in altering the gut microbiome in women with PCOS Background To our knowledge , no reports are available indicating the effects of synbiotic supplementation on hormonal status , biomarkers of inflammation and oxidative stress in subjects with polycystic ovary syndrome ( PCOS ) . This research was done to assess the effects of synbiotic supplementation on hormonal status , biomarkers of inflammation and oxidative stress in subjects with PCOS . Methods This r and omized double-blind , placebo-controlled trial was conducted on 60 subjects diagnosed with PCOS according to the Rotterdam criteria . Subjects were r and omly assigned into two groups to take either synbiotic ( n = 30 ) or placebo ( n = 30 ) for 12 weeks . Endocrine , inflammation and oxidative stress biomarkers were quantified at baseline and after the 12-week intervention . Results After the 12-week intervention , compared with the placebo , synbiotic supplementation significantly increased serum sex hormone-binding globulin ( SHBG ) ( changes from baseline in synbiotic group : + 19.8 ± 47.3 vs. in placebo group : + 0.5 ± 5.4 nmol/L , p = 0.01 ) , plasma nitric oxide ( NO ) ( changes from baseline in synbiotic group : + 5.5 ± 4.8 vs. in placebo group : + 0.3 ± 9.1 μmol/L , p = 0.006 ) , and decreased modified Ferriman Gallwey ( mF-G ) scores ( changes from baseline in synbiotic group : − 1.3 ± 2.5 vs. in placebo group : − 0.1 ± 0.5 , p = 0.01 ) and serum high-sensitivity C-reactive protein ( hs-CRP ) ( changes from baseline in synbiotic group : − 950.0 ± 2246.6 vs. in placebo group : + 335.3 ± 2466.9 ng/mL , p = 0.02 ) . We did not observe any significant effect of synbiotic supplementation on other hormonal status and biomarkers of oxidative stress . Conclusions Overall , synbiotic supplementation for 12 weeks in PCOS women had beneficial effects on SHBG , mFG scores , hs-CRP and NO levels , but did not affect other hormonal status and biomarkers of oxidative stress . Trial registration This study was retrospectively registered in the Iranian website ( www.i rct .ir ) for registration of clinical trials ( I RCT 201509115623N53 ) , on 2015–09 - 27 Many studies have been done on the hypocholesterolaemic effect of probiotic yoghurt . The results , however , are not conclusive . The aim of the present study was to test the effect of probiotic and conventional yoghurt on the lipid profile in women . In a r and omised trial , ninety female volunteers aged 19 - 49 years were assigned to three groups . Subjects consumed daily 300 g probiotic yoghurt containing Lactobacillus acidophilus La5 and Bifidobacterium lactis Bb12 or 300 g conventional yoghurt or no yoghurt for 6 weeks . Fasting blood sample s , 3 d dietary records and anthropometric measurements were collected at baseline ( T1 ) , end of week 3 ( T2 ) and end of week 6 ( T3 ) . Lipid profile parameters were determined by enzymic methods . Results showed no significant difference in lipid profile within any group throughout the study . Comparing mean differences ( T1 - T3 ) among the three groups showed : no difference in TAG and LDL-cholesterol , a decrease in cholesterol in both conventional ( P < 0.05 ) and probiotic yoghurt groups ( P < 0.005 ) compared with the control group , a decrease in total : HDL-cholesterol ratio for conventional ( P < 0.05 ) and probiotic yoghurt groups ( P < 0.001 ) compared with the control group , and an increase in HDL-cholesterol in the probiotic yoghurt group ( P < OUTPUT:
The administration of probiotic/synbiotic were associated with a significant improvement in FPG , FBI , HOMA I-R , BMI . It also modified Ferriman-Gallway , serum triglycerides , serum testosterone , hs-CRP , NO , TAC , GSH , and MDA . Subgroup analysis of the type of intervention showed that probiotics were associated with greater testosterone and FPG reduction ; synbiotics administration result ed in a more pronounced decrease of the FBI . Subgroup analyses on the duration of therapy showed that , probiotic/synbiotic administration had a significantly greater effect on QUICK-I in the case of women with 12-weeks of therapy than in the 8-weeks therapy group . Nevertheless , we did not observe any significant difference was observed in terms of FBI , HOMA-IR , and FPG . Probiotics and synbiotics seem to either an effect on/influence metabolic , hormonal and inflammatory parameters , or can influence them . Consequently , it could lead to an improvement of fertility in PCOS
MS2_dynamic_1_shot451
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: OBJECTIVE To use two different exercise programs over a 2-year period to reduce falls and their sequelae among residents of two long-term care facilities . DESIGN R and omized , controlled trial . SETTING The study took place at two long-term care facilities with services ranging from independent living to skilled nursing . PARTICIPANTS One hundred and ten participants whose average age was 84 and who were capable of ambulating with or without assistive devices and could follow simple directions . INTERVENTION Participants were r and omized to one of two exercise groups ( resistance/endurance plus basic enhanced programming or tai chi plus basic enhanced programming ) or to a control group ( basic enhanced programming only ) . Exercise classes were held three times per week throughout the study . MEASUREMENTS Participants were evaluated for cognitive and physical functioning at baseline and 6 , 12 , and 24 months . Falls were determined from incident reports filed by the nursing staffs at the facilities . RESULTS Time to first fall , time to death , number of days hospitalized , and incidence of falls did not differ among the treatment and control groups ( P>.05 ) . Among all participants , those who fell had significantly lower baseline Folstein Mini-Mental State Examination and instrumental activities of daily living scores and experienced significantly greater declines in these measures over the 2-year program . CONCLUSION There were no significant differences in falls among the two exercise groups and the control group . Lack of treatment differences and low adherence rates suggest that residents of long-term care facilities may require individualized exercise interventions that can be adapted to their changing needs The eight FICSIT ( Frailty and Injuries : Cooperative Studies of Intervention Techniques ) sites test different intervention strategies in selected target groups of older adults . To compare the relative potential of these interventions to reduce frailty and fall-related injuries , all sites share certain descriptive ( risk-adjustment ) measures and outcome measures . This article describes the shared measures , which are referred to as the FICSIT Common Data Base ( CDB ) . The description is divided into four sections according to the four FICSIT committees responsible for the CDB : ( 1 ) psychosocial health and demographic measures ; ( 2 ) physical health measures ; ( 3 ) fall-related measures ; and ( 4 ) cost and cost-effectiveness measures . Because the structure of the FICSIT trial is unusual , the CDB should expedite secondary analyses of various research questions dealing with frailty and falls BACKGROUND Falls in elderly people are a common presenting complaint to accident and emergency departments . Current practice commonly focuses on the injury , with little systematic assessment of the underlying cause , functional consequences , and possibilities for future prevention . We undertook a r and omised controlled study to assess the benefit of a structured inderdisciplinary assessment of people who have fallen in terms of further falls . METHODS Eligible patients were aged 65 years and older , lived in the community , and presented to an accident and emergency department with a fall . Patients assigned to the intervention group ( n=184 ) underwent a detailed medical and occupational-therapy assessment with referral to relevant services if indicated ; those assigned to the control group ( n=213 ) received usual care only . The analyses were by intention to treat . Follow-up data were collected every 4 months for 1 year . FINDINGS At 12-month follow-up , 77 % of both groups remained in the study . The total reported number of falls during this period was 183 in the intervention group compared with 510 in the control group ( p=0.0002 ) . The risk of falling was significantly reduced in the intervention group ( odds ratio 0.39 [ 95 % CI 0.23 - 0.66 ] ) as was the risk of recurrent falls ( 0.33 [ 0.16 - 0.68 ] ) . In addition , the odds of admission to hospital were lower in the intervention group ( 0.61 [ 0.35 - 1.05 ] ) whereas the decline in Barthel score with time was greater in the control group ( p<0.00001 ) . INTERPRETATION The study shows that an interdisciplinary approach to this high-risk population can significantly decrease the risk of further falls and limit functional impairment OBJECTIVE To investigate the effect of a second task on balance and gait maneuvers used in everyday life . Our hypothesis was that those who were more distracted by a familiar manual task performed concurrently with functional maneuvers were more frail and more prone to falls . DESIGN A cross-sectional design with prospect i ve follow-up for falls . SETTING Sheltered accommodation in Umeå , Sweden . PARTICIPANTS Forty-two residents ( 30 women , 12 men ; mean age + /- SD = 79.7 + /- 6.1 years ) , ambulant with or without a walking aid , able to follow simple instructions and able to carry a tumbler . MEASUREMENTS Timed Up & Go ( TUG ) , i.e. , the time taken to rise from an armchair , walk 3 meters , turn round , and sit down again . TUG was repeated with an added manual task ( TUGmanual ) , which was to carry a glass of water while walking . The Montgomery-Asberg Depression Rating Scale , Barthel Index , Functional Reach , Mini-Mental State Examination , and Line Bisection test were used to assess for frailty . The subjects were followed-up prospect ively regarding falls indoors for a period of 6-months . RESULTS Subjects with a time difference ( diffTUG ) between TUGmanual and TUG of > or = 4.5 seconds were considered to be distracted by the second task . Ten subjects had a difference in time of > or = 4.5 seconds . These subjects were more frail , and seven of them fell indoors during the follow-up period ( odds ratio 4.7 , 95%Confidence Interval ( CI ) 1.5 - 14.2 ) . CONCLUSION The time difference between the TUGmanual and the TUG appears to be a valid marker of frailty and a useful tool for identifying older persons prone to falling BACKGROUND OUTPUT: Contribution This r and omized trial shows that a multidisciplinary fall prevention program reduces falls and femoral fractures in older people living in residential care facilities . The program included general as well as resident-specific , tailored strategies . Other trials have not shown reductions in falls or injuries ( 10 - 13 ) but have shown fewer hospital admissions ( 11 ) and improvements in mobility ( 12 ) , visual acuity , and hypotension ( 13 ) . The use of hip protectors has consistently proved effective in preventing hip fractures in selected high-risk population s ( 14 ) . Increasing the staff 's knowledge about fall prevention was believed to be the starting point of a process that would produce long-term results . INPUT: The eight FICSIT ( Frailty and Injuries : Cooperative Studies of Intervention Techniques ) sites test different intervention strategies in selected target groups of older adults . To compare the relative potential of these interventions to reduce frailty and fall-related injuries , all sites share certain descriptive ( risk-adjustment ) measures and outcome measures . This article describes the shared measures , which are referred to as the FICSIT Common Data Base ( CDB ) . The description is divided into four sections according to the four FICSIT committees responsible for the CDB : ( 1 ) psychosocial health and demographic measures ; ( 2 ) physical health measures ; ( 3 ) fall-related measures ; and ( 4 ) cost and cost-effectiveness measures . Because the structure of the FICSIT trial is unusual , the CDB should expedite secondary analyses of various research questions dealing with frailty and falls OBJECTIVES To test the hypothesis that scores on 4 falls risk measures will differ significantly in patients reporting recurrent falls compared with those who do not ; and to explore the validity of each measure to predict such falls status . DESIGN A convenience sample was tested to establish the sensitivity and specificity of the Functional Reach Test , Timed Up & Go test , one-leg stance test ( OLST ) , and balance subsection of the Performance Oriented Mobility Assessment ( B-POMA ) . A 12-month retrospective falls history was used to identify recurrent fallers . SETTING A day hospital for the elderly . PARTICIPANTS Convenience sample of 30 day hospital patients . The inclusion criteria were : ability to rise from a chair and walk 6 m ; no severe cognitive impairment or blindness ; age 65 years or older . INTERVENTIONS Not applicable . MAIN OUTCOME MEASURES Scores on the 4 tests and retrospective falls histories . RESULTS Scores on the B-POMA and OLST showed significant differences between fallers and nonfallers ( P<.05 ) . An OLST time of 1.02 seconds or less ( odds ratio [OR]=15.2 ; 95 % confidence interval [ CI ] , 1.72 - 133.95 ) and B-POMA score of 11 or less ( OR=18.5 ; 95 % CI , 2.05 - 167.79 ) were predictive of day hospital patients having a history of recurrent falls . CONCLUSIONS OLST and B-POMA both have potential as screening tools for risk of falls , but this observation requires confirmation in a prospect i ve study Objective To determine the efficacy of a targeted multifactorial falls prevention programme in elderly care wards with relatively short lengths of stay . Design Cluster r and omised trial . Setting 24 elderly care wards in 12 hospitals in Sydney , Australia . Participants 3999 patients , mean age 79 years , with a median hospital stay of seven days . Interventions A nurse and physiotherapist each worked for 25 hours a week for three months in all intervention wards . They provided a targeted multifactorial intervention that included a risk assessment of falls , staff and patient education , drug review , modification of bedside and ward environments , an exercise programme , and alarms for selected patients . Main outcome measure Falls during hospital stay . Results Intervention and control wards were similar at baseline for previous rates of falls and individual patient characteristics . Overall , 381 falls occurred during the study . No difference was found in fall rates during follow-up between intervention and control wards : respectively , 9.26 falls per 1000 bed days and 9.20 falls per 1000 bed days ( P=0.96 ) . The incidence rate ratio adjusted for individual lengths of stay and previous fall rates in the ward was 0.96 ( 95 % confidence interval 0.72 to 1.28 ) . Conclusion A targeted multifactorial falls prevention programme was not effective among older people in hospital wards with relatively short lengths of stay . Trial registration Australian New Zeal and Clinical Trials Registry ACTRNO 12605000467639 BACKGROUND Executive function ( EF ) deficits may increase fall risk , even among older adults with no overt cognitive impairment . Indeed , the effects of dual tasking ( DT ) on gait , a challenge to executive control , are more exaggerated in persons with a history of falls . Prospect i ve evidence is , however , lacking . METHODS We prospect ively evaluated whether EF predicts falls over a 2-year period among 262 community-living , healthy , and well-functioning older adults , focusing on the 201 who reported no falls during the previous year . At baseline , participants completed a computerized cognitive battery that generated an index of EF and other cognitive domains . Gait was assessed using performance-based tests and by quantifying walking during single- and dual-task conditions . RESULTS The 262 participants ( mean age : 76.3 ± 4.3 years , 60.3 % women ) had intact cognitive function on testing , a low comorbidity index , and good mobility . The EF index predicted future falls . Among those who reported no previous falls , participants in the worst EF quartile were three times more likely to fall during the 2 years of follow-up , and they were more likely to transition from nonfaller to faller sooner . DT gait variability also predicted future falls and multiple falls , whereas other measures of cognitive function , gait , and mobility did not . CONCLUSIONS Among healthy older adults , individuals with poorer EF are more prone to falls . Higher-level cognitive functions such as those regulated by the frontal lobes are apparently needed for safe everyday navigation that dem and s multitasking . Optimal screening , early detection , and treatment of falls should , apparently , also target this cognitive domain Background Falling is a common problem in the fast-growing elderly population . Multitasking or engaging in two or more activities at the same time is common in daily living . Objective To determine the usefulness of the trail-walking test ( TWT ) for predicting a fall in community-dwelling elderly individuals . Methods This was a prospect i ve study OUTPUT:
Conclusion The Timed Up and Go test has limited ability to predict falls in community dwelling elderly and should not be used in isolation to identify individuals at high risk of falls in this setting
MS2_dynamic_1_shot452
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: Background Supporting 21st century health care and the practice of evidence -based medicine ( EBM ) requires ubiquitous access to clinical information and to knowledge-based re sources to answer clinical questions . Many questions go unanswered , however , due to lack of skills in formulating questions , crafting effective search strategies , and accessing data bases to identify best levels of evidence . Methods This r and omized trial was design ed as a pilot study to measure the relevancy of search results using three different interfaces for the PubMed search system . Two of the search interfaces utilized a specific framework called PICO , which was design ed to focus clinical questions and to prompt for publication type or type of question asked . The third interface was the st and ard PubMed interface readily available on the Web . Study subjects were recruited from interns and residents on an inpatient general medicine rotation at an academic medical center in the US . Thirty-one subjects were r and omized to one of the three interfaces , given 3 clinical questions , and asked to search PubMed for a set of relevant articles that would provide an answer for each question . The success of the search results was determined by a precision score , which compared the number of relevant or gold st and ard articles retrieved in a result set to the total number of articles retrieved in that set . Results Participants using the PICO templates ( Protocol A or Protocol B ) had higher precision scores for each question than the participants who used Protocol C , the st and ard PubMed Web interface . ( Question 1 : A = 35 % , B = 28 % , C = 20 % ; Question 2 : A = 5 % , B = 6 % , C = 4 % ; Question 3 : A = 1 % , B = 0 % , C = 0 % ) 95 % confidence intervals were calculated for the precision for each question using a lower boundary of zero . However , the 95 % confidence limits were overlapping , suggesting no statistical difference between the groups . Conclusion Due to the small number of search es for each arm , this pilot study could not demonstrate a statistically significant difference between the search protocol s. However there was a trend towards higher precision that needs to be investigated in a larger study to determine if PICO can improve the relevancy of search results OBJECTIVE To examine the long-term effects of an intervention combining teacher training , parent education , and social competence training for children during the elementary grade s on adolescent health-risk behaviors at age 18 years . DESIGN Nonr and omized controlled trial with follow-up 6 years after intervention . SETTING Public elementary schools serving high-crime areas in Seattle , Wash. PARTICIPANTS Of the fifth- grade students enrolled in participating schools , 643 ( 76 % ) were given written parental consent for the longitudinal study and 598 ( 93 % ) were followed up and interviewed at age 18 years . INTERVENTIONS A full intervention provided in grade s 1 through 6 of 5 days of in-service training for teachers each intervention year , developmentally appropriate parenting classes offered to parents when children were in grade s 1 through 3 and 5 through 6 , and developmentally adjusted social competence training for children in grade s 1 and 6 . A late intervention , provided in grade s 5 and 6 only , paralleled the full intervention at these grade s. MAIN OUTCOME MEASURES Self-reported violent and nonviolent crime , substance use , sexual activity , pregnancy , bonding to school , school achievement , grade repetition and school dropout , suspension and /or expulsion , and school misbehavior ; delinquency charges from court records ; grade point average ; California Achievement Test scores : and disciplinary action reports from school records . RESULTS Fewer students receiving full intervention than control students reported violent delinquent acts ( 48.3 % vs 59.7 % ; P=.04 ) , heavy drinking ( 15.4 % vs 25.6 % ; P=.04 ) , sexual intercourse ( 72.1 % vs 83.0 % ; P=.02 ) , having multiple sex partners ( 49.7 % vs 61.5 % ; P=.04 ) , and pregnancy or causing pregnancy ( 17.1 % vs 26.4 % ; P=.06 ) by age 18 years . The full intervention student group reported more commitment ( P=.03 ) and attachment ( P=.006 ) to school , better academic achievement ( P=.01 ) , and less school misbehavior ( P=.02 ) than control students . Late intervention in grade s 5 and 6 only did not significantly affect health-risk behaviors in adolescence . CONCLUSIONS A package of interventions with teachers , parents , and children provided throughout the elementary grade s can have enduring effects in reducing violent behavior , heavy drinking , and sexual intercourse by age 18 years among multiethnic urban children . Results are consistent with the theoretical model guiding the intervention and support efforts to reduce health-risk behaviors through universal interventions in selected communities or schools serving high-crime neighborhoods PURPOSE The purpose of this investigation was to assess the School-Based Adolescent Health Care Program , which provided comprehensive health-related services in 24 school-based health centers . METHODS The outcomes evaluation compared a cohort of students attending 19 participating schools and a national sample of urban youths , using logit models to control for observed differences between the two groups of youths . Outcome measures included self-reports concerning health center utilization , use of other health care providers , knowledge of key health facts , substance use , sexual activity , contraceptive use , pregnancies and births , and health status . RESULTS The health centers increased students ' access to health care and improved their health knowledge . However , the estimated impacts on health status and risky behaviors were inconsistent , and most were small and not statistically significant . CONCLUSIONS School-based health centers can increase students ' health knowledge and access to health-related services , but more intensive or different services are needed if they are to significantly reduce risk-taking behaviors OBJECTIVES A theory-based curriculum design ed to delay the onset of intercourse and increase use of condoms was implemented in the classrooms of six Los Angeles middle schools . METHODS The curriculum activities were very interactive , emphasized skill building , and were implemented OUTPUT: Identified evidence indicated no consistent difference in rates of pregnancies between intervention recipients and controls INPUT: Background Supporting 21st century health care and the practice of evidence -based medicine ( EBM ) requires ubiquitous access to clinical information and to knowledge-based re sources to answer clinical questions . Many questions go unanswered , however , due to lack of skills in formulating questions , crafting effective search strategies , and accessing data bases to identify best levels of evidence . Methods This r and omized trial was design ed as a pilot study to measure the relevancy of search results using three different interfaces for the PubMed search system . Two of the search interfaces utilized a specific framework called PICO , which was design ed to focus clinical questions and to prompt for publication type or type of question asked . The third interface was the st and ard PubMed interface readily available on the Web . Study subjects were recruited from interns and residents on an inpatient general medicine rotation at an academic medical center in the US . Thirty-one subjects were r and omized to one of the three interfaces , given 3 clinical questions , and asked to search PubMed for a set of relevant articles that would provide an answer for each question . The success of the search results was determined by a precision score , which compared the number of relevant or gold st and ard articles retrieved in a result set to the total number of articles retrieved in that set . Results Participants using the PICO templates ( Protocol A or Protocol B ) had higher precision scores for each question than the participants who used Protocol C , the st and ard PubMed Web interface . ( Question 1 : A = 35 % , B = 28 % , C = 20 % ; Question 2 : A = 5 % , B = 6 % , C = 4 % ; Question 3 : A = 1 % , B = 0 % , C = 0 % ) 95 % confidence intervals were calculated for the precision for each question using a lower boundary of zero . However , the 95 % confidence limits were overlapping , suggesting no statistical difference between the groups . Conclusion Due to the small number of search es for each arm , this pilot study could not demonstrate a statistically significant difference between the search protocol s. However there was a trend towards higher precision that needs to be investigated in a larger study to determine if PICO can improve the relevancy of search results Background The question of whether air pollution contributes to asthma onset remains unresolved . Objectives In this study , we assessed the association between asthma onset in children and traffic-related air pollution . Methods We selected a sample of 217 children from participants in the Southern California Children ’s Health Study , a prospect i ve cohort design ed to investigate associations between air pollution and respiratory health in children 10–18 years of age . Individual covariates and new asthma incidence ( 30 cases ) were reported annually through question naires during 8 years of follow-up . Children had nitrogen dioxide monitors placed outside their home for 2 weeks in the summer and 2 weeks in the fall – winter season as a marker of traffic-related air pollution . We used multilevel Cox models to test the associations between asthma and air pollution . Results In models controlling for confounders , incident asthma was positively associated with traffic pollution , with a hazard ratio ( HR ) of 1.29 [ 95 % confidence interval ( CI ) , 1.07–1.56 ] across the average within-community interquartile range of 6.2 ppb in annual residential NO2 . Using the total interquartile range for all measurements of 28.9 ppb increased the HR to 3.25 ( 95 % CI , 1.35–7.85 ) . Conclusions In this cohort , markers of traffic-related air pollution were associated with the onset of asthma . The risks observed suggest that air pollution exposure contributes to new-onset asthma Background Physical inactivity among children is an increasing problem that adversely affects children ’s health . A better underst and ing of factors which affect physical activity ( PA ) will help create effective interventions aim ed at raising the activity levels of children . This cross-sectional study examined the associations of PA with individual ( biological , social , behavioral , psychological ) and environmental ( East vs. West Germany , rural vs. urban regions ) characteristics in children . Methods Information on PA and potential correlates was collected from 1843 girls and 1997 boys using question naires during the 10-year follow-up of two prospect i ve birth cohort studies ( GINIplus and LISAplus ) . Study regions represent urban and rural sites as well as East and West of Germany . Logistic regression modeling was applied to examine cross-sectional associations between individual as well as environmental factors and PA levels . Results Five of fourteen variables were significantly associated with PA . Among children aged 10 , girls tended to be less active than boys , especially with respect to vigorous PA ( OR = 0.72 for summer ) . Children who were not a member of a sports club showed a substantially reduced amount of PA in winter ( OR = 0.15 ) . Rural environments promote moderate PA , particularly in winter ( OR = 1.88 ) , whereas an increased time outdoors primarily promotes moderate PA in summer ( OR = 12.41 ) . Children with abnormal emotional symptoms exhibited reduced physical activity , particularly in winter ( OR = 0.60 ) . BMI , puberty , parental BMI , parental education , household income , siblings , TV/PC consumption , and method of arriving school , were not associated with PA . Conclusions When considering correlates of PA from several domains simultaneously , only few factors ( sex , sports club membership , physical environment , time outdoors , and emotional symptoms ) appear to be relevant . Although the causality needs to be ascertained in longitudinal studies , variables which can not be modified should be used to identify risk groups while modifiable variables , such as sports club activities , may be addressed in intervention programs Background The pre-school years are considered critical for establishing healthy lifestyle behaviours such as physical activity . Levels of physical activity track through childhood into adulthood , thus establishing habitual physical activity early in life is vital . Time spent outdoors is associated with greater physical activity and playground interventions have been shown to increase physical activity in school aged children . There are few pre-school , playground-based interventions , and evaluations of these have found mixed results . A OUTPUT:
The systematic review revealed overall positive effects of outdoor time on physical activity , sedentary behaviour , and cardiorespiratory fitness , although causality could not be assumed due to a lack of RCTs . Motor skill development was unrelated to outdoor time ; however , this relationship was only examined in a single study of preschool children . No studies were found that examined associations between outdoor time and musculoskeletal fitness
MS2_dynamic_1_shot453
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: Objective : To examine the link between childhood overweight status and elementary school outcomes . Design : Prospect i ve study design : multivariate regression models examining the association between changes in overweight status and school outcomes between kindergarten entry and end of third grade , after controlling for various child , family and school characteristics . Subjects : Nationally representative sample of US children who entered kindergarten in 1998 , with longitudinal data on body mass index ( BMI ) and school outcomes at kindergarten entry and end of third grade . Measurements : Wide range of elementary school outcomes collected in each wave including academic achievement ( math and reading st and ardized test scores ) ; teacher reported internalizing and externalizing behavior problems ( BP ) , social skills ( self-control , interpersonal skills ) and approaches to learning ; school absences ; and grade repetition . Measurements of height and weight in each wave were used to compute BMI and indicators of overweight status based on CDC growth charts . A rich set of control variables capturing child , family , and school characteristics . Results : Moving from not-overweight to overweight between kindergarten entry and end of third grade was significantly associated ( P<0.05 ) with reductions in test scores , and teacher ratings of social-behavioral outcomes and approaches to learning among girls . However , this link was mostly absent among boys , with two exceptions – boys who became overweight had significantly fewer externalizing BPs ( P<0.05 ) , but more absences from school compared to boys who remained normal weight . Being always-overweight was associated with more internalizing BP among girls but fewer externalizing BPs among boys . Conclusion : Change in overweight status during the first 4 years in school is a significant risk factor for adverse school outcomes among girls but not boys . Girls who become overweight during the early school years and those who start school being overweight and remain that way may need to be monitored carefully This study investigated the relationship between adolescents ' academic performance and participation in physical activity . 232 boys and girls from Years 8–11 ( ages 13–16 years ) were r and omly selected , and their academic performance was assessed on previous examination scores in English , Mathematics , and Science . Participants were also asked to list all the sports-based physical activities in which they normally participated during a typical week and to indicate how many times per week they took part in each activity and the duration of each . Overall , no significant correlations were found , although weak negative correlations were recorded between the amount of time ( in minutes ) in sport and exercise and English scores for children ages 13 , 14 , and 16 years . A similar association was also noted for Science scores of children 16 years old PURPOSE This study was conducted to determine the effect of physical education class enrollment and physical activity on academic achievement in middle school children . METHODS Participants were 214 sixth- grade students r and omly assigned to physical education during either first or second semesters . Moderate and vigorous physical activity ( MVPA ) ( number of 30-min time blocks ) outside of school was assessed using the 3-d physical activity recall ( 3DPAR ) . The 3DPAR time blocks were converted to ordinal data with scores of 1 ( no activity ) , 2 ( some activity ) , or 3 ( activity meeting Healthy People 2010 guidelines ) . Academic achievement was assessed using grade s from four core academic classes and st and ardized test scores ( Terra Nova percentiles ) . RESULTS Grade s were similar regardless of whether students were enrolled in physical education during first or second semesters . Physical education classes averaged only 19 min of MVPA . Students who either performed some or met Healthy People 2010 guidelines for vigorous activity had significantly higher grade s ( P < 0.05 ) than students who performed no vigorous activity in both semesters . Moderate physical activity did not affect grade s. St and ardized test scores were not significantly related to physical education class enrollment or physical activity levels . CONCLUSION Although academic achievement was not significantly related to physical education enrollment , higher grade s were associated with vigorous physical activity , particularly activity meeting recommended Healthy People 2010 levels An evaluation is reported of an exercise-based approach to remediation of dyslexia-related disorders . Pupils in three years of a Warwickshire junior school were screened for risk of literacy difficulty using the Dyslexia Screening Test ( DST ) . The 35 children scoring 0.4 or over on the DST were divided r and omly into two groups matched for age and DST score . One quarter of the participants had an existing diagnosis of dyslexia , dyspraxia or ADHD . Both groups received the same treatment at school but the intervention group used the DDAT exercise programme daily at home . Performance on the DST and specialist cerebellar/vestibular and eye movement tests were assessed initially and after six months . Cerebellar/vestibular signs were substantially alleviated following the exercise treatment whereas there were no significant changes for the control group . Even after allowing for the passage of time , there were significant improvements for the intervention group in postural stability , dexterity , phonological skill , and ( one-tailed ) for naming fluency and semantic fluency . Reading fluency showed a highly significant improvement for the intervention group , and nonsense passage reading was also improved significantly . Significantly greater improvements for the intervention group than the control group occurred for dexterity , reading , verbal fluency and semantic fluency . Substantial and significant improvements ( compared with those in the previous year ) also occurred for the exercise group on national st and ardized tests of reading , writing and comprehension . It is concluded that , in addition to its direct effects on balance , dexterity and eye movement control , the benefits of the DDAT exercise treatment transferred significantly to cognitive skills underlying literacy , to the reading process , and to st and ardized national literacy attainment tests The effects of a 2-year health-related school physical education program on st and ardized academic achievement scores was assessed in 759 children who completed Metropolitan Achievement Tests before and after the program . Schools were r and omly assigned to condition : ( a ) Specialists taught the Sports , Play , and Active Recreation for Kids curriculum ; ( b ) classroom teachers were trained to implement the curriculum ; and ( c ) controls continued their usual programs . The Trained Te OUTPUT: Results Quasi-experimental data indicate that allocating up to an additional hour per day of curricular time to PA programmes does not affect the academic performance of primary school students negatively , even though the time allocated to other subjects usually shows a corresponding reduction . An additional curricular emphasis on PE may result in small absolute gains in grade point average ( GPA ) , and such findings strongly suggest a relative increase in performance per unit of academic teaching time . Further , the overwhelmingly majority of such programmes have demonstrated an improvement in some measures of physical fitness ( PF ) . Cross-sectional observations show a positive association between academic performance and PA , but PF does not seem to show such an association . PA has positive influences on concentration , memory and classroom behaviour . Data from quasi-experimental studies find support in mechanistic experiments on cognitive function , pointing to a positive relationship between PA and intellectual performance . Conclusion Given competent providers , PA can be added to the school curriculum by taking time from other subjects without risk of hindering student academic achievement . On the other h and , adding time to " academic " or " curricular " subjects by taking time from physical education programmes does not enhance grade s in these subjects and may be detrimental to health INPUT: Objective : To examine the link between childhood overweight status and elementary school outcomes . Design : Prospect i ve study design : multivariate regression models examining the association between changes in overweight status and school outcomes between kindergarten entry and end of third grade , after controlling for various child , family and school characteristics . Subjects : Nationally representative sample of US children who entered kindergarten in 1998 , with longitudinal data on body mass index ( BMI ) and school outcomes at kindergarten entry and end of third grade . Measurements : Wide range of elementary school outcomes collected in each wave including academic achievement ( math and reading st and ardized test scores ) ; teacher reported internalizing and externalizing behavior problems ( BP ) , social skills ( self-control , interpersonal skills ) and approaches to learning ; school absences ; and grade repetition . Measurements of height and weight in each wave were used to compute BMI and indicators of overweight status based on CDC growth charts . A rich set of control variables capturing child , family , and school characteristics . Results : Moving from not-overweight to overweight between kindergarten entry and end of third grade was significantly associated ( P<0.05 ) with reductions in test scores , and teacher ratings of social-behavioral outcomes and approaches to learning among girls . However , this link was mostly absent among boys , with two exceptions – boys who became overweight had significantly fewer externalizing BPs ( P<0.05 ) , but more absences from school compared to boys who remained normal weight . Being always-overweight was associated with more internalizing BP among girls but fewer externalizing BPs among boys . Conclusion : Change in overweight status during the first 4 years in school is a significant risk factor for adverse school outcomes among girls but not boys . Girls who become overweight during the early school years and those who start school being overweight and remain that way may need to be monitored carefully IMPORTANCE Many early life risk factors for childhood obesity are more prevalent among blacks and Hispanics than among whites and may explain the higher prevalence of obesity among racial/ethnic minority children . OBJECTIVE To examine the extent to which racial/ethnic disparities in adiposity and overweight are explained by differences in risk factors during pregnancy ( gestational diabetes and depression ) , infancy ( rapid infant weight gain , feeding other than exclusive breastfeeding , and early introduction of solid foods ) , and early childhood ( sleeping < 12 h/d , presence of a television set in the room where the child sleeps , and any intake of sugar-sweetened beverages or fast food ) . DESIGN Prospect i ve prebirth cohort study . SETTING Multisite group practice in Massachusetts . PARTICIPANTS Participants included 1116 mother-child pairs ( 63 % white , 17 % black , and 4 % Hispanic ) EXPOSURE Mother 's report of child 's race/ethnicity . MAIN OUTCOMES AND MEASURES Age- and sex-specific body mass index ( BMI ) z score , total fat mass index from dual-energy x-ray absorptiometry , and overweight or obesity , defined as a BMI in the 85th percentile or higher at age 7 years . RESULTS Black ( 0.48 U [ 95 % CI , 0.31 to 0.64 ] ) and Hispanic ( 0.43 [ 0.12 to 0.74 ] ) children had higher BMI z scores , as well as higher total fat mass index and overweight/obesity prevalence , than white children . After adjustment for socioeconomic confounders and parental BMI , differences in BMI z score were attenuated for black and Hispanic children ( 0.22 U [ 0.05 to 0.40 ] and 0.22 U [ -0.08 to 0.52 ] , respectively ) . Adjustment for pregnancy risk factors did not substantially change these estimates . However , after further adjustment for infancy and childhood risk factors , we observed only minimal differences in BMI z scores between whites , blacks ( 0.07 U [ -0.11 to 0.26 ] ) , and Hispanics ( 0.04 U [ -0.27 to 0.35 ] ) . We observed similar attenuation of racial/ethnic differences in adiposity and prevalence of overweight or obesity . CONCLUSIONS AND RELEVANCE Racial/ethnic disparities in childhood adiposity and obesity are determined by factors operating in infancy and early childhood . Efforts to reduce obesity disparities should focus on preventing early life risk factors Early nutrition in animals affects both behavior and brain structure . In humans , r and omized trials show that early nutrition affects later cognition , notably in males . We hypothesized that early nutrition also influences brain structure , measurable using magnetic resonance imaging . Prior research suggested that the cau date nucleus may be especially vulnerable to early environment and that its size relates to IQ . To test the hypothesis that the cau date nucleus could be a neural substrate for cognitive effects of early nutrition , we compared two groups of adolescents , assigned a St and ard- or High-nutrient diet in the postnatal weeks after preterm birth . Groups had similar birth status and neonatal course . Scans and IQ data were obtained from 76 adolescents and volumes of several subcortical structures were calculated . The High-nutrient group had significantly larger cau date volumes and higher Verbal IQ ( VIQ ) . Cau date volumes correlated significantly with VIQ in the St and ard-nutrient group only . Cau date volume was influenced by early nutrition and related selectively to VIQ in males , but not in females . Our findings may partly explain the effects of early diet on cognition and the predominant effects in males . They are among the first to show that human brain structure can be influenced by early nutrition Determinants of a child 's diet shortly after weaning and lactation have been relatively understudied . The aim of the present study was hence to identify common dietary patterns in toddlers and to explore parental and child indicators of these dietary patterns . OUTPUT:
A healthier dietary pattern was associated with better cognitive outcomes in all studies , although some of the reported associations were weak and the measures used varied across the studies . Conclusions Physical activity and healthy diets in early childhood are associated with better cognitive outcomes in young children .
MS2_dynamic_1_shot454
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: Background and Purpose — A new gait training strategy for patients with stroke seeks to increase walking speed through treadmill training . This study compares the effects of structured speed-dependent treadmill training ( STT ) ( with the use of an interval paradigm to increase the treadmill speed stepwise according to principles of sport physiology ) with limited progressive treadmill training ( LTT ) and conventional gait training ( CGT ) on clinical outcome measures for patients with hemiparesis . Methods — Sixty ambulatory poststroke patients were each r and omly selected to receive 1 of the 3 different gait therapies : 20 subjects were treated with STT , 20 subjects were trained to walk on a treadmill with a 20 % increase of belt speed over the treatment period ( LTT ) , and 20 subjects were treated with CGT . Treatment outcomes were assessed on the basis of overground walking speed , cadence , stride length , and Functional Ambulation Category scores . Results — After a 4-week training period , the STT group scored significantly higher than the LTT and CGT groups for overground walking speed ( STT versus LTT , P < 0.001 ; STT versus CGT , P < 0.001 ) , cadence ( STT versus LTT , P = 0.007 ; STT versus CGT , P < 0.001 ) , stride length ( STT versus LTT , P < 0.001 ; STT versus CGT , P < 0.001 ) , and Functional Ambulation Category scores ( STT versus LTT , P = 0.007 ; STT versus CGT , P < 0.001 ) . Conclusions — Structured STT in poststroke patients result ed in better walking abilities than LTT or CGT . This gait training strategy provides a dynamic and integrative approach for the treatment of gait dysfunction after stroke OBJECTIVE To compare the effects of speed-dependent treadmill training on gait and balance performance in patients with sub-acute stroke . DESIGN Single-blinded r and omized controlled trial . SUBJECTS A total of 26 patients with sub-acute stroke were r and omly assigned to experimental ( n = 13 ) and control ( n = 13 ) groups . METHODS Subjects in the experimental group underwent short interval walking trials with stepwise increases in treadmill speed ( speed-dependent treadmill training ) , following the principles of sprint training . Control subjects received gait training on the treadmill at a steady speed . Gait speed , stride length , cadence , and Berg 's Balance Score were recorded and analysed before and after the 10 training sessions . RESULTS Results of 2-way repeated measures analysis of variance showed significant group × time interactions for gait speed and stride length ( p < 0.05 ) . Within each subject group there were improvements in all gait parameters and Berg ’s Balance Score after the training programme . In addition , the experimental group showed significantly larger increases in gait speed ( mean 0.15 m/s , 95 % confidence interval 0.04–0.26 ) and stride length ( mean 0.16 m , 95 % confidence interval 0.02–0.30 ) than the control subjects . CONCLUSION Speed-dependent treadmill training in patients with sub-acute stroke result ed in larger gains in gait speed and stride length compared with steady speed . The positive findings provide evidence for clinical practice of speed-dependent treadmill training in enhancing gait function after stroke Background — Exercise training reduces the symptoms of chronic heart failure . Which exercise intensity yields maximal beneficial adaptations is controversial . Furthermore , the incidence of chronic heart failure increases with advanced age ; it has been reported that 88 % and 49 % of patients with a first diagnosis of chronic heart failure are > 65 and > 80 years old , respectively . Despite this , most previous studies have excluded patients with an age > 70 years . Our objective was to compare training programs with moderate versus high exercise intensity with regard to variables associated with cardiovascular function and prognosis in patients with postinfa rct ion heart failure . Methods and Results — Twenty-seven patients with stable postinfa rct ion heart failure who were undergoing optimal medical treatment , including & bgr;-blockers and angiotensin-converting enzyme inhibitors ( aged 75.5±11.1 years ; left ventricular [ LV ] ejection fraction 29 % ; & OV0312;o2peak 13 mL · kg−1 · min−1 ) were r and omized to either moderate continuous training ( 70 % of highest measured heart rate , ie , peak heart rate ) or aerobic interval training ( 95 % of peak heart rate ) 3 times per week for 12 weeks or to a control group that received st and ard advice regarding physical activity . & OV0312;o2peak increased more with aerobic interval training than moderate continuous training ( 46 % versus 14 % , P<0.001 ) and was associated with reverse LV remodeling . LV end-diastolic and end-systolic volumes declined with aerobic interval training only , by 18 % and 25 % , respectively ; LV ejection fraction increased 35 % , and pro-brain natriuretic peptide decreased 40 % . Improvement in brachial artery flow-mediated dilation ( endothelial function ) was greater with aerobic interval training , and mitochondrial function in lateral vastus muscle increased with aerobic interval training only . The MacNew global score for quality of life in cardiovascular disease increased in both exercise groups . No changes occurred in the control group . Conclusions — Exercise intensity was an important factor for reversing LV remodeling and improving aerobic capacity , endothelial function , and quality of life in patients with postinfa rct ion heart failure . These findings may have important implication s for exercise training in rehabilitation programs and future studies Low-volume sprint interval training ( SIT ) , or repeated sessions of brief , intense intermittent exercise , elicits metabolic adaptations that resemble traditional high-volume endurance training ( ET ) OUTPUT: Conclusion : High-intensity training is promising as a time-efficient exercise strategy in cardiovascular rehabilitation , but data on endothelial effects in cerebrovascular rehabilitation are warranted . INPUT: Background and Purpose — A new gait training strategy for patients with stroke seeks to increase walking speed through treadmill training . This study compares the effects of structured speed-dependent treadmill training ( STT ) ( with the use of an interval paradigm to increase the treadmill speed stepwise according to principles of sport physiology ) with limited progressive treadmill training ( LTT ) and conventional gait training ( CGT ) on clinical outcome measures for patients with hemiparesis . Methods — Sixty ambulatory poststroke patients were each r and omly selected to receive 1 of the 3 different gait therapies : 20 subjects were treated with STT , 20 subjects were trained to walk on a treadmill with a 20 % increase of belt speed over the treatment period ( LTT ) , and 20 subjects were treated with CGT . Treatment outcomes were assessed on the basis of overground walking speed , cadence , stride length , and Functional Ambulation Category scores . Results — After a 4-week training period , the STT group scored significantly higher than the LTT and CGT groups for overground walking speed ( STT versus LTT , P < 0.001 ; STT versus CGT , P < 0.001 ) , cadence ( STT versus LTT , P = 0.007 ; STT versus CGT , P < 0.001 ) , stride length ( STT versus LTT , P < 0.001 ; STT versus CGT , P < 0.001 ) , and Functional Ambulation Category scores ( STT versus LTT , P = 0.007 ; STT versus CGT , P < 0.001 ) . Conclusions — Structured STT in poststroke patients result ed in better walking abilities than LTT or CGT . This gait training strategy provides a dynamic and integrative approach for the treatment of gait dysfunction after stroke Background and Purpose — This study compared the psychometric properties of 3 clinical balance measures , the Berg Balance Scale ( BBS ) , the Balance subscale of the Fugl-Meyer test ( FM-B ) , and the Postural Assessment Scale for Stroke Patients ( PASS ) , in stroke patients with a broad range of neurological and functional impairment from the acute stage up to 180 days after onset . Methods — One hundred twenty-three stroke patients were followed up prospect ively with the 3 balance measures 14 , 30 , 90 , and 180 days after stroke onset ( DAS ) . Reliability ( interrater reliability and internal consistency ) and validity ( concurrent validity , convergent validity , and predictive validity ) of each measure were examined . A comparison of the responsiveness of each of the 3 measures was made on the basis of the entire group of patients and 3 separate groups classified by degree of neurological severity . Results — The FM-B and BBS showed a significant floor or ceiling effect at some DAS points , whereas the PASS did not show these effects . The BBS , FM-B , and PASS all had good reliability and validity for patients at different recovery stages after stroke . The results of effect size demonstrated fair to good responsiveness of all 3 measures within the first 90 DAS but , as expected , only a low level of responsiveness at 90 to 180 DAS . The PASS was more responsive to changes in severe stroke patients at the earliest period after stroke onset , 14 to 30 DAS . Conclusions — All 3 measures tested showed very acceptable levels of reliability , validity , and responsiveness for both clinicians and research ers . The PASS showed slightly better psychometric characteristics than the other 2 measures OBJECTIVE To evaluate the effectiveness of a treadmill and overground walking program in reducing the disability and h and icap associated with poor walking performance after stroke . DESIGN R and omized , placebo-controlled clinical trial with a 3-month follow-up . SETTING General community . PARTICIPANTS A volunteer sample of 29 ambulatory individuals ( less 2 dropouts ) who were living in the community after having suffered a stroke more than 6 months previously . INTERVENTIONS The experimental group participated in a 30-minute treadmill and overground walking program , 3 times a week for 4 weeks . The control group received a placebo consisting of a low-intensity , home exercise program and regular telephone contact . MAIN OUTCOME MEASURES Walking speed ( over 10 m ) , walking capacity ( distance over 6 min ) , and h and icap ( stroke-adapted 30-item version of the Sickness Impact Profile ) measured by a blinded assessor . RESULTS The 4-week treadmill and overground walking program significantly increased walking speed ( P=.02 ) and walking capacity ( P<.001 ) , but did not decrease h and icap ( P=.85 ) compared with the placebo program . These gains were largely maintained 3 months after the cessation of training ( P</=.05 ) . CONCLUSIONS The treadmill and overground walking program was effective in improving walking in persons residing in the community after stroke . This suggests that the routine provision of accessible , long-term , community-based walking programs would be beneficial in reducing disability after stroke The purpose of this study was to compare the effects of a task-oriented exercise program with and without altered sensory input on postural stability in subjects with stroke . Sixteen hemiparetic subjects , at least 6 months post-stroke , were r and omly assigned to the experimental or control group , and participated in an 8-week task-oriented exercise program focusing on balance and mobility exercises . Exercises were performed under normal conditions by the control group , and under conditions of vision and surface manipulation by the experimental group . Pre- and post-test assessment s involved the measurement of the center of pressure ( COP ) displacement during double-legged stance and sit-to-st and under four sensory conditions : ( 1 ) eyes open , normal surface ; ( 2 ) eyes open , soft surface ; ( 3 ) eyes closed , normal surface ; and ( 4 ) eyes closed , soft surface , as well as the 10-m walking test . Results showed significant improvements ( P<0.05 ) in COP displacement under sensory conditions ( 1 ) and ( OUTPUT:
Nonsignificant summary effect sizes in favor of task-oriented circuit class training were found for the step test and balance control . This meta- analysis supports the use of task-oriented circuit class training to improve gait and gait-related activities in patients with chronic stroke .
MS2_dynamic_1_shot455
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: Background The existing literature on weight management interventions targeting physical activity and healthy eating in mental health care appears to provide only limited evidence . The aim of the study was to examine the effectiveness of a 10-week health promotion intervention , followed by a 6-month follow-up period in individuals with mental disorders living in sheltered housing in the Fl and ers region ( Belgium ) . Methods The study had a cluster preference r and omized controlled design . Twenty-five sheltered housing organisations agreed to participate ( 16 in the intervention group , nine in the control group ) . In the intervention group , 225 individuals agreed to participate , while in the control group 99 individuals entered into the study . The main outcomes were changes in body weight , Body Mass Index , waist circumference and fat mass . Secondary outcomes consisted of changes in physical activity levels , eating habits , health-related quality of life and psychiatric symptom severity . Results A significant difference was found between the intervention group and the control group regarding body weight ( −0.35 vs. + 0.22 kg ; p=0.04 ) , Body Mass Index ( −0.12 vs. + 0.08 kg/m2 ; p=0.04 ) , waist circumference ( −0.29 vs. + 0.55 cm ; p<0.01 ) , and fat mass ( −0.99 vs. −0.12 % ; p<0.01 ) . The decrease in these outcomes in the intervention group disappeared during the follow up period , except for fat mass . Within the intervention group , a larger decrease in the primary outcomes was found in the participants who completed the intervention . No significant differences between the two groups in changes in the secondary outcomes were found , except for the pedometer-determined steps/day . In the intervention group , the mean number of daily steps increased , while it decreased in the control group . Conclusions The study demonstrated that small significant improvements in the primary outcomes are possible in individuals with mental disorders . Integration of health promotion activities targeting physical activity and healthy eating into daily care are , however , necessary to maintain the promising results .Trial registration This study is registered at Clinical Trials.gov BACKGROUND : Persons with schizophrenia spectrum disorders ( SSDs ) contend with multiple barriers to exercise . Interventions are needed to enhance attitudes theoretically linked to exercise behavior . OBJECTIVE : To examine the effect of Walk , Address Sensations , Learn About Exercise , Cue Exercise for SSDs ( WALC-S ) intervention on exercise self-efficacy ( SEE ) and outcome expectations ( OEES ) in 97 out patients with SSDs . DESIGN : Experimental , pre- and posttest . R and omization to experimental ( WALC-S ) or time- and -attention control ( TAC ) after baseline SEE and OEES measures . Measures repeated after WALC-S or TAC . RESULTS : N = 97 , 46 % female , 43 % African American , average age 46.9 years ( SD = 2.0 ) . Mean SEE scores were significantly higher in WALC-S participants after intervention , F(1 , 95 ) = 5.92 , p = .0168 , however , mean OEES scores were significantly higher in control participants after intervention , F(1 , 95 ) = 5.76 , p = .0183 . CONCLUSION : This is the first study to examine SEE and OEES in SSDs . Interventions to enhance exercise attitudes are a critical first step toward the ultimate goal of increasing exercise participation Objective To investigate the effectiveness of facilitated physical activity as an adjunctive treatment for adults with depression presenting in primary care . Design Pragmatic , multicentre , two arm parallel r and omised controlled trial . Setting General practice s in Bristol and Exeter . Participants 361 adults aged 18 - 69 who had recently consulted their general practitioner with symptoms of depression . All those r and omised had a diagnosis of an episode of depression as assessed by the clinical interview schedule-revised and a Beck depression inventory score of 14 or more . Interventions In addition to usual care , intervention participants were offered up to three face to face sessions and 10 telephone calls with a trained physical activity facilitator over eight months . The intervention was based on theory and aim ed to provide individually tailored support and encouragement to engage in physical activity . Main outcome measures The primary outcome was self reported symptoms of depression , assessed with the Beck depression inventory at four months post-r and omisation . Secondary outcomes included use of antidepressants and physical activity at the four , eight , and 12 month follow-up points , and symptoms of depression at eight and 12 month follow-up . Results There was no evidence that participants offered the physical activity intervention reported improvement in mood by the four month follow-up point compared with those in the usual care group ; adjusted between group difference in mean Beck depression inventory score −0.54 ( 95 % confidence interval −3.06 to 1.99 ; P=0.68 ) . Similarly , there was no evidence that the intervention group reported a change in mood by the eight and 12 month follow-up points . Nor was there evidence that the intervention reduced antidepressant use compared with usual care ( adjusted odds ratio 0.63 , 95 % confidence interval 0.19 to 2.06 ; P=0.44 ) over the duration of the trial . However , participants allocated to the intervention group reported more physical activity during the follow-up period than those allocated to the usual care group ( adjusted odds ratio 2.27 , 95 % confidence interval 1.32 to 3.89 ; P=0.003 ) . Conclusions The addition of a facilitated physical activity intervention to usual care did not improve depression outcome or reduce use of antidepressants compared with usual care alone . Trial registration Current Controlled Trials IS RCT N16900744 BACKGROUND Overweight and obesity are epidemic among persons with serious mental illness , yet weight-loss trials systematic ally exclude this vulnerable population . Lifestyle interventions require OUTPUT: The present results indicate preliminary evidence of how the motivational processes do not differ between individuals with SMI and the general population , and that they are independent of diagnosis , medication , age , gender , and body mass index . Results from the current systematic review can give some tentative guidance on how to facilitate motivation for physical activity within mental health-care . INPUT: Objective : Overweight and obesity are epidemic in population s with serious mental illnesses . We developed and pilot-tested a behavioral weight-loss intervention appropriately tailored for persons with serious mental disorders . Methods : We conducted a single-arm pilot study in two psychiatric rehabilitation day programs in Maryl and , and enrolled 63 overweight or obese adults . The 6-month intervention provided group and individual weight management and group physical activity classes . The primary outcome was weight change from baseline to 6 months . Results : A total of 64 % of those potentially eligible enrolled at the centers . The mean age was 43.7 years ; 56 % were women ; 49 % were white ; and over half had schizophrenia or a schizoaffective disorder . One-third had hypertension and one-fifth had diabetes . In total , 52 ( 82 % ) completed the study ; others were discharged from psychiatric centers before completion of the study . Average attendance across all weight management sessions was 70 % ( 87 % on days participants attended the center ) and 59 % for physical activity classes ( 74 % on days participants attended the center ) . From a baseline mean of 210.9 lbs ( s.d . 43.9 ) , average weight loss for 52 participants was 4.5 lb ( s.d . 12.8 ) ( P<0.014 ) . On average , participants lost 1.9 % of body weight . Mean waist circumference change was 3.1 cm ( s.d . 5.6 ) . Participants on average increased the distance on the 6-minute walk test by 8 % . Conclusion : This pilot study documents the feasibility and preliminary efficacy of a behavioral weight-loss intervention in adults with serious mental illness who were attendees at psychiatric rehabilitation centers . The results may have implication s for developing weight-loss interventions in other institutional setting s such as schools or nursing homes The 6-minute walk test is used in clinical practice and clinical trials of lung diseases ; however , it is not clear whether replicate tests need to be performed to assess performance . Furthermore , little is known about the impact of walking course layout on test performance . We conducted 6-minute walks on 761 patients with severe emphysema ( mean + /- SD FEV1 % predicted = 26.3 + /- 7.2 ) who were participants in the National Emphysema Treatment Trial . Four hundred seventy participants had repeated walks on a separate day . The second test was improved by an average of 7.0 + /- 15.2 % ( 66.1 + /- 146 feet , p < 0.0001 , by paired t test ) , with an intraclass correlation coefficient of 0.88 between days . The course layout had an effect on the distance walked . Participants tested on continuous ( circular or oval ) courses had a 92.2-foot longer walking distance than those tested on straight ( out and back ) courses . Course length had no significant effect on walking distance . The training effect found in these patients with severe emphysema is less than in previous reports of patients with chronic obstructive pulmonary disease . Furthermore , the layout of the track may influence the 6-minute walk performance Background : Patients with schizophrenia have a high risk of cardiovascular disease ( CVD ) . High aerobic intensity training ( HIT ) improve peak oxygen uptake ( VO2peak ) , net mechanical efficiency of walking and risk factors for CVD but has not been investigated in patients with schizophrenia . Aims : To investigate effects from HIT on VO2peak , net mechanical efficiency of walking and risk factors for CVD in patients with schizophrenia . Methods : 25 in patients ( F20–29 , ICD-10 ) were allocated to either HIT or playing computer games ( CG ) , 3 days per week for 8 weeks . HIT consisted of 4 × 4-min intervals with 3-min break periods , at 85–95 % and 70 % of peak heart rate , respectively . Results : 12 and seven patients completed HIT and CG , respectively . The baseline VO2peak in both groups combined ( n = 19 ) was 36.8 ± 8.2 ml/kg/min and 3.12 ± 0.55 l/min . The HIT group improved VO2peak by 12 % from 3.17 ± 0.59 to 3.56 ± 0.68 l/min ( P < 0.001 ) , more than the CG group ( P = 0.014 ) . Net mechanical efficiency of walking improved by 12 % in the HIT group from 19.8 ± 3.0 % to 22.2 ± 4.5 % ( P = 0.005 ) , more than the CG group ( P = 0.031 ) . The psychiatric symptoms , expressed as the Positive and Negative Syndrome Scale ( PANSS ) and the Calgary Depression Scale for Schizophrenia ( CDSS ) , did not improve in either group . Conclusions : VO2peak and net mechanical efficiency of walking improved significantly by 8 weeks of HIT . HIT should be included in rehabilitation in order to improve physical capacity and contribute risk reduction of CVD Background Weight gain is common for people with schizophrenia and this has serious implication s for health and well being . Objectives To determine the effects of both pharmacological ( excluding medication switching ) and non pharmacological strategies for reducing or preventing weight gain in people with schizophrenia . Search methods We search ed key data bases and the Cochrane Schizophrenia Group 's trials register ( April 2006 ) , reference sections within relevant papers , h and search ed key journals , and contacted the first author of each relevant study and other experts to collect further information . Selection criteria We included all clinical r and omised controlled trials comparing any pharmacological or non pharmacological intervention for weight gain ( diet and exercise counselling ) with st and ard care OUTPUT:
The 6MWD is usually negatively associated with a higher Body Mass Index , increased cigarette consumption , higher doses of antipsychotic medication and lower physical self-worth in individuals with schizophrenia . The 6MWT demonstrates high reliability . IMPLICATION S FOR REHABILITATION The Six-Minute Walk Test reliably assesses the functional exercise capacity in patients with schizophrenia . The impact of therapeutic interventions on patients , as measured by the 6MWT , can not be confirmed .
MS2_dynamic_1_shot456
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: BACKGROUND Few weight loss surgery trials have evaluated the changes in health-related quality of life ( HRQOL ) relative to obese individuals not participating in weight loss interventions . In a prospect i ve study at a bariatric surgery practice , we evaluated the 2-year changes in HRQOL in gastric bypass patients compared with 2 severely obese groups who did not undergo surgical weight loss . METHODS A total of 308 gastric bypass patients were compared with 253 individuals who sought but did not undergo gastric bypass and 272 population -based obese individuals using the weight-related ( Impact of Weight on Quality of Life-Lite ) and general ( Medical Outcomes Study 36-item Short-Form Health Survey ) HRQOL question naires at baseline and 2 years of follow-up . RESULTS The percentage of weight loss was 34.2 % for the gastric bypass and 1.4 % for the no gastric bypass groups , with a .5 % gain for population -based obese group . Both measures of HRQOL showed greater improvements for the gastric bypass group , even after controlling for baseline differences . Effect sizes for changes in physical and weight-related HRQOL were very large for gastric bypass , but small to medium for the 2 comparison groups . Effect sizes for changes in the psychosocial aspects of HRQOL were moderate to very large for gastric bypass , but small for the 2 comparison groups . Of the gastric bypass patients , 97 % had meaningful improvements in the Impact of Weight on Quality of Life-Lite total score compared with 43 % of the no gastric bypass group and 30 % of the population -based obese group . CONCLUSION Dramatic improvements had occurred in weight-related and physical HRQOL for gastric bypass patients at 2 years after surgery compared with 2 severely obese groups who had not undergone surgery . These results support the effectiveness of gastric bypass surgery in improving patients ' HRQOL OBJECTIVES To prospect ively examine whether changes in smoking , heavy alcohol consumption , sedentary lifestyle , and obesity are associated with the risk of erectile dysfunction . METHODS Data were collected as part of a cohort study of a r and om sample of men 40 to 70 years old , selected from street listings in the Boston Metropolitan Area , Massachusetts . In-home interviews were completed by 1709 men at baseline in 1987 to 1989 and 1156 men at follow-up in 1995 to 1997 ( average follow-up 8.8 years ) . Analyses included 593 men without erectile dysfunction at baseline , who were free of prostate cancer , and had not been treated for heart disease or diabetes . The incidence of moderate to complete erectile dysfunction was determined by discriminant analysis of responses to a self-administered sexual function question naire . RESULTS Obesity status was associated with erectile dysfunction ( P = 0.006 ) , with baseline obesity predicting a higher risk regardless of follow-up weight loss . Physical activity status was associated with erectile dysfunction ( P = 0.01 ) , with the highest risk among men who remained sedentary and the lowest among those who remained active or initiated physical activity . Changes in smoking and alcohol consumption were not associated with the incidence of erectile dysfunction ( P > 0.3 ) . CONCLUSIONS Midlife changes may be too late to reverse the effects of smoking , obesity , and alcohol consumption on erectile dysfunction . In contrast , physical activity may reduce the risk of erectile dysfunction even if initiated in midlife . Early adoption of healthy lifestyles may be the best approach to reducing the burden of erectile dysfunction on the health and well-being of older men Objective and Participants : The authors examined cognitive and affective dimensions of body image of a r and omized sample of 188 college men on the basis of body mass index ( BMI ) . Methods : They conducted chi-square tests and ANOVAs to determine differences between 4 BMI groups ( underweight , normal weight , overweight , and obese ) on demographics and body image measures . Results : The authors found significant differences in regard to total body image ( p < .001 ) , weight or shape concern ( p < .001 ) , and body dissatisfaction ( p < .001 ) . BMI was significantly correlated with negative body image . Overweight and obese participants reported significantly higher levels of negative body image than did normal- and underweight participants . Overweight participants reported significantly higher weight and shape concerns than did underweight , normal-weight , and obese participants . In regard to body dissatisfaction , underweight , overweight , and obese participants reported significantly higher levels of body dissatisfaction than that reported by normal-weight participants . Conclusions : BMI may be an important factor in identifying potential body image disorders in college-aged men INTRODUCTION Weight loss in sexually active women improves their quality of life . At present , no studies have investigated whether weight loss may affect female sexual function in severe obese women . AIM The aim of this study was to investigate the effects of different programs of weight loss on female sexual dysfunction complaints and on endothelial function in premenopausal obese females . METHODS Forty-four out of overall 80 obese fertile women ( age 18 - 49 years ; mean 36 years ) were enrolled because of sexual complaints at Female Sexual Function Index-6 ( FSFI-6 score ≤19 ) . Patients were then allocated to different treatments of 8 weeks duration each : an intensive residential program with hypocaloric diet plus controlled physical exercise along with lifestyle modifications at a specialized clinic ( Group A , N = 23 ) and a non-intensive outpatient clinic program consisting of hypocaloric diet and physical exercise at home ( Group B , N = 21 ) . Afterward , overall patients were allocated to an extended 8-week follow-up period consisting of outpatient clinic controlled diet plus physical exercise at home . MA OUTPUT: Research demonstrates an association between obesity , mental health , and sexual functioning , but has failed to identify casual pathways between these conditions . INPUT: BACKGROUND We analyzed the health-related quality of life ( HRQOL ) and its determinants in the first year after laparoscopic adjustable gastric b and ing ( LAGB ) . The setting was 10 Italian public and private bariatric surgery centers . METHODS Data collected in an ongoing , prospect i ve , 3-year multicenter Italian study on the changes in HRQOL after LAGB were used . HRQOL was investigated using the Medical Outcomes Study Short-Form 36 question naire . Hunger , satiety , and the self-perceived effects of LAGB were recorded . RESULTS A total of 334 patients were enrolled . The follow-up rate was 92.2 % . The percentage of excess weight loss was 39.6 % ± 25.8 % , with very few side effects or complications . Hunger in the morning ( 0 - 10 scale ) was 4.5 ± 2.7 before surgery and 3.8 ± 2.4 after 1 year ( P < .001 ) . Satiety after a meal ( 0 - 10 scale ) was 7.1 ± 2.7 before surgery and 8.2 ± 1.9 at 1 year ( P < .001 ) . The self-perceived effect of LAGB on caloric intake ( 0 - 10 scale ) was 8.4 ± 1.9 after 1 year . The scores for the 8 Medical Outcomes Study Short-Form 36 subscales were significantly improved after surgery . The physical component summary score was 52.6 ± 11.9 at baseline and 79.1 ± 15.6 after 1 year ( P < .001 ) . The corresponding mental component summary scores were 52.2 ± 12.3 and 76.5 ± 17.2 ( P < .001 ) . Greater physical component summary improvement was independently associated with a low initial physical component summary ( P < .001 ) , high satiety ( P = .002 ) , a high percentage of excess weight loss ( P = .013 ) , and a high self-perceived effect of the LAGB ( P = .026 ) . Greater mental component summary improvement was associated with a low initial mental component summary ( P < .001 ) , high satiety ( P < .001 ) , a low frequency of heartburn ( P = .004 ) , and a high percentage of excess weight loss ( P = .012 ) . CONCLUSIONS Significant improvements in HRQOL were observed in the first year after LAGB . A poor baseline HRQOL , a high efficacy of the b and ing in eating control , and better weight loss might influence HRQOL changes BACKGROUND Improvements in health-related quality of life ( HR-QoL ) occur after bariatric surgery . However , sustainability of these changes over time remains debated . METHODS Data collected in a prospect i ve 3-year multicenter Italian study on changes of HR-QoL after laparoscopic adjustable gastric b and ing were used . HR-QoL has investigated with the SF-36 question naire . Hunger , satiety , and the self-perceived effects of LAGB were recorded . RESULTS A total of 230 patients ( 53 male and 177 female ) were analyzed . Body mass index was 41.4±5.4 kg/m2 at baseline , declined to 33.8±5.8 kg/m2 12 months after surgery ( P<.001 ) , and further reduced to 31.9±5.1 kg/m2 36 months after surgery ( P<.001 versus 12 months ) . Scores in the SF-36 subscales were lower than in the general Italian population at baseline . The physical component summary score was 51.9±11.6 at baseline , improved to 79.2±15.4 at 12 months ( P<.001 ) , and stabilized to 79.8±15.6 at 36 months . The mental summary score was 52.3±11.8 at baseline , improved to 75.2±17.3 at 12 months ( P<.001 ) , and stabilized to 74.2±17.5 at 36 months . A decline>10 points between 12 and 36 months in the summary scores was observed in 22.0 % of the patients for PCS and in 26.8 % for MCS . In a multiple linear regression analysis , deterioration in HR-QoL in the 12 - 36 months period was associated to the presence of better HR-QoL values at 12 months and to a more pronounced reduction of the self-perceived effect of the b and ing at 36 months . CONCLUSION Improvements in HR-QoL observed in the first year after surgery maintained up to the third year after gastric b and ing BACKGROUND Being overweight or obese has substantial effects on individuals ' perceptions of their health and quality of life ( QoL ) . Generic measures often miss important QoL information , and existing obesity-specific instruments have shortcomings with respect to cross-cultural input , application to differing levels of severity , conceptual clarity , and patient burden . OBJECTIVE This study aim ed to develop culturally sensitive measures of QoL and symptoms in overweight or obese persons , both those trying to lose weight and those not trying to lose weight . METHODS Currently accepted criteria and guidelines for question naire development were streamlined and augmented to include cross-cultural input from 5 European countries and the United States . The preliminary pool of items was created based on qualitative interviews conducted in the United States , followed by an early check of item translatability and preharmonization across all language s. Ten additional qualitative in-country interviews were then conducted to produce further culture-specific items . This was followed by 2 forward and 1 backward translation , plus cognitive debriefing interviews in each country OUTPUT:
Only outcomes of the IWQoL , SF-36 and OWQoL show QoL outcomes that exceed community norms . The QoL is increased after bariatric surgery on both the short and long term . However , due to the heterogeneity of the studies and the generality of the question naires is it hard to make a distinction between different surgeries and difficult to see a relation with medical profit .
