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We identified three primary mechanisms of spillovers : reduced disease transmission , social proximity and substitution of re sources within households . We found the strongest evidence for spillovers through reduced disease transmission , particularly vaccines and mass drug administration . In general , the proportion of a population receiving an intervention was associated with improved health . We found evidence of publication bias for certain spillover estimates but not for total or direct effects . Conclusions We found the strongest evidence for spillovers from vaccines and mass drug administration to control infectious disease . There was little high quality evidence of spillovers for other interventions

Background Many interventions delivered to improve health may benefit not only direct recipients but also people in close physical or social proximity . Our objective was to review all published literature about the spillover effects of interventions on health outcomes in low-middle income countries and to identify methods used in estimating these effects .

The Minicommunity Design to Assess Indirect Effects of Vaccination

Abstract We propose the minicommunity design to estimate indirect effects of vaccination . Establishing indirect effects of vaccination in unvaccinated sub population s could have important implication s for global vaccine policies . In the minicommunity design , the household or other small transmission unit serves as the cluster in which to estimate indirect effects of vaccination , similar to studies in larger communities to estimate indirect , total , and overall effects . Examples from the literature include studies in small transmission units to estimate indirect effects of pertussis , pneumococcal , influenza , and cholera vaccines . We characterize the minicommunity design by several method ologic considerations , including the assignment mechanism , ascertainment , the role of transmission outside the transmission unit , and the relation of the size of the transmission unit to number of people vaccinated . The minicommunity study for indirect effects is contrasted with studies to estimate vaccine effects on infectiousness and protective effects under conditions of household exposure within small transmission units . The minicommunity design can be easily implemented in individually r and omized studies by enrolling and following-up members of households of the r and omized individuals . The methodology for the minicommunity design for estimating indirect effects of vaccination deserves much future research

We identified three primary mechanisms of spillovers : reduced disease transmission , social proximity and substitution of re sources within households . We found the strongest evidence for spillovers through reduced disease transmission , particularly vaccines and mass drug administration . In general , the proportion of a population receiving an intervention was associated with improved health . We found evidence of publication bias for certain spillover estimates but not for total or direct effects . Conclusions We found the strongest evidence for spillovers from vaccines and mass drug administration to control infectious disease . There was little high quality evidence of spillovers for other interventions

Background Many interventions delivered to improve health may benefit not only direct recipients but also people in close physical or social proximity . Our objective was to review all published literature about the spillover effects of interventions on health outcomes in low-middle income countries and to identify methods used in estimating these effects .

We identified three primary mechanisms of spillovers : reduced disease transmission , social proximity and substitution of re sources within households . We found the strongest evidence for spillovers through reduced disease transmission , particularly vaccines and mass drug administration . In general , the proportion of a population receiving an intervention was associated with improved health . We found evidence of publication bias for certain spillover estimates but not for total or direct effects . Conclusions We found the strongest evidence for spillovers from vaccines and mass drug administration to control infectious disease . There was little high quality evidence of spillovers for other interventions

Background Many interventions delivered to improve health may benefit not only direct recipients but also people in close physical or social proximity . Our objective was to review all published literature about the spillover effects of interventions on health outcomes in low-middle income countries and to identify methods used in estimating these effects .

Indirect Effect of 7-Valent Pneumococcal Conjugate Vaccine on Pneumococcal Carriage in Newborns in Rural Gambia: A Randomised Controlled Trial

Background Gambian infants frequently acquire Streptococcus pneumoniae soon after birth . We investigated the indirect effect of 7-valent pneumococcal conjugate vaccine ( PCV-7 ) on pneumococcal acquisition in newborn Gambian babies . Methods Twenty-one villages were r and omised to receive PCV-7 to all subjects ( 11 vaccinated villages ) or to infants aged 2–30 months ( 10 control villages ) . Other control villagers received Meningococcal C conjugate vaccine . From 328 babies born during the trial , nasopharyngeal swabs were collected after birth , then weekly until 8 weeks of age when they received their first dose of PCV-7 . Pneumococcal carriage and acquisition rates were compared between the study arms and with a baseline study . Results 57.4 % of 2245 swabs were positive for S. pneumoniae . Overall carriage was similar in both arms . In vaccinated villages fewer infants carried pneumococci of vaccine serotypes ( VT ) ( 16.9 % [ 31/184 ] vs. 37.5 % [ 54/144 ] , p<0.001 ) and more carried pneumococci of non-vaccine serotypes ( NVT ) ( 80.9 % [ 149/184 ] vs. 75.7 % [ 109/144 ] , p = 0.246 ) . Infants from vaccinated villages had a significantly lower acquisition rate of VT ( HR 0.39 [ 0.26–0.58 ] , p<0.001 ) and increased acquisition of NVT ( HR 1.16 [ 0.87–1.56 ] , p = 0.312 ) . VT carriage ( 51.6 % vs. 37.5 % , p = 031 in control and 46.1 % vs. 16.8 % , p<0.001 in vaccinated villages ) and acquisition rates ( HR 0.68 [ 0.50–0.92 ] , p = 0.013 in control villages and HR 0.31 [ 0.19–0.50 ] , p<.001 in vaccinated villages ) were significantly lower in both study arms than in the baseline study . NVT carriage ( 63.2 % vs. 75.7 % , p = 0.037 in control and 67.2 % vs. 75.3 % , p = 0.005 in vaccinated villages ) and acquisition rates ( HR 1.48 [ 1.06–2.06 ] , p = 0.022 ) and ( HR 1.52 [ 1.11–2.10 ] , p = 0.010 respectively ) were significantly higher . Conclusion PCV-7 significantly reduced carriage of VT pneumococci in unvaccinated infants . This indirect effect likely originated from both the child and adult vaccinated population s. Increased carriage of NVT pneumococci needs ongoing monitoring . Trial Registration IS RCT N Register

We identified three primary mechanisms of spillovers : reduced disease transmission , social proximity and substitution of re sources within households . We found the strongest evidence for spillovers through reduced disease transmission , particularly vaccines and mass drug administration . In general , the proportion of a population receiving an intervention was associated with improved health . We found evidence of publication bias for certain spillover estimates but not for total or direct effects . Conclusions We found the strongest evidence for spillovers from vaccines and mass drug administration to control infectious disease . There was little high quality evidence of spillovers for other interventions

Background Many interventions delivered to improve health may benefit not only direct recipients but also people in close physical or social proximity . Our objective was to review all published literature about the spillover effects of interventions on health outcomes in low-middle income countries and to identify methods used in estimating these effects .

We identified three primary mechanisms of spillovers : reduced disease transmission , social proximity and substitution of re sources within households . We found the strongest evidence for spillovers through reduced disease transmission , particularly vaccines and mass drug administration . In general , the proportion of a population receiving an intervention was associated with improved health . We found evidence of publication bias for certain spillover estimates but not for total or direct effects . Conclusions We found the strongest evidence for spillovers from vaccines and mass drug administration to control infectious disease . There was little high quality evidence of spillovers for other interventions

Background Many interventions delivered to improve health may benefit not only direct recipients but also people in close physical or social proximity . Our objective was to review all published literature about the spillover effects of interventions on health outcomes in low-middle income countries and to identify methods used in estimating these effects .

Assessment of herd protection against trachoma due to repeated mass antibiotic distributions: a cluster-randomised trial

BACKGROUND Trachoma-control programmes distribute oral azithromycin to treat the ocular strains of chlamydia that cause the disease and to control infection . Theoretically , elimination of infection is feasible if untreated individuals receive an indirect protective effect from living in repeatedly treated communities , which is similar to herd protection in vaccine programmes . We assessed indirect protection against trachoma with mass azithromycin distributions . METHODS In a cluster r and omised trial , 24 subkebeles ( government-defined units ) in Amhara , Ethiopia , were r and omised , with use of a simple r and om sample , to distribution four times per year of single-dose oral azithromycin to children aged 1 - 10 years ( 12 subkebeles , 4764 children ) , or to delayed treatment until after the study ( control ; 12 subkebeles , 6014 children ) . We compared the prevalence of ocular chlamydial infection in untreated individuals 11 years and older between baseline and 12 months in the treated subkebeles , and at 12 months between the treated and control subkebeles . Health-care and laboratory personnel were blinded to study group . Analysis was intention to treat . The study is registered with clinical trials.gov , number NCT00322972 . FINDINGS At 12 months , 637 children aged 1 - 10 years and 561 adults and children aged 11 years and older were analysed in the children-treated group , and 618 and 550 , respectively , in the control group . The mean prevalence of infection in children decreased from 48.4 % ( 95 % CI 42.9 - 53.9 ) to 3.6 % ( 0.8 - 6.4 ) after four mass treatments . At 12 months , the mean prevalence of infection in the untreated age group ( > /=11 years ) was 47 % ( 95 % CI 33 - 57 ) less than baseline ( p=0.002 ) , and 35 % ( 95 % CI 1 - 57 ) less than that in untreated communities ( p=0.04 ) . INTERPRETATION Frequent treatment of children , who are a core group for transmission of trachoma , could eventually eliminate infection from the entire community . Herd protection is offered by repeated mass antibiotic treatments , providing a strategy for elimination of a bacterial disease when an effective vaccine is unavailable . FUNDING National Institutes of Health

We identified three primary mechanisms of spillovers : reduced disease transmission , social proximity and substitution of re sources within households . We found the strongest evidence for spillovers through reduced disease transmission , particularly vaccines and mass drug administration . In general , the proportion of a population receiving an intervention was associated with improved health . We found evidence of publication bias for certain spillover estimates but not for total or direct effects . Conclusions We found the strongest evidence for spillovers from vaccines and mass drug administration to control infectious disease . There was little high quality evidence of spillovers for other interventions

Background Many interventions delivered to improve health may benefit not only direct recipients but also people in close physical or social proximity . Our objective was to review all published literature about the spillover effects of interventions on health outcomes in low-middle income countries and to identify methods used in estimating these effects .

We identified three primary mechanisms of spillovers : reduced disease transmission , social proximity and substitution of re sources within households . We found the strongest evidence for spillovers through reduced disease transmission , particularly vaccines and mass drug administration . In general , the proportion of a population receiving an intervention was associated with improved health . We found evidence of publication bias for certain spillover estimates but not for total or direct effects . Conclusions We found the strongest evidence for spillovers from vaccines and mass drug administration to control infectious disease . There was little high quality evidence of spillovers for other interventions

Background Many interventions delivered to improve health may benefit not only direct recipients but also people in close physical or social proximity . Our objective was to review all published literature about the spillover effects of interventions on health outcomes in low-middle income countries and to identify methods used in estimating these effects .

Vaccine Protection of Bangladeshi Infants and Young Children Against Cholera: Implications for Vaccine Deployment and Person-to-Person Transmission

Background : Killed oral cholera vaccines are internationally licensed for older children and adults , but not for infants and young children . We investigated whether mass immunization of older children and adults can confer herd protection to children too young to be vaccinated . Methods : We analyzed the first year of surveillance of an individually r and omized , placebo-controlled trial of killed oral cholera vaccines in 89,596 older Bangladeshi children and adult women . Vaccine herd protection of children less than 2 years of age , who were too young to participate in the trial , was evaluated by determining whether the incidence of cholera during the first year of follow-up of this age group was lower in residential clusters with higher levels of vaccine coverage than in clusters with lower levels of vaccine coverage . Results : Vaccine coverage of the targeted population ranged from 4 % to 65 % in different clusters . The incidence ( cases per 1000 ) of cholera among children less than 2 years of age ranged from 18.9 in clusters in the lowest quintile of vaccine coverage to 8.6 in clusters in the highest quintile ( P = 0.004 for the inverse association between vaccine coverage and risk of cholera ) Vaccine coverage of adult women ( relative risk of cholera = 0.95 for each percent increase in vaccine coverage ; 95 % confidence interval : 0.92–0.99 ; P < 0.01 ) , but not of older children , was independently associated with a lower risk of cholera in children less than 2 years of age . Conclusions : Vaccination of older age groups was associated with protection of children too young to be vaccinated . The pronounced herd protection of young children associated with vaccination of adult women suggests that adult women may play a prominent role in the transmission of cholera to young children in this setting

We identified three primary mechanisms of spillovers : reduced disease transmission , social proximity and substitution of re sources within households . We found the strongest evidence for spillovers through reduced disease transmission , particularly vaccines and mass drug administration . In general , the proportion of a population receiving an intervention was associated with improved health . We found evidence of publication bias for certain spillover estimates but not for total or direct effects . Conclusions We found the strongest evidence for spillovers from vaccines and mass drug administration to control infectious disease . There was little high quality evidence of spillovers for other interventions

Background Many interventions delivered to improve health may benefit not only direct recipients but also people in close physical or social proximity . Our objective was to review all published literature about the spillover effects of interventions on health outcomes in low-middle income countries and to identify methods used in estimating these effects .

We identified three primary mechanisms of spillovers : reduced disease transmission , social proximity and substitution of re sources within households . We found the strongest evidence for spillovers through reduced disease transmission , particularly vaccines and mass drug administration . In general , the proportion of a population receiving an intervention was associated with improved health . We found evidence of publication bias for certain spillover estimates but not for total or direct effects . Conclusions We found the strongest evidence for spillovers from vaccines and mass drug administration to control infectious disease . There was little high quality evidence of spillovers for other interventions

Background Many interventions delivered to improve health may benefit not only direct recipients but also people in close physical or social proximity . Our objective was to review all published literature about the spillover effects of interventions on health outcomes in low-middle income countries and to identify methods used in estimating these effects .

Developments in cluster randomized trials and Statistics in Medicine.

The design and analysis of cluster r and omized trials has been a recurrent theme in Statistics in Medicine since the early volumes . In celebration of 25 years of Statistics in Medicine , this paper review s recent developments , particularly those that featured in the journal . Issues in design such as sample size calculations , matched paired design s , cohort versus cross-sectional design s , and practical design problems are covered . Developments in analysis include modification of robust methods to cope with small numbers of clusters , generalized estimation equations , population averaged and cluster specific models . Finally , issues on presenting data , some other clustering issues and the general problem of evaluating complex interventions are briefly mentioned

We identified three primary mechanisms of spillovers : reduced disease transmission , social proximity and substitution of re sources within households . We found the strongest evidence for spillovers through reduced disease transmission , particularly vaccines and mass drug administration . In general , the proportion of a population receiving an intervention was associated with improved health . We found evidence of publication bias for certain spillover estimates but not for total or direct effects . Conclusions We found the strongest evidence for spillovers from vaccines and mass drug administration to control infectious disease . There was little high quality evidence of spillovers for other interventions

Background Many interventions delivered to improve health may benefit not only direct recipients but also people in close physical or social proximity . Our objective was to review all published literature about the spillover effects of interventions on health outcomes in low-middle income countries and to identify methods used in estimating these effects .

We identified three primary mechanisms of spillovers : reduced disease transmission , social proximity and substitution of re sources within households . We found the strongest evidence for spillovers through reduced disease transmission , particularly vaccines and mass drug administration . In general , the proportion of a population receiving an intervention was associated with improved health . We found evidence of publication bias for certain spillover estimates but not for total or direct effects . Conclusions We found the strongest evidence for spillovers from vaccines and mass drug administration to control infectious disease . There was little high quality evidence of spillovers for other interventions

Background Many interventions delivered to improve health may benefit not only direct recipients but also people in close physical or social proximity . Our objective was to review all published literature about the spillover effects of interventions on health outcomes in low-middle income countries and to identify methods used in estimating these effects .

CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials

The CONSORT statement is used worldwide to improve the reporting of r and omised controlled trials . Kenneth Schulz and colleagues describe the latest version , CONSORT 2010 , which up date s the reporting guideline based on new method ological evidence and accumulating experience . To encourage dissemination of the CONSORT 2010 Statement , this article is freely accessible on bmj.com and will also be published in the Lancet , Obstetrics and Gynecology , PLoS Medicine , Annals of Internal Medicine , Open Medicine , Journal of Clinical Epidemiology , BMC Medicine , and Trials

We identified three primary mechanisms of spillovers : reduced disease transmission , social proximity and substitution of re sources within households . We found the strongest evidence for spillovers through reduced disease transmission , particularly vaccines and mass drug administration . In general , the proportion of a population receiving an intervention was associated with improved health . We found evidence of publication bias for certain spillover estimates but not for total or direct effects . Conclusions We found the strongest evidence for spillovers from vaccines and mass drug administration to control infectious disease . There was little high quality evidence of spillovers for other interventions

Background Many interventions delivered to improve health may benefit not only direct recipients but also people in close physical or social proximity . Our objective was to review all published literature about the spillover effects of interventions on health outcomes in low-middle income countries and to identify methods used in estimating these effects .

We identified three primary mechanisms of spillovers : reduced disease transmission , social proximity and substitution of re sources within households . We found the strongest evidence for spillovers through reduced disease transmission , particularly vaccines and mass drug administration . In general , the proportion of a population receiving an intervention was associated with improved health . We found evidence of publication bias for certain spillover estimates but not for total or direct effects . Conclusions We found the strongest evidence for spillovers from vaccines and mass drug administration to control infectious disease . There was little high quality evidence of spillovers for other interventions

Background Many interventions delivered to improve health may benefit not only direct recipients but also people in close physical or social proximity . Our objective was to review all published literature about the spillover effects of interventions on health outcomes in low-middle income countries and to identify methods used in estimating these effects .

Population effect of 10-valent pneumococcal conjugate vaccine on nasopharyngeal carriage of Streptococcus pneumoniae and non-typeable Haemophilus influenzae in Kilifi, Kenya: findings from cross-sectional carriage studies

Summary Background The effect of 7-valent pneumococcal conjugate vaccine ( PCV ) in developed countries was enhanced by indirect protection of unvaccinated individuals , mediated by reduced nasopharyngeal carriage of vaccine-serotype pneumococci . The potential indirect protection of 10-valent PCV ( PCV10 ) in a developing country setting is unknown . We sought to estimate the effectiveness of introduction of PCV10 in Kenya against carriage of vaccine serotypes and its effect on other bacteria . Methods PCV10 was introduced into the infant vaccination programme in Kenya in January , 2011 , accompanied by a catch-up campaign in Kilifi County for children aged younger than 5 years . We did annual cross-sectional carriage studies among an age-stratified , r and om population sample in the 2 years before and 2 years after PCV10 introduction . A nasopharyngeal rayon swab specimen was collected from each participant and was processed in accordance with WHO recommendations . Prevalence ratios of carriage before and after introduction of PCV10 were calculated by log-binomial regression . Findings About 500 individuals were enrolled each year ( total n=2031 ) . Among children younger than 5 years , the baseline ( 2009–10 ) carriage prevalence was 34 % for vaccine-serotype Streptococcus pneumoniae , 41 % for non-vaccine-serotype Streptococcus pneumoniae , and 54 % for non-typeable Haemophilus influenzae . After PCV10 introduction ( 2011–12 ) , these percentages were 13 % , 57 % , and 40 % , respectively . Adjusted prevalence ratios were 0·36 ( 95 % CI 0·26–0·51 ) , 1·37 ( 1·13–1·65 ) , and 0·62 ( 0·52–0·75 ) , respectively . Among individuals aged 5 years or older , the adjusted prevalence ratios for vaccine-serotype and non-vaccine-serotype S pneumoniae carriage were 0·34 ( 95 % CI 0·18–0·62 ) and 1·13 ( 0·92–1·38 ) , respectively . There was no change in prevalence ratio for Staphylococcus aureus ( adjusted prevalence ratio for those < 5 years old 1·02 , 95 % CI 0·52–1·99 , and for those ≥5 years old 0·90 , 0·60–1·35 ) . Interpretation After programmatic use of PCV10 in Kilifi , carriage of vaccine serotypes was reduced by two-thirds both in children younger than 5 years and in older individuals . These findings suggest that PCV10 introduction in Africa will have substantial indirect effects on invasive pneumococcal disease . Funding GAVI Alliance and Wellcome Trust

We identified three primary mechanisms of spillovers : reduced disease transmission , social proximity and substitution of re sources within households . We found the strongest evidence for spillovers through reduced disease transmission , particularly vaccines and mass drug administration . In general , the proportion of a population receiving an intervention was associated with improved health . We found evidence of publication bias for certain spillover estimates but not for total or direct effects . Conclusions We found the strongest evidence for spillovers from vaccines and mass drug administration to control infectious disease . There was little high quality evidence of spillovers for other interventions

Background Many interventions delivered to improve health may benefit not only direct recipients but also people in close physical or social proximity . Our objective was to review all published literature about the spillover effects of interventions on health outcomes in low-middle income countries and to identify methods used in estimating these effects .

We identified three primary mechanisms of spillovers : reduced disease transmission , social proximity and substitution of re sources within households . We found the strongest evidence for spillovers through reduced disease transmission , particularly vaccines and mass drug administration . In general , the proportion of a population receiving an intervention was associated with improved health . We found evidence of publication bias for certain spillover estimates but not for total or direct effects . Conclusions We found the strongest evidence for spillovers from vaccines and mass drug administration to control infectious disease . There was little high quality evidence of spillovers for other interventions

Background Many interventions delivered to improve health may benefit not only direct recipients but also people in close physical or social proximity . Our objective was to review all published literature about the spillover effects of interventions on health outcomes in low-middle income countries and to identify methods used in estimating these effects .

Promoting Transparency in Social Science Research

Social scientists should adopt higher transparency st and ards to improve the quality and credibility of research . There is growing appreciation for the advantages of experimentation in the social sciences . Policy-relevant cl aims that in the past were backed by theoretical arguments and inconclusive correlations are now being investigated using more credible methods . Changes have been particularly pronounced in development economics , where hundreds of r and omized trials have been carried out over the last decade . When experimentation is difficult or impossible , research ers are using quasi-experimental design s. Governments and advocacy groups display a growing appetite for evidence -based policy-making . In 2005 , Mexico established an independent government agency to rigorously evaluate social programs , and in 2012 , the U.S. Office of Management and Budget advised federal agencies to present evidence from r and omized program evaluations in budget requests ( 1 , 2 )

We identified three primary mechanisms of spillovers : reduced disease transmission , social proximity and substitution of re sources within households . We found the strongest evidence for spillovers through reduced disease transmission , particularly vaccines and mass drug administration . In general , the proportion of a population receiving an intervention was associated with improved health . We found evidence of publication bias for certain spillover estimates but not for total or direct effects . Conclusions We found the strongest evidence for spillovers from vaccines and mass drug administration to control infectious disease . There was little high quality evidence of spillovers for other interventions

Background Many interventions delivered to improve health may benefit not only direct recipients but also people in close physical or social proximity . Our objective was to review all published literature about the spillover effects of interventions on health outcomes in low-middle income countries and to identify methods used in estimating these effects .

In addition , the more CCM-incorporated the information technology-based interventions were , the more improvements there were in HbA1c levels . CONCLUSIONS Information technology strategies combined with the other elements of chronic care models are associated with improved glycemic control in people with diabetes . No clinical ly relevant impact was observed on low-density lipoprotein levels and blood pressure , but there was evidence that the cost of care was lower

BACKGROUND Information technology-based interventions are increasingly being used to manage health care . However , there is conflicting evidence regarding whether these interventions improve outcomes in people with type 2 diabetes . OBJECTIVE The objective of this study was to conduct a systematic review and meta- analysis of clinical trials , assessing the impact of information technology on changes in the levels of hemoglobin A1c ( HbA1c ) and mapping the interventions with chronic care model ( CCM ) elements .

Diabetes intervention in the information age.

Sustained improvement in blood glucose control is the only treatment outcome which will reduce or eliminate the long term complications of diabetes mellitus . We have design ed and evaluated an electronic information system which facilitates this task . The system is voice-interactive , physician directed and affords , to remote patients , 24 h access via touch-tone telephone . Accordingly , patients access the system each day to report self-measured blood glucose levels or hypoglycaemic symptoms together with dietary changes , planned exercise , stress , illness or other lifestyle events . In turn they receive immediate advice with respect to medication dosing changes , and other pertinent feedback . Preliminary system beta-testing for safety and efficacy was performed for one year in an open study of 204 patients derived from two independent , health-care environments . Among the two testing centres , over 60,000 telephone cells were received by the computer systems during the start-up year . Safety and efficacy expectations were met . In addition , prevalence of diabetes related crises ( hyperglycaemia or hypoglycaemia ) fell approximately 3-fold . Glycated haemoglobin fell significantly ( 1.0 - 1.3 % ) in patients actively using the system . In control groups of patients not actively using the system , there were no improvements in metabolic control while body weights were stable in all groups . The new system was safe and effective in our h and s and empowered our health professionals to provide improved diabetes care

In addition , the more CCM-incorporated the information technology-based interventions were , the more improvements there were in HbA1c levels . CONCLUSIONS Information technology strategies combined with the other elements of chronic care models are associated with improved glycemic control in people with diabetes . No clinical ly relevant impact was observed on low-density lipoprotein levels and blood pressure , but there was evidence that the cost of care was lower

BACKGROUND Information technology-based interventions are increasingly being used to manage health care . However , there is conflicting evidence regarding whether these interventions improve outcomes in people with type 2 diabetes . OBJECTIVE The objective of this study was to conduct a systematic review and meta- analysis of clinical trials , assessing the impact of information technology on changes in the levels of hemoglobin A1c ( HbA1c ) and mapping the interventions with chronic care model ( CCM ) elements .

In addition , the more CCM-incorporated the information technology-based interventions were , the more improvements there were in HbA1c levels . CONCLUSIONS Information technology strategies combined with the other elements of chronic care models are associated with improved glycemic control in people with diabetes . No clinical ly relevant impact was observed on low-density lipoprotein levels and blood pressure , but there was evidence that the cost of care was lower

BACKGROUND Information technology-based interventions are increasingly being used to manage health care . However , there is conflicting evidence regarding whether these interventions improve outcomes in people with type 2 diabetes . OBJECTIVE The objective of this study was to conduct a systematic review and meta- analysis of clinical trials , assessing the impact of information technology on changes in the levels of hemoglobin A1c ( HbA1c ) and mapping the interventions with chronic care model ( CCM ) elements .

Overcoming Clinical Inertia: A Randomized Clinical Trial of a Telehealth Remote Monitoring Intervention Using Paired Glucose Testing in Adults With Type 2 Diabetes

Background Type 2 diabetes mellitus is a worldwide challenge . Practice guidelines promote structured self-monitoring of blood glucose ( SMBG ) for informing health care providers about glycemic control and providing patient feedback to increase knowledge , self-efficacy , and behavior change . Paired glucose testing — pairs of glucose results obtained before and after a meal or physical activity — is a method of structured SMBG . However , frequent access to glucose data to interpret values and recommend actions is challenging . A complete feedback loop— data collection and interpretation combined with feedback to modify treatment — has been associated with improved outcomes , yet there remains limited integration of SMBG feedback in diabetes management . Incorporating telehealth remote monitoring and asynchronous electronic health record ( EHR ) feedback from certified diabetes educators (CDEs)—specialists in glucose pattern management — employ the complete feedback loop to improve outcomes . Objective The purpose of this study was to evaluate a telehealth remote monitoring intervention using paired glucose testing and asynchronous data analysis in adults with type 2 diabetes . The primary aim was change in glycated hemoglobin (A1c)—a measure of overall glucose management — between groups after 6 months . The secondary aims were change in self-reported Summary of Diabetes Self-Care Activities ( SDSCA ) , Diabetes Empowerment Scale , and Diabetes Knowledge Test . Methods A 2-group r and omized clinical trial was conducted comparing usual care to telehealth remote monitoring with paired glucose testing and asynchronous virtual visits . Participants were aged 30 - 70 years , not using insulin with A1c levels between 7.5 % and 10.9 % ( 58 - 96 mmol/mol ) . The telehealth remote monitoring tablet computer transmitted glucose data and facilitated a complete feedback loop to educate participants , analyze actionable glucose data , and provide feedback . Data from paired glucose testing were analyzed asynchronously using computer-assisted pattern analysis and were shared with patients via the EHR weekly . CDEs called participants monthly to discuss paired glucose testing trends and treatment changes . Separate mixed-effects models were used to analyze data . Results Participants ( N=90 ) were primarily white ( 64 % , 56/87 ) , mean age 58 ( SD 11 ) years , mean body mass index 34.1 ( SD 6.7 ) kg/m2 , with diabetes for mean 8.2 ( SD 5.4 ) years , and a mean A1c of 8.3 % ( SD 1.1 ; 67 mmol/mol ) . Both groups lowered A1c with an estimated average decrease of 0.70 percentage points in usual care group and 1.11 percentage points in the treatment group with a significant difference of 0.41 percentage points at 6 months ( SE 0.08 , t159=–2.87 , P=.005 ) . Change in medication ( SE 0.21 , t157=–3.37 , P=.009 ) was significantly associated with lower A1c level . The treatment group significantly improved on the SDSCA subscales carbohydrate spacing ( P=.04 ) , monitoring glucose ( P=.001 ) , and foot care ( P=.02 ) . Conclusions An eHealth model incorporating a complete feedback loop with telehealth remote monitoring and paired glucose testing with asynchronous data analysis significantly improved A1c levels compared to usual care . Trial Registration Clinical trials.gov NCT01715649 ; https://www . clinical trials.gov/ct2/show/NCT01715649 ( Archived by WebCite at http://www.webcitation.org/6ZinLl8D0 )

In addition , the more CCM-incorporated the information technology-based interventions were , the more improvements there were in HbA1c levels . CONCLUSIONS Information technology strategies combined with the other elements of chronic care models are associated with improved glycemic control in people with diabetes . No clinical ly relevant impact was observed on low-density lipoprotein levels and blood pressure , but there was evidence that the cost of care was lower

BACKGROUND Information technology-based interventions are increasingly being used to manage health care . However , there is conflicting evidence regarding whether these interventions improve outcomes in people with type 2 diabetes . OBJECTIVE The objective of this study was to conduct a systematic review and meta- analysis of clinical trials , assessing the impact of information technology on changes in the levels of hemoglobin A1c ( HbA1c ) and mapping the interventions with chronic care model ( CCM ) elements .

In addition , the more CCM-incorporated the information technology-based interventions were , the more improvements there were in HbA1c levels . CONCLUSIONS Information technology strategies combined with the other elements of chronic care models are associated with improved glycemic control in people with diabetes . No clinical ly relevant impact was observed on low-density lipoprotein levels and blood pressure , but there was evidence that the cost of care was lower

BACKGROUND Information technology-based interventions are increasingly being used to manage health care . However , there is conflicting evidence regarding whether these interventions improve outcomes in people with type 2 diabetes . OBJECTIVE The objective of this study was to conduct a systematic review and meta- analysis of clinical trials , assessing the impact of information technology on changes in the levels of hemoglobin A1c ( HbA1c ) and mapping the interventions with chronic care model ( CCM ) elements .