MS2_dynamic_1_shot457
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: Auricular acupuncture can be an effective treatment for acute anxiety , but there is a lack of direct comparisons of acupuncture to proven st and ard drug treatments . In this study we compared the efficacy of auricular acupuncture with intranasal midazolam , placebo acupuncture , and no treatment for reducing dental anxiety . Patients having dental extraction s ( n = 67 ) were r and omized to ( i ) auricular acupuncture , ( ii ) placebo acupuncture , and ( iii ) intranasal midazolam and compared with a no treatment group . Anxiety was assessed before the interventions , at 30 min , and after the dental extraction . Physiological variables were assessed continuously . With the no treatment group as control , the auricular acupuncture group , and the midazolam group were significantly less anxious at 30 min as compared with patients in the placebo acupuncture group ( Spielberger Stait-Trait Anxiety Inventory X1 , P = 0.012 and < 0.001 , respectively ) . In addition , patient compliance assessed by the dentist was significantly improved if auricular acupuncture or application of intranasal midazolam had been performed ( P = 0.032 and 0.049 , respectively ) . In conclusion , both , auricular acupuncture and intranasal midazolam were similarly effective for the treatment of dental anxiety Acupuncture is one of the most widely used and broadly research ed of the complementary and alternative therapies , but high- quality trials generally show no benefit over sham acupuncture . Many would view this result as evidence of ineffectiveness for this intervention . This discussion article focuses on the report of a large multicenter r and omized controlled trial of acupuncture for chronic low-back pain ( CLBP ) in the lay and academic press , the ensuing discussion , and its impact on both clinical practice and service provision . The authors suggest that interpretive bias has affected reporting , leading to question able conclusions and advocacy in favor of this form of care that may exceed the evidence . They also suggest that a lack of underst and ing of research into the placebo effect may have contributed to confusion in the interpretation of these trials Background : Auricular acupuncture is a promising method for postoperative pain relief . However , there is no evidence for its use after ambulatory surgery . Our aim was to test whether auricular acupuncture is better than invasive needle control for complementary analgesia after ambulatory knee surgery . Methods : One hundred and twenty patients undergoing ambulatory arthroscopic knee surgery under st and ardized general anesthesia were r and omly assigned to receive auricular acupuncture or a control procedure . Fixed indwelling acupuncture needles were inserted before surgery and retained in situ until the following morning . Postoperative rescue analgesia was directed to achieve pain intensity less than 40 mm on a 100-mm visual analogue scale . The primary outcome measure was the postoperative requirement for ibuprofen between surgery and examination the following morning . Results : Intention-to-treat analysis showed that patients from the control group ( n = 59 ) required more ibuprofen than patients from the auricular acupuncture group ( n = 61 ) : median ( interquartile range ) 600 ( 200–800 ) v. 200 ( 0–600 ) mg ( p = 0.012 ) . Pain intensity on a visual analogue scale was similar in both groups at all time points registered . The majority of patients in both groups believed that they had received true acupuncture and wanted to repeat it in future . Interpretation : Auricular acupuncture reduced the requirement for ibuprofen after ambulatory knee surgery relative to an invasive needle control procedure In alternative health care iridology is used as a diagnostic aid . The diagnosis of gall bladder disease was used to study its validity and interperformer consistency . The presence of an inflamed gall bladder containing gall stones is said to be easily recognised by certain signs in the lower lateral part of the iris of the right eye . Stereo colour slides were made of the right eye . Stereo colour slides were made of the right eye of 39 patients with this disease and 39 control subjects of the same sex and age . The slides were presented in a r and om order to five leading iridologists without supplementary information . The prevalence of the disease was estimated at 56 % . The median validity was 51 % with 54 % sensitivity and 52 % specificity . These results were close to chance validity ( iota = 0.03 ) . None of the iridologists reached a high validity . The median interperformer consistency was 60 % . This was only slightly higher than chance consistency ( kappa = 0.18 ) . This study showed that iridology is not a useful diagnostic aid OBJECTIVES Reflexology is an increasingly popular complementary therapy in which parts of the body are deemed to be represented on the soles of the feet . The aim of this study was to investigate whether this representation can be used as a valid method of diagnosis . METHODS Three experienced reflexologists took part in this study . Eighteen adults with one or more of six specified conditions were identified from primary care records . Two reflexologists , who were blinded to the patients ' conditions and monitored , then examined each patient 's feet and rated the probability that each of the six conditions was present . RESULTS There is little evidence that the distribution of ratings vary with the status of the condition . Receiver operating curves suggest that this diagnostic method is very poor at distinguishing between the presence and absence of conditions . Inter-rater reliability ( kappa ) scores were very low , providing no evidence of agreement between the examiners . CONCLUSION Despite certain limitations to the data provided by this study , the results do not suggest that reflexology techniques are a valid method of diagnosis Iridology is an analysis of health based on examination of the iris of the eye . One hundred forty-three patients had photographs taken of both eyes . Nine-five patients were free of kidney disease , defined as a creatinine level of less than 1.2 mg/dL ( mean OUTPUT: Where this is the case , it is suggested that subjecting these therapies to empirical evaluation may be tantamount to evaluating the absurd INPUT: OBJECTIVE Administration of placebo can result in a clinical response indistinguishable from that seen with active antidepressant treatment . Functional brain correlates of this phenomenon have not been fully characterized . METHOD Changes in brain glucose metabolism were measured by using positron emission tomography in hospitalized men with unipolar depression who were administered placebo as part of an inpatient imaging study of fluoxetine . Common and unique response effects to administration of placebo or fluoxetine were assessed after a 6-week , double-blind trial . RESULTS Placebo response was associated with regional metabolic increases involving the prefrontal , anterior cingulate , premotor , parietal , posterior insula , and posterior cingulate and metabolic decreases involving the subgenual cingulate , parahippocampus , and thalamus . Regions of change overlapped those seen in responders administered active fluoxetine . Fluoxetine response , however , was associated with additional subcortical and limbic changes in the brainstem , striatum , anterior insula , and hippocampus , sources of efferent input to the response-specific regions identified with both agents . CONCLUSIONS The common pattern of cortical glucose metabolism increases and limbic-paralimbic metabolism decreases in placebo and fluoxetine responders suggests that facilitation of these changes may be necessary for depression remission , regardless of treatment modality . Clinical improvement in the group receiving placebo as part of an inpatient study is consistent with the well-recognized effect that altering the therapeutic environment may significantly contribute to reducing clinical symptoms . The additional subcortical and limbic metabolism decreases seen uniquely in fluoxetine responders may convey additional advantage in maintaining long-term clinical response and in relapse prevention OBJECTIVE For decades , lithium has been prescribed to treat bipolar disorder . Its efficacy has been documented by clinical trials and by data from specialized clinics . An issue of considerable interest is the use of lithium in managed care systems . This project examined the use of lithium and its continuity of use by enrollees of a health maintenance organization ( HMO ) . METHOD In a 6-year longitudinal cohort study , 1,594 lithium users aged 15 years and older who were enrolled in an HMO were followed from 1986 - 1991 . Data were obtained from automated data bases and from medical record review of a r and om 5 % sub sample of the group ( N = 74 ) . RESULTS Bipolar disorder was the most frequent morbidity treated . Eighty-four percent ( N = 62 or 74 ) received services from a psychiatrist . Annual prevalence of lithium use increased over the 6-year period from 1.4 to 2.3 persons per thous and HMO members . Duration of use varied widely with some long-term but many short-term users . Discontinuation of treatment was associated with evaluated rates of psychiatric hospitalization and use of psychiatric emergency services . Lithium users were much more likely to receive a variety of other psychotropic drugs than nonusers of the same sex and age . CONCLUSIONS Lithium use in this population was more often sporadic than continuous . Discontinuation of lithium was associated with psychiatric hospitalization . If lithium is to be a cost-effective treatment for bipolar disorder , managed care systems will need to improve adherence to drug treatment regimens Maintenance studies in bipolar disorder have received increased attention in recent years . The interest is driven by apparent contradictions between results of early placebo-controlled trials of lithium and recent open studies , as well as interest in a new group of drugs with mood-stabilizing properties . The multiple outcome indices that require attention in prophylactic bipolar disorder studies add a dimension not present in acute studies of bipolar disorder . We present the methodology of a recently completed r and omized , double-blind , placebo-controlled , parallel-group comparison of divalproex and lithium . We examine the consequences of salient design features , along with their implication s for future studies . A fundamental conclusion is that such maintenance studies should be design ed and executed to emphasize enrollment of patients with relatively active , severe forms of the illness . This goal is not achieved simply , as inherent features of long-term , placebo-controlled studies drive recruitment and enrollment in the direction of patients with milder forms of bipolar disorder . Attention to the frequency of both manic and depressive episodes and the severity of an index manic episode may aid in the selection of patients most suitable for studies design ed to achieve adequate statistical power OBJECTIVE The primary intent of this study was to compare the efficacy and safety of olanzapine and placebo in the treatment of acute mania . METHOD The design involved a r and om-assignment , double-blind , placebo-controlled parallel group study of 3 weeks ' duration . After a 2- to 4-day screening period , qualified patients were assigned to either olanzapine ( N = 70 ) or placebo ( N = 69 ) . Patients began double-blind therapy with either olanzapine , 10 mg , or placebo given once per day . After the first day of treatment , the daily dose could be adjusted upward or downward , as clinical ly indicated , by one capsule ( olanzapine , 5 mg/day ) within the allowed range of one to four capsules . The primary efficacy measure in the protocol was defined as a change from baseline to endpoint in total score on the Young Mania Rating Scale . Clinical response was defined a priori as a decrease of 50 % or more from baseline in Young Mania Rating Scale total score . RESULTS The olanzapine group experienced significantly greater mean improvement in Young Mania Rating Scale total score than the placebo group . On the basis of the clinical response criteria , significantly more olanzapine-treated patients ( 48.6 % ) responded than those assigned to placebo ( 24.2 % ) . Somnolence , dizziness , dry mouth , and weight gain occurred significantly more often with olanzapine . OUTPUT:
Placebo response in bipolar disorder trials is more likely to occur in patients who are mildly ill , bipolar II , mixed-episode , first-episode , rapid cycling , atypical , non-psychotic , substance abusers and medically ill . The use of concomitant medication such as benzodiazepines , a high frequency of visits , a high number of treatment groups and sites , fixed-dose design s , and the concomitant use of psychotherapy are likely to increase placebo response . There are a number of clinical and method ological variables that are associated with placebo response
MS2_dynamic_1_shot458
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: This paper reports the results of a cross-sectional study of the association between nutritional , environmental and socio-demographic factors , and malaria occurrence among 445 children under 5 years of age in a Sudanese rural community . The overall frequency of malaria as defined by a history of clinical illness during the previous 2 months was 27 % . Malaria occurrence was positively associated with the degree of malnutrition as assessed by weight-for-age . The age-adjusted odds ratio for mild malnutrition and history of malaria was 1.2 ( 95 % confidence interval ( CI ) : 0.7 - 2.0 ) and for moderate malnutrition and malaria was 2.1 ( 95 % CI : 1.1 - 4.0 ) . Malaria was less frequent among children 0 - 11 months of age relative to older children ( OR = 0.4 ; 95 % CI:0.2 - 0.7 ) , and was inversely associated with ownership of a refrigerator ( OR = 0.5 ; 95 % CI:0.36 - 0.94 ) , an indicator of socio-economic status . Indicators of crowding were the best predictors of the risk of malaria . Less malaria was observed in households with three or more rooms ( OR = 0.6 ; 95 % CI:0.37 - 0.98 ) and more malaria was observed in households with more than five people ( OR = 2.5 ; 95 % CI:1.4 - 4.5 ) . Malaria was slightly , but not significantly , more frequent among boys and was associated with anaemia , which was probably an outcome of malaria in the past . These data suggest that undernutrition may increase the risk of malaria , and draw attention to the importance of socio-economic and environmental factors in relation to this disease . These relationships deserve further examination in prospect i ve follow-up studies that are better able to evaluate the temporal relations of malnutrition and malaria OBJECTIVE Our study in Port Harcourt children with asymptomatic malaria aim ed at assessing the baseline anthropometric indices of nutritional status , and whether their nutritional status ( especially under nutrition ) offers any advantage for living in malaria endemic areas . DESIGN Cross-sectional study was used . SETTING Rumueme Community in Port Harcourt , Nigeria . SUBJECTS Apparently healthy children aged 1 - 8 years of both sexes ( Boys = 117 , Girls = 123 ; Ratio 1:1.05 ) , 240 children from r and omly selected households within the study community participated in the study . RESULTS Of the 240 children , 66 ( 27.5 % ) were infected with malaria ( P falciparum ) . Children below 5 years had a higher parasitaemic rate ( 36.36 % ) than those in 5 - 8 years group ( 21.27 % ) . Our baseline data showed that 17.5 % were underweight ( WFA Z < -2 ) , 3.75 % were stunted ( HFA Z < -2 ) and 22.5 % were wasting ( WFH Z < -2 ) . Children who are underweight were found to be at higher risk of acquiring malaria infection than the well nourished children ( RR = 1.02 , chi2 = 0.320 , p < 0.02 , 95 % CI 0.34 - 2.37 ) . Under nutrition was more prominent in the children below 5 years than the older children ( RR = 3.625 , chi2 = 10.36 , p < 0.006 , 95 % CI 1.81 - 5.43 ) . The haemoglobin value of parasitized children ( 10.8 + /- 1.9 g/dl ) was significantly lower than the non-parasitized group ( 11.3 + /- 1.7 g/dl , ) ( p < 0.01 ) . CONCLUSION We concluded that the presence of under nutrition places children ( especially below 5 years of age ) at higher risk of malaria related morbidity . Children in malaria endemic areas need adequate nutrition to withst and the negative impact of malaria Background Malaria is preventable and treatable when recommended interventions are properly implemented . Thus , diagnosis and treatment focus on symptomatic individuals while asymptomatic Plasmodium infection ( PI ) plays a role in the sustainability of the transmission and may also have an impact on the morbidity of the disease in terms of anaemia , nutritional status and even cognitive development of children . The objective of this study was to assess PI prevalence and its relationship with known morbidity factors in a vulnerable but asymptomatic stratum of the population . Methods A simple r and om sample , household survey in asymptomatic children under the age of five was conducted from April to September 2012 in two health areas of the health zone of Mont Ngafula 1 , Kinshasa , Democratic Republic of Congo . Results The PI prevalence were 30.9 % ( 95 % CI : 26.5 - 35.9 ) and 14.3 % ( 95 % CI : 10.5 - 18.1 ) in Cité Pumbu and Kindele health areas , respectively , ( OR : 2.7 ; p < 0.001 ) . All were Plasmodium falciparum infected and 4 % were co-infected with Plasmodium malariae . In Cité Pumbu and Kindele , the prevalence of anaemia ( haemoglobin < 11 g/dL ) was 61.6 % ( 95 % CI : 56.6 - 66.5 ) and 39.3 % ( 95 % CI : 34.0 - 44.6 ) , respectively , ( OR : 2.5 ; p < 0.001 ) . The health area of Cité Pumbu had 32 % ( 95 % CI : 27.5 - 37.0 ) of chronic mal OUTPUT: Divergent results were reported on the effect of malnutrition on malaria risk . While no consistent association between risk of malaria and acute malnutrition was found , chronic malnutrition was relatively consistently associated with severity of malaria such as high-density parasitemia and anaemia . Furthermore , there is little information on the effect of malnutrition on therapeutic responses to artemisinin combination therapies ( ACTs ) and their pharmacokinetic properties in malnourished children in published literature . Conclusions The evidence on the effect of malnutrition on malaria risk remains inconclusive . INPUT: BACKGROUND No comprehensive data on the clinical features and the prognosis of cerebral malaria in the South Pacific are available at present . We conducted a prospect i ve study in children with cerebral malaria to assess the case fatality rate ( CFR ) in the region and to identify potential risk factors for death . METHODS We recruited 134 children admitted to the Madang General Hospital between April 1991 and October 1993 with a strictly defined diagnosis of cerebral malaria . Besides clinical examination , we collected a blood sample for parasitological haematological and biochemical assessment . RESULTS The CFR was 11.9 % and the prevalence of residual neurological sequelae at discharge was 1.5 % . The proportion of children presenting with deep coma ( 12 % ) or hypoglycaemia ( 17 % ) was lower in our study than in African ones , where severe complications are more frequent . Also mortality associated with hypoglycaemia on admission was lower . Clinical or laboratory conditions significantly associated with death were deep coma , malarial anaemia and hyperleucocytosis . CONCLUSIONS All conditions associated with deep coma , such as shock , hypoglycaemia and acidosis , should be corrected . Also prompt administration of blood transfusions to patients with anaemia is likely to reduce the occurrence of death in Papua New Guinean children with cerebral malaria BACKGROUND The relation between malnutrition and malaria is controversial . On the one h and , malaria may cause malnutrition , whereas on the other h and , malnutrition itself may modulate susceptibility to the disease . OBJECTIVE The objective was to investigate the association between Plasmodium falciparum malaria and malnutrition in a cohort of Kenyan children . DESIGN The study involved the longitudinal follow-up of children aged 0 - 95 [ corrected ] mo for clinical malaria episodes and anthropometric measurements through 4 cross-sectional surveys . We used Poisson regression analysis to investigate the association between malaria and nutritional status . RESULTS The crude incidence rate ratios ( IRRs ) for malaria during the 6-mo period before assessment in children defined as malnourished on the basis of low height-for-age or low weight-for-age z scores ( < -2 ) were 1.17 ( 95 % CI : 0.91 , 1.50 ; P=0.21 ) and 0.94 ( 0.71 , 1.25 ; P=0.67 ) , respectively , which suggests no association between malaria and the subsequent development of protein-energy malnutrition . However , we found that age acted as an effect modifier in the association between malaria episodes and malnutrition on prospect i ve follow-up . The IRR for malaria in children aged 0 - 2 y , who were subsequently characterized as underweight , was 1.65 ( 1.10 , 2.20 ; P=0.01 ) , and a significant overall relation between malaria and stunting was found on regression analysis after adjustment for the interaction with age ( IRR : 1.91 ; 1.01 , 3.58 ; P=0.04 ) . CONCLUSION Although children living on the coast of Kenya continue to experience clinical episodes of uncomplicated malaria throughout the first decade of life , the effect of malaria on nutritional status appears to be greatest during the first 2 y of life BACKGROUND Previous analyses derived the relative risk ( RR ) of dying as a result of low weight-for-age and calculated the proportion of child deaths worldwide attributable to underweight . OBJECTIVES The objectives were to examine whether the risk of dying because of underweight varies by cause of death and to estimate the fraction of deaths by cause attributable to underweight . DESIGN Data were obtained from investigators of 10 cohort studies with both weight-for-age category ( < -3 SDs , -3 to < -2 SDs , -2 to < -1 SD , and > -1 SD ) and cause of death information . All 10 studies contributed information on weight-for-age and risk of diarrhea , pneumonia , and all-cause mortality ; however , only 6 studies contributed information on deaths because of measles , and only 3 studies contributed information on deaths because of malaria or fever . With use of weighted r and om effects models , we related the log mortality rate by cause and anthropometric status in each study to derive cause-specific RRs of dying because of undernutrition . Prevalences of each weight-for-age category were obtained from analyses of 310 national nutrition surveys . With use of the RR and prevalence information , we then calculated the fraction of deaths by cause attributable to undernutrition . RESULTS The RR of mortality because of low weight-for-age was elevated for each cause of death and for all-cause mortality . Overall , 52.5 % of all deaths in young children were attributable to undernutrition , varying from 44.8 % for deaths because of measles to 60.7 % for deaths because of diarrhea . CONCLUSION A significant proportion of deaths in young children worldwide is attributable to low weight-for-age , and efforts to reduce malnutrition should be a policy priority Objective : To examine the relation of circulating appetite neuropeptides , CCK-8 sulphate ( CCK-8s ) and β-endorphin , and the tumour necrosis factor-alpha ( TNF-α ) and soluble TNF receptors ( sTNFR ) to the anorexia and wasting associated with HIV-infection . Design : Cross-sectional analysis . Setting : A university-based HIV/AIDS ambulatory clinic in Madrid , Spain . Participants : Thirty-six r and omly selected AIDS patients without concomitant diseases or secondary infections were classified into two groups : 19 patients with wasting and 17 with normal body weight , and 18 healthy controls . Measurements : Nutritional status was OUTPUT:
Conclusions This systematic review found that most of the evidence associating malaria and malnutrition comes from P. falciparum endemic areas , with a significant heterogeneity in studies ’ design . Apparently malnutrition has not a great impact on malaria morbidity , but could have a negative impact on malaria mortality and severity . Most studies show no association between malaria and subsequent malnutrition in P. falciparum areas . In Plasmodium vivax endemic areas , malaria was associated with malnutrition in children .
MS2_dynamic_1_shot459
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: The aim of the study was to evaluate the safety and efficacy of viscosupplementation with hylan G-F 20 in patients with mild to moderate osteoarthritis ( OA ) presenting with persistent knee pain 4–12 weeks after arthroscopic meniscectomy . A prospect i ve , multi-centre , open study was carried out in patients with pain due to OA of the knee , not resolved by simple analgesics , 4–12 weeks after undergoing arthroscopic meniscectomy . To be eligible , patients had to score ≥50 mm and ≤90 mm on both walking pain and patient global assessment visual analogue scales ( VAS ; 0–100 mm ) at baseline and be radiologically diagnosed pre-operatively with OA grade I or II on the Kellgren-Lawrence scale , with < 50 % joint space narrowing . Patients received three intra-articular , 2 ml injections of hylan G-F 20 in the target knee with an interval of 1 week between injections , and were followed for 52 weeks . The primary efficacy endpoint was the change from baseline in the walking pain VAS score at 26 weeks . Secondary outcome measures were the walking pain VAS scores at all other time points , the WOMAC Index at all time points , and patient and physician global assessment at all time points . The safety of the treatment was assessed using adverse event ( AE ) reports . A total of 62 patients ( mean age 55.4 years , 52 % male ) were enrolled . The mean walking pain VAS score decreased by 36.8 mm from baseline at 26 weeks ( P < 0.0001 ) , and also showed statistically significant decreases ( P < 0.0001 ) at all other time points . The change in WOMAC total and subscale scores from baseline were statistically significant ( P < 0.0001 ) at all time points , as were the decreases in the physician and patient global assessment VAS scores . There were 18 target knee AEs ( mostly pain and /or swelling and /or effusion ) in 12 patients ( 19 % ) considered to be at least possibly related to treatment . The majority of these ( 78 % ) were mild or moderate in intensity . One patient ( 1.6 % ) experienced a serious adverse event ( synovitis ) in the target knee that was considered possibly related to study treatment . Hylan G-F 20 provides effective pain relief and improves stiffness and physical function in patients with mild to moderate OA presenting with persistent osteoarthritic pain 4–12 weeks after arthroscopic meniscectomy . Symptomatic efficacy was maximised at 12 weeks and maintained at 26 and 52 weeks . The type ( pain and /or swelling and /or effusion ) and the intensity ( mostly mild/moderate ) of AEs reported in this study are similar to those reported in other trials in different patient population s , but the incidence was higher ( 19 % ) . The risk/benefit of hylan G-F 20 in this particular population of patients is favourable Background Osteoarthritis is the most prevalent joint disease and a frequent cause of joint pain , functional loss , and disability . Osteoarthritis often becomes chronic , and conventional treatments have demonstrated only modest clinical benefits without lesion reversal . Cell-based therapies have shown encouraging results in both animal studies and a few human case reports . We design ed a pilot study to assess the feasibility and safety of osteoarthritis treatment with mesenchymal stromal cells ( MSCs ) in humans and to obtain early efficacy information for this treatment . Methods Twelve patients with chronic knee pain unresponsive to conservative treatments and radiologic evidence of osteoarthritis were treated with autologous exp and ed bone marrow MSCs by intra-articular injection ( 40 × 106 cells ) . Clinical outcomes were followed for 1 year and included evaluations of pain , disability , and quality of life . Articular cartilage quality was assessed by quantitative magnetic resonance imaging T2 mapping . Results Feasibility and safety were confirmed , and strong indications of clinical efficacy were identified . Patients exhibited rapid and progressive improvement of algofunctional indices that approached 65 % to 78 % by 1 year . This outcome compares favorably with the results of conventional treatments . Additionally , quantification of cartilage quality by T2 relaxation measurements demonstrated a highly significant decrease of poor cartilage areas ( on average , 27 % ) , with improvement of cartilage quality in 11 of the 12 patients . Conclusions MSC therapy may be a valid alternative treatment for chronic knee osteoarthritis . The intervention is simple , does not require hospitalization or surgery , provides pain relief , and significantly improves cartilage quality Systematic review s ( SRs ) are an increasingly popular evidence -based tool and are often used to answer complex research questions across many different research domains . Early SR methodology was advanced by social scientists , and the term meta- analysis was coined by a social scientist who also conducted research in psychology . SRs have recently become popular in healthcare and are likely to be beneficial in any field . The aim of this report is to highlight issues in SR conduct with a focus on the field of nutrition and to make recommendations on improving SR conduct in this area . Development of the research question is probably the most important step in conducting an SR . The 4 main components of an answerable question are 1 ) the patient , population , or problem ; 2 ) the intervention , independent variable , or exposure ; 3 ) the comparators ; and 4 ) the dependent variables or outcomes of interest . The question will be used to determine the optimal methods for conducting the SR . SRs often include study design s beyond r and omized trials and do not always include a meta- analysis of the results . Other topics explored include underst and ing and interpreting discordant review s and the importance of reporting tools [ eg , QUality Of Reporting Of Meta-analyses ( QUOROM Statement ) or CONsoli date d St and ards Of Reporting of Trials ( CONSORT Statement ) ] . OUTPUT: Lifestyle modifications ( moderate exercise and weight loss ) , paracetamol , glucosamine , Intraarticular Hyaluronic Acid ( IAHA ) and platelet-rich-plasma ( PRP ) injections have a low risk of harm and beneficial ≥12 month outcomes . Although Nonsteroidal Anti-inflammatory Drugs ( NSAIDs ) provide pain relief , they are associated with increased risk of medical complications . Cortisone injections are associated with radiological cartilage degeneration at > 12 months . Arthroscopy for degenerative meniscal tears in KOA leads to a 3-fold increase in total knee arthroplasty ( TKA ) . TKA improves primary outcomes of KOA but has a low rate of significant medical complications . Treatment with opioids has a lack of evidence for use and a high risk of long-term harm . The use of IAHA and PRP may provide additional symptomatic benefit without the risk of harm . TKA is associated with significant medical complications but is justified by the efficacy of joint replacement in late-stage disease . INPUT: Objective . To evaluate changes in bladder capacity and potassium sensitivity after glycosaminoglycan ( GAG ) substitution therapy . Material and methods . The study population comprised two groups of female patients with bladder pain syndrome/interstitial cystitis ( BPS/IC ) : responders ( those with symptom improvement ) and non-responders ( those without symptom improvement ) after a 10-week period of intravesical , episodic , weekly , GAG substitution therapy . A total of 27 volunteers with increased pre-therapeutic potassium sensitivity were enrolled in the study and re-evaluated using the modified comparative potassium test ( maximal bladder capacity with a saline solution versus a 0.2 M KCl solution ) following intravesical GAG substitution therapy . Results . In the 13 responders , the average maximal bladder capacity increased by 17 % with the saline solution and by 101.5 % with the 0.2 M KCl solution . In the 14 non-responders , post-therapeutic average maximal bladder capacity was decreased by 35 % with the saline solution and remained relatively unchanged after instillation with a 0.2 M KCl solution . Conclusion . These data demonstrate that in patients who respond symptomatically to intravesical GAG substitution therapy , cystometric bladder capacity is increased , whereas non-responders experience a decrease in bladder capacity INTRODUCTION It has been reported in an open-label study that the combination of alkalinized lidocaine and heparin can immediately relieve the symptoms of urinary urgency , frequency , and pain associated with interstitial cystitis ( IC ) . This combination has also been reported to relieve pain associated with sex in patients with IC . AIM The aim of this study was to corroborate these findings in a multicenter setting . METHODS The study design was a multicenter prospect i ve , double-blind , crossover , placebo-controlled trial . Each participant met all of the clinical National Institute of Diabetes and Digestive and Kidney Diseases criteria ( excluding cystoscopy ) for IC . Each patient received drug and control , in r and om order , within 48 hours of enrolling in the study . MAIN OUTCOME MEASURES The primary outcome measure was percent change in pain score ( 11-point analog pain scale ) 12 hours after receiving the drug or control . Secondary measures were the global assessment response ( GAR ) of symptoms and 12-hour average urgency reduction determined from 11-point urgency scales . RESULTS Eighteen ( 18 ) patients completed the trial . The average reduction of pain over 12 hours was 21 % for control and 42 % for active drug ( P = 0.0363 ) . GAR was 13 % for control and 50 % for drug ( P = 0.0137 ) . Average urgency reduction was 13 % for control and 35 % for drug ( P = 0.0328 ) . CONCLUSIONS The combination of alkalinized lidocaine and heparin provides up to 12 hours of relief from urgency and pain associated with IC . This combination provides significant immediate relief of symptoms for patients with IC The aims of this study were to evaluate the efficacy and tolerability of intravesical instillations of high-molecular-weight hyaluronic acid ( HA ) 1.6 % and chondroitin sulfate ( CS ) 2.0 % in patients with refractory painful bladder syndrome/interstitial cystitis ( PBS/IC ) and to observe their impact on Quality of Life . Twenty-three women were enrolled . They received bladder instillations with HA and CS weekly for 20 weeks and then monthly for 3 months . Mean follow-up after completion of therapy was 5 months . We observed a significant improvement in urinary symptoms on voiding diaries and Visual Analogue Scale for frequency ( p = 0.045 ) , urgency ( p = 0.005 ) , and pain ( p = 0.001 ) . The O’Leary – Sant Interstitial Cystitis Symptom Index and Interstitial Cystitis Problem Index result ed in a significant improvement in both scores ( p = 0.004 and 0.01 , respectively ) . The Pelvic Pain and Urgency/Frequency Symptom Scale only showed significant improvement in the symptom score ( p = 0.001 ) . This promising experience seems to offer an additional therapeutic option in patients with refractory PBS/IC OBJECTIVE It is not always possible to clearly differentiate the symptoms of overactive bladder and interstitial cystitis . A prospect i ve r and omized study was performed to determine whether instillation of sodium chondroitin sulphate for treatment of interstitial cystitis is also effective in treating overactive bladder . The expected benefit of this therapeutic approach in overactive bladder is based on the assumption that the glycosaminoglycan layer may be damaged in overactive bladder as well . MATERIAL AND METHODS Patients with chronic overactive bladder were r and omized to one of two study groups each including 41 patients . Group A was treated with an anticholinergic agent ( tolterodine ) , group B with sodium chondroitin sulphate ( Uropol S ) . The diagnosis was established on the basis of a gynecologic examination and history , urodynamic testing , introital ultrasound , and cystoscopy . Patients were treated for 12 months . RESULTS An improvement of symptoms was reported by 15/35 ( 43 % ) of the patients in group A ( p = 0.000 ) as compared with 23/32 ( 72 % ) of the patients in group B. The subjective outcome was corroborated by means of urodynamic testing , number of pads used , voiding frequency , and nycturia ( voiding diary ) . Quality of life increased significantly in both groups in the course of treatment but there was no significant difference between both groups . CONCLUSION The results of the study presented here suggest OUTPUT:
HMW-HA was significantly superior in cost effectiveness and cost efficacy to all other instillation regimes .
MS2_dynamic_1_shot460
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: Background Flaxseed has received attention for its anti-inflammatory and antioxidant role . The present study hypothesizes if flaxseed added to a weight loss diet could improve the lipid and metabolic profiles and decrease risk factors related to cardiovascular disease . Methods In a prospect i ve , single blinded 42 days protocol , subjects were allocated into two groups with low carbohydrates intake : GriceLC ( 35 % of carbohydrate and 60 g of raw rice powder per day ) and GflaxLC ( 32 % of carbohydrate and 60 g of flaxseed powder per day ) . Blood pressure , anthropometric measures and serum levels of isoprostane , C-reactive protein , Tumor Necrosis Factor-alpha , glucose , lipidic profile , uric acid , adiponectin , leptin and insulin were measured at baseline and at the end of interventions . Serum and urinary enterodiol and enterolactione were also measured . Results A total of 27 men with cardiovascular risk factors were evaluated , with mean age of 33 ± 10 years to GriceLC and 40 ± 9 years to GflaxLC . Both groups experienced weight loss and systolic blood pressure reduction . A decrease in inflammatory markers ( CRP and TNF-α ) was observed after flaxseed intake ( mean decrease of 25 % and 46 % for GflaxLC respectively ) . All groups also showed improvement in levels of total cholesterol , LDL-c , uric acid and adiponectin . Only GflaxLC group showed a decrease in triglyceride levels . Conclusion This study suggests that flaxseed added to a weight loss diet could be an important nutritional strategy to reduce inflammation markers such as CRP and TNF-α . Trial registration Clinical Trials.gov NCT02132728 Background Dietary fibers have been proposed to play a role in cardiovascular risk as well as body weight management . Flaxseeds are a good source of dietary fibers , and a large proportion of these are water-soluble viscous fibers . Method Here , we examine the effect of flaxseed dietary fibers in different food matrices on blood lipids and fecal excretion of fat and energy in a double-blind r and omized crossover study with 17 subjects . Three different 7-d diets were tested : a low-fiber control diet ( Control ) , a diet with flaxseed fiber drink ( 3/day ) ( Flax drink ) , and a diet with flaxseed fiber bread ( 3/day ) ( Flax bread ) . Total fat and energy excretion was measured in feces , blood sample s were collected before and after each period , and appetite sensation registered 3 times daily before main meals . Results Compared to control , Flax drink lowered fasting total-cholesterol and LDL-cholesterol by 12 and 15 % , respectively , ( p < 0.01 ) , whereas Flax bread only produced a reduction of 7 and 9 % , respectively ( p < 0.05 ) . Fecal fat and energy excretion increased by 50 and 23 % with Flax drink consumption compared to control ( p < 0.05 ) , but only fecal fat excretion was increased with Flax bread compared to control ( p < 0.05 ) . Conclusion Both Flax drink and Flax bread result ed in decreased plasma total and LDL-cholesterol and increased fat excretion , but the food matrix and /or processing may be of importance . Viscous flaxseed dietary fibers may be a useful tool for lowering blood cholesterol and potentially play a role in energy balance . Trial Registration Clinical Trials.gov : Malnutrition and chronic inflammation in dialysis patients negatively impact their survival prognosis , and nutrients , such as omega-3 oils , are postulated to reduce proinflammatory response . In this r and omized , double-blind , multicenter , placebo-controlled trial , we investigated the effects of flaxseed oil ( FO ) on the inflammatory state of patients with chronic renal failure undergoing renal replacement therapy with hemodialysis ( HD ) . We hypothesized that FO supplementation lowers C-reactive protein ( CRP ) levels . One hundred sixty patients with chronic renal failure who received HD therapy of 3 dialysis units over a 3-month period in South Brazil were included . The patients received blind doses of FO ( 1 g twice a day ) and placebo ( mineral oil , 1 g twice a day ) for a period of 120 days . Inflammation was observed in 89 patients ( 61 % ) at the beginning of the study . There was a correlation between CRP and the body mass index ( R(s ) = 0.22 ; P = .022 ) and high-density lipoprotein cholesterol ( R(s ) = -0.23 ; P = .032 ) , and the CRP levels decreased significantly over time in the group that received FO compared with the control group ( P < .001 ) . During the study period , 33.3 % of the FO group changed from an inflamed to a not-inflamed category , whereas only 16.9 % changed in the mineral oil group ( P = .04 ) . We conclude that the administration of FO decreases the CRP levels and that inflammation in HD patients appears to be correlated to their body mass index and reduced high-density lipoprotein cholesterol levels . Studies with a larger number of patients and over a longer duration are necessary to corroborate these findings Flaxseed is one of the richest sources of lignans and is increasingly used in food products or as a supplement . Plant lignans can be converted by intestinal bacteria into the so-called enterolignans , enterodiol and enterolactone . For a proper evaluation of potential health effects of enterolignans , information on their bioavailability is essential . The aim of this study was to investigate whether crushing and milling of flaxseed enhances the bioavailability of enterolign OUTPUT: This meta- analysis of RCTs showed significant reductions in both SBP and DBP following supplementation with various flaxseed products INPUT: Sesame ingestion has been shown to improve blood lipids in humans and antioxidative ability in animals . Sesamin , a sesame lignan , was recently reported to be converted by intestinal microflora to enterolactone , a compound with estrogenic activity and also an enterometabolite of flaxseed lignans , which are known to be phytoestrogens . Whether sesame can be a source of phytoestrogens is unknown . This study was design ed to investigate the effect of sesame ingestion on blood sex hormones , lipids , tocopherol , and ex vivo LDL oxidation in postmenopausal women . Twenty-six healthy subjects attended , and 24 completed , this r and omized , placebo-controlled , crossover study . Half of them consumed 50 g sesame seed powder daily for 5 wk , followed by a 3-wk washout period , then a 5-wk 50-g rice powder placebo period . The other half received the 2 supplements in reverse order . After sesame treatment , plasma total cholesterol ( TC ) , LDL-C , the ratio of LDL-C to HDL-C , thiobarbituric acid reactive substances in oxidized LDL , and serum dehydroepi and rosterone sulfate decreased significantly by 5 , 10 , 6 , 23 , and 18 % , respectively . The ratio of alpha- and gamma-tocopherol to TC increased significantly by 18 and 73 % , respectively . All of these variables differed significantly between the 2 treatments . Serum sex hormone-binding globulin and urinary 2-hydroxyestrone ( n = 8) increased significantly by 15 and 72 % , respectively , after sesame treatment , and these concentrations tended to differ ( P = 0.065 and P = 0.090 , respectively ) from those after the placebo treatment . These results suggest that sesame ingestion benefits postmenopausal women by improving blood lipids , antioxidant status , and possibly sex hormone status We studied the effects of dietary intervention with three vegetable oils ( Linola , corn or sesame oil , all good sources of gamma-tocopherol ) on absolute and relative concentrations of alpha- and gamma-tocopherol in human serum . The oils contained only small amounts of linolenic acid but varying amounts of oleic and linoleic acids , and they had different concentrations of alpha-tocopherol . Forty healthy female students ( mean age 26 y ) were r and omly assigned to one of three groups and consumed a diet that contained one of the three oils for 4 wk . Refined oils were distributed as ingredients in specially prepared buns , in margarine or as dressing . Serum tocopherols , serum lipoproteins and plasma malondialdehyde concentrations were measured . The gamma-tocopherol concentrations normalized to serum lipids increased significantly in the corn and sesame oil groups ( P < 0.01 ) , and the alpha-/gamma-tocopherol ratios decreased significantly from baseline concentrations in all groups ( P < 0.05 ) . The alpha-tocopherol concentrations did not change during the diet period in any of the three groups . Serum cholesterol , serum apolipoprotein B and plasma malondialdehyde concentrations decreased significantly only in the Linola oil group ( P < 0.05 ) . These data show that a moderately modified natural diet that contains both alpha- and gamma-tocopherol increases the serum gamma-tocopherol concentration in healthy women without affecting the serum alpha-tocopherol concentration Sesamin , one of the lignans contained in sesame , has been considered to have medicinal effects . It has been reported that sesamin suppressed the development of hypertension in rats . In this study , using a double-blind , cross-over , placebo-controlled trial , we investigated the effect of 4-wk administration of sesamin on blood pressure ( BP ) in mildly hypertensive humans . Twenty-five middle-aged subjects with mild hypertension were divided into two groups , matched by age and body mass index . Twelve subjects were allocated to 4-wk intake of capsules with 60 mg sesamin per day and 13 subjects to 4-wk intake of a placebo ( period 1 ) . After a 4-wk washout period , the subjects received the alternative administration for 4 wk ( period 2 ) . BP decreased with statistical significance with the administration of sesamin ( systolic : 137.6+/-2.2 to 134.1+/-1.7 mmHg , p=0.044 , diastolic : 87.7+/-1.3 to 85.8+/-1.0 mmHg , p=0.045 ) , but little changed with the placebo ( systolic : 135.0+/-1.8 to 135.1+/-1.7 mmHg , diastolic : 85.9+/-1.2 to 86.6+/-1.2 mmHg ) . In conclusion , 4-wk administration of 60 mg sesamin significantly decreased BP by an average of 3.5 mmHg systolic BP and 1.9 mmHg diastolic BP . These results suggest that sesamin has an antihypertensive effect in humans . Epidemiological studies suggested that a 2 - 3 mmHg decrease in BP reduces the rate of cardiovascular diseases ; therefore , it is considered that BP reduction achieved by sesamin may be meaningful to prevent cardiovascular diseases BACKGROUND AND AIMS Pre- clinical studies suggest that sesame and its lignans induce beneficial changes in risk factors related to cardiovascular disease and increase the bioavailability of mammalian lignans . However , only very few intervention trials have investigated the potential bioactivities of sesame in humans . We aim ed to investigate the effects of sesame supplementation in humans on OUTPUT:
It was concluded that sesame consumption can significantly reduce blood TAG levels but there is insufficient evidence to support its hypocholesterolaemic effects .
MS2_dynamic_1_shot461
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: Aims /hypothesisThe study aim ed to compare the effects of a 2 year intervention with a low-fat diet ( LFD ) or a low-carbohydrate diet ( LCD ) , based on four group meetings to achieve compliance . Methods This was a prospect i ve r and omised parallel trial involving 61 adults with type 2 diabetes consecutively recruited in primary care and r and omised by drawing ballots . Patients that did not speak Swedish could not be recruited . The primary outcomes in this non-blinded study were weight and HbA1c . Patients on the LFD aim ed for 55–60 energy per cent ( E% ) and those on LCD for 20 E% from carbohydrate . Results The mean BMI and HbA1c of the participants were 32.7 ± 5.4 kg/m2 and 57.0 ± 9.2 mmol/mol , respectively . No patients were lost to follow-up . Weight loss did not differ between groups and was maximal at 6 months : LFD −3.99 ± 4.1 kg ( n = 31 ) ; LCD −4.31 ± 3.6 kg ( n = 30 ) ; p < 0.001 within groups . At 24 months , patients on the LFD had lost −2.97 ± 4.9 kg and those on LCD −2.34 ± 5.1 kg compared with baseline ( p = 0.002 and p = 0.020 within groups , respectively ) . HbA1c fell in the LCD group only ( LCD at 6 months −4.8 ± 8.3 mmol/mol , p = 0.004 , at 12 months −2.2 ± 7.7 mmol/mol , p = 0.12 ; LFD at 6 months −0.9 ± 8.8 mmol/mol , p = 0.56 ) . At 6 months , HDL-cholesterol had increased with the LCD ( from 1.13 ± 0.33 mmol/l to 1.25 ± 0.47 mmol/l , p = 0.018 ) while LDL-cholesterol did not differ between groups . Insulin doses were reduced in the LCD group ( 0 months , LCD 42 ± 65 E , LFD 39 ± 51 E ; 6 months , LCD 30 ± 47 E , LFD 38 ± 48 E ; p = 0.046 for between-group change ) . Conclusions /interpretationWeight changes did not differ between the diet groups , while insulin doses were reduced significantly more with the LCD at 6 months , when compliance was good . Thus , aim ing for 20 % of energy intake from carbohydrates is safe with respect to cardiovascular risk compared with the traditional LFD and this approach could constitute a treatment alternative . Trial registration : Clinical Trials.gov NCT01005498 Funding : University Hospital of Linköping Research Funds , Linköping University , the County Council of Östergötl and , and the Diabetes Research Centre of Linköping BACKGROUND The appropriate dietary intervention for overweight persons with type 2 diabetes mellitus ( DM2 ) is unclear . Trials comparing the effectiveness of diets are frequently limited by short follow-up times and high dropout rates . AIM The effects of a low carbohydrate Mediterranean ( LCM ) , a traditional Mediterranean ( TM ) , and the 2003 American Diabetic Association ( ADA ) diet were compared , on health parameters during a 12-month period . METHODS In this 12-month trial , 259 overweight diabetic patients ( mean age 55 years , mean body mass index 31.4 kg/m(2 ) ) were r and omly assigned to one of the three diets . The primary end-points were reduction of fasting plasma glucose , HbA1c and triglyceride ( TG ) levels . RESULTS 194 patients out of 259 ( 74.9 % ) completed follow-up . After 12 months , the mean weight loss for all patients was 8.3 kg : 7.7 kg for ADA , 7.4 kg for TM and 10.1 kg for LCM diets . The reduction in HbA1c was significantly greater in the LCM diet than in the ADA diet ( -2.0 and -1.6 % , respectively , p < 0.022 ) . HDL cholesterol increased ( 0.1 mmol/l + /- 0.02 ) only on the LCM ( p < 0.002 ) . The reduction in serum TG was greater in the LCM ( -1.3 mmol/l ) and TM ( -1.5 mmol/l ) than in the ADA ( -0.7 mmol/l ) , p = 0.001 . CONCLUSIONS An intensive 12-month dietary intervention in a community-based setting was effective in improving most modifiable cardiovascular risk factors in all the dietary groups . Only the LCM improved HDL levels and was superior to both the ADA and TM in improving glycaemic control BACKGROUND The effects of a carbohydrate-restricted diet on weight loss and risk factors for atherosclerosis have been incompletely assessed . METHODS We r and omly assigned 132 severely obese subjects ( including 77 blacks and 23 women ) with a mean body-mass index of 43 and a high prevalence of diabetes ( 39 percent ) or the metabolic syndrome ( 43 percent ) to a carbohydrate-restricted ( low-carbohydrate ) diet or a calorie- and fat-restricted ( low-fat ) diet . RESULTS Seventy-nine subjects completed the six-month study OUTPUT: The proportion of daily energy provided by carbohydrate intake is not an important determinant of response to dietary management , especially when considering longer term trials . INPUT: Background Our aim was to compare the effects of a Paleolithic ( ' Old Stone Age ' ) diet and a diabetes diet as generally recommended on risk factors for cardiovascular disease in patients with type 2 diabetes not treated with insulin . Methods In a r and omized cross-over study , 13 patients with type 2 diabetes , 3 women and 10 men , were instructed to eat a Paleolithic diet based on lean meat , fish , fruits , vegetables , root vegetables , eggs and nuts ; and a Diabetes diet design ed in accordance with dietary guidelines during two consecutive 3-month periods . Outcome variables included changes in weight , waist circumference , serum lipids , C-reactive protein , blood pressure , glycated haemoglobin ( HbA1c ) , and areas under the curve for plasma glucose and plasma insulin in the 75 g oral glucose tolerance test . Dietary intake was evaluated by use of 4-day weighed food records . Results Study participants had on average a diabetes duration of 9 years , a mean HbA1c of 6,6 % units by Mono-S st and ard and were usually treated with metformin alone ( 3 subjects ) or metformin in combination with a sulfonylurea ( 3 subjects ) or a thiazolidinedione ( 3 subjects ) . Mean average dose of metformin was 1031 mg per day . Compared to the diabetes diet , the Paleolithic diet result ed in lower mean values of HbA1c ( -0.4 % units , p = 0.01 ) , triacylglycerol ( -0.4 mmol/L , p = 0.003 ) , diastolic blood pressure ( -4 mmHg , p = 0.03 ) , weight ( -3 kg , p = 0.01 ) , BMI ( -1 kg/m2 , p = 0.04 ) and waist circumference ( -4 cm , p = 0.02 ) , and higher mean values of high density lipoprotein cholesterol ( + 0.08 mmol/L , p = 0.03 ) . The Paleolithic diet was mainly lower in cereals and dairy products , and higher in fruits , vegetables , meat and eggs , as compared with the Diabetes diet . Further , the Paleolithic diet was lower in total energy , energy density , carbohydrate , dietary glycemic load , saturated fatty acids and calcium , and higher in unsaturated fatty acids , dietary cholesterol and several vitamins . Dietary GI was slightly lower in the Paleolithic diet ( GI = 50 ) than in the Diabetic diet ( GI = 55 ) . Conclusion Over a 3-month study period , a Paleolithic diet improved glycemic control and several cardiovascular risk factors compared to a Diabetes diet in patients with type 2 diabetes . Trial registration Clinical Trials.gov NCT00435240 Background / objectives : Formulas developed to estimate diet-dependent net acid excretion ( NAE ) generally agree with measured values for typical Western diets . Whether they can also appropriately predict NAE for ‘ Paleolithic-type ’ ( Paleo ) diets — which contain very high amounts of fruits and vegetables ( F&V ) and concurrent high amounts of protein is unknown . Here , we compare measured NAEs with established NAE estimates in subjects with Type 2 diabetes (T2D).Subjects/ methods : Thirteen subjects with well-controlled T2D were r and omized to either a Paleo or American Diabetes Association ( ADA ) diet for 14 days . Twenty-four hour urine collection s were performed at baseline and end of the diet period , and analyzed for titratable acid , bicarbonate and ammonium to calculate measured NAE . Three formulas for estimating NAE from dietary intake were used ; two ( NAE_diet R or L ) that include dietary mineral intake and sulfate- and organic acid ( OA ) production , and one that is empirically derived ( NAE_diet F ) only considering potassium and protein intake . Results : Measured NAE on the Paleo diet was significantly lower than on the ADA-diet ( + 31±22 vs 112±52 mEq/day , P=0.002 ) . Although all formula estimates showed similar and reasonable correlations ( r=0.52–0.76 ) with measured NAE , each one underestimated measured values . The formula with the best correlation did not contain an estimate of dietary OA production . Conclusions : Paleo-diets are lower in NAE than typical Western diets . However , commonly used formulas clearly underestimate NAE , especially for diets with very high F&V ( as the Paleo diet ) , and in subjects with T2D . This may be due to an inappropriate estimation of proton loads stemming from OAs , underlining the necessity for improved measures of OA-related proton sources Aims /hypothesisMost studies of diet in glucose intolerance and type 2 diabetes have focused on intakes of fat , carbohydrate , fibre , fruits and vegetables . Instead , we aim ed to compare diets that were available during human evolution with more recently introduced ones . Methods Twenty-nine patients with ischaemic heart disease plus either glucose intolerance or type 2 diabetes were r and omised to receive ( 1 ) a Palaeolithic ( ‘ Old Stone Age ’ ) diet ( n = 14 ) , based on lean meat , fish , fruits , vegetables , root vegetables , eggs and nuts ; or ( 2 ) a Consensus ( Mediterranean-like ) diet ( n = 15 ) , based on whole grains , low-fat dairy products , vegetables , fruits , fish , oils and margarines . Primary outcome variables were changes in weight , waist circumference and plasma glucose AUC ( AUC Glucose0–120 ) and plasma OUTPUT:
The home-delivery ( n = 1 ) and dietary recommendation ( n = 3 ) RCTs showed similar effects with the exception of greater improvements in triglycerides relative to the control with the home delivery . None of the RCTs evaluated an improvement in quality of life . The Paleolithic diet result ed in greater short-term improvements in metabolic syndrome components than did guideline -based control diets .
MS2_dynamic_1_shot462
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: 4 Background : Adjuvant RT for pT3 R1 or R0 patients ( pts . ) after RP remains controversial . The EORTC-phase-III- study suggested a 20 % better biochemical control ( bNED ) after 10 years for RT but no survival advantage . In contrast , the SWOG trial stated not only a gain in bNED but also an improved metastasis free and overall survival after 12 years follow-up . Now , 10-years results from the ARO 96 - 02 study are available , which are based on the most precisely defined cohort among the three trials . METHODS 385 men with prostate cancer were r and omized to either 60 Gy RT ( arm A ; n=193 ) or WS ( arm B ; n=192 ) before achieving an undetectable PSA . Pts . were stratified for Gleason-score , margin status , neoadjuvant hormonal treatment and stage ( pT3a+b vs. c ) . When the undetectable PSA-level after RP was not achieved , progressive disease was stated and the pts . left arm A/B. Data analysis was by intent-to-treat ( ITT ) . PSA-progression for pts . with undetectable post-RP PSA was defined as two consecutive increasing PSA . The primary endpoint was bNED . The study was powered to demonstrate a 15 % increase in bNED for RT . RESULTS 78 pts . ( 20 % ) did not achieve an undetectable PSA and were stated as progressive disease ( arm A : 45 pts . , arm B : 33 pts . ) . Additionally , 34 pts . ( 23 % ) from the RT-arm did not receive RT . Therefore , 114 pts . had RT ( arm A ) and 159 pts . WS ( arm B ) . Median follow up was 111.3 months for arm A and 113.3 months for arm B . bNED at 10 years increased to 56 % for arm A ( RT ) compared with 35 % for arm B ( WS ) ( hazard ratio= 0.51 ; p = 0.00002 . Out of 307 ITT pts . , 15 died from prostate cancer , 23 for other and 5 for unknown reasons . There was no significant profit from ART regarding the endpoints metastasis-free survival ( p=0.56 ) or overall survival ( p=0.59 ) . Worst late side effects to the rectum were two grade 2 cases after ART . Grade ≥2 bladder toxicity occurred in 4 out of 148 ITT pts . No grade 4 events were reported . CONCLUSIONS With only one grade 3 case of late toxicity , ART was safe in pT3 prostate cancer . At 10 years median follow up , it reduced the risk of bNED by 49 % . The study was not powered to detect differences in OS . CLINICAL TRIAL INFORMATION ARO 96 - 02/AUO AP 09/95 BACKGROUND Although there is r and omized evidence that radical prostatectomy improves survival , there are few data on how benefit varies by baseline risk . OBJECTIVE We aim ed to create a statistical model to calculate the decrease in risk of death associated with surgery for an individual patient , using stage , grade , prostate-specific antigen , and age as predictors . DESIGN , SETTING , AND PARTICIPANTS A total of 695 men with T1 or T2 prostate cancer participated in the Sc and inavian Prostate Cancer Group 4 trial ( SPCG-4 ) . INTERVENTION Patients in SPCG-4 were r and omized to radical prostatectomy or conservative management . OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS Competing risk models were created separately for the radical prostatectomy and the watchful waiting group , with the difference between model predictions constituting the estimated benefit for an individual patient . RESULTS AND LIMITATIONS Individualized predictions of surgery benefit varied widely depending on age and tumor characteristics . At 65 yr of age , the absolute 10-yr risk reduction in prostate cancer mortality attributable to radical prostatectomy ranged from 4.5 % to 17.2 % for low- versus high-risk patients . Little expected benefit was associated with surgery much beyond age 70 . Only about a quarter of men had an individualized benefit within even 50 % of the mean . A limitation is that estimates from SPCG-4 have to be applied cautiously to contemporary patients . CONCLUSIONS Our model suggests that it is hard to justify surgery in patients with Gleason 6 , T1 disease or in those patients much above 70 yr of age . Conversely , surgery seems unequivocally of benefit for patients who have Gleason 8 , or Gleason 7 , stage T2 . For patients with Gleason 6 T2 and Gleason 7 T1 , treatment is more of a judgment call , depending on patient preference and other clinical findings , such as the number of positive biopsy cores and comorbidities PURPOSE To perform a r and omized trial comparing 70 and 80 Gy radiotherapy for prostate cancer . PATIENTS AND METHODS A total of 306 patients with localized prostate cancer were r and omized . No and rogen deprivation was allowed . The primary endpoint was biochemical relapse according to the modified 1997-American Society for Therapeutic Radiology and Oncology and Phoenix definitions . Toxicity was grade d using the Radiation Therapy Oncology Group 1991 criteria and the late effects on normal tissues-subjective , objective , management , analytic scales ( LENT-SOMA ) scales . The patients ' quality of life was scored using the European Organization for Research and Treatment of Cancer Quality of Life Question naire 30-item cancer-specific and 25-item prostate-specific modules . RESULTS The median follow-up was 61 months OUTPUT: EBRT , BT and RP were found to be effective in the management of localised prostate cancer . While higher doses of EBRT seem to be related to favourable survival-related outcomes they might , depending on technique , involve more adverse events , e.g. gastrointestinal and genitourinary toxicity . Aside from mixed findings regarding urinary function , BT and radical prostatectomy were comparable in terms of quality of life and biochemical progression-free survival while favouring BT regarding patient satisfaction and sexual function . There might be advantages of EBRT ( with/without HT ) compared to cryoablation ( with/without HT ) . Based on this systematic review , there is no strong evidence to support one therapy over another as EBRT , BT and RP can all be considered as effective monotherapies for localised disease with EBRT also effective for post-operative management . All treatments have unique adverse events profiles . INPUT: CRA4504 Background : The impact of radiotherapy on overall survival ( OS ) in men with locally advanced CaP is unclear . The SPCG-7 trial recently showed a benefit to RT for CaP specific mortality . Our primary objective was to assess the effect of RT on OS when added to lifelong ADT in men with locally advanced CaP. METHODS Patients with T3/T4 ( 1057 ) or T2 , PSA > 40 μ g/l ( 119 ) or T2 PSA > 20 μ g/l and Gleason ≥ 8 ( 25 ) and N0 /NX , M0 prostate adenocarcinoma were r and omized to lifelong ADT ( bilateral orchiectomy or LHRH agonist ) with or without RT ( 65 - 69 Gy to prostate ± seminal vesicles with or without 45Gy to pelvic nodes ) . The primary endpoint was OS and secondary endpoints included disease specific survival ( DSS ) , time to disease progression and quality of life . RESULTS 1205 patients were r and omized from 1995 to 2005 , 602 to ADT and 603 to ADT+RT ( well balanced with respect to baseline characteristics ) . A protocol specified second interim analysis on OS was performed in Aug 2009 ( data cut-off Dec 31 2008 ) . The DSMC recommended release of the results to the Trial Committee for publication . The median follow-up is 6.0 years and 320 patients have died ( 175 ADT and 145 ADT+RT ) . 10 % of patients had no follow-up data beyond 2006 . The addition of RT to ADT significantly reduced the risk of death ( hazard ratio [ HR ] 0.77 , 95 % CI 0.61 - 0.98 , p=0.033 ) . 140 patients died of disease and /or treatment ( 89 on ADT and 51 on ADT+RT ) The disease specific survival HR was 0.57 ( 95 % CI 0.41 - 0.81 , p=0.001 ) favoring ADT+RT . The 10 year cumulative disease specific death rates were estimated at 15 % with ADT+ RT and 23 % with ADT alone . Grade ≥2 late GI toxicity rates were similar in both arms ( proctitis , 1.3 % ADT alone , 1.8 % ADT+RT ) . CONCLUSIONS The trial results indicate a substantial overall survival and disease specific survival benefit for the combined modality approach ( ADT+RT ) in the management of patients with locally advanced prostate cancer with no significant increase in late treatment toxicity . In view of this data combined modality therapy ( ADT+RT ) should be the st and ard treatment approach for these patients . Supported by NCI-US Grant # 5U10CA077202 - 12 , CCSRI Grant # 15469 . No significant financial relationships to disclose BACKGROUND The optimal upper limit of the normal range for prostate-specific antigen ( PSA ) is unknown . We investigated the prevalence of prostate cancer among men in the Prostate Cancer Prevention Trial who had a PSA level of 4.0 ng per milliliter or less . METHODS Of 18,882 men enrolled in the prevention trial , 9459 were r and omly assigned to receive placebo and had an annual measurement of PSA and a digital rectal examination . Among these 9459 men , 2950 men never had a PSA level of more than 4.0 ng per milliliter or an abnormal digital rectal examination , had a final PSA determination , and underwent a prostate biopsy after being in the study for seven years . RESULTS Among the 2950 men ( age range , 62 to 91 years ) , prostate cancer was diagnosed in 449 ( 15.2 percent ) ; 67 of these 449 cancers ( 14.9 percent ) had a Gleason score of 7 or higher . The prevalence of prostate cancer was 6.6 percent among men with a PSA level of up to 0.5 ng per milliliter , 10.1 percent among those with values of 0.6 to 1.0 ng per milliliter , 17.0 percent among those with values of 1.1 to 2.0 ng per milliliter , 23.9 percent among those with values of 2.1 to 3.0 ng per milliliter , and 26.9 percent among those with values of 3.1 to 4.0 ng per milliliter . The prevalence of high- grade cancers increased from 12.5 percent of cancers associated with a PSA level of 0.5 ng per milliliter or less to 25.0 percent of cancers associated with a PSA level of 3.1 to 4.0 ng per milliliter . CONCLUSIONS Biopsy-detected prostate cancer , including high- grade cancers , is not rare among men with PSA levels of 4.0 ng per milliliter or less -- levels generally thought to be in the normal range PURPOSE Active surveillance for favorable risk prostate cancer is an approach that may reduce the risk of overtreatment of clinical ly insignificant prostate cancer . In fact , some patients with favorable risk disease at diagnosis harbor more aggressive disease and may be at risk for prostate cancer mortality despite close monitoring . This is a detailed report of 5 of 453 patients on surveillance who died of prostate cancer . MATERIAL S AND METHODS A large phase 2 prospect i ve trial of active surveillance in patients with favorable risk prostate cancer was initiated in 1995 . Eligible patients had favorable risk prostate cancer ( prostate specific antigen 10 ng/ml or less , Gleason 6 or less , T1c/T2a ) . Epstein criteria for clinical ly insignificant pro OUTPUT:
Active surveillance represents a viable option in men with low-risk PCa and a long life expectancy . PSA doubling time in < 3 yr or a biopsy progression indicates the need for active intervention . In men with locally advanced PCa in whom local therapy is not m and atory , watchful waiting ( WW ) is a treatment alternative to and rogen-deprivation therapy ( ADT ) with equivalent oncologic efficacy . Active treatment is mostly recommended for patients with localised disease and a long life expectancy with radical prostatectomy ( RP ) shown to be superior to WW in a prospect i ve r and omised trial . Nerve-sparing RP represents the approach of choice in organ-confined disease ; neoadjuvant and rogen deprivation demonstrates no improvement of outcome variables . For locally advanced disease , adjuvant ADT for 3 yr results in superior disease-specific and overall survival rates and represents the treatment of choice .
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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: INTRODUCTION The use of fluoroquinolones as prophylaxis for bacterial infections in patients with chemotherapy induced neutropenia is debatable . The present study was conducted to assess the prophylactic efficacy of fluoroquinolones in adult neutropenic patients with hematologic malignancies . MATERIAL S AND METHODS For the period 1994 through 2000 a prospect i ve , r and omized trial was conducted at the University Clinic of Hematology ( Medical University , Plovdiv ) . Two groups of patients were included -- experimental group , consisting of 36 patients with 41 granulocytopenic episodes and a control group of 34 patients with 41 granulocytopenic episodes . Non parametrical and psi methods were used for statistical analysis . Kaplan-Meier test was employed to determine patients ' survival rate . Comparison of survival rates between the two groups was performed using the log-rank test . RESULTS A statistically significant difference between the two groups was found in the number of infection-free neutropenic episodes ( P < 0.001 ) , in infection-related mortality rate ( p = 0.001 ) and mortality rate within 1 month of the onset of infection ( p < 0.001 ) . Difference in long term survival rates was not statistically significant ( p > 0.05 ) . CONCLUSIONS Prophylaxis with fluoroquinolones reduced the occurrence of infection in adult neutropenic patients without affecting the long-term survival . Moreover , it is especially beneficial for patients with severe neutropenia and during the active phase of the disease We compared ciprofloxacin alone with ciprofloxacin plus rifampin ( C + R ) as a prophylactic antibacterial regimen for 40 patients with solid tumors treated with high-dose chemotherapy and autologous stem cell transplantation support . No differences were found between groups in the time elapsed to the onset of fever , incidence of febrile episodes , amphotericin B use , and length of hospital stay . However , C + R combination prophylaxis significantly reduced the incidence of gram-positive bacteremia ( five versus zero episodes ) but was associated with a higher incidence of drug-related side effects In neutropenic patients , quinolone-based oral antibacterial chemoprophylaxis has reduced morbidity and mortality attributable to aerobic gram-negative bacteria [ 1 - 3 ] . Gram-positive organisms , predominantly viridans streptococci and coagulase-negative staphylococci , have emerged as the most common pathogens isolated in association with infection among neutropenic persons receiving quinolone [ 4 - 7 ] . St and ard empiric antibacterial regimens that target aerobic gram-negative pathogens have required the addition of broader-spectrum gram-positive coverage to achieve a response [ 8 , 9 ] . Newer quinolone agents with broader in vitro gram-positive activity have recently emerged as possible c and i date s for antibacterial chemoprophylaxis regimens . Ofloxacin is a synthetic carboxyquinolone agent with in vitro activity against aerobic gram-negative bacilli similar to that of norfloxacin but with greater activity against gram-positive organisms , such as staphylococci and streptococci [ 10 ] . Early studies [ 11 - 15 ] suggested a promising role for this agent for antibacterial prophylaxis in neutropenic patients ; however , gram-positive infections have remained a problem . Strategies to reduce gram-positive infection by combining prophylactic trimethoprim-sulfamethoxazole or quinolones with other gram-positive agents , such as erythromycin [ 16 - 18 ] , roxithromycin [ 19 ] , or the penicillins [ 15 , 20 , 21 ] , have had variable success . Studies of prophylaxis with ofloxacin in neutropenic rats at the University of Manitoba [ 22 ] showed that adding rifampin to ofloxacin reduced both viridans streptococcal and staphylococcal bacteremia . Accordingly , the National Cancer Institute of Canada Clinical Trials Group design ed an open , r and omized , controlled phase III clinical trial to test the hypothesis that an increase in the gram-positive activity of an oral quinolone-based antibacterial prophylaxis regimen would have a clinical ly significant effect on the incidence of gram-positive infection in neutropenic patients with cancer receiving cytotoxic therapy . Methods Patients Patients between 18 and 70 years of age were eligible for inclusion in this trial if they 1 ) had acute myeloid leukemia or acute lymphocytic leukemia or had received an autologous bone marrow transplant ; 2 ) were receiving cytotoxic therapy for primary remission-induction , reinduction for first relapse , postremission consolidation , or conditioning for bone marrow autografting ; 3 ) had an absolute neutrophil count ( segmented plus b and neutrophils ) of 0.5 109/L or greater at study entry , with an expectation that severe neutropenia [ neutrophil count less than 0.5 109/L ] would occur at 14 days or thereafter ; 4 ) had a negative pregnancy test result [ a criterion applicable to women of child-bearing age ] ; and 5 ) provided informed written consent . Patients were excluded if they were febrile ( oral temperature more than 38 C ) ; had gastrointestinal conditions that might interfere with drug absorption ; were hypersensitive to any of the study agents ; had major renal ( serum creatinine level more than 180 mol/L ) , hepatic ( liver function test results more than twice normal ) , or cardiovascular ( uncontrolled hypertension or congestive failure ) disorders ; had received systemic antimicrobial therapy for OUTPUT: Patients treated with quinolones have a non-significant increase in colonization by quinolone-resistant bacteria . There is no difference in the number of infections caused by pathogens resistant to quinolones . As quinolone prophylaxis reduces the risk of death in neutropenic patients , the risk associated with colonization and infections caused by quinolone-resistant organisms does not outweigh the gain . INPUT: OBJECTIVE To compare , prospect ively , 4 different schemes of antibiotic prophylaxis previously to transrectal prostate biopsy . MATERIAL S AND METHODS 257 patients were r and omized in 4 groups : Group I : single dose of ciprofloxacin 2 hours before the procedure ; Group II : ciprofloxacin 3 days ; Group III : chloramphenicol 3 days ; and Group IV : norfloxacin 3 days . The complication rate was assessed in a blind way on the third and on the thirtieth days through a question naire . Groups were compared by the qui-square method and , in small sample s , by the Fisher method , with statistical significance of 95 % . RESULTS Complications index throughout the sample differed between the 4 groups of patients under study , being 3.1 % for group I , 2.1%for group II , 18.3 % for group III and 10.5 % for group IV . Schemes employing ciprofloxacin were statistically superior to those that used norfloxacin or chloramphenicol ( p < 0.05 ) . There was no difference between a single dose and 3 days of ciprofloxacin ( p > 0.05 ) . CONCLUSION Schemes using ciprofloxacin presented better results in prophylaxis previously to prostate biopsy . We recommend using a single dose of ciprofloxacin due to its posologic ease and low cost , associated with a therapeutic response equivalent to 3-day regimens Purpose To compare the antibiotic prophylaxis based on quinolone administered orally with a combination of cephalosporin administered periprostatically and a fluoroquinolone orally , in terms of post-prostate bioptic infectious complication rates in those men undergoing transrectal ultrasound-guided prostate biopsy ( TRUS gpb ) . Methods In a prospect i ve , r and omized , double-blind study , 150 consecutive patients were r and omized to receive 10 ml lidocaine 1 % in Group A and ceftriaxone 1 g diluted in a solution of 10 ml of lidocaine 1 % in Group B , before TRUS gpb . All signed the informed consent . The men were asked to grade the pain using a ten points visual analogue scale close after TRUS gpb . In a telephone interview at 3 and 6 days , they were asked about early and late complications , assessing rectal bleeding , urinary retection , fewer , haematuria , urethral bleeding and hematospermia . Results Of the 150 men enrolled , 135 , 70 in Groups A and 65 in Group B , completed the study . Four men ( 5.7 % ) in Group A developed sepsis after TRUS gpb requiring hospital admission and intravenous antibiotic treatment , while none in Group B. Escherichia coli was the only organism isolated . The mean pain score was 2.76 ± 1.69 and 1.73 ± 1.26 for Group A and B , respectively ( p = 0.08 ) . Complications , evaluated at 3 and 6 days after the procedure through a telephone interview , were similar in both Groups . Conclusions The antibiotic prophylaxis based on the combination of ceftriaxone administered periprostatically and ciprofloxacin orally is able to offer a best control on infections caused by fluoroquinolone-resistant E. coli Transrectal biopsy is one of the more popular methods for the diagnosis of prostatic cancer . However , there is disagreement as to whether the use of prophylactic antimicrobials decreases the incidence of fever and urinary tract infections , which may follow this procedure . A prospect i ve r and omized double-blind study involving 63 patients was instituted to determine the efficacy of carbenicillin indanyl sodium in reducing these complications . The protocol consisted of administration of 2 tablets of 4 times daily of a placebo or the treatment drug 24 hours before and after biopsy . Clean catch urine cultures were obtained 24 hours before biopsy and at 48 hours and 2 weeks after the procedure . Blood cultures were performed 15 minutes after biopsy . In addition , clinical parameters were monitored closely in the hospital for 48 hours after biopsy . A total of 48 patients was considered evaluable . Of 23 patients who received the study drug 2 ( 8.6 per cent ) had positive urine cultures at 48 hours compared to 9 of 25 ( 36 per cent ) from the placebo group . A similar result was observed from the 2-week culture data , in which 2 of 23 patients ( 8.6 per cent ) in the treatment group had positive urine cultures as opposed to 5 of 25 ( 20 per cent ) receiving the placebo . Fever occurred in 48 per cent of the placebo and in 17 per cent of the carbenicillin groups . Our data indicate that prophylactic administration of carbenicillin indanyl sodium decreases the complications of fever and urinary tract infections following transrectal biopsy of the prostate BACKGROUND Infection is a serious adverse effect of prostate biopsy ( P-Bx ) , and recent reports suggest an increasing incidence . OBJECTIVE The aim of this multinational multicentre study was to evaluate prospect ively the incidence of infective complications after P-Bx and identify risk factors . DESIGN , SETTING , AND PARTICIPANTS The study was performed as an adjunct to the Global Prevalence Study of Infections in Urology ( GPIU ) during 2010 and 2011 . Men undergoing P-Bx in participating centres during the 2-wk period commencing on the GPIU study census day were eligible . OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS Baseline data were collected and OUTPUT:
Widespread use of fluoroquinolone prophylaxis may be associated with an increase in resistant Escherichia coli strains , posing a potentially major health issue in the future .
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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: Evidence -based practice involves the use of evidence from systematic review s and r and omised controlled trials , but the extent of this evidence in physiotherapy has not previously been surveyed . The aim of this survey is to describe the quantity and quality of r and omised controlled trials and the quantity of systematic review s relevant to physiotherapy . The Physiotherapy Evidence Data base ( PEDro ) was search ed . The quality of trials was assessed with the PEDro scale . The search identified a total of 2,376 r and omised controlled trials and 332 systematic review s. The first trial was published in 1955 and the first review was published in 1982 . Since that time , the number of trials and review s has grown exponentially . The mean PEDro quality score has increased from 2.8 in trials published between 1955 and 1959 to 5.0 for trials published between 1995 and 1999 . There is a substantial body of evidence about the effects of physiotherapy . However , there remains scope for improvements in the quality of the conduct and reporting of clinical trials & NA ; Pain intensity is frequently measured on an 11‐point pain intensity numerical rating scale ( PI‐NRS ) , where 0=no pain and 10=worst possible pain . However , it is difficult to interpret the clinical importance of changes from baseline on this scale ( such as a 1‐ or 2‐point change ) . To date , there are no data driven estimates for clinical ly important differences in pain intensity scales used for chronic pain studies . We have estimated a clinical ly important difference on this scale by relating it to global assessment s of change in multiple studies of chronic pain . Data on 2724 subjects from 10 recently completed placebo‐controlled clinical trials of pregabalin in diabetic neuropathy , postherpetic neuralgia , chronic low back pain , fibromyalgia , and osteoarthritis were used . The studies had similar design s and measurement instruments , including the PI‐NRS , collected in a daily diary , and the st and ard seven‐point patient global impression of change ( PGIC ) , collected at the endpoint . The changes in the PI‐NRS from baseline to the endpoint were compared to the PGIC for each subject . Categories of ‘ much improved ’ and ‘ very much improved ’ were used as determinants of a clinical ly important difference and the relationship to the PI‐NRS was explored using graphs , box plots , and sensitivity/specificity analyses . A consistent relationship between the change in PI‐NRS and the PGIC was demonstrated regardless of study , disease type , age , sex , study result , or treatment group . On average , a reduction of approximately two points or a reduction of approximately 30 % in the PI‐NRS represented a clinical ly important difference . The relationship between percent change and the PGIC was also consistent regardless of baseline pain , while higher baseline scores required larger raw changes to represent a clinical ly important difference . The application of these results to future studies may provide a st and ard definition of clinical ly important improvement in clinical trials of chronic pain therapies . Use of a st and ard outcome across chronic pain studies would greatly enhance the comparability , validity , and clinical applicability of these studies Study Design . A follow‐up study of a cohort of 444 patients aged 16 to 59 years who consulted with their general practitioners(GPs ) in 1987‐1988 for an incident episode of back pain . Objectives . To determine the proportion of patients with back pain in whom chronic back problems develop after a follow‐up of 7 years , to compare health outcomes and labor force participation of patients with and without chronic back problems and to identify determinants of chronicity . Summary of Background Data . The incidence and prevalence of back pain are very high . A large proportion of the costs related to medical consumption , absence from work , and disability are probably caused by chronic back problems . It is unknown what proportion of back problems become chronic , especially after a long follow‐up period , and which factors can predict chronicity . Methods . Data on the course of the symptoms and medical consumption from the period between 1987‐1988 and 1991 were gathered retrospectively . Data on several health outcomes , including LFP , and data on some work characteristics were collected prospect ively in 1991 . A more extensive data set on health outcomes including psychologic status and working situation was collected in 1994 . Results . Chronic back problems developed in 28 % of the patients . These patients reported more pain , higher levels of medical re source consumption , worse health outcomes , and lower labor force participation . Episodes of back pain before 1987‐1988 , severe pain in 1991 , and disability score in 1991 were positively associated with chronicity in 1994 , difficulties with job performance in 1991 , and frequent stooping in the subgroup of patients who held a paying job in the follow‐up period . Conclusions . Even after a follow‐up of 7 years , the proportion of people with chronic back problems was high . The consequences for quality of life , labor force participation , and consumption of medical re sources are clear . Further research is necessary to examine determinants and ways to prevent chronicity Properly conducted r and omised trials can aid clinical decision-making by providing unbiased estimates of the average size of treatment effects . This paper , the first of two , discusses how readers of clinical trials can extract simple estimates of treatment effect size from trial reports when trial outcomes are measured on a continuous scale . When making decisions about therapy for individual patients , these estimates can be modified on the basis of patient characteristics . Modified estimates of treatment effect size can be used to determine if the effect of treatment is likely to be large enough to be " clinical ly worthwhile " . This approach optimises clinical decision-making by combining unbiased estimates of the size of treatment effect from clinical trials with clinical intuition and patient preferences Most systematic review s rely substantially on the assessment of the method ological quality of the individual trials . The aim of this study was to obtain consensus among experts about a set of generic core items for quality assessment of r and omized clinical trials ( RCTs ) . The invited participants were experts in the field of quality assessment of RCTs OUTPUT: It is concluded that spinal manipulation does not produce clinical ly worthwhile decreases in pain compared with sham treatment , and does not produce clinical ly worthwhile reductions in disability compared with NSAIDs for patients with chronic low back pain . It is not clear whether spinal manipulation is more effective than NSAIDs in reducing pain of patients with chronic low back pain INPUT: BACKGROUND AND PURPOSE Physiotherapists ' use of research evidence with clinical decision-making has interested research ers world-wide since 1980 ; however , little is known about such practice s in Australia . The present survey sought information on Australian physiotherapists ' perceptions of the importance of research , and barriers to uptake of evidence in clinical practice , when compared with an international cohort from 2001 . METHOD An Australian-relevant version of an English ( UK ) National Health Service ( NHS ) survey instrument was used to canvass 453 physiotherapists , r and omly selected from the South Australian Physiotherapy Registration Board 2004 - 2005 records . The first survey was mailed in August 2005 , a reminder was sent two weeks later to non-responders and a follow-up survey was sent in April 2006 to non-responders whose addresses had changed since 2005 . RESULTS There was a 51 % response rate . Of the non-responders , 12 % were not contactable at their listed address , highlighting the mobility of Australian physiotherapists . Most respondents had undertaken research as students ( 59.5 % ) or as students and clinicians ( 11.5 % ) . Of these , 37.1 % were encouraged to embark on more research , and 20.5 % were discouraged . The significant predictors of positive perceived importance of research were : previous research experience ; being positive about undertaking further research ; working in hospitals and holding a postgraduate degree . Clinicians working privately were significantly less likely than managers to be positive about research importance . The only significant predictor for not perceiving barriers to uptake of evidence was being positive about undertaking future research . CONCLUSIONS The study identified constraints on uptake of evidence into practice that were related to accessing , reading and interpreting published research , and implementing findings . Found consistently across employment categories were barriers relating to lack of time , uncertainty about what the research reported , scepticism about the value of research and being isolated from peer support and literature sources . The responses indicated a positive shift towards evidence uptake since the 2001 NHS survey , suggesting an influence of increased exposure to information on evidence -based practice . A greater focus on research whilst training , the application of educational strategies for empowerment , better knowledge transfer and upskilling within the workplace , and ensuring dedicated time and organizational support for research activities are indicated Background Many authors , as well as the American Physical Therapy Association , advocate that physical therapists adopt practice patterns based on research evidence , known as evidence -based practice ( EBP ) . At the same time , physical therapists should be capable of integrating EBP within the day-to-day practice of physical therapy . The purpose of this study was to determine the extent to which personal characteristics and the characteristics of the social system in the workplace influence the propensity of physical therapists to adopt EBP . Methods The study used a 69 item mailed self-completion question naire . The question naire had four major sections . The first three sections were each drawn from a different theoretical framework and from different authors ' work . The instrument was developed to capture the propensity of physical therapists to adopt EBP , characteristics of the social system in the workplace of physical therapists , personal characteristics of physical therapists , and selected demographic variables of physical therapists . The eligible population consisted of 3,897 physical therapists licensed by the state of Georgia in the United States of America . A r and om sample of 1320 potential participants was drawn . Results 939 question naires were returned for a response rate of 73 % . 831 of the participants ' question naires were useable and became the basis for the study . There was a moderate association between desire for learning ( r = .36 , r2 = .13 ) , highest degree held ( r = .29 , r2 = .08 ) , practicality ( r = .27 , r2 = .07 ) and nonconformity ( r = .24 , r2 = .06 ) and the propensity to adopt EBP . A negative correlation was found between age , years licensed and percentage of time in direct patient care . The findings demonstrated that the best three variables for predicting the propensity to adopt EBP in physical therapy were : desire for learning , highest degree held , and practicality . Conclusion The study confirms there is no single factor to facilitate research evidence into day-to-day practice . Multiple practice change strategies will be needed to facilitate change in practice Background Training in the five steps of evidence -based practice ( EBP ) has been recommended for inclusion in entry-level health professional training . The effectiveness of EBP education has been explored predominantly in the medical and nursing professions and more commonly in post-graduate than entry-level students . Few studies have investigated longitudinal changes in EBP attitudes and behaviours . This study aim ed to assess the changes in EBP knowledge , attitudes and behaviours in entry-level physiotherapy students transitioning into the workforce . Methods A prospect i ve , observational , longitudinal design was used , with two cohorts . From 2008 , 29 participants were tested in their final year in a physiotherapy program , and after the first and second workforce years . From 2009 , 76 participants were tested in their final entry-level and first workforce years . Participants completed an Evidence -Based Practice Profile question naire ( EBP2 ) , which includes self-report EBP domains [ Relevance , Terminology ( knowledge of EBP concepts ) , Confidence , Practice ( EBP implementation ) , Sympathy ( disposition towards EBP ) ] . Mixed model analysis with sequential Bonferroni adjustment was used to analyse the matched data . Effect sizes ( ES ) ( 95 % CI ) were calculated for all changes . Results Effect sizes of the changes in EBP domains were small ( ES range 0.02 to 0.42 ) . While most changes were not significant there was a consistent pattern of decline in scores for Relevance in the first workforce year ( ES -0.42 to -0.29 ) followed by an improvement in the second year ( ES + 0.27 ) . Scores in Termin OUTPUT:
RESULTS Many physiotherapists hold positive attitudes towards EBP . However , this does not necessarily translate into consistent , high- quality EBP . Many barriers to EBP implementation are apparent , including : lack of time and skills , and misperceptions of EBP .
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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: Recent research has suggested that enhanced retraining for stroke patients using haptics ( robotic forces ) and graphics ( visual display ) to generate a practice environment that can artificially enhance error rather than reducing it , can stimulate new learning and foster accelerated recovery . We present an evaluation of early results of this novel post-stroke robotic-aided therapy trial that incorporates these ideas in a large VR system and simultaneously employs the patient , the therapist , and the technology to accomplish effective therapy Background . The 10-meter walk test and 6-minute walk test are increasingly used to evaluate the recovery of walking in patients with incomplete spinal cord injury . So far , there is no evidence whether the application of different walking distances provides complementary information about ambulatory capacity in patients with incomplete spinal cord injury . Studies about testing preferred and maximum speeds in subjects with incomplete spinal cord injury are lacking . Objective . To determine whether the combined testing of short and long distances as well as preferred and maximum speeds provides additional information about walking capacity in subjects with incomplete spinal cord injury . Methods . Depending on the objective , the subjects with incomplete spinal cord injury and age-matched control subjects had to perform the 10-meter walk test or 6-minute walk test at preferred and /or maximum walking speed . Results . During recovery , the preferred walking speed increased but did not differ when assessed during short or long distances in 51 subjects with incomplete spinal cord injury at 1 , 3 , and 6 months after injury ( mean and SD , 6-minute walk test : 0.37 ± 0.52 , 0.87 ± 0.56 , and 1.14 ± 0.52 ms —1 ; 10-meter walk test : 0.40 ± 0.53 , 0.88 ± 0.51 , and 1.12 ± 0.51 ms—1 , respectively ) . In 18 subjects with incomplete spinal cord injury , both preferred and maximum walking speeds assessed with the 10-meter walk test predicted the walking speeds of the 6-minute walk test well . Subjects with incomplete spinal cord injury prefer to walk closer to their maximum walking speed ( 74 % ± 10 % ) compared to control subjects ( 59 % ± 8 % ) . Conclusions . The velocity used for the 6-minute walking distance and the 10-meter walking speed provides comparable information in patients with incomplete spinal cord injury who can perform both tests . However , tests of the preferred and maximum walking speed add information about walking capacity . Due to the easier applicability of the 10-meter walk test in the clinical setting , the authors suggest performing this test at the preferred and maximum speeds for the assessment of walking capacity by 1 month after incomplete spinal cord injury Fifty individuals with incomplete tetraplegia due to trauma underwent serial prospect i ve examinations to quantify motor and sensory recovery . None of 5 patients who were motor complete with the presence of sacral ( S4-S5 ) sharp/dull touch sensation unilaterally recovered any lower extremity motor function . However , in 8 motor complete subjects having bilateral sacral sharp/dull sensation present , the mean lower extremity motor score increased to 12.1 + /- 7.8 at 1 year . In 3 of the 8 cases , functional ( > or = 3/5 ) recovery was seen in some muscles at 1 year . Though mean upper and lower extremity ASIA Motor Scores increased significantly ( p < .001 ) between 1 month and 1 year for the entire sample , the annualized rate of motor recovery rapidly declined in the first 6 months and then subsequently approached plateau . Eighty-seven percent ( 20 of 23 ) of patients having a lower extremity motor score > or = 10 at 1 month were community ambulators using crutches and orthoses at 1 year follow-up We used a lower limb robotic exoskeleton controlled by the wearer 's muscle activity to study human locomotor adaptation to disrupted muscular coordination . Ten healthy subjects walked while wearing a pneumatically powered ankle exoskeleton on one limb that effectively increased plantar flexor strength of the soleus muscle . Soleus electromyography amplitude controlled plantar flexion assistance from the exoskeleton in real time . We hypothesized that subjects ' gait kinematics would be initially distorted by the added exoskeleton power , but that subjects would reduce soleus muscle recruitment with practice to return to gait kinematics more similar to normal . We also examined the ability of subjects to recall their adapted motor pattern for exoskeleton walking by testing subjects on two separate sessions , 3 days apart . The mechanical power added by the exoskeleton greatly perturbed ankle joint movements at first , causing subjects to walk with significantly increased plantar flexion during stance . With practice , subjects reduced soleus recruitment by approximately 35 % and learned to use the exoskeleton to perform almost exclusively positive work about the ankle . Subjects demonstrated the ability to retain the adapted locomotor pattern between testing sessions as evidence d by similar muscle activity , kinematic and kinetic patterns between the end of the first test day and the beginning of the second . These results demonstrate that robotic exoskeletons controlled by muscle activity could be useful tools for testing neural mechanisms of human locomotor adaptation An active ankle-foot orthoses ( AAFO ) is presented where the impedance of the orthotic joint is modulated throughout the walking cycle to treat drop-foot gait . During controlled plantar flexion , a biomimetic torsional spring control is applied where orthotic joint stiffness is actively adjusted to minimize forefoot collisions with the ground . Throughout late stance , joint impedance is minimized so as not to impede powered plantar flexion movements , and during the swing phase , a torsional spring-damper control lifts the foot to provide toe clearance . To assess the clinical effects of variable-impedance control , kinetic and kinematic gait data were collected on two drop-foot participants wearing the AAFO . For each participant , zero , constant , and variable impedance control strategies were evaluated and the results were compared to the mechanics of three age , weight , and height matched normals . We find that actively adjusting joint impedance reduces the occurrence of slap foot allows greater powered plantar flexion and provides for less kinematic difference OUTPUT: RESULTS The actuated ankle-foot orthoses currently available are characterized by several combinations of an actuator and a control mechanism . Both the actuator and the control strategy substantially influence human-machine interaction and therefore the potential of the device to assist in modifying locomotor function and potentially modify the underlying motor control mechanisms . CONCLUSION Due to small sample sizes , limited studies in patients with spinal cord injury , and limitations in study design , it is difficult to draw firm conclusions on the effect of different types of actuated ankle-foot orthoses . Based on the limited data available , pneumatic artificial muscles in combination with proportional myoelectric control are suggested to have the potential to meet most of the preconditions to restore the attributes of normal gait and therefore facilitate neuroplasticity INPUT: Background When people with stroke recover gait speed , they report improved function and reduced disability . However , the minimal amount of change in gait speed that is clinical ly meaningful and associated with an important difference in function for people poststroke has not been determined . Objective The purpose of this study was to determine the minimal clinical ly important difference ( MCID ) for comfortable gait speed ( CGS ) associated with an improvement in the modified Rankin Scale ( mRS ) score for people between 20 to 60 days poststroke . Design This was a prospect i ve , longitudinal , cohort study . Methods The participants in this study were 283 people with first-time stroke prospect ively enrolled in the ongoing Locomotor Experience Applied Post Stroke ( LEAPS ) multi-site r and omized clinical trial . Comfortable gait speed was measured and mRS scores were obtained at 20 and 60 days poststroke . Improvement of ≥1 on the mRS was used to detect meaningful change in disability level . Results Mean ( SD ) CGS was 0.18 ( 0.16 ) m/s at 20 days and 0.39 ( 0.22 ) m/s at 60 days poststroke . Among all participants , 47.3 % experienced an improvement in disability level ≥1 . The MCID was estimated as an improvement in CGS of 0.16 m/s anchored to the mRS . Limitations Because the mRS is not a gait-specific measure of disability , the estimated MCID for CGS was only 73.9 % sensitive and 57.0 % specific for detecting improvement in mRS scores . Conclusions We estimate that the MCID for gait speed among patients with subacute stroke and severe gait speed impairments is 0.16 m/s . Patients with subacute stroke who increase gait speed ≥0.16 m/s are more likely to experience a meaningful improvement in disability level than those who do not . Clinicians can use this reference value to develop goals and interpret progress in patients with subacute stroke OBJECTIVE To evaluate gait biomechanics after training with a virtual reality ( VR ) system and to eluci date underlying mechanisms that contributed to the observed functional improvement in gait speed and distance . DESIGN A single blind r and omized control study . SETTING Gait analysis laboratory in a rehabilitation hospital and the community . PARTICIPANTS Fifteen men and three women with hemiparesis caused by stroke . INTERVENTIONS Subjects trained on a six-degree of freedom force-feedback robot interfaced with a VR simulation . Subjects were r and omized to either a VR group ( n=9 ) or non-VR group ( NVR , n=9 ) . Training was performed three times a week for 4 weeks for approximately 1h each visit . MAIN OUTCOME MEASURES Kinematic and kinetic gait parameters . RESULTS Subjects in the VR group demonstrated a significantly larger increase in ankle power generation at push-off as a result of training ( p=0.036 ) . The VR group had greater change in ankle ROM post-training ( 19.5 % ) as compared to the NVR group ( 3.3 % ) . Significant differences were found in knee ROM on the affected side during stance and swing , with greater change in the VR group . No significant changes were observed in kinematics or kinetics of the hip post-training . CONCLUSIONS These findings are encouraging because they support the potential for recovery of force and power of the lower extremity for individuals with chronic hemiparesis . It is likely that the effects of training included improved motor control at the ankle , which enabled the cascade of changes that produced the functional improvements seen after training Background and Purpose — Gait velocity is a powerful indicator of function and prognosis after stroke . Gait velocity can be stratified into clinical ly meaningful functional ambulation classes , such as household ambulation ( < 0.4 m/s ) , limited community ambulation ( 0.4 to 0.8 m/s ) , and full community ambulation ( > 0.8 m/s ) . The purpose of the current study was to determine whether changes in velocity-based community ambulation classification were related to clinical ly meaningful changes in stroke-related function and quality of life . Methods — In subacute stroke survivors with mild to moderate deficits who participated in a r and omized clinical trial of stroke rehabilitation and had a baseline gait velocity of 0.8 m/s or less , we assessed the effect of success versus failure to achieve a transition to the next class on function and quality of life according to domains of the Stroke Impact Scale ( SIS ) . Results — Of 64 eligible participants , 19 were initially household ambulators , and 12 of them ( 68 % ) transitioned to limited community ambulation , whereas of 45 initially limited community ambulators , 17 ( 38 % ) became full community ambulators . Function and quality -of-life SIS scores after treatment were significantly higher among survivors who achieved a favorable transition compared with those who did not . Among household ambulators , those who transitioned to limited or full community ambulation had significantly better SIS scores in mobility ( P=0.0299 ) and participation ( P=0.0277 ) . Among limited community ambulators , those who achieved the transition to full community ambulatory status had significantly better scores in SIS participation ( P=0.0085 ) . Conclusions — A gait velocity gain that results in a transition to a higher class of ambulation results in better function and quality of life , especially for household ambulators . Household ambulators possibly had more severe stroke deficits , reducing the risk of “ ceiling ” effects in SIS-measured activities of daily living and instrumental activities of daily living . Outcome assessment based on transitions within a mobility classification scheme that is rooted in gait velocity yields potentially meaningful indicators of clinical benefit . Outcomes should be selected that are clinical ly meaningful for all levels of severity Background and Purpose — Training of the lower extremity ( LE ) using a robot coupled with virtual environments has shown to transfer to improved overground locomotion . The purpose of this study was to determine whether the transfer of training of LE movements to locomotion was greater using a virtual environment coupled with a OUTPUT:
CONCLUSIONS : This review provided evidence that walking training associated with virtual reality-based training was effective in increasing walking speed after stroke , and result ed in better results than non-virtual reality interventions
MS2_dynamic_1_shot466
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: OBJECTIVE To assess the efficacy and safety of aripiprazole versus placebo as adjunctive treatment to st and ard antidepressant therapy ( ADT ) in patients with major depressive disorder ( MDD ) who showed an incomplete response to 1 prospect i ve and 1 to 3 historical courses of ADT within the current episode . METHOD The study comprised a 7- to 28-day screening phase , an 8-week prospect i ve treatment phase , and a 6-week double-blind treatment phase . Patients with DSM-IV-TR-defined MDD were enrolled between June 16 , 2004 , and April 27 , 2006 . During prospect i ve treatment , patients received ADT : escitalopram , fluoxetine , paroxetine controlled-release , sertraline , or venlafaxine extended-release , each with single-blind , adjunctive placebo . Incomplete responders continued ADT and were r and omly assigned to double-blind , adjunctive placebo or adjunctive aripiprazole ( 2 - 15 mg/day with fluoxetine or paroxetine ; 2 - 20 mg/day with all others ) . The primary efficacy endpoint was the mean change from end of prospect i ve treatment to end of double-blind treatment ( week 14 , last observation carried forward ) in Montgomery-Asberg Depression Rating Scale ( MADRS ) total score ( analysis of covariance ) . RESULTS A total of 178 patients were r and omly assigned to adjunctive placebo and 184 to adjunctive aripiprazole . Baseline demographics were similar between groups ( mean MADRS total score of 26.0 ) . Mean change in MADRS total score was significantly greater with adjunctive aripiprazole ( -8.8 ) than adjunctive placebo ( -5.8 ; p < .001 ) . Adverse events ( AEs ) that occurred in > or = 10 % of patients with adjunctive placebo or adjunctive aripiprazole were akathisia ( 4.5 % vs. 23.1 % ) , headache ( 10.8 % vs. 6.0 % ) , and restlessness ( 3.4 % vs. 14.3 % ) . Discontinuations due to AEs were low with adjunctive placebo ( 1.7 % ) and adjunctive aripiprazole ( 2.2 % ) ; only 1 adjunctive aripiprazole-treated patient discontinued due to akathisia . CONCLUSIONS In patients with MDD who showed an incomplete response to ADT , adjunctive aripiprazole was efficacious and well tolerated . CLINICAL TRIALS REGISTRATION Clinical Trials.gov identifier NCT00095823 BACKGROUND Previous reports have suggested that lamotrigine is effective as an antidepressant augmentation agent in patients with treatment-resistant unipolar depression . This study is the largest double-blind placebo-controlled study conducted to date of lamotrigine in this role . METHOD In this multicenter trial , conducted at 19 sites , patients aged 18 - 65 years with a DSM-IV/ICD-10 diagnosis of unipolar , nonpsychotic major depressive disorder ( confirmed by the Mini-International Neuropsychiatric Interview ) who had failed at least 1 adequate trial of an antidepressant ( N = 183 ) were first treated for 8 weeks with open-label paroxetine or paroxetine controlled-release in dosages up to 50 mg/d or 62.5 mg/d , respectively . Individuals with a 17-item Hamilton Depression Rating Scale ( HDRS-17 ) score ≥ 15 ( n = 96 ) were then r and omized on a double-blind basis to receive either placebo or lamotrigine in dosages titrated upward to a maximum of 400 mg/d for 10 weeks . Sixty-five patients completed the study . The primary outcome measure was the Montgomery-Asberg Depression Rating Scale ( MADRS ) , and the main secondary outcome measures were the HDRS-17 and Clinical Global Impressions-Severity of Illness ( CGI-S ) and Clinical Global Impressions-Improvement ( CGI-I ) ratings . Data were collected from 2003 to 2006 . RESULTS Results of the primary efficacy analysis of the r and omized patients using the MADRS , HDRS-17 , CGI-S , and CGI-I did not demonstrate a statistically significant difference between lamotrigine and placebo groups , although some secondary analyses were suggestive of efficacy , particularly in those patients who completed the study ( completer analysis ) and in more severely ill patients ( HDRS-17 ≥ 25 ) . CONCLUSIONS This add-on study of patients with treatment-resistant depression failed to detect a statistically significant difference between lamotrigine and placebo given for 10 weeks . However , post hoc analyses suggest that future studies of lamotrigine 's efficacy might focus on specific subgroups with depression . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00901407 BACKGROUND This phase 2 study examined the efficacy and tolerability of edivoxetine , a highly selective norepinephrine reuptake inhibitor , as an adjunctive treatment for patients with major depressive disorder ( MDD ) who have a partial response to selective serotonin reuptake inhibitor ( SSRI ) treatment . METHODS Study design consisted of double-blind , 10-week therapy of adjunctive edivoxetine ( 6 - 18 mg once daily ) or adjunctive placebo with SSRI . Inclusion /entry criteria included partial response to current SSRI by investigator opinion and a GRID 17-item Hamilton Rating Scale for Depression ( HAMD17 ) total score ≥16 . OUTPUT: Thus , where a benefit was observed on the SDS total or mean , this was generally driven by improvement on the " social life " and " family life " items . Conclusion The SDS , a self-rated functional measure , is informative in acute r and omized placebo-controlled studies of adjunctive therapy in patients with MDD and inadequate response to ADT . However , the item that measures work performance may be less relevant to this population than the items that measure social and family life INPUT: OBJECTIVE To assess the efficacy and safety of aripiprazole versus placebo as adjunctive treatment to st and ard antidepressant therapy ( ADT ) in patients with major depressive disorder ( MDD ) who showed an incomplete response to 1 prospect i ve and 1 to 3 historical courses of ADT within the current episode . METHOD The study comprised a 7- to 28-day screening phase , an 8-week prospect i ve treatment phase , and a 6-week double-blind treatment phase . Patients with DSM-IV-TR-defined MDD were enrolled between June 16 , 2004 , and April 27 , 2006 . During prospect i ve treatment , patients received ADT : escitalopram , fluoxetine , paroxetine controlled-release , sertraline , or venlafaxine extended-release , each with single-blind , adjunctive placebo . Incomplete responders continued ADT and were r and omly assigned to double-blind , adjunctive placebo or adjunctive aripiprazole ( 2 - 15 mg/day with fluoxetine or paroxetine ; 2 - 20 mg/day with all others ) . The primary efficacy endpoint was the mean change from end of prospect i ve treatment to end of double-blind treatment ( week 14 , last observation carried forward ) in Montgomery-Asberg Depression Rating Scale ( MADRS ) total score ( analysis of covariance ) . RESULTS A total of 178 patients were r and omly assigned to adjunctive placebo and 184 to adjunctive aripiprazole . Baseline demographics were similar between groups ( mean MADRS total score of 26.0 ) . Mean change in MADRS total score was significantly greater with adjunctive aripiprazole ( -8.8 ) than adjunctive placebo ( -5.8 ; p < .001 ) . Adverse events ( AEs ) that occurred in > or = 10 % of patients with adjunctive placebo or adjunctive aripiprazole were akathisia ( 4.5 % vs. 23.1 % ) , headache ( 10.8 % vs. 6.0 % ) , and restlessness ( 3.4 % vs. 14.3 % ) . Discontinuations due to AEs were low with adjunctive placebo ( 1.7 % ) and adjunctive aripiprazole ( 2.2 % ) ; only 1 adjunctive aripiprazole-treated patient discontinued due to akathisia . CONCLUSIONS In patients with MDD who showed an incomplete response to ADT , adjunctive aripiprazole was efficacious and well tolerated . CLINICAL TRIALS REGISTRATION Clinical Trials.gov identifier NCT00095823 OBJECTIVE To evaluate the efficacy and tolerability of once-daily extended release quetiapine fumarate ( quetiapine XR ) as monotherapy treatment for major depressive disorder ( MDD ) . METHOD This 8-week ( 6-week active-treatment , r and omized phase ; 2-week posttreatment drug-discontinuation/tapering phase ) , multicenter , double-blind , r and omized , parallel-group , placebo- and active-controlled , phase 3 study was conducted between April 2006 and May 2007 . In total , 612 patients with Diagnostic and Statistical Manual of Mental Disorders , Fourth Edition (DSM-IV)-defined MDD were r and omly assigned to quetiapine XR 150 mg/day or 300 mg/day , duloxetine 60 mg/day ( active control ) , or placebo . The primary endpoint was the change from baseline to week 6 in Montgomery-Asberg Depression Rating Scale ( MADRS ) total score . RESULTS At week 6 , both doses of quetiapine XR ( p < .001 ) and duloxetine ( p < .01 ) significantly reduced mean MADRS total score versus placebo . A significant reduction was seen at week 1 with quetiapine XR 150 mg/day and 300 mg/day versus placebo ( p < .01 ) , but not with duloxetine . Response rates ( > or= 50 % reduction in MADRS total score ) at week 6 were significantly higher for both doses of quetiapine XR ( p < .01 ) and duloxetine ( p < .05 ) versus placebo . Remission rates ( MADRS score < or= 8) were significantly higher for quetiapine XR 300 mg/day and duloxetine versus placebo ( p < .05 ) , but not for quetiapine XR 150 mg/day . Hamilton Rating Scale for Depression , Hamilton Rating Scale for Anxiety , and Clinical Global Impressions-Severity of Illness total scores and the proportion of patients with Clinical Global Impressions-Improvement scores of 1 or 2 ( " much/very much improved " ) were significantly improved with both doses of quetiapine XR and duloxetine versus placebo . The most common adverse events reported were dry mouth , sedation , and somnolence for quetiapine XR and nausea , headache , dizziness , and dry mouth for duloxetine . CONCLUSION Quetiapine XR monotherapy ( 150 mg/day and 300 mg/day ) is effective , with safety and tolerability consistent with the known profile of quetiapine XR , in the treatment of patients with MDD , with onset of symptom improvement demonstrated at week 1 . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00321490 OBJECTIVE Patients ( 30 - 50 % ) with non-psychotic major depression will not respond despite an adequate trial of antidepressant medication . This study evaluated risperidone as an augmenting agent for patients who failed or OUTPUT:
There were some beneficial effects compared to placebo or antidepressants but tolerability was worse . Quetiapine was more effective than placebo treatment . Aripiprazole and quetiapine and partly also olanzapine and risperidone augmentation showed beneficial effects compared to placebo . Some evidence indicated beneficial effects of low-dose amisulpride for dysthymic people . Most SGAs showed worse tolerability
MS2_dynamic_1_shot467
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: BACKGROUND Optimal alignment of the prosthesis in total knee arthroplasty results in improved patient outcomes . The goal of this study was to determine the most accurate technique for component alignment in total knee arthroplasty by comparing computer-assisted surgery with two conventional techniques involving use of an intramedullary guide for the femur and either an intramedullary or an extramedullary guide for the tibia . METHODS One hundred and seven patients were r and omized prior to surgery to one of three arms : computer-assisted surgery for both the femur and the tibia ( the computer-assisted surgery group ) , intramedullary guides for both the femur and the tibia ( the intramedullary guide group ) , and an intramedullary guide for the femur and an extramedullary guide for the tibia ( the extramedullary guide group ) . Measurements of alignment on hip-to-ankle radiographs and computed tomography ( CT ) scans made three months after surgery were evaluated . The operative times and complications were compared among the three groups . RESULTS The coronal tibiofemoral angle demonstrated , on average , less malalignment in the computer-assisted surgery group ( 1.91 ° ) than in the extramedullary ( 3.22 ° ) and intramedullary ( 2.59 ° ) groups ( p = 0.007 ) . The coronal tibiofemoral angle was > 3 ° of varus or valgus deviation in 19 % ( seven ) of the thirty-six patients treated with computer-assisted surgery compared with 38 % ( thirteen ) of the thirty-four in the extramedullary guide group and 36 % ( thirteen ) of the thirty-six in the intramedullary guide group ( p = 0.022 ) . The increase in accuracy with computer-assisted surgery came at a cost of increased operative time . The operative time for the computer-assisted surgery group averaged 107 minutes compared with eighty-three and eighty minutes , respectively , for the surgery with the extramedullary and intramedullary guides ( p < 0.0001 ) . There was no significant difference in any of the outcomes between the intramedullary and extramedullary guide groups . CONCLUSIONS This study provides evidence that the implant alignment with computer-assisted total knee arthroplasty , as measured with radiography and computed tomography , is significantly improved compared with that associated with conventional surgery with intramedullary or extramedullary guides . This finding adds to the body of evidence showing an improved radiographic outcome with computer-assisted surgery compared with that following conventional total knee arthroplasty Background The Knee injury and Osteoarthritis Outcome Score ( KOOS ) is an extension of the Western Ontario and McMaster Universities Osteoarthrtis Index ( WOMAC ) , the most commonly used outcome instrument for assessment of patient-relevant treatment effects in osteoarthritis . KOOS was developed for younger and /or more active patients with knee injury and knee osteoarthritis and has in previous studies on these groups been the more responsive instrument compared to the WOMAC . Some patients eligible for total knee replacement have expectations of more dem and ing physical functions than required for daily living . This encouraged us to study the use of the Knee injury and Osteoarthritis Outcome Score ( KOOS ) to assess the outcome of total knee replacement . Methods We studied the test-retest reliability , validity and responsiveness of the Swedish version LK 1.0 of the KOOS when used to prospect ively evaluate the outcome of 105 patients ( mean age 71.3 , 66 women ) after total knee replacement . The follow-up rates at 6 and 12 months were 92 % and 86 % , respectively . Results The intraclass correlation coefficients were over 0.75 for all subscales indicating sufficient test-retest reliability . Bl and -Altman plots confirmed this finding . Over 90 % of the patients regarded improvement in the subscales Pain , Symptoms , Activities of Daily Living , and knee-related Quality of Life to be extremely or very important when deciding to have their knee operated on indicating good content validity . The correlations found in comparison to the SF-36 indicated the KOOS measured expected constructs . The most responsive subscale was knee-related Quality of Life . The effect sizes of the five KOOS subscales at 12 months ranged from 1.08 to 3.54 and for the WOMAC from 1.65 to 2.56 . Conclusion The Knee injury and Osteoarthritis Outcome Score ( KOOS ) is a valid , reliable , and responsive outcome measure in total joint replacement . In comparison to the WOMAC , the KOOS improved validity and may be at least as responsive as the WOMAC To compare the alignment after computer-navigated total knee arthroplasty , 52 patients were r and omly allocated to 2 groups . Twenty-seven patients received a total knee arthroplasty with the aid of a kinematic computer-navigation system , and 25 patients received a total knee arthroplasty with the conventional method . Both groups were well balanced concerning demographic data and preoperative scores . At 3-month follow-up , the mechanical alignment of the leg reached the desired straight axis in more cases with the computer-navigated implantation . This difference was statistically significant . The femoral and tibial mechanical anteroposterior axis and the femoral and tibial sagittal tilt ( slope ) measured on sagittal x-rays were not significantly improved in this patient group Purpose This study aim ed to verify if the navigation system used in high tibial osteotomy ( HTO ) adds precision to the procedure regarding mechanical axis correction and prevention of tibial slope increases . Methods In this historically controlled study , patients with medial osteoarthrosis and genuvarum underwent HTO between 2004 and 2012 ; the first 20 were operated with the conventional technique , using pre-planning correction by the Dugdale method and 18 further patients were operated with the navigation system introduced in our hospital . OUTPUT: Postoperative clinical and functional scores were improved by navigated HTO although it is not demonstrated if there is significant improvement compared to conventional HTO . Radiographic outcomes reported commonly were weight-bearing mechanical axis , coronal plane angle , and posterior tibial slope angle in the sagittal plane . Studies have shown HTO gives significant correction of mechanical alignment and navigated HTO produces significantly less change in posterior tibial slope postoperatively compared to conventional . Conclusion Navigation HTO results in improved mechanical axis alignment and demonstrates significantly better control over the tibial slope angle change postoperatively compared to conventional methods ; however , these improvements have not yet been reflected in clinical outcome scores . Overall the studies report HTO does create significantly improved knee scores and functions compared to patients ’ preoperative ratings regardless of technique . INPUT: Abstract Purpose It was our hypothesis that patient-specific instrumentation ( PSI ) can improve the accuracy of the rotational alignment in TKA based on the concept of the system and on the potential to clearly identify pre-operatively during planning the classical anatomical l and marks that serve as references to set-up the rotation both for the femur and tibia . Material s and methods In this prospect i ve comparative r and omized study , 40 patients ( 20 in each group ) operated in our institution between September 2012 and January 2013 by the 2 senior authors were included . R and omization of patients into one of the two groups was done by the Hospital Informatics Department with the use of a systematic sampling method . All patients received the same cemented high-flex mobile bearing TKA . In the PSI group , implant position was compared to the planed position using previously vali date d dedicated software . The position of the implants ( frontal and sagittal ) was compared in the 2 groups on st and ard X-rays , and the rotational position was analysed on post-operative CT-scan . Results 90 % of the patients add < 2 ° or mm of difference between the planned position of the implants and the obtained position , except for the tibial rotation where the variations were much higher . Mean HKA was 179 ° ( 171–185 ) in the PSI group with 4 outliers ( 2 varus : 171 ° and 172 ° :184 ° and 185 ° ) and 178.3 ° with 2 outliers ( 171 ° and 176 ° ) in the control group . No difference was observed between the two groups concerning the frontal and sagittal position of the implants on the ML and AP X-rays . No significant difference of femoral rotation was observed between the two groups with a mean of 0.4 ° in the PSI group and 0.2 ° in the control group ( p : n.s ) . Mean tibial rotation was 8 ° of internal rotation in the PSI group and 15 ° of internal rotation in the st and ard group ( p : n.s ) . Conclusion Based on our results , we were unable to confirm our hypothesis as PSI can not improve rotation in TKA . More work needs to be done to more clearly define the place of PSI in TKA , to keep on improving the accuracy of the system and to better define the individual targets in TKA in terms of frontal , sagittal and rotational positioning of the implant for each patient . Level of evidence Prospect i ve comparative r and omized study , Level II Background Recently , patient-specific guides ( PSGs ) have been introduced , cl aim ing a significant improvement in accuracy and reproducibility of component positioning in TKA . Despite intensive marketing by the manufacturers , this cl aim has not yet been confirmed in a controlled prospect i ve trial . Questions / purpose sWe ( 1 ) compared three-planar component alignment and overall coronal mechanical alignment between PSG and conventional instrumentation and ( 2 ) logged the need for applying changes in the suggested position of the PSG . Methods In this r and omized controlled trial , we enrolled 128 patients . In the PSG cohort , surgical navigation was used as an intraoperative control . When the suggested cut deviated more than 3 ° from target , the use of PSG was ab and oned and marked as an outlier . When cranial-caudal position or size was adapted , the PSG was marked as modified . All patients underwent long-leg st and ing radiography and CT scan . Deviation of more than 3 ° from the target in any plane was defined as an outlier . Results The PSG and conventional cohorts showed similar numbers of outliers in overall coronal alignment ( 25 % versus 28 % ; p = 0.69 ) , femoral coronal alignment ( 7 % versus 14 % ) ( p = 0.24 ) , and femoral axial alignment ( 23 % versus 17 % ; p = 0.50 ) . There were more outliers in tibial coronal ( 15 % versus 3 % ; p = 0.03 ) and sagittal 21 % versus 3 % ; p = 0.002 ) alignment in the PSG group than in the conventional group . PSGs were ab and oned in 14 patients ( 22 % ) and modified in 18 ( 28 % ) . Conclusions PSGs do not improve accuracy in TKA and , in our experience , were somewhat impractical in that the procedure needed to be either modified or ab and oned with some frequency . Level of Evidence Level I , therapeutic study . See instructions for authors for a complete description of levels of evidence BACKGROUND Patient-specific femoral and tibial cutting blocks produced with use of data from preoperative computed tomography ( CT ) or magnetic resonance imaging ( MRI ) scans have been employed recently to optimize component alignment in total knee arthroplasty . We report the results of a r and omized controlled trial in which CT scans were used to compare postoperative component alignment between patients treated with custom instruments and those managed with traditional instruments . METHODS The in-hospital data and early clinical outcomes , including Knee Society scores , were determined in a r and omized clinical trial of forty-seven patients who had undergone a total of forty-eight primary total knee arthroplasties with patient-specific instruments ( twenty-two knees ) or st and ard instruments ( twenty-six knees ) . Orientation of the implants was compared by using three-dimensional CT data . RESULTS No significant differences were found between the study and control groups with respect to any clinical outcome after a minimum of six months of follow-up . The patient-specific tibial cutting block was ab and oned in favor of a st and ard external alignment jig in seven of the twenty-two study knees because of possible malalignment . A detailed analysis of intent-to-treat and per- protocol groups of study and control knees did not show any significant improvement in component alignment , including femoral component rotation in the axial plane , in the patients treated with the custom instruments . The percentage of outliers -- defined as less than -3 ° or more than 3 ° from the correct orientation of the tibial slope -- was significantly higher in the group treated with use of patient-specific blocks OUTPUT:
We found that there was no significant benefit from using PS instrumentation in primary knee arthroplasty to aid in the positioning of either the tibial or femoral components . Furthermore sagittal plane tibial component positioning was worse in the PS than the traditional ST group . Our results suggest that at present PS instrumentation is not superior to ST instrumentation in primary total knee arthroplasty .
MS2_dynamic_1_shot468
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more CONTEXT We wanted to investigate vitamin D in low-risk prostate cancer . OBJECTIVES The objective of the study was to determine whether vitamin D(3 ) supplementation at 4000 IU/d for 1 yr is safe and would result in a decrease in serum levels of prostate-specific antigen ( PSA ) or in the rate of progression . DESIGN In this open-label clinical trial ( Investigational New Drug 77,839 ) , subjects were followed up until repeat biopsy . SETTING All subjects were enrolled through the Medical University of South Carolina and the Ralph H. Johnson Veterans Affairs Medical Center , both in Charleston , SC . PATIENTS AND OTHER PARTICIPANTS All subjects had a diagnosis of low-risk prostate cancer . Fifty-two subjects were enrolled in the study , 48 completed 1 yr of supplementation , and 44 could be analyzed for both safety and efficacy objectives . INTERVENTION The intervention included vitamin D(3 ) soft gels ( 4000 IU ) . MAIN OUTCOME MEASURES Adverse events were monitored throughout the study . PSA serum levels were measured at entry and every 2 months for 1 yr . Biopsy procedures were performed before enrollment ( for eligibility ) and after 1 yr of supplementation . RESULTS No adverse events associated with vitamin D(3 ) supplementation were observed . No significant changes in PSA levels were observed . However , 24 of 44 subjects ( 55 % ) showed a decrease in the number of positive cores or decrease in Gleason score ; five subjects ( 11 % ) showed no change ; 15 subjects ( 34 % ) showed an increase in the number of positive cores or Gleason score . CONCLUSION Patients with low-risk prostate cancer under active surveillance may benefit from vitamin D(3 ) supplementation at 4000 IU/d Non-r and omised studies of the effects of interventions are critical to many areas of healthcare evaluation , but their results may be biased . It is therefore important to underst and and appraise their strengths and weaknesses . We developed ROBINS-I ( “ Risk Of Bias In Non-r and omised Studies - of Interventions ” ) , a new tool for evaluating risk of bias in estimates of the comparative effectiveness ( harm or benefit ) of interventions from studies that did not use r and omisation to allocate units ( individuals or clusters of individuals ) to comparison groups . The tool will be particularly useful to those undertaking systematic review s that include non-r and omised studies Objective A small r and omized controlled trial suggested that vitamin D might increase the production of testosterone in men , which is supported by experimental studies in animals and a cross‐sectional study showing positive associations between plasma 25‐hydroxyvitamin D [ 25(OH)D ] and testosterone and concordant seasonal variation of both biomarkers The male reproductive tract has been identified as a target tissue for vitamin D , and previous data suggest an association of 25-hydroxyvitamin D [ 25(OH)D ] with testosterone levels in men . We therefore aim ed to evaluate whether vitamin D supplementation influences testosterone levels in men . Healthy overweight men undergoing a weight reduction program who participated in a r and omized controlled trial were analyzed for testosterone levels . The entire study included 200 nondiabetic subjects , of whom 165 participants ( 54 men ) completed the trial . Participants received either 83 μg ( 3,332 IU ) vitamin D daily for 1 year ( n = 31 ) or placebo ( n = 2 3 ) . Initial 25(OH)D concentrations were in the deficiency range ( < 50 nmol/l ) and testosterone values were at the lower end of the reference range ( 9.09 - 55.28 nmol/l for males aged 20 - 49 years ) in both groups . Mean circulating 25(OH)D concentrations increased significantly by 53.5 nmol/l in the vitamin D group , but remained almost constant in the placebo group . Compared to baseline values , a significant increase in total testosterone levels ( from 10.7 ± 3.9 nmol/l to 13.4 ± 4.7 nmol/l ; p < 0.001 ) , bioactive testosterone ( from 5.21 ± 1.87 nmol/l to 6.25 ± 2.01 nmol/l ; p = 0.001 ) , and free testosterone levels ( from 0.222 ± 0.080 nmol/l to 0.267 ± 0.087 nmol/l ; p = 0.001 ) were observed in the vitamin D supplemented group . By contrast , there was no significant change in any testosterone measure in the placebo group . Our results suggest that vitamin D supplementation might increase testosterone levels . Further r and omized controlled trials are warranted to confirm this hypothesis Background Systematic Review s ( SRs ) of experimental animal studies are not yet common practice , but awareness of the merits of conducting such SRs is steadily increasing . As animal intervention studies differ from r and omized clinical trials ( RCT ) in many aspects , the methodology for SRs of clinical trials needs to be adapted and optimized for animal intervention studies . The Cochrane Collaboration developed a Risk of Bias ( RoB ) tool to establish consistency and avoid discrepancies in assessing the method ological quality of RCTs . A similar initiative is warranted in the field of animal experimentation . Methods We provide an RoB tool for animal intervention studies ( SYRCLE ’s RoB tool ) . This tool is based on the Cochrane RoB OUTPUT: Discussion To our knowledge , this will be the first systematic synthesis of the evidence underpinning the vitamin D-testosterone-prostate cancer mechanistic pathway . INPUT: To assess the immediate and sustained relief of the symptoms of interstitial cystitis/painful bladder syndrome ( IC/PBlS ) after a consecutive 5‐day course of treatment with intravesical alkalinized lidocaine ( PSD597 ) , and to characterize the pharmacokinetics of single and multiple doses of intravesical PSD597 in a subgroup of patients OBJECTIVE To evaluate the therapeutic efficacy of intravesical pentosanpolysulphate ( PPS ) compared with placebo in patients with interstitial cystitis ( IC ) . PATIENTS AND METHODS Twenty patients who fulfilled the diagnostic criteria for IC participated in a double-blind placebo-controlled study ; 10 received intravesical PPS ( 300 mg in 50 mL of 0.9 % sodium chloride ) applied twice a week for 3 months and the other 10 received a placebo . Symptomatic relief and objective variables ( bladder capacity voiding volumes and urinary frequency ) were assessed after 3 months and the long-term outcome of those continuing treatment was determined . RESULTS Of the patients treated with PPS , four gained significant symptomatic relief compared with only two receiving placebo . Only the urodynamic bladder capacity showed a statistically significant increase in patients treated with PPS ( P = 0.047 ) . At 18 months from the start of the study , the symptoms were relieved in eight patients while still receiving PPS instillations and in four without treatment . CONCLUSIONS These results suggest that intravesical PPS is an effective option for the treatment of IC and shows that the intravesical application of PPS is a safe treatment with no important side-effects PURPOSE We compared intravesical bacillus Calmette-Guerin ( BCG ) to placebo instillations in patients with treatment refractory interstitial cystitis ( IC ) . MATERIAL S AND METHODS Subjects who met the National Institutes of Health-National Institute for Diabetes and Digestive and Kidney Diseases criteria for IC , and reported at least moderate pain and frequency for a minimum of 6 months before study entry , were r and omized to 6 weekly double-blinded intravesical instillations of either BCG or placebo , and then followed for a total of 34 weeks . The primary outcome was a patient reported global response assessment at week 34 , supplemented with medications for IC during weeks 31 to 34 . Secondary outcomes included a 24-hour voiding diary , pain , urgency , vali date d IC symptom indexes and adverse events . The target sample size was 260 participants , design ed to detect a difference in response rates between placebo and BCG of 30 % and 50 % , respectively . RESULTS A total of 265 participants were r and omized and 17 ( 6 % ) patients withdrew from study . The response rates for the primary outcome were 12 % for placebo and 21 % for BCG ( p = 0.062 ) . Small improvements were observed for all secondary outcomes , some more so with BCG , but these differences were of borderline statistical significance . Although a large number of adverse events were reported in the BCG arm , there was no statistically significant difference between the treatment arms in overall adverse event rates . CONCLUSIONS Although the BCG safety profile was acceptable , the response rate for the primary outcome was low . Effective medical treatment for patients with moderate to severe interstitial cystitis remains elusive PURPOSE To evaluate the efficacy and safety of intravesical Bacillus Calmette-Gurein injection in the treatment of female patients with interstitial cystitis . MATERIAL S AND METHODS Thirty women meeting the National Institute of Arthritis , Diabetes , digestive and kidney diseases criteria for interstitial cystitis , were r and omized in a double-blinded fashion in two groups each consisted of 15 patients to receive six , weekly instillation of 120 mg BCG vaccine of Iranian Institute of pastor or placebo . Periodic question naires on symptoms of interstitial cystitis , voiding diaries , bladder capacity at first desire to void , and maximum bladder capacity were obtained . Adverse events were closely monitored during the treatment and follow-up phases of the study . Subjective and objective baseline values were compared with the follow-up data . RESULTS With a mean follow-up of 24 ( range 6 to 33 ) months 11 out of 15 ( 73 % ) in BCG group , and 3 out of 15 ( 20 % ) in placebo group responded to the treatment ( p<0.002 ) . Responders were defined the patients with more than 40 % improvement in the symptoms of interstitial cystitis . The global improvement in symptoms and signs of interstitial cystitis was 62 % . Adverse events were similar in both groups , mostly irritative in nature and no significant systemic event was noted . BCG did not worsen interstitial cystitis symptoms . CONCLUSION We concluded that intravesical BCG is safe , effective , available , and inexpensive with relatively durable results in the treatment of interstitial cystitis PURPOSE We assess the efficacy of intravesical administration of oxybutynin chloride in patients with interstitial cystitis . MATERIAL S AND METHODS The study included 36 women with a mean age of 45 years with a diagnosis of interstitial cystitis . Patients were treated with gradual intravesical instillation of saline oxybutynin solution ( oxybutynin group ) or gradual filling of simple saline ( control group ) . Evaluation parameters consisted of symptom problem index , voids per day , volume per void , functional bladder capacity , volume at first sensation , cystometric bladder capacity and cystometric volume at first sensation . RESULTS Statistically significant improvement of all evaluated parameters was found in both groups . When comparing the outcomes statistically significant improvement of parameters favored the oxybutynin group . CONCLUS OUTPUT:
Meta- analysis of BCG therapy showed improvement in symptoms according to the Wisconsin Interstitial Cystitis Symptom Inventory , but no difference in 24-h urinary frequency . Conclusions Meta- analysis showed an improvement exclusively of the symptoms as measured by the Wisconsin Interstitial Cystitis Inventory , but not in 24-h urinary frequency , with BCG therapy .