Web-based care management in patients with poorly controlled diabetes.

OBJECTIVE To assess the effects of web-based care management on glucose and blood pressure control over 12 months in patients with poorly controlled diabetes . RESEARCH DESIGN AND METHODS For this study , 104 patients with diabetes and HbA(1c ) ( A1C ) > or = 9.0 % who received their care at a Department of Veterans Affairs medical center were recruited . All participants completed a diabetes education class and were r and omized to continue with their usual care ( n = 52 ) or receive web-based care management ( n = 52 ) . The web-based group received a notebook computer , glucose and blood pressure monitoring devices , and access to a care management website . The website provided educational modules , accepted uploads from monitoring devices , and had an internal messaging system for patients to communicate with the care manager . RESULTS Participants receiving web-based care management had lower A1C over 12 months ( P < 0.05 ) when compared with education and usual care . Persistent website users had greater improvement in A1C when compared with intermittent users ( -1.9 vs. -1.2 % ; P = 0.051 ) or education and usual care ( -1.4 % ; P < 0.05 ) . A larger number of website data uploads was associated with a larger decline in A1C ( highest tertile -2.1 % , lowest tertile -1.0 % ; P < 0.02 ) . Hypertensive participants in the web-based group had a greater reduction in systolic blood pressure ( P < 0.01 ) . HDL cholesterol rose and triglycerides fell in the web-based group ( P < 0.05 ) . CONCLUSIONS Web-based care management may be a useful adjunct in the care of patients with poorly controlled diabetes

In addition , the more CCM-incorporated the information technology-based interventions were , the more improvements there were in HbA1c levels . CONCLUSIONS Information technology strategies combined with the other elements of chronic care models are associated with improved glycemic control in people with diabetes . No clinical ly relevant impact was observed on low-density lipoprotein levels and blood pressure , but there was evidence that the cost of care was lower

BACKGROUND Information technology-based interventions are increasingly being used to manage health care . However , there is conflicting evidence regarding whether these interventions improve outcomes in people with type 2 diabetes . OBJECTIVE The objective of this study was to conduct a systematic review and meta- analysis of clinical trials , assessing the impact of information technology on changes in the levels of hemoglobin A1c ( HbA1c ) and mapping the interventions with chronic care model ( CCM ) elements .

In addition , the more CCM-incorporated the information technology-based interventions were , the more improvements there were in HbA1c levels . CONCLUSIONS Information technology strategies combined with the other elements of chronic care models are associated with improved glycemic control in people with diabetes . No clinical ly relevant impact was observed on low-density lipoprotein levels and blood pressure , but there was evidence that the cost of care was lower

BACKGROUND Information technology-based interventions are increasingly being used to manage health care . However , there is conflicting evidence regarding whether these interventions improve outcomes in people with type 2 diabetes . OBJECTIVE The objective of this study was to conduct a systematic review and meta- analysis of clinical trials , assessing the impact of information technology on changes in the levels of hemoglobin A1c ( HbA1c ) and mapping the interventions with chronic care model ( CCM ) elements .

The Cholesterol, Hypertension, And Glucose Education (CHANGE) study: results from a randomized controlled trial in African Americans with diabetes.

BACKGROUND Cardiovascular disease ( CVD ) and diabetes account for one-third of the mortality difference between African American and white patients . We evaluated the effect of a CVD risk reduction intervention in African Americans with diabetes . METHODS We r and omized 359 African Americans with type 2 diabetes to receive usual care or a nurse telephone intervention . The 12-month intervention provided monthly self-management support and quarterly medication management facilitation . Co primary outcomes were changes in systolic blood pressure ( SBP ) , hemoglobin A1c ( HbA1c ) , and low-density lipoprotein cholesterol ( LDL-C ) over 12 months . We estimated between-intervention group differences over time using linear mixed-effects models . The secondary outcome was self-reported medication adherence . RESULTS The sample was 72 % female ; 49 % had low health literacy , and 37 % had annual income < $ 10,000 . Model-based estimates for mean baseline SBP , HbA1c , and LDL-C were 136.8 mm Hg ( 95 % CI 135.0 - 138.6 ) , 8.0 % ( 95 % CI 7.8 - 8.2 ) , and 99.1 mg/dL ( 95 % CI 94.7 - 103.5 ) , respectively . Intervention patients received 9.9 ( SD 3.0 ) intervention calls on average . Primary providers replied to 76 % of nurse medication management facilitation contacts , 18 % of these result ed in medication changes . There were no between-group differences over time for SBP ( P = .11 ) , HbA1c ( P = .66 ) , or LDL-C ( P = .79 ) . Intervention patients were more likely than those receiving usual care to report improved medication adherence ( odds ratio 4.4 , 95 % CI 1.8 - 10.6 , P = .0008 ) , but adherent patients did not exhibit relative improvement in primary outcomes . CONCLUSIONS This intervention improved self-reported medication adherence but not CVD risk factor control among African Americans with diabetes . Further research is needed to determine how to maximally impact CVD risk factors in African American patients

In addition , the more CCM-incorporated the information technology-based interventions were , the more improvements there were in HbA1c levels . CONCLUSIONS Information technology strategies combined with the other elements of chronic care models are associated with improved glycemic control in people with diabetes . No clinical ly relevant impact was observed on low-density lipoprotein levels and blood pressure , but there was evidence that the cost of care was lower

BACKGROUND Information technology-based interventions are increasingly being used to manage health care . However , there is conflicting evidence regarding whether these interventions improve outcomes in people with type 2 diabetes . OBJECTIVE The objective of this study was to conduct a systematic review and meta- analysis of clinical trials , assessing the impact of information technology on changes in the levels of hemoglobin A1c ( HbA1c ) and mapping the interventions with chronic care model ( CCM ) elements .

In addition , the more CCM-incorporated the information technology-based interventions were , the more improvements there were in HbA1c levels . CONCLUSIONS Information technology strategies combined with the other elements of chronic care models are associated with improved glycemic control in people with diabetes . No clinical ly relevant impact was observed on low-density lipoprotein levels and blood pressure , but there was evidence that the cost of care was lower

BACKGROUND Information technology-based interventions are increasingly being used to manage health care . However , there is conflicting evidence regarding whether these interventions improve outcomes in people with type 2 diabetes . OBJECTIVE The objective of this study was to conduct a systematic review and meta- analysis of clinical trials , assessing the impact of information technology on changes in the levels of hemoglobin A1c ( HbA1c ) and mapping the interventions with chronic care model ( CCM ) elements .

Improving Diabetes Care in Practice

OBJECTIVE —The purpose of this study was to determine whether implementation of a multicomponent organizational intervention can produce significant change in diabetes care and outcomes in community primary care practice s. RESEARCH DESIGN AND METHODS —This was a group-r and omized , controlled clinical trial evaluating the practical effectiveness of a multicomponent intervention ( TRANSLATE ) in 24 practice s. The intervention included implementation of an electronic diabetes registry , visit reminders , and patient-specific physician alerts . A site coordinator facilitated previsit planning and a monthly review of performance with a local physician champion . The principle outcomes were the percentage of patients achieving target values for the composite of systolic blood pressure ( SBP ) < 130 mmHg , LDL cholesterol < 100 mg/dl , and A1C < 7.0 % at baseline and 12 months . Six process measures were also followed . RESULTS —Over 24 months , 69,965 visits from 8,405 adult patients with type 2 diabetes were recorded from 238 health care providers in 24 practice s from 17 health systems . Diabetes process measures increased significantly more in intervention than in control practice s , giving net increases as follows : foot examinations 35.0 % ( P < 0.0.001 ) ; annual eye examinations 25.9 % ( P < 0.001 ) ; renal testing 28.5 % ( P < 0.001 ) ; A1C testing 8.1%(P < 0.001 ) ; blood pressure monitoring 3.5 % ( P = 0.05 ) ; and LDL testing 8.6 % ( P < 0.001 ) . Mean A1C adjusted for age , sex , and comorbidity decreased significantly in intervention practice s ( P < 0.02 ) . At 12 months , intervention practice s had significantly greater improvement in achieving recommended clinical values for SBP , A1C , and LDL than control clinics ( P = 0.002 ) . CONCLUSIONS — Introduction of a multicomponent organizational intervention in the primary care setting significantly increases the percentage of type 2 diabetic patients achieving recommended clinical outcomes

In addition , the more CCM-incorporated the information technology-based interventions were , the more improvements there were in HbA1c levels . CONCLUSIONS Information technology strategies combined with the other elements of chronic care models are associated with improved glycemic control in people with diabetes . No clinical ly relevant impact was observed on low-density lipoprotein levels and blood pressure , but there was evidence that the cost of care was lower

BACKGROUND Information technology-based interventions are increasingly being used to manage health care . However , there is conflicting evidence regarding whether these interventions improve outcomes in people with type 2 diabetes . OBJECTIVE The objective of this study was to conduct a systematic review and meta- analysis of clinical trials , assessing the impact of information technology on changes in the levels of hemoglobin A1c ( HbA1c ) and mapping the interventions with chronic care model ( CCM ) elements .

In addition , the more CCM-incorporated the information technology-based interventions were , the more improvements there were in HbA1c levels . CONCLUSIONS Information technology strategies combined with the other elements of chronic care models are associated with improved glycemic control in people with diabetes . No clinical ly relevant impact was observed on low-density lipoprotein levels and blood pressure , but there was evidence that the cost of care was lower

BACKGROUND Information technology-based interventions are increasingly being used to manage health care . However , there is conflicting evidence regarding whether these interventions improve outcomes in people with type 2 diabetes . OBJECTIVE The objective of this study was to conduct a systematic review and meta- analysis of clinical trials , assessing the impact of information technology on changes in the levels of hemoglobin A1c ( HbA1c ) and mapping the interventions with chronic care model ( CCM ) elements .

Impact of MyCareTeam for poorly controlled diabetes mellitus.

OBJECTIVE Web-based diabetes management can be used to provide frequent interactions between patients and providers and thus result in improved glycemic control . METHODS In a single-center , prospect i ve feasibility study , 16 poorly controlled patients with either type 1 or 2 diabetes mellitus were enrolled to assess the impact of using MyCareTeam , a web-based diabetes management application , for diabetes management . Patients were asked to transfer their blood glucose data electronically , maintain exercise logs , and communicate with their provider via MyCareTeam . The provider gave clinical interventions to optimize blood glucose control and provided feedback via MyCareTeam . Diabetes , nutrition , and exercise information was also available via MyCareTeam . RESULTS A significant reduction of over 2.22 % points in hemoglobin A1C was seen for the total patient population . Differences between moderate/heavy users ( n = 8) versus light/never users ( n = 8) of MyCareTeam were evaluated for intergroup differences based upon utilization . Moderate/heavy users had a significant 6-month A1C reduction of 3.15 percentage points compared with a reduction of 1.28 percentage points in light/never users . Other secondary end points were improved as well , including systolic blood pressure , diastolic blood pressure , total cholesterol , high-density lipoprotein , low-density lipoprotein , and triglycerides . However , as expected , body mass index levels increased because of aggressive diabetes management with insulin therapy . CONCLUSIONS These results demonstrate a significant treatment effect from the MyCareTeam application . A larger r and omized control trial is under way at the Boston Veterans Administration Healthcare System . If these results are confirmed as expected , then web-based diabetes management may prove to be the link to achieving target American Diabetes Association glycemic goals in patients with poorly controlled diabetes

In addition , the more CCM-incorporated the information technology-based interventions were , the more improvements there were in HbA1c levels . CONCLUSIONS Information technology strategies combined with the other elements of chronic care models are associated with improved glycemic control in people with diabetes . No clinical ly relevant impact was observed on low-density lipoprotein levels and blood pressure , but there was evidence that the cost of care was lower

BACKGROUND Information technology-based interventions are increasingly being used to manage health care . However , there is conflicting evidence regarding whether these interventions improve outcomes in people with type 2 diabetes . OBJECTIVE The objective of this study was to conduct a systematic review and meta- analysis of clinical trials , assessing the impact of information technology on changes in the levels of hemoglobin A1c ( HbA1c ) and mapping the interventions with chronic care model ( CCM ) elements .

In addition , the more CCM-incorporated the information technology-based interventions were , the more improvements there were in HbA1c levels . CONCLUSIONS Information technology strategies combined with the other elements of chronic care models are associated with improved glycemic control in people with diabetes . No clinical ly relevant impact was observed on low-density lipoprotein levels and blood pressure , but there was evidence that the cost of care was lower

BACKGROUND Information technology-based interventions are increasingly being used to manage health care . However , there is conflicting evidence regarding whether these interventions improve outcomes in people with type 2 diabetes . OBJECTIVE The objective of this study was to conduct a systematic review and meta- analysis of clinical trials , assessing the impact of information technology on changes in the levels of hemoglobin A1c ( HbA1c ) and mapping the interventions with chronic care model ( CCM ) elements .

Improved Glycemic Control Without Hypoglycemia in Elderly Diabetic Patients Using the Ubiquitous Healthcare Service, a New Medical Information System

OBJECTIVE To improve quality and efficiency of care for elderly patients with type 2 diabetes , we introduced elderly-friendly strategies to the clinical decision support system (CDSS)-based ubiquitous healthcare ( u-healthcare ) service , which is an individualized health management system using advanced medical information technology . RESEARCH DESIGN AND METHODS We conducted a 6-month r and omized , controlled clinical trial involving 144 patients aged > 60 years . Participants were r and omly assigned to receive routine care ( control , n = 48 ) , to the self-monitored blood glucose ( SMBG , n = 47 ) group , or to the u-healthcare group ( n = 49 ) . The primary end point was the proportion of patients achieving A1C < 7 % without hypoglycemia at 6 months . U-healthcare system refers to an individualized medical service in which medical instructions are given through the patient ’s mobile phone . Patients receive a glucometer with a public switched telephone network-connected cradle that automatically transfers test results to a hospital-based server . Once the data are transferred to the server , an automated system , the CDSS rule engine , generates and sends patient-specific messages by mobile phone . RESULTS After 6 months of follow-up , the mean A1C level was significantly decreased from 7.8 ± 1.3 % to 7.4 ± 1.0 % ( P < 0.001 ) in the u-healthcare group and from 7.9 ± 1.0 % to 7.7 ± 1.0 % ( P = 0.020 ) in the SMBG group , compared with 7.9 ± 0.8 % to 7.8 ± 1.0 % ( P = 0.274 ) in the control group . The proportion of patients with A1C < 7 % without hypoglycemia was 30.6 % in the u-healthcare group , 23.4 % in the SMBG group ( 23.4 % ) , and 14.0 % in the control group ( P < 0.05 ) . CONCLUSIONS The CDSS-based u-healthcare service achieved better glycemic control with less hypoglycemia than SMBG and routine care and may provide effective and safe diabetes management in the elderly diabetic patients

In addition , the more CCM-incorporated the information technology-based interventions were , the more improvements there were in HbA1c levels . CONCLUSIONS Information technology strategies combined with the other elements of chronic care models are associated with improved glycemic control in people with diabetes . No clinical ly relevant impact was observed on low-density lipoprotein levels and blood pressure , but there was evidence that the cost of care was lower

BACKGROUND Information technology-based interventions are increasingly being used to manage health care . However , there is conflicting evidence regarding whether these interventions improve outcomes in people with type 2 diabetes . OBJECTIVE The objective of this study was to conduct a systematic review and meta- analysis of clinical trials , assessing the impact of information technology on changes in the levels of hemoglobin A1c ( HbA1c ) and mapping the interventions with chronic care model ( CCM ) elements .