MS2_dynamic_1_shot469
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: Abstract Background Diabetes prevalence is increasing . The Finnish Diabetes Prevention Study ( DPS ) showed a 58 % reduction in Type 2 Diabetes ( T2D ) incidence in adults with impaired glucose tolerance ( IGT ) . The European Diabetes Prevention Study ( EDIPS ) extends the DPS to different European population s , using the same study design . In the Newcastle arm of this study ( EDIPS-Newcastle ) , we tested the hypothesis that T2D can be prevented by lifestyle intervention and explored secondary outcomes in relation to diabetes incidence . Methods We recruited 102 participants ( 42 men and 60 women , mean age 57 years , mean BMI 34 kgm-2 ) with IGT to EDIPS-Newcastle and r and omised to Intervention and usual care Control groups . The intervention included individual motivational interviewing aim ed at : weight reduction , increase in physical activity , fibre and carbohydrate intake and reduction of fat intake ( secondary outcomes ) . The primary outcome was diagnosis of T2D . Results Mean duration of follow-up was 3.1 years . T2D was diagnosed in 16 participants ( I = 5 , C = 11 ) . Absolute incidence of T2D was 32.7 per 1000 person-years in the Intervention-group and 67.1 per 1000 person-years in the Control-group . The overall incidence of diabetes was reduced by 55 % in the Intervention-group , compared with the Control-group : RR 0.45 ( 95%CI 0.2 to 1.2).Explanatory survival analysis of secondary outcomes showed that those who sustained beneficial changes for two or more years reduced their risk of developing T2D . Conclusion Our results are consistent with other diabetes prevention trials . This study was design ed as part of a larger study and although the sample size limits statistical significance , the results contribute to the evidence that T2D can be prevented by lifestyle changes in adults with IGT . In explanatory analysis small sustained beneficial changes in weight , physical activity or dietary factors were associated with reduction in T2D incidence . Trial Registration International St and ard R and omised Controlled Trial Number registry ( IS RCT N)Registry number : IS RCT N 15670600 http://www.controlled-trials.com/is rct n/ search .html?srch=15670600%26sort=3%26dir = Background R and omised controlled trials demonstrate a 60 % reduction in type 2 diabetes incidence through lifestyle modification programmes . The aim of this study is to determine whether such programmes are feasible in primary health care . Methods An intervention study including 237 individuals 40–75 years of age with moderate or high risk of developing type 2 diabetes . A structured group programme with six 90 minute sessions delivered during an eight month period by trained nurses in Australian primary health care in 2004–2006 . Main outcome measures taken at baseline , three , and 12 months included weight , height , waist circumference , fasting plasma glucose and lipids , plasma glucose two hours after oral glucose challenge , blood pressure , measures of psychological distress and general health outcomes . To test differences between baseline and follow-up , paired t-tests and Wilcoxon rank sum tests were performed . Results At twelve months participants ' mean weight reduced by 2.52 kg ( 95 % confidence interval 1.85 to 3.19 ) and waist circumference by 4.17 cm ( 3.48 to 4.87 ) . Mean fasting glucose reduced by 0.14 mmol/l ( 0.07 to 0.20 ) , plasma glucose two hours after oral glucose challenge by 0.58 mmol/l ( 0.36 to 0.79 ) , total cholesterol by 0.29 mmol/l ( 0.18 to 0.40 ) , low density lipoprotein cholesterol by 0.25 mmol/l ( 0.16 to 0.34 ) , triglycerides by 0.15 mmol/l ( 0.05 to 0.24 ) and diastolic blood pressure by 2.14 mmHg ( 0.94 to 3.33 ) . Significant improvements were also found in most psychological measures . Conclusion This study provides evidence that a type 2 diabetes prevention programme using lifestyle intervention is feasible in primary health care setting s , with reductions in risk factors approaching those observed in clinical trials . Trial NumberCurrent Controlled Trials IS RCT Effective , cost-effective , safe , and feasible interventions to improve lifestyle behavior in at-risk population s are needed in primary care . In the Hoorn Prevention Study , the authors implemented a theory-based lifestyle intervention in which trained practice nurses used an innovative combination of motivational interviewing ( MI ) and problem-solving treatment ( PST ) . This article presents the intervention ’s reach , effectiveness in terms of process outcomes , adoption , and implementation . Recruitment strategy and participant flow were documented accurately . The effectiveness in terms of determinants of behavioral change was measured using a vali date d question naire . Question naires were also used to assess participant satisfaction and compliance , as well as practice nurses ’ confidence in providing the intervention . Counseling sessions were tape recorded to assess MI , PST , and general counseling competence . The findings indicate that the recruitment strategy was adequate and result ed in a reasonably extensive reach of the target population . Practice nurses were competent and confident in their provision of MI and PST , and participant satisfaction was high . Nevertheless , the number of sessions attended was low , and almost no effects were seen on determinants of behavioral change . The authors conclude that implementing this type of intervention in primary care is feasible , but more is needed to effectively facilitate changes in determinants of lifestyle behavior in this population BACKGROUND The Diabetes Prevention OUTPUT: Conclusion Our findings identify that program intensity plays a major role in weight loss outcomes . However , programs that have high uptake — both in terms of good coverage of invitees and their willingness to accept the invitation — can still have considerable impact in lowering diabetes risk in a population , even with a low intensity intervention that only leads to low or moderate weight loss . INPUT: Abstract Background Diabetes prevalence is increasing . The Finnish Diabetes Prevention Study ( DPS ) showed a 58 % reduction in Type 2 Diabetes ( T2D ) incidence in adults with impaired glucose tolerance ( IGT ) . The European Diabetes Prevention Study ( EDIPS ) extends the DPS to different European population s , using the same study design . In the Newcastle arm of this study ( EDIPS-Newcastle ) , we tested the hypothesis that T2D can be prevented by lifestyle intervention and explored secondary outcomes in relation to diabetes incidence . Methods We recruited 102 participants ( 42 men and 60 women , mean age 57 years , mean BMI 34 kgm-2 ) with IGT to EDIPS-Newcastle and r and omised to Intervention and usual care Control groups . The intervention included individual motivational interviewing aim ed at : weight reduction , increase in physical activity , fibre and carbohydrate intake and reduction of fat intake ( secondary outcomes ) . The primary outcome was diagnosis of T2D . Results Mean duration of follow-up was 3.1 years . T2D was diagnosed in 16 participants ( I = 5 , C = 11 ) . Absolute incidence of T2D was 32.7 per 1000 person-years in the Intervention-group and 67.1 per 1000 person-years in the Control-group . The overall incidence of diabetes was reduced by 55 % in the Intervention-group , compared with the Control-group : RR 0.45 ( 95%CI 0.2 to 1.2).Explanatory survival analysis of secondary outcomes showed that those who sustained beneficial changes for two or more years reduced their risk of developing T2D . Conclusion Our results are consistent with other diabetes prevention trials . This study was design ed as part of a larger study and although the sample size limits statistical significance , the results contribute to the evidence that T2D can be prevented by lifestyle changes in adults with IGT . In explanatory analysis small sustained beneficial changes in weight , physical activity or dietary factors were associated with reduction in T2D incidence . Trial Registration International St and ard R and omised Controlled Trial Number registry ( IS RCT N)Registry number : IS RCT N 15670600 http://www.controlled-trials.com/is rct n/ search .html?srch=15670600%26sort=3%26dir = BACKGROUND Public health decision-making is hampered by inappropriate adherence to underpowered r and omized controlled trials ( RCTs ) which give inconclusive results and lead to decision-makers being loath to recommend interventions with strong theoretical and observational support . METHODS We outline situations in which robust decisions about health interventions can be made without trial evidence . We present a new approach in which theory , causal models and past observations are given proper regard in the decision-making process . RESULTS Using our approach , we provide examples where the use of causal theories and observations in areas , such as salt reduction , smoking cessation and gardening to improve mental health , is sufficient for deciding that such interventions are effective for improving health without needing the support of underpowered RCTs . Particularly where RCT evidence is inconclusive , our approach may provide similar aggregate health outcomes for society for vastly lower cost . CONCLUSIONS When knowledge and theoretical underst and ing are unable sufficiently to reduce doubt about the direction of effect from an intervention , decisions should be made using evidence -based medicine approaches . There are , however , many cases where the combination of robust theory , causal underst and ing and observation are able to provide sufficient evidence of the direction of effect from an intervention that current practice should be altered OBJECTIVE To pilot , among women with gestational diabetes mellitus ( GDM ) , the feasibility of a prenatal/postpartum intervention to modify diet and physical activity similar to the Diabetes Prevention Program . The intervention was delivered by telephone , and support for breastfeeding was addressed . RESEARCH DESIGN AND METHODS The goal was to help women return to their prepregnancy weight , if it was normal , or achieve a 5 % reduction from prepregnancy weight if overweight . Eligible participants were identified shortly after a GDM diagnosis ; 83.8 % consented to be r and omly assigned to intervention or usual medical care ( 96 and 101 women , respectively ) . The retention was 85.2 % at 12 months postpartum . RESULTS The proportion of women who reached the postpartum weight goal was higher , although not statistically significant , in the intervention condition than among usual care ( 37.5 vs. 21.4 % , absolute difference 16.1 % , P = 0.07 ) . The intervention was more effective among women who did not exceed the recommended gestational weight gain ( difference in the proportion of women meeting the weight goals : 22.5 % , P = 0.04 ) . The intervention condition decreased dietary fat intake more than the usual care ( condition difference in the mean change in percent of calories from fat : −3.6 % , P = 0.002 ) and increased breastfeeding , although not significantly ( condition difference in proportion : 15.0 % , P = 0.09 ) . No differences in postpartum physical activity were observed between conditions . CONCLUSIONS This study suggests that a lifestyle intervention that starts during pregnancy and continues postpartum is feasible and may prevent pregnancy weight retention and help overweight women lose weight . Strategies to help postpartum women overcome barriers to increasing physical activity are needed Background Type 2 diabetes is a major health problem in many countries including India . Yoga may be an effective type 2 diabetes prevention strategy in India , particularly given its cultural familiarity . Methods This was a parallel , r and omized controlled pilot study to collect feasibility and preliminary efficacy data on yoga for diabetes risk factors among people at high risk of diabetes . Primary outcomes included : changes in BMI , waist circumference , fasting blood glucose , postpr and ial blood glucose OUTPUT:
Conclusions HbA1c is neither sensitive nor specific for detecting pre‐diabetes ; fasting glucose is specific but not sensitive . Interventions in people classified through screening as having pre‐diabetes have some efficacy in preventing or delaying onset of type 2 diabetes in trial population s. As screening is inaccurate , many people will receives an incorrect diagnosis and be referred on for interventions while others will be falsely reassured and not offered the intervention . These findings suggest that “ screen and treat ” policies alone are unlikely to have substantial impact on the worsening epidemic of type 2 diabetes .
MS2_dynamic_1_shot470
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: Background —Hypertension is a leading mortality risk factor yet inadequately controlled in most affected subjects . Effective programs to address this problem are lacking . We hypothesized that an information technology – supported management program could help improve blood pressure ( BP ) control . Methods and Results —This r and omized controlled trial included 223 primary care hypertensive subjects with mean 24-hour BP > 130/80 and daytime BP > 135/85 mm Hg measured with ambulatory monitoring ( ABPM ) . Intervention subjects received a BP monitor and access to an information technology – supported adherence and BP monitoring system providing nurses , pharmacists , and physicians with monthly reports . Control subjects received usual care . The mean ( ±SD ) follow-up was 348 ( ±78 ) and 349 ( ±84 ) days in the intervention and control group , respectively . The primary end point of the change in the mean 24-hour ambulatory BP was consistently greater in intervention subjects for both systolic ( −11.9 versus −7.1 mm Hg ; P<0.001 ) and diastolic BP ( −6.6 versus −4.5 mm Hg ; P=0.007 ) . The proportion of subjects that achieved Canadian Guideline target BP ( 46.0 % versus 28.6 % ) was also greater in the intervention group ( P=0.006 ) . We observed similar BP declines for ABPM and self-recorded home BP suggesting the latter could be an alternative for confirming BP control . The intervention was associated with more physician-driven antihypertensive dose adjustments or changes in agents ( P=0.03 ) , more antihypertensive classes at study end ( P=0.007 ) , and a trend toward improved adherence measured by prescription refills ( P=0.07 ) . Conclusions —This multidisciplinary information technology – supported program that provided feedback to patients and healthcare providers significantly improved blood pressure levels in a primary care setting BACKGROUND St and ard office-based approaches to controlling hypertension show limited success . Such suboptimal hypertension control reflects in part the absence of both an infrastructure for patient education and frequent , regular blood pressure ( BP ) monitoring . We tested the efficacy of a physician-directed , nurse-managed , home-based system for hypertension management with st and ardized algorithms to modulate drug therapy , based on patients ' reports of home BP . METHODS We r and omized out patients requiring drug therapy for hypertension according to the Joint National Committee on Prevention , Detection , Evaluation , and Treatment of High Blood Pressure ( JNC VI ) criteria to receive usual medical care only ( UC , n = 76 ) or usual care plus nurse care management intervention ( INT , n = 74 ) over a 6-month period . RESULTS Patients receiving INT achieved greater reductions in office BP values at 6 months than those receiving UC : 14.2 + /- 18.1 versus 5.7 + /- 18.7 mm Hg systolic ( P < .01 ) and 6.5 + /- 10.0 versus 3.4 + /- 7.9 mm Hg diastolic , respectively ( P < .05 ) . At 6 months , we observed one or more changes in drug therapy in 97 % of INT patients versus 43 % of UC patients , and 70 % of INT patients received two or more drugs versus 46 % of UC . Average daily adherence to medication , measured by electronic drug event monitors , was superior among INT subjects ( mean + /- SD , 80.5 % + /- 23.0 % ) than among UC subjects ( 69.2 + /- 31.1 % ; t(113 ) = 2.199 , P = .03 ) . There were no significant adverse drug reactions in either group . CONCLUSIONS Telephone-mediated nurse management can successfully address many of the systems-related and patient-related issues that limit pharmacotherapeutic effectiveness for hypertension BACKGROUND Although beta-blockers and angiotensin-converting enzyme ( ACE ) inhibitors are often used together , there is a lack of quantitative evidence for the efficacy of this combination in reducing blood pressure ( BP ) . OBJECTIVE The aim of this r and omized , double-blind , placebo-controlled , crossover study was to quantify the combined effect of a beta-blocker ( atenolol ) and an ACE inhibitor ( lisinopril ) in lowering BP . METHODS Participants who were > or = 40 years of age and enrolled in the hypertension or anticoagulation clinics at St. Bartholomew 's Hospital , London , United Kingdom , were r and omized to 3 consecutive 4-week treatments consisting of atenolol 25 mg plus placebo , lisinopril 5 mg plus placebo , and atenolol 25 mg plus lisinopril 5 mg , plus a period of 2 placebos . At the end of each period , seated BP was measured in the right arm using electronic monitors . RESULTS The mean placebo-adjusted peak BP reductions among the 47 participants ( mean age , 62 [ range 42 - 82 ] years ; 75 % male ; 70 % white/30 % Asian ; mean baseline BP , 145/82 mm Hg ) who completed all 4 periods were significantly greater with the combination of both drugs than with either drug alone ( P < 0.001 ) . The systolic reductions were 22.9 mm Hg with combination treatment , 16.1 mm Hg with atenolol treatment , and 12.5 mm Hg with lisinopril treatment , and the diastolic reductions were 13.9 , 9.8 , and 6.8 mm Hg , respectively . The BP-lowering effect of the 2 drugs together was similar to that expected from the sum of each OUTPUT: Self-monitoring was most effective in those with fewer antihypertensive medications and higher baseline sBP up to 170 mmHg . No differences in efficacy were seen by sex or by most comorbidities . Self-monitoring alone is not associated with lower BP or better control , but in conjunction with co- interventions ( including systematic medication titration by doctors , pharmacists , or patients ; education ; or lifestyle counselling ) leads to clinical ly significant BP reduction which persists for at least 12 months . INPUT: Introduction Self-management of hypertension , including self-monitoring and antihypertensive medication titration , lowers blood pressure ( BP ) at 1 year compared to usual care . The aim of the current trial is to assess the effectiveness of the Home and Online Management and Evaluation of Blood Pressure ( HOME BP ) intervention for the self-management of hypertension in primary care . Methods and analysis The HOME BP trial will be a r and omised controlled trial comparing BP self-management — consisting of the HOME BP online digital intervention with self-monitoring , lifestyle advice and antihypertensive drug titration — with usual care for people with uncontrolled essential hypertension . Eligible patients will be recruited from primary care and r and omised to usual care or to self-management using HOME BP . The primary outcome will be the difference in mean systolic BP ( mm Hg ) at 12-month follow-up between the intervention and control groups adjusting for baseline BP and covariates . Secondary outcomes ( also adjusted for baseline and covariates where appropriate ) will be differences in mean BP at 6 months and diastolic BP at 12 months ; patient enablement ; quality of life , and economic analyses including all key re sources associated with the intervention and related services , adopting a broad societal perspective to include NHS , social care and patient costs , considered within trial and modelled with a lifetime horizon . Medication beliefs , adherence and changes ; self-efficacy ; perceived side effects and lifestyle changes will be measured for process analyses . Qualitative analyses will explore patient and healthcare professional experiences of HOME BP to gain insights into the factors affecting acceptability , feasibility and adherence . Ethics and dissemination This study has received NHS ethical approval ( REC reference 15/SC/0082 ) . The findings from HOME BP will be disseminated widely through peer- review ed publications , scientific conferences and workshops . If successful , HOME BP will be directly applicable to UK primary care management of hypertension . Trial registration number IS RCT N13790648 ; pre- results BACKGROUND Less than 50 % of patients with hypertensive disease manage to maintain their blood pressure ( BP ) within normal levels . OBJECTIVE The aim of this study is to evaluate whether cloud BP system integrated with computerized physician order entry ( CPOE ) can improve BP management as compared with traditional care . METHODS A r and omized controlled trial done on a r and om sample of 382 adults recruited from 786 patients who had been diagnosed with hypertension and receiving treatment for hypertension in two district hospitals in the north of Taiwan . Physicians had access to cloud BP data from CPOE . Neither patients nor physicians were blinded to group assignment . The study was conducted over a period of seven months . RESULTS At baseline , the enrollees were 50 % male with a mean ( SD ) age of 58.18 ( 10.83 ) years . The mean sitting BP of both arms was no different . The proportion of patients with BP control at two , four and six months was significantly greater in the intervention group than in the control group . The average capture rates of blood pressure in the intervention group were also significantly higher than the control group in all three check-points . CONCLUSIONS Cloud-based BP system integrated with CPOE at the point of care achieved better BP control compared to traditional care . This system does not require any technical skills and is therefore suitable for every age group . The praise and assurance to the patients from the physicians after review ing the Cloud BP records positively reinforced both BP measuring and medication adherence behaviors Background Latinos experience disproportionately higher rates of uncontrolled hypertension as compared to Blacks and Whites . While poor adherence is a major contributor to disparities in blood pressure control , data in Latino patients are scant . More importantly , translation of interventions to improve medication adherence in community-based primary care practice s , where the majority of Latino patients receive their care is non-existent . Methods Using a r and omized controlled design , this study evaluates the effectiveness of a culturally tailored , practice -based intervention compared to usual care on medication adherence , among 148 Latino patients with uncontrolled hypertension who are non-adherent to their antihypertensive medications . Bilingual medical assistants trained as Health Coaches deliver the intervention using an electronic medical record system-embedded adherence script . Patients r and omized to the intervention group receive patient-centered counseling with a Health Coach to develop individualized self-monitoring strategies to overcome barriers and improve adherence behaviors . Health Coach sessions are held biweekly for the first 3 months ( 6 sessions total ) and then monthly for the remaining 3 months ( 3 sessions total ) . Patients r and omized to the usual care group receive st and ard hypertension treatment recommendations as determined by their primary care providers . The primary outcome is the rate of medication adherence at 6 months . The secondary outcome is reduction in systolic and diastolic blood pressure at 6 months . Discussion If successful , findings from this study will provide salient information on the translation of culturallytailored , evidence -based interventions targeted at medication adherence and blood pressure control into practice -based setting s for this high-risk population .Trial registration NCT01643473 on 16 July 2012 BACKGROUND Many dementia and cardiovascular disease ( CVD ) cases in older adults are attributable to modifiable vascular and lifestyle-related risk factors , providing opportunities for prevention . In the Healthy Aging Through Internet Counselling in the Elderly ( HATICE ) r and omized controlled trial , an internet-based multidomain intervention is being tested to improve the cardiovascular risk ( CVR ) profile of older adults . OBJECTIVE To design a multidomain intervention to improve CVR , based on the guidelines for CVR management , and administered through a coach-supported , interactive , platform to over 2500 community-dwellers aged 65 + in three OUTPUT:
The most commonly described determinants at the patient level were lack of education , lack of self-awareness , lack of self-efficacy , and forgetfulness . Clinical inertia and an inadequate health workforce were the most commonly targeted determinants at the health care team and system level . Taking medication , interactive patient-provider communication , self-measurement , and lifestyle management were the most cited patient behaviors at both levels . Most of the DIs did not include support from peers or family members , despite its reported effectiveness and the rate of social media penetration .
MS2_dynamic_1_shot471
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: Objective To compare adherence and persistence to typical versus atypical antipsychotics and between specific atypical agents in the usual care of schizophrenia and to examine the association between adherence and persistence . Method Data were drawn from a 3-year prospect i ve , nonr and omized , noninterventional study of schizophrenia conducted during 1997–2003 . Initiators on haloperidol , risperidone , olanzapine , quetiapine , and clozapine with at least 1 year of follow-up were included ( n = 878 ) . Adherence ( Medication Possession Ratio , MPR ) and persistence ( time to all-cause medication discontinuation ) were assessed using medical record prescription information . Analyses employed multivariate statistics adjusted for group differences . Results Overall , 58 % of the patients were deemed adherent ( MPR > 80 % ) . Adherence rates were higher : for atypical ( 59.4 % ) than typical antipsychotics ( 34.5 % , p < 0.001 ) , for clozapine ( 77 % ) than each comparator excluding olanzapine ( p < 0.01 ) , and for olanzapine ( 64 % ) than risperidone ( 57 % , p = 0.027 ) and quetiapine ( 52 % , p = 0.019 ) . Differences between risperidone and quetiapine were not statistically significant . Adherence and persistence were highly correlated ( r = 0.957 , p < 0.001 ) . Conclusion In the usual care of schizophrenia , medication adherence and persistence appear to be highly correlated and to significantly differ between typical and atypical antipsychotics and among atypical agents . The choice of antipsychotic may play a meaningful role in patients ’ adherence to and persistence with antipsychotic medications BACKGROUND The relative effectiveness of second-generation ( atypical ) antipsychotic drugs as compared with that of older agents has been incompletely addressed , though newer agents are currently used far more commonly . We compared a first-generation antipsychotic , perphenazine , with several newer drugs in a double-blind study . METHODS A total of 1493 patients with schizophrenia were recruited at 57 U.S. sites and r and omly assigned to receive olanzapine ( 7.5 to 30 mg per day ) , perphenazine ( 8 to 32 mg per day ) , quetiapine ( 200 to 800 mg per day ) , or risperidone ( 1.5 to 6.0 mg per day ) for up to 18 months . Ziprasidone ( 40 to 160 mg per day ) was included after its approval by the Food and Drug Administration . The primary aim was to delineate differences in the overall effectiveness of these five treatments . RESULTS Overall , 74 percent of patients discontinued the study medication before 18 months ( 1061 of the 1432 patients who received at least one dose ) : 64 percent of those assigned to olanzapine , 75 percent of those assigned to perphenazine , 82 percent of those assigned to quetiapine , 74 percent of those assigned to risperidone , and 79 percent of those assigned to ziprasidone . The time to the discontinuation of treatment for any cause was significantly longer in the olanzapine group than in the quetiapine ( P<0.001 ) or risperidone ( P=0.002 ) group , but not in the perphenazine ( P=0.021 ) or ziprasidone ( P=0.028 ) group . The times to discontinuation because of intolerable side effects were similar among the groups , but the rates differed ( P=0.04 ) ; olanzapine was associated with more discontinuation for weight gain or metabolic effects , and perphenazine was associated with more discontinuation for extrapyramidal effects . CONCLUSIONS The majority of patients in each group discontinued their assigned treatment owing to inefficacy or intolerable side effects or for other reasons . Olanzapine was the most effective in terms of the rates of discontinuation , and the efficacy of the conventional antipsychotic agent perphenazine appeared similar to that of quetiapine , risperidone , and ziprasidone . Olanzapine was associated with greater weight gain and increases in measures of glucose and lipid metabolism A modification of an earlier rating scale for extrapyramidal system disturbance is described , and evidence for the validity and reliability of the scale is presented . The usefulness of the scale in studies of neuroleptic drugs is discussed . By its application it is possible to quantify extrapyramidal side effects and to separate them into four principal factors The aims of this prospect i ve study were to examine the predictive values of self-stigma , insight , and perceived adverse effects of medication for remission of depressive symptoms , suicidal risk , and medication adherence in patients with depressive disorders over a 1-year follow-up period . One hundred seventy-four participants who were in a state of obvious depression underwent an index interview to determine their degree of self-stigma , insight , and perceived adverse effects of medication . One year later , they were reassessed to determine the severity of their depressive symptoms , suicidal risk , and the level of the medication adherence , and their associations with the 3 possible predictors at the index interview were examined . The results of this study indicated that perceiving more severe adverse effects of medication at the index interview increased the risks of the nonremission of depressive symptoms , occurrence of suicidal ideation or attempt , and medication nonadherence in patients with depressive disorders in the 1-year period . However , the degrees of self-stigma and insight did not predict the severity of depressive symptoms , suicidal risk , or the level of the medication adherence . Based on OUTPUT: Results : Content validity was appropriately established for only one of the tools , reliability was inappropriately evaluated for all but one tool , and the assessment of responsiveness was not acceptable for any tool . INPUT: BACKGROUND Executive function deficits have been reported repeatedly in children with Attention Deficit Hyperactivity Disorder ( ADHD ) . Stimulant medication has been shown to be effective in improving cognitive performance on most executive function tasks , but neuropsychological tests of executive function in this population have yielded inconsistent results . Method ological limitations may explain these inconsistencies . This study aim ed to measure executive function in medicated and non-medicated children with ADHD by using a computerized battery , the Cambridge Neuropsychological Test Automated Battery ( CANTAB ) , which is sensitive to executive function deficits in older patients with frontostriatal neurological impairments . METHODS Executive function was assessed in 30 children with ADHD : 15 were stimulant medication naive and 15 were treated with stimulant medication . These two groups were compared to 15 age , sex and IQ matched controls . RESULTS The unmedicated children with ADHD displayed specific cognitive impairments on executive function tasks of spatial short-term memory , spatial working memory , set-shifting ability and planning ability . Impairments were also seen on spatial recognition memory and delayed matching to sample , while pattern recognition memory remained intact . The medicated children with ADHD were not impaired on any of the above executive function tasks except for deficits in spatial recognition memory . CONCLUSIONS ADHD is associated with deficits in executive function . Stimulant medication is associated with better executive function performance . Prospect i ve follow-up studies are required to examine these effects BACKGROUND Impairments in language and communication are core features of autism spectrum disorders ( ASDs ) . The basis for this association is poorly understood . How early language is related to each of the triad of impairments characteristic of ASDs is also in need of clarification . AIMS This is the first study that aims to determine the extent to which shared genetic and environmental factors underlie the association between early language performance and autistic-like traits ( ALTs ) in middle childhood . METHODS & PROCEDURES Data came from a population -based twin sample ( n = 6087 pairs ) assessed prospect ively at 2 , 3 , 4 and 8 years . ALTs measured by the Childhood Asperger Syndrome Test ( CAST ) at 8 years were investigated in relation to language assessed by the MacArthur Communicative Development Inventory ( CDI ) at 2 , 3 and 4 years . Multivariate model fitting techniques were used to analyse the origins of this association . OUTCOMES & RESULTS Total CAST scores , as well as Social and Communication subscales , at 8 years were weakly but significantly negatively correlated with language ability at 2 , 3 and 4 years . Correlations between language and restrictive and repetitive behaviours and interests ( RRBI ) were not significant . The phenotypic correlations between language and Social and Communication ALTs were almost entirely mediated by shared genetic influences . There were specific genetic influences on early language that were not shared with ALTs , and specific genetic influences on ALTs not shared with earlier language performance . CONCLUSIONS This is the first study to demonstrate shared genetic influences in relation to language performance as an early antecedent of later ALTs . These results support the idea that the triad of core features in ALTs are aetiologically heterogeneous , with early language relating to social and communication impairments but not RRBIs Sixteen children meeting diagnostic criteria for Attention Deficit Disorder with Hyperactivity ( ADD-H ) were tested on methylpheni date ( 0.3 mg/kg ) and placebo on cognitive , learning , academic and behavioral measures in a double-blind study . Assessment s were carried out in the laboratory and in the children 's regular classrooms . Results indicate methylpheni date -induced improvements on a majority of the measures . Drug-induced changes reflected increased output , accuracy and efficiency and improved learning acquisition . There was also evidence of increased effort and self-correcting behaviours . It is argued that review ers have underestimated the potential of stimulants to improve the performance of ADD-H children on academic , learning and cognitive tasks OBJECTIVE The paucity of data concerning the long-term natural history of attention-deficit hyperactivity disorder ( ADHD ) , a common childhood psychiatric disorder , prompted a longitudinal study to investigate the adult sequelae of the childhood disorder . DESIGN Prospect i ve study , follow-up intervals ranging from 13 to 19 years ( mean , 16 years ) , with blind systematic clinical assessment s. SUBJECTS Ninety-one white males ( mean age , 26 years ) , representing 88 % of a cohort systematic ally diagnosed as hyperactive in childhood , and 95 ( 95 % ) of comparison cases of similar race , gender , age , whose teachers had voiced no complaints about their school behavior in childhood . RESULTS Prob and s had significantly higher rates than comparisons of ADHD symptoms ( 11 % vs 1 % ) , antisocial personality disorders ( 18 % vs 2 % ) , and drug abuse disorders ( 16 % vs 4 % ) . Significant comorbidity occurred between antisocial and drug disorders . Educational and occupational achievements were significantly compromised in the prob and s. These disadvantages were independent of psychiatric status . We did not find increased rates of affective or anxiety disorders in the prob and s. CONCLUSIONS Childhood ADHD predicts specific adult psychiatric disorders , namely antisocial and drug abuse disorders . In the adolescent outcome of this cohort , we found that these disturbances were dependent on the continuation of ADHD symptoms . In contrast , in adulthood , antisocial and drug disorders appeared , in part , independent of sustained ADHD . In addition , regardless of psychiatric status , ADHD placed children at relative risk for educational and vocational disadvantage . The results do not support a relationship between childhood ADHD and adult mood or anxiety disorders OUTPUT:
Taken together , the studies pointed at substantial evidence for a negative association between ADHD symptoms and mathematical ability . This association was particularly marked for the inattentive component of ADHD than for the hyperactive-impulsive component . Evidence from twin studies also showed a significant genetic correlation between mathematics and ADHD , which was greater for the inattentive component of ADHD compared to the hyperactive-impulsive component . Conclusions The differential relationship of the hyperactivity-impulsivity and inattention domains with mathematics emphasises the heterogeneity within the disorder and suggests a partially different aetiology of the two ADHD domains .
MS2_dynamic_1_shot472
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: Averaged evoked potentials ( EPs ) to clicks , r and om pitch changes ( signals ) , and r and om deletions of stimuli within a regular train of tones were examined in five autistic and five normal children . Brainstem auditory EPs were abnormal in one of the autistic patients . The early cortical EP components P60 and N100 showed no differences across groups , whereas the P200 component of the cortical responses to clicks , as well as the late positive component ( P300 ) to the pitch changes and deleted stimuli , were significantly smaller in the autistic subjects as a group . Furthermore , when P200 and P300 amplitudes were averaged across conditions for the individual subjects , these components were smaller in every autistic subject than in any of the normal subjects . These results are consistent with the view that there are auditory defects in autism that may sometimes involve lower levels of neural transmission as manifested by abnormalities in the brainstem and auditory EP , but are more consistently manifest in higher aspects of processing that involve the registration and storage of stimulus information . It is suggested that the severe language disorder in childhood autism may be secondary to the basic deficits in higher auditory processing Event-related brain potentials ( ERPs ) of 13 - 21-year-old autistic subjects and age-matched controls were elicited by auditory stimuli in a variation of orienting response paradigms . Unexpected , novel sounds ( bizarre concoctions of human , mechanical and computer sounds ) were r and omly inserted as probes in a sequence of expected , non-novel sounds ( the word ' me ' ) . In order to help ensure that both subject groups were attending to this stream of information , each subject was required to press a button to a specified target sound ( the word ' you ' ) also r and omly inserted in the sequence of expected non-novel sounds . The ERP results showed that in both groups , unexpected , novel probes and also targets evoked a different neurophysiological response than did expected , non-novel sounds . This suggests that the autistic group did not misperceive novel information as non-novel and were able to make simple classification decisions as accurately as normal controls . However , in the autistic group , there may be less ' processing ' of the novel probes and of targets : compared to the control group , the autistic group had smaller amplitudes of two long-latency components to novels and smaller P3b amplitudes to targets . The two components to novels were termed A/Pcz/300 ( A = auditory ; P = positive ; cz = electrode site of maximum amplitude ; 300 = latency in msec ) and A/Ncz/800 . In another sequence of sounds , subjects simply listened to frequently presented ' me ' sounds ( 90 % ) and infrequently presented ' you ' sounds ( 10 % ) . In this no-task condition , no differences between autistic and normal control subjects were found Eighty children , 3–17 years of age , with autism or Asperger syndrome and mild to severe distress in the presence of some sounds , were r and omly allocated to two groups . The experimental group received auditory training and the control group listened to the same unmodified music under the same conditions . Significant improvements in behavior and severity of autism were maintained for 12 months by both groups . Informal data suggested that a range of abnormal responses to sound and other sensory abnormalities may also have improved . Verbal and performance IQ increased significantly 3 to 12 months after interventions . Findings suggest that some aspect of both auditory training and listening to selected unmodified music may have a beneficial effect on children with autism and sound sensitivity , and indicate a need for further research into the effects that led to these changes and the mechanisms involved in the sensory abnormalities commonly associated with autism Due to the myriad of problems associated with autism , parents often consider alternative treatments . The investigation was undertaken to determine the effects of the Tomatis Method on language skills in children with autism utilizing a r and omized , double-blind , placebo-controlled , crossover design . The results indicated that although the majority of the children demonstrated general improvement in language over the course of the study , it did not appear to be related to the treatment condition . The percent change for Group 1 ( Placebo/Treatment ) for treatment was 17.41 % , and placebo was 24.84 % . Group 2 ( Treatment/Placebo ) showed −3.98 % change for treatment and 14.15 % change for placebo . The results reflect a lack of improvement in language using the Tomatis Method for children with autism Compared 8- to 14-year-old children with either autism or receptive developmental language disorder ( RDLD ) to age- and IQ-matched normal controls in their ability to detect both frequent ( p=.70 ) and infrequent ( p=.30 ) r and omly presented auditory stimuli under task and no-task conditions . Event-related brain potentials ( ERPs ) , behavioral reaction times , and target detection accuracy rates were measured . Although the three groups of children performed in a similar manner on behavioral measures , only the children with autism demonstrated an abnormally small amplitude of the P3b , a component of the ERP . This result is interpreted in terms of ( a ) the consistency of this finding with other ERP studies involving older individuals with autism ; and ( b ) its significance with respect to the difficulty children with autism have in modifying their expectancies to context ually relevant sequences of auditory information Auditory integration training and a control treatment were provided for 16 children with autism in a crossover experimental design . Measures , blind to treatment order , included parent and teacher ratings of behavior , direct observational recordings , IQ , language , and social/adaptive tests . Significant differences tended to show that the control condition was superior on parent-rated measures of hyperactivity and on direct observational measures of ear-occlusion . No differences were detected on teacher-rated measures . Children 's IQs and language comprehension did not increase , but adaptive/social behavior scores and expressive language quotients decreased . The majority of parents ( 56 % ) were unable to report in retrospect when their child had received auditory integration training . No individual child was identified as benefiting clinical ly or educationally from the treatment OUTPUT: There is no evidence that auditory integration therapy or other sound therapies are effective as treatments for autism spectrum disorders . As synthesis of existing data has been limited by the disparate outcome measures used between studies , there is not sufficient evidence to prove that this treatment is not effective . As such , there is no evidence to support the use of auditory integration therapy at this time INPUT: This study extends findings on the effects of intensive applied behavior analytic treatment for children with autism who began treatment at a mean age of 5.5 years . The behavioral treatment group ( n = 13 , 8 boys ) was compared to an eclectic treatment group ( n = 12 , 11 boys ) . Assignment to groups was made independently based on the availability of qualified supervisors . Both behavioral and eclectic treatment took place in public kindergartens and elementary schools for typically developing children . At a mean age of 8 years , 2 months , the behavioral treatment group showed larger increases in IQ and adaptive functioning than did the eclectic group . The behavioral treatment group also displayed fewer aberrant behaviors and social problems at follow-up . Results suggest that behavioral treatment was effective for children with autism in the study BACKGROUND This prospect i ve study compared outcome for pre-school children with autism spectrum disorders ( ASD ) receiving autism-specific nursery provision or home-based Early Intensive Behavioural Interventions ( EIBI ) in a community setting . METHODS Forty-four 23- to 53-month-old children with ASD participated ( 28 in EIBI home-based programmes ; 16 in autism-specific nurseries ) . Cognitive , language , play , adaptive behaviour skills and severity of autism were assessed at intake and 2 years later . RESULTS Both groups showed improvements in age equivalent scores but st and ard scores changed little over time . At follow-up , there were no significant group differences in cognitive ability , language , play or severity of autism . The only difference approaching significance ( p = .06 ) , in favour of the EIBI group , was for Vinel and Daily Living Skills st and ard scores . However , there were large individual differences in progress , with intake IQ and language level best predicting overall progress . CONCLUSIONS Home-based EIBI , as implemented in the community , and autism-specific nursery provision produced comparable outcomes after two years of intervention An intervention group ( n=23 ) of preschool children with autism was identified on the basis of parent preference for early intensive behavioral intervention and a comparison group ( n=21 ) identified as receiving treatment as usual . Prospect i ve assessment was undertaken before treatment , after 1 year of treatment , and again after 2 years . Groups did not differ on assessment s at baseline but after 2 years , robust differences favoring intensive behavioral intervention were observed on measures of intelligence , language , daily living skills , positive social behavior , and a statistical measure of best outcome for individual children . Measures of parental well-being , obtained at the same three time points , produced no evidence that behavioral intervention created increased problems for either mothers or fathers of children receiving it ABSTRACT . Although previous studies have shown favorable results with early intensive behavioral treatment ( EIBT ) for children with autism , it remains important to replicate these findings , particularly in community setting s. The authors conducted a 3-year prospect i ve outcome study that compared 2 groups : ( 1 ) 21 children who received 35 to 40 hours per week of EIBT from a community agency that replicated Lovaas ' model of EIBT and ( 2 ) 21 age- and IQ-matched children in special education classes at local public schools . A quasi-experimental design was used , with assignment to groups based on parental preference . Assessment s were conducted by independent examiners for IQ ( Bayley Scales of Infant Development or Wechsler Preschool and Primary Scales of Intelligence ) , language ( Reynell Developmental Language Scales ) , nonverbal skill ( Merrill-Palmer Scale of Mental Tests ) , and adaptive behavior ( Vinel and Adaptive Behavior Scales ) . Analyses of covariance , with baseline scores as covariates and Year 1 - 3 assessment s as repeated measures , revealed that , with treatment , the EIBT group obtained significantly higher IQ ( F = 5.21 , p = .03 ) and adaptive behavior scores ( F = 7.84 , p = .01 ) than did the comparison group . No difference between groups was found in either language comprehension ( F = 3.82 , p = .06 ) or nonverbal skill . Six of the 21 EIBT children were fully included into regular education without assistance at Year 3 , and 11 others were included with support ; in contrast , only 1 comparison child was placed primarily in regular education . Although the study was limited by the nonr and om assignment to groups , it does provide evidence that EIBT can be successfully implemented in a community setting OUTPUT:
There is some evidence that EIBI is an effective behavioral treatment for some children with ASD .
MS2_dynamic_1_shot473
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: AIMS Flavanol-rich chocolate ( FRC ) is beneficial for vascular and platelet function by increasing nitric oxide bioavailability and decreasing oxidative stress . Congestive heart failure ( CHF ) is characterized by impaired endothelial and increased platelet reactivity . As statins are ineffective in CHF , alternative therapies are a clinical need . We therefore investigated whether FRC might improve cardiovascular function in patients with CHF . METHODS AND RESULTS Twenty patients with CHF were enrolled in a double-blind , r and omized placebo-controlled trial , comparing the effect of commercially available FRC with cocoa-liquor-free control chocolate ( CC ) on endothelial and platelet function in the short term ( 2 h after ingestion of a chocolate bar ) and long term ( 4 weeks , two chocolate bars/day ) . Endothelial function was assessed non-invasively by flow-mediated vasodilatation of the brachial artery . Flow-mediated vasodilatation significantly improved from 4.98 ± 1.95 to 5.98 ± 2.32 % ( P = 0.045 and 0.02 for between-group changes ) 2h after intake of FRC to 6.86 ± 1.76 % after 4 weeks of daily intake ( P = 0.03 and 0.004 for between groups ) . No effect on endothelial-independent vasodilatation was observed . Platelet adhesion significantly decreased from 3.9 ± 1.3 to 3.0 ± 1.3 % ( P = 0.03 and 0.05 for between groups ) 2 h after FRC , an effect that was not sustained at 2 and 4 weeks . Cocoa-liquor-free CC had no effect , either on endothelial function or on platelet function . Blood pressure and heart rate did not change in either group . CONCLUSION Flavanol-rich chocolate acutely improves vascular function in patients with CHF . A sustained effect was seen after daily consumption over a 4-week period , even after 12 h abstinence . These beneficial effects were paralleled by an inhibition of platelet function in the presence of FRC only Background Dark chocolate ( DC ) is abundant in flavanols which have been reported to increase the bioavailability and bioactivity of nitric oxide ( NO ) . Increasing NO bioavailability has often demonstrated reduced oxygen cost and performance enhancement during submaximal exercise . Methods Nine moderately-trained male participants volunteered to undertake baseline ( BL ) measurements that comprised a cycle V.O2max$$ \overset{.}{V}{O}_{2 max } $ $ test followed by cycling at 80 % of their established gas exchange threshold ( GET ) for 20-min and then immediately followed by a two-minute time-trial ( TT ) . Using a r and omised crossover design participants performed two further trials , two weeks apart , with either 40 g of DC or white chocolate ( WC ) being consumed daily . Oxygen consumption , RER , heart rate and blood lactate ( BLa ) were measured during each trial . Results DC consumption increased GET and TT performance compared to both BL and WC ( P < 0.05 ) . DC consumption increased V.O2max$$ \overset{.}{V}{O}_{2 max } $ $ by 6 % compared to BL ( P < 0.05 ) , but did not reach statistical significance compared to WC . There were no differences in the moderate-intensity cycling for V.O2$$ \overset{.}{V}{O}_2 $ $ , RER , BLa and heart rate between conditions , although , V.O2$$ \overset{.}{V}{O}_2 $ $ and RER exhibited consistently lower trends following DC consumption compared to BL and WC , these did not reach statistical significance . Conclusion Chronic supplementation with DC result ed in a higher GET and enhanced TT performance . Consequently , ingestion of DC reduced the oxygen cost of moderate intensity exercise and may be an effective ergogenic aid for short- duration moderate intensity exercise The consumption of a diet rich in certain flavonoids , including the flavanol sub-class , has been associated with a reduced risk for vascular disease . We evaluated the effects of the regular consumption ( 14 d ) of a flavanol-containing milk chocolate ( FCMC ) or cocoa butter chocolate ( CBC ) on variables related to vascular disease risk , oxidative stress and physical activity . Twenty-eight free-living , young ( 18–20 years old ) male soccer players consumed daily 105 g of FCMC ( 168 mg of flavanols ) or CBC ( < 5 mg of flavanols ) , as part of their normal diet . The consumption of FCMC was significantly associated with a decrease in diastolic blood pressure ( -5 mm Hg ) , mean blood pressure ( -5 mm Hg ) , plasma cholesterol ( -11 % ) , LDL-cholesterol ( -15 % ) , malondialdehyde ( -12 % ) , urate ( -11 % ) and lactate dehydrogenase ( LDH ) activity ( -11 % ) , and an increase in vitamin E/cholesterol ( + 12 % ) . No relevant changes in these variables were associated with CBC consumption . No changes in the plasma levels of (-)-epicatechin were observed following analysis of fasting blood sample s. In conclusion , FCMC consumption was associated with changes in several variables often associated with cardiovascular health and oxidant stress . The presence of significant quantities of flavanols in FCMC is likely to have been one of the contributing factors to these results Impaired endothelial vasodilatation may contribute to the exaggerated blood pressure ( BP ) responses to exercise in individuals who are overweight/obese . The present study investigated whether consumption of cocoa flavanols , which improve endothelium-dependent flow-mediated dilatation ( FMD ) , can modify BP responsiveness to exercise . Twenty-one volunteers ( OUTPUT: Results Acute , sub-chronic ( 2 weeks ) and chronic ( 3 months ) CF intake reduced exercise-induced oxidative stress . Evidence on the effect of CF on exercise-induced inflammation and platelet activation was scarce . Acute CF intake reduced and tempered the exercise-induced increase in blood pressure in obese participants . Acute and sub-chronic CF intake altered fat and carbohydrate metabolism during exercise . Acute and sub-chronic CF intake did not have ergogenic effects in athletes , while chronic CF intake improved mitochondrial efficiency in untrained participants . While combining sub-chronic CF intake and exercise training improved cardiovascular risk factors and vascular function , evidence on the synergistic effects of CF and exercise training on oxidative stress , inflammation , and fat and glucose metabolism was lacking . Conclusion CF intake may improve vascular function , reduce exercise-induced oxidative stress , and alter fat and carbohydrate utilization during exercise , but without affecting exercise performance . INPUT: AIMS Flavanol-rich chocolate ( FRC ) is beneficial for vascular and platelet function by increasing nitric oxide bioavailability and decreasing oxidative stress . Congestive heart failure ( CHF ) is characterized by impaired endothelial and increased platelet reactivity . As statins are ineffective in CHF , alternative therapies are a clinical need . We therefore investigated whether FRC might improve cardiovascular function in patients with CHF . METHODS AND RESULTS Twenty patients with CHF were enrolled in a double-blind , r and omized placebo-controlled trial , comparing the effect of commercially available FRC with cocoa-liquor-free control chocolate ( CC ) on endothelial and platelet function in the short term ( 2 h after ingestion of a chocolate bar ) and long term ( 4 weeks , two chocolate bars/day ) . Endothelial function was assessed non-invasively by flow-mediated vasodilatation of the brachial artery . Flow-mediated vasodilatation significantly improved from 4.98 ± 1.95 to 5.98 ± 2.32 % ( P = 0.045 and 0.02 for between-group changes ) 2h after intake of FRC to 6.86 ± 1.76 % after 4 weeks of daily intake ( P = 0.03 and 0.004 for between groups ) . No effect on endothelial-independent vasodilatation was observed . Platelet adhesion significantly decreased from 3.9 ± 1.3 to 3.0 ± 1.3 % ( P = 0.03 and 0.05 for between groups ) 2 h after FRC , an effect that was not sustained at 2 and 4 weeks . Cocoa-liquor-free CC had no effect , either on endothelial function or on platelet function . Blood pressure and heart rate did not change in either group . CONCLUSION Flavanol-rich chocolate acutely improves vascular function in patients with CHF . A sustained effect was seen after daily consumption over a 4-week period , even after 12 h abstinence . These beneficial effects were paralleled by an inhibition of platelet function in the presence of FRC only The consumption of cocoa and dark chocolate is associated with a lower risk of CVD , and improvements in endothelial function may mediate this relationship . Less is known about the effects of cocoa/chocolate on the augmentation index ( AI ) , a measure of vascular stiffness and vascular tone in the peripheral arterioles . We enrolled thirty middle-aged , overweight adults in a r and omised , placebo-controlled , 4-week , cross-over study . During the active treatment ( cocoa ) period , the participants consumed 37 g/d of dark chocolate and a sugar-free cocoa beverage ( total cocoa = 22 g/d , total flavanols ( TF ) = 814 mg/d ) . Colour-matched controls included a low-flavanol chocolate bar and a cocoa-free beverage with no added sugar ( TF = 3 mg/d ) . Treatments were matched for total fat , saturated fat , carbohydrates and protein . The cocoa treatment significantly increased the basal diameter and peak diameter of the brachial artery by 6 % ( + 2 mm ) and basal blood flow volume by 22 % . Substantial decreases in the AI , a measure of arterial stiffness , were observed in only women . Flow-mediated dilation and the reactive hyperaemia index remained unchanged . The consumption of cocoa had no effect on fasting blood measures , while the control treatment increased fasting insulin concentration and insulin resistance ( P= 0·01 ) . Fasting blood pressure ( BP ) remained unchanged , although the acute consumption of cocoa increased resting BP by 4 mmHg . In summary , the high-flavanol cocoa and dark chocolate treatment was associated with enhanced vasodilation in both conduit and resistance arteries and was accompanied by significant reductions in arterial stiffness in women Consumption of flavanol-rich dark chocolate ( DC ) has been shown to decrease blood pressure ( BP ) and insulin resistance in healthy subjects , suggesting similar benefits in patients with essential hypertension ( EH ) . Therefore , we tested the effect of DC on 24-hour ambulatory BP , flow-mediated dilation ( FMD ) , and oral glucose tolerance tests ( OGTTs ) in patients with EH . After a 7-day chocolate-free run-in phase , 20 never-treated , grade I patients with EH ( 10 males ; 43.7±7.8 years ) were r and omized to receive either 100 g per day DC ( containing 88 mg flavanols ) or 90 g per day flavanol-free white chocolate ( WC ) in an isocaloric manner for 15 days . After a second 7-day chocolate-free period , patients were crossed over to the other treatment . Noninvasive 24-hour ambulatory BP , FMD , OGTT , serum cholesterol , and markers of vascular inflammation were evaluated at the end of each treatment . The homeostasis model assessment of insulin resistance ( HOMA-IR ) , quantitative insulin sensitivity check index ( QUICKI ) , and insulin sensitivity index ( ISI ) were calculated from OGTT values . Ambulatory BP decreased after DC ( 24-hour systolic BP −11.9±7.7 mm Hg , P<0.0001 ; 24-hour diastolic BP −8.5±5.0 mm Hg , P<0.0001 ) but not WC . DC but not WC decreased HOMA-IR ( P<0.0001 ) , but it improved QUICKI , ISI , and FMD . DC also decreased serum LDL cholesterol OUTPUT:
Conclusion : Cocoa/DC supplementation does not reduce anthropometric measures significantly . However subgroup analysis regarding dose ( ≥ 30 g/day ) and duration ( between 4 to 8 weeks ) revealed significant reduction of body weight and BMI
MS2_dynamic_1_shot474
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: Insulin resistance , a key component of the metabolic syndrome , is a risk factor for diabetes mellitus and cardiovascular disease . Acetyl-l-carnitine infusion acutely ameliorated insulin sensitivity in type 2 diabetics with insulin resistance . In this sequential off-on-off pilot study , we prospect ively evaluated the effects of 24-week oral acetyl-l-carnitine ( 1 g twice daily ) therapy on the glucose disposal rate ( GDR ) , assessed by hyperinsulinemic euglycemic clamps , and components of the metabolic syndrome in nondiabetic subjects at increased cardiovascular risk a priori segregated into 2 groups with GDR ≤7.9 ( n=16 ) or > 7.9 ( n=16 ) mg/kg per minute , respectively . Baseline GDR and systolic blood pressure were negatively correlated ( n=32 ; P=0.001 ; r=−0.545 ) , and patients with GDR ≤7.9 mg/kg per minute had higher systolic/diastolic blood pressure than those with higher GDR . Acetyl-l-carnitine increased GDR from 4.89±1.47 to 6.72±3.12 mg/kg per minute ( P=0.003 , Bonferroni-adjusted ) and improved glucose tolerance in patients with GDR ≤7.9 mg/kg per minute , whereas it had no effects in those with higher GDRs . Changes in GDR were significantly different between groups ( P=0.017 , ANCOVA ) . Systolic blood pressure decreased from 144.0±13.6 to 135.1±8.4 mm Hg and from 130.8±12.4 to 123.8±10.8 mm Hg in the lower and higher GDR groups , respectively ( P<0.05 for both ; P<0.001 overall ) and progressively recovered toward baseline over 8 weeks posttreatment . Total and high molecular weight adiponectin levels followed specular trends . Diastolic blood pressure significantly decreased only in those with higher GDRs . Treatment was well tolerated in all of the patients . Acetyl-l-carnitine safely ameliorated arterial hypertension , insulin resistance , impaired glucose tolerance , and hypoadiponectinemia in subjects at increased cardiovascular risk . Whether these effects may translate into long-term cardioprotection is worth investigating CONTEXT Popular diets , particularly those low in carbohydrates , have challenged current recommendations advising a low-fat , high-carbohydrate diet for weight loss . Potential benefits and risks have not been tested adequately . OBJECTIVE To compare 4 weight-loss diets representing a spectrum of low to high carbohydrate intake for effects on weight loss and related metabolic variables . DESIGN , SETTING , AND PARTICIPANTS Twelve-month r and omized trial conducted in the United States from February 2003 to October 2005 among 311 free-living , overweight/obese ( body mass index , 27 - 40 ) nondiabetic , premenopausal women . INTERVENTION Participants were r and omly assigned to follow the Atkins ( n = 77 ) , Zone ( n = 79 ) , LEARN ( n = 79 ) , or Ornish ( n = 76 ) diets and received weekly instruction for 2 months , then an additional 10-month follow-up . MAIN OUTCOME MEASURES Weight loss at 12 months was the primary outcome . Secondary outcomes included lipid profile ( low-density lipoprotein , high-density lipoprotein , and non-high-density lipoprotein cholesterol , and triglyceride levels ) , percentage of body fat , waist-hip ratio , fasting insulin and glucose levels , and blood pressure . Outcomes were assessed at months 0 , 2 , 6 , and 12 . The Tukey studentized range test was used to adjust for multiple testing . RESULTS Weight loss was greater for women in the Atkins diet group compared with the other diet groups at 12 months , and mean 12-month weight loss was significantly different between the Atkins and Zone diets ( P<.05 ) . Mean 12-month weight loss was as follows : Atkins , -4.7 kg ( 95 % confidence interval [ CI ] , -6.3 to -3.1 kg ) , Zone , -1.6 kg ( 95 % CI , -2.8 to -0.4 kg ) , LEARN , -2.6 kg ( -3.8 to -1.3 kg ) , and Ornish , -2.2 kg ( -3.6 to -0.8 kg ) . Weight loss was not statistically different among the Zone , LEARN , and Ornish groups . At 12 months , secondary outcomes for the Atkins group were comparable with or more favorable than the other diet groups . CONCLUSIONS In this study , premenopausal overweight and obese women assigned to follow the Atkins diet , which had the lowest carbohydrate intake , lost more weight at 12 months than women assigned to follow the Zone diet , and had experienced comparable or more favorable metabolic effects than those assigned to the Zone , Ornish , or LEARN diets [ corrected ] While questions remain about long-term effects and mechanisms , a low-carbohydrate , high-protein , high-fat diet may be considered a feasible alternative recommendation for weight loss . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00079573 Vegetarians have relatively low blood pressure ( BP ) levels and consume less protein than do nonvegetarians , and there have been suggestions that certain proteins may raise BP . To determine whether dietary protein supplements raise the BP of vegetarians , 58 g/per day of a OUTPUT: Results of biomarker studies and r and omized controlled trials indicated a beneficial effect of protein on BP . This beneficial effect may be mainly driven by plant protein , according to results in observational studies . There was some evidence that BP in people with elevated BP and /or older age could be more sensitive to dietary protein . CONCLUSIONS / SIGNIFICANCE In conclusion , evidence suggests a small beneficial effect of protein on BP , especially for plant protein . INPUT: Insulin resistance , a key component of the metabolic syndrome , is a risk factor for diabetes mellitus and cardiovascular disease . Acetyl-l-carnitine infusion acutely ameliorated insulin sensitivity in type 2 diabetics with insulin resistance . In this sequential off-on-off pilot study , we prospect ively evaluated the effects of 24-week oral acetyl-l-carnitine ( 1 g twice daily ) therapy on the glucose disposal rate ( GDR ) , assessed by hyperinsulinemic euglycemic clamps , and components of the metabolic syndrome in nondiabetic subjects at increased cardiovascular risk a priori segregated into 2 groups with GDR ≤7.9 ( n=16 ) or > 7.9 ( n=16 ) mg/kg per minute , respectively . Baseline GDR and systolic blood pressure were negatively correlated ( n=32 ; P=0.001 ; r=−0.545 ) , and patients with GDR ≤7.9 mg/kg per minute had higher systolic/diastolic blood pressure than those with higher GDR . Acetyl-l-carnitine increased GDR from 4.89±1.47 to 6.72±3.12 mg/kg per minute ( P=0.003 , Bonferroni-adjusted ) and improved glucose tolerance in patients with GDR ≤7.9 mg/kg per minute , whereas it had no effects in those with higher GDRs . Changes in GDR were significantly different between groups ( P=0.017 , ANCOVA ) . Systolic blood pressure decreased from 144.0±13.6 to 135.1±8.4 mm Hg and from 130.8±12.4 to 123.8±10.8 mm Hg in the lower and higher GDR groups , respectively ( P<0.05 for both ; P<0.001 overall ) and progressively recovered toward baseline over 8 weeks posttreatment . Total and high molecular weight adiponectin levels followed specular trends . Diastolic blood pressure significantly decreased only in those with higher GDRs . Treatment was well tolerated in all of the patients . Acetyl-l-carnitine safely ameliorated arterial hypertension , insulin resistance , impaired glucose tolerance , and hypoadiponectinemia in subjects at increased cardiovascular risk . Whether these effects may translate into long-term cardioprotection is worth investigating L-Carnitine ( L-C ) transports fatty acids into mitochondria for oxidation and is marketed as a weight loss supplement . In a double-blind investigation to test the weight loss efficacy of L-C , 36 moderately overweight premenopausal women were pair matched on Body Mass Index ( BMI ) and r and omly assigned to two groups ( N = 18 ) . For 8 weeks the L-C group ingested 2 g twice daily of L-C , while the placebo ( P ) group ingested the same amount of lactose . All subjects walked for 30 min ( 60 - 70 % maximum heart rate ) 4 days/week . Body composition , resting energy expenditure ( REE ) and substrate utilization were estimated before and after treatment . For the subjects who completed the study ( 15 P , 13 L-C ) , no significant changes in mean total body mass ( TBM ) , fat mass FM , and resting lipid utilization occurred over time , nor were there any significant differences between groups for any variable . Conversely REE increased significantly for all subjects , but no between group differences existed . Five of the L-C group experienced nausea or diarrhea and consequently did not complete the study . Eight weeks of L-C ingestion and walking did not significantly alter the TBM or FM of overweight women , thereby casting doubt on the efficacy of L-C supplementation for weight loss BACKGROUND AND OBJECTIVE Molecular mechanisms of most anti-obesity drugs are remained to be clear . MicroRNAs that are noncoding RNA molecules supposed to regulate biological processes concomitant to obesity and have attracted a lot of attention to themselves . The miR-27a and miR-143 expression levels in obese and non-obese rats during weight changes and L-carnitine ( LC ) effects on them was investigated in this study . MATERIAL S AND METHODS In the present study 12 male Wistar rats were r and omly divided into normal fat diet and high fat diet groups to develop obesity . After 8 weeks rats were weighted and half of diet induced obese rats were r and omly selected to receive 200 mg LC kg -1 b.wt . for 4 weeks . At the end epididymal fat was isolated to investigate expression level of microRNAs by real-time PCR . RESULTS After 12 weeks , high fat diet in comparison with normal fat diet mediated significant decrease and increase in expression levels of miR-27a and miR-143 , respectively . These changes were modified in groups , which had received LC in a 4 weeks period . Furthermore , rats in this group gained less weight . CONCLUSION Findings of this study suggest that the changes of microRNAs expression probably play a role in pathogenesis of obesity , might be modulated by means of dietary agents and supplements and modify weight gain trend BACKGROUND A previous study has demonstrated that L-carnitine reduces plasma lipoprotein(a ) ( Lp[a ] ) levels in patients with hypercholesterolemia . OBJECTIVE To test a tolerable Lp(a)-reducing agent in diabetic patients , we assessed the effect of a dietary supplementation of L-carnitine on plasma lipid levels , particularly Lp(a ) , of patients with type 2 diabetes mellitus ( DM ) and hypercholesterolemia . METHODS In this 6-month , r and OUTPUT:
Conclusion l-carnitine consumption does not reduce serum leptin significantly . However , a significant effect on leptin was observed in diabetic patients and patients who received doses more than 3 mg per day in the course of < 12 weeks
MS2_dynamic_1_shot475
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: PURPOSE This Phase II trial evaluated the toxicity , local control , and overall survival in patients treated with sequential gemcitabine and linear accelerator-based single-fraction stereotactic body radiotherapy ( SBRT ) . METHODS AND MATERIAL S Twenty patients with locally advanced , nonmetastatic pancreatic adenocarcinoma were enrolled on this prospect i ve single-institution , institutional review board-approved study . Gemcitabine was administered on Days 1 , 8 , and 15 , and SBRT on Day 29 . Gemcitabine was restarted on Day 43 and continued for 3 - 5 cycles . SBRT of 25 Gy in a single fraction was delivered to the internal target volume with a 2- 3-mm margin using a nine-field intensity-modulated radiotherapy technique . Respiratory gating was used to account for breathing motion . Follow-up evaluations occurred at 4 - 6 weeks , 10 - 12 weeks , and every 3 months after SBRT . RESULTS All patients completed SBRT and a median of five cycles of chemotherapy . Follow-up for the 2 remaining alive patients was 25.1 and 36.4 months . No acute Grade 3 or greater nonhematologic toxicity was observed . Late Grade 3 or greater toxicities occurred in 1 patient ( 5 % ) and consisted of a duodenal perforation ( G4 ) . Three patients ( 15 % ) developed ulcers ( G2 ) that were medically managed . Overall , median survival was 11.8 months , with 1-year survival of 50 % and 2-year survival of 20 % . Using serial computed tomography , the freedom from local progression was 94 % at 1 year . CONCLUSION Linear accelerator-delivered SBRT with sequential gemcitabine result ed in excellent local control of locally advanced pancreatic cancer . Future studies will address strategies for reducing long-term duodenal toxicity associated with SBRT Background First-line treatment with FOLFIRINOX significantly increases overall survival ( OS ) in patients with metastatic pancreatic adenocarcinoma ( PA ) compared with gemcitabine . The aim of this observational cohort was to evaluate the tolerability and efficacy of this regimen in unresectable locally advanced PA ( LAPA ) . Patients and Methods From February 2010 to February 2012 , all consecutive patients from 11 French centers treated by FOLFIRINOX for a histologically proven LAPA were prospect ively enrolled . Unresectability was defined independently by each center ’s multidisciplinary staff at diagnosis . Absence of metastatic disease was confirmed by chest-abdomen-pelvis computed tomography scan . FOLFIRINOX was delivered every 2 weeks as previously reported until progressive disease , major toxicity , or consolidation treatment by radiotherapy and /or surgery . Results Seventy-seven patients were enrolled . They received a median number of five cycles ( 1–30 ) . Grade 3–4 toxicities were neutropenia ( 11 % ) , nausea ( 9 % ) , diarrhea ( 6 % ) , fatigue ( 6 % ) , and anemia ( 1 % ) . Grade 2–3 sensory neuropathy occurred in 25 % of patients . No toxic death was reported and only 6 % of patients had to stop treatment because of toxicity . Disease control rate was 84 with 28 % of objective response ( Response Evaluation Criteria in Solid Tumors ) . Seventy-five percent of patients received a consolidation therapy : 70 % had radiotherapy and 36 % underwent a surgical resection , with a curative intent . Within the whole cohort , 1-year OS rate was 77 % ( 95 % CI 65–86 ) and 1-year progression-free survival rate was 59 % ( 95 % CI 46–70 ) . Conclusion First-line FOLFIRINOX for LAPA seems to be effective and have a manageable toxicity profile . These promising results will have to be confirmed in a phase III r and omized trial Background : Through a phase I study with a fixed radiation dose of 54 Gy and escalating doses of weekly gemcitabine , we established a recommended dose of gemcitabine at 250 mg/m2 in combination with radiation therapy for patients with unresectable pancreatic cancer . Objective : The purpose of this phase-II study was to evaluate the safety and efficacy of the regimen which was established in the phase I study . Methods : In all patients with unresectable stage III and limited stage IV pancreatic cancer with no distant metastasis except for para-aortic lymph node involvement at a level as low as the left renal vein , a total dose of 54 Gy was delivered in 30 fractions of 1.8 Gy/d . Gemcitabine was given weekly at a dose of 250 mg/m2 . Results : Between December 2002 and March 2006 , 22 patients were enrolled in this study and one withdrew after enrollment . Twenty of 21 patients ( 95 % ) completed the protocol therapy . Radiologic partial response was observed in 6 and stable disease was noted in 15 . Normalization of the tumor marker ( CA19 - 9 ) occurred in 61 % of patients . The 1-year survival rate was 74 % and the median survival time was 16.6 months . The major toxicity was leucopenia ; grade 3 in 14 ( 67 % ) , anorexia grade 3 in 2 ( 9.5 % ) , and grade 3 gastric ulcer in 2 ( 10 % ) in National Cancer Institute 's Common Terminology Criteria for Adverse Events version 3.0 ( NCI-CTCAE v3.0 ) . Neither grade 4 nor 5 was recognized . Conclusion : Treatment with gemcitabine combined with radiation therapy according to the OUTPUT: These results suggest that SBRT for LAPC may result in a modest improvement in 2-year OS with decreased rates of acute grade 3/4 toxicity and no change in 1-year-OS or late toxicity . INPUT: PURPOSE This Phase II trial evaluated the toxicity , local control , and overall survival in patients treated with sequential gemcitabine and linear accelerator-based single-fraction stereotactic body radiotherapy ( SBRT ) . METHODS AND MATERIAL S Twenty patients with locally advanced , nonmetastatic pancreatic adenocarcinoma were enrolled on this prospect i ve single-institution , institutional review board-approved study . Gemcitabine was administered on Days 1 , 8 , and 15 , and SBRT on Day 29 . Gemcitabine was restarted on Day 43 and continued for 3 - 5 cycles . SBRT of 25 Gy in a single fraction was delivered to the internal target volume with a 2- 3-mm margin using a nine-field intensity-modulated radiotherapy technique . Respiratory gating was used to account for breathing motion . Follow-up evaluations occurred at 4 - 6 weeks , 10 - 12 weeks , and every 3 months after SBRT . RESULTS All patients completed SBRT and a median of five cycles of chemotherapy . Follow-up for the 2 remaining alive patients was 25.1 and 36.4 months . No acute Grade 3 or greater nonhematologic toxicity was observed . Late Grade 3 or greater toxicities occurred in 1 patient ( 5 % ) and consisted of a duodenal perforation ( G4 ) . Three patients ( 15 % ) developed ulcers ( G2 ) that were medically managed . Overall , median survival was 11.8 months , with 1-year survival of 50 % and 2-year survival of 20 % . Using serial computed tomography , the freedom from local progression was 94 % at 1 year . CONCLUSION Linear accelerator-delivered SBRT with sequential gemcitabine result ed in excellent local control of locally advanced pancreatic cancer . Future studies will address strategies for reducing long-term duodenal toxicity associated with SBRT PURPOSE This phase III trial compared the efficacy and safety of gemcitabine ( Gem ) plus capecitabine ( GemCap ) versus single-agent Gem in advanced/metastatic pancreatic cancer . PATIENTS AND METHODS Patients were r and omly assigned to receive GemCap ( oral capecitabine 650 mg/m2 twice daily on days 1 to 14 plus Gem 1,000 mg/m2 by 30-minute infusion on days 1 and 8 every 3 weeks ) or Gem ( 1,000 mg/m2 by 30-minute infusion weekly for 7 weeks , followed by a 1-week break , and then weekly for 3 weeks every 4 weeks ) . Patients were stratified according to center , Karnofsky performance score ( KPS ) , presence of pain , and disease extent . RESULTS A total of 319 patients were enrolled between June 2001 and June 2004 . Median overall survival ( OS ) time , the primary end point , was 8.4 and 7.2 months in the GemCap and Gem arms , respectively ( P = .234 ) . Post hoc analysis in patients with good KPS ( score of 90 to 100 ) showed a significant prolongation of median OS time in the GemCap arm compared with the Gem arm ( 10.1 v 7.4 months , respectively ; P = .014 ) . The overall frequency of grade 3 or 4 adverse events was similar in each arm . Neutropenia was the most frequent grade 3 or 4 adverse event in both arms . CONCLUSION GemCap failed to improve OS at a statistically significant level compared with st and ard Gem treatment . The safety of GemCap and Gem was similar . In the subgroup of patients with good performance status , median OS was improved significantly . GemCap is a practical regimen that may be considered as an alternative to single-agent Gem for the treatment of advanced/metastatic pancreatic cancer patients with a good performance status CONTEXT Sympathectomy is currently used as the fourth step of the modified World Health Organization ( WHO ) analgesic ladder . Sympathectomy can be performed early , before the second step on the ladder . OBJECTIVES We hypothesized that early sympathectomy would reduce pain and opioid consumption and improve quality of life . METHODS One hundred nine patients , with inoperable abdominal or pelvic cancer , reporting visceral pain of 40 - 70 on a visual analogue scale and taking nonopioid analgesics were allocated r and omly into two groups : either blocks were performed before Step 2 of the WHO ladder , then analgesics were managed according to the ladder ( Group I ) or analgesics were given according to the WHO ladder , and blocks were performed as the fourth step after failure of strong opioids to control pain ( Group II ) . Visual analogue scale scores , responder analysis , daily opioid consumption , related side effects , and quality of life were assessed . RESULTS Responders were significantly higher in Group I ( P < 0.0001 ) , and partial responders and nonresponders significantly increased in Group II ( P < 0.0001 and 0.006 , respectively ) . Opioid consumption significantly decreased in Group I ( P < 0.0001 during first 12 months and 0.007 at the last assessment time ) , with concomitant significant reduction in related side effects . The number of patients who had a good analgesic response on tramadol significantly increased in Group I during the first five months ( P < 0.05 ) . European Organization for Research and Treatment of Cancer Quality of Life Question naire-Core 30 global quality -of-life subscale scores revealed significant improvement until the fifth month in Group I ( P < 0.05 ) . CONCLUSION Sympathectomy before Step 2 on the WHO analgesic ladder seems to lead to better pain control , less opioid consumption , and better quality of life in cancer patients Purpose Chemoradiation therapy ( CRT ) for patients with locally advanced pancreatic cancer ( LAPC ) provides survival benefits but may result in considerable to OUTPUT:
Initial systemic chemotherapy ( 6 months ) with a combination regimen is recommended for most patients ( for some patients radiation therapy may be offered up front ) with Eastern Cooperative Oncology Group performance status 0 or 1 and a favorable comorbidity profile . There is no clear evidence to support one regimen over another .
MS2_dynamic_1_shot476
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: The objectives of this prospect i ve cohort study , conducted in New Haven , Connecticut , from 1998 to 2004 , were to describe disability states experienced by older persons , to evaluate the rate of transitions between states and the duration of disability episodes , and to determine whether these findings differ on the basis of physical frailty -- a condition of low physical capacity and vulnerability to adverse functional outcomes . Participants included 754 persons aged 70 years or older who were initially independent in four key activities of daily living : bathing , dressing , walking , or transferring . Disability was assessed during monthly telephone interviews for a median of 60 months , and participants were classified each month according to the following four states : no disability , mild disability ( one or two activities ) , severe disability ( three or four activities ) , and death . Transitions between states of disability and independence were common , with a majority of both frail and nonfrail participants experiencing at least one transition . The rate of transitions varied greatly among individuals . Nonfrail participants had lower rates of transition from less to more disability , higher rates of transition from more to less disability , and slightly shorter duration s of disability . To fully underst and the disabling process , investigators and clinicians must consider the episodic and recurrent nature of disability OBJECTIVE To test the feasibility of two models of home meal delivery with Meals-on-Wheels ( MOW ) applicants who were identified as being malnourished or " at-risk " as determined by the vali date d Mini Nutritional Assessment ( MNA ) . DESIGN A 6-month , prospect i ve comparative study of two nutrition intervention models with data collection at baseline , 3 months , and 6 months . R and omized treatment assignment was followed , with a few exceptions linked to particular client circumstances . SUBJECTS A total of 203 older adults ( age range = 60 to 90 years ) newly applying for homebound meal service were enrolled . At baseline , the body mass index ( BMI ) was 26.3+/-7.2 ( mean+/-SD ) in the " Traditional " MOW model ( 101 subjects including 30 malnourished ) , and the BMI was 27.6+/-9.0 in the " New " MOW model ( 102 subjects including 26 malnourished ) ( P = ns ) . INTERVENTION Study participants received either the Traditional MOW program of five hot meals per week , meeting 33 % of the Daily Reference Intake ( DRI ) or the restorative , comprehensive New MOW program of three meals and two snacks per day , 7 days a week , meeting 100 % of the DRI . Assessment s were conducted in the home of the participants . Main outcome measures The MNA was used to evaluate nutritional risk and status of participants at baseline , 3 months , and 6 months . St and ardized functional impairment scales , Activities of Daily Living ( ADL ) , and Instrumental Activities of Daily Living ( IADL ) evaluated limitations in activities of daily living and life management skills . Statistical analysis Comparisons between treatment groups were calculated with t tests or Wilcoxon rank-sum tests when appropriate . Comparisons among time periods between treatment groups were conducted with repeated measures analysis of variance . A general linear model was used to evaluate the relationship between change in functional status and BMI , controlling for sex . RESULTS The New MOW group gained significantly more weight between baseline and 3 months than did the Traditional MOW group ( 2.78 lb vs -1.46 lb , respectively , P = .0120 ) and again between baseline and 6 months ( 4.30 lb vs -1.72 lb , respectively , P = .0004 ) . MNA improved faster in the New MOW group . Functional change appeared to be related more to BMI and age than to treatment intervention . The malnourished participants in both groups took longer to affect positive change in nutrition measurements , with the New MOW group showing the most improvement over the 6-month measurement period . Both delivery models were well accepted . CONCLUSIONS Applicants for home meal delivery have varying nutrition needs . By addressing nutritional risk , interventions can be targeted to meet these needs . A new , restorative , comprehensive meal program improved nutritional status and decreased nutritional risk and can possibly impact independence and functionality BACKGROUND The Short Physical Performance Battery ( SPPB ) , which includes walking , balance , and chair st and s tests , independently predicts mobility disability and activities of daily living disability . To date , however , there is no definitive evidence from r and omized controlled trials that SPPB scores can be improved . Our objective was to assess the effect of a comprehensive physical activity ( PA ) intervention on the SPPB and other physical performance measures . METHODS A total of 424 sedentary persons at risk for disability ( ages 70 - 89 years ) were r and omized to a moderate-intensity PA intervention or a successful aging ( SA ) health education intervention and were followed for an average of 1.2 years . RESULTS The mean baseline SPPB score on a scale of 0 - 12 , with 12 corresponding to highest performance , was 7.5 . At 6 and 12 months , the PA versus SA group adjusted SPPB ( + /- st and ard error ) scores were 8.7 + /- 0.1 versus 8.0 + /- 0.1 , and 8.5 + /- 0.1 versus 7.9 + /- 0.2 , respectively ( p < .001 ) . The 400-meter walking speed was also significantly improved in the PA group . The PA group had a lower incidence of major mobility disability defined as incapacity to complete a 400-meter walk ( hazard ratio = 0.71 , 95 % confidence interval = 0.44 - 1.20 ) . CONCLUSIONS A structured PA intervention improved the SPPB score and other measures of physical performance . An intervention that improves the SPPB performance may also offer benefit on more distal health outcomes , such as mobility disability OBJECTIVE To determine whether a home-based physical therapy ( PT ) OUTPUT: Results No evidence was found for the effect of nutritional interventions on disability measures . There was no evidence for the effect of single lower extremity strength training on disability . Differences between the multi-component interventions in e.g. individualization , duration , intensity and setting hamper the interpretation of the elements that consistently produced successful outcomes . Conclusion There is an indication that relatively long-lasting and high-intensive multicomponent exercise programs have a positive effect on ADL and IADL disability for community-living moderate physically frail older persons . INPUT: BACKGROUND A major obstacle to screening for early mobility disability ( ie , mobility difficulty ) , a major public health concern , is the lack of a method that identifies those who are at high risk . The goal of this study was to develop easy-to-use clinical nomograms for estimation of the probability of incident mobility difficulty . METHODS We conducted a population -based prospect i ve study using data from 266 high physically and cognitively functioning older women , aged 70 to 80 years , who were free of mobility disability at the baseline evaluation of the Women 's Health and Aging Study II . The outcome measure was incident mobility disability within 18 months , defined as self-reported difficulty walking 0.8 km , climbing 10 steps , or transferring from or into a car or bus . Logistic regression and receiver operating characteristic curve analyses were used for evaluation of the optimal combination of self-reported and performance-based mobility measures . Bootstrap sampling and estimation was used for validation . RESULTS Predictive nomograms were developed based on a final model that included 3 simple-to-obtain measures of pre clinical disability : self-report of modification in mobility tasks without having difficulty with them , one-leg stance balance , and time to walk 1 m at a usual pace . Final model accuracy ( as estimated by the area under the receiver operating characteristic curve ) was 73 % ( SE = 0.04 ) . Validation analysis confirmed the high accuracy of these nomograms . CONCLUSIONS An original tool was developed for assessment of the risk of mobility difficulty in older women that can be used to assist physicians and research ers in deciding which women to target for preventive interventions OBJECTIVES To vali date self-reported pre clinical mobility limitation concept and self-report assessment method against muscle power and walking speed , and to study the predictive validity of pre clinical mobility limitation with respect to future risk of manifest mobility limitation . DESIGN Observational prospect i ve cohort study and cross-sectional analysis . SETTING Research laboratory and community . PARTICIPANTS A total of 632 community-living ( age range , 75 - 81 y ) women and men took part in the baseline assessment s and 302 persons in the semi-annual interviews on mobility limitation over 2 years . INTERVENTIONS Not applicable . MAIN OUTCOME MEASURES Walking speed , muscle power , and self-reported pre clinical and manifest mobility limitation . Pre clinical mobility limitation was defined as self-reported tiredness or modification of task performance without task difficulty . At baseline , 4 subgroups were created according to self-reported pre clinical mobility limitation in any of 3 mobility tasks ( walking 2 km , walking 0.5 km , climbing up stairs ) : no limitation , pre clinical limitation , and minor and major manifest limitation . RESULTS At baseline , participants with pre clinical mobility limitation showed intermediate levels of walking speed and muscle power , compared with those with no limitation or manifest mobility limitation . Participants reporting baseline pre clinical mobility limitation had 3- to 6-fold higher age- and sex-adjusted risk of progressing to major manifest mobility limitation during the 2-year follow-up compared with participants with no limitation at baseline , whereas the risk among those with minor limitation at baseline was 14- to 18-fold higher compared with those with no limitation . CONCLUSIONS The self-report assessment tool proved to be a valid measure to capture the early signs of disability and may serve as an inexpensive tool for identifying those nondisabled persons at high risk for future disability OBJECTIVES To identify levels of knee extensor strength that are associated with high and low risk of incident severe mobility limitation ( SML ) in initially well-functioning older adults . DESIGN Prospect i ve cohort study . SETTING University clinic center . PARTICIPANTS One thous and three hundred fifty-five men and 1,429 women ( aged 73.6+/-2.85 ) who reported no mobility limitation . MEASUREMENTS Unilateral knee extensor isokinetic strength of participants was obtained . Participants were followed over a median of 5.90 years for the onset of SML , defined as two consecutive reports of a lot of difficulty or inability to walk one-quarter of a mile or climb 10 steps . Deciles of knee extension strength relative to body weight were evaluated to identify cutpoints most predictive of incident SML . Cutpoints were then compared with prevalence of having slow gait speed ( < 1.22 m/s ) and mortality . RESULTS Two sex-specific knee extension strength cutpoints were found . High and low risk of SML corresponded to less than 1.13 newton-meters (Nm)/kg ( 1st decile ) and more than 1.71 Nm/kg ( 6th decile ) in men and less than 1.01 Nm/kg ( 3rd decile ) and more than 1.34 Nm/kg ( 7th decile ) in women , respectively . Moderate risk was defined as being between the low- and high-risk cutpoints . Individuals with knee extension strength in the high- and moderate-risk categories were more likely to have a gait speed less than 1.22 m/s ( hazard ratio (HR)=7.00 , 95 % confidence interval (CI)=5.47 - 8.96 and HR=2.14 7.00 , 95 % CI=1.73 - 2.64 , respectively ) and had a higher risk of death ( HR=1.77 , 95 % CI=1.41 - 2.23 and HR=1.51 , 95 % CI=1.24 - 1.84 , respectively ) than individuals in the low-risk category . Adjustment for demographic factors , health behaviors , and medical conditions did not alter these associations . CONCLUSION Knee extensor strength cutpoints provide objective markers to identify initially well-functioning older adults at high and low risk of future mobility limitation Background Interventions that enhance mobility in frail older people are needed to maintain health and independence , yet definitive evidence of effective interventions is lacking . Our objective OUTPUT:
Commonly measured constructs of mobility included walking , climbing stairs , and lower extremity function . There was heterogeneity in ways of defining and measuring mobility limitation in older adults living in the community .
MS2_dynamic_1_shot477
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: Objective : To examine the effects of iron deficiency and its treatment by iron supplementation or a high iron diet on fatigue and general health measures in women of childbearing age . Design : R and omised controlled trial to compare supplement and dietary treatment of iron deficiency . Subjects : 44 iron deficient ( serum ferritin < 15 μg/L or serum ferritin 15–20 μg/L , plus two of the following : serum iron < 10 μmol/L , total iron binding capacity > 68 μmol/L or transferrin saturation < 15 % ) and 22 iron replete ( hemoglobin ≥120 g/L and serum ferritin > 20 μg/L ) women 18 to 50 years of age were matched for age and parity . Interventions : Iron deficient women were r and omly allocated to either iron supplementation or a high iron diet for 12 weeks . Measures of Outcome : Iron deficient and iron replete participants had iron studies performed and completed the Piper Fatigue Scale ( PFS ) and the SF-36 general health and well-being question naire at baseline ( T0 ) , following the 12 week intervention ( T1 ) and again after a six-month non-intervention phase ( T2 ) . The SF-36 includes measures of physical ( PCS ) and mental ( MCS ) health and vitality ( VT ) . Results : MCS and VT scores were lower and PFS scores were higher for iron deficient women ( diet and supplement groups ) than iron replete women at baseline . Both intervention groups showed similar improvements in MCS , VT and PFS scores during the intervention phase , but mean increases in serum ferritin were greater in the supplement than the diet group . PCS scores were not related to iron status . Conclusions : Treatment of iron deficiency with either supplementation or a high iron diet results in improved mental health and decreased fatigue among women of childbearing age Background Vegetarian diets have been associated with lower risk of chronic disease , but little is known about the health effects of low meat diets and the reliability of self-reported vegetarian status . We aim ed to establish an analytical cohort over-represented with vegetarians , pescetarians and 1 day/week meat consumers , and to describe their lifestyle and dietary characteristics . In addition , we were able to compare self-reported vegetarians with vegetarians whose status has been confirmed by their response on the extensive food frequency question naire ( FFQ ) . Study methods Embedded within the Netherl and s Cohort Study ( n = 120,852 ; including 1150 self-reported vegetarians ) , the NLCS-Meat Investigation Cohort ( NLCS-MIC ) was defined by combining all FFQ-confirmed-vegetarians ( n = 702 ) , pescetarians ( n = 394 ) , and 1 day/week meat consumers ( n = 1,396 ) from the total cohort with a r and om sample of 2–5 days/week- and 6–7 days/week meat consumers ( n = 2,965 and 5,648 , respectively ) . Results Vegetarians , pescetarians , and 1 day/week meat consumers had more favorable dietary intakes ( e.g. higher fiber/vegetables ) and lifestyle characteristics ( e.g. lower smoking rates ) compared to regular meat consumers in both sexes . Vegetarians adhered to their diet longer than pescetarians and 1 day/week meat consumers . 75 % of vegetarians with a prevalent cancer at baseline had changed to this diet after diagnosis . 50 % of self-reported vegetarians reported meat or fish consumption on the FFQ . Although the misclassification that occurred in terms of diet and lifestyle when merely relying on self-reporting was relatively small , the impact on associations with disease risk remains to be studied . Conclusion We established an analytical cohort over-represented with persons at the lower end of the meat consumption spectrum which should facilitate prospect i ve studies of major cancers and causes of death using ≥20.3 years of follow-up BACKGROUND Gene mutations associated with iron overload have been identified . How food and nutrient intakes affect iron status in persons who may be at risk of iron overload because their genetic status is unknown . OBJECTIVE The objective was to determine the relation between food and nutrient intakes , HFE genotype , and iron status . Foods and nutrients associated with iron stores , with adjustment for gene mutations associated with hemochromatosis , were explored . DESIGN A prospect i ve cohort of women aged 35 - 69 y ( the UK Women 's Cohort Study ) provided information on diet through a question naire and food diary ; 6779 women in the cohort provided cheek cell sample s , blood sample s , or both , which were genotyped for C282Y and H63D mutations , and 2489 women also had their iron status assessed . Relations between serum ferritin and iron intake were investigated by using multiple linear regression , with adjustment for potential confounders . RESULTS The strongest dietary association with serum ferritin concentration was a positive association with heme iron and not with nonheme or total iron . Weaker positive associations were seen with red and white meat , and negative associations were seen with total energy and white and brown whole-meal bread , independent of genotype and other potential confounders . The effect of genotype on ferritin concentrations primarily occurred after menopause , at which time a strong interaction between genotype and heme iron intake was observed . Other factors associated with serum ferritin concentrations were age , body mass index , blood donation , menopausal status , and HFE genotype . CONCLUSIONS Postmenopausal women eating a diet rich in heme iron and who were C282Y homozygotes had the highest serum ferritin concentrations The effects of three diets -- high meat ( HM ) , low meat ( OUTPUT: However , the optimum quantity or frequency of flesh intake required to maintain or achieve a healthy iron status remains unclear . INPUT: Objective To assess the use , side effects and discontinuation rates of iron preparations during pregnancy . Design Six hundred and twelve r and omly selected postpartum women completed a question naire on iron supplement use in the second and third trimesters . Results Of the 517 women ( 84.5 % ) reported using iron supplements , 453 were eligible for the study . The most common preparation was ferrous fumarate ( 46.8 % , P < 0.01 ) , followed by ferrous sulfate ( 31.8 % ) , ferric polymaltose ( 12.4 % ) , and ferric bisglycinate ( 7.3 % ) . Almost half the participants ( 45 % ) reported at least one adverse effect , especially constipation ( 27.4 % , P < 0.01 ) , nausea ( 10.8 % ) . Multivitamin preparations and ferric bisglycinate were associated with the fewest side effects ( 23.7 , 21.2 % respectively , P < 0.01 ) , and ferrous fumarate and immediate-release ferrous sulfate with the most ( 56.3 , 53.7 % respectively ) . Eighty-three women discontinued their originally prescribed iron preparation , mainly ( 89 % ) due to side effects . Discontinuation rates were lowest for the multivitamin and ferric bisglycinate ( 10.5 , 9.1 % , respectively ) . In most cases , the specific preparation was recommended by the women ’s physician ( 76 % ) . Conclusion Ferrous fumarate-containing multivitamin preparations and ferric bisglycinate , although infrequently recommended as the first-line of iron supplementation , may be associated with less side effects and better compliance Side-effects of iron supplementation lead to poor compliance . A weekly-dose schedule of iron supplementation rather than a daily-dose regimen has been suggested to produce fewer side-effects , thereby achieving a higher compliance . This study compared side-effects of iron supplementation and their impact on compliance among pregnant women in Bangladesh . These women were assigned to receive either weekly doses of 2 x 60 mg iron ( one tablet each Friday morning and evening ) or a daily dose of 1 x 60 mg iron . Fifty antenatal care centres were r and omly assigned to prescribe either a weekly- or a daily-supplementation regimen ( 86 women in each group ) . Side-effects were assessed by recall after one month of supplementation and used for predicting compliance in the second and third months of supplementation . Compliance was monitored using a pill bottle equipped with an electronic counting device that recorded date and time whenever the pill bottle was opened . Of five gastrointestinal side-effects ( heartburn , nausea , vomiting , diarrhoea , or constipation ) assessed , vomiting occurred more frequently in the weekly group ( 21 % ) than in the daily group ( 11 % , p<0.05 ) . Compliance ( ratio between observed and recommended tablet intake ) was significantly higher in the weekly-supplementation regimen ( 93 % ) than in the daily-supplementation regimen ( 61 % , p<0.05 ) . Overall , gastrointestinal side-effects were not significantly associated with compliance . However , the presence of nausea and /or vomiting reduced compliance in both the regimens-but only among women from the lower socioeconomic group . In conclusion , weekly supplementation of iron in pregnancy had a higher compliance compared to daily supplementation of iron despite a higher frequency of side-effects . The findings support the view that gastrointestinal side-effects generally have a limited influence on compliance , at least in the dose ranges studied . Efforts to further reduce side-effects of iron supplementation may not be a successful strategy for improving compliance and effectiveness of antenatal iron supplementation Objective Evaluate the safety and efficacy of bovine lactoferrin ( bLf ) versus the ferrous sulphate st and ard intervention in curing iron deficiency ( ID ) and ID anaemia ( IDA ) in pregnant women affected by hereditary thrombophilia ( HT ) . Design Interventional study . Setting Secondary -level hospital for complicated pregnancies in Rome , Italy . Population 295 HT pregnant women ( ≥18 years ) suffering from ID/IDA . Methods Women were enrolled in Arm A or B in accordance with their personal choice . In Arm A , 156 women received oral administration of 100 mg of bLf twice a day ; in Arm B , 139 women received 520 mg of ferrous sulphate once a day . Therapies lasted until delivery . Main outcome measures Red blood cells , haemoglobin , total serum iron , serum ferritin ( haematological parameters ) were assayed before and every 30 days during therapy until delivery . Serum IL-6 , key factor in inflammatory and iron homeostasis disorders , was detected at enrolment and after therapy at delivery . Possible maternal , foetal , and neonatal adverse effects were assessed . Results Haematological parameters were significantly higher in Arm A than in Arm B pregnant women ( P ≤ 0.0001 ) . Serum IL-6 significantly decreased in bLf-treated women and increased in ferrous sulphate-treated women . BLf did not exert any adverse effect . Adverse effects in 16.5 % of ferrous sulphate-treated women were recorded . Arm A women experienced no miscarriage compared to five miscarriages in Arm B women . Conclusions Differently from ferrous sulphate , bLf is safe and effective in curing ID/IDA associated with a consistent decrease of serum IL-6 . The absence of miscarriage among bLf-treated women provided an unexpected benefit . Trial registration : Clinical Trials.gov Identifier NCT01221844 Iron homeostasis in pregnancy compensates for increased iron requirements and in women of OUTPUT:
Significantly less gastrointestinal side effects were reported with lactoferrin treatment . No significant differences existed with regard to other outcomes . In conclusion , for pregnant women with IDA , daily oral bovine lactoferrin is just as good as ferrous sulfate in improving hematological parameters with fewer gastrointestinal side effects .
MS2_dynamic_1_shot478
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: Background Distress and burnout among medical and psychology professionals are commonly reported and have implication s for the quality of patient care delivered . Already in the course of university studies , medicine and psychology students report mental distress and low life satisfaction . There is a need for interventions that promote better coping skills in students in order to prevent distress and future burnout . This study examines the effect of a seven-week Mindfulness-Based Stress Reduction ( MBSR ) programme on mental distress , study stress , burnout , subjective well-being , and mindfulness of medical and psychology students . Methods A total of 288 students ( mean age = 23 years , 76 % female ) from the University of Oslo and the University of Tromsø were r and omly allocated to an intervention or control group . The control group continued with their st and ard university courses and received no intervention . Participants were evaluated using self-reported measures both before and after the intervention . These were : the ‘ General Health Question naire , Maslach Burnout Inventory Student version , Perceived Medical School Stress , Subjective Well-being , and Five Facet Mindfulness Question naire ’ and additional indices of compliance . Results Following the intervention , a moderate effect on mental distress ( Hedges’g 0.65 , CI = .41 , .88 ) , and a small effect on both subjective well-being ( Hedges’g 0.40 , CI = .27 , .63 ) and the mindfulness facet ‘ non-reacting ’ ( Hedges’g 0.33 , CI = .10 , .56 ) were found in the intervention group compared with the control group . A higher level of programme attendance and reported mindfulness exercises predicted these changes . Significant effects were only found for female students who additionally reported reduced study stress and an increase in the mindfulness facet ‘ non-judging ’ . Gender specific effects of participation in the MBSR programme have not previously been reported , and gender differences in the present study are discussed . Conclusion Female medical and psychology students experienced significant positive improvements in mental distress , study stress , subjective well-being and mindfulness after participating in the MBSR programme . Trial registration The inability to cope successfully with the enormous stress of medical education may lead to a cascade of consequences at both a personal and professional level . The present study examined the short-term effects of an 8-week meditation-based stress reduction intervention on premedical and medical students using a well-controlled statistical design . Findings indicate that participation in the intervention can effectively ( 1 ) reduce self-reported state and trait anxiety , ( 2 ) reduce reports of overall psychological distress including depression , ( 3 ) increase scores on overall empathy levels , and ( 4 ) increase scores on a measure of spiritual experiences assessed at termination of intervention . These results ( 5 ) replicated in the wait-list control group , ( 6 ) held across different experiments , and ( 7 ) were observed during the exam period . Future research should address potential long-term effects of mindfulness training for medical and premedical students Recovered recurrently depressed patients were r and omized to treatment as usual ( TAU ) or TAU plus mindfulness-based cognitive therapy ( MBCT ) . Replicating previous findings , MBCT reduced relapse from 78 % to 36 % in 55 patients with 3 or more previous episodes ; but in 18 patients with only 2 ( recent ) episodes corresponding figures were 20 % and 50 % . MBCT was most effective in preventing relapses not preceded by life events . Relapses were more often associated with significant life events in the 2-episode group . This group also reported less childhood adversity and later first depression onset than the 3-or-more-episode group , suggesting that these groups represented distinct population s. MBCT is an effective and efficient way to prevent relapse/recurrence in recovered depressed patients with 3 or more previous episodes OBJECTIVE This study aim ed to determine whether the practice of mindfulness reduces the level of stress experienced by senior medical students . METHODS We carried out a multicentre , single-blinded , r and omised controlled trial with intention-to-treat analysis in three clinical schools attached to the University of Tasmania , Hobart , Tasmania . Participants included 66 medical students in their final 2 years of study in 2009 . Participants were block-r and omised to either an intervention or a usual care control group . The intervention used an audio CD of guided mindfulness practice design ed and produced for this trial . Participants were advised to use the intervention daily over the 8 weeks of the trial . All participants completed two self-report question naires , at baseline and at 8 weeks , respectively . The intervention group also completed a question naire at 16 weeks to provide follow-up data . The primary outcome measure was the difference over time in scores on the Perceived Stress Scale ( PSS ) . The secondary outcome measure referred to differences over time in scores on the subscales of the Depression , Anxiety and Stress Scale ( DASS ) . RESULTS Mean baseline scores on the PSS and the stress component of the DASS were 15.7 ( maximal score of 40 ) and 13.2 ( maximal score of 42 ) , respectively , both of which exceed scores in age-matched normative control data . Using multivariable analysis , participants in the intervention group demonstrated significant reductions in scores on the PSS ( - 3.44 , 95 % confidence interval [ CI ] - 6.20 to - 0.68 ; p < 0.05 ) and the anxiety component of the DASS ( - 2.82 , 95 % CI - 4.99 to - 0.64 ; p < 0.05 ) . A borderline significant effect was demonstrated on the stress component of the DASS ( - 3.69 , 95 % CI - 7.38 to 0.01 ; p = 0.05 ) . Follow-up at 8 weeks post-trial revealed that the effect was maintained . CONCLUSIONS Mindfulness practice reduced stress and anxiety in senior medical students . Stress is prevalent in medical students and can have adverse effects on both student health and patients . A simple , self OUTPUT: Half of studies review ed included predominantly female sample s. CONCLUSIONS Mixed evidence was found for the use of MBIs for reducing psychological distress in undergraduate medical students . INPUT: Background Distress and burnout among medical and psychology professionals are commonly reported and have implication s for the quality of patient care delivered . Already in the course of university studies , medicine and psychology students report mental distress and low life satisfaction . There is a need for interventions that promote better coping skills in students in order to prevent distress and future burnout . This study examines the effect of a seven-week Mindfulness-Based Stress Reduction ( MBSR ) programme on mental distress , study stress , burnout , subjective well-being , and mindfulness of medical and psychology students . Methods A total of 288 students ( mean age = 23 years , 76 % female ) from the University of Oslo and the University of Tromsø were r and omly allocated to an intervention or control group . The control group continued with their st and ard university courses and received no intervention . Participants were evaluated using self-reported measures both before and after the intervention . These were : the ‘ General Health Question naire , Maslach Burnout Inventory Student version , Perceived Medical School Stress , Subjective Well-being , and Five Facet Mindfulness Question naire ’ and additional indices of compliance . Results Following the intervention , a moderate effect on mental distress ( Hedges’g 0.65 , CI = .41 , .88 ) , and a small effect on both subjective well-being ( Hedges’g 0.40 , CI = .27 , .63 ) and the mindfulness facet ‘ non-reacting ’ ( Hedges’g 0.33 , CI = .10 , .56 ) were found in the intervention group compared with the control group . A higher level of programme attendance and reported mindfulness exercises predicted these changes . Significant effects were only found for female students who additionally reported reduced study stress and an increase in the mindfulness facet ‘ non-judging ’ . Gender specific effects of participation in the MBSR programme have not previously been reported , and gender differences in the present study are discussed . Conclusion Female medical and psychology students experienced significant positive improvements in mental distress , study stress , subjective well-being and mindfulness after participating in the MBSR programme . Trial registration In a prospect i ve r and omised controlled trial , 48 students were r and omly assigned to stress reduction training before exams with self-hypnosis , Johrei or a mock neurofeedback relaxation control . Peripheral blood lymphocyte sub population s and self-reported stress ( Perceived Stress Scale ) were measured before training and 1 - 2 months later as exams approached . Absolute number and percentages of CD3(+)CD4(+ ) and CD3(+)CD8(+ ) T lymphocytes , CD3(-)CD56(+ ) Natural Killer cells ( NK cells ) and NK cell cytotoxic activity was measured from venous blood . Stressed participants showed small but significant declines in both CD3(-)CD56(+ ) NK cell percentages and NK cell cytotoxic activity levels while CD3(+)CD4(+ ) T cell percentages increased , changes supported by correlations with perceived stress . The effects of stress were moderated in those who learned Johrei at exam time ; 11/12 showed increases in CD3(-)CD56(+ ) NK cell percentages with decreased percentages of CD3(+)CD4(+ ) T cells , effects not seen in the relaxation control group . Stress was also buffered in those who learned and practised self-hypnosis in whom CD3(-)CD56(+ ) NK cell and CD3(+)CD4(+ ) T cell levels were maintained , and whose CD3(+)CD8(+ ) T cell percentages , shown previously to decline with exams , increased . The results compliment beneficial effects on mood of self-hypnosis and Johrei . The results are in keeping with beneficial influences of self-hypnosis and provide the first evidence of the suggestive value of the Japanese Johrei procedure for stress reduction , which clearly warrants further investigation Abstract This study ( N = 35 ) used a r and omized control design , and participants were collected from a variety of groups . After evaluating their degree of stress and burnout , coping styles , general well-being , and hypnotizability , participants were matched by stress level and r and omly assigned to an intervention or wait-list group . The intervention comprised an audio recording of a hypnotic induction accompanied by suggestions for progressive relaxation , imagery , and anchoring to be used for 2 weeks . The results show that , as compared with baseline and wait-list conditions , the hypnotic intervention had a medium-to-large beneficial effect on participants ’ experience of stress , burnout , and well-being . Some participants also decreased their use of the coping strategy escape-avoidance postintervention . Hypnotizability correlated significantly or marginally with some outcomes of the intervention , but only for 1 group Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more AIM The aim of this investigation was to measure the impact of a self-administered hypnosis intervention on resilience and the inflammatory cytokine IL-6 . METHOD Over a period of 12 weeks , 11 participants listened to a self-administered hypnosis stress reduction program design ed to recondition and improve participants ' emotional and physical reactions to perceived work and life stressors . Subjects were administered subjective measures of coping , resilience , and stress tolerance , as well as , IL-6 , an objective blood measure of inflammatory activity . RESULTS After 12 weeks , participants were observed to have a significantly lower IL-6 serum level from baseline . Further , participants reported a significant decrease in the use of negative appraisal coping ( such as , self-deprecating statements , perfectionism , and catastrophic and pessimistic thinking ) , and an improvement in eating/nutritional habits following the intervention . Baseline eating/nutritional habits and threat minimization coping significantly predicted a change in serum IL-6 over the course of the inter OUTPUT:
Conclusions Due to exploratory design s and high risk of bias , the effectiveness of hypnosis or hypnotherapy in stress reduction remains still unclear .
MS2_dynamic_1_shot479
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: BACKGROUND Surgery for cervical spondylotic myelopathy ( CSM ) is generally safe and effective . Nonetheless , complications occur in 11 % to 38 % of patients . Knowledge of important predictors of complications will help clinicians identify high-risk patients and institute prevention and management strategies . OBJECTIVE To identify clinical and surgical predictors of perioperative complications in CSM patients . METHODS Four hundred seventy-nine surgical CSM patients were enrolled in the prospect i ve CSM-International study at 16 sites . A panel of physicians review ed all adverse events and classified each as related or unrelated to surgery . Univariate analyses were performed to determine differences between patients who experienced a perioperative complication and those who did not . A complication prediction rule was developed using multiple logistic regression . RESULTS Seventy-eight patients experienced 89 perioperative complications ( 16.25 % ) . On univariate analysis , the major clinical risk factors were ossification of the posterior longitudinal ligament ( OPLL ) ( P = .055 ) , number of comorbidities ( P = .002 ) , comorbidity score ( P = .006 ) , diabetes mellitus ( P = .001 ) , and coexisting gastrointestinal ( P = .039 ) and cardiovascular ( P = .046 ) disorders . Patients undergoing a 2-stage surgery ( P = .002 ) and those with a longer operative duration ( P = .001 ) were at greater risk of perioperative complications . A final prediction model consisted of diabetes mellitus ( odds ratio [ OR ] = 1.96 , P = .060 ) , number of comorbidities ( OR = 1.20 , P = .069 ) , operative duration ( OR = 1.07 , P = .002 ) , and OPLL ( OR = 1.75 , P = .040 ) . CONCLUSION Surgical CSM patients have a higher risk of perioperative complications if they have a greater number of comorbidities , coexisting diabetes mellitus , OPLL , and a longer operative duration . Surgeons can use this information to discuss the risks and benefits of surgery with patients , to plan case-specific preventive strategies , and to ensure appropriate management in the perioperative period . ABBREVIATIONS BMI , body mass indexCSM , cervical spondylotic myelopathymJOA , modified Japanese Orthopaedic AssociationOPLL , ossification of the posterior longitudinal ligament IMPORTANCE Oral steroids are commonly used to treat acute sciatica due to a herniated disk but have not been evaluated in an appropriately powered clinical trial . OBJECTIVE To determine if oral prednisone is more effective than placebo in improving function and pain among patients with acute sciatica . DESIGN , SETTING , AND PARTICIPANTS R and omized , double-blind , placebo-controlled clinical trial conducted from 2008 to 2013 in a large integrated health care delivery system in Northern California . Adults ( n=269 ) with radicular pain for 3 months or less , an Oswestry Disability Index ( ODI ) score of 30 or higher ( range , 0 - 100 ; higher scores indicate greater dysfunction ) , and a herniated disk confirmed by magnetic resonance imaging were eligible . INTERVENTIONS Participants were r and omly assigned in a 2:1 ratio to receive a tapering 15-day course of oral prednisone ( 5 days each of 60 mg , 40 mg , and 20 mg ; total cumulative dose = 600 mg ; n = 181 ) or matching placebo ( n = 88 ) . MAIN OUTCOMES AND MEASURES The primary outcome was ODI change at 3 weeks ; secondary outcomes were ODI change at 1 year , change in lower extremity pain ( measured on a 0 - 10 scale ; higher scores indicate more pain ) , spine surgery , and Short Form 36 Health Survey ( SF-36 ) Physical Component Summary ( PCS ) and Mental Component Summary ( MCS ) scores ( 0 - 100 scale ; higher scores better ) . RESULTS Observed baseline and 3-week mean ODI scores were 51.2 and 32.2 for the prednisone group and 51.1 and 37.5 for the placebo group , respectively . The prednisone-treated group showed an adjusted mean 6.4-point ( 95 % CI , 1.9 - 10.9 ; P = .006 ) greater improvement in ODI scores at 3 weeks than the placebo group and a mean 7.4-point ( 95 % CI , 2.2 - 12.5 ; P = .005 ) greater improvement at 52 weeks . Compared with the placebo group , the prednisone group showed an adjusted mean 0.3-point ( 95 % CI , -0.4 to 1.0 ; P = .34 ) greater reduction in pain at 3 weeks and a mean 0.6-point ( 95 % CI , -0.2 to 1.3 ; P = .15 ) greater reduction at 52 weeks . The prednisone group showed an adjusted mean 3.3-point ( 95 % CI , 1.3 - 5.2 ; P = .001 ) greater improvement in the SF-36 PCS score at 3 weeks , no difference in the SF-36 PCS score at 52 weeks ( mean , 2.5 ; 95 % CI , -0.3 to 5.4 ; P = .08 ) , no change in the SF-36 MCS score at 3 weeks ( mean , 2.2 ; 95 % CI , -0.4 to 4.8 ; P = .10 ) , and an adjusted 3.6-point ( 95 % CI , 0.6 - 6.7 ; P = .02 OUTPUT: The patients who underwent total disc replacement had better patient-reported outcome measure results , with no difference in neurological improvement , return to work , or major complication rates . There was higher patient satisfaction and a lower subsequent surgical procedure rate in the total disc replacement group . INPUT: Background : Postoperative infection is one of the most common complications after spine surgeries . In our study , surgical site infection ( SSI ) is described as ; superficial ( i.e. , skin and subcutaneous tissues ) and deep ( i.e. , fascia and muscles ) infections occurring in the short term ( i.e. , 1-month ) after spine surgeries ( Centers for Disease Control and Prevention definition 81.00–81.08 ) . To detect the risk factors for the occurrence of such a complication , studies require a large number of patients , a high quality of data and adequate analysis . In this study , we prospect ively enrolled 987 patients undergoing spinal surgery over a 3 years period . Methods : From November 2010 to November 2013 , 987 patients had a variety of spinal operations that included ; disc herniation , spinal stenosis , spondylolisthesis , fracture-dislocations , spine and spinal cord tumors , and syringomyelia . Patients under the age of 10 , those with a recent history of infection and antibiotherapy , and patients with immunodeficiency disorders were excluded . Results : Of the 987 spine procedures performed , 27 ( 2.73 % ) developed postoperative infections . Multi-variant data analysis indicated that multiple factors correlated with an increased risk of SSI in descending order ; trauma , a past history of diabetes , smoking , being confined to bed , in the perioperative period , mean blood sugar levels above 120 mg/dl , longer lengths of incisions , and longer hospital stay . Conclusion : Considering the preventable nature of most of the factors contributing to SSI , it should be possible to reduce these complications Study Design . Prospect i ve cohort study . Objective . To study risk factors linked to spinal fusion surgical wound infection ( SWI ) incidence and compare the incidence with rates in Madrid Region , Spain and United States as a whole . Summary of Background Data . SWI is one of the complications posed by spinal surgery . Indeed , spinal surgery has a higher infection rate than do other orthopedic surgeries such as total hip or knee arthroplasty . The study of risk factors that are susceptible to be modified will enable both the incidence of SWI and , by extension , related morbidity , mortality , and costs to be reduced . Methods . All patients undergoing spinal fusion at a tertiary hospital from June 2011 to June 2014 were included . Infection rate was calculated , and the association between risk factors and SWI incidence was assessed by reference to odds ratio ( OR ) with univariate and multivariate analysis . Results . The study population ( n = 892 ) had a SWI rate of 3.9 % . The st and ardized infection ratio of our hospital was 0.58 with respect to the Madrid Region , 0.76 with respect to Spain 's national rate and 2.05 with respect to the US NHSN/CDC . The multivariate analysis showed that predictive factors of SWI were diabetes mellitus ( OR 2.81 , 95 % confidence interval , CI : 1.18–6.72 , P < 0.05 ) , chronic obstructive pulmonary disease ( COPD ) ( OR 5.16 , 95 % CI : 2.04–13.08 , P < 0.05 ) , duration of surgery higher than the 75th percentile ( OR 5.39 , 95 % CI : 1.77–110.84 , P < 0.05 ) and dirty surgery ( OR 14.01 , 95 % CI : 1.01–28.88 , P < 0.05 ) . Conclusion . Independent risk factors for SWI in spinal fusion are existence of diabetes mellitus , COPD , duration of surgery higher than the 75th percentile and dirty surgery . Knowing these risk factors enables action to be taken to reduce the SWI rate . Level of Evidence : Purpose Studies have examined infection rates following spine surgery and their relationship to post-operative complications and increased length of stay . Few studies , however , have investigated predictors of infection , specifically in the setting of operative intervention for cervical spondylotic myelopathy ( CSM ) . This study aims to identify the incidence and factors predictive of infection amongst this cohort . Methods This study performed a retrospective review of the prospect ively collected American College of Surgeons National Surgical Quality Improvement Program ( NSQIP ) data base . Patients included those treated surgically for CSM ( ICD-9 code 721.1 ) from 2010 to 2012 . Patient demographics and surgical data were collected with outcome variables including the occurrence of one of the following surgical site infections ( SSIs ) within 30 days of index operation : superficial SSI , deep incisional SSI , and organ/space SSI . Results 3057 patients were included in this analysis . Overall infection rate was 1.15 % ( 35/3057 ) , of which 54.3 % ( 19/35 ) were superficial SSIs , 28.6 % ( 10/35 ) were deep incisional SSI , and 20 % ( 7/35 ) were peri-spinal SSI . Logistic regression revealed factors associated with SSI included : higher BMI [ OR 1.162 ( CI 1.269–1.064 ) , p = 0.001 ] and operative time ≥208 min [ OR 4.769 ( CI 20.220–1.125 ) , p = 0.034 ] . Conclusions The overall SSI rate for the examined CSM cohort was 1.15 % . This study identified increased BMI and operative time ≥208 min as predictors of infection in surgical CSM patients . This information should be carefully considered OUTPUT:
Surgical associated factors — preoperative radiation/postoperative blood transfusion , combined anterior/posterior approach , surgical invasiveness , or levels of instrumentation were associated with increased SSI . There is mixed evidence of age , duration of surgery , surgical team , intraoperative blood loss , dural tear , and urinary tract infection/urinary catheter in association with SSI . Conclusion : SSIs are associated with many risk factors that can be patient or surgically related .
MS2_dynamic_1_shot480
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: Background —In patients with atrial fibrillation ( AF ) undergoing radiofrequency ( RF ) electrical disconnection of multiple pulmonary veins ( PVs ) , the incidence of late conduction recurrences has not been systematic ally determined . Methods and Results —Using a prospect ively design ed , multistep approach , we aim ed at assessing the correlation between acute achievement and chronic maintenance of electrical conduction block across RF lesions disconnecting the distal tract of the PV in 43 patients ( 52.3±8.2 years ) with AF . Forty-one left superior ( LS ) , 42 right superior ( RS ) , 25 left inferior ( LI ) , and 9 right inferior ( RI ) PVs were targeted during 108 EP procedures ( 2.6±0.5 per patient ) . Seventeen patients underwent 2 procedures , 23 patients underwent 3 procedures , and 3 patients underwent 4 procedures . During the first attempt , electrical disconnection was achieved in 112 PVs ( 95.7 % ) . During a next procedure ( time interval , 4.6±1.9 months ) , conduction recurrence was observed in 32 of 39 LSPVs ( 82.1 % ) , 29 of 40 RSPVs ( 72.5 % ) , 20 of 24 LIPVs ( 83.3 % ) , and 7 of 9 RIPV ( 77.8 % ) . After reablation at gap sites , a later procedure ( time interval , 5.1±2.4 months ) revealed a second recurrence in 13 of 22 LSPVs ( 59.1 % ) and 14 of 19 RSPVs ( 73.7 % ) . Conclusions —Conduction recurrence across disconnecting RF lesions can be observed in ≈80 % of cases 4 months after ablation . After reablation , similar recurrence rates are observed 5 months later . This high rate of late conduction recurrence may contribute significantly to AF recurrence in patients undergoing catheter ablation aim ing at disconnection of multiple PVs BACKGROUND Atrial fibrillation ( AF ) recurrence after pulmonary vein isolation ( PVI ) is associated with PV to left atrium reconduction . Effective lesion creation necessitates adequate contact force between the ablation catheter and myocardium . OBJECTIVE The purpose of this study was to study the utility of contact force-guided ablation on immediate and long-term outcomes . METHODS Seventy-five patients with highly symptomatic paroxysmal AF underwent wide circumferential PVI using an irrigated-tip radiofrequency catheter . In 25 patients , ablation was guided by real-time contact force measurements ( CF group ; SmartTouch , Biosense Webster ) . A control group of 50 patients underwent PVI using a st and ard nonforce sensing catheter ( st and ard group ; ThermoCool , Biosense Webster ) . After PVI , all patients underwent adenosine testing to unmask dormant conduction . Patients were followed up at 3 , 6 , and 12 months and by transtelephonic monitoring as well . RESULTS Dormant conduction was unmasked and subsequently eliminated in 4 PV pairs ( 8 % ; 16 % of patients ) in the CF group and 35 PV pairs ( 35 % ; 52 % of patients ) in the st and ard group ( P = .0004 per PV pair ; P = .0029 per patient ) . The single-procedure , off-antiarrhythmic drug freedom from recurrent atrial arrhythmias at 1 year was 88 % in the CF group vs 66 % in the st and ard group ( P = .047 ) . Procedure duration and fluoroscopy time were significantly longer in the CF group ( P = .0038 and P = .0001 , respectively ) . CONCLUSION The use of real-time contact force guidance results in a significant reduction in the prevalence of dormant conduction with improved long-term freedom from recurrent arrhythmias . The utility of a contact force-guided approach requires evaluation in a long-term prospect i ve r and omized study BACKGROUND Contact force ( CF ) information may improve the safety and efficacy of ablation for paroxysmal atrial fibrillation ( PAF ) . OBJECTIVE The purpose of this study was to assess the impact of CF data on ablation for PAF . METHODS Patients undergoing first-time PAF ablation were r and omized at 7 UK centers to ablation with ( CF-on ) or without ( CF-off ) CF data available to the operator , using the same ablation catheter and mapping system . An ablation CF of 5 - 40 g was targeted . Pulmonary vein ( PV ) reconnection was assessed with adenosine at 60 minutes . Follow-up for arrhythmia recurrence was for 1 year with 7-day Holter recordings at 6 and 12 months . RESULTS One hundred seventeen patients were studied ( 59 CF-on , 58 CF-off ) . In the CF-on group , a reduction in acute PV reconnection rates ( 22 % vs 32 % , P = .03 ) but no significant difference in 1-year success rates off antiarrhythmic drugs ( 49 % vs 52 % , P = .9 ) was observed . There was no difference in major complication rates : 2 of 59 ( 3 % ) CF-on , 3 of 58 ( 5 % ) CF-off ( P = .7 ) . Procedural and fluoroscopy times were not significantly different ( P>.5 ) . Overall mean CFs per ablation were not different between groups ( 13.4 [9.1 - 19.6]g CF-on , 13.4 [7.4 - 22.4]g CF-off , P = .5 ) , but a greater proportion of readings in the CF-on group were in the target range OUTPUT: Conclusion : CF‐guided RF catheter ablation was associated with a significant AF/atrial tachycardia‐free survival benefit compared with non‐CF‐guided ablation in patients with paroxysmal AF rather than persistent AF . In addition , CF‐guided ablation strategy also reduced the procedure time , fluoroscopy time , as well as RF time despite no distinct effect on the alleviation of procedure‐related complications INPUT: OBJECTIVES This study sought to assess the safety and effectiveness of a novel cryoballoon ablation technology design ed to achieve single-delivery pulmonary vein ( PV ) isolation . BACKGROUND St and ard radiofrequency ablation is effective in eliminating atrial fibrillation ( AF ) but requires multiple lesion delivery at the risk of significant complications . METHODS Patients with documented symptomatic paroxysmal AF and previously failed therapy with ≥ 1 membrane active antiarrhythmic drug underwent 2:1 r and omization to either cryoballoon ablation ( n = 163 ) or drug therapy ( n = 82 ) . A 90-day blanking period allowed for optimization of antiarrhythmic drug therapy and reablation if necessary . Effectiveness of the cryoablation procedure versus drug therapy was determined at 12 months . RESULTS Patients had highly symptomatic AF ( 78 % paroxysmal , 22 % early persistent ) and experienced failure of at least one antiarrhythmic drug . Cryoablation produced acute isolation of three or more PVs in 98.2 % and all four PVs in 97.6 % of patients . PVs isolation was achieved with the balloon catheter alone in 83 % . At 12 months , treatment success was 69.9 % ( 114 of 163 ) of cryoblation patients compared with 7.3 % of antiarrhythmic drug patients ( absolute difference , 62.6 % [ p < 0.001 ] ) . Sixty-five ( 79 % ) drug-treated patients crossed over to cryoablation during 12 months of study follow-up due to recurrent , symptomatic AF , constituting drug treatment failure . There were 7 of the result ing 228 cryoablated patients ( 3.1 % ) with a > 75 % reduction in PV area during 12 months of follow-up . Twenty-nine of 259 procedures ( 11.2 % ) were associated with phrenic nerve palsy as determined by radiographic screening ; 25 of these had resolved by 12 months . Cryoablation patients had significantly improved symptoms at 12 months . CONCLUSIONS The STOP AF trial demonstrated that cryoballoon ablation is a safe and effective alternative to antiarrhythmic medication for the treatment of patients with symptomatic paroxysmal AF , for whom at least one antiarrhythmic drug has failed , with risks within accepted st and ards for ablation therapy . ( A Clinical Study of the A rct ic Front Cryoablation Balloon for the Treatment of Paroxysmal Atrial Fibrillation [ Stop AF ] ; NCT00523978 ) INTRODUCTION There are limited comparative data on catheter ablation of atrial fibrillation ( CAAF ) using the second-generation cryoballoon ( CB-2 ) versus point-by-point radiofrequency ( RF ) . This study examines the acute/long-term CAAF outcomes using these 2 strategies . METHODS AND RESULTS In this multicenter , retrospective , nonr and omized analysis , procedural and clinical outcomes of 1,196 patients ( 76 % with paroxysmal AF ) undergoing CAAF using CB-2 ( n = 773 ) and open-irrigated , non-force sensing RF ( n = 423 ) were evaluated . Pulmonary vein isolation was achieved in 98 % with CB-2 and 99 % with RF ( P = 0.168 ) . CB-2 was associated with shorter ablation time ( 40 ± 14 min vs. 66 ± 26 min ; P < 0.001 ) and procedure time ( 145 ± 49 minutes vs. 188 ± 42 minutes ; P < 0.001 ) , but greater fluoroscopic utilization ( 29 ± 13 minutes vs. 23 ± 14 minutes ; P < 0.001 ) . While transient ( 7.6 % vs. 0 % ; P < 0.001 ) and persistent ( 1.2 % vs. 0 % ; P = 0.026 ) phrenic nerve palsy occurred exclusively with CB-2 , other adverse event rates were similar between CB-2 ( 1.6 % ) and RF ( 2.6 % ) ; P = 0.207 . However , freedom from AF/atrial flutter/tachycardia at 12 months following a single procedure without antiarrhythmic therapy was greater with CB-2 ( 76.6 % ) versus RF ( 60.4 % ) ; P < 0.001 . While this difference was evident in patients with paroxysmal AF ( P < 0.001 ) , it did not reach significance in those with persistent AF ( P = 0.089 ) . Additionally , CB-2 was associated with reduced long-term need for antiarrhythmic therapy ( 16.7 % vs. 22.0 % ; P = 0.024 ) and repeat ablations ( 14.6 % vs. 24.1 % ; P < 0.001 ) . CONCLUSION In this multicenter , retrospective , nonr and omized study , CAAF using CB-2 coupled with RF as occasionally required was associated with greater freedom from atrial arrhythmias at 12 months following a single procedure without antiarrhythmic therapy when compared to open-irrigated , non-force sensing RF , alone OBJECTIVES The purpose of this study was to investigate long-term outcomes of freedom from atrial fibrillation ( AF ) after pulmonary vein ( PV ) isolation using cryoballoon ablation with balloon-size selection based on individual PV diameters . BACKGROUND Data are lacking on long-term outcomes from cryoablation and on the most effective balloon size . METHODS This was a prospect i ve observational study OUTPUT:
Conclusions CB-2 tended to be more effective in comparison to NCF catheter and at least non-inferior to CF catheter , with shorter procedure time and similar safety endpoint
MS2_dynamic_1_shot481
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: To comprehend the results of a r and omised controlled trial ( RCT ) , readers must underst and its design , conduct , analysis , and interpretation . That goal can be achieved only through total transparency from authors . Despite several decades of educational efforts , the reporting of RCTs needs improvement . Investigators and editors developed the original CONSORT ( Consoli date d St and ards of Reporting Trials ) statement to help authors improve reporting by use of a checklist and flow diagram . The revised CONSORT statement presented here incorporates new evidence and addresses some criticisms of the original statement . The checklist items pertain to the content of the Title , Abstract , Introduction , Methods , Results , and Discussion . The revised checklist includes 22 items selected because empirical evidence indicates that not reporting this information is associated with biased estimates of treatment effect , or because the information is essential to judge the reliability or relevance of the findings . We intended the flow diagram to depict the passage of participants through an RCT . The revised flow diagram depicts information from four stages of a trial ( enrolment , intervention allocation , follow- up , and analysis ) . The diagram explicitly shows the number of participants , for each intervention group , included in the primary data analysis . Inclusion of these numbers allows the reader to judge whether the authors have done an intention- to-treat analysis . In sum , the CONSORT statement is intended to improve the reporting of an RCT , enabling readers to underst and a trial 's conduct and to assess the validity of its results The aim of this work was to investigate the long-term effects of a single application of a water-cooled pulsed neodymium yttrium aluminium garnet ( Nd : YAG ) laser , in combination with scaling and root planing ( SRP ) for the treatment of periodontal inflammation . Twenty-two patients were included in this split-mouth single blind r and omized controlled clinical trial . The parameters of the air and water-cooled Nd : YAG laser were : 4 W , 80 mJ/pulse , 50 Hz and a pulse width of 350 μs . The “ test side ” was treated with a single application of Nd : YAG laser and SRP ; while the “ control side ” was treated with SRP alone . At baseline , and after a median follow-up time of 20 months ( range 12–39 ) , periodontal inflammatory parameters ( plaque index [ PI ] , gingival index [ GI ] , probing pocket depth [ PPD ] ) , and marginal bone loss ( on digital bite-wing radiographs ) were measured . Gingival crevicular fluid ( GCF ) was collected from the teeth 35 , 36 , 45 , and 46 at baseline and at follow-up . Pl ( p < 0.01 ) , GI ( p < 0.01 ) , and PPD ( p < 0.001 ) were significantly lower on the test side compared to the control side at follow-up . Radiological results showed significantly less bone loss on the test side compared to the control side ( p < 0.05 ) . GCF volume was lower on the test side compared to the control side ( p < 0.01 ) . In conclusion , a single application of Nd : YAG laser in combination with SRP had a positive long-term effect on periodontal health compared to treatment by SRP alone Eighty-two periodontal patients were treated in a split mouth design with coronal scaling ( CS ) , root planing ( RP ) , modified Widman surgery ( MW ) , and flap with osseous resection surgery ( FO ) which were r and omly assigned to various quadrants in the dentition . Therapy was performed in 3 phases : non-surgical , surgical , and supportive periodontal treatment ( SPT ) < or = 7 years . Clinical data consisted of probing depth ( PD ) , clinical attachment level ( CAL ) , gingival recession ( REC ) , bleeding on probing ( BOP ) , suppuration ( SUP ) , and supragingival plaque ( PL ) . Because of the necessity to exit many CS treated sites due to breakdown , data for CS were reported only up to 2 years . All therapies produced mean PD reduction with FO > MW > RP > CS following the surgical phase for all probing depth severities . By the end of year 2 there were no differences between the therapies in the 1 to 4 mm sites . There were no differences in PD reduction between MW and RP treated sites by the end of year 3 in the 5 to 6 mm sites and by the end of year 5 in the > or = 7 mm sites . FO produced greater PD reduction in > or = 5 mm sites through year 7 of SPT . Following the surgical phase , FO produced a mean CAL loss and CS and RP produced a slight gain in 1 - 4 mm sites . RP and MW produced a greater gain of CAL than CS and FO following the surgical phase in 5 to 6 mm sites , but the magnitude of difference decreased during SPT . Similar CAL gains were produced by RP , MW , and FO in sites > or = 7 mm . These gains were greater than that produced by CS and were sustained during SPT . Recession was produced with FO > MW > RP > CS . This relationship was maintained throughout SPT . The prevalences of BOP , SUP , and PL were greatly reduced throughout the study and were comparable between sites treated by RP , MW , and FO while the CS sites had more BOP and SUP BACKGROUND The association among periodontal conditions , socioeconomic status ( SES ) , and diabetes has been reported . However , there is a lack of published data comparing periodontal conditions among individuals with poorly controlled type 2 diabetes mellitus ( T2D ) . The aim of the present study was to compare the periodontal conditions and SES between subjects with T2D and non-diabetic controls . METHODS A total of 75 ( 31 males and 44 females ) individuals with T2D ( 62 poorly controlled and 13 well-controlled ) and 99 non-diabetic patients ( healthy controls ; 51 males and 48 females ) participated in the study . Plaque index ( PI ) , bleeding on probing ( OUTPUT: Qualitative assessment of the articles consistently showed an improved treatment effect among non-smokers versus smokers . Considering the relatively homogenous information available , the authors conclude that active smokers could be c and i date s for periodontal flap surgical procedures . However , the magnitude of the therapeutic effect is compromised in smokers compared with non-smokers . INPUT: To comprehend the results of a r and omised controlled trial ( RCT ) , readers must underst and its design , conduct , analysis , and interpretation . That goal can be achieved only through total transparency from authors . Despite several decades of educational efforts , the reporting of RCTs needs improvement . Investigators and editors developed the original CONSORT ( Consoli date d St and ards of Reporting Trials ) statement to help authors improve reporting by use of a checklist and flow diagram . The revised CONSORT statement presented here incorporates new evidence and addresses some criticisms of the original statement . The checklist items pertain to the content of the Title , Abstract , Introduction , Methods , Results , and Discussion . The revised checklist includes 22 items selected because empirical evidence indicates that not reporting this information is associated with biased estimates of treatment effect , or because the information is essential to judge the reliability or relevance of the findings . We intended the flow diagram to depict the passage of participants through an RCT . The revised flow diagram depicts information from four stages of a trial ( enrolment , intervention allocation , follow- up , and analysis ) . The diagram explicitly shows the number of participants , for each intervention group , included in the primary data analysis . Inclusion of these numbers allows the reader to judge whether the authors have done an intention- to-treat analysis . In sum , the CONSORT statement is intended to improve the reporting of an RCT , enabling readers to underst and a trial 's conduct and to assess the validity of its results PURPOSE As clinical diagnosis of secondary caries is the most common reason for restoration replacement , fluoride-releasing restorative material s have been developed to address this problem . The purpose s of this study were to verify demineralization inhibition produced by 5 restorative material s su bmi tted to two methods of in vitro cariogenic challenge and verify whether these methods influence material behavior by means of polarized light microscopy and microhardness . METHODS Class V cavities were prepared on buccal surfaces of 100 extracted primary molars and r and omly restored with 1 of the 4 fluoride-releasing material s , Fuji IX , Vitremer , Dyract , Tetric Ceram , and Filtek Z250 as control material ( N=10 ) . Specimens were su bmi tted to in vitro caries induction by two different methods , acid gel immersion , and pH cycling . Teeth su bmi tted to gel were then sectioned and prepared for polarized light microscopy in water , while teeth cycled were prepared for microhardness evaluation . RESULTS Polarized light microscopy : Means of demineralization areas ( microm(2 ) ) differed significantly , depending on the restorative material . Tukey 's test revealed the smallest demineralization areas adjacent to Fuji IX and Vitremer restorations , with no difference between them ( P>.05 ) . The greatest demineralization area mean values were verified using Dyract and Filtek Z250 , without differences between them ( P>.05 ) . Microhardness : Glass ionomer cements ( GICs ) performed better on the area of great cariogenic challenge , closer to the surface , than other material s indicating minor mineral loss during pH cycling . The compomer Dyract presented similar performance to GICs and composite resin Tetric Ceram , but it was better than Filtek Z250 . CONCLUSION The experimental model of caries lesion induction may influence material performance . GICs , however , are superior in preventing in vitro demineralization independently of the method Previous papers in this series on evidence -based dentistry have discussed the first 2 steps in seeking answers to clinical problems formulating a clear question and strategically search ing for evidence . The next step , critical appraisal of the evidence , is made easier if one underst and s the basic concepts of clinical research design . The strongest design , especially for questions related to therapeutic or preventive interventions , is the r and omized , controlled trial . Questions relating to diagnosis , prognosis and causation are often studied with observational , rather than experimental , research design s. The strongest study design should be used whenever possible . Rules have been established to grade research evidence . This paper , the fourth in the series , presents an overview of research methodology most commonly used in the dental literature OBJECTIVE The aim of this in vitro study was to evaluate the interaction between two sources of fluoride ( restorative systems and dentifrices ) in inhibiting artificial root caries development . METHODS One hundred and eighty tooth segments were embedded in polyester resin , and s and ed flat . Cylindrical cavities 1.0mm-deep and 1.5mm-diameter were prepared in root dentin and r and omly restored by fluoride-containing restorative systems : Ketac-fil/Espe ( Ke ) , Fuji II LC/GC Corp ( Fj ) , F2000/3 M ( F2 ) , Surefil/Dentsply ( Su ) or a control : Filtek Z250/3 M ( Z2 ) . Ten experimental groups were made to test the association among the five restorative systems and two dentifrices : with F(- ) ( Sensodyne Baking Soda ) or without F(- ) ( Sensodyne Original ) ( n=18 ) . After surface polishing , a 1mm-wide margin around the restorations was demarcated and initial dentin surface Knoop microhardness values ( KHN(i ) ) were obtained . The specimens were su bmi tted to a pH-cycling model , and to applications of slurries of dentifrice . Afterwards the final dentin surface Knoop microhardness values ( KHN(f ) ) were measured . RESULTS The differences between KHN(i ) and KHN(f ) , and the covariate KHN(i ) were considered by the ANCOVA and Tukey 's test ( alpha=0.05 ) . The interaction between restorative system and dentifrice was statistically significant ( p=0.0026 ) . All restorative systems provided some protection against artificial caries challenge when associated with the fluoride-containing dentifrice treatment . The means ( st and ard deviation ) of reductions in Knoop hardness values for systems associated with the fluoride-containing dentifrice were : Ke : OUTPUT:
The evidence suggests that RM-GIC is associated with a higher reduction of demineralization in adjacent hard tooth tissue than composite resin without fluoride . No difference was found when RM-GIC was compared with fluoride-containing composite resin . RM-GIC showed efficacy in reducing demineralization .