In addition , the more CCM-incorporated the information technology-based interventions were , the more improvements there were in HbA1c levels . CONCLUSIONS Information technology strategies combined with the other elements of chronic care models are associated with improved glycemic control in people with diabetes . No clinical ly relevant impact was observed on low-density lipoprotein levels and blood pressure , but there was evidence that the cost of care was lower

BACKGROUND Information technology-based interventions are increasingly being used to manage health care . However , there is conflicting evidence regarding whether these interventions improve outcomes in people with type 2 diabetes . OBJECTIVE The objective of this study was to conduct a systematic review and meta- analysis of clinical trials , assessing the impact of information technology on changes in the levels of hemoglobin A1c ( HbA1c ) and mapping the interventions with chronic care model ( CCM ) elements .

Biophysiologic outcomes of the Enhancing Adherence in Type 2 Diabetes (ENHANCE) trial.

BACKGROUND Behavioral research to improve lifestyle in broadly defined population s of patients with type 2 diabetes is limited . OBJECTIVE We evaluated a behavioral intervention featuring technology-based self-monitoring on biophysiologic outcomes of glycemic control and markers of cardiovascular risk . DESIGN In this single-site , r and omized clinical trial , participants were stratified by good and poor glycemic control ( glycated hemoglobin < 8 % or ≥8 % ) and absence or presence of kidney disease , ( estimated glomerular filtration rate ≥60 or < 60 mL/min ) and r and omized within strata . Measurements were obtained at 0 , 3 , and 6 months . PARTICIPANTS / SETTING Self-referred , community-dwelling adults with type 2 diabetes mellitus . INTERVENTION The intervention group received Social Cognitive Theory-based counseling paired with technology-based self-monitoring , and results were compared with an attention control group . MAIN OUTCOME MEASURES Glycated hemoglobin , fasting serum glucose , lipid levels , blood pressure , weight , body mass index , and waist circumference were evaluated . STATISTICAL ANALYSES PERFORMED Mean differences within and between r and omization groups were compared over time . Intervention effects over time were estimated using r and om intercept models . RESULTS Two hundred ninety-six subjects were r and omized , 256 ( 86.5 % ) completed 3-month and 246 ( 83.1 % ) completed 6-month assessment s. Glycated hemoglobin was reduced in the intervention group by 0.5 % at 3 months and 0.6 % at 6 months ( P<0.001 for each ) , and the control group by 0.3 % ( P<0.001 ) at 3 months and 0.2 % ( P<0.05 ) at 6 months ; but between-group differences were not significant . In those with baseline glycated hemoglobin ≥8 % and estimated glomerular filtration rate ≥60 mL/min , glycated hemoglobin was reduced in the intervention group by 1.5 % at 3 months and 1.8 % at 6 months ( P<0.001 for each ) , and the control group by 0.9 % ( P<0.001 ) at 3 months and 0.8 % ( P<0.05 ) at 6 months ; but between-group differences were not significant . In r and om intercept models , the estimated reduction in glycated hemoglobin of 0.29 % was not significant . CONCLUSIONS Two behavioral approaches to improving general lifestyle management in individuals with type 2 diabetes mellitus were effective in improving glycemic control , but no significant between-group differences were observed

In addition , the more CCM-incorporated the information technology-based interventions were , the more improvements there were in HbA1c levels . CONCLUSIONS Information technology strategies combined with the other elements of chronic care models are associated with improved glycemic control in people with diabetes . No clinical ly relevant impact was observed on low-density lipoprotein levels and blood pressure , but there was evidence that the cost of care was lower

BACKGROUND Information technology-based interventions are increasingly being used to manage health care . However , there is conflicting evidence regarding whether these interventions improve outcomes in people with type 2 diabetes . OBJECTIVE The objective of this study was to conduct a systematic review and meta- analysis of clinical trials , assessing the impact of information technology on changes in the levels of hemoglobin A1c ( HbA1c ) and mapping the interventions with chronic care model ( CCM ) elements .

In addition , the more CCM-incorporated the information technology-based interventions were , the more improvements there were in HbA1c levels . CONCLUSIONS Information technology strategies combined with the other elements of chronic care models are associated with improved glycemic control in people with diabetes . No clinical ly relevant impact was observed on low-density lipoprotein levels and blood pressure , but there was evidence that the cost of care was lower

BACKGROUND Information technology-based interventions are increasingly being used to manage health care . However , there is conflicting evidence regarding whether these interventions improve outcomes in people with type 2 diabetes . OBJECTIVE The objective of this study was to conduct a systematic review and meta- analysis of clinical trials , assessing the impact of information technology on changes in the levels of hemoglobin A1c ( HbA1c ) and mapping the interventions with chronic care model ( CCM ) elements .

Web-Based Collaborative Care for Type 2 Diabetes

OBJECTIVE —To test Web-based care management of glycemic control using a shared electronic medical record with patients who have type 2 diabetes . RESEARCH DESIGN AND METHODS —We conducted a trial of 83 adults with type 2 diabetes r and omized to receive usual care plus Web-based care management or usual care alone between August 2002 and May 2004 . All patients had GHb ≥7.0 % , had Web access from home , and could use a computer with English language –based programs . Intervention patients received 12 months of Web-based care management . The Web-based program included patient access to electronic medical records , secure e-mail with providers , feedback on blood glucose readings , an educational Web site , and an interactive online diary for entering information about exercise , diet , and medication . The primary outcome was change in GHb . RESULTS —GHb levels declined by 0.7 % ( 95 % CI 0.2−1.3 ) on average among intervention patients compared with usual-care patients . Systolic blood pressure , diastolic blood pressure , total cholesterol levels , and use of in-person health care services did not differ between the two groups . CONCLUSIONS —Care management delivered through secure patient Web communications improved glycemic control in type 2 diabetes

In addition , the more CCM-incorporated the information technology-based interventions were , the more improvements there were in HbA1c levels . CONCLUSIONS Information technology strategies combined with the other elements of chronic care models are associated with improved glycemic control in people with diabetes . No clinical ly relevant impact was observed on low-density lipoprotein levels and blood pressure , but there was evidence that the cost of care was lower

BACKGROUND Information technology-based interventions are increasingly being used to manage health care . However , there is conflicting evidence regarding whether these interventions improve outcomes in people with type 2 diabetes . OBJECTIVE The objective of this study was to conduct a systematic review and meta- analysis of clinical trials , assessing the impact of information technology on changes in the levels of hemoglobin A1c ( HbA1c ) and mapping the interventions with chronic care model ( CCM ) elements .

In addition , the more CCM-incorporated the information technology-based interventions were , the more improvements there were in HbA1c levels . CONCLUSIONS Information technology strategies combined with the other elements of chronic care models are associated with improved glycemic control in people with diabetes . No clinical ly relevant impact was observed on low-density lipoprotein levels and blood pressure , but there was evidence that the cost of care was lower

BACKGROUND Information technology-based interventions are increasingly being used to manage health care . However , there is conflicting evidence regarding whether these interventions improve outcomes in people with type 2 diabetes . OBJECTIVE The objective of this study was to conduct a systematic review and meta- analysis of clinical trials , assessing the impact of information technology on changes in the levels of hemoglobin A1c ( HbA1c ) and mapping the interventions with chronic care model ( CCM ) elements .

The Vermont Diabetes Information System: A Cluster Randomized Trial of a Population Based Decision Support System

BACKGROUND Optimal care for patients with diabetes is difficult to achieve in clinical practice . OBJECTIVE To evaluate the impact of a registry and decision support system on processes of care , and physiologic control . PARTICIPANTS R and omized trial with clustering at the practice level , involving 7,412 adults with diabetes in 64 primary care practice s in the Northeast . INTERVENTIONS Provider decision support ( reminders for overdue diabetes tests , alerts regarding abnormal results , and quarterly population reports with peer comparisons ) and patient decision support ( reminders and alerts ) . MEASUREMENTS AND MAIN RESULTS Process and physiologic outcomes were evaluated in all subjects . Functional status was evaluated in a r and om patient sample via question naire . We used multiple logistic regression to quantify the effect , adjusting for clustering and potential confounders . Intervention subjects were significantly more likely to receive guideline -appropriate testing for cholesterol ( OR = 1.39 ; [ 95%CI 1.07 , 1.80 ] P = 0.012 ) , creatinine ( OR = 1.40 ; [ 95%CI 1.06 , 1.84 ] P = 0.018 ) , and proteinuria ( OR = 1.74 ; [ 95%CI 1.13 , 1.69 ] P = 0.012 ) , but not A1C ( OR = 1.17 ; [ 95 % CI 0.80 , 1.72 ] P = 0.43 ) . Rates of control of A1C and LDL cholesterol were similar in the two groups . There were no differences in blood pressure , body mass index , or functional status . CONCLUSIONS A chronic disease registry and decision support system based on easily obtainable laboratory data was feasible and acceptable to patients and providers . This system improved the process of laboratory monitoring in primary care , but not physiologic control

In addition , the more CCM-incorporated the information technology-based interventions were , the more improvements there were in HbA1c levels . CONCLUSIONS Information technology strategies combined with the other elements of chronic care models are associated with improved glycemic control in people with diabetes . No clinical ly relevant impact was observed on low-density lipoprotein levels and blood pressure , but there was evidence that the cost of care was lower

BACKGROUND Information technology-based interventions are increasingly being used to manage health care . However , there is conflicting evidence regarding whether these interventions improve outcomes in people with type 2 diabetes . OBJECTIVE The objective of this study was to conduct a systematic review and meta- analysis of clinical trials , assessing the impact of information technology on changes in the levels of hemoglobin A1c ( HbA1c ) and mapping the interventions with chronic care model ( CCM ) elements .

In addition , the more CCM-incorporated the information technology-based interventions were , the more improvements there were in HbA1c levels . CONCLUSIONS Information technology strategies combined with the other elements of chronic care models are associated with improved glycemic control in people with diabetes . No clinical ly relevant impact was observed on low-density lipoprotein levels and blood pressure , but there was evidence that the cost of care was lower

BACKGROUND Information technology-based interventions are increasingly being used to manage health care . However , there is conflicting evidence regarding whether these interventions improve outcomes in people with type 2 diabetes . OBJECTIVE The objective of this study was to conduct a systematic review and meta- analysis of clinical trials , assessing the impact of information technology on changes in the levels of hemoglobin A1c ( HbA1c ) and mapping the interventions with chronic care model ( CCM ) elements .

Combined Task Delegation, Computerized Decision Support, and Feedback Improve Cardiovascular Risk for Type 2 Diabetic Patients

OBJECTIVE —The Diabetes Care Protocol combines task delegation ( a practice nurse ) , computerized decision support , and feedback every 3 months . We studied the effect of the Diabetes Care Protocol on A1C and cardiovascular risk factors in type 2 diabetic patients in primary care . RESEARCH DESIGN AND METHODS —In a cluster r and omized trial , mean changes in cardiovascular risk factors between the intervention and control groups after 1 year were calculated by generalized linear models . RESULTS —Throughout the Netherl and s , 26 intervention practice s included 1,699 patients and 29 control practice s 1,692 patients . The difference in A1C change was not significant , whereas total cholesterol , LDL cholesterol , and blood pressure improved significantly more in the intervention group . The 10-year coronary heart disease risk estimate of the UK Prospect i ve Diabetes Study improved 1.4 % more in the intervention group . CONCLUSIONS —Delegation of routine diabetes care to a practice nurse combined with computerized decision support and feedback did not improve A1C but reduced cardiovascular risk in type 2 diabetes patients

In addition , the more CCM-incorporated the information technology-based interventions were , the more improvements there were in HbA1c levels . CONCLUSIONS Information technology strategies combined with the other elements of chronic care models are associated with improved glycemic control in people with diabetes . No clinical ly relevant impact was observed on low-density lipoprotein levels and blood pressure , but there was evidence that the cost of care was lower

BACKGROUND Information technology-based interventions are increasingly being used to manage health care . However , there is conflicting evidence regarding whether these interventions improve outcomes in people with type 2 diabetes . OBJECTIVE The objective of this study was to conduct a systematic review and meta- analysis of clinical trials , assessing the impact of information technology on changes in the levels of hemoglobin A1c ( HbA1c ) and mapping the interventions with chronic care model ( CCM ) elements .

In addition , the more CCM-incorporated the information technology-based interventions were , the more improvements there were in HbA1c levels . CONCLUSIONS Information technology strategies combined with the other elements of chronic care models are associated with improved glycemic control in people with diabetes . No clinical ly relevant impact was observed on low-density lipoprotein levels and blood pressure , but there was evidence that the cost of care was lower

BACKGROUND Information technology-based interventions are increasingly being used to manage health care . However , there is conflicting evidence regarding whether these interventions improve outcomes in people with type 2 diabetes . OBJECTIVE The objective of this study was to conduct a systematic review and meta- analysis of clinical trials , assessing the impact of information technology on changes in the levels of hemoglobin A1c ( HbA1c ) and mapping the interventions with chronic care model ( CCM ) elements .

Effects of a Brief Office-Based Intervention to Facilitate Diabetes Dietary Self-Management

OBJECTIVE There is a pressing need for brief practical interventions that address diabetes management . Using a r and omized design , we evaluated a medical office-based intervention focused on behavioral issues relevant to dietary self-management . RESEARCH DESIGN AND METHODS There were 206 adult diabetes patients r and omized to usual care or brief intervention , which consisted of touchscreen computer-assisted assessment to provide immediate feedback on key barriers to dietary self-management , and goal setting and problem-solving counseling for patients . Follow-up components to the single session intervention included phone calls and interactive video or videotape instruction as needed . RESULTS Multivariate analyses of covariance revealed that the brief intervention produced greater improvements than usual care on a number of measures of dietary behavior ( e.g. , fewer calories from saturated fat , fewer high-fat eating habits and behaviors ) at the 3-month follow-up . There were also significant differences favoring intervention on changes in serum cholesterol levels and patient satisfaction but not on glycosylated hemoglobin . The intervention effects were relatively robust across a variety of patient characteristics , the two participating physicians , and intervention staff members . CONCLUSIONS If the long-term results are equally positive and generalize to other setting , this intervention could provide a prototype for a feasible cost-effective way to integrate patient views and behavioral management into office-based care for diabetes

In addition , the more CCM-incorporated the information technology-based interventions were , the more improvements there were in HbA1c levels . CONCLUSIONS Information technology strategies combined with the other elements of chronic care models are associated with improved glycemic control in people with diabetes . No clinical ly relevant impact was observed on low-density lipoprotein levels and blood pressure , but there was evidence that the cost of care was lower

BACKGROUND Information technology-based interventions are increasingly being used to manage health care . However , there is conflicting evidence regarding whether these interventions improve outcomes in people with type 2 diabetes . OBJECTIVE The objective of this study was to conduct a systematic review and meta- analysis of clinical trials , assessing the impact of information technology on changes in the levels of hemoglobin A1c ( HbA1c ) and mapping the interventions with chronic care model ( CCM ) elements .

In addition , the more CCM-incorporated the information technology-based interventions were , the more improvements there were in HbA1c levels . CONCLUSIONS Information technology strategies combined with the other elements of chronic care models are associated with improved glycemic control in people with diabetes . No clinical ly relevant impact was observed on low-density lipoprotein levels and blood pressure , but there was evidence that the cost of care was lower

BACKGROUND Information technology-based interventions are increasingly being used to manage health care . However , there is conflicting evidence regarding whether these interventions improve outcomes in people with type 2 diabetes . OBJECTIVE The objective of this study was to conduct a systematic review and meta- analysis of clinical trials , assessing the impact of information technology on changes in the levels of hemoglobin A1c ( HbA1c ) and mapping the interventions with chronic care model ( CCM ) elements .