MS2_dynamic_1_shot482
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: There is limited information on the effects of vitamin D on serum 25 hydroxyvitamin D ( 25OHD ) in young people and none on African Americans . The main objective of this trial was to measure the effect of different doses of vitamin D3 on serum 25OHD and serum parathyroid hormone ( PTH ) in young women with vitamin D insufficiency ( serum 25OHD ≤ 20 ng/mL ( 50 nmol/L ) . A r and omized double-blind placebo-controlled trial of vitamin D3 was conducted in young white and African American women , age 25 to 45 years . A total of 198 healthy white ( 60 % ) and African American ( 40 % ) women were r and omly assigned to placebo , or to 400 , 800 , 1600 , or 2400 IU of vitamin D3 daily . Calcium supplements were added to maintain a total calcium intake of 1000 to 1200 mg daily . The primary outcomes of the study were the final serum 25OHD and PTH levels at 12 months . The absolute increase in serum 25OHD with 400 , 800 , 1600 , and 2400 IU of vitamin D daily was slightly greater in African American women than in white women . On the highest dose of 2400 IU/d , the mixed model predicted that mean 25OHD increased from baseline 12.4 ng/mL ( 95 % confidence interval [ CI ] , 9.2 - 15.7 ) to 43.2 ng/mL ( 95 % CI , 38.2 - 48.1 ) in African American women and from 15.0 ng/mL ( 95 % CI , 12.3 - 17.6 ) to 39.1 ng/mL ( 95 % CI , 36.2 - 42.0 ) in white women . There was no significant effect of vitamin D dose on serum PTH in either race but there was a significant inverse relationship between final serum PTH and serum 25OHD . Serum 25OHD exceeded 20 ng/mL in 97.5 % of whites on the 400 IU/d dose and between 800 and 1600 IU/d for African Americans . The recommended dietary allowance ( RDA ) suggested by the Institute of Medicine for young people is 600 IU daily . The increase in serum 25OHD after vitamin D supplementation was similar in young and old , and in white and African American women OBJECTIVE In observational studies , low serum 25-hydroxyvitamin D [ 25(OH)D ] concentrations have been associated with insulin resistance and other risk factors for cardiovascular disease . RESEARCH DESIGN AND METHODS We present 1-year data from an ongoing 5-year trial in 511 individuals with impaired fasting glucose ( IFG ) and /or impaired glucose tolerance ( IGT ) r and omly assigned to 20,000 IU/week vitamin D3 or placebo . An oral glucose tolerance test was performed at baseline and after 1 year . RESULTS Mean baseline serum 25(OH)D was 59.9 nmol/L and 61.1 nmol/L in the vitamin D and placebo groups , respectively , and increased by 45.8 nmol/L and 3.4 nmol/L , respectively . With adjustment for baseline concentrations , no differences in measures of glucose metabolism , insulin secretion or sensitivity , blood pressure , or hs-CRP were found after 1 year . There was a slight , but significant decrease in total and LDL cholesterol in the vitamin D group compared with the placebo group , but as there was also a decrease in HDL cholesterol , the change in the total/HDL cholesterol ratio did not differ significantly . Only analyzing subjects with 25(OH)D < 50 nmol/L did not change the results . CONCLUSIONS This study shows that vitamin D supplementation does not improve glycemic indices , blood pressure , or lipid status in subjects with IFG and /or IGT CONTEXT Observational studies show an association between low vitamin D status assessed by circulating 25-hydroxyvitamin D and cardiovascular events and mortality . Data from r and omized controlled trials are limited . OBJECTIVE The aim of this study was to test whether daily doses of vitamin D(3 ) at 400 or 1000 IU/d for 1 yr affected conventional markers of cardiovascular disease ( CVD ) risk . DESIGN We conducted a parallel-group , double-blind , placebo-controlled r and omized controlled trial . R and omization was computer generated . Participants and study investigators were blinded to intervention groupings throughout the trial . SETTING The study was conducted at the Clinical Research Facility , University of Aberdeen , United Kingdom . PARTICIPANTS A total of 305 healthy postmenopausal women aged 60 - 70 yr were recruited for the study . INTERVENTION Each woman received a daily capsule of 400 or 1000 IU vitamin D(3 ) or placebo r and omly allocated . MAIN OUTCOME MEASURES Primary outcomes were serum lipid profile [ total , high-density lipoprotein , and low-density lipoprotein cholesterol ; triglycerides ; and apolipoproteins A-1 and B100 ] , insulin resistance ( homeostatic model assessment ) , inflammatory biomarkers ( high-sensitivity C-reactive protein , IL-6 , soluble intracellular adhesion molecule-1 ) , and blood pressure . RESULTS A total of 265 ( 87 % ) participants completed all study visits . Small differences between groups for serum apol OUTPUT: In subgroup analyses , it was shown that the effect of vitamin D supplementation on risk of hypercalcemia , hypercalciuria , or kidney stones was not modified by baseline 25-hydroxyvitamin D , vitamin D dose and duration , or calcium co-supplementation . CONCLUSIONS Long-term vitamin D supplementation result ed in increased risks of hypercalcemia and hypercalciuria , which were not dose related . However , vitamin D supplementation did not increase risk of kidney stones . INPUT: Background For adults , vitamin D intake of 100 mcg ( 4000 IU)/day is physiologic and safe . The adequate intake ( AI ) for older adults is 15 mcg ( 600 IU)/day , but there has been no report focusing on use of this dose . Methods We compared effects of these doses on biochemical responses and sense of wellbeing in a blinded , r and omized trial . In Study 1 , 64 out patients ( recruited if summer 2001 25(OH)D < 61 nmol/L ) were given 15 or 100 mcg/day vitamin D in December 2001 . Biochemical responses were followed at subsequent visits that were part of clinical care ; 37 patients completed a wellbeing question naire in December 2001 and February 2002 . Subjects for Study 2 were recruited if their 25(OH)D was < 51 nmol/L in summer 2001 . 66 out patients were given vitamin D ; 51 completed a wellbeing question naire in both December 2002 and February 2003 . Results In Study 1 , basal summer 25-hydroxyvitamin D [ 25(OH)D ] averaged 48 ± 9 ( SD ) nmol/L. Supplementation for more than 6 months produced mean 25(OH)D levels of 79 ± 30 nmol/L for the 15 mcg/day group , and 112 ± 41 nmol/L for the 100 mcg/day group . Both doses lowered plasma parathyroid hormone with no effect on plasma calcium . Between December and February , wellbeing score improved more for the 100-mcg/day group than for the lower-dosed group ( 1-tail Mann-Whitney p = 0.036 ) . In Study 2 , 25(OH)D averaged 39 ± 9 nmol/L , and winter wellbeing scores improved with both doses of vitamin D ( two-tail p < 0.001 ) . Conclusion The highest AI for vitamin D brought summertime 25(OH)D to > 40 nmol/L , lowered PTH , and its use was associated with improved wellbeing . The 100 mcg/day dose produced greater responses . Since it was ethically necessary to provide a meaningful dose of vitamin D to these insufficient patients , we can not rule out a placebo wellbeing response , particularly for those on the lower dose . This work confirms the safety and efficacy of both 15 and 100 mcg/day vitamin D3 in patients who needed additional vitamin Background Controversies are common in medicine . Some arise when the conclusions of research publications directly contradict each other , creating uncertainty for frontline clinicians . Discussion In this paper , we review how research ers can look at very similar data yet have completely different conclusions based purely on an over-reliance of statistical significance and an unclear underst and ing of confidence intervals . The dogmatic adherence to statistical significant thresholds can lead authors to write dichotomized absolute conclusions while ignoring the broader interpretations of very consistent findings . We describe three examples of controversy around the potential benefit of a medication , a comparison between new medications , and a medication with a potential harm . The examples include the highest levels of evidence , both meta-analyses and r and omized controlled trials . We will show how in each case the confidence intervals and point estimates were very similar . The only identifiable differences to account for the contrasting conclusions arise from the serendipitous finding of confidence intervals that either marginally cross or just fail to cross the line of statistical significance . Summary These opposing conclusions are false disagreements that create unnecessary clinical uncertainty . We provide helpful recommendations in approaching conflicting conclusions when they are associated with remarkably similar results OBJECTIVE To compare the effects of dydrogesterone and calcium plus vitamin D in women with severe premenstrual syndrome ( PMS ) . METHOD In this r and omized , double-blind , placebo-controlled study , 180 Shiraz University students with PMS used question naires daily to rate their symptoms for 2 menstrual cycles . Then , the students were r and omly assigned to take a tablet containing either 5 mg of dydrogesterone , 500 mg of calcium plus 200 mg of vitamin D , or a placebo twice daily from the 15th to the 24th day of the cycle for 2 more cycles , and to use the same question naires during the intervention cycles . The collected data were then analyzed by repeated-measurement design and multilevel modeling tests . RESULT Treatment with dydrogesterone or calcium plus vitamin D decreased symptom severity in a similar way ( by 4.64 % and 4.20 % , respectively ) and placebo was associated with a 3.42 % decrease . CONCLUSION Treatment with dydrogesterone or calcium plus vitamin D had a similar effect on symptom severity in women with PMS OBJECTIVE : Observational studies suggest that serum levels of 25-hydroxyvitamin D ( 25[OH]D ) are inversely associated with acute respiratory infections ( ARIs ) . We hypothesized that vitamin D supplementation of children with vitamin D deficiency would lower the risk of ARIs . METHODS : By using cluster r and omization , classrooms of 744 Mongolian schoolchildren were r and omly assigned to different treatments in winter ( January – March ) . This analysis focused on a subset of 247 children who were assigned to daily ingestion of unfortified regular milk ( control ; n = 104 ) or milk fortified with 300 IU of vitamin D3 ( n = 143 ) . This comparison was double-blinded . The primary outcome was the number of parent-reported ARIs over the past 3 months . RESULTS : At baseline , the median serum 25 OUTPUT:
The evidence shows that vitamin D supplementation provides some benefit in fracture prevention ( likely ∼10–15 % relative reduction ) , particularly at a dose ≥800 IU and with calcium ; a likely benefit in the rate of falls , though it is less clear whether the number of fallers changes ; and a possible small ( ∼5 % ) relative reduction in mortality . Evidence does not support the use of vitamin D supplementation for the prevention of cancer , respiratory infections or rheumatoid arthritis . Similarly , evidence does not support vitamin D supplementation for the treatment of multiple sclerosis and rheumatoid arthritis or for improving depression/mental well-being . Regular testing of 25-hydroxyvitamin D is generally not required , and mega-doses ( ≥300,000 IU ) appear to increase harms .
MS2_dynamic_1_shot483
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: BACKGROUND This study exp and ed previous NIOSH-IRS research examining the effects of rest breaks and stretching exercises on symptoms and performance in data -entry workers . METHODS All workers spent 4 weeks with conventional breaks ( two 15 min breaks per day ) and 4 weeks with supplementary breaks ( two 15 min breaks plus four 5 min breaks per day ) . One-half were assigned at r and om to a group instructed to perform brief stretching exercises during breaks . The remainder comprised the " no stretching " ( control ) group . RESULTS 51 workers ( stretch group n = 21 ; no stretch group n = 30 ) completed the study symptom question naires . Discomfort and eyestrain were significantly lower with supplementary breaks , and supplementary breaks attenuated accumulation of discomfort and eyestrain during work sessions . Data -entry speed was significantly faster with supplementary breaks so that work output was maintained , despite replacing 20 min of work time with break time . In the stretch group , workers reported stretching during only 25 % of conventional breaks and 39 % of supplementary breaks , and no significant effects of stretching on discomfort or performance were observed . CONCLUSIONS These results provide further converging evidence that supplementary breaks reliably minimize discomfort and eyestrain without impairing productivity . Low compliance in performing stretches prevented valid assessment of stretching effects . Further research on stretching exercises and exercise compliance is warranted Objective : To investigate the effect of two contrasting physical activity worksite interventions versus a reference intervention ( REF ) on various health outcomes . Methods : A 1-year r and omized controlled trial was conducted with specific resistance training ( SRT ) , all-round physical exercise ( APE ) , and REF . Results : SRT and APE compared with REF showed significant reductions in systolic blood pressure ( ∼6 mm Hg ) , body fat percentage ( ∼2.2 body fat% ) , as well as shoulder and back pain ( ∼30 % reduction in duration ) . Muscle strength ( APE and SRT ) and maximal oxygen uptake ( APE ) increased approximately 10 % . Conclusions : Worksite intervention with both SRT as well as APE is recommended , since these activities compared with REF result ed in clinical ly relevant reductions of cardiovascular and metabolic syndrome-related risk factors as well as musculoskeletal pain symptoms , in combination with minor increases in physical capacity UNLABELLED This study was design ed to evaluate the health and economic benefits of a workplace vaccination programme against influenza funded by the employer . Employees of a Malaysian petrochemical plant volunteered to take part in this prospect i ve , non-r and omised , non-placebo-controlled study . Demographic and health information , including influenza-like symptoms , sick leave and post-vaccination adverse events were collected via question naires . Cost-benefit analyses were performed from the employer 's perspective . RESULTS A total of 1,022 employees took part in the study , with 504 choosing to be vaccinated against influenza , and 518 remaining unvaccinated . The rate of influenza-like illness ( ILI ) was lower among vaccinated ( 8.13 % ) than non-vaccinated subjects ( 30.31 % ) . Fever and respiratory symptoms were associated with all ILI cases . ILI-related sick leave was taken by 58.54 % of vaccinated employees with ILI and 71.34 % of non-vaccinated employees with ILI . Vaccination was financially beneficial , with the employer saving up to US dollar 53.00 per vaccinated employee when labour costs only were considered . Savings rose to up to US dollar 899.70 when the operating income of each employee was also considered . Workplace vaccination of healthy adults against influenza had a clear impact on ILI rates , absenteeism and reduced productivity in this Malaysian company . The health benefits translated into financial benefits for the employer , with cost savings significantly outweighting the costs of the vaccination programme Abstract Background : While preliminary laboratory tests indicate that a hip belt reduces the load on the back , neck and shoulders associated with musculoskeletal strain , an orchard trial is needed to more realistically assess both effectiveness and acceptability . Objective : to evaluate the hip belt 's effectiveness in three areas : worker acceptance , worker productivity , and one-day muscle fatigue of the back and shoulder . Methods : Ninety-six New York apple harvest workers were r and omly assigned to use the intervention hip belt or placebo belt for one week . In a second week all workers switched conditions . Subjects were interviewed at the end of each week to ascertain intervention acceptance . Employer records were review ed to determine bushels picked per day . Subjects also underwent muscle fatigue testing at the beginning and again at the end of one workday during each week . Results : Ninety-one percent of the subjects favored the intervention hip belt . Use of the intervention did not appreciably slow picking speed ( bushels per hour ) as compared to placebo ( 8.8 bu/ hr vs. 8.89 bu/hr ) . Both were significantly faster than the regular equipment condition ( 8.13 bu/hr ) . No significant differences in one-day muscle fatigue were found with intervention use . Conclusions : The belt was acceptable to the workers and did not hinder productivity . However , the anticipated ergonomic benefits were not demonstrable using one-day strength testing Background Cost-effective interventions to improve diet and physical activity are a public health priority . Alive ! is an email-based intervention to increase physical activity , reduce saturated and trans fats and added sugars , and increase fruit and vegetable consumption . It was shown to improve these behaviors in a large r and omized controlled trial . Objective ( 1 ) To describe the components and behavioral principles underlying Alive ! , and ( 2 ) to report effects of the intervention on the secondary outcomes : health-related quality of life , presenteeism , self-efficacy , and stage of change . Methods The Alive ! behavior change model is design ed to OUTPUT: There is preliminary evidence that some WHP programs can positively affect presenteeism and that certain risk factors are of importance . INPUT: BACKGROUND This study exp and ed previous NIOSH-IRS research examining the effects of rest breaks and stretching exercises on symptoms and performance in data -entry workers . METHODS All workers spent 4 weeks with conventional breaks ( two 15 min breaks per day ) and 4 weeks with supplementary breaks ( two 15 min breaks plus four 5 min breaks per day ) . One-half were assigned at r and om to a group instructed to perform brief stretching exercises during breaks . The remainder comprised the " no stretching " ( control ) group . RESULTS 51 workers ( stretch group n = 21 ; no stretch group n = 30 ) completed the study symptom question naires . Discomfort and eyestrain were significantly lower with supplementary breaks , and supplementary breaks attenuated accumulation of discomfort and eyestrain during work sessions . Data -entry speed was significantly faster with supplementary breaks so that work output was maintained , despite replacing 20 min of work time with break time . In the stretch group , workers reported stretching during only 25 % of conventional breaks and 39 % of supplementary breaks , and no significant effects of stretching on discomfort or performance were observed . CONCLUSIONS These results provide further converging evidence that supplementary breaks reliably minimize discomfort and eyestrain without impairing productivity . Low compliance in performing stretches prevented valid assessment of stretching effects . Further research on stretching exercises and exercise compliance is warranted Background Low back pain ( LBP ) and neck pain ( NP ) are a major public health problem with considerable costs for individuals , companies and society . Therefore , prevention is imperative . The Stay@Work study investigates the (cost-)effectiveness of Participatory Ergonomics ( PE ) to prevent LBP and NP among workers . Methods In a r and omised controlled trial ( RCT ) , a total of 5,759 workers working at 36 departments of four companies is expected to participate in the study at baseline . The departments consisting of about 150 workers are pre-stratified and r and omised . The control departments receive usual practice and the intervention departments receive PE . Within each intervention department a working group is formed including eight workers , a representative of the management , and an occupational health and safety coordinator . During a one day meeting , the working group follows the steps of PE in which the most important risk factors for LBP and NP , and the most adequate ergonomic measures are identified on the basis of group consensus . The implementation of ergonomic measures at the department is performed by the working group . To improve the implementation process , so-called ' ergocoaches ' are trained . The primary outcome measure is an episode of LBP and NP . Secondary outcome measures are actual use of ergonomic measures , physical workload , psychosocial workload , intensity of pain , general health status , sick leave , and work productivity . The cost-effectiveness analysis is performed from the societal and company perspective . Outcome measures are assessed using question naires at baseline and after 6 and 12 months . Data on the primary outcome as well as on intensity of pain , sick leave , work productivity , and health care costs are collected every 3 months . Discussion Prevention of LBP and NP is beneficial for workers , employers , and society . If the intervention is proven (cost-)effective , the intervention can have a major impact on LBP and NP prevention and , thereby , on work disability prevention . Results are expected in 2010.Trial registration IS RCT Abstract Background : While preliminary laboratory tests indicate that a hip belt reduces the load on the back , neck and shoulders associated with musculoskeletal strain , an orchard trial is needed to more realistically assess both effectiveness and acceptability . Objective : to evaluate the hip belt 's effectiveness in three areas : worker acceptance , worker productivity , and one-day muscle fatigue of the back and shoulder . Methods : Ninety-six New York apple harvest workers were r and omly assigned to use the intervention hip belt or placebo belt for one week . In a second week all workers switched conditions . Subjects were interviewed at the end of each week to ascertain intervention acceptance . Employer records were review ed to determine bushels picked per day . Subjects also underwent muscle fatigue testing at the beginning and again at the end of one workday during each week . Results : Ninety-one percent of the subjects favored the intervention hip belt . Use of the intervention did not appreciably slow picking speed ( bushels per hour ) as compared to placebo ( 8.8 bu/ hr vs. 8.89 bu/hr ) . Both were significantly faster than the regular equipment condition ( 8.13 bu/hr ) . No significant differences in one-day muscle fatigue were found with intervention use . Conclusions : The belt was acceptable to the workers and did not hinder productivity . However , the anticipated ergonomic benefits were not demonstrable using one-day strength testing This study examined the effects of supplementary rest breaks on musculoskeletal discomfort , eyestrain , mood , and performance in data -entry workers . Two rest break schedules were compared in a within-subjects design . Workers alternated between a ‘ conventional ’ and a ‘ supplementary ’ schedule in 4-week intervals . The conventional schedule contained a 15-min break during the first half of the work shift and a 15-min break during the second half of the shift . The supplementary schedule contained the same two 15-min breaks , and a 5-min break during each hour which otherwise did not contain a break , for a total of 20 extra minutes of break time . Results are based on data from 42 workers . They indicated that discomfort in several areas of the body , and eyestrain , were significantly lower under the supplementary than under the conventional schedule . While symptoms increased from pre- to post-work periods under both schedules , the magnitude of the increases was significantly less under the supplementary schedule . In addition , increases in discomfort of the right forearm , wrist and h and over the course of the work week under the conventional schedule were eliminated under the supplementary schedule . These beneficial effects were obtained without reductions in data -entry performance Introduction : Lateral and medial epicondylitis associated with work activity OUTPUT:
There was low- to very low- quality evidence that other interventions were not effective in reducing work-related upper limb and neck MSDs in adults . We found moderate- quality evidence to suggest that the use of arm support with alternative mouse may reduce the incidence of neck/shoulder MSDs , but not right upper limb MSDs . Moreover , we found moderate- quality evidence to suggest that the incidence of neck/shoulder and right upper limb MSDs is not reduced when comparing alternative and conventional mouse with and without arm support . However , given there were multiple comparisons made involving a number of interventions and outcomes , high- quality evidence is needed to determine the effectiveness of these interventions clearly . While we found very-low- to low- quality evidence to suggest that other ergonomic interventions do not prevent work-related MSDs of the upper limb and neck , this was limited by the paucity and heterogeneity of available studies .
MS2_dynamic_1_shot484
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: In order to determine whether giving iron to iron-deficient children increases their susceptibility to malaria , 213 Gambian children aged between 6 months and 5 years with iron-deficiency anaemia were r and omized to receive either oral iron or placebo during the rainy season when malaria transmission is maximal . Haematological and iron measurements improved significantly in the group given iron . Regular morbidity surveys showed that fever associated with parasitaemia occurred more frequently in the iron-treated group than in the placebo group . This difference was not significant for all parasitaemias grouped together , but became significant and progressively larger for parasitaemias of ten or more positive fields per 100 high power fields ( P less than 0.025 ) , and for parasitaemias of 50 or more positive fields per 100 high power fields ( P less than 0.01 ) . Three children in the iron-treated group but none in the placebo group had more than one episode of fever and parasitaemia . Splenomegaly rates rose appreciably during the study in both groups , but in children at age 2 years the splenomegaly rate at the end of the study was significantly greater in the iron-treated group . We concluded that there is a significantly increased risk of fever associated with severe malarial parasitaemia for children with iron-deficiency anaemia given iron during the season of maximal malaria transmission in this part of The Gambia OBJECTIVE To determine whether extended oral iron therapy corrects lower developmental test scores in infants with iron-deficiency anemia . STUDY DESIGN Double-blind , controlled trial in Costa Rica involving 32 12- to 23-month-old infants with iron-deficiency anemia and 54 nonanemic control subjects . Anemic infants were treated with orally administered iron for 6 months ; half the nonanemic children were treated with iron and half with placebo . Developmental test scores and hematologic status were evaluated before treatment , after 3 months , and after 6 months . RESULTS Iron-deficient anemic infants received lower mental test scores than nonanemic infants at all three time points ( p < 0.05 pretreatment and at 3 months , p = 0.07 at 6 months ) . There were no significant differences in motor test scores . More of the anemic infants were rated as unusually tearful and unhappy . Anemic infants came from families with lower maternal education and less support for child development and were less likely to be breast fed , were weaned earlier , and consumed more cow milk . CONCLUSIONS Lower mental test scores persisted in infants with iron-deficiency anemia despite extended oral iron therapy and an excellent hematologic response . Iron-deficiency anemia may serve as a marker for a variety of nutritional and family disadvantages that may adversely affect infant development OBJECTIVE To evaluate the effectiveness of universal prophylactic targeting with iron sulfate on daily or weekly basis in the prevention of anemia in infants . METHODS R and omized clinical field trial with children between ages six and 12 months seen at primary health care units in the municipality of Rio de Janeiro , Brazil , between 2004 and 2005 . Three concurrent cohorts were compared : daily group ( n=150 ; 12.5 mg Fe/day ) ; weekly group ( n=147 ; 25 mg Fe/week ) and control group . The intervention consisted of universal supplementation with iron sulfate for 24 weeks , combined with educational adherence-promoting measures . OUTCOME mean serum hemoglobin concentration , distribution and prevalence of anemia ( Hb<110.0 g/l ) at age 12 months . Effectiveness was evaluated considering both intent to treat and adherence to protocol , using multiple regression analysis ( linear and Poisson ) . RESULTS Groups were homogeneous in terms of descriptive variables . The intervention was implemented successfully , with high adhesion to protocol in both groups , and no statistical difference between them . After adjustment , only the daily regimen showed a protective effect . Adherence analysis demonstrated an evident dose-response effect on mean Hb and prevalence of anemia only for the daily regimen . No protective effect was detected for the weekly regimen . CONCLUSIONS Universal supplementation with iron sulfate from six to 12 months of age was effective in increasing serum Hb and decreasing risk of anemia only when administered on a daily basis The effect of iron supplementation on attending behavior of 96 1-y-old infants was assessed in a double-blind , r and omized , controlled trial of iron dextran in Papua New Guinea . The treatment group received an injection of iron dextran at 2 mo ; the controls received a placebo injection . Because many children had malarial parasitemia at testing , presence of malaria was used in the analysis . A significant interaction was found between iron and malaria infection on total fixation time : iron-supplemented groups and placebo-treated parasitemic children showed significantly higher total fixation scores than did placebo-treated aparasitemic children . Blood analysis of iron status showed similar results , with lowest iron status evident in the placebo-treated aparasitemic group . There was no effect of treatment on rate of habituation or dishabituation . Supplemental iron treatment has a significant effect on attention but the direction of the effect depends on the presence of malaria infection OBJECTIVE To assess the effect of an improved local ingredient-based gruel fortified or not with selected multiple micronutrients ( MM ) on Hb concentration of young children . DESIGN In a nutrition centre that we opened in their villages , children received either MM supplement ( containing iron , zinc , vitamin A , vitamin C and iodine ) with the improved gruel ( MMGG ) or the improved gruel only ( GG ) , twice daily , 6 d/week , for 6 months . We assessed baseline and endpoint Hb concentration and anthropometric indices . SETTING Kongoussi , a rural and poor district of Burkina Faso . SUBJECTS In a community-based trial , we r and omly assigned 131 children aged 6 - 23 months with Hb concentrations in the OUTPUT: Overall , iron result ed in fewer anaemic children at follow up , and the end average change in haemoglobin from base line was higher with iron . Authors ' conclusions Iron treatment does not increase the risk of clinical malaria when regular malaria prevention or management services are provided . Where re sources are limited , iron can be administered without screening for anaemia or for iron deficiency , as long as malaria prevention or management services are provided efficiently . 12 April 2019 No up date planned Other There is high‐certainty evidence that oral iron supplements do not adversely affect children living in malaria‐endemic areas , meaning further research is unlikely to change our confidence in the estimate of effect . INPUT: Iron deficiency anaemia is a most common micronutrient deficiency affecting mostly the low socioeconomic population s of the developing world . The objective of this study was to evaluate the feasibility of iron fortification of household drinking water to prevent iron deficiency anaemia among members of the low socioeconomic families of Southern Brazil . A total of 21 low socioeconomic families representing 88 subjects including 1 - 6 years old children whose haemoglobin level was between 10 and 12 g/dl were selected to participate in this study . Nine families in the control group were supplied with placebo solution and 12 families in the experimental group were supplied iron solution with ascorbic acid to be added to their domestic drinking water over a period of 4 months . The feasibility and acceptability of iron fortified drinking water was assessed through home visits and question naires . Blood sample s were collected at the beginning and after 4 months of the study for the determination of haemoglobin and serum ferritin levels . The results of this study indicated that iron fortified drinking water was well received by the low socioeconomic families and that it was effective in improving the haemoglobin and serum ferritin levels . It can be concluded from this study that iron fortification of household drinking water is a simple and effective alternative for developing countries along with other technological approaches to iron fortification of foods OBJECTIVES This study hypothesized that besides iron deficiency , intestinal parasites infection is also a determinant of anemia in schoolchildren in rural Vietnam . METHODS 400 primary schoolchildren from 20 primary schools in Tam Nong district , a poor rural area in Vietnam , were r and omly selected from enrollment lists . Venous blood ( 5ml ) was collected in a cross sectional study and analyzed for hemoglobin ( Hb ) , serum ferritin ( SF ) , serum transferrin receptor ( TfR ) , serum C-reactive protein ( CRP ) and total immunoglobulin E ( IgE ) . Stools sample s were examined for hookworm , Trichuris , and Ascaris infection . Logistic regression was used to assess the effect of intestinal parasites on anemia . RESULTS The prevalence of anemia ( Hb < 115g/l ) was 25 % . Iron deficiency ( TfR > 8.5mg/L ) occurred in 2 % of the children . The prevalence of intestinal parasites was 92 % with the highest prevalence for Trichuris ( 76 % ) and Ascaris ( 71 % ) . More than 30 % and 80 % of the children showed an elevated CRP ( > or = 8 mg/L ) and IgE ( > 90 IU/ml ) concentration . Anemia status was borderline significantly associated with SF and not associated with TfR and CRP . The prevalence odds ratio for Trichuris infection was 1.96 ( 95 % CI 1.07 - 3.59 ) and 2.00 ( 95 % CI 1.08 - 3.65 ) with iron deficiency reflected by TfR and SF , respectively . CONCLUSION Anemia is highly prevalent among schoolchildren in Vietnam but may not be associated with iron deficiency . Trichuris infection is associated with a doubled risk of anemia , not mediated through iron deficiency . Chronic infection may play a role in anemia , but needs further investigation BACKGROUND Children participating in the Integrated Child Development Service ( ICDS ) in India have high rates of iron and vitamin A deficiency . OBJECTIVE The objective was to assess the efficacy of a premix fortified with iron and vitamin A and added at the community level to prepared khichdi , a rice and dal mixture , in increasing iron and vitamin A stores and decreasing the prevalence of iron deficiency , anemia , and vitamin A deficiency . DESIGN This cluster , r and omized , double-blind , controlled trial was initiated in 30 Anganwadi centers ( daycare centers ) in West Bengal state , India . Children aged 36 - 66 mo ( n = 516 ) attending village-based ICDS centers were r and omly assigned to receive either a fortified or a nonfortified premix for 24 wk . Blood was drawn at 0 and 24 wk by venipuncture for the measurement of hemoglobin , serum ferritin , and serum retinol . RESULTS The change in the hemoglobin concentration of anemic children was significantly different between fortified and nonfortified khichdi groups ( P < 0.001 ) . Prevalence rates of anemia , iron deficiency , and iron deficiency anemia were significantly lower after 24 wk in the fortified-khichdi group than in the nonfortified-khichdi group ( P < 0.001 ) . There were no significant differences in serum retinol concentrations or in the prevalence of vitamin A deficiency between the fortified- and nonfortified-khichdi groups . CONCLUSION A premix fortified with iron , vitamin A , and folic acid and added to supplementary food at the community level can be effective at increasing iron stores and reducing the prevalence of iron deficiency and anemia BACKGROUND Iron fortification of rice could be an effective strategy for reducing iron deficiency anemia in South Asia . OBJECTIVE We aim ed to determine whether extruded rice grains fortified with micronized ground ferric pyrophosphate ( MGFP ) would increase body iron stores in children . DESIGN In a double-blind , 7-mo , school-based feeding trial in Bangalore , India , iron-depleted , 6 - 13-y-old children ( n = 184 ) were r and omly assigned to receive either a rice-based lunch meal fortified with 20 mg Fe as MGFP or an identical but unfortified control meal . The meals were consumed under direct supervision , and daily leftovers were weighed . All children were dewormed at baseline and at 3.5 mo . OUTPUT:
We observed an association between intake of Fe-fortified foods and Hb concentration in children aged < 10 years . Fe-fortified foods could be an effective strategy for reducing Fe-deficiency anaemia in children
MS2_dynamic_1_shot485
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: BACKGROUND It has been extensively shown , mainly in US population s , that sugar-sweetened beverages ( SSBs ) are associated with increased risk of type 2 diabetes ( T2D ) , but less is known about the effects of artificially sweetened beverages ( ASBs ) . OBJECTIVE We evaluated the association between self-reported SSB , ASB , and 100 % fruit juice consumption and T2D risk over 14 y of follow-up in the French prospect i ve Etude Epidémiologique auprès des femmes de la Mutuelle Générale de l'Education Nationale-European Prospect i ve Investigation into Cancer and Nutrition cohort . DESIGN A total of 66,118 women were followed from 1993 , and 1369 incident cases of T2D were diagnosed during the follow-up . Cox regression models were used to estimate HRs and 95 % CIs for T2D risk . RESULTS The average consumption of sweetened beverages in consumers was 328 and 568 mL/wk for SSBs and ASBs , respectively . Compared with nonconsumers , women in the highest quartiles of SSB and ASB consumers were at increased risk of T2D with HRs ( 95 % CIs ) of 1.34 ( 1.05 , 1.71 ) and 2.21 ( 1.56 , 3.14 ) for women who consumed > 359 and > 603 mL/wk of SSBs and ASBs , respectively . Strong positive trends in T2D risk were also observed across quartiles of consumption for both types of beverage ( P = 0.0088 and P < 0.0001 , respectively ) . In sensitivity analyses , associations were partly mediated by BMI , although there was still a strong significant independent effect . No association was observed for 100 % fruit juice consumption . CONCLUSIONS Both SSB consumption and ASB consumption were associated with increased T2D risk . We can not rule out that factors other than ASB consumption that we did not control for are responsible for the association with diabetes , and r and omized trials are required to prove a causal link between ASB consumption and T2D BACKGROUND The accumulation of abdominal fat increases risk of metabolic disorders and premature death . There is a dearth of prospect i ve data on the association between caloric beverage consumption and surrogate markers of abdominal adiposity . OBJECTIVE The aim of this study was to assess the relation between consumption of nonalcoholic caloric beverages , including soft drinks , fruit juice , whole milk , and skim and low-fat milk , and changes in waist circumference ( WC ) and odds of 10-y incidence of abdominal obesity . METHODS We conducted a prospect i ve , population -based study of 2181 Spanish men and women aged 25 - 74 y who were followed from 2000 to 2009 . We measured weight , height , and WC , and recorded data on diet and leisure-time physical activity ( LTPA ) with the use of vali date d question naires . We fit multivariable linear and logistic regression models . RESULTS A 100 kcal increase in soft drink consumption was associated with a 1.1 cm increase in WC ( P = 0.018 ) after 10 y of follow-up . Substitution of 100 kcal of soft drinks with 100 kcal of whole milk or 100 kcal of juice was associated with a 1.3 cm ( 95 % CI : 0.3 , 2.4 ) and 1.1 cm ( 95 % CI : 0.03 , 2.2 ) decrease in WC , respectively . Increasing consumption of soft drinks from baseline to follow-up led to WC gain compared with maintaining nonconsumption . Greater soft drink consumption was positively associated ( P = 0.029 ) with increased odds of 10-y incidence of abdominal obesity . CONCLUSION Adults ' consumption of soft drinks was associated with increased WC and odds of 10-y incidence of abdominal obesity . This association was moderate but consistent in all statistical models Objective To evaluate the effectiveness of a school-based intervention involving the families and teachers that aim ed to promote healthy eating habits in adolescents ; the ultimate aim of the intervention was to reduce the increase in body mass index ( BMI ) of the students . Design Paired cluster r and omized school-based trial conducted with a sample of fifth grade rs . Setting Twenty classes were r and omly assigned into either an intervention group or a control group . Participants From a total of 574 eligible students , 559 students participated in the study ( intervention : 10 classes with 277 participants ; control : 10 classes with 282 participants ) . The mean age of students was 11 years . Intervention Students attended 9 nutritional education sessions during the 2010 academic year . Parents/guardians and teachers received information on the same subjects . Main Outcome Measurement Changes in BMI and percentage of body fat . Results Intention-to-treat analysis showed that changes in BMI were not significantly different between the 2 groups ( β = 0.003 ; p = 0.75 ) . There was a major reduction in the consumption of sugar-sweetened beverages and cookies in the intervention group ; students in this group also consumed more fruits . Conclusion Encouraging the adoption of healthy eating habits promoted important changes in the adolescent diet , but this did not lead to a reduction in BMI gain . Strategies based exclusively on the quality of diet may not reduce weight gain among adolescents . Trial Registration Clinical trials.gov NCT01046474 The aim of the present study was to examine the associations of sugary drink consumption and its substitution with alternative beverages with body weight gain among young children predisposed to future weight gain . Secondary analysis of the Healthy Start Study OUTPUT: Conclusion : Recent evidence suggests that SSB consumption is positively associated with or has an effect on obesity indices in children and adults . INPUT: BACKGROUND It has been extensively shown , mainly in US population s , that sugar-sweetened beverages ( SSBs ) are associated with increased risk of type 2 diabetes ( T2D ) , but less is known about the effects of artificially sweetened beverages ( ASBs ) . OBJECTIVE We evaluated the association between self-reported SSB , ASB , and 100 % fruit juice consumption and T2D risk over 14 y of follow-up in the French prospect i ve Etude Epidémiologique auprès des femmes de la Mutuelle Générale de l'Education Nationale-European Prospect i ve Investigation into Cancer and Nutrition cohort . DESIGN A total of 66,118 women were followed from 1993 , and 1369 incident cases of T2D were diagnosed during the follow-up . Cox regression models were used to estimate HRs and 95 % CIs for T2D risk . RESULTS The average consumption of sweetened beverages in consumers was 328 and 568 mL/wk for SSBs and ASBs , respectively . Compared with nonconsumers , women in the highest quartiles of SSB and ASB consumers were at increased risk of T2D with HRs ( 95 % CIs ) of 1.34 ( 1.05 , 1.71 ) and 2.21 ( 1.56 , 3.14 ) for women who consumed > 359 and > 603 mL/wk of SSBs and ASBs , respectively . Strong positive trends in T2D risk were also observed across quartiles of consumption for both types of beverage ( P = 0.0088 and P < 0.0001 , respectively ) . In sensitivity analyses , associations were partly mediated by BMI , although there was still a strong significant independent effect . No association was observed for 100 % fruit juice consumption . CONCLUSIONS Both SSB consumption and ASB consumption were associated with increased T2D risk . We can not rule out that factors other than ASB consumption that we did not control for are responsible for the association with diabetes , and r and omized trials are required to prove a causal link between ASB consumption and T2D BACKGROUND & AIMS Diets high in fructose have been proposed to contribute to nonalcoholic fatty liver disease . We compared the effects of high-fructose and matched glucose intake on hepatic triacylglycerol ( TAG ) concentration and other liver parameters . DESIGN In a double-blind study , we r and omly assigned 32 healthy but central ly overweight men to groups that received either a high-fructose or high-glucose diet ( 25 % energy ) . These diets were provided during an initial isocaloric period of 2 weeks , followed by a 6-week washout period , and then again during a hypercaloric 2-week period . The primary outcome measure was hepatic level of TAG , with additional assessment s of TAG levels in serum and soleus muscle , hepatic levels of adenosine triphosphate , and systemic and hepatic insulin resistance . RESULTS During the isocaloric period of the study , both groups had stable body weights and concentrations of TAG in liver , serum , and soleus muscle . The high-fructose diet produced an increase of 22 ± 52 μmol/L in the serum level of uric acid , whereas the high-glucose diet led to a reduction of 23 ± 25 μmol/L ( P < .01 ) . The high-fructose diet also produced an increase of 0.8 ± 0.9 in the homeostasis model assessment of insulin resistance , whereas the high-glucose diet produced an increase of only 0.1 ± 0.7 ( P = .03 ) . During the hypercaloric period , participants in the high-fructose and high-glucose groups had similar increases in weight ( 1.0 ± 1.4 vs 0.6 ± 1.0 kg ; P = .29 ) and absolute concentration of TAG in liver ( 1.70 % ± 2.6 % vs 2.05 % ± 2.9 % ; P = .73 ) and serum ( 0.36 ± 0.75 vs 0.33 ± 0.38 mmol/L ; P = .91 ) , and similar results in biochemical assays of liver function . Body weight changes were associated with changes in liver biochemistry and concentration of TAGs . CONCLUSIONS In the isocaloric period , overweight men who were on a high-fructose or a high-glucose diet did not develop any significant changes in hepatic concentration of TAGs or serum levels of liver enzymes . However , in the hypercaloric period , both high-fructose and high-glucose diets produced significant increases in these parameters without any significant difference between the 2 groups . This indicates an energy-mediated , rather than a specific macronutrient-mediated , effect . Clinical trials.gov no : NCT01050140 OBJECTIVE Adverse effects of hypercaloric , high-fructose diets on insulin sensitivity and lipids in human subjects have been shown repeatedly . The implication s of fructose in amounts close to usual daily consumption , however , have not been well studied . This study assessed the effect of moderate amounts of fructose and sucrose compared with glucose on glucose and lipid metabolism . RESEARCH DESIGN AND METHODS Nine healthy , normal-weight male volunteers ( aged 21–25 years ) were studied in this double-blind , r and omized , cross-over trial . All subjects consumed four different sweetened beverages ( 600 mL/day ) for 3 weeks each : medium fructose ( MF ) at 40 g/day , and high fructose ( HF ) , high glucose ( HG ) , and high sucrose ( OUTPUT:
A literature analysis supported links between sugar intake and both total energy intake and body weight gain , and between sugar intake and blood triglycerides independently of total energy intake . The effects of sugar on blood triglycerides were shown to be mediated by the fructose component of sucrose and were observed with an intake of fructose > 50 g/day . In addition , prospect i ve cohort studies showed associations between sugar intake and the risk of diabetes/insulin resistance , cardiovascular diseases , NAFLD , and hyperuricemia .
MS2_dynamic_1_shot486
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: Background To investigate the risk of first-time acute coronary syndrome ( ACS ) , stroke and venous thromboembolism ( VTE ) in patients with ankylosing spondylitis ( AS ) , psoriatic arthritis ( PsA ) and undifferentiated spondyloarthritis ( uSpA ) , compared to each other and to the general population ( GP ) . Methods This is a prospect i ve nationwide cohort study . Cohorts with AS ( n = 6448 ) , PsA ( n = 16,063 ) and uSpA ( n = 5190 ) patients and a GP ( n = 266,435 ) cohort , were identified 2001–2009 in the Swedish National Patient and Population registers . The follow-up began 1 January 2006 , or 6 months after the first registered spondyloarthritis ( SpA ) diagnosis thereafter , and ended at ACS/stroke/VTE event , death , emigration or 31 December 2012 . Crude and age- and sex-st and ardized incidence rates ( SIRs ) and hazard ratios ( HRs ) were calculated for incident ACS , stroke or VTE , respectively . Results St and ardized to the GP cohort , SIRs for ACS were 4.3 , 5.4 and 4.7 events per 1000 person-years at risk in the AS , PsA and uSpA cohort , respectively , compared to 3.2 in the GP cohort . SIRs for stroke were 5.4 , 5.9 and 5.7 events per 1000 person-years at risk in the AS , PsA and uSpA cohort compared to 4.7 in the GP cohort . Corresponding SIRs for VTE were 3.6 , 3.2 and 3.5 events per 1000 person-years at risk compared to 2.2 in the GP cohort . Age- and sex-adjusted HRs ( 95 % CI ) for ACS events were significantly increased in AS ( 1.54 ( 1.31–1.82 ) ) , PsA ( 1.76 ( 1.59–1.95 ) ) and uSpA ( 1.36 ( 1.05–1.76 ) ) compared to GP . Age-adjusted HRs for ACS was significantly decreased in female AS patients ( 0.59 ( 0.37–0.97 ) ) compared to female PsA patients . Age- and sex-adjusted HRs for stroke events were significantly increased in AS ( 1.25 ( 1.06–1.48 ) ) and PsA ( 1.34 ( 1.22–1.48 ) ) , and nonsignificantly increased in uSpA ( 1.16 ( 0.91–1.47 ) ) compared to GP . For VTE the age- and sex-adjusted HRs for AS , PsA and uSpA were equally and significantly increased with about 50 % compared to GP . Conclusions Patients with AS , PsA and uSpA are at increased risk for ACS and stroke events , which emphasizes the importance of identification of and intervention against cardiovascular risk factors in SpA patients . Increased alertness for VTE is warranted in patients with STUDY OBJECTIVES To underst and reasons for compliance and non-compliance with a home based exercise regimen by patients with osteoarthritis of the knee . DESIGN A qualitative study , nested within a r and omised controlled trial , examining the effectiveness of physiotherapy in reducing pain and increasing mobility in knee osteoarthritis . In the intervention arm , participants undertook a series of simple exercises and repositioning of the kneecap using tape . In depth interviews were conducted with a subset of participants in the intervention arm using open ended questions , guided by a topic schedule , to encourage patients to describe their experiences and reflect on why they did or did not comply with the physiotherapy . Interviews were audiotaped , fully transcribed and analysed thematically according to the method of constant comparison . A model explaining factors influencing compliance was developed . SETTING Patients were interviewed at home . The study was nested within a pragmatic r and omised controlled trial . PARTICIPANTS Twenty participants in the intervention arm of the r and omised trial were interviewed three months after they had completed the physiotherapy programme . Eight were interviewed again one year later . MAIN RESULTS Initial compliance was high because of loyalty to the physiotherapist . Reasoning underpinning continued compliance was more complex , involving willingness and ability to accommo date exercises within everyday life , the perceived severity of symptoms , attitudes towards arthritis and comorbidity and previous experiences of osteoarthritis . A necessary precondition for continued compliance was the perception that the physiotherapy was effective in ameliorating unpleasant symptoms . CONCLUSIONS Non-compliance with physiotherapy , as with drug therapies , is common . From the patient 's perspective , decisions about whether or not to comply are rational but often can not be predicted by therapists or research ers . Ultimately , this study suggests that health professionals need to underst and reasons for non-compliance if they are to provide supportive care and trialists should include qualitative research within trials whenever levels of compliance may have an impact on the effectiveness of the intervention Fernández-de-las-Peñas C , Alonso-Blanco C , Alguacil-Diego IM , Miangolarra-Page JC : One-year follow-up of two exercise interventions for the management of patients with ankylosing spondylitis : A r and omized controlled trial . Am J Phys Med Rehabil 2006;85:559–567 . Objective : To assess the long-term effects on functional and mobility outcomes of two exercise interventions for the management of patients with ankylosing spondylitis . Design : In an extended 12-mo follow-up of a r and omized controlled trial , 40 patients who were OUTPUT: Conflicting evidence was found as to whether supervision of exercise improved adherence . Adherence to prescribed exercise in SpA was poorly reported and predominately for people with AS . The levels of adherence and factors affecting prescribed exercise in SpA remain unclear . INPUT: OBJECTIVES This study aims to assess the impact of a structured education and home exercise programme in daily practice patients with ankylosing spondylitis . METHODS A total of 756 patients with ankylosing spondylitis ( 72 % males , mean age 45 years ) participated in a 6-month prospect i ve multicentre controlled study , 381 of whom were r and omised to an education intervention ( a 2-hour informative session about the disease and the implementation of a non-supervised physical activity programme at home ) and 375 to st and ard care ( controls ) . Main outcome measures included Bath Ankylosing Spondylitis Disease Activity and Functional Index ( BASDAI , BASFI ) . Secondary outcome measures were 0 - 10 cm visual analog scale ( VAS ) for total pain , nocturnal pain and global disease activity and quality of life ( ASQoL ) , knowledge of disease ( self-evaluation ordinal scale ) and daily exercise ( diary card ) . RESULTS At 6 months , the adjusted mean difference between control and educational groups for BASDAI was 0.32 , 95 % confidence interval ( CI ) 0.10 - 0.54 , p=0.005 , and for BASFI 0.31 , 95%CI 0.12 - 0.51 , p=0.002 . Significant differences were found also in VAS for total pain , patient´s global assessment and in ASQoL. Patients in the education group increased their knowledge about the disease and its treatments significantly ( p<0.001 ) and practised more regular exercise than controls ( p<0.001 ) . CONCLUSIONS A structured education and home exercise programme for patients with ankylosing spondylitis in daily practice was feasible and helped to increase knowledge and exercise . Although statistically significant , the magnitudes of the clinical benefits in terms of disease activity and physical function were poor Fernández-de-las-Peñas C , Alonso-Blanco C , Morales-Cabezas M , Miangolarra-Page JC : Two exercise interventions for the management of patients with ankylosing spondylitis : A r and omized controlled trial . Am J Phys Med Rehabil 2005;84:407–419 . Objective : The purpose of this clinical trial was to evaluate the impact of a 4-month comprehensive protocol of strengthening and flexibility exercises developed by our research group versus conventional exercises for patients with Ankylosing Spondylitis ( AS ) on functional and mobility outcomes . Design : R and omized controlled trial . Forty-five patients diagnosed with AS according to the modified criteria of New York were allocated to control or experimental groups using a r and om numbers table . The control group was treated with a conventional protocol of physical therapy in AS , whereas the experimental group was treated with the protocol suggested by our research group . The conventional intervention consisted of 20 exercises : motion and flexibility exercises of the cervical , thoracic , and lumbar spine ; stretching of the shortened muscles ; and chest expansion exercises . The experimental protocol is based on the postural affectation of the AS and the treatment of the shortened muscle chains in these patients according to the Global Posture Reeducation ( GPR ) method . This intervention employs specific strengthening and flexibility exercises in which the shortened muscle chains are stretched and strengthened . The study lasted 4 mos . During this period , patients received a weekly group session managed by an experienced physiotherapist . Each session lasted an hour , and there were 15 total sessions . Changes in activity , mobility , and functional capacity were evaluated by an assessor blinded to the intervention , using the following previously vali date d scores from the Bath group : BASMI ( tragus to wall distance , modified Schöber test , cervical rotation , lumbar side flexion , and intermalleolar distance ) , BASDAI ( The Bath Ankylosing Spondylitis Disease Activity Index ) , and BASFI ( The Bath Ankylosing Spondylitis Functional Index ) . Results : Both groups showed an improvement ( prepost scores ) in all the outcome measures , mobility measures of the BASMI index , as well as in BASFI and BASDAI indexes . In the control group , the improvement in tragus to wall distance ( P = 0.009 ) and in lumbar side flexion ( P = 0.02 ) was statistically significant . Although the rest of the outcomes also improved , they did not reach a significant level ( P > 0.05 ) . In the experimental group , the improvement in all the clinical measures of the BASMI index ( P < 0.01 ) and in the BASFI index ( P = 0.003 ) was statistically significant . The intergroup comparison between the improvement ( prepost scores ) in both groups showed that the experimental group obtained a greater improvement than the control group in all the clinical measures of the BASMI index , except in tragus to wall distance , as well as in the BASFI index . Conclusions : The experimental protocol developed by our research group , based on the GPR method and specific strengthening and flexibility exercises of the muscle chains , offers promising results in the management of patients suffering from AS . Further trials on this topic are required Abstract Ankylosing spondylitis ( AS ) is a chronic systemic inflammatory disease that affects mainly the axial skeleton and causes significant pain and disability . Aquatic ( water-based ) exercise may have a beneficial effect in various musculoskeletal conditions . The aim of this study was to compare the effectiveness of aquatic exercise interventions with l and -based exercises ( home-based exercise ) in the treatment of AS . Patients with AS were r and omly assigned to receive either home-based exercise or aquatic exercise treatment protocol . Home-based exercise program was demonstrated by a physiotherapist on one occasion and then , exercise manual booklet was given to all patients in this group . Aquatic exercise program consisted of 20 sessions , 5 × per week for 4 weeks in a swimming pool at 32–33 ° C . All the patients in both groups were assessed for pain , spinal mobility , disease activity , disability , and quality of life . Evaluations were performed before treatment OUTPUT:
Most studies showed a positive effect of exercise on Bath Ankylosing Spondylitis Disease Activity Index , Bath Ankylosing Spondylitis Functional Index , pain , mobility , function and quality of life . Results support a multimodal approach , including educational sessions and maintaining home-based program .
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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: Heart failure ( HF ) is the leading cause of rehospitalization in older adults . The purpose of this pilot study was to examine whether telemonitoring by an advanced practice nurse reduced subsequent hospital readmissions , emergency department visits , costs , and risk of hospital readmission for patients with HF . One hundred two patient/caregiver dyads were r and omized into 2 groups postdischarge ; 84 dyads completed the study . Hospital readmissions , emergency department visits , costs , and days to readmission were abstract ed from medical records . Participants were interviewed soon after discharge and 3 months later about effects of telemonitoring on depressive symptoms , quality of life , and caregiver mastery . There were no significant differences due to telemonitoring for any outcomes . Caregiver mastery , informal social support , and electronic home monitoring were not significant predictors for risk of hospital readmission . Further studies should address the interaction between the advanced practice nurse and follow-up intervention with telemonitoring of patients with HF to better target those who are most likely to benefit OBJECTIVES We sought to identify whether home telemonitoring ( HTM ) improves outcomes compared with nurse telephone support ( NTS ) and usual care ( UC ) for patients with heart failure who are at high risk of hospitalization or death . BACKGROUND Heart failure is associated with a high rate of hospitalization and poor prognosis . Telemonitoring could help implement and maintain effective therapy and detect worsening heart failure and its cause promptly to prevent medical crises . METHODS Patients with a recent admission for heart failure and left ventricular ejection fraction ( LVEF ) < 40 % were assigned r and omly to HTM , NTS , or UC in a 2:2:1 ratio . HTM consisted of twice-daily patient self-measurement of weight , blood pressure , heart rate , and rhythm with automated devices linked to a cardiology center . The NTS consisted of specialist nurses who were available to patients by telephone . Primary care physicians delivered UC . The primary end point was days dead or hospitalized with NTS versus HTM at 240 days . RESULTS Of 426 patients r and omly assigned , 48 % were aged > 70 years , mean LVEF was 25 % ( SD , 8) and median plasma N-terminal pro-brain natriuretic peptide was 3,070 pg/ml ( interquartile range 1,285 to 6,749 pg/ml ) . During 240 days of follow-up , 19.5 % , 15.9 % , and 12.7 % of days were lost as the result of death or hospitalization for UC , NTS , and HTM , respectively ( no significant difference ) . The number of admissions and mortality were similar among patients r and omly assigned to NTS or HTM , but the mean duration of admissions was reduced by 6 days ( 95 % confidence interval 1 to 11 ) with HTM . Patients r and omly assigned to receive UC had higher one-year mortality ( 45 % ) than patients assigned to receive NTS ( 27 % ) or HTM ( 29 % ) ( p = 0.032 ) . CONCLUSIONS Further investigation and refinement of the application of HTM are warranted because it may be a valuable role for the management of selected patients with heart failure Background — Assessment of the quality of care for out patients with heart failure ( HF ) has focused on the development and use of process-based performance measures , with the supposition that these care process measures are associated with clinical outcomes . However , this association has not been evaluated for current and emerging outpatient HF measures . Methods and Results — Performance on 7 HF process measures ( 4 current and 3 emerging ) and 2 summary measures was assessed at baseline in patients from 167 US outpatient cardiology practice s with patients prospect ively followed up for 24 months . Participants included 15 177 patients with reduced left ventricular ejection fraction ( ⩽35 % ) and chronic HF or post – myocardial infa rct ion . Multivariable analyses were performed to assess the process- outcome relationship for each measure in eligible patients . Vital status was available for 11 621 patients . The mortality rate at 24 months was 22.1 % . Angiotensin-converting enzyme inhibitor or angiotensin receptor blocker use , & bgr;-blocker use , anticoagulant therapy for atrial fibrillation , cardiac resynchronization therapy , implantable cardioverter-defibrillators , and HF education for eligible patients were each independently associated with improved 24-month survival , whereas aldosterone antagonist use was not . The all-or-none and composite care summary measures were also independently associated with improved survival . Each 10 % improvement in composite care was associated with a 13 % lower odds of 24-month mortality ( adjusted odds ratio , 0.87 ; 95 % confidence interval , 0.84 to 0.90 ; P<0.0001 ) . Conclusions — Current and emerging outpatient HF process measures are positively associated with patient survival . These HF measures may be useful for assessing and improving HF care . Clinical Trial Registration — URL : http://www . clinical trials.gov . Unique identifier : NCT00303979 OBJECTIVE To study the impact of remote patient monitoring ( RPM ) upon the most frequent diagnosis in hospitalized patients over 65 years of age-heart failure ( HF ) . We examined the effect of RPM on hospital utilization and Medicare costs of HF patients receiving home care . MATERIAL S AND METHODS Two studies were simultaneously conducted : A r and omized and a matched-cohort study . In the r and omized study , 168 subjects were r and omly assigned ( after hospitalization ) to home care utilizing RPM ( live nursing visits and video-based nursing visits ) or to home care receiving live nursing visits only . In the matched-cohort OUTPUT: Several studies found that access to a specialist heart failure team/service reduced hospital readmissions and mortality . In primary care , a collaborative model of care where the primary physician shared the care with a cardiologist , improved patient outcomes compared to a primary physician only . During hospitalisation , quality improvement programs improved the quality of inpatient care result ing in reduced hospital readmissions and mortality . In the transitional care phase , heart failure programs , nurse-led clinics , and early outpatient follow-up reduced hospital readmissions . Conclusion Re design ing systems of care aim ed at improving the translation of evidence into clinical practice and transitional care can potentially improve patient outcomes in a cohort of patients known for high readmission rates and mortality INPUT: Background Home telemonitoring ( HTM ) of chronic heart failure ( HF ) promises to improve care by timely indications when a patient ’s condition is worsening . Simple rules of sudden weight change have been demonstrated to generate many alerts with poor sensitivity . Trend alert algorithms and bio-impedance ( a more sensitive marker of fluid change ) , should produce fewer false alerts and reduce workload . However , comparisons between such approaches on the decisions made and the time spent review ing alerts has not been studied . Methods Using HTM data from an observational trial of 91 HF patients , a simulated telemonitoring station was created and used to present virtual caseloads to clinicians experienced with HF HTM systems . Clinicians were r and omised to either a simple ( i.e. an increase of 2 kg in the past 3 days ) or advanced alert method ( either a moving average weight algorithm or bio-impedance cumulative sum algorithm ) . Results In total 16 clinicians review ed the caseloads , 8 r and omised to a simple alert method and 8 to the advanced alert methods . Total time to review the caseloads was lower in the advanced arms than the simple arm ( 80 ± 42 vs. 149 ± 82 min ) but agreements on actions between clinicians were low ( Fleiss kappa 0.33 and 0.31 ) and despite having high sensitivity many alerts in the bio-impedance arm were not considered to need further action . Conclusion Advanced alerting algorithms with higher specificity are likely to reduce the time spent by clinicians and increase the percentage of time spent on changes rated as most meaningful . Work is needed to present bio-impedance alerts in a manner which is intuitive for clinicians Background Evidence that home telemonitoring for patients with chronic heart failure ( CHF ) offers clinical benefit over usual care is controversial as is evidence of a health economic advantage . Methods Between January 2010 and June 2013 , patients with a confirmed diagnosis of CHF were enrolled and r and omly assigned to 2 study groups comprising usual care with and without an interactive bi-directional remote monitoring system ( Motiva ® ) . The primary endpoint in CardioBBEAT is the Incremental Cost-Effectiveness Ratio ( ICER ) established by the groups ’ difference in total cost and in the combined clinical endpoint “ days alive and not in hospital nor inpatient care per potential days in study ” within the follow-up of 12 months . Results A total of 621 predominantly male patients were enrolled , whereof 302 patients were assigned to the intervention group and 319 to the control group . Ischemic cardiomyopathy was the leading cause of heart failure . Despite r and omization , subjects of the control group were more often in NYHA functional class III – IV , and exhibited peripheral edema and renal dysfunction more often . Additionally , the control and intervention groups differed in heart rhythm disorders . No differences existed regarding risk factor profile , comorbidities , echocardiographic parameters , especially left ventricular and diastolic diameter and ejection fraction , as well as functional test results , medication and quality of life . While the observed baseline differences may well be a play of chance , they are of clinical relevance . Therefore , the statistical analysis plan was extended to include adjusted analyses with respect to the baseline imbalances . Conclusions CardioBBEAT provides prospect i ve outcome data on both , clinical and health economic impact of home telemonitoring in CHF . The study differs by the use of a high evidence level r and omized controlled trial ( RCT ) design along with actual cost data obtained from health insurance companies . Its results are conducive to informed political and economic decision-making with regard to home telemonitoring solutions as an option for health care . Overall , it contributes to developing advanced health economic evaluation instruments to be deployed within the specific context of the German Health Care System . Trial registration Clinical Trials.gov NCT02293252 ; date of registration : 10 November Background Heart failure is a prevalent health problem associated with costly hospital readmissions . Transitional care programs have been shown to reduce readmissions but are costly to implement . Evidence regarding the effectiveness of telemonitoring in managing the care of this chronic condition is mixed . The objective of this r and omized controlled comparative effectiveness study is to evaluate the effectiveness of a care transition intervention that includes pre-discharge education about heart failure and post-discharge telephone nurse coaching combined with home telemonitoring of weight , blood pressure , heart rate , and symptoms in reducing all-cause 180-day hospital readmissions for older adults hospitalized with heart failure . Methods / Design A multi-center , r and omized controlled trial is being conducted at six academic health systems in California . A total of 1,500 patients aged 50 years and older will be enrolled during a hospitalization for treatment of heart failure . Patients in the intervention group will receive intensive patient education using the ‘ teach-back ’ method and receive instruction in using the telemonitoring equipment . Following hospital discharge , they will receive a series of nine scheduled health coaching telephone calls over 6 months from nurses located in a central ized call center . The nurses also will call patients and patients ’ physicians in response to alerts generated by the telemonitoring system , based on predetermined parameters . The primary outcome is readmission for any cause within 180 days . Secondary outcomes include 30-day readmission , mortality , hospital days , emergency department ( ED ) visits , hospital cost , and health-related quality of life . Discussion BEAT-HF is one of the largest r and omized controlled trials of telemonitoring in patients with heart failure , and the first explicitly to adapt the care transition approach and combine it with remote telemonitoring . The study population also includes patients with a wide range of demographic and socioeconomic characteristics . Once completed , the study will be a rich re source of information on how best to use remote technology in the care management of patients with chronic heart failure . Trial registration Clinical Trials.gov # NCT01360203 BACKGROUND Because of potential side effects and logistical difficulty of titrating medications , out patients with congestive heart failure rarely receive appropriate doses of carvedil OUTPUT:
St and ardised description of the telemonitoring algorithm can expedite the identification of key components in telemonitoring algorithms that allow accurate prediction of worsening heart failure
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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: Background —In patients with atrial fibrillation ( AF ) undergoing radiofrequency ( RF ) electrical disconnection of multiple pulmonary veins ( PVs ) , the incidence of late conduction recurrences has not been systematic ally determined . Methods and Results —Using a prospect ively design ed , multistep approach , we aim ed at assessing the correlation between acute achievement and chronic maintenance of electrical conduction block across RF lesions disconnecting the distal tract of the PV in 43 patients ( 52.3±8.2 years ) with AF . Forty-one left superior ( LS ) , 42 right superior ( RS ) , 25 left inferior ( LI ) , and 9 right inferior ( RI ) PVs were targeted during 108 EP procedures ( 2.6±0.5 per patient ) . Seventeen patients underwent 2 procedures , 23 patients underwent 3 procedures , and 3 patients underwent 4 procedures . During the first attempt , electrical disconnection was achieved in 112 PVs ( 95.7 % ) . During a next procedure ( time interval , 4.6±1.9 months ) , conduction recurrence was observed in 32 of 39 LSPVs ( 82.1 % ) , 29 of 40 RSPVs ( 72.5 % ) , 20 of 24 LIPVs ( 83.3 % ) , and 7 of 9 RIPV ( 77.8 % ) . After reablation at gap sites , a later procedure ( time interval , 5.1±2.4 months ) revealed a second recurrence in 13 of 22 LSPVs ( 59.1 % ) and 14 of 19 RSPVs ( 73.7 % ) . Conclusions —Conduction recurrence across disconnecting RF lesions can be observed in ≈80 % of cases 4 months after ablation . After reablation , similar recurrence rates are observed 5 months later . This high rate of late conduction recurrence may contribute significantly to AF recurrence in patients undergoing catheter ablation aim ing at disconnection of multiple PVs BACKGROUND Atrial fibrillation ( AF ) recurrence after pulmonary vein isolation ( PVI ) is associated with PV to left atrium reconduction . Effective lesion creation necessitates adequate contact force between the ablation catheter and myocardium . OBJECTIVE The purpose of this study was to study the utility of contact force-guided ablation on immediate and long-term outcomes . METHODS Seventy-five patients with highly symptomatic paroxysmal AF underwent wide circumferential PVI using an irrigated-tip radiofrequency catheter . In 25 patients , ablation was guided by real-time contact force measurements ( CF group ; SmartTouch , Biosense Webster ) . A control group of 50 patients underwent PVI using a st and ard nonforce sensing catheter ( st and ard group ; ThermoCool , Biosense Webster ) . After PVI , all patients underwent adenosine testing to unmask dormant conduction . Patients were followed up at 3 , 6 , and 12 months and by transtelephonic monitoring as well . RESULTS Dormant conduction was unmasked and subsequently eliminated in 4 PV pairs ( 8 % ; 16 % of patients ) in the CF group and 35 PV pairs ( 35 % ; 52 % of patients ) in the st and ard group ( P = .0004 per PV pair ; P = .0029 per patient ) . The single-procedure , off-antiarrhythmic drug freedom from recurrent atrial arrhythmias at 1 year was 88 % in the CF group vs 66 % in the st and ard group ( P = .047 ) . Procedure duration and fluoroscopy time were significantly longer in the CF group ( P = .0038 and P = .0001 , respectively ) . CONCLUSION The use of real-time contact force guidance results in a significant reduction in the prevalence of dormant conduction with improved long-term freedom from recurrent arrhythmias . The utility of a contact force-guided approach requires evaluation in a long-term prospect i ve r and omized study BACKGROUND Contact force ( CF ) information may improve the safety and efficacy of ablation for paroxysmal atrial fibrillation ( PAF ) . OBJECTIVE The purpose of this study was to assess the impact of CF data on ablation for PAF . METHODS Patients undergoing first-time PAF ablation were r and omized at 7 UK centers to ablation with ( CF-on ) or without ( CF-off ) CF data available to the operator , using the same ablation catheter and mapping system . An ablation CF of 5 - 40 g was targeted . Pulmonary vein ( PV ) reconnection was assessed with adenosine at 60 minutes . Follow-up for arrhythmia recurrence was for 1 year with 7-day Holter recordings at 6 and 12 months . RESULTS One hundred seventeen patients were studied ( 59 CF-on , 58 CF-off ) . In the CF-on group , a reduction in acute PV reconnection rates ( 22 % vs 32 % , P = .03 ) but no significant difference in 1-year success rates off antiarrhythmic drugs ( 49 % vs 52 % , P = .9 ) was observed . There was no difference in major complication rates : 2 of 59 ( 3 % ) CF-on , 3 of 58 ( 5 % ) CF-off ( P = .7 ) . Procedural and fluoroscopy times were not significantly different ( P>.5 ) . Overall mean CFs per ablation were not different between groups ( 13.4 [9.1 - 19.6]g CF-on , 13.4 [7.4 - 22.4]g CF-off , P = .5 ) , but a greater proportion of readings in the CF-on group were in the target range OUTPUT: Conclusion : CF‐guided RF catheter ablation was associated with a significant AF/atrial tachycardia‐free survival benefit compared with non‐CF‐guided ablation in patients with paroxysmal AF rather than persistent AF . In addition , CF‐guided ablation strategy also reduced the procedure time , fluoroscopy time , as well as RF time despite no distinct effect on the alleviation of procedure‐related complications INPUT: Background —Atrial fibrillation ( AF ) ablation is increasingly used in clinical practice . We aim ed to study the natural history and long-term outcomes of ablated AF . Methods and Results —We followed 831 patients after pulmonary vein isolation ( PVI ) performed in 2005 . We documented clinical outcomes using our prospect i ve AF registry with most recent up date on this group of patients in October 2009 . In the first year after ablation , 23.8 % had early recurrence . Over long-term follow-up ( 55 months ) , only 8.9 % had late arrhythmia recurrence defined as occurring beyond the first year after ablation . Repeat ablations in patients with late recurrence revealed conduction recovery in at least 1 of the previously isolated PVs in all of them and right-sided triggers with isoproterenol testing in 55.6 % . At last follow-up , clinical improvement was 89.9 % ( 79.4 % arrhythmia-free off antiarrhythmic drugs and 10.5 % with AF controlled with antiarrhythmic drugs ) . Only 4.6 % continued to have drug-resistant AF . It was possible to safely discontinue anticoagulation in a substantial proportion of patients with no recurrence in the year after ablation ( CHADS score ⩽2 , stroke incidence of 0.06 % per year ) . The procedure-related complication rate was very low . Conclusions —Pulmonary vein isolation is safe and efficacious for long-term maintenance of sinus rhythm and control of symptoms in patients with drug-resistant AF . It obviates the need for antiarrhythmic drugs , negative dromotropic agents , and anticoagulants in a substantial proportion of patients BACKGROUND Atrial fibrillation ( AF ) recurrence after pulmonary vein isolation ( PVI ) is associated with PV to left atrium reconduction . Effective lesion creation necessitates adequate contact force between the ablation catheter and myocardium . OBJECTIVE The purpose of this study was to study the utility of contact force-guided ablation on immediate and long-term outcomes . METHODS Seventy-five patients with highly symptomatic paroxysmal AF underwent wide circumferential PVI using an irrigated-tip radiofrequency catheter . In 25 patients , ablation was guided by real-time contact force measurements ( CF group ; SmartTouch , Biosense Webster ) . A control group of 50 patients underwent PVI using a st and ard nonforce sensing catheter ( st and ard group ; ThermoCool , Biosense Webster ) . After PVI , all patients underwent adenosine testing to unmask dormant conduction . Patients were followed up at 3 , 6 , and 12 months and by transtelephonic monitoring as well . RESULTS Dormant conduction was unmasked and subsequently eliminated in 4 PV pairs ( 8 % ; 16 % of patients ) in the CF group and 35 PV pairs ( 35 % ; 52 % of patients ) in the st and ard group ( P = .0004 per PV pair ; P = .0029 per patient ) . The single-procedure , off-antiarrhythmic drug freedom from recurrent atrial arrhythmias at 1 year was 88 % in the CF group vs 66 % in the st and ard group ( P = .047 ) . Procedure duration and fluoroscopy time were significantly longer in the CF group ( P = .0038 and P = .0001 , respectively ) . CONCLUSION The use of real-time contact force guidance results in a significant reduction in the prevalence of dormant conduction with improved long-term freedom from recurrent arrhythmias . The utility of a contact force-guided approach requires evaluation in a long-term prospect i ve r and omized study BACKGROUND Contact force ( CF ) monitoring could be useful in accomplishing circumferential pulmonary vein ( PV ) isolation ( CPVI ) for atrial fibrillation ( AF ) . OBJECTIVE The purpose of this study was to compare procedure parameters and outcomes between CF-guided and non-guided CPVI . METHODS Thirty-eight consecutive AF patients ( mean age 60 ± 11 years , 28 paroxysmal AF ) undergoing CPVI were r and omized to non-CF-guided ( n = 19 ) and CF-guided ( n = 19 ) groups . CPVI was performed with the ThermoCool SmartTouch catheter in both groups . The end-point was bidirectional block between the left atrium ( LA ) and PV . In the CF group , CF was kept between 10 and 20 g during CPVI , whereas in the non-CF group , all CF information was blanked . Radiofrequency energy at 30 W in the anterior and 25 W in the posterior LA wall was applied for 20 - 25 seconds at each point . RESULTS CPVI was successfully accomplished without any major complications in both groups . Mean CF in the non-CF and CF groups were 5.9 ± 4.5 g and 11.1 ± 4.3 g , respectively , for left-side CPVI , and 9.8 ± 6.6 g and 12.1 ± 4.8 g , respectively , for right-side CPVI ( both P < .001 ) . The procedure and fluoroscopy times for CPVI in the non-CF and CF groups were 96 ± 39 minutes and 59 ± 16 minutes , respectively ( P < .001 ) , and 22 ± 63 seconds and 9 ± 20 seconds ( P = NS ) , respectively . Total number of residual conduction gaps was 6.3 ± 3.0 in the non-CF group and 2.8 ± 1.9 in the CF group ( P < .001 ) . During 6-month follow-up , 84.2 % of patients in the non-CF group and 94.7 % in the CF group were free OUTPUT:
In conclusion , this meta- analysis shows that the use of CF technology decreases AF recurrence at a median follow-up of 12 months and also led to decreased use of RF during ablation . There was no difference in total procedure length and fluoroscopy exposure
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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: To address the epidemic of hypertension in blacks born and living in sub-Saharan Africa , we compared in a r and omised clinical trial ( NCT01030458 ) single-pill combinations of old and new antihypertensive drugs in patients ( 30–69 years ) with uncomplicated hypertension ( 140–179/90–109 mm Hg ) . After ⩾4 weeks off treatment , 183 of 294 screened patients were assigned to once daily bisoprolol/hydrochlorothiazide 5/6.25 mg ( n=89 ; R ) or amlodipine/valsartan 5/160 mg ( n=94 ; E ) and followed up for 6 months . To control blood pressure ( < 140/<90 mm Hg ) , bisoprolol and amlodipine could be doubled ( 10 mg per day ) and α-methyldopa ( 0.5–2 g per day ) added . Sitting blood pressure fell by 19.5/12.0 mm Hg in R patients and by 24.8/13.2 mm Hg in E patients and heart rate decreased by 9.7 beats per minute in R patients with no change in E patients ( –0.2 beats per minute ) . The between-group differences ( R minus E ) were 5.2 mm Hg ( P<0.0001 ) systolic , 1.3 mm Hg ( P=0.12 ) diastolic , and 9.6 beats per minute ( P<0.0001 ) . In 57 R and 67 E patients with data available at all visits , these estimates were 5.5 mm Hg ( P<0.0001 ) systolic , 1.8 mm Hg ( P=0.07 ) diastolic and 9.8 beats per minute ( P<0.0001 ) . In R compared with E patients , 45 vs 37 % ( P=0.13 ) proceeded to the higher dose of r and omised treatment and 33 vs 9 % ( P<0.0001 ) had α-methyldopa added . There were no between-group differences in symptoms except for ankle oedema in E patients ( P=0.012 ) . In conclusion , new compared with old drugs lowered systolic blood pressure more and therefore controlled hypertension better in native African black patients Background The efficacy of angiotensin-converting enzyme ( ACE ) inhibitors in decreasing blood pressure in African patients is controversial . Objective We examined the ambulatory blood pressure ( ABP ) response to a diuretic and an ACE inhibitor in hypertensive patients of East African descent and evaluated the individual characteristics that determined treatment efficacy . Design A single-blind r and omized AB/BA crossover design . Setting Hypertensive families of East African descent from the general population in the Seychelles . Participants Fifty-two ( 29 men and 23 women ) out of 62 eligible hypertensive patients were included . Main outcome measures ABP response to 20 mg lisinopril ( LIS ) daily and 25 mg hydrochlorothiazide ( HCT ) daily given for a 4-week period . Results The daytime systolic/diastolic ABP response to HCT was 4.9 [ 95 % confidence interval ( CI ) 1.2–8.6]/3.6 ( 1.0–6.2 ) mmHg for men and 12.9 (9.2–16.6)/6.3 ( 3.7–8.8 ) mmHg for women . With LIS the response was 18.8 (15.0–22.5)/14.6 ( 12.0–17.1 ) mmHg for men and 12.4 (8.7–16.2)/7.7 ( 5.1–10.2 ) mmHg for women . The night-time systolic/diastolic response to HCT was 5.0 (0.6–9.4)/2.7 [ (−0.4)–5.7 ] mmHg for men and 11.5 (7.1–16.0)/5.7 ( 2.6–8.8 ) mmHg for women , and to LIS was 18.7 (14.2–22.1)/15.4 ( 12.4–18.5 ) mmHg for men and 3.5 [(−1.0)–7.9]/2.3 [ (−0.8)–5.4 ] mmHg for women . Linear regression analyses showed that gender is an independent predictor of the ABP responses to HCT and to LIS . Conclusions Hypertensive patients of African descent responded better to LIS than to HCT . Men responded better to LIS than to HCT and women responded similarly to both drugs Objective : To investigate HIV , its treatment , and hypertension as stroke risk factors in Malawian adults . Methods : We performed a case-control study of 222 adults with acute stroke , confirmed by MRI in 86 % , and 503 population controls , frequency-matched for age , sex , and place of residence , using Global Positioning System for r and om selection . Multivariate logistic regression models were used for case-control comparisons . Results : HIV infection ( population attributable fraction [ PAF ] 15 % ) and hypertension ( PAF 46 % ) were strongly linked to stroke . HIV was the predominant risk factor for young stroke ( ≤45 years ) , with a prevalence of 67 % and an adjusted odds ratio ( aOR ) ( 95 % confidence interval ) of 5.57 ( 2.43–12.8 ) ( PAF 42 % ) . There was an increased risk of a stroke in patients with untreated HIV infection ( aOR 4.48 [ 2.44–8.24 ] , p < 0. OUTPUT: Fewer studies assessing combination therapy were available , but there was a trend towards superiority for CCBs plus ACE inhibitors or diuretics compared to other combinations . Evidence broadly supports current guidelines and provides a clear rationale for promoting CCBs as first-line agents and early initiation of combination therapy . INPUT: The antihypertensive effects of telmisartan 80 mg versus valsartan 160 mg , both combined with hydrochlorothiazide ( HCTZ ) 25 mg , were assessed in a pooled analysis from two large trials with identical study design s in patients with stage 1–2 hypertension . The trials were double-blind with a 4:4:1 r and omization scheme to compare once-daily telmisartan 80 mg and HCTZ 25 mg versus once-daily valsartan 160 mg and HCTZ 25 mg versus once-daily placebo on reductions in clinic blood pressure ( BP ) . The primary end point was changes from baseline in BP at the end of 8 weeks . In total , 2121 patients were r and omized ( telmisartan – HCTZ , 942 , valsartan – HCTZ , 952 , and placebo , 227 ) and had baseline seated BPs of 154/102 and 155/102 mm Hg in the two studies , respectively . Changes from baseline in BP after administration of telmisartan – HCTZ ( −24.5/−18.0 mm Hg ) were significantly greater than for both placebo ( −4.1/−6.5 mm Hg ) and valsartan – HCTZ ( −22.3/−16.8 mm Hg ) ( versus placebo , P<0.0001 for systolic and diastolic BP ; versus valsartan – HCTZ , P=0.0004 for systolic BP and P=0.0019 for diastolic BP ) . Adverse event rates were higher in the placebo group than in the active treatment groups ( placebo , 41 % , telmisartan – HCTZ , 30 % , and valsartan – HCTZ , 30 % , P<0.05 ) . These data confirm that telmisartan – HCTZ at doses of 80/25 mg lowered systolic and diastolic BP to a greater extent than valsartan – HCTZ at doses of 160/25 mg in stage 1–2 hypertension . The magnitude of the BP-lowering effect provides support for the use of angiotensin receptor blockers with higher doses of a thiazide diuretic ( 25 mg ) to improve hypertension control Increased arterial stiffness , as estimated from aortic pulse wave velocity ( Ao-PWV ) , and albuminuria are independent predictors for cardiovascular disease in type 2 diabetes mellitus ( T2DM ) . Whether angiotensin receptor blockers ( ARBs ) , drugs with cardio-renal protective effects , improve Ao-PWV to a greater extent than other equipotent antihypertensive medications remains unclear . After a 4-week washout phase , we compared the effects of valsartan ( n=66 ) , an ARB , with that of amlodipine ( n=65 ) , a calcium channel blocker on Ao-PWV in 131 T2DM patients with pulse pressure ( PP ) ≥60 mm Hg and raised albumin excretion rate ( AER ) in a 24-week r and omized , double-blind , parallel group study . Hydrochlorothiazide ( HCTZ ) 25 mg/d was added to valsartan 160 mg and amlodipine 5 mg/od uptitrated to 10 mg/od after 4 weeks to ensure equivalent BP control . After 24 weeks brachial and central aortic PP had fallen to a similar extent with attained mean ( SD ) brachial and central PP of 61.6 ( 13.6 ) and 47.3 ( 14.1 ) mm Hg in the valsartan/HCTZ group and 61.5 ( 12.2 ) and 47.3 ( 9.9 ) mm Hg in the amlodipine group , respectively . Ao-PWV showed a significantly greater reduction , mean ( 95 % CI ) , −0.9 m/s ( −1.4 to −0.3 ) for valsartan/HCTZ compared to amlodipine ( P=0.002 ) . AER fell significantly only with Val/HCTZ from 30.8(20.4 , 46.5 ) to 18.2(12.5 , 26.3 ) mcg/min , ( P=0.01 ) with between treatment difference in favor of Val/HCTZ of −15.3mcg/min ( P<0.001 ) . Changes in AER and Ao-PWV were not correlated . Valsartan/HCTZ improves arterial stiffness and AER to a significantly greater extent than amlodipine despite similar central and brachial BP control . These 2 effects , which appear independent of each other , may explain the specific cardio-renal protective properties of ARBs BACKGROUND The aim of the study was to evaluate whether the combined treatment of calcium channel blocker , amlodipine and beta-blocker , betaxolol , favorably affects cardiac autonomic nervous activity ( CANA ) and health-related quality of life ( HRQL ) . METHODS AND RESULTS A total of 65 patients with a poor blood pressure ( BP ) control with a low dose amlodipine therapy were r and omly assigned to the amlodipine dose-up group ( n=21 ) and betaxolol adding group ( n=44 ) . Before and after a 6-month treatment , BP , heart rate variability ( HRV ) , HRQL and blood chemistries were evaluated . Low frequency ( LF ) spectra/high frequency ( HF ) spectra and HF/total power spectra ( TP ) were calculated as indexes of CANA , and OUTPUT:
Effects of antihypertensive drugs on SBP variability are dose-dependent and persist when used in combinations . Use of a high dose of a calcium channel blocker alone or in combination with other agents is therefore likely to be particularly effective in prevention of stroke
MS2_dynamic_1_shot490
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: Abstract Objective : To evaluate the use of a computerised support system for decision making for implementing evidence based clinical guidelines for the management of asthma and angina in adults in primary care . Design : A before and after pragmatic cluster r and omised controlled trial utilising a two by two incomplete block design . Setting : 60 general practice s in north east Engl and . Participants : General practitioners and practice nurses in the study practice s and their patients aged 18 or over with angina or asthma . Main outcome measures : Adherence to the guidelines , based on review of case notes and patient reported generic and condition specific outcome measures . Results : The computerised decision support system had no significant effect on consultation rates , process of care measures ( including prescribing ) , or any patient reported outcomes for either condition . Levels of use of the software were low . Conclusions : No effect was found of computerised evidence based guidelines on the management of asthma or angina in adults in primary care . This was probably due to low levels of use of the software , despite the system being optimised as far as was technically possible . Even if the technical problems of producing a system that fully supports the management of chronic disease were solved , there remains the challenge of integrating the systems into clinical encounters where busy practitioners manage patients with complex , multiple conditions OBJECTIVE : Asthma continues to be 1 of the most common chronic diseases of childhood and affects ∼6 million US children . Although National Asthma Education Prevention Program guidelines exist and are widely accepted , previous studies have demonstrated poor clinician adherence across a variety of population s. We sought to determine if clinical decision support ( CDS ) embedded in an electronic health record ( EHR ) would improve clinician adherence to national asthma guidelines in the primary care setting . METHODS : We conducted a prospect i ve cluster-r and omized trial in 12 primary care sites over a 1-year period . Practice s were stratified for analysis according to whether the site was urban or suburban . Children aged 0 to 18 years with persistent asthma were identified by International Classification of Diseases , Ninth Revision codes for asthma . The 6 intervention- practice sites had CDS alerts imbedded in the EHR . Outcomes of interest were the proportion of children with at least 1 prescription for controller medication , an up-to- date asthma care plan , and the performance of office-based spirometry . RESULTS : Increases in the number of prescriptions for controller medications , over time , was 6 % greater ( P = .006 ) and 3 % greater for spirometry ( P = .04 ) in the intervention urban practice s. Filing an up-to- date asthma care plan improved 14 % ( P = .03 ) and spirometry improved 6 % ( P = .003 ) in the suburban practice s with the intervention . CONCLUSION : In our study , using a cluster-r and omized trial design , CDS in the EHR , at the point of care , improved clinician compliance with National Asthma Education Prevention Program guidelines AIM To compare the degree of asthma control in 2001 and 2005 in a primary care setting in Sweden . METHOD Two similar question naire surveys were performed in 2001 and 2005 with 1,012 and 224 asthma patients aged 18 - 45 r and omly selected from 42 and 56 primary health care centres , respectively . A classification of asthma control similar to the GINA guidelines was made using information obtained from the question naire . RESULTS In 2001 , 36.6 % had achieved asthma control , 23.8 % were partly controlled and 39.6 % uncontrolled . In 2005 , the corresponding figures were 40.2 % , 26.8 % and 33.0 % , respectively , with no difference between the two surveys ( p=0.114 ) . Uncontrolled asthma was more common in women ( p<0.001 in the first and p<0.05 in the second survey ) and smokers ( p<0.01 in the first and p<0.01 in the second survey ) . The use of combination corticosteroid/long-acting bronchodilator inhalers had increased - 34.2 % and 48.2 % , respectively ( p<0.001 ) - and many patients used their inhaled corticosteroids periodically . CONCLUSION In spite of treatment guidelines many patients in Swedish primary care still have insufficient asthma control Objective To determine whether mobile phone based monitoring improves asthma control compared with st and ard paper based monitoring strategies . Design Multicentre r and omised controlled trial with cost effectiveness analysis . Setting UK primary care . Participants 288 adolescents and adults with poorly controlled asthma ( asthma control question naire ( ACQ ) score ≥1.5 ) from 32 practice s. Intervention Participants were central ly r and omised to twice daily recording and mobile phone based transmission of symptoms , drug use , and peak flow with immediate feedback prompting action according to an agreed plan or paper based monitoring . Main outcome measures Changes in scores on asthma control question naire and self efficacy ( knowledge , attitude , and self efficacy asthma question naire ( KASE-AQ ) ) at six months after r and omisation . Assessment of outcomes was blinded . Analysis was on an intention to treat basis . Results There was no significant difference in the change in asthma control or self efficacy between the two groups ( ACQ : mean change 0.75 in mobile group v 0.73 in paper group , mean difference in change −0.02 ( 95 % confidence interval −0.23 to 0.19 ) ; KASE-AQ score : mean change −4.4 v −2.4 , mean difference 2.0 ( −0.3 to 4.2 ) ) . The numbers of patients who had acute exacerbations , steroid courses , and unscheduled consultations were similar in both groups , with similar healthcare costs . Overall , the mobile phone service was more expensive because of the expenses of telemonitoring . OUTPUT: Overall , CDSSs for professionals were ineffective . Usage of the systems was generally low : in the only trial at low risk of bias the CDSS was not used at all . When a CDSS was used , compliance with the advice offered was also low . However , if actually used , CDSSs could result in closer guideline adherence ( improve investigating , prescribing and issuing of action plans ) and could improve some clinical outcomes . The study at moderate risk of bias showed increased prescribing of inhaled steroids . Conclusions : The current generation of CDSSs is unlikely to result in improvements in outcomes for patients with asthma because they are rarely used and the advice is not followed . INPUT: RATIONALE , AIMS AND OBJECTIVES To assess the outcomes of a clinical decision support ( CDS ) intervention design ed for home care patients with high medication regimen complexity ( MRC ) and to examine correlates of CDS use . METHOD The CDS consisted of a computerized algorithm that identified high MRC patients , electronic alerts and a care management module . Nurses were r and omized upon identification of an eligible patient . Full intention to treat and intervention group-only analyses were completed . Regression-adjusted outcomes were hospitalization , emergency department use and reduction in MRC . RESULTS Five hundred nurses were r and omized with 7919 of their patients . Approximately 20 % of the intervention group was hospitalized versus 21 % in the control group ; 16.5 % versus 16.7 % had an emergency department visit ; and 6 % in each group dropped below the high MRC threshold . No statistically significant differences were found in the intention to treat analysis . Eighty-two percent of intervention nurses used the CDS but for only 42 % of their patients . Among intervention patients , CDS use ( vs. non-use ) was associated with reduced MRC and hospitalization . CDS use was associated with various clinician and patient characteristics . CONCLUSION CDS use was limited , negating the impact of the intervention overall . Findings on correlates of CDS use and the relationship between CDS use and positive outcomes suggest that CDS use and outcomes could be enhanced by avoiding short patient lengths of stay , improving continuity of care , increasing reliance on salaried nurses and /or increasing per diem nurses ' incentives to use CDS This study was aim ed to investigate the effects of computerized decision support system in improving the prescription of drugs for cardiovascular prevention . A total of 197 Italian general practitioners were r and omly allocated to receive either the alerting computerized decision support system integrated into st and ard software ( intervention arm ) or the st and ard software alone ( control arm ) . Data on 21230 patients with diabetes , 3956 with acute myocardial infa rct ion , and 2158 with stroke were analysed . The proportion of patients prescribed with cardiovascular drugs and days of drug – drug interaction exposure were evaluated . Computerized decision support system significantly increased the proportion of patients with diabetes prescribed with antiplatelet drugs ( intervention : + 2.7 % vs. control : + 0.15 % ; p < 0.001 ) or lipidlowering drugs ( + 4.2 % vs. + 2.8 % ; p = 0.001 ) . A statistically significant decrease in days of potential interactions has been observed only among patients with stroke ( −1.2 vs. −0.5 days/person-year ; p = 0.001 ) . In conclusion , computerized decision support system significantly increased the use of recommended cardiovascular drugs in diabetic patients , but it did not influence the exposure to potential Background — Indirect evidence shows that alerting users with clinical decision support systems seems to change behavior more than requiring users to actively initiate the system . However , r and omized trials comparing these methods in a clinical setting are lacking . We studied the effect of both alerting and on-dem and decision support with respect to screening and treatment of dyslipidemia based on the guidelines of the Dutch College of General Practitioners . Methods and Results — In a clustered r and omized trial design , 38 Dutch general practice s ( 77 physicians ) and 87 886 of their patients ( 39 433 men 18 to 70 years of age and 48 453 women 18 to 75 years of age ) who used the ELIAS electronic health record participated . Each practice was assigned to receive alerts , on-dem and support , or no intervention . We measured the percentage of patients screened and treated after 12 months of follow-up . In the alerting group , 65 % of the patients requiring screening were screened ( relative risk versus control=1.76 ; 95 % confidence interval , 1.41 to 2.20 ) compared with 35 % of patients in the on-dem and group ( relative risk versus control=1.28 ; 95 % confidence interval , 0.98 to 1.68 ) and 25 % of patients in the control group . In the alerting group , 66 % of patients requiring treatment were treated ( relative risk versus control=1.40 ; 95 % confidence interval , 1.15 to 1.70 ) compared with 40 % of patients ( relative risk versus control=1.19 ; 95 % confidence interval , 0.94 to 1.50 ) in the on-dem and group and 36 % of patients in the control group . Conclusion — The alerting version of the clinical decision support systems significantly improved screening and treatment performance for dyslipidemia by general practitioners OBJECTIVE To evaluate the impact of systematic patient evaluation and patient and provider feedback on the processes and intermediate outcomes of diabetes care in Independent Practice Association model internal medicine practice s. RESEARCH DESIGN AND METHODS Nine practice s providing care to managed care patients were r and omly assigned as intervention or comparison sites . Intervention-site subjects had Annual Diabetes Assessment Program ( ADAP ) assessment s ( HbA(1c ) , blood pressure , lipids , smoking , retinal photos , urine microalbumin , and foot examination ) at years 1 and 2 . Comparison-site subjects had ADAP assessment s at year 2 . At Intervention sites , year 1 ADAP results were review ed with subjects , mailed to providers , and incorporated into electronic medical records with guideline -generated suggestions for treatment and follow-up . Medical records were evaluated for both groups for the year before both the year 1 and year 2 ADAP assessment s. Processes and intermediate outcomes were compared using linear and logistic mixed hierarchical models . RESULTS Of 284 eligible subjects , 103 of 173 ( 60 % ) at the Intervention sites and 71 of 111 OUTPUT:
Among CVRM patients , the results tended towards a beneficial effect of CDSS , but only LDL-c target attainment in diabetes patients reached statistical significance . Prompting , integration into the electronical health record , patient empowerment , and medication support were related to more effective CVRM . Conclusion We did not find a clear clinical benefit from CDSS in cardiovascular risk factor levels and target attainment . Some features of CDSS seem more promising than others . Clinical relevance of CDSS in CVRM might additionally be sought in the improvement of shared decision making and patient empowerment
MS2_dynamic_1_shot491
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: Objectives : To study the prevalence of hypovitaminosis D , the effect of vitamin D supplementation on serum 25-hydroxyvitamin D [ S-25(OH)D ] , and the intakes of vitamin D and calcium in Finnish 9− to 15-year-old athletic and nonathletic girls . Design : 1-year follow-up study ( February 1997-March 1998 ) with three months of vitamin D supplementation ( 10 μg/d ) from October to January . Setting : Turku University Central Hospital , Finl and .Subjects : 191 female volunteers aged 9–15 y ( 131 athletes and 60 controls ) . Methods : Vitamin D and calcium intakes were estimated by a four-day food recording and a semi-quantitative food frequency question naire ( FFQ ) . S-25(OH)D was followed by radioimmunoassay ( RIA ) . Results : At baseline the mean S-25(OH)D concentration was 33.9 nmol/l among all girls . In winter severe hypovitaminosis D ( S-25(OH)D<20 nmol/l ) occurred in 13.4 % of the participants and in 67.7 % S-25(OH)D was below 37.5 nmol/l . By the next summer the mean S-25(OH)D concentration was 62.9 nmol/l and in 1.6 % of the subjects it was below 37.5 nmol/l . The prevalence of severe hypovitaminosis D was not significantly reduced by three months of vitamin D ( 10 μg/d ) supplementation . At baseline , the mean intake of vitamin D was 2.9 μg/d by food recording and 4.3 μg/d by FFQ . The mean calcium intake was 1256 mg/d and 1580 mg/d , respectively . The intakes of vitamin D and calcium remained unchanged during the follow-up period . The athletes consumed more calcium than nonathletic controls , whereas the intake of vitamin D was quite similar among both groups . The vitamin D intake by FFQ correlated with the S-25(OH)D concentration in wintertime ( r=0.28 , P<0.01 ) . Conclusion : Hypovitaminosis D is fairly common in growing Finnish girls in the wintertime , and three months of vitamin D supplementation with 10 μg/d was insufficient in preventing hypovitaminosis D. The daily dietary vitamin D intake was insufficient ( < 5 μg/d ) in the majority of participants , while the calcium intake was usually sufficient . Sponsorship : Supported by the Yrjö Jahnsson Foundation , The Turku University Foundation , and the Medical Research Foundation of the Turku University Central Hospital Objective To investigate whether vitamin D supplementation can decrease the mortality and morbidity of low birthweight infants in low income countries . Design R and omised controlled trial . Setting Large government hospital in New Delhi , India . Participants 2079 low birthweight infants born at term ( > 37 weeks ’ gestation ) . Main outcome measures Primary outcome was admission to hospital or death during the first six months of life . Main secondary outcome was growth . Interventions Weekly vitamin D supplements for six months at a dose of one recommended nutrient intake per day ( 35 µg/week ) . Infants were visited weekly at home for observed supplementation and were brought to the clinic monthly for clinical examination and anthropometric measurements . Results Between group differences were not significant for death or hospital admissions ( 92 among 1039 infants in the vitamin D group v 99 among 1040 infants in the placebo group ; adjusted rate ratio 0.93 , 95 % confidence interval 0.68 to 1.29 ; P=0.68 ) , or referral to the outpatient clinic for moderate morbidity . Vitamin D supplementation result ed in better vitamin D status as assessed by plasma calcidiol levels at six months . In adjusted analyses , vitamin D treatment significantly increased st and ard deviation ( z ) scores at six months for weight , length , and arm circumference and decreased the proportion of children with stunted growth ( length for age z score ≤2 ) or with arm circumference z scores of 2 or less . Conclusion A weekly dose of vitamin D result ed in better vitamin D status and benefited the classic vitamin D function of bone growth but did not decrease the incidence of severe morbidity or death among young low birthweight infants . Trial registration Clinical Trials.gov NCT00415402 BACKGROUND Provision of fortified juices may provide a convenient method to maintain and increase blood fat-soluble vitamins . OBJECTIVE To determine whether children consuming orange juice fortified with calcium and combinations of vitamins D , E , and A could increase serum 25-hydroxyvitamin D [ 25(OH)D ] , α-tocopherol , and retinol levels . DESIGN A 12-week r and omized , double-blind , controlled trial . PARTICIPANTS / SETTING One hundred eighty participants ( aged 8.04±1.42 years ) were recruited at Tufts ( n=70 ) and Boston University ( n=110 ) during 2005 - 2006 . Of those recruited , 176 children were r and omized into three groups : CaD ( 700 mg calcium+200 IU vitamin D ) , CaDEA ( 700 mg calcium+200 IU vitamin D+12 IU vitamin E+2,000 IU vitamin A as beta carotene ) , or Ca ( 700 mg calcium ) . Children consumed two 240-mL glasses of CaD , CaDEA , or Ca fortified orange juice daily for 12 weeks . MAIN OUTPUT: In these two trials there were no obvious differences between supplemented and unsupplemented children regarding episodes of diarrhoea . This may be due to time elapsed at measurement from the last dose , incomplete compliance , or increased need of vitamin D with infant age . INPUT: INTRODUCTION A high peak bone mass may be essential for reducing the risk of osteoporosis later in life and a sufficient vitamin D level during puberty may be necessary for optimal bone accretion and obtaining a high peak bone mass . Dietary intake and synthesis during winter of vitamin D might be limited but the effect of vitamin D supplementation in adolescence on bone mass is not well established . OBJECTIVE To investigate the effect of supplementation with 5 and 10 microg/day vitamin D(3 ) for 12 months in 11- to 12-year-old girls on bone mass and bone turnover as well as the possible influence of VDR and ER genotype on the effect of the supplementation . METHODS The girls ( n=221 ) were r and omized to receive either 5 microg or 10 microg vitamin D(3 ) supplementation per day or placebo for 12 months . Whole body and lumbar spine bone mass measured by DXA and pubertal status were determined at baseline and after 12 months whereas physical activity and dietary intake of calcium and vitamin D were assessed at baseline . Serum ( S ) 25-hydroxyvitamin D ( 25OHD ) , S-osteocalcin , S-parathyroid hormone , S-calcium , S-inorganic phosphate , urinary ( U ) pyridinoline ( Pyr ) and deoxpyridinoline ( Dpyr ) were measured at baseline and after 6 and 12 months . RESULTS The S-25OHD concentration increased ( p<0.001 ) relative to the baseline values in the groups receiving either 5 microg/day ( mean+/-SD ; 11.0+/-10.3 nmol/l , baseline 41.9+/-17.6 nmol/l ) or 10 microg/day ( 13.3+/-11.8 nmol/l , baseline 44.4+/-16.6 nmol/l ) vitamin D(3 ) for 12 months compared to placebo ( -3.1+/-9.8 nmol/l , baseline 43.4+/-17.1 nmol/l ) . There was no effect of vitamin D-supplementation on biomarkers for bone turnover or on whole body or spine bone mineral augmentation . However , vitamin D supplementation increased whole body bone mineral density ( BMD ) ( p=0.007 ) and bone mineral content ( BMC ) ( p=0.048 ) in the FF VDR genotype but not in the Ff or ff VDR genotypes . CONCLUSION Supplementation with vitamin D ( 5 or 10 microg/day ) over 12 months increased the S-25OHD concentration but there was no effect on indices of bone health in the entire group of girls . However , there was an effect on BMD for a subgroup with the FF VDR genotype indicating an influence of genotype Objective : To assess the vitamin D status of healthy young people living in Northern Irel and and the effect of vitamin D supplementation on vitamin D status and bone turnover . Design : Double-blinded r and omised controlled intervention study . Setting : University of Ulster , Coleraine , Northern Irel and .Subjects : In total , 30 apparently healthy students ( 15 male and 15 female subjects ) , aged 18–27 years , were recruited from the university , with 27 completing the intervention . Interventions : Subjects were r and omly assigned , to receive either 15 μg ( 600 IU ) vitamin D3 and 1500 mg calcium/day ( vitamin D group ) , or 1500 mg calcium/day ( control group ) for 8 weeks between January and March . Vitamin D status , bone turnover markers , serum calcium and parathyroid hormone concentrations were measured at baseline and post intervention . Results : At baseline , vitamin D status was low in both the vitamin D group ( 47.9 ( s.d . 16.0 ) ) and the control group ( 55.5 ( s.d . 18.6 ) nmol/l 25(OH)D ) . Post intervention vitamin D status was significantly higher in the vitamin D-treated group ( 86.5 ( s.d . 24.5 ) ) compared to the control group ( 48.3 ( s.d . 16.8 ) nmol/l ) ( P<0.0001 ) . There was no significant effect of supplementation on bone turnover markers or PTH concentrations . Conclusions : This study suggests that young adults in Northern Irel and do not consume an adequate daily dietary intake of vitamin D to maintain plasma vitamin D concentrations in the wintertime . A daily supplement of 15 μg vitamin D3 significantly increased vitamin D status in these individuals to levels of sufficiency . Achievement of an optimum vitamin D status among young adults may have future positive health implication The necessity and safety of an oral calcium ( Ca ) and vitamin D regimen was evaluated in a population of 66 independently living and 73 institutionalized elderly women over an 11-week winter period . The members of both groups were r and omly assigned into trial and control groups . Serum Ca , creatinine , and calcidiol levels were measured before and after the trial . The regimen consisted of 1.558 g of Ca and 45 micrograms ( equal to 1,800 IU ) of vitamin D administered daily in addition to the normal diet . The controls received no treatment . A majority of the elderly subjects living independently had ensured their Ca , and a quarter of them also their vitamin D intake on their own initiative . The mean serum calcidiol concentration before the trial was 24.1 nmol/L in the institutionalized and 38.5 nmol/L in the elderly subjects living independently ( P less than .001 ) . After the trial , OUTPUT:
Inclusion of 95 % range in the model to account for inter-individual variability increased the predicted intake of vitamin D needed to maintain serum 25(OH)D ≥ 50 nmol/l to 930 IU/d .
MS2_dynamic_1_shot492
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: Ten men and nine women ages 35 to 55 consumed two diets for 6 weeks each in a cross-over design . The diets were composed of identical natural foods and 30 % of the calories as either sucrose or wheat starch . Carbohydrate , fat , and protein supplied 43 , 42 , and 15 % of the calories , respectively . Of the calories 10 % was eaten at breakfast ( 7:00 to 8:30 AM ) and 90 % at dinner ( 4:30 to 6:30 PM ) . Inital body weights were essentially maintained . Fasting serum insulin and glucose levels were significantly higher with the sucrose than with the starch diet . The insulin response and the insulin : glucose ratios after a sucrose load ( 2 g/kg body weight ) were greater after the subjects consumed the sucrose diet . Sucrose feeding produced increases in fasting serum insulin , the insulin : glucose ratio and the insulin response to a sucrose load that were of greater magnitude in a subgroup of nine subjects classified as potentially carbohydrate-sensitive than in normal subjects . Glucose response to a sucrose load and fasting serum glucagon did not differ significantly with diet . Fasting insulin and glucose showed significant increases as a function of time on diet . These results indicate that sucrose feeding produces undersirable changes in several of the parameters associated with glucose tolerance To examine whether artificial sweeteners aid in the control of long-term food intake and body weight , we gave free-living , normal-weight subjects 1150 g soda sweetened with aspartame ( APM ) or high-fructose corn syrup ( HFCS ) per day . Relative to when no soda was given , drinking APM-sweetened soda for 3 wk significantly reduced calorie intake of both females ( n = 9 ) and males ( n = 21 ) and decreased the body weight of males but not of females . However , drinking HFCS-sweetened soda for 3 wk significantly increased the calorie intake and body weight of both sexes . Ingesting either type of soda reduced intake of sugar from the diet without affecting intake of other nutrients . Drinking large volumes of APM-sweetened soda , in contrast to drinking HFCS-sweetened soda , reduces sugar intake and thus may facilitate the control of calorie intake and body weight We have studied whether the sucrose-induced reduction of insulin sensitivity and cellular insulin binding in normal man is related to the fructose or the glucose moiety . Seven young healthy subjects were fed their usual diets plus 1000 kcal extra glucose per day and eight young healthy subjects were fed their usual diets with addition of 1000 kcal extra fructose per day . The dietary regimens continued for 1 week . Before change of diet there were no statistically significant differences between body weight and fasting plasma concentrations of glucose , insulin , and ketone bodies in the two groups studied . High-glucose feeding caused no significant changes in insulin binding or insulin sensitivity whereas high-fructose feeding was accompanied by a significant reduction both of insulin binding ( P less than 0.05 ) and insulin sensitivity ( P less than 0.05 ) . The changes in insulin binding and insulin sensitivity correlated linearly ( r = 0.52 , P less than 0.01 ) . We conclude that fructose seems to be responsible for the impaired insulin binding and insulin sensitivity induced by sucrose Ten men and nine women aged 35 to 55 consumed two diets for 6 weeks each in a cross-over design . The diets were composed of identical natural foods and 30 % of the calories as either sucrose or wheat starch . Carbohydrate , fat and protein supplied 43 , 42 , and 15 % of the calories , respectively . The dietary pattern consisted of two meals divided so as to provide 10 % of the calories at breakfast ( 7:00 to 8:30 AM ) and 90 % of the calories at dinner ( 4:30 to 6:30 PM ) . Initial body weights were essentially maintained . The gastric inhibitory polypeptide response after a sucrose load ( 2 g/kg body weight ) was significantly greater ( P < 0.01 ) after th subjects consumed the sucrose rather than the starch diet . The gastric inhibitory polypeptide response was significantly greater ( P < 0.01 ) after 6 weeks on diet than during pretest . These results suggest that the increases in insulin levels observed after sucrose feeding may be mediated by an effect on the enteric hormone gastric inhibitory polypeptide IMPORTANCE Increases in fructose consumption have paralleled the increasing prevalence of obesity , and high-fructose diets are thought to promote weight gain and insulin resistance . Fructose ingestion produces smaller increases in circulating satiety hormones compared with glucose ingestion , and central administration of fructose provokes feeding in rodents , whereas central ly administered glucose promotes satiety . OBJECTIVE To study neurophysiological factors that might underlie associations between fructose consumption and weight gain . DESIGN , SETTING , AND PARTICIPANTS Twenty healthy adult volunteers underwent 2 magnetic resonance imaging sessions at Yale University in conjunction with fructose or glucose drink ingestion in a blinded , r and om-order , crossover design . MAIN OUTCOME MEASURES Relative changes in hypothalamic regional cerebral blood flow ( CBF ) after glucose or fructose ingestion . Secondary outcomes included whole-brain analyses to explore regional CBF changes , functional connectivity analysis to investigate correlations between the hypothalamus and other brain region responses , and hormone responses to fructose and glucose ingestion . RESULTS There was a significantly greater reduction in hypothalamic CBF after glucose vs fructose ingestion ( OUTPUT: Buijsse B , Boeing H , Drogan D , et al. Consumption of fatty foods and incident type 2 diabetes in population s from eight European countries . Petersen KF , Laurent D , Yu C , Cline GW , Shulman GI . Hawkins M , Gabriely I , Wozniak R , Vilcu C , Shamoon H , Rossetti L. Fructose improves the ability of hyperglycemia per se to regulate glucose production in type 2 diabetes . Diabetes . Sievenpiper JL , Chiavaroli L , de Souza RJ , et al. ‘ Catalytic ’ doses of fructose may benefit glycaemic control without harming cardiometabolic risk factors : a small meta- analysis of r and omised controlled feeding trials . Egli L , Lecoultre V , Theytaz F , et al. Exercise prevents fructose-induced hypertriglyceridemia in healthy young subjects . INPUT: BACKGROUND Previous short-term studies ( < or = 6 h ) showed differences in energy expenditure ( EE ) and macronutrient oxidation in response to overfeeding with different types of dietary carbohydrate . This finding could have implication s for obesity . OBJECTIVE We used 96-h continuous whole-body calorimetry in 8 lean and 5 obese women to assess metabolic disposal ( energy dissipation and glycogen or fat storage ) of a controlled excess of dietary energy supplied as different carbohydrate sources or as fat . DESIGN Five dietary treatments were applied in r and om order : energy balance ( control ) and overfeeding by 50 % of energy requirements with fat ( O(fat ) ) or predominantly with glucose , fructose , or sucrose ( O(cho ) ) . Macronutrient oxidation rates were assessed from nonprotein gaseous exchanges . Net macronutrient balances were calculated as cumulative differences between intake and oxidation . RESULTS Increased EE in response to overfeeding dissipated 7.9 % of the energy excess with a variation in EE of < 1.7 % across overfeeding treatments ( NS ) . EE during the O(fat ) treatment significantly exceeded that during the control treatment in the lean but not in the obese women . There were no significant differences between lean and obese women in macronutrient oxidation or balances , so data were pooled . O(cho ) induced glycogen storage on day 1 ( approximately 100 g ) but thereafter progressively stimulated carbohydrate oxidation so that balance was reached on days 3 and 4 . Fat oxidation was proportionately suppressed . Of the excess carbohydrate , 74 % was oxidized ; there were no significant differences between the various O(cho ) treatments . O(fat ) stimulated fat oxidation by 18 % and suppressed carbohydrate oxidation . On average , 12 % of the excess energy was stored as glycogen and 88 % as fat ; there was no significant difference between overfeeding treatments . CONCLUSION There was no significant difference in fat balance during controlled overfeeding with fat , fructose , glucose , or sucrose We have studied whether the sucrose-induced reduction of insulin sensitivity and cellular insulin binding in normal man is related to the fructose or the glucose moiety . Seven young healthy subjects were fed their usual diets plus 1000 kcal extra glucose per day and eight young healthy subjects were fed their usual diets with addition of 1000 kcal extra fructose per day . The dietary regimens continued for 1 week . Before change of diet there were no statistically significant differences between body weight and fasting plasma concentrations of glucose , insulin , and ketone bodies in the two groups studied . High-glucose feeding caused no significant changes in insulin binding or insulin sensitivity whereas high-fructose feeding was accompanied by a significant reduction both of insulin binding ( P less than 0.05 ) and insulin sensitivity ( P less than 0.05 ) . The changes in insulin binding and insulin sensitivity correlated linearly ( r = 0.52 , P less than 0.01 ) . We conclude that fructose seems to be responsible for the impaired insulin binding and insulin sensitivity induced by sucrose BACKGROUND About 9 % of average dietary energy intake in the United States comes from fructose . Such a high consumption raises concern about the metabolic effects of this sugar . OBJECTIVE The objective of this study was to determine the effect of dietary fructose on plasma lipids . DESIGN The study was conducted in the General Clinical Research Center at Fairview-University of Minnesota Medical Center . The participants were 24 healthy adult volunteers ( 12 men and 12 women ; 6 of each sex were aged < 40 y and 6 of each sex were aged > /=40 y ) . All subjects received 2 isoenergetic study diets assigned by using a r and omized , balanced crossover design . One diet provided 17 % of energy as fructose . The other diet was sweetened with glucose and was nearly devoid of fructose . Each diet was fed for 6 wk . Both diets were composed of common foods and contained nearly identical amounts of carbohydrate , protein , fat , fiber , cholesterol , and saturated , monounsaturated , and polyunsaturated fatty acids . All meals were prepared in the metabolic kitchen of the General Clinical Research Center . RESULTS The responses to the study diets differed by sex . In men , the fructose diet produced significantly higher fasting , postpr and ial , and daylong plasma triacylglycerol concentrations than did the glucose diet . The daylong plasma triacylglycerol concentration after 6 wk of the fructose diet was 32 % greater in men than the corresponding concentration during the glucose diet ( P : < 0.001 ) . The fructose diet had no significant effect on fasting or postpr and ial plasma triacylglycerol concentrations in women . The fructose diet also had no persistent effect on fasting plasma cholesterol , HDL cholesterol , or LDL cholesterol in either men or women . CONCLUSIONS Dietary fructose was associated with increased fasting and postpr and ial plasma triacylglycerol concentrations in men . Diets high in added fructose may be undesirable , particularly for men . Glucose may be a suitable replacement sugar CONTEXT Sugar-sweetened beverages like soft drinks and fruit punches contain large amounts of readily absorbable sugars and may contribute to weight gain and an increased risk of type 2 diabetes , but these relationships have been minimally addressed in adults . OBJECTIVE To examine the association between consumption of sugar-sweetened beverages and weight change and risk of type 2 diabetes in women . DESIGN , SETTING , OUTPUT:
The weight-increasing effect of fructose in hypercaloric trials may have been attributable to excess energy rather than fructose itself . Fructose does not seem to cause weight gain when it is substituted for other carbohydrates in diets providing similar calories . Free fructose at high doses that provided excess calories modestly increased body weight , an effect that may be due to the extra calories rather than the fructose .