A pragmatic cluster randomised controlled trial of a Diabetes REcall And Management system: the DREAM trial

Abstract Background Following the introduction of a computerised diabetes register in part of the northeast of Engl and , care initially improved but then plateaued . We therefore enhanced the existing diabetes register to address these problems . The aim of the trial was to evaluate the effectiveness and efficiency of an area wide ' extended , ' computerised diabetes register incorporating a full structured recall and management system , including individualised patient management prompts to primary care clinicians based on locally-adapted , evidence -based guidelines . Methods The study design was a pragmatic , cluster r and omised controlled trial , with the general practice as the unit of r and omisation . Set in 58 general practice s in three Primary Care Trusts in the northeast of Engl and , the study outcomes were the clinical process and outcome variables held on the diabetes register , patient-reported outcomes , and service and patient costs . The effect of the intervention was estimated using generalised linear models with an appropriate error structure . To allow for the clustering of patients within practice s , population averaged models were estimated using generalized estimating equations . Results Patients in intervention practice s were more likely to have at least one diabetes appointment recorded ( OR 2.00 , 95 % CI 1.02 , 3.91 ) , to have a recording of a foot check ( OR 1.87 , 95 % CI 1.09 , 3.21 ) , have a recording of receiving dietary advice ( OR 2.77 , 95 % CI 1.22 , 6.29 ) , and have a recording of blood pressure ( BP ) ( OR 2.14 , 95 % CI 1.06 , 4.36 ) . There was no difference in mean HbA1c or BP levels , but the mean cholesterol level in patients from intervention practice s was significantly lower ( -0.15 mmol/l , 95 % CI -0.25 , -0.06 ) . There were no differences in patient-reported outcomes or in patient-reported use of drugs , or uptake of health services . The average cost per patient was not significantly different between the intervention and control groups . Costs incurred in administering the system at the register and in general practice were in addition to these . Conclusion This study has shown benefits from an area-wide , computerised diabetes register incorporating a full structured recall and individualised patient management system . However , these benefits were achieved at a cost . In future , these costs may fall as electronic data exchange becomes a reliable reality . Trial registration : International St and ard R and omised Controlled Trial Number ( IS RCT N ) Register , IS RCT N32042030

In addition , the more CCM-incorporated the information technology-based interventions were , the more improvements there were in HbA1c levels . CONCLUSIONS Information technology strategies combined with the other elements of chronic care models are associated with improved glycemic control in people with diabetes . No clinical ly relevant impact was observed on low-density lipoprotein levels and blood pressure , but there was evidence that the cost of care was lower

BACKGROUND Information technology-based interventions are increasingly being used to manage health care . However , there is conflicting evidence regarding whether these interventions improve outcomes in people with type 2 diabetes . OBJECTIVE The objective of this study was to conduct a systematic review and meta- analysis of clinical trials , assessing the impact of information technology on changes in the levels of hemoglobin A1c ( HbA1c ) and mapping the interventions with chronic care model ( CCM ) elements .

In addition , the more CCM-incorporated the information technology-based interventions were , the more improvements there were in HbA1c levels . CONCLUSIONS Information technology strategies combined with the other elements of chronic care models are associated with improved glycemic control in people with diabetes . No clinical ly relevant impact was observed on low-density lipoprotein levels and blood pressure , but there was evidence that the cost of care was lower

BACKGROUND Information technology-based interventions are increasingly being used to manage health care . However , there is conflicting evidence regarding whether these interventions improve outcomes in people with type 2 diabetes . OBJECTIVE The objective of this study was to conduct a systematic review and meta- analysis of clinical trials , assessing the impact of information technology on changes in the levels of hemoglobin A1c ( HbA1c ) and mapping the interventions with chronic care model ( CCM ) elements .

An endocrinologist-supported intervention aimed at providers improves diabetes management in a primary care site: improving primary care of African Americans with diabetes (IPCAAD) 7.

OBJECTIVE Management of diabetes is frequently suboptimal in primary care setting s , where providers often fail to intensify therapy when glucose levels are high , a problem known as clinical inertia . We asked whether interventions targeting clinical inertia can improve outcomes . RESEARCH DESIGN AND METHODS A controlled trial over a 3-year period was conducted in a municipal hospital primary care clinic in a large academic medical center . We studied all patients ( 4,138 ) with type 2 diabetes who were seen in continuity clinics by 345 internal medicine residents and were r and omized to be control subjects or to receive one of three interventions . Instead of consultative advice , the interventions were hard copy computerized reminders that provided patient-specific recommendations for management at the time of each patient 's visit , individual face-to-face feedback on performance for 5 min every 2 weeks , or both . RESULTS Over an average patient follow-up of 15 months within the intervention site , improvements in and final HbA1c ( A1C ) with feedback + reminders ( deltaA1C 0.6 % , final A1C 7.46 % ) were significantly better than control ( deltaA1C 0.2 % , final A1C 7.84 % , P < 0.02 ) ; changes were smaller with feedback only and reminders only ( P = NS vs. control ) . Trends were similar but not significant with systolic blood pressure ( sBP ) and LDL cholesterol . Multivariable analysis showed that the feedback intervention independently facilitated attainment of American Diabetes Association goals for both A1C and sBP . Over a 2-year period , overall glycemic control improved in the intervention site but did not change in other primary care sites ( final A1C 7.5 vs. 8.2 % , P < 0.001 ) . CONCLUSIONS Feedback on performance aim ed at overcoming clinical inertia and given to internal medicine resident primary care providers improves glycemic control . Partnering generalists with diabetes specialists may be important to enhance diabetes management in other primary care setting

In addition , the more CCM-incorporated the information technology-based interventions were , the more improvements there were in HbA1c levels . CONCLUSIONS Information technology strategies combined with the other elements of chronic care models are associated with improved glycemic control in people with diabetes . No clinical ly relevant impact was observed on low-density lipoprotein levels and blood pressure , but there was evidence that the cost of care was lower

BACKGROUND Information technology-based interventions are increasingly being used to manage health care . However , there is conflicting evidence regarding whether these interventions improve outcomes in people with type 2 diabetes . OBJECTIVE The objective of this study was to conduct a systematic review and meta- analysis of clinical trials , assessing the impact of information technology on changes in the levels of hemoglobin A1c ( HbA1c ) and mapping the interventions with chronic care model ( CCM ) elements .

In addition , the more CCM-incorporated the information technology-based interventions were , the more improvements there were in HbA1c levels . CONCLUSIONS Information technology strategies combined with the other elements of chronic care models are associated with improved glycemic control in people with diabetes . No clinical ly relevant impact was observed on low-density lipoprotein levels and blood pressure , but there was evidence that the cost of care was lower

BACKGROUND Information technology-based interventions are increasingly being used to manage health care . However , there is conflicting evidence regarding whether these interventions improve outcomes in people with type 2 diabetes . OBJECTIVE The objective of this study was to conduct a systematic review and meta- analysis of clinical trials , assessing the impact of information technology on changes in the levels of hemoglobin A1c ( HbA1c ) and mapping the interventions with chronic care model ( CCM ) elements .

A controlled trial of web-based diabetes disease management: the MGH diabetes primary care improvement project.

OBJECTIVE To test effects of a web-based decision support tool , the diabetes Disease Management Application ( DMA ) , developed to improve evidence -based management of type 2 diabetes . RESEARCH DESIGN AND METHODS We conducted a group r and omized controlled trial of 12 intervention and 14 control staff providers and 307 intervention and 291 control patients with type 2 diabetes in a hospital-based internal medicine clinic . Providers were r and omly assigned from May 1998 through April 1999 to have access to the DMA ( intervention ) or not to have access ( control ) . The DMA displays interactive patient-specific clinical data , treatment advice , and links to other web-based care re sources . We compared patients in the intervention and control groups for changes in processes and outcomes of care from the year preceding the study through the year of the study by intention-to-treat analysis . RESULTS The DMA was used for 42 % of scheduled patient visits . The number of HbA(1c ) tests obtained per year increased significantly in the intervention group ( + 0.3 tests/year ) compared with the control group ( -0.04 tests/year , P = 0.008 ) , as did the number of LDL cholesterol tests ( intervention , + 0.2 tests/year ; control , + 0.01 tests/year ; P = 0.02 ) and the proportions of patients undergoing at least one foot examination per year ( intervention , + 9.8 % ; control , -0.7 % ; P = 0.003 ) . Levels of HbA(1c ) decreased by 0.2 in the intervention group and increased by 0.1 in the control group ( P = 0.09 ) ; proportions of patients with LDL cholesterol levels < 130 mg/dl increased by 20.3 % in the intervention group and 10.5 % in the control group ( P = 0.5 ) . CONCLUSIONS Web-based patient-specific decision support has the potential to improve evidence -based parameters of diabetes care

In addition , the more CCM-incorporated the information technology-based interventions were , the more improvements there were in HbA1c levels . CONCLUSIONS Information technology strategies combined with the other elements of chronic care models are associated with improved glycemic control in people with diabetes . No clinical ly relevant impact was observed on low-density lipoprotein levels and blood pressure , but there was evidence that the cost of care was lower

BACKGROUND Information technology-based interventions are increasingly being used to manage health care . However , there is conflicting evidence regarding whether these interventions improve outcomes in people with type 2 diabetes . OBJECTIVE The objective of this study was to conduct a systematic review and meta- analysis of clinical trials , assessing the impact of information technology on changes in the levels of hemoglobin A1c ( HbA1c ) and mapping the interventions with chronic care model ( CCM ) elements .

In addition , the more CCM-incorporated the information technology-based interventions were , the more improvements there were in HbA1c levels . CONCLUSIONS Information technology strategies combined with the other elements of chronic care models are associated with improved glycemic control in people with diabetes . No clinical ly relevant impact was observed on low-density lipoprotein levels and blood pressure , but there was evidence that the cost of care was lower

BACKGROUND Information technology-based interventions are increasingly being used to manage health care . However , there is conflicting evidence regarding whether these interventions improve outcomes in people with type 2 diabetes . OBJECTIVE The objective of this study was to conduct a systematic review and meta- analysis of clinical trials , assessing the impact of information technology on changes in the levels of hemoglobin A1c ( HbA1c ) and mapping the interventions with chronic care model ( CCM ) elements .

Impact of automated calls with nurse follow-up on diabetes treatment outcomes in a Department of Veterans Affairs Health Care System: a randomized controlled trial.

OBJECTIVE We evaluated automated telephone disease management ( ATDM ) with telephone nurse follow-up as a strategy for improving diabetes treatment processes and outcomes in Department of Veterans Affairs ( VA ) clinics . We also compared the results with those of a prior ATDM trial conducted in a county health care system . RESEARCH DESIGN AND METHODS A total of 272 VA patients with diabetes using hypoglycemic medications were r and omized . During the 1-year study period , intervention patients received biweekly ATDM health assessment and self-care education calls , and a nurse educator followed up with patients based on their ATDM assessment reports . Telephone surveys were used to measure patients ' self-care , symptoms , and satisfaction with care . Outpatient service use was evaluated using electronic data bases and self-reports , and glycemic control was measured by HbA1c and serum glucose testing . RESULTS At 12 months , intervention patients reported more frequent glucose self-monitoring and foot inspections than patients receiving usual care and were more likely to be seen in podiatry and diabetes specialty clinics . Intervention patients also were more likely than control patients to have had a cholesterol test . Among patients with baseline HbA1c levels > or = 8 % , mean end-point values were lower among intervention patients than control patients ( 8.7 vs. 9.2 % , respectively ; P = 0.04 ) . Among intervention and control patients with baseline values > or = 9 % , mean end-point values were 9.1 and 10.2 % , respectively ( P = 0.04 ) . At follow-up , intervention patients reported fewer symptoms of poor glycemic control than control patients and greater satisfaction with their health care . CONCLUSIONS This intervention improved the quality of VA diabetes care . Intervention effects for most end points replicated findings from the prior county clinic trial , although intervention-control differences in the current study were smaller because of the relatively good self-care and health status among the current study 's enrollees

In addition , the more CCM-incorporated the information technology-based interventions were , the more improvements there were in HbA1c levels . CONCLUSIONS Information technology strategies combined with the other elements of chronic care models are associated with improved glycemic control in people with diabetes . No clinical ly relevant impact was observed on low-density lipoprotein levels and blood pressure , but there was evidence that the cost of care was lower

BACKGROUND Information technology-based interventions are increasingly being used to manage health care . However , there is conflicting evidence regarding whether these interventions improve outcomes in people with type 2 diabetes . OBJECTIVE The objective of this study was to conduct a systematic review and meta- analysis of clinical trials , assessing the impact of information technology on changes in the levels of hemoglobin A1c ( HbA1c ) and mapping the interventions with chronic care model ( CCM ) elements .

In addition , the more CCM-incorporated the information technology-based interventions were , the more improvements there were in HbA1c levels . CONCLUSIONS Information technology strategies combined with the other elements of chronic care models are associated with improved glycemic control in people with diabetes . No clinical ly relevant impact was observed on low-density lipoprotein levels and blood pressure , but there was evidence that the cost of care was lower

BACKGROUND Information technology-based interventions are increasingly being used to manage health care . However , there is conflicting evidence regarding whether these interventions improve outcomes in people with type 2 diabetes . OBJECTIVE The objective of this study was to conduct a systematic review and meta- analysis of clinical trials , assessing the impact of information technology on changes in the levels of hemoglobin A1c ( HbA1c ) and mapping the interventions with chronic care model ( CCM ) elements .

Research Paper: A Randomized Trial Comparing Telemedicine Case Management with Usual Care in Older, Ethnically Diverse, Medically Underserved Patients with Diabetes Mellitus: 5 Year Results of the IDEATel Study

CONTEXT Telemedicine is a promising but largely unproven technology for providing case management services to patients with chronic conditions and lower access to care . OBJECTIVES To examine the effectiveness of a telemedicine intervention to achieve clinical management goals in older , ethnically diverse , medically underserved patients with diabetes . DESIGN , Setting , and Patients A r and omized controlled trial was conducted , comparing telemedicine case management to usual care , with blinded outcome evaluation , in 1,665 Medicare recipients with diabetes , aged > /= 55 years , residing in federally design ated medically underserved areas of New York State . Interventions Home telemedicine unit with nurse case management versus usual care . Main Outcome Measures The primary endpoints assessed over 5 years of follow-up were hemoglobin A1c ( HgbA1c ) , low density lipoprotein ( LDL ) cholesterol , and blood pressure levels . RESULTS Intention-to-treat mixed models showed that telemedicine achieved net overall reductions over five years of follow-up in the primary endpoints ( HgbA1c , p = 0.001 ; LDL , p < 0.001 ; systolic and diastolic blood pressure , p = 0.024 ; p < 0.001 ) . Estimated differences ( 95 % CI ) in year 5 were 0.29 ( 0.12 , 0.46)% for HgbA1c , 3.84 ( -0.08 , 7.77 ) mg/dL for LDL cholesterol , and 4.32 ( 1.93 , 6.72 ) mm Hg for systolic and 2.64 ( 1.53 , 3.74 ) mm Hg for diastolic blood pressure . There were 176 deaths in the intervention group and 169 in the usual care group ( hazard ratio 1.01 [ 0.82 , 1.24 ] ) . CONCLUSIONS Telemedicine case management result ed in net improvements in HgbA1c , LDL-cholesterol and blood pressure levels over 5 years in medically underserved Medicare beneficiaries . Mortality was not different between the groups , although power was limited . Trial Registration http:// clinical trials.gov Identifier : NCT00271739

In addition , the more CCM-incorporated the information technology-based interventions were , the more improvements there were in HbA1c levels . CONCLUSIONS Information technology strategies combined with the other elements of chronic care models are associated with improved glycemic control in people with diabetes . No clinical ly relevant impact was observed on low-density lipoprotein levels and blood pressure , but there was evidence that the cost of care was lower

BACKGROUND Information technology-based interventions are increasingly being used to manage health care . However , there is conflicting evidence regarding whether these interventions improve outcomes in people with type 2 diabetes . OBJECTIVE The objective of this study was to conduct a systematic review and meta- analysis of clinical trials , assessing the impact of information technology on changes in the levels of hemoglobin A1c ( HbA1c ) and mapping the interventions with chronic care model ( CCM ) elements .

In addition , the more CCM-incorporated the information technology-based interventions were , the more improvements there were in HbA1c levels . CONCLUSIONS Information technology strategies combined with the other elements of chronic care models are associated with improved glycemic control in people with diabetes . No clinical ly relevant impact was observed on low-density lipoprotein levels and blood pressure , but there was evidence that the cost of care was lower

BACKGROUND Information technology-based interventions are increasingly being used to manage health care . However , there is conflicting evidence regarding whether these interventions improve outcomes in people with type 2 diabetes . OBJECTIVE The objective of this study was to conduct a systematic review and meta- analysis of clinical trials , assessing the impact of information technology on changes in the levels of hemoglobin A1c ( HbA1c ) and mapping the interventions with chronic care model ( CCM ) elements .

The impact of planned care and a diabetes electronic management system on community-based diabetes care: the Mayo Health System Diabetes Translation Project.

OBJECTIVE The Mayo Health System Diabetes Translation Project sought to assess models of community-based diabetes care and use of a diabetes electronic management system ( DEMS ) . Planned care is a re design ed model of chronic disease care that involves guideline implementation , support of self-management , and use of clinical information systems . RESEARCH DESIGN AND METHODS We studied adult diabetic patients attending three primary care practice sites in Wisconsin and Minnesota . We implemented planned care at all sites and DEMS in the practice of 16 primary care providers . We assessed quality of diabetes care using st and ard indicators for 200 patients r and omly selected from each site at baseline and at 24 months of implementation . We used multivariable analyses to estimate the association between planned care and DEMS and each quality indicator . RESULTS Planned care was associated with improvements in measurement of HbA(1c ) ( odds ratio 7.0 [ 95 % CI 4.2 - 11.6 ] ) , HDL cholesterol ( 5.6 [ 4.1 - 7.5 ] ) , and microalbuminuria ( 5.3 [ 3.5 - 8.0 ] ) , as well as the provision of tobacco advice ( 6.9 [ 4.7 - 10.1 ] ) , among other performance measures . DEMS use was associated with improvements in all indicators , including microalbuminuria ( 3.2 [ 1.9 - 5.2 ] ) , retinal examination ( 2.4 [ 1.5 - 3.9 ] ) , foot examinations ( 2.3 [ 1.2 - 4.4 ] ) , and self-management support ( 2.6 [ 1.7 - 3.8 ] ) . Although planned care was associated with improvements in metabolic control , we observed no additional metabolic benefit when providers used DEMS . CONCLUSIONS Planned care was associated with improved performance and metabolic outcomes in primary care . DEMS use augmented the impact of planned care on performance outcomes but not on metabolic outcomes . Optimal identification of the best translation of evidence to diabetes practice will require longer follow-up or new care-delivery models

In addition , the more CCM-incorporated the information technology-based interventions were , the more improvements there were in HbA1c levels . CONCLUSIONS Information technology strategies combined with the other elements of chronic care models are associated with improved glycemic control in people with diabetes . No clinical ly relevant impact was observed on low-density lipoprotein levels and blood pressure , but there was evidence that the cost of care was lower

BACKGROUND Information technology-based interventions are increasingly being used to manage health care . However , there is conflicting evidence regarding whether these interventions improve outcomes in people with type 2 diabetes . OBJECTIVE The objective of this study was to conduct a systematic review and meta- analysis of clinical trials , assessing the impact of information technology on changes in the levels of hemoglobin A1c ( HbA1c ) and mapping the interventions with chronic care model ( CCM ) elements .

In addition , the more CCM-incorporated the information technology-based interventions were , the more improvements there were in HbA1c levels . CONCLUSIONS Information technology strategies combined with the other elements of chronic care models are associated with improved glycemic control in people with diabetes . No clinical ly relevant impact was observed on low-density lipoprotein levels and blood pressure , but there was evidence that the cost of care was lower

BACKGROUND Information technology-based interventions are increasingly being used to manage health care . However , there is conflicting evidence regarding whether these interventions improve outcomes in people with type 2 diabetes . OBJECTIVE The objective of this study was to conduct a systematic review and meta- analysis of clinical trials , assessing the impact of information technology on changes in the levels of hemoglobin A1c ( HbA1c ) and mapping the interventions with chronic care model ( CCM ) elements .

The D-Net diabetes self-management program: long-term implementation, outcomes, and generalization results.

BACKGROUND A prerequisite to translating research findings into practice is information on consistency of implementation , maintenance of results , and generalization of effects . This follow-up report is one of the few experimental studies to provide such information on Internet-based health education . METHODS We present follow-up data 10 months following r and omization on the " Diabetes Network ( D-Net ) " Internet-based self-management project , a r and omized trial evaluating the incremental effects of adding ( 1 ) tailored self-management training or ( 2 ) peer support components to a basic Internet-based , information-focused comparison intervention . Participants were 320 adult type 2 diabetes patients from participating primary care offices , mean age 59 ( SD = 9.2 ) , who were relatively novice Internet users . RESULTS All intervention components were consistently implemented by staff , but participant website usage decreased over time . All conditions were significantly improved from baseline on behavioral , psychosocial , and some biological outcomes ; and there were few differences between conditions . Results were robust across on-line coaches , patient characteristics , and participating clinics . CONCLUSIONS The basic D-Net intervention was implemented well and improvements were observed across a variety of patients , interventionists , and clinics . There were , however , difficulties in maintaining usage over time and additions of tailored self-management and peer support components generally did not significantly improve results

In addition , the more CCM-incorporated the information technology-based interventions were , the more improvements there were in HbA1c levels . CONCLUSIONS Information technology strategies combined with the other elements of chronic care models are associated with improved glycemic control in people with diabetes . No clinical ly relevant impact was observed on low-density lipoprotein levels and blood pressure , but there was evidence that the cost of care was lower

BACKGROUND Information technology-based interventions are increasingly being used to manage health care . However , there is conflicting evidence regarding whether these interventions improve outcomes in people with type 2 diabetes . OBJECTIVE The objective of this study was to conduct a systematic review and meta- analysis of clinical trials , assessing the impact of information technology on changes in the levels of hemoglobin A1c ( HbA1c ) and mapping the interventions with chronic care model ( CCM ) elements .

In addition , the more CCM-incorporated the information technology-based interventions were , the more improvements there were in HbA1c levels . CONCLUSIONS Information technology strategies combined with the other elements of chronic care models are associated with improved glycemic control in people with diabetes . No clinical ly relevant impact was observed on low-density lipoprotein levels and blood pressure , but there was evidence that the cost of care was lower

BACKGROUND Information technology-based interventions are increasingly being used to manage health care . However , there is conflicting evidence regarding whether these interventions improve outcomes in people with type 2 diabetes . OBJECTIVE The objective of this study was to conduct a systematic review and meta- analysis of clinical trials , assessing the impact of information technology on changes in the levels of hemoglobin A1c ( HbA1c ) and mapping the interventions with chronic care model ( CCM ) elements .

Chronic care model and shared care in diabetes: randomized trial of an electronic decision support system.

OBJECTIVE To assess the effect of a specialist telemedicine intervention for improving diabetes care using the chronic care model ( CCM ) . PARTICIPANTS AND METHODS As part of the CCM , 97 primary care physicians at 6 primary care practice s in Rochester , MN , referred 639 patients to an on-site diabetes educator between July 1 , 2001 , and December 31 , 2003 . On first referral , physicians were central ly r and omized to receive a telemedicine intervention ( specialty advice and evidence -based messages regarding medication management for cardiovascular risk ) or no intervention , keeping outcome assessors and data analysts blinded to group assignment . After each subsequent clinical encounter , endocrinologists review ed an abstract from the patient 's electronic medical record and provided management recommendations and supporting evidence to intervention physicians via e-mail . Control physicians received e-mail with periodic generic information about cardiovascular risk reduction in diabetes . Outcome measures included diabetes care processes ( diabetes test completion ) , outcomes ( metabolic and cardiovascular risk factors , estimated coronary artery disease risk ) , and patient costs ( payer perspective ) . RESULTS During the intervention , 951 ( 70 % ) of the 1361 endocrinology review s detected performance gaps and result ed in a message ; primary care physicians reported using 49 % of messages in patient care . With a mean of 21 months ' follow-up , the intervention , compared with control , did not significantly enhance metabolic outcomes or reduce estimated risk of coronary artery disease ( adjusted mean difference , -1 % ; 95 % confidence interval , -19 % to 17 % ) . The intervention group incurred lower costs ( P=.02 ) but not in diabetes-related costs . CONCLUSION Specialty telemedicine did not significantly enhance the value of CCM in primary care

In addition , the more CCM-incorporated the information technology-based interventions were , the more improvements there were in HbA1c levels . CONCLUSIONS Information technology strategies combined with the other elements of chronic care models are associated with improved glycemic control in people with diabetes . No clinical ly relevant impact was observed on low-density lipoprotein levels and blood pressure , but there was evidence that the cost of care was lower

BACKGROUND Information technology-based interventions are increasingly being used to manage health care . However , there is conflicting evidence regarding whether these interventions improve outcomes in people with type 2 diabetes . OBJECTIVE The objective of this study was to conduct a systematic review and meta- analysis of clinical trials , assessing the impact of information technology on changes in the levels of hemoglobin A1c ( HbA1c ) and mapping the interventions with chronic care model ( CCM ) elements .

In addition , the more CCM-incorporated the information technology-based interventions were , the more improvements there were in HbA1c levels . CONCLUSIONS Information technology strategies combined with the other elements of chronic care models are associated with improved glycemic control in people with diabetes . No clinical ly relevant impact was observed on low-density lipoprotein levels and blood pressure , but there was evidence that the cost of care was lower

BACKGROUND Information technology-based interventions are increasingly being used to manage health care . However , there is conflicting evidence regarding whether these interventions improve outcomes in people with type 2 diabetes . OBJECTIVE The objective of this study was to conduct a systematic review and meta- analysis of clinical trials , assessing the impact of information technology on changes in the levels of hemoglobin A1c ( HbA1c ) and mapping the interventions with chronic care model ( CCM ) elements .

The Effect of Intensive Treatment of Diabetes on the Development and Progression of Long‐Term Complications in Insulin‐Dependent Diabetes Mellitus

BACKGROUND Long-term microvascular and neurologic complications cause major morbidity and mortality in patients with insulin-dependent diabetes mellitus ( IDDM ) . We examined whether intensive treatment with the goal of maintaining blood glucose concentrations close to the normal range could decrease the frequency and severity of these complications . METHODS A total of 1441 patients with IDDM--726 with no retinopathy at base line ( the primary -prevention cohort ) and 715 with mild retinopathy ( the secondary -intervention cohort ) were r and omly assigned to intensive therapy administered either with an external insulin pump or by three or more daily insulin injections and guided by frequent blood glucose monitoring or to conventional therapy with one or two daily insulin injections . The patients were followed for a mean of 6.5 years , and the appearance and progression of retinopathy and other complications were assessed regularly . RESULTS In the primary -prevention cohort , intensive therapy reduced the adjusted mean risk for the development of retinopathy by 76 percent ( 95 percent confidence interval , 62 to 85 percent ) , as compared with conventional therapy . In the secondary -intervention cohort , intensive therapy slowed the progression of retinopathy by 54 percent ( 95 percent confidence interval , 39 to 66 percent ) and reduced the development of proliferative or severe nonproliferative retinopathy by 47 percent ( 95 percent confidence interval , 14 to 67 percent ) . In the two cohorts combined , intensive therapy reduced the occurrence of microalbuminuria ( urinary albumin excretion of > or = 40 mg per 24 hours ) by 39 percent ( 95 percent confidence interval , 21 to 52 percent ) , that of albuminuria ( urinary albumin excretion of > or = 300 mg per 24 hours ) by 54 percent ( 95 percent confidence interval 19 to 74 percent ) , and that of clinical neuropathy by 60 percent ( 95 percent confidence interval , 38 to 74 percent ) . The chief adverse event associated with intensive therapy was a two-to-threefold increase in severe hypoglycemia . CONCLUSIONS Intensive therapy effectively delays the onset and slows the progression of diabetic retinopathy , nephropathy , and neuropathy in patients with IDDM

In addition , the more CCM-incorporated the information technology-based interventions were , the more improvements there were in HbA1c levels . CONCLUSIONS Information technology strategies combined with the other elements of chronic care models are associated with improved glycemic control in people with diabetes . No clinical ly relevant impact was observed on low-density lipoprotein levels and blood pressure , but there was evidence that the cost of care was lower

BACKGROUND Information technology-based interventions are increasingly being used to manage health care . However , there is conflicting evidence regarding whether these interventions improve outcomes in people with type 2 diabetes . OBJECTIVE The objective of this study was to conduct a systematic review and meta- analysis of clinical trials , assessing the impact of information technology on changes in the levels of hemoglobin A1c ( HbA1c ) and mapping the interventions with chronic care model ( CCM ) elements .

In addition , the more CCM-incorporated the information technology-based interventions were , the more improvements there were in HbA1c levels . CONCLUSIONS Information technology strategies combined with the other elements of chronic care models are associated with improved glycemic control in people with diabetes . No clinical ly relevant impact was observed on low-density lipoprotein levels and blood pressure , but there was evidence that the cost of care was lower

BACKGROUND Information technology-based interventions are increasingly being used to manage health care . However , there is conflicting evidence regarding whether these interventions improve outcomes in people with type 2 diabetes . OBJECTIVE The objective of this study was to conduct a systematic review and meta- analysis of clinical trials , assessing the impact of information technology on changes in the levels of hemoglobin A1c ( HbA1c ) and mapping the interventions with chronic care model ( CCM ) elements .

Individualized electronic decision support and reminders to improve diabetes care in the community: COMPETE II randomized trial

Background : Diabetes mellitus is a complex disease with serious complications . Electronic decision support , providing information that is shared and discussed by both patient and physician , encourages timely interventions and may improve the management of this chronic disease . However , it has rarely been tested in community-based primary care . Methods : In this pragmatic r and omized trial , we r and omly assigned adult primary care patients with type 2 diabetes to receive the intervention or usual care . The intervention involved shared access by the primary care provider and the patient to a Web-based , colour-coded diabetes tracker , which provided sequential monitoring values for 13 diabetes risk factors , their respective targets and brief , prioritized messages of advice . The primary outcome measure was a process composite score . Secondary outcomes included clinical composite scores , quality of life , continuity of care and usability . The outcome assessors were blinded to each patient ’s intervention status . Results : We recruited sequentially 46 primary care providers and then 511 of their patients ( mean age 60.7 [ st and ard deviation 12.5 ] years ) . Mean follow-up was 5.9 months . The process composite score was significantly better for patients in the intervention group than for control patients ( difference 1.27 , 95 % confidence interval [ CI ] 0.79–1.75 , p < 0.001 ) ; 61.7 % ( 156/253 ) of patients in the intervention group , compared with 42.6 % ( 110/258 ) of control patients , showed improvement ( difference 19.1 % , p < 0.001 ) . The clinical composite score also had significantly more variables with improvement for the intervention group ( 0.59 , 95 % CI 0.09–1.10 , p = 0.02 ) , including significantly greater declines in blood pressure ( −3.95 mm Hg systolic and −2.38 mm Hg diastolic ) and glycated hemoglobin ( −0.2 % ) . Patients in the intervention group reported greater satisfaction with their diabetes care . Interpretation : A shared electronic decision-support system to support the primary care of diabetes improved the process of care and some clinical markers of the quality of diabetes care . ( Clinical Trials.gov trial register no. NCT00813085 .

In addition , the more CCM-incorporated the information technology-based interventions were , the more improvements there were in HbA1c levels . CONCLUSIONS Information technology strategies combined with the other elements of chronic care models are associated with improved glycemic control in people with diabetes . No clinical ly relevant impact was observed on low-density lipoprotein levels and blood pressure , but there was evidence that the cost of care was lower

BACKGROUND Information technology-based interventions are increasingly being used to manage health care . However , there is conflicting evidence regarding whether these interventions improve outcomes in people with type 2 diabetes . OBJECTIVE The objective of this study was to conduct a systematic review and meta- analysis of clinical trials , assessing the impact of information technology on changes in the levels of hemoglobin A1c ( HbA1c ) and mapping the interventions with chronic care model ( CCM ) elements .

In addition , the more CCM-incorporated the information technology-based interventions were , the more improvements there were in HbA1c levels . CONCLUSIONS Information technology strategies combined with the other elements of chronic care models are associated with improved glycemic control in people with diabetes . No clinical ly relevant impact was observed on low-density lipoprotein levels and blood pressure , but there was evidence that the cost of care was lower

BACKGROUND Information technology-based interventions are increasingly being used to manage health care . However , there is conflicting evidence regarding whether these interventions improve outcomes in people with type 2 diabetes . OBJECTIVE The objective of this study was to conduct a systematic review and meta- analysis of clinical trials , assessing the impact of information technology on changes in the levels of hemoglobin A1c ( HbA1c ) and mapping the interventions with chronic care model ( CCM ) elements .

The effects of a web-based intervention on the physical outcomes associated with diabetes among adults age 60 and older: a randomized trial.

BACKGROUND The emergence of the World Wide Web in the last decade has made it feasible for the Internet to be a vehicle for chronic disease management . METHODS A r and omized controlled trial ( n = 62 ) testing the effects of a 6-month web-based intervention plus usual care , compared with usual care alone , among adults 60 years of age and older with diabetes . The outcomes were hemoglobin A1c ( HbA1c ) , blood pressure , weight , cholesterol , and high-density lipoprotein ( HDL ) levels . RESULTS A multivariate analysis of covariance controlling for all baseline outcome variables , age , gender , and number of years with diabetes showed significant ( P = 0.001 ) reductions in HbA1c , weight , and cholesterol level and significant improvement in HDL levels in the intervention versus the control group . CONCLUSIONS Findings show a web-based intervention was effective in improving HbA1c , weight , cholesterol , and HDL levels at a 6-month follow-up . Future research is needed to investigate the long-term effectiveness of web-based interventions

In addition , the more CCM-incorporated the information technology-based interventions were , the more improvements there were in HbA1c levels . CONCLUSIONS Information technology strategies combined with the other elements of chronic care models are associated with improved glycemic control in people with diabetes . No clinical ly relevant impact was observed on low-density lipoprotein levels and blood pressure , but there was evidence that the cost of care was lower

BACKGROUND Information technology-based interventions are increasingly being used to manage health care . However , there is conflicting evidence regarding whether these interventions improve outcomes in people with type 2 diabetes . OBJECTIVE The objective of this study was to conduct a systematic review and meta- analysis of clinical trials , assessing the impact of information technology on changes in the levels of hemoglobin A1c ( HbA1c ) and mapping the interventions with chronic care model ( CCM ) elements .

In addition , the more CCM-incorporated the information technology-based interventions were , the more improvements there were in HbA1c levels . CONCLUSIONS Information technology strategies combined with the other elements of chronic care models are associated with improved glycemic control in people with diabetes . No clinical ly relevant impact was observed on low-density lipoprotein levels and blood pressure , but there was evidence that the cost of care was lower

BACKGROUND Information technology-based interventions are increasingly being used to manage health care . However , there is conflicting evidence regarding whether these interventions improve outcomes in people with type 2 diabetes . OBJECTIVE The objective of this study was to conduct a systematic review and meta- analysis of clinical trials , assessing the impact of information technology on changes in the levels of hemoglobin A1c ( HbA1c ) and mapping the interventions with chronic care model ( CCM ) elements .

Use of a Registry-generated Audit, Feedback, and Patient Reminder Intervention in an Internal Medicine Resident Clinic—A Randomized Trial

BACKGROUND Disease registries , audit and feedback , and clinical reminders have been reported to improve care processes . OBJECTIVE To assess the effects of a registry-generated audit , feedback , and patient reminder intervention on diabetes care . DESIGN R and omized controlled trial conducted in a resident continuity clinic during the 2003–2004 academic year . PARTICIPANTS Seventy-eight categorical Internal Medicine residents caring for 483 diabetic patients participated . Residents r and omized to the intervention ( n = 39 ) received instruction on diabetes registry use ; quarterly performance audit , feedback , and written reports identifying patients needing care ; and had letters sent quarterly to patients needing hemoglobin A1c or cholesterol testing . Residents r and omized to the control group ( n = 39 ) received usual clinic education . MEASUREMENTS Hemoglobin A1c and lipid monitoring , and the achievement of intermediate clinical outcomes ( hemoglobin A1c < 7.0 % , LDL cholesterol < 100 mg/dL , and blood pressure < 130/85 mmHg ) were assessed . RESULTS Patients cared for by residents in the intervention group had higher adherence to guideline recommendations for hemoglobin A1c testing ( 61.5 % vs 48.1 % , p = .01 ) and LDL testing ( 75.8 % vs 64.1 % , p = .02 ) . Intermediate clinical outcomes were not different between groups . CONCLUSIONS Use of a registry-generated audit , feedback , and patient reminder intervention in a resident continuity clinic modestly improved diabetes care processes , but did not influence intermediate clinical outcomes

In addition , the more CCM-incorporated the information technology-based interventions were , the more improvements there were in HbA1c levels . CONCLUSIONS Information technology strategies combined with the other elements of chronic care models are associated with improved glycemic control in people with diabetes . No clinical ly relevant impact was observed on low-density lipoprotein levels and blood pressure , but there was evidence that the cost of care was lower

BACKGROUND Information technology-based interventions are increasingly being used to manage health care . However , there is conflicting evidence regarding whether these interventions improve outcomes in people with type 2 diabetes . OBJECTIVE The objective of this study was to conduct a systematic review and meta- analysis of clinical trials , assessing the impact of information technology on changes in the levels of hemoglobin A1c ( HbA1c ) and mapping the interventions with chronic care model ( CCM ) elements .

In addition , the more CCM-incorporated the information technology-based interventions were , the more improvements there were in HbA1c levels . CONCLUSIONS Information technology strategies combined with the other elements of chronic care models are associated with improved glycemic control in people with diabetes . No clinical ly relevant impact was observed on low-density lipoprotein levels and blood pressure , but there was evidence that the cost of care was lower

BACKGROUND Information technology-based interventions are increasingly being used to manage health care . However , there is conflicting evidence regarding whether these interventions improve outcomes in people with type 2 diabetes . OBJECTIVE The objective of this study was to conduct a systematic review and meta- analysis of clinical trials , assessing the impact of information technology on changes in the levels of hemoglobin A1c ( HbA1c ) and mapping the interventions with chronic care model ( CCM ) elements .

Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35): prospective observational study

Abstract Objective : To determine the relation between exposure to glycaemia over time and the risk of macrovascular or microvascular complications in patients with type 2 diabetes . Design : Prospect i ve observational study . Setting : 23 hospital based clinics in Engl and , Scotl and , and Northern Irel and . Participants : 4585 white , Asian Indian , and Afro-Caribbean UKPDS patients , whether r and omised or not to treatment , were included in analyses of incidence ; of these , 3642 were included in analyses of relative risk . Outcome measures : Primary predefined aggregate clinical outcomes : any end point or deaths related to diabetes and all cause mortality . Secondary aggregate outcomes : myocardial infa rct ion , stroke , amputation ( including death from peripheral vascular disease ) , and microvascular disease ( predominantly retinal photo-coagulation ) . Single end points : non-fatal heart failure and cataract extraction . Risk reduction associated with a 1 % reduction in up date d mean HbA1c adjusted for possible confounders at diagnosis of diabetes . Results : The incidence of clinical complications was significantly associated with glycaemia . Each 1 % reduction in up date d mean HbA1c was associated with reductions in risk of 21 % for any end point related to diabetes ( 95 % confidence interval 17 % to 24 % , P<0.0001 ) , 21 % for deaths related to diabetes ( 15 % to 27 % , P<0.0001 ) , 14 % for myocardial infa rct ion ( 8 % to 21 % , P<0.0001 ) , and 37 % for microvascular complications ( 33 % to 41 % , P<0.0001 ) . No threshold of risk was observed for any end point . Conclusions : In patients with type 2 diabetes the risk of diabetic complications was strongly associated with previous hyperglycaemia . Any reduction in HbA1c is likely to reduce the risk of complications , with the lowest risk being in those with HbA1c values in the normal range ( < 6.0 % )

In addition , the more CCM-incorporated the information technology-based interventions were , the more improvements there were in HbA1c levels . CONCLUSIONS Information technology strategies combined with the other elements of chronic care models are associated with improved glycemic control in people with diabetes . No clinical ly relevant impact was observed on low-density lipoprotein levels and blood pressure , but there was evidence that the cost of care was lower

BACKGROUND Information technology-based interventions are increasingly being used to manage health care . However , there is conflicting evidence regarding whether these interventions improve outcomes in people with type 2 diabetes . OBJECTIVE The objective of this study was to conduct a systematic review and meta- analysis of clinical trials , assessing the impact of information technology on changes in the levels of hemoglobin A1c ( HbA1c ) and mapping the interventions with chronic care model ( CCM ) elements .

In addition , the more CCM-incorporated the information technology-based interventions were , the more improvements there were in HbA1c levels . CONCLUSIONS Information technology strategies combined with the other elements of chronic care models are associated with improved glycemic control in people with diabetes . No clinical ly relevant impact was observed on low-density lipoprotein levels and blood pressure , but there was evidence that the cost of care was lower

BACKGROUND Information technology-based interventions are increasingly being used to manage health care . However , there is conflicting evidence regarding whether these interventions improve outcomes in people with type 2 diabetes . OBJECTIVE The objective of this study was to conduct a systematic review and meta- analysis of clinical trials , assessing the impact of information technology on changes in the levels of hemoglobin A1c ( HbA1c ) and mapping the interventions with chronic care model ( CCM ) elements .

Practice-linked online personal health records for type 2 diabetes mellitus: a randomized controlled trial.

BACKGROUND Web-based personal health records ( PHRs ) have been advocated as a means to improve type 2 diabetes mellitus ( DM ) care . However , few Web-based systems are linked directly to the electronic medical record ( EMR ) used by physicians . METHODS We r and omized 11 primary care practice s. Intervention practice s received access to a DM-specific PHR that imported clinical and medications data , provided patient-tailored decision support , and enabled the patient to author a " Diabetes Care Plan " for electronic su bmi ssion to their physician prior to upcoming appointments . Active control practice s received a PHR to up date and su bmi t family history and health maintenance information . All patients attending these practice s were encouraged to sign up for online access . RESULTS We enrolled 244 patients with DM ( 37 % of the eligible population with registered online access , 4 % of the overall population of patients with DM ) . Study participants were younger ( mean age , 56.1 years vs 60.3 years ; P < .001 ) and lived in higher-income neighborhoods ( median income , $ 53,784 vs $ 49,713 ; P < .001 ) but had similar baseline glycemic control compared with non participants . More patients in the intervention arm had their DM treatment regimens adjusted ( 53 % vs 15 % ; P < .001 ) compared with active controls . However , there were no significant differences in risk factor control between study arms after 1 year ( P = .53 ) . CONCLUSIONS Previsit use of online PHR linked to the EMR increased rates of DM-related medication adjustment . Low rates of online patient account registration and good baseline control among participants limited the intervention 's impact on overall risk factor control . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00251875

In addition , the more CCM-incorporated the information technology-based interventions were , the more improvements there were in HbA1c levels . CONCLUSIONS Information technology strategies combined with the other elements of chronic care models are associated with improved glycemic control in people with diabetes . No clinical ly relevant impact was observed on low-density lipoprotein levels and blood pressure , but there was evidence that the cost of care was lower

BACKGROUND Information technology-based interventions are increasingly being used to manage health care . However , there is conflicting evidence regarding whether these interventions improve outcomes in people with type 2 diabetes . OBJECTIVE The objective of this study was to conduct a systematic review and meta- analysis of clinical trials , assessing the impact of information technology on changes in the levels of hemoglobin A1c ( HbA1c ) and mapping the interventions with chronic care model ( CCM ) elements .

In addition , the more CCM-incorporated the information technology-based interventions were , the more improvements there were in HbA1c levels . CONCLUSIONS Information technology strategies combined with the other elements of chronic care models are associated with improved glycemic control in people with diabetes . No clinical ly relevant impact was observed on low-density lipoprotein levels and blood pressure , but there was evidence that the cost of care was lower

BACKGROUND Information technology-based interventions are increasingly being used to manage health care . However , there is conflicting evidence regarding whether these interventions improve outcomes in people with type 2 diabetes . OBJECTIVE The objective of this study was to conduct a systematic review and meta- analysis of clinical trials , assessing the impact of information technology on changes in the levels of hemoglobin A1c ( HbA1c ) and mapping the interventions with chronic care model ( CCM ) elements .

Impact of computer-generated personalized goals on HbA(1c).

OBJECTIVE The public is increasingly aware of the importance of HbA(1c ) testing , yet the vast majority of patients with diabetes do not know their HbA(1c ) status or goal . We set forth to evaluate the impact of a system that provides uniquely formatted and personalized reports of diabetes status and goals on changes in HbA(1c ) levels . RESEARCH DESIGN AND METHODS A total of 150 patients with diabetes were r and omized to receive either st and ard care or intervention inclusive of a computer-generated 11 " x 17 " color poster depicting an individual 's HbA(1c ) status and goals along with personalized steps to aid in goal achievement . All patients enrolled received diabetes education during the 3 months before enrollment . HbA(1c ) was performed at baseline and 6 months . RESULTS At baseline , there were no significant differences between patient groups in terms of age , sex , education level , race , and HbA(1c ) or lipid levels . Among patients with baseline HbA(1c ) > or = 7.0 % , there was an 8.6 % ( 0.77 % absolute ) reduction in HbA(1c ) among control subjects compared with a 17.0 % ( 1.69 % absolute ) decline in the intervention group ( P = 0.032 ) . There were no differences between the control and intervention groups with respect to the frequency of patients experiencing any decline in HbA(1c ) ( 63 vs. 69 % , P = 0.87 ) ; among these patients experiencing a decline , the most substantial reductions were seen with the control group , which had a 13.3 % ( 1.15 % absolute ) decline compared with the intervention patients , who reduced their HbA(1c ) by 24.2 % ( 2.26 % absolute reduction ; P = 0.0048 ) . At study close , 77 % of the patients had their poster displayed on their refrigerator . CONCLUSIONS This unique and personalized computer-generated intervention result ed in HbA(1c ) lowering comparable to that of hypoglycemic agents

In addition , the more CCM-incorporated the information technology-based interventions were , the more improvements there were in HbA1c levels . CONCLUSIONS Information technology strategies combined with the other elements of chronic care models are associated with improved glycemic control in people with diabetes . No clinical ly relevant impact was observed on low-density lipoprotein levels and blood pressure , but there was evidence that the cost of care was lower

BACKGROUND Information technology-based interventions are increasingly being used to manage health care . However , there is conflicting evidence regarding whether these interventions improve outcomes in people with type 2 diabetes . OBJECTIVE The objective of this study was to conduct a systematic review and meta- analysis of clinical trials , assessing the impact of information technology on changes in the levels of hemoglobin A1c ( HbA1c ) and mapping the interventions with chronic care model ( CCM ) elements .

In addition , the more CCM-incorporated the information technology-based interventions were , the more improvements there were in HbA1c levels . CONCLUSIONS Information technology strategies combined with the other elements of chronic care models are associated with improved glycemic control in people with diabetes . No clinical ly relevant impact was observed on low-density lipoprotein levels and blood pressure , but there was evidence that the cost of care was lower

BACKGROUND Information technology-based interventions are increasingly being used to manage health care . However , there is conflicting evidence regarding whether these interventions improve outcomes in people with type 2 diabetes . OBJECTIVE The objective of this study was to conduct a systematic review and meta- analysis of clinical trials , assessing the impact of information technology on changes in the levels of hemoglobin A1c ( HbA1c ) and mapping the interventions with chronic care model ( CCM ) elements .

Do automated calls with nurse follow-up improve self-care and glycemic control among vulnerable patients with diabetes?

PURPOSE We sought to evaluate the effect of automated telephone assessment and self-care education calls with nurse follow-up on the management of diabetes . SUBJECTS AND METHODS We enrolled 280 English- or Spanish-speaking adults with diabetes who were using hypoglycemic medications and who were treated in a county health care system . Patients were r and omly assigned to usual care or to receive an intervention that consisted of usual care plus bi-weekly automated assessment and self-care education calls with telephone follow-up by a nurse educator . Outcomes measured at 12 months included survey-reported self-care , perceived glycemic control , and symptoms , as well as glycosylated hemoglobin ( Hb A1c ) and serum glucose levels . RESULTS We collected follow-up data for 89 % of enrollees ( 248 patients ) . Compared with usual care patients , intervention patients reported more frequent glucose monitoring , foot inspection , and weight monitoring , and fewer problems with medication adherence ( all P -0.03 ) . Follow-up Hb A , , levels were 0.3 % lower in the intervention group ( P = 0.1 ) , and about twice as many intervention patients had Hb A1c levels within the normal range ( P = 0.04 ) . Serum glucose levels were 41 mg/dL lower among intervention patients than usual care patients ( P = 0.002 ) . Intervention patients also reported better glycemic control ( P = 0.005 ) and fewer diabetic symptoms ( P < 0.0001 ) , including fewer symptoms of hyperglycemia and hypoglycemia . CONCLUSIONS Automated calls with telephone nurse follow-up may be an effective strategy for improving self-care behavior and glycemic control , and for decreasing symptoms among vulnerable patients with diabetes

In addition , the more CCM-incorporated the information technology-based interventions were , the more improvements there were in HbA1c levels . CONCLUSIONS Information technology strategies combined with the other elements of chronic care models are associated with improved glycemic control in people with diabetes . No clinical ly relevant impact was observed on low-density lipoprotein levels and blood pressure , but there was evidence that the cost of care was lower

BACKGROUND Information technology-based interventions are increasingly being used to manage health care . However , there is conflicting evidence regarding whether these interventions improve outcomes in people with type 2 diabetes . OBJECTIVE The objective of this study was to conduct a systematic review and meta- analysis of clinical trials , assessing the impact of information technology on changes in the levels of hemoglobin A1c ( HbA1c ) and mapping the interventions with chronic care model ( CCM ) elements .

In addition , the more CCM-incorporated the information technology-based interventions were , the more improvements there were in HbA1c levels . CONCLUSIONS Information technology strategies combined with the other elements of chronic care models are associated with improved glycemic control in people with diabetes . No clinical ly relevant impact was observed on low-density lipoprotein levels and blood pressure , but there was evidence that the cost of care was lower

BACKGROUND Information technology-based interventions are increasingly being used to manage health care . However , there is conflicting evidence regarding whether these interventions improve outcomes in people with type 2 diabetes . OBJECTIVE The objective of this study was to conduct a systematic review and meta- analysis of clinical trials , assessing the impact of information technology on changes in the levels of hemoglobin A1c ( HbA1c ) and mapping the interventions with chronic care model ( CCM ) elements .

Evaluating the impact of mobile telephone technology on type 2 diabetic patients' self-management: the NICHE pilot study.

RATIONALE , AIMS AND OBJECTIVES Utilizing information technology , such as Internet and cellphones , holds great promise in enhancing diabetic care . Yet few studies have examined the impact of cellphone technology on type 2 diabetics ' self-care . The primary aim of the study is to examine the feasibility of utilizing this technology to assist with diabetes self-care in a clinic population as well as its impact on clinical outcomes . METHODS Thirty patients with a diagnosis of type 2 diabetes at two Community Health Centers were r and omized to intervention or control . Intervention patients participated in a brief intervention and received tailored daily messages via cellphone prompting them to enhance their diabetic self-care behaviour . Patients at the control site continued with their st and ard diabetes self-management . RESULTS A mean improvement in HbA1c levels was apparent ( -0.1 , SD = 0.3 % ; P = 0.1534 ) in the intervention group , compared with a mean deterioration in the control ( 0.3 , SD = 1.0 % ; P = 0.3813 ) , yet without statistical significance . Self-efficacy scores improved significantly in the intervention group ( -0.5 , SD = 0.6 ; P = 0.0080 ) compared with no improvement in the control ( 0.0 , SD = 1.0 ; P = 0.9060 ) . Participants encountered numerous technological barriers when attempting to adhere to the intervention protocol . CONCLUSION The results indicate the intervention had a positive impact on some clinical outcome and self-efficacy . Although the technology appears feasible in a clinical setting technology must be made more user-friendly before a larger phase II trial is conducted

In addition , the more CCM-incorporated the information technology-based interventions were , the more improvements there were in HbA1c levels . CONCLUSIONS Information technology strategies combined with the other elements of chronic care models are associated with improved glycemic control in people with diabetes . No clinical ly relevant impact was observed on low-density lipoprotein levels and blood pressure , but there was evidence that the cost of care was lower

BACKGROUND Information technology-based interventions are increasingly being used to manage health care . However , there is conflicting evidence regarding whether these interventions improve outcomes in people with type 2 diabetes . OBJECTIVE The objective of this study was to conduct a systematic review and meta- analysis of clinical trials , assessing the impact of information technology on changes in the levels of hemoglobin A1c ( HbA1c ) and mapping the interventions with chronic care model ( CCM ) elements .

In addition , the more CCM-incorporated the information technology-based interventions were , the more improvements there were in HbA1c levels . CONCLUSIONS Information technology strategies combined with the other elements of chronic care models are associated with improved glycemic control in people with diabetes . No clinical ly relevant impact was observed on low-density lipoprotein levels and blood pressure , but there was evidence that the cost of care was lower

BACKGROUND Information technology-based interventions are increasingly being used to manage health care . However , there is conflicting evidence regarding whether these interventions improve outcomes in people with type 2 diabetes . OBJECTIVE The objective of this study was to conduct a systematic review and meta- analysis of clinical trials , assessing the impact of information technology on changes in the levels of hemoglobin A1c ( HbA1c ) and mapping the interventions with chronic care model ( CCM ) elements .

Telemedicine improved diabetic management.

Effective control of diabetes is known to delay or prevent the end-organ complications of this disease . Can telemedicine improve a patient 's ability to self-manage diabetes ? Twenty-eight patients entered a study comparing home telemedicine consultation with st and ard outpatient care . A nurse case manager contacted the telemedicine group once a week under the direction of a primary care physician , who contacted the telemedicine group once a month . Laboratory studies and total body weight were measured at the beginning and at the end of the 3-month study . The hemoglobin A1c ( HbA1c ) and total body weight improved significantly in the intervention ( telemedicine ) group , as shown by a 16 % reduction in mean HbA1c level ( from 9.5 to 8.2 % ) and a 4 % mean weight reduction ( from 214.3 to 206.7 pounds ) . Based on our experience , we present a functionally based telemedicine classification system to improve the application of electronic medicine in future studies

In addition , the more CCM-incorporated the information technology-based interventions were , the more improvements there were in HbA1c levels . CONCLUSIONS Information technology strategies combined with the other elements of chronic care models are associated with improved glycemic control in people with diabetes . No clinical ly relevant impact was observed on low-density lipoprotein levels and blood pressure , but there was evidence that the cost of care was lower

BACKGROUND Information technology-based interventions are increasingly being used to manage health care . However , there is conflicting evidence regarding whether these interventions improve outcomes in people with type 2 diabetes . OBJECTIVE The objective of this study was to conduct a systematic review and meta- analysis of clinical trials , assessing the impact of information technology on changes in the levels of hemoglobin A1c ( HbA1c ) and mapping the interventions with chronic care model ( CCM ) elements .

In addition , the more CCM-incorporated the information technology-based interventions were , the more improvements there were in HbA1c levels . CONCLUSIONS Information technology strategies combined with the other elements of chronic care models are associated with improved glycemic control in people with diabetes . No clinical ly relevant impact was observed on low-density lipoprotein levels and blood pressure , but there was evidence that the cost of care was lower

BACKGROUND Information technology-based interventions are increasingly being used to manage health care . However , there is conflicting evidence regarding whether these interventions improve outcomes in people with type 2 diabetes . OBJECTIVE The objective of this study was to conduct a systematic review and meta- analysis of clinical trials , assessing the impact of information technology on changes in the levels of hemoglobin A1c ( HbA1c ) and mapping the interventions with chronic care model ( CCM ) elements .

Health information technology and physician perceptions of quality of care and satisfaction.

OBJECTIVE To examine across seven countries the relationship between physician office information system capacity and the quality of care . DESIGN Multivariate analysis of a cross-sectional 2006 r and om survey of primary care physicians in seven countries : Australia , Canada , Germany , the Netherl and s , New Zeal and , United Kingdom , and United States . MAIN OUTCOME MEASURES coordination and safety of care , care for chronically ill patients , and satisfaction with practice of medicine . RESULTS The study finds significant disparities in the quality of health care between practice s with low information system capacity and those with high technical capacity after controlling for within country differences and practice size . There were significant physician satisfaction differences with the overall experience of practicing medicine by information system level . CONCLUSIONS For policy leaders , the seven-nation survey suggests that health systems that promote information system infrastructure are better able to address coordination and safety issues , particularly for patients with multiple chronic conditions , as well as to maintain primary care physician workforce satisfaction

In addition , the more CCM-incorporated the information technology-based interventions were , the more improvements there were in HbA1c levels . CONCLUSIONS Information technology strategies combined with the other elements of chronic care models are associated with improved glycemic control in people with diabetes . No clinical ly relevant impact was observed on low-density lipoprotein levels and blood pressure , but there was evidence that the cost of care was lower

BACKGROUND Information technology-based interventions are increasingly being used to manage health care . However , there is conflicting evidence regarding whether these interventions improve outcomes in people with type 2 diabetes . OBJECTIVE The objective of this study was to conduct a systematic review and meta- analysis of clinical trials , assessing the impact of information technology on changes in the levels of hemoglobin A1c ( HbA1c ) and mapping the interventions with chronic care model ( CCM ) elements .

In addition , the more CCM-incorporated the information technology-based interventions were , the more improvements there were in HbA1c levels . CONCLUSIONS Information technology strategies combined with the other elements of chronic care models are associated with improved glycemic control in people with diabetes . No clinical ly relevant impact was observed on low-density lipoprotein levels and blood pressure , but there was evidence that the cost of care was lower

BACKGROUND Information technology-based interventions are increasingly being used to manage health care . However , there is conflicting evidence regarding whether these interventions improve outcomes in people with type 2 diabetes . OBJECTIVE The objective of this study was to conduct a systematic review and meta- analysis of clinical trials , assessing the impact of information technology on changes in the levels of hemoglobin A1c ( HbA1c ) and mapping the interventions with chronic care model ( CCM ) elements .

Impact of Electronic Health Record Clinical Decision Support on Diabetes Care: A Randomized Trial

PURPOSE We wanted to assess the impact of an electronic health record – based diabetes clinical decision support system on control of hemoglobin A1c ( glycated hemoglobin ) , blood pressure , and low-density lipoprotein ( LDL ) cholesterol levels in adults with diabetes . METHODS We conducted a clinic-r and omized trial conducted from October 2006 to May 2007 in Minnesota . Included were 11 clinics with 41 consenting primary care physicians and the physicians ’ 2,556 patients with diabetes . Patients were r and omized either to receive or not to receive an electronic health record (EHR)–based clinical decision support system design ed to improve care for those patients whose hemoglobin A1c , blood pressure , or LDL cholesterol levels were higher than goal at any office visit . Analysis used general and generalized linear mixed models with repeated time measurements to accommo date the nested data structure . RESULTS The intervention group physicians used the EHR-based decision support system at 62.6 % of all office visits made by adults with diabetes . The intervention group diabetes patients had significantly better hemoglobin A1c ( intervention effect −0.26 % ; 95 % confidence interval , −0.06 % to −0.47 % ; P=.01 ) , and better maintenance of systolic blood pressure control ( 80.2 % vs 75.1 % , P=.03 ) and borderline better maintenance of diastolic blood pressure control ( 85.6 % vs 81.7 % , P = .07 ) , but not improved low-density lipoprotein cholesterol levels ( P = .62 ) than patients of physicians r and omized to the control arm of the study . Among intervention group physicians , 94 % were satisfied or very satisfied with the intervention , and moderate use of the support system persisted for more than 1 year after feedback and incentives to encourage its use were discontinued . CONCLUSIONS EHR-based diabetes clinical decision support significantly improved glucose control and some aspects of blood pressure control in adults with type 2 diabetes

In addition , the more CCM-incorporated the information technology-based interventions were , the more improvements there were in HbA1c levels . CONCLUSIONS Information technology strategies combined with the other elements of chronic care models are associated with improved glycemic control in people with diabetes . No clinical ly relevant impact was observed on low-density lipoprotein levels and blood pressure , but there was evidence that the cost of care was lower

BACKGROUND Information technology-based interventions are increasingly being used to manage health care . However , there is conflicting evidence regarding whether these interventions improve outcomes in people with type 2 diabetes . OBJECTIVE The objective of this study was to conduct a systematic review and meta- analysis of clinical trials , assessing the impact of information technology on changes in the levels of hemoglobin A1c ( HbA1c ) and mapping the interventions with chronic care model ( CCM ) elements .

The efficacy was particularly highlighted when looking at the marked improvement in serum vitamin B12 levels and hematological parameters , for example hemoglobin level , mean erythrocyte cell volume and reticulocyte count . Oral cobalamin