MS2_dynamic_1_shot493
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: BACKGROUND : This study was undertaken to test the hypothesis that early enteral nutrition might reduce the incidence of serious complications after major abdominal surgery . METHODS : In a r and omised double blind prospect i ve trial 30 patients received Nutri-drink and 30 patients received placebo through a nasoduodenal feeding tube . On the day of operation the patients were given median 600 ml of either nutrition or placebo , 60 ml per hour . On the first postoperative day the patients received either 1000 ml ( median ) of nutrition or placebo , on day 2 1200 ml ( median ) nutrition , 1400 ml placebo , on day 3 1000 ml ( median ) nutrition , 1150 ml placebo , and on day 4 1000 ml ( median ) nutrition , 800 ml placebo . All patients were followed up for 30 days by the same investigator . RESULTS : The two groups were similar with regard to nutritional status and type of operation . The rate of postoperative infectious complications was significantly lower in the nutrition group , two of 30 compared with 14 of 30 in the placebo group ( p = 0.0009 ) . CONCLUSION : Early enteral nutrition given to patients after major abdominal surgery results in an important reduction in infectious complications BACKGROUND & AIM The immunomodulating nutrition was supposed to reduce the incidence of complications in surgical patients , but many authors have question ed its value recently . The aim of the study was to assess the impact of enteral immunonutrition in postoperative period . METHODS Between January 2003 and December 2009 , 305 malnourished patients ( 123 F , 182 M , m. age 60.8 ) undergoing resection for pancreatic or gastric cancer , after preoperative 14 days of parenteral feeding , were r and omized in double-blind manner to receive either postoperative immunomodulating enteral diet ( IMEN ) or st and ard oligopeptide diet ( SEN ) . Outcome measures of the intend-to-treat analysis were : number and type of complications , length of hospitalization , mortality , and vital organ function . RESULTS Median postoperative hospital stay was 17.1 days in SEN and 13.1 days in IMEN group ( p = 0.006 ) . Infectious complications were observed in 60 patients ( 39.2 % ) in SEN and 43 ( 28.3 % ) in IMEN group ( p = 0.04 ) . Differences were also observed in overall morbidity ( 47.1 vs 33.5 % , p = 0.01 ) and mortality ( 5.9 vs 1.3 % , p = 0.03 ) , but the ratio of surgical complications , organ function , and treatment tolerance did not differ . CONCLUSIONS The study proved that postoperative immunomodulating enteral nutrition should be the treatment of choice in malnourished surgical cancer patients . The Clinical Trials Data base registry number : NCT00576940 Postoperative oral nutritional supplementation has been shown to be of clinical benefit . This study examined the clinical effects and cost of administration of oral supplements both before and after surgery Background / Aim Perioperative administration of immunoenriched diets attenuates the perioperative inflammatory response and reduces postoperative infection complications . However , many questions still remain unresolved in this area , such as the length of diet administration , diet composition , and the mechanisms involved . We performed an open , r and omized , triple-arm study comparing the effect of two perioperative feeding regimens with a postoperative one . Methods 46 c and i date s for major elective surgery for malignancy in the upper gastrointestinal tract were r and omized to drink preoperatively either 1 L of an immunoenriched formula ( Impact ) for 5 days ( IEF group ) or 1 L of Impact plus ( Impact enriched with glycine ) for 2 days ( IEF plus group ) . The same product as the patient received preoperatively was given to both groups for 7 days postoperatively . In the control group ( CON group ) , patients only received Impact for 7 days postoperatively ; there was no preoperative treatment . The main outcome measures were postoperative C-reactive protein ( CRP ) serum levels . Results In the two preoperatively supplemented groups ( treatment groups ) , perioperative endotoxin levels , CRP ( postoperative day 7 ) , and TNF-α ( postoperative days 1 and 3 ) levels were significantly lower compared to the CON group ( p < .01 ) . Furthermore , the length of postoperative IMU/ICU stay ( Impact 1.9 ± 1.3 days ; Impact plus 2.2 ± 1.1 days ; control group 5.9 ± 0.8 days ) and length of hospital stay ( Impact 19.7 ± 2.3 days ; Impact plus 20.1 ± 1.3 days ; control group 29.1 ± 3.6 days ) were both reduced in the treatment groups compared to the control group . Infectious complications ( Impact 2/14 ( 14 % ) ; Impact plus 5/17 ( 29 % ) ; control group 10/15 ( 67 % ) ) also showed a trend toward reduction in the treatment groups . Conclusions Perioperative administration of an immunoenriched diet significantly reduces systemic perioperative inflammation and postoperative complications in patients undergoing major abdominal cancer surgery , when compared with postoperative diet administration alone . A shortened preoperative feeding regimen of 2 days with Impact enriched with glycine ( Impact plus ) was as effective as Impact administered for 5 days preoperatively Castrostomy feeding OUTPUT: Some unwanted effects have also been reported with components of IE nutrition in critical care patients and it is unknown whether there would be detrimental effects by administering IE nutrition to patients who could require critical care support after their surgery . INPUT: CONTEXT Postoperative enteral nutrition is thought to reduce complications and speed recovery after pancreatic resection . There is little evidence on the best route for delivery of enteral nutrition . Currently we use percutaneous transperitoneal jejunostomy or percutaneous transperitoneal gastrojejunostomy , or the nasojejunal route to deliver enteral nutrition , according to surgeon preference . OBJECTIVE To compare morbidity , efficiency , and safety of these three routes for enteral nutrition following pancreaticoduodenectomy . PATIENTS Data were obtained from a prospect ively maintained data base , for all patients undergoing pancreatic resection between January 2007 and June 2008 . One-hundred pancreatic resected patients underwent enteral nutrition : 93 had Whipple 's operations and 7 had total pancreatectomies . INTERVENTION Enteral nutrition was delivered by agreed protocol , starting within 24 h of operation and increasing over 2 - 3 days to meet full nutritional requirement . RESULTS Delivery route of enteral nutrition was : percutaneous transperitoneal jejunostomy in 25 ( 25 % ) , percutaneous transperitoneal gastrojejunostomy in 32 ( 32 % ) and nasojejunal in 43 ( 43 % ) . The incidence of catheter-related complications was higher in percutaneous techniques : 24 % in percutaneous transperitoneal jejunostomy and 34 % in percutaneous transperitoneal gastrojejunostomy as compared to nasojejunal technique ( 12 % ) . Median time to complete establishment of oral intake was 14 , 14 and 10 days in percutaneous transperitoneal jejunostomy , percutaneous transperitoneal gastrojejunostomy , and nasojejunal groups , respectively . Nasojejunal tubes were removed at median 11 days ( mean 11.5 days ) compared to 5 - 6 weeks for percutaneous transperitoneal jejunostomy and percutaneous transperitoneal gastrojejunostomy . Commonest catheter-related complication in the percutaneous transperitoneal jejunostomy and percutaneous transperitoneal gastrojejunostomy was blockage ( n=6 ; 10.5 % ) , followed by pain after removal of feeding tube at 5 - 6 weeks ( n=5 ; 8.8 % ) , whereas in the nasojejunal group it was blockage ( n=3 ; 7.0 % ) , followed by displacement ( n=2 ; 4.7 % ) . Two patients died postoperatively in this cohort , however , there were no catheter-related mortalities . CONCLUSION Enteral nutrition following pancreatic resection can be delivered in different ways . Nasojejunal feeding was associated with fewest and less serious complications . On current evidence surgeon preference is a reasonable way to decide enteral nutrition but a r and omized controlled trial is needed to address this issue Background Poor nutrition in the first months after oesophago-gastric resection is a contributing factor to the reduced quality of life seen in these patients . The aim of this pilot and feasibility study was to ascertain the feasibility of conducting a multi-centre r and omised controlled trial to evaluate routine home enteral nutrition in these patients . Methods Patients undergoing oesophagectomy or total gastrectomy were r and omised to either six weeks of home feeding through a jejunostomy ( intervention ) , or treatment as usual ( control ) . Intervention comprised overnight feeding , providing 50 % of energy and protein requirements , in addition to usual oral intake . Primary outcome measures were recruitment and retention rates at six weeks and six months . Nutritional intake , nutritional parameters , quality of life and healthcare costs were also collected . Interviews were conducted with a sample of participants , to ascertain patient and carer experiences . Results Fifty-four of 112 ( 48 % ) eligible patients participated in the study over the 20 months . Study retention at six weeks was 41/54 patients ( 76 % ) and at six months was 36/54 ( 67 % ) . At six weeks , participants in the control group had lost on average 3.9 kg more than participants in the intervention group ( 95 % confidence interval [ CI ] 1.6 to 6.2 ) . These differences remained evident at three months ( mean difference 2.5 kg , 95 % CI −0.5 to 5.6 ) and at six months ( mean difference 2.5 kg , 95 % CI −1.2 to 6.1 ) . The mean values observed in the intervention group for mid arm circumference , mid arm muscle circumference , triceps skin fold thickness and right h and grip strength were greater than for the control group at all post hospital discharge time points . The economic evaluation suggested that it was feasible to collect re source use and EQ-5D data for a full cost-effectiveness analysis . Thematic analysis of 15 interviews identified three main themes related to the intervention and the trial : 1 ) a positive experience , 2 ) the reasons for taking part , and 3 ) uncertainty of the study process . Conclusions This study demonstrated that home enteral feeding by jejunostomy was feasible , safe and acceptable to patients and their carers . Whether home enteral feeding as ’ usual practice ’ is a cost-effective therapy would require confirmation in an appropriately powered , multi-centre study .Trial registration UK Clinical Research Network ID 12447 ( main trial , first registered 30 May 2012 ) ; UK Clinical Research Network ID 13361 ( qualitative sub study , first registered 30 May 2012 ) ; Clinical Trials.gov NCT01870817 ( first registered 28 May 2013 ABSTRACT Objective : To evaluate the change in respiratory function and functional capacity according to the type of preoperative fasting . Methods : R and omized prospect i ve clinical trial , with OUTPUT:
this guideline reflects the recommendations of the group of specialists of the Brazilian College of Surgeons , the Brazilian Society of Parenteral and Enteral Nutrition and the ACERTO Project for nutritional interventions in the perioperative period of Elective General Surgery . The prescription of these recommendations can accelerate the postoperative recovery of patients su bmi tted to elective general surgery , with decrease in morbidity , length of stay and rehospitalization , and consequently , of costs
MS2_dynamic_1_shot494
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: OBJECTIVE It has been proposed that 50%-75 % of the efficacy of antidepressant medication represents the placebo effect , since many depressed patients improve when treated with either medication or placebo . This study examined brain function in depressed subjects receiving either active medication or placebo and sought to determine whether quantitative electroencephalography ( QEEG ) could detect differences in brain function between medication and placebo responders . Both QEEG power and cordance , a new measure that reflects cerebral perfusion and is sensitive to the effect of antidepressant medication , were examined . METHOD Fifty-one subjects with major depression were enrolled in one of two independent , 9-week double-blind , placebo-controlled studies in which either fluoxetine ( N=24 ) or venlafaxine ( N=27 ) was the active medication . Serial QEEG recordings were performed during the course of treatment . After 9 weeks , the blind was broken and subjects were classified as medication responders , placebo responders , medication nonresponders , or placebo nonresponders . RESULTS No significant pretreatment differences in clinical or QEEG measures were found among the four outcome groups . Placebo responders , however , showed a significant increase in prefrontal cordance starting early in treatment that was not seen in medication responders ( who showed decreased cordance ) or in medication nonresponders or placebo nonresponders ( who showed no significant change ) . There was no significant change in QEEG power during treatment . CONCLUSIONS These findings suggest that " effective " placebo treatment induces changes in brain function that are distinct from those associated with antidepressant medication . If these results are confirmed , cordance may be useful for differentiating between medication and placebo responders Background The reasoning behind evaluating medical interventions is that a hierarchy of methods exists which successively produce improved and therefore more rigorous evidence based medicine upon which to make clinical decisions . At the foundation of this hierarchy are case studies , retrospective and prospect i ve case series , followed by cohort studies with historical and concomitant non-r and omized controls . Open-label r and omized controlled studies ( RCTs ) , and finally blinded , placebo-controlled RCTs , which offer most internal validity are considered the most reliable evidence . Rigorous RCTs remove bias . Evidence from RCTs forms the basis of meta-analyses and systematic review s. This hierarchy , founded on a pharmacological model of therapy , is generalized to other interventions which may be complex and non-pharmacological ( healing , acupuncture and surgery ) . Discussion The hierarchical model is valid for limited questions of efficacy , for instance for regulatory purpose s and newly devised products and pharmacological preparations . It is inadequate for the evaluation of complex interventions such as physiotherapy , surgery and complementary and alternative medicine ( CAM ) . This has to do with the essential tension between internal validity ( rigor and the removal of bias ) and external validity ( generalizability ) . Summary Instead of an Evidence Hierarchy , we propose a Circular Model . This would imply a multiplicity of methods , using different design s , counterbalancing their individual strengths and weaknesses to arrive at pragmatic but equally rigorous evidence which would provide significant assistance in clinical and health systems innovation . Such evidence would better inform national health care technology assessment agencies and promote evidence based health reform & NA ; Patient , provider , and clinical investigator expectations concerning treatments are believed to play important roles in patient response . This study examined the association of patient and research nurse/physician pretreatment expectations of pain relief with actual pain relief , the accuracy of patient and research nurse guesses about patient medication assignment , and changes in research nurse and patient pain relief expectations over the course of a r and omized double‐blind trial of amitriptyline versus an active placebo for patients with chronic pain and spinal cord injuries ( SCI ) . Patient expectations of pain relief with amitriptyline were associated significantly with actual pain decrease for patients in the amitriptyline , but not placebo , condition . Research nurse/physician expectations did not predict patient pain relief . Both patients and the research nurse were able to guess patient medication assignment at a rate significantly greater than chance . The research nurse 's , but not the patients ’ , expectations of pain relief with amitriptyline decreased significantly over the course of the study . These findings have implication s for future r and omized controlled trials . Fully double‐blind conditions are very difficult to achieve , and it is informative to assess patient and research clinician expectations and guesses regarding medication assignment Background Assumptions underlying placebo controlled trials include that the placebo effect impacts on all study arms equally , and that treatment effects are additional to the placebo effect . However , these assumptions have recently been challenged , and different mechanisms may potentially be operating in the placebo and treatment arms . The objective of the current study was to explore the nature of placebo versus pharmacological effects by comparing predictors of the placebo response with predictors of the treatment response in a r and omised , placebo-controlled trial of a phytotherapeutic combination for the treatment of menopausal symptoms . A substantial placebo response was observed but no significant difference in efficacy between the two arms . Methods A post hoc analysis was conducted on data from 93 participants who completed this previously published study . Variables at baseline were investigated as potential predictors of the response on any of the endpoints of flushing , overall menopausal symptoms and depression . Focused tests were conducted using hierarchical linear regression analyses . Based on these findings , analyses were conducted for both groups separately . These findings are discussed in relation to existing literature on placebo effects . Results Distinct differences in predictors were observed between the placebo and active groups . A significant difference was found for study entry anxiety , and Greene Climacteric Scale ( GCS ) scores , on all three endpoints . Attitude to menopause was found to differ significantly between the two groups for GCS scores . Examination of the individual arms found anxiety at study entry to predict placebo response on all three outcome measures individually . In contrast , low anxiety was significantly associated with improvement in the active treatment group . None of the variables found to predict the placebo response was relevant to the treatment arm . Conclusion This study was a post hoc analysis of predict OUTPUT: Although this study examined placebo effects and not the whole placebo response as in r and omised controlled trials , it does suggest that the additivity assumption may be incorrect , and that the estimated drug effects in r and omised controlled trials may be underestimated , particularly in studies reporting large placebo responses . INPUT: OBJECTIVE To investigate the role of frontal EEG as predictor of clinical response to SSRIs or venlafaxine in major depressive disorder ( MDD ) . METHOD 82 subjects ( age 35.9+/-13.0 ; 47.6 % female ) meeting DSM-IV criteria for MDD entered an 8-week prospect i ve treatment with SSRIs or venlafaxine . At baseline and week 1 we recorded serial , 4-channel EEGs ( F7-Fpz , F8-Fpz , A1-Fpz , A2-Fpz ) . We evaluated prospect ively the relative theta power as predictor of treatment outcome . We also developed an Antidepressant Treatment Response ( ATR ) index using EEG parameters assessed at baseline and week 1 . RESULTS 45 subjects ( 54.9 % ) responded to treatment ( HAM-D-17 reduction > or=50 % ) . At baseline , frontal relative theta power ( i.e. , 4 - 8 Hz power/2 - 20 Hz power ) was significantly ( p=0.017 ) lower ( 21 % ) in treatment responders than in non-responders ( 24 % ) . Baseline relative theta power predicted treatment response with 63 % accuracy [ 64 % sensitivity , 62 % specificity , 66 % area under the receiver operator curve ( AUROC ) ( p=0.014 ) ] . Relative theta power at week 1 predicted treatment response with 60 % accuracy [ 62 % sensitivity , 57 % specificity , 61 % AUROC ( p=0.089 ) ] . ATR predicted response with 70 % accuracy [ 82 % sensitivity , 54 % specificity , 72 % AUROC ( p=0.001 ) ] . CONCLUSION Using automated analysis of frontal EEG collected during the first week of antidepressant treatment it may be possible to facilitate prediction of SSRI or venlafaxine efficacy in MDD Background The present study examined absolute alpha power using quantitative electroencephalogram ( qEEG ) in bilateral temporal and parietal cortices in novice soldiers under the influence of methylpheni date ( MPH ) during the preparatory aim ing period in a practical pistol-shooting task . We anticipated higher bi-hemispheric cortical activation in the preparatory period relative to pre-shot baseline in the methylpheni date group when compared with the control group because methylpheni date has been shown to enhance task-related cognitive functions . Methods Twenty healthy , novice soldiers were equally distributed in control ( CG ; n = 10 ) and MPH groups 10 mg ( MG ; n = 10 ) using a r and omized , double blind design . Subjects performed a pistol-shooting task while electroencephalographic activity was acquired . Results We found main effects for group and practice blocks on behavioral measures , and interactions between group and phases on electroencephalographic measures for the electrodes T3 , T4 , P3 and P4 . Regarding the behavioral measures , the MPH group demonstrated significantly poorer in shooting performance when compared with the control and , in addition , significant increases in the scores over practice blocks were found on both groups . In addition , regarding the electroencephalographic data , we observed a significant increase in alpha power over practice blocks , but alpha power was significantly lower for the MPH group when compared with the placebo group . Moreover , we observed a significant decrease in alpha power in electrodes T4 and P4 during PTM . Conclusion Although we found no correlation between behavioral and EEG data , our findings show that MPH did not prevent the learning of the task in healthy subjects . However , during the practice blocks ( PBs ) it also did not favor the performance when compared with control group performance . It seems that the CNS effects of MPH dem and ed an initial readjustment period of integrated operations relative to the sensorimotor system . In other words , MPH seems to provoke a period of initial instability due to a possible modulation in neural activity , which can be explained by lower levels of alpha power ( i.e. , higher cortical activity ) . However , after the end of the PB1 a new stabilization was established in neural circuits , due to repetition of the task , result ing higher cortical activity during the task . In conclusion , MPH group performance was not initially superior to that of the control group , but eventually exceeded it , albeit without achieving statistical significance UNLABELLED Quantitative EEG ( QEEG ) effects of therapeutic doses of carbamazepine ( CBZ ) , oxcarbazepine ( OXC ) , valproate ( VA ) and lamotrigine ( LA ) monotherapy were investigated in patients with beginning epilepsy . Baseline waking EEG ( EEG1 ) was recorded in the untreated state , the second EEG ( EEG2 ) was done after 8 weeks of reaching the therapeutic dose . Left occipital data were used for analysis . QEEG target parameters were absolute b and -power ( delta : AD , theta : AT , alpha : AA , beta : AB ) , and alpha mean frequency ( AMF ) . Group effects ( untreated versus treated condition in the CBZ , VA , OXC , LA groups ) were computed for each target parameter . One group with benign rol and ic epilepsy remained untreated for clinical reasons and served to estimate the QEEG test-retest differences . In addition , the individual QEEG response to each drug was calculated as ( EEG2-EEG1 ) . RESULTS statistically significant ( p<0.05 ) group differences indicated the QEEG domain systematic ally affected by the drugs . CBZ caused AT increase and AMF decrease . OXC caused AMF decrease . VA and LA did not decrease AMF ( LA even increased it ) , but reduced broad-b and power . Individual power and AMF changes showed considerable variability in each group . > 0.5 Hz AMF decrease ( that was reported to predict cognitive impairment in prior studies ) occurred in 10/41 patients in the CBZ group but never in the OXC , VA , LA groups . The results may be utilized in planning further studies addressing the relationship between ant OUTPUT:
RESULTS Following an extensive review of selected studies from the 201 articles , the studies indicate that each of the psychotropic medications review ed impact alpha , beta , delta and theta waves independently and differently from each other . Additionally , certain medications , particularly haloperidol and valproic acid , have dissimilar results exemplified in all waveforms .
MS2_dynamic_1_shot495
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: Objective : To assess pain and swelling in the first 7 days after periapical surgery and their relationship with the agent used for bleeding control . Study Design : A prospect i ve study was conducted between October 2006 and March 2009 . Patients subjected to root surgery , who completed the question naire and who consented to the postoperative instructions were included in the study . The subjects were divided into two groups according to the hemostatic agent used : A ) gauze impregnated with anesthetic solution with vasoconstrictor ; or B ) aluminum chloride . The patients were administered a question naire , and were asked to record the severity of their pain and swelling on a plain horizontal visual analog scale ( VAS ) . Data were recorded by the patients on the first 7 postoperative days . In addition , the patients were asked to record analgesic consumption . Results : A total of 76 question naires ( 34 in group A and 42 in group B ) were taken to be correctly completed . Pain was reported to be most intense two hours after surgery . At this point 52.6 % of the patients had no pain . Seventy-five percent of the patients consumed analgesics in the first 24 hours . There were no significant differences between the two groups in terms of the intensity of pain or in the consumption of analgesics . Swelling reached its maximum peak on the second day ; at this point , 60.6 % of the patients suffered mild or moderate swelling . The Expasyl ™ group showed significantly greater swelling than the gauzes group . Conclusion : The type of hemostatic agent used did not influence either the degree of pain or the need for analgesia among the patients in this study . However , the patients belonging to the Expasyl ™ group suffered greater swelling than the patients treated with gauzes impregnated with anesthetic solution with vasoconstrictor . Key words : Hemostasis , periradicular surgery , aluminum chloride , pain , swelling This clinical study prospect ively evaluated the influence of various predictors on healing outcome 1 year after periapical surgery . The study cohort included 194 teeth in an equal number of patients . Three teeth were lost for the follow-up ( 1.5 % drop-out rate ) . Clinical and radiographic measures were used to determine the healing outcome . For statistical analysis , results were dichotomized ( healed versus nonhealed ) . The overall success rate was 83.8 % ( healed cases ) . The only individual predictors to prove significant for the outcome were pain at initial examination ( p=0.030 ) and other clinical signs or symptoms at initial examination ( p=0.042 ) , meaning that such teeth had lower healing rates 1 year after periapical surgery compared with teeth without such signs or symptoms . Logistic regression revealed that pain at initial examination ( odds ratio=2.59 , confidence interval=1.2 - 5.6 , p=0.04 ) was the only predictor reaching significance . Several predictors almost reached statistical significance : lesion size ( p=0.06 ) , retrofilling material ( p=0.06 ) , and postoperative healing course ( p=0.06 ) This prospect i ve clinical study aim ed to evaluate the benefits of the endoscope as an aid to root-end management , and to assess the treatment outcome during 2 years following surgery . Forty-three endodontic surgical procedures in 30 patients were performed with the aid of an endoscope and followed for a period of 2 years . Radiographic criteria and clinical evaluation were used to assess the outcome . All cases were evaluated in terms of healing and functionality . 91.1 % and 90.7 % of the teeth evaluated after 1 and 2 years , respectively , were classified as successful . We found no statistically significant differences for both healing and functionality between the 1- and 2-year evaluations . No difference related to tooth type or tooth location was found at the 2-year follow-up . Fisher 's exact test was used to statistically assess the difference between successful and unsuccessful cases for each of the variables considered . The endoscope can be an aid for endodontic surgical procedures in terms of both periapical healing and functionality up to 2 years follow-up INTRODUCTION Obtaining hemostasis in the surgical crypt during periradicular surgery is essential . It allows for improved visibility and contributes to a dry environment suitable for the placement of moisture-sensitive root-end filling material . Although current material s may not be moisture sensitive during setting , hemostasis is important for proper placement of root-end filling material s during apical surgery . A new hemostatic agent , HemCon dental dressing ( Patterson Dental , St Paul , MN ) , may improve upon the efficacy of wound healing and hemostasis both in extent and time . The aim of this study was to evaluate the hemostatic effect of HemCon in osseous wound sites and evaluate the wound healing potential and percentage of new bone formation in osseous crypts treated with HemCon . METHODS A split-mouth design was used with r and om allocation of sham and experimental sites in 12 rabbits . In experimental sites , either HemCon or 15.5 % ferric sulfate was applied to osseous crypts created with a round bur . Hemostatic efficacy was evaluated using predetermined scores . Rabbits were sacrificed at 21 days , and tissues were harvested and prepared for histologic evaluation . A blinded pathologist scored sample s relative to inflammation . The percentage of new bone deposition was calculated using NIS Elements software ( Nikon Instruments Inc , Melville , NY ) . RESULTS There was no statistical significant difference in hemostatic efficacy or wound healing between HemCon and ferric sulfate ( P > .05 ) . The HemCon group showed a significantly higher percentage of new bone deposition compared with the controls ( P < .01 ) . CONCLUSIONS HemCon shows promise as an adjunct to the endodontic surgical armamentarium We did apicectomies of 30 teeth with periradicular lesions in 23 patients , using a 3 mm endoscope . Two patients failed to attend for postoperative assessment and of the remaining 21 OUTPUT: When using aluminium chloride ( Expasyl ® ) , over 90 % of the apical lesions improved , but this agent seemed to increase swelling . Epinephrine with collagen did not significantly raise either blood pressure or heart rate . CONCLUSIONS Despite the use of several haemostatic material s in apical surgery , there is little evidence on their effectiveness and safety . The most effective haemostatic agents were calcium sulphate and epinephrine plus collagen . Epinephrine plus collagen did not seem to significantly raise blood pressure or heart rate during surgery . Aluminium chloride did not increase postoperative pain but could slightly increase postoperative swelling . INPUT: PURPOSE The effects of 2 chemical retraction agents on gingival blood flow and systemic blood pressure in subjects with healthy gingiva were investigated . MATERIAL S AND METHODS Thirty volunteer dental students were selected for the study and r and omly divided into 2 groups . Aluminium chloride-impregnated cord ( right side ) and nonimpregnated cord ( left side ) were placed in the gingival sulcus of group 1 . Epinephrine-impregnated cord ( right side ) and nonimpregnated cord ( left side ) were placed in group 2 . Blood flow in the retracted marginal gingiva was measured by laser Doppler flowmetry , and the systemic blood pressures of subjects were recorded before and after the retraction procedure . RESULTS A statistically significant decrease in blood flow was observed in group 2 , but there was no significant change in gingival blood flow in group 1 . A decrease in diastolic blood pressure of the subjects in group 2 was also observed . However , there was no significant change in blood pressure of the subjects in group 1 . CONCLUSION Gingival retraction affects gingival blood flow temporarily . Epinephrine-impregnated cords can be used safely in patients who have healthy gingiva , if patient stress and gingival trauma are avoided during cord placement Aim : The aim of this in vitro study was to evaluate the microleakage of two different generation bonding agents in the presence of various surface contaminants . Material s and Methods : Class V cavities were prepared on 150 extracted human permanent molars . The sample s were r and omly divided into two main groups of 75 teeth each . Group I : Fifth generation bonding system ( Single Bond , 3 M ) . Group II : Seventh generation bonding system ( iBond , Kulzer ) . Subgroups were formed according to exposure to different surface contaminants ( saliva , blood , caries disclosing agent and haemostatic agent ) . Cavities were restored with hybrid composite ( Z-100 , 3 M ) and evaluated for microleakage . The scores were subjected to ‘ t ’ test and analysis of variance ( ANOVA ) test . Results : Single Bond and iBond did not provide complete resistance to microleakage when there was no contamination . Microleakage was minimum in the no contamination subgroup and maximum with the haemostatic agent subgroup for both the groups . Conclusion : Single bond showed lesser micro leakage in contaminated conditions Objective : This in vitro study evaluated the effect of Ankaferd Blood Stopper ( ABS ) contamination on the microleakage of one-step and two-step self-etching adhesives . Study design : Class V cavities were prepared at the cemento-enamel junction on both buccal and lingual surfaces of 60 freshly extracted human molars . Teeth were r and omly assigned into three groups according to contamination material applied ( Group I , no contamination ; Group II , blood contamination ; Group III , ABS contamination ) . In contaminated groups , one drop of blood and ABS solution was applied directly to the dentin surface and air-dried . Each group was further divided into two subgroups according to bonding agent used [ Group A , Clearfil SE Bond ( two-step self-etching adhesive ) ; Group B , Adper Easy One ( one-step self-etching adhesive ) ] . Adhesive material s were applied according to the manufacturers ’ recommendations . The specimens were restored using a universal microhybrid composite ( Arabesk ) . After thermocycling ( 5000x , 5 ° C – 55 ° C ) and immersion in a 0.5 % basic fuchsin , dye penetration was evaluated under a stereomicroscope . Statistical analysis was performed with Kruskal-Wallis and Mann-Whitney U tests at p < 0.05 . Results : Significantly higher microleakage scores were observed when one-step self-etching adhesive was applied to blood- and ABS-contaminated dentin . However , when a two-step self etching adhesive was used , microleakage was observed only following blood contamination , not following ABS contamination . Conclusions : Although , blood contamination before adhesive application result ed in increased microleakage with both one-step and two-step self-etching adhesive systems , ABS contamination did not affect microleakage when a two-step self-ething adhesive system was used . Key words : Ankaferd Blood Stopper , blood , microleakage , self-etching adhesive Objectives : Since hemostatic agents can induce changes on enamel and dentin surfaces and influence composite resin adhesion , the aim of the present study was to evaluate the effect of the aluminum chloride hemostatic agent on the gingival margin microleakage of class V ( Cl V ) composite resin restorations bonded with all-in-one adhesive . Study design : Cl V cavities were prepared on the buccal surfaces of 60 sound bovine permanent incisors . Gingival margins of the cavities were placed 1.5 mm apical to the cemento-enamel junction ( CEJ ) . The teeth were r and omly divided into two groups of 30 . In group 1 , the cavities were restored without the application of a hemostatic agent ; in group 2 , the cavities were restored after the application of the hemostatic agent . In both groups all-in-one adhesive and Z250 composite resin were used to restore the cavities with the incremental technique . After finishing and polishing , the sample s underwent a thermocycling procedure , followed by immersion in 2 % basic fuschin solution for 24 hours . The sample s were sectioned and gingival microleakage was evaluated under a stereomicroscope . The non-parametric Mann-Whitney U test was used to compare microleakage between the two groups . Statistical significance was defined at P<0.05 . Results : A statistically significant difference was observed in microleakage between the two groups ( P<0.001 ) . Conclusions : Contamination of Cl V composite resin restorations bonded with all-in-one adhesive with aluminum chloride hemostatic agent significantly increases restoration OUTPUT:
Scanning electron microscopy revealed partial removal of the smear layer or an etching effect of dentin as a result of the application of hemostatic agents on dentin . PRACTICAL IMPLICATION S Adhesive procedures may be affected adversely when performed on dentin and enamel contaminated by hemostatic agents . Hemostatic agents may induce changes in the dentin surface morphology . The results of this review indicate that the bond strength of self-etching adhesive systems is affected more negatively than is that of etch- and -rinse systems .
MS2_dynamic_1_shot496
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: We studied the acute effects of 4 different chest physical therapy regimens using a r and omised cross-over design in 14 patients with cystic fibrosis . Treatment A consisted of postural drainage , percussion and vibration ; treatment B of postural drainage and periodic application of a face mask with positive expiratory pressure ( PEP ) ; treatment C of PEP in the sitting position ; treatment D of the forced expiration technique in the sitting position . In terms of sputum expectorated , treatments B and C were superior to treatment D and especially to treatment A ( p less than 0.05 ) . Skin oxygen tension , PSO2 was monitored continuously during and for 35 min after treatment . A substantial and prolonged decay in PSO2 was observed during treatment A , quite different from other patterns seen . During and even following treatment C , an increase in PSO2 was noted . PEP was well accepted by the patients , who preferred treatment C , and we suggest it is incorporated in chest physical therapy regimens if the therapeutic objective is to increase expectoration The use of a positive expiratory pressure ( PEP ) mask was compared with postural drainage in the treatment of 10 patients with cystic fibrosis . The patients were allocated r and omly in a crossover fashion to the two regimens and evaluated initially by a physiotherapist and over a 4 week treatment period by use of a diary card . There was no significant difference in sputum production or change in lung function between each technique as assessed by the physiotherapist . Diary card evaluation also failed to demonstrate a difference in sputum production , symptom score or peak expiratory flow rate between the 4 week treatment periods . It was concluded that PEP mask therapy is an acceptable and effective alternative to postural drainage in interval therapy of patients with cystic fibrosis , although the patients have tended to revert to postural drainage during acute exacerbations We studied the effectiveness of some of the components of a physiotherapy regimen on the removal of mucus from the lungs of 6 subjects with cystic fibrosis . On 5 r and omized study days , after inhalation of a 99mTc-human serum albumin aerosol to label primarily the large airways , the removal of lung radioactivity was measured during 40 min of ( a ) spontaneous cough while at rest ( control ) , ( b ) postural drainage , ( c ) postural drainage plus mechanical percussion , ( d ) combined maneuvers ( postural drainage , deep breathing with vibrations , and percussion ) administered by a physiotherapist , ( e ) directed vigorous cough . Measurements continued for an additional 2 h of quiet rest . Compared with the control day , all forms of intervention significantly improved the removal of mucus : cough ( p less than 0.005 ) , physiotherapy maneuvers ( 0.005 less than or equal to p less than 0.01 ) , postural drainage ( p less than 0.05 ) , and postural drainage plus percussion ( p less than 0.01 ) . However , there was no significant difference between regimented cough alone and therapist-administered combined maneuvers , nor between postural drainage alone and with mechanical percussion . We conclude that in cystic fibrosis , vigorous , regimented cough sessions may be as effective as therapist-administered physiotherapy in removing pulmonary secretions . Postural drainage , although better than the control maneuver , was not as effective as cough and was not enhanced by mechanical percussion . Frequent , vigorous self-directed cough sessions are potentially as useful as more complex measures for effective bronchial toilet Fourteen patients with cystic fibrosis were trained in 2 self-administered chest physiotherapy ( PT ) techniques : high-pressure PEP-mask physiotherapy ( PEP ) , and autogenic drainage ( AD ) . They then visited the clinic on 5 consecutive days , and , in a r and om order , performed 1 of the following : PEP , AD , PEP followed by AD ( PEP-AD ) , AD followed by PEP ( AD-PEP ) , and , no PT except for spontaneous coughing . Lung function was measured repeatedly before , during , and after PT ; time needed for and sputum produced by each form of PT was recorded . PEP produced the highest amount of sputum , followed by PEP-AD , AD-PEP , and AD ; all 4 forms of PT produced significantly more sputum than coughing . Lung function improved significantly after PEP , AD , and PEP-AD , but PEP-induced changes did not exceed those after AD . Within the investigated group , the PEP-induced lung function improvement per milliliter of sputum produced was significantly lower for those patients with airway hyperreactivity . The fact that the highest sputum yield with PEP was not reflected in higher PEP-effected lung function changes might thus be explained by PEP-induced bronchospasm in patients with airway hyperreactivity . PEP clears more sputum than AD or combined techniques ; patients with airway hyperreactivity , however , should either prefer AD or should take a bronchodilator premedication before PEP BACKGROUND Children 's physical activity patterns are characterized by short-term anaerobic activities . Anaerobic exercise performance in children with cystic fibrosis ( CF ) has received little attention compared to aerobic performance . This study investigated the effects of anaerobic training in children with CF . DESIGN AND METHODS Twenty patients were r and omly assigned to the training group ( TG ) [ 11 patients ; mean ( + /- SD ) age , 13.6 + /- 1.3 years ; mean FEV(1 ) , 75.2 + /- 20.7 % predicted ] or the control group ( CG ) [ 9 patients ; mean age , 14.2 + /- 2.1 years ; FEV(1 ) , 82.1 + /- 19.1 % predicted ] . The TG trained 2 days per week for 12 weeks , with each session lasting OUTPUT: RESULTS Review 1 provides some evidence from short-term trials of the benefit of airway clearance over no airway clearance in improved mucus transport but no definitive evidence from long-term trials to support the efficacy of airway clearance over no airway clearance ; review 2 provides some evidence that conventional chest physiotherapy ( CCPT ) is at least as effective as other forms of airway clearance , but that patients may have a preference for self-administered treatments over CCPT ; review 3 provides some evidence that positive expiratory pressure ( PEP ) is at least as effective as other forms of airway clearance ; review 4 provides some evidence to support the use of non-invasive ventilation during airway clearance in patients with moderate to severe disease who have difficulty clearing sputum ; review 5 provides some evidence of the benefits of different types of physical training . CONCLUSION The Cochrane systematic review s summarised in this paper provide some evidence to support the inclusion of physical therapies in the care-management plan of CF . INPUT: Abstract Background : Chest physiotherapy is a common practice after open reflux and obesity surgery . It is now possible to perform fundoplication and vertical b and ed gastroplasty ( VBG ) by the laparoscopic technique . The aim of this study was to evaluate in a prospect i ve , r and omized , controlled trial whether chest physiotherapy affects the postoperative course . Method : A series of 40 patients underwent laparoscopic fundoplication ; another 40 underwent laparoscopic VBG . Twenty patients in each series received prophylactic chest physiotherapy ; the other 20 served as control patients and were not given any information or training . Results : Postoperatively , all patients had a significant reduction in respiratory function , measured as oxygen saturation , forced vital capacity , and peak expiratory flow , but the differences between the groups within each series were not significant . Postoperatively , one patient in the VBG treatment group had hypoxemia ( SaO2 < 92 % ) versus two control patients . One control patient developed postoperative pneumonia . Conclusions : This study indicates that routine chest physiotherapy is not necessary in patients undergoing laparoscopic upper gastrointestinal surgery , such as fundoplication and VBG Forty-nine adults who had undergone cardiopulmonary bypass surgery were r and omly assigned to one of three exercise programs to determine if either maximal inspiratory breathing exercises or incentive spirometry offered a therapeutic advantage over early mobilization alone . After extubation , the patients started their assigned exercise programs . A physical examination and pulmonary function tests were performed preoperatively , at the start of the exercise program , and 24 and 48 hours after the start of the program . The results showed a significant decrease ( approximately 50 % ) in lung volumes but no airflow obstruction in patients who had coronary artery bypass graft . In those patients who had valve replacement , lung volumes fell , and in addition , mild airflow obstruction occurred . A majority of patients had postoperative pulmonary complications . There were no significant differences among the exercise programs in improving lung volumes and airflow or in preventing postoperative complications . We conclude that maximal inspiratory breathing exercises or incentive spirometry , when used in addition to early mobilization , offers no therapeutic advantage over early mobilization alone after cardiopulmonary bypass surgery Postoperative pulmonary complications , alveolar-arteriolar oxygen difference ( [A-a]O2-diff ) , peak expiratory flow ( PEF ) and forced vital capacity ( FVC ) were compared in patients using continuous positive airway pressure ( CPAP ) and positive expiratory pressure ( PEP ) administered by face mask against those of a control group using a deep-breathing device ( Triflo ) . Forty-three consecutive , r and omized patients undergoing elective upper abdominal surgery were included . CPAP , PEP and Triflo were administered for 30 consecutive breaths in every waking hour for three days postoperatively . The (A-a)O2-difference increased equally and significantly in the three groups after surgery , reaching a maximum on the first postoperative day . After this day , however , (A-a)O2-diff decreased in the CPAP and PEP groups , being significantly lower in the PEP group compared to the control group , two days postoperatively ( p less than 0.05 ) and significantly lower in both the PEP and CPAP groups three days postoperatively ( p less than 0.001 and p less than 0.05 , respectively . ) PEF did not differ significantly between the groups before or after surgery , while FVC was significantly higher in the PEP and CPAP groups , compared to control , on the third postoperative day ( p less than 0.05 ) . Atelectatic consolidation was observed in six of 15 patients in the control group three days postoperatively , the incidence being significantly lower in both the PEP group ( 0 of 15 , p less than 0.001 ) and the CPAP group ( one of 13 , p less than 0.05 ) . We concluded that periodic face mask administration of CPAP and PEP are superior to deep breathing exercises with respect to gas exchange , preservation of lung volumes and development of atelectasis after upper abdominal surgery . We also conclude that the simple and commercially available PEP mask is as effective as the more complicated CPAP system One hundred and ten men undergoing coronary artery bypass grafting took part in a prospect i ve r and omised study comparing three physiotherapy protocol s. All patients were taught self supported huffing and coughing by a physiotherapist and encouraged to move about . This comprised the sole treatment for the 37 control patients ( group 3 ) . Additional physiotherapy included breathing exercises for the 35 patients in group 1 and use of an incentive spirometer for the 38 patients in group 2 . Functional residual capacity ( FRC ) was measured daily at the bedside until the fifth postoperative day and arterial blood gas tensions were measured on the second and fourth postoperative days . After surgery patients developed a severe restrictive ventilatory defect and profound arterial hypoxaemia . There were no differences between the three groups . Mean FRC on day 2 was 1.90 litres ( 61 % of the preoperative value ) , increasing to 2.32 1 by day 5 ( 76 % of the preoperative value ) . The mean arterial oxygen tension was 7.37 kPa on day 2 and 8.58 kPa on day 4 . Four patients in group 1 , two in group 2 , and five in group 3 developed a chest infection . It is concluded that the addition of breathing exercises or incentive spirometry to a regimen of early mobilisation and huffing and coughing confers no extra benefit after uncomplicated coronary artery bypass grafting A national survey of hospitals was conducted to evaluate the usage of lung expansion maneuvers in the prevention and management of postoperative atelectasis associated with abdominal and thoracic surgery . Equal numbers of hospitals were r and omly selected OUTPUT:
Presently , the evidence does not support the use of IS for decreasing the incidence of PPCs following cardiac or upper abdominal surgery
MS2_dynamic_1_shot497
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: Background Laparoscopic sleeve gastrectomy ( LSG ) and laparoscopic Roux-en-Y gastric bypass ( LRYGB ) achieve similar type 2 diabetes mellitus ( T2DM ) remission rates . Since a great variability exists in defining T2DM remission , an expert panel proposed partial and complete remission criteria that include the maintenance of fasting plasma glucose ( FPG ) and glycosylated hemoglobin ( A1c ) objectives for at least 1 year . The 2-year T2DM remission rate and time needed to reach it after LSG or LRYGB were compared using different remission criteria . Methods This was a prospect i ve cohort study of 55 T2DM subjects operated on with LSG ( n = 21 ) or LRYGB ( n = 34 ) . Four models for defining remission were used : Buchwald criteria ( FPG < 100 mg/dl or A1c < 6 % ) , American Diabetes Association ( ADA ) complete ( FPG < 100 mg/dl plus A1c < 6 % maintained for at least 1 year ) , ADA partial ( FPG < 125 mg/dl with A1c < 6.5 % maintained for at least 1 year ) , and ADA complete without time requirement . Results Both groups were comparable , except for higher A1c levels in the LSG group . The remission rate ranged from 43.6 % using ADA complete remission to 92.7 % with Buchwald criteria , with no differences between surgical procedures . Differences were found in the time to achieve remission only when ADA complete remission criteria ( 5.1 ± 2.9 months LRYGB and 9.0 ± 3.8 months LSG , p = 0.014 ) and ADA without time requirement criteria ( 4.9 ± 2.7 months LRYGB and 8.4 ± 3.9 months LSG , p = 0.005 ) were used . Conclusions T2DM remission rate varies widely depending on the criteria used for its definition . Remission occurred sooner after LRYGB when the strictest criteria to define remission were used Objective : To present long-term results of a large series of patients su bmi tted to laparoscopic Roux-en-Y gastric bypass ( RYGBP ) for morbid obesity . Background : Reports on long-term results of RYGBP are scarce and focus primarily on weight loss . Our aim is to provide mid- to long-term data of RYGBP , with detailed results on weight loss , evolution of comorbidities and quality of life , also using the BAROS score . Methods : All patients who underwent a primary RYGBP for morbid obesity in our 2 hospitals between 1999 and August 2008 were included . Data were collected prospect ively in a computerized data base , and review ed for the purpose of this study . Results : A total of 379 patients were included in the analysis of long-term results , 282 women , and 97 men , with a mean BMI of 46.3 kg/m2 . After 5 years , 74.9 % of the patients achieved an excess weight loss of at least 50 % , with a mean of 62.7 % and 76.8 % achieved a BMI < 35 kg/m2 . The corresponding figures after 7 years were 64.9 , 58.1 , and 71.9 , respectively . There was a small but significant long-term weight regain . All comorbidities improved markedly in the vast majority of patients , with no significant difference between the 3- and 5-year terms . Quality of life also improved markedly , and more than 95 % of the patients had a good to excellent 5-year overall result according to the BAROS score . Conclusions : Laparoscopic RYGBP for morbid obesity results in good and maintained weight loss up to 7 years in the majority of patients , improves quality of life and markedly improves all the evaluated comorbidities , result ing in good to excellent overall 5-year results in 97 % of the patients according to the BAROS score BACKGROUND Obesity not only increases the chances of developing diabetes-one of the top causes of death in the United States-but it also results in further medical complications . OBJECTIVE To compare the 6-month and 1-year postoperative remission rates of type 2 diabetic ( T2D ) patients after bariatric surgery based on preoperative glycosylated hemoglobin ( A1C ) stratification and pharmacologic therapy : insulin-dependent diabetic ( IDD ) versus noninsulin-dependent diabetic ( NIDD ) . SETTING Academic hospital , United States . METHODS We retrospectively analyzed a prospect ively maintained data base of 186 obese patients with a diagnosis T2D who had undergone either a sleeve gastrectomy or a Roux-en-Y gastric bypass surgery at our hospital . RESULTS At 6 months ( n = 180 ) , patients who were stratified by preoperative A1C levels ( < 6.5 ; ≥6.5 to<8 ; ≥8 ) had 70.5 % , 51.7 % , and 30.0 % remission rates ( P<.001 ) and at 1 year ( n = 118 ) patients had 72.0 % , 54.0 % , and 42.8 % remission rates ( P = .053 ) , respectively . When patients were substratified by preoperative pharmacologic therapy , IDD and NIDD patients had different remission rates within the same A1C level . At 6-months follow-up within A1C ≥6.5 to<8 ( IDD versus NIDD ) , the remission rate was 23.5 % versus 64.1 % ( odds ratio [ OR ] : .173 , confidence interval [ CI ] : .0471 , .6308 , P = .0079 ) OUTPUT: After stratifying for different criteria for remission , RYGB still tended to result in higher remission rates , but the difference was not statistically significant . This review demonstrates important remission of T2DM following SG . Nevertheless , as remission was significantly more often observed following RYGB surgery , the latter procedure remains the gold st and ard for reaching T2DM remission in patients with concurrent obesity INPUT: OBJECTIVE To determine the within-trial cost-efficacy of surgical therapy relative to conventional therapy for achieving remission of recently diagnosed type 2 diabetes in class I and II obese patients . RESEARCH DESIGN AND METHODS Efficacy results were derived from a 2-year r and omized controlled trial . A health sector perspective was adopted , and within-trial intervention costs included gastric b and ing surgery , mitigation of complications , outpatient medical consultations , medical investigations , pathology , weight loss therapies , and medication . Re source use was measured based on data drawn from a trial data base and patient medical records and valued based on private hospital costs and government schedules in 2006 Australian dollars ( AUD ) . An incremental cost-effectiveness analysis was undertaken . RESULTS Mean 2-year intervention costs per patient were 13,400 AUD for surgical therapy and 3,400 AUD for conventional therapy , with laparoscopic adjustable gastric b and ( LAGB ) surgery accounting for 85 % of the difference . Outpatient medical consultation costs were three times higher for surgical patients , whereas medication costs were 1.5 times higher for conventional patients . The cost differences were primarily in the first 6 months of the trial . Relative to conventional therapy , the incremental cost-effectiveness ratio for surgical therapy was 16,600 AUD per case of diabetes remitted ( currency exchange : 1 AUD = 0.74 USD ) . CONCLUSIONS Surgical therapy appears to be a cost-effective option for managing type 2 diabetes in class I and II obese patients Laparoscopic adjustable gastric b and ing ( LAGB ) and vertical-b and ed gastroplasty ( VBG ) are surgical treatment modalities for morbid obesity . This prospect i ve study describes the long-term results of LAGB and VBG . One hundred patients were included in the study . Fifty patients underwent LAGB and 50 patients , open VBG . Study parameters were weight loss , changes in obesity-related comorbidities , long-term complications , re-operations including conversions to other bariatric procedures and laboratory parameters including vitamin status . From 91 patients ( 91 % ) , data were obtained with a mean follow-up duration of 84 months ( 7 years ) . Weight loss [ percent excess weight loss ( EWL ) ] was significantly more after VBG compared with LAGB , 66 % versus 54 % , respectively . All comorbidities significantly decreased in both groups . Long-term complications after VBG were mainly staple line disruption ( 54 % ) and incisional hernia ( 27 % ) . After LAGB , the most frequent complications were pouch dilatation ( 21 % ) and anterior slippage ( 17 % ) . Major re-operations after VBG were performed in 60 % of patients . All re-operations following were conversions to Roux-en-Y gastric bypass ( RYGB ) . In the LAGB group , 33 % of patients had a refixation or replacement of the b and , and 11 % underwent conversion to another bariatric procedure . There were no significant differences in weight loss between patients with or without re- interventions . No vitamin deficiencies were present after 7 years , although supplement usage was inconsistent . This long-term follow-up study confirms the high occurrence of late complications after restrictive bariatric surgery . The failure rate of 65 % after VBG is too high , and this procedure is not performed anymore in our institution . The re-operation rate after LAGB is decreasing as a result of new techniques and material s. Results of the re-operations are good with sustained weight loss and reduction in comorbidities . However , in order to achieve these results , a durable and complete follow-up after restrictive procedures is imperative BACKGROUND Duodenal switch provides greater weight loss than gastric bypass in severely obese patients ; however , comparative data on the changes in gastrointestinal symptoms , bowel function , eating behavior , dietary intake , and psychosocial functioning are limited . METHODS The setting for the present study was 2 university hospitals in Norway and Sweden . Participants with a body mass index of 50 - 60 kg/m(2 ) were r and omly assigned to gastric bypass ( n = 31 ) or duodenal switch ( n = 29 ) and followed up for 2 years . Of the 60 patients , 97 % completed the study . Their mean weight decreased by 31.2 % after gastric bypass and 44.8 % after duodenal switch . At inclusion and 1 and 2 years of follow-up , the participants completed the Gastrointestinal Symptom Rating Scale , a bowel function question naire , the Three-Factor Eating Question naire-R21 , a 4-day food record , and the Obesity-related Problems scale . RESULTS Compared with the gastric bypass group , the duodenal switch group reported more symptoms of diarrhea ( P = .0002 ) , a greater mean number of daytime defecations ( P = .007 ) , and more anal leakage of stool ( 50 % versus 18 % of participants , respectively ; P = .015 ) after 2 years . The scores for uncontrolled and emotional eating were significantly and similarly reduced after both operations . The mean total caloric intake and intake of fat and carbohydrates were significantly reduced in both groups . Protein intake was significantly reduced only after gastric bypass ( P = .008 , between-group comparison ) . Psychosocial function was significantly improved after both operations ( P = .23 , between the 2 groups ) . CONCLUSION Gastrointestinal side effects and anal leakage of stool were more pronounced after duodenal switch than after gastric bypass . Both procedures led to reduced uncontrolled and emotional eating , reduced caloric intake , and improved psychosocial functioning BACKGROUND There are few studies of long-term outcomes for either laparoscopic adjustable g OUTPUT:
Surgery results in greater improvement in weight loss outcomes and weight associated comorbidities compared with non-surgical interventions , regardless of the type of procedures used . When compared with each other , certain procedures result ed in greater weight loss and improvements in comorbidities than others . Outcomes were similar between RYGB and sleeve gastrectomy , and both of these procedures had better outcomes than adjustable gastric b and ing . For people with very high BMI , biliopancreatic diversion with duodenal switch result ed in greater weight loss than RYGB . Isolated sleeve gastrectomy led to better weight-loss outcomes than adjustable gastric b and ing after three years follow-up .
MS2_dynamic_1_shot498
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: AIMS To determine the effect of trophic feeding on clinical outcome in ill preterm infants . METHODS A r and omised , controlled , prospect i ve study of 100 preterm infants , weighing less than 1750 g at birth and requiring ventilatory support and parenteral nutrition , was performed . Group TF ( 48 infants ) received trophic feeding from day 3 ( 0.5–1 ml/h ) along with parenteral nutrition until ventilatory support finished . Group C ( 52 infants ) received parenteral nutrition alone . “ Nutritive ” milk feeding was then introduced to both groups . Clinical outcomes measured included total energy intake and growth over the first six postnatal weeks , sepsis incidence , liver function , milk tolerance , duration of respiratory support , duration of hospital stay and complication incidence . RESULTS Groups were well matched for birthweight , gestation and CRIB scores . Infants in group TF had significantly greater energy intake , mean difference 41.4 ( 95 % confidence interval 9 , 73.7 ) kcal/kg p=0.02 ; weight gain , 130 ( CI 1 , 250 ) g p = 0.02 ; head circumference gain , mean difference 0.7 ( CI 0.1 , 1.3 ) cm , p = 0.04 ; fewer episodes of culture confirmed sepsis , mean difference −0.7 ( −1.3 , −0.2 ) episodes , p = 0.04 ; less parenteral nutrition , mean difference −11.5 ( CI −20 , −3 ) days , p = 0.03 ; tolerated full milk feeds ( 165 ml/kg/day ) earlier , mean difference −11.2 ( CI −19 , −3 ) days , p = 0.03 ; reduced requirement for supplemental oxygen , mean difference −22.4 ( CI−41.5 , −3.3 ) days , p = 0.02 ; and were discharged home earlier , mean difference −22.1 ( CI −42.1 , −2.2 ) days , p = 0.04 . There was no significant difference in the relative risk of any complication . CONCLUSIONS Trophic feeding improves clinical outcome in ill preterm infants requiring parenteral nutrition . Key messages Timing of the introduction of milk feeds in sick low birthweight infants is controversial . Almost all infants with non-surgical illness can tolerate at least some milk as trophic feeds . Trophic feeding leads to improved energy intake , weight gain , milk tolerance , less sepsis and earlier hospital discharge . No increase in major complication rate is seen following trophic feeding A study was performed to determine if the addition of a fortifier to expressed breast milk ( EBM ) affected gastric emptying in low birthweight infants . Using ultrasonography , the gastric emptying of EBM alone was compared with that containing a fortifier , in a blind , crossover study . Twenty two low birthweight infants were studied : median ( range ) gestation 31.5 weeks ( 28 - 37 ) ; birthweight 1495 g ( 1000 - 2480 g ) . The gastric antral cross-sectional area ( ACSA ) was measured by ultrasonography before each feed and then sequentially after its completion until the ACSA returned to its pre-feed value . The half emptying time was calculated as the time taken for the ACSA to decrease to half the maximum increment . The mean difference ( st and ard error ) between half emptying times for EBM alone and for EBM with added fortifier was not significant : 1.48 ( 4.9 ) minutes . These data show that fortifying breast milk does not affect gastric emptying and suggests that the practice is unlikely to affect feed tolerance in low birthweight infants BACKGROUND Preterm children are at high risk of poor growth performance . In 2 r and omized trials , preterm infants fed preterm formula grew better in the neonatal period than those fed banked donor breast milk or st and ard term formula . OBJECTIVE Our objective was to test the hypothesis that for preterm infants , the neonatal period is a critical one for programming growth performance and that early diet influences long-term growth . DESIGN A total of 926 preterm infants were recruited into 2 parallel , r and omized trials of neonatal diet . In trial 1 , infants were fed either banked donor breast milk or preterm formula whereas in trial 2 , infants were fed either st and ard term formula or preterm formula . Within each trial , the allocated milk was the sole diet for some infants ( study A ) , whereas for others it was a supplement to maternal breast milk , given when not enough expressed breast milk was available ( study B ) . We followed up 781 of 833 survivors ( 94 % ) to age 7.5 - 8 y. Trained assessors obtained anthropometric measurements according to a st and ard protocol . RESULTS Despite significantly better neonatal growth performance in infants fed preterm formula ( compared with either banked donor breast milk or st and ard formula ) , early diet had no influence on weight , height , head circumference , or skinfold thicknesses at 9 or 18 mo postterm or at age 7.5 - 8 y. CONCLUSIONS These findings suggest that the preterm period is not a critical window for nutritional programming of growth , which contrasts with evidence from these trials showing that early diet influences later neurodevelopment Despite potential benefits , human milk may fail to meet preterm infants ' nutrient requirements . We tested the hypothesis that fortified breast milk , fed alone or with preterm formula , would improve neurodevelopment and growth at 18-mo follow-up without adverse short-term clinical or biochemical consequences . Two hundred seventy-five preterm infants from two medical centers ( birth weight < 1850 g ; mean gestation 29.8 + /- 2.7 wk ) whose mothers chose to provide breast milk were r and omly assigned to receive for a mean of 39 d a multinutrient fort OUTPUT: On the other h and , enteral feeding ( with milk , not water2 ) in the first five days of life promotes endocrine adaptation and the maturation of motility patterns,3 provides luminal nutrient , and probably benefits immune function.4Potential clinical benefits are therefore earlier tolerance of enteral feeds , reduced risk of infection , and earlier discharge . A systematic review of studies published to 1997 concluded that it reduced INPUT: OBJECTIVE To compare the duration of parenteral nutrition , growth , and morbidity in extremely premature infants fed exclusive diets of either bovine milk-based preterm formula ( BOV ) or donor human milk and human milk-based human milk fortifier ( HUM ) , in a r and omized trial of formula vs human milk . STUDY DESIGN Multicenter r and omized controlled trial . The authors studied extremely preterm infants whose mothers did not provide their milk . Infants were fed either BOV or an exclusive human milk diet of pasteurized donor human milk and HUM . The major outcome was duration of parenteral nutrition . Secondary outcomes were growth , respiratory support , and necrotizing enterocolitis ( NEC ) . RESULTS Birth weight ( 983 vs 996 g ) and gestational age ( 27.5 vs 27.7 wk ) , in BOV and HUM , respectively , were similar . There was a significant difference in median parenteral nutrition days : 36 vs 27 , in BOV vs HUM , respectively ( P = .04 ) . The incidence of NEC in BOV was 21 % ( 5 cases ) vs 3 % in HUM ( 1 case ) , P = .08 ; surgical NEC was significantly higher in BOV ( 4 cases ) than HUM ( 0 cases ) , P = .04 . CONCLUSIONS In extremely preterm infants given exclusive diets of preterm formula vs human milk , there was a significantly greater duration of parenteral nutrition and higher rate of surgical NEC in infants receiving preterm formula . This trial supports the use of an exclusive human milk diet to nourish extremely preterm infants in the neonatal intensive care unit OBJECTIVES Human milk ( HM ) feeding is associated with lower incidence and severity of costly prematurity-specific morbidities compared to formula feeding in very low birth weight ( VLBW ; < 1,500 g ) infants . However , the costs of providing HM are not routinely reimbursed by payers and can be a significant barrier for mothers . This study determined the initial maternal cost of providing 100 mL of HM for VLBW infants during the early neonatal intensive care unit ( NICU ) stay . METHODS This secondary analysis examined data from 111 mothers who provided HM for their VLBW infants during the early NICU stay . These data were collected during a multisite , r and omized clinical trial where milk output and time spent pumping were recorded for every pumping session ( n = 13,273 ) . The cost analysis examined the cost of the breast pump rental , pump kit , and maternal opportunity cost ( an estimate of the cost of maternal time ) . RESULTS Mean daily milk output and time spent pumping were 558.2 mL ( SD = 320.7 ; range = 0 - 2,024 ) and 98.7 minutes ( SD = 38.6 ; range = 0 - 295 ) , respectively . The mean cost of providing 100 mL of HM varied from $ 2.60 to $ 6.18 when maternal opportunity cost was included and from $ 0.95 to $ 1.55 when it was excluded . The cost per 100 mL of HM declined with every additional day of pumping and was most sensitive to the costs of the breast pump rental and pump kit . CONCLUSIONS These findings indicate that HM is reasonably inexpensive to provide and that the maternal cost of providing milk is mitigated by increasing milk output over the early NICU stay OBJECTIVE This study evaluated the cost-effectiveness of a 100 % human milk-based diet composed of mother 's milk fortified with a donor human milk-based human milk fortifier ( HMF ) versus mother 's milk fortified with bovine milk-based HMF to initiate enteral nutrition among extremely premature infants in the neonatal intensive care unit ( NICU ) . METHODS A net expected costs calculator was developed to compare the total NICU costs among extremely premature infants who were fed either a bovine milk-based HMF-fortified diet or a 100 % human milk-based diet , based on the previously observed risks of overall necrotizing enterocolitis ( NEC ) and surgical NEC in a r and omized controlled study that compared outcomes of these two feeding strategies among 207 very low birth weight infants . The average NICU costs for an extremely premature infant without NEC and the incremental costs due to medical and surgical NEC were derived from a separate analysis of hospital discharges in the state of California in 2007 . The sensitivity of cost-effectiveness results to the risks and costs of NEC and to prices of milk supplements was studied . RESULTS The adjusted incremental costs of medical NEC and surgical NEC over and above the average costs incurred for extremely premature infants without NEC , in 2011 US$ , were $ 74,004 ( 95 % confidence interval , $ 47,051-$100,957 ) and $ 198,040 ( 95 % confidence interval , $ 159,261-$236,819 ) per infant , respectively . Extremely premature infants fed with 100 % human-milk based products had lower expected NICU length of stay and total expected costs of hospitalization , result ing in net direct savings of 3.9 NICU days and $ 8,167.17 ( 95 % confidence interval , $ 4,405-$11,930 ) per extremely premature infant ( p < 0.0001 ) . Costs savings from the donor HMF strategy were sensitive to price and quantity of donor HMF , percentage reduction in risk of overall NEC and surgical NEC achieved , and incremental costs of surgical NEC . CONCLUSIONS Compared with feeding extremely premature infants with mother 's milk fortified with bovine milk-based supplement OUTPUT:
It is likely that donor milk provides short-term cost savings by reducing the incidence of NEC .
MS2_dynamic_1_shot499
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: BACKGROUND Antioxidant defenses are one possible mechanism for decreasing oxidative damage and its potentially negative effects on age-related bone mass . OBJECTIVE This study cross-sectionally examined whether higher dietary intakes , total intakes , and serum concentrations of antioxidants may be associated with higher bone mineral density ( BMD ) . DESIGN Total hip ( and subregions ) , spine , and total-body BMDs were measured in 11,068 women aged 50 - 79 y enrolled in the Women 's Health Initiative Observational Study and Clinical Trial at 3 clinics . Antioxidant intakes from diet ( vitamin A , retinol , beta-carotene , vitamin C , vitamin E , and selenium ) were estimated by using a self-reported food-frequency question naire . Antioxidants from supplements were estimated with an interviewer-administered question naire . A r and om subset ( n = 379 ) had serum concentrations of retinol , carotenoids , and tocopherols measured . RESULTS After adjustment for important BMD-related covariates , increasing intakes of antioxidants were not independently associated with BMD . A significant interaction effect was observed between intake of total vitamin C ( lower three-fourths compared with highest one-fourth ) and use of hormone therapy ( HT ) ( P < 0.01 ) . The beneficial effect of current HT use on femoral neck BMD appeared to be greater in women with higher concentrations of total vitamin C. This interaction was also significant for total-body ( P < 0.045 ) , spine ( P = 0.03 ) , and total-hip BMDs ( P = 0.029 ) . CONCLUSIONS Our results do not support independent associations between dietary intake , total intake , or serum concentrations of antioxidants and BMD in women participating in the Women 's Health Initiative . The extent to which HT use may interact with vitamin C intake and BMD warrants further exploration BACKGROUND Cases of enhanced anticoagulant effect in response to high-dose vitamin E supplementation have been reported among patients taking oral anticoagulants . Although a vitamin E-vitamin K interaction was proposed to underlie this effect , it has not been systematic ally investigated in adults with normal baseline coagulation status . OBJECTIVE The objective was to study the effect of 12 wk of supplementation with 1000 IU RRR-alpha-tocopherol/d on biochemical measures of vitamin K status in men and women not taking oral anticoagulants . DESIGN Vitamin K status , which was assessed with the use of plasma phylloquinone concentrations , the degree of under-gamma-carboxylation of prothrombin ( proteins induced by vitamin K absence-factor II , PIVKA-II ) , and the percentage of undercarboxylated osteocalcin ( ucOC ) , was determined in 38 men and women with rheumatoid arthritis ( study A ) and in 32 healthy men ( study B ) participating in 2 independent , 12-wk r and omized clinical trials of vitamin E supplementation ( 1000 IU/d ) . RESULTS Mean ( + /- SD ) PIVKA-II increased from 1.7 + /- 1.7 to 11.9 + /- 16.1 ng/mL ( P < 0.001 ) in study A and from 1.8 + /- 0.6 to 5.3 + /- 3.9 ng/mL ( P < 0.001 ) in study B in response to 12 wk of vitamin E supplementation . An increase in PIVKA-II is indicative of poor vitamin K status . In contrast , the other measures of vitamin K status ( ie , plasma phylloquinone concentration and percentage of ucOC ) did not change significantly in response to the supplementation . CONCLUSIONS High-dose vitamin E supplementation increased PIVKA-II in adults not receiving oral anticoagulant therapy . The clinical significance of these changes warrants further investigation , but high doses of vitamin E may antagonize vitamin K. Whether such an interaction is potentially beneficial or harmful remains to be determined Postmenopausal osteoporotic bone loss occurs mainly due to cessation of ovarian function , a condition associated with increased free radicals . Vitamin E , a lipid-soluble vitamin , is a potent antioxidant which can scavenge free radicals in the body . In this study , we investigated the effects of alpha-tocopherol and pure tocotrienol on bone microarchitecture and cellular parameters in ovariectomized rats . Three-month-old female Wistar rats were r and omly divided into ovariectomized control , sham-operated , and ovariectomized rats treated with either alpha-tocopherol or tocotrienol . Their femurs were taken at the end of the four-week study period for bone histomorphometric analysis . Ovariectomy causes bone loss in the control group as shown by reduction in both trabecular volume ( BV/TV ) and trabecular number ( Tb . N ) and an increase in trabecular separation ( Tb . S ) . The increase in osteoclast surface ( Oc . S ) and osteoblast surface ( Ob . S ) in ovariectomy indicates an increase in bone turnover rate . Treatment with either alpha-tocopherol or tocotrienol prevents the reduction in BV/TV and Tb . N as well as the increase in Tb . S , while reducing the Oc . S and increasing the Ob . S. In conclusion , the two forms of vitamin E were able to prevent bone loss due to ovariectomy . Both tocotrienol and alpha-tocopherol exert similar effects in preserving bone microarchitecture in estrogen-deficient rat model Vitamin E absorption requires the presence of fat ; however , limited information exists on the influence OUTPUT: Our review found that αTF exerted beneficial , harmful or null effects on bone formation cells . Animal studies generally showed positive effects of αTF supplementation on bone in various models of osteoporosis . However , high-dose αTF was possibly detrimental to bone in normal animals . Three possible reasons high dosage of αTF can be detrimental to bone include its interference with Vitamin K function on bone , the blocking of the entry of other Vitamin E isomers beneficial to bone , and the role of αTF as a prooxidant . However , these adverse effects have not been shown in human studies . In conclusion , αTF may have a dual role in bone health , whereby in the appropriate doses it is beneficial but in high doses it may be harmful to bone INPUT: BACKGROUND Vitamin K modulates cytokines involved in bone turnover , including interleukin-6 ( IL-6 ) and osteoprotegerin in vitro . OBJECTIVE The objective of this study was to assess 1 ) associations between measures of vitamin K status [ plasma phylloquinone and serum percentage of undercarboxylated osteocalcin ( % ucOC ) ] and IL-6 , osteoprotegerin , and C-reactive protein ( CRP ) concentrations and 2 ) the effect of daily 500 mug phylloquinone supplementation for 3 y on cytokine concentrations . DESIGN Concentrations of IL-6 , osteoprotegerin , and CRP and bone mineral density ( BMD ) were measured at baseline and after 3 y of follow-up in 379 healthy men and women ( 60 - 81 y ; 58.5 % women ) participating in a r and omized trial that studied the effect of vitamin K supplementation on bone loss . RESULTS Cross-sectionally , plasma phylloquinone was inversely associated with IL-6 and CRP , whereas serum % ucOC was inversely associated with IL-6 . Osteoprotegerin was associated positively with plasma phylloquinone and inversely with % ucOC . No differences were observed in the 3-y change in IL-6 , osteoprotegerin , and CRP concentrations between participants who received phylloquinone supplementation and those who did not . Overall , no association was observed between the 3-y changes in circulating cytokines and BMD . CONCLUSIONS Poor vitamin K status was associated with high concentrations of cytokines involved in bone turnover , but vitamin K supplementation did not confer a decrease in cytokine concentrations . The healthy status of this cohort may explain a lack of effect of vitamin K supplementation on cytokine concentrations . This trial was registered with www . clinical trials.gov as NCT00183001 OBJECTIVE Compelling biological pathways suggest that selenium ( Se ) may lower onset of type 2 diabetes mellitus ( T2DM ) , but very few studies have evaluated this relationship , with mixed results . We examined the association between toenail Se and incidence of T2DM . RESEARCH DESIGN AND METHODS We performed prospect i ve analyses in two separate U.S. cohorts , including 3,630 women and 3,535 men , who were free of prevalent T2DM and heart disease at baseline in 1982–1983 and 1986–1987 , respectively . Toenail Se concentration was quantified using neutron activation analysis , and diabetes cases were identified by biennial question naires and confirmed by a detailed supplementary question naire . Hazard ratios of incident T2DM according to Se levels were calculated using Cox proportional hazards . RESULTS During 142,550 person-years of follow-up through 2008 , 780 cases of incident T2DM occurred . After multivariable adjustment , the risk of T2DM was lower across increasing quintiles of Se , with pooled relative risks across the two cohorts of 1.0 ( reference ) , 0.91 ( 95 % CI 0.73–1.14 ) , 0.78 ( 0.62–0.99 ) , 0.72 ( 0.57–0.91 ) , and 0.76 ( 0.60–0.97 ) , respectively ( P for trend = 0.01 ) . Results were similar excluding the few individuals ( 4 % ) who used Se supplements . In semiparametric analyses , the inverse relationship between Se levels and T2DM risk appeared to be linear . CONCLUSIONS At dietary levels of intake , individuals with higher toenail Se levels are at lower risk for T2DM . Further research is required to determine whether varying results in this study versus prior trials relate to differences in dose , source , statistical power , residual confounding factors , or underlying population risk OBJECTIVE —Vitamin K has a potentially beneficial role in insulin resistance , but evidence is limited in humans . We tested the hypothesis that vitamin K supplementation for 36 months will improve insulin resistance in older men and women . RESEARCH DESIGN AND METHODS —This was an ancillary study of a 36-month , r and omized , double-blind , controlled trial design ed to assess the impact of supplementation with 500 μg/day phylloquinone on bone loss . Study participants were older nondiabetic men and women ( n = 355 ; aged 60–80 years ; 60 % women ) . The primary outcome of this study was insulin resistance as measured by homeostasis model assessment ( HOMA-IR ) at 36 months . Fasting plasma insulin and glucose were examined as the secondary outcomes . RESULTS —The effect of 36-month vitamin K supplementation on HOMA-IR differed by sex ( sex × treatment interaction P = 0.02 ) . HOMA-IR was statistically significantly lower at the 36-month visit among men in the supplement group versus the men in the control group ( P = 0.01 ) after adjustment for baseline HOMA-IR , BMI , and body weight change . There were no statistically significant differences in outcome measures between intervention groups in women . CONCLUSIONS —Vitamin K supplementation for 36 months at doses attainable in the diet may reduce progression of insulin resistance in older men Consumption of sugar-sweetened beverages has been shown , largely in American population s , to increase type 2 diabetes incidence . We aim ed to evaluate the association of consumption of sweet beverages ( juices and nectars , sugar-sweetened soft drinks and artificially sweetened soft drinks ) with type 2 diabetes incidence in European adults . We established a case – cohort study including 12,403 incident type 2 diabetes cases and a stratified sub OUTPUT:
Sensitivity analysis showed that overall estimates were not affected by elimination of any study . We did not observe any evidence regarding publication bias . In conclusion , vitamin K supplementation had no significant effect on glycemic control in healthy subjects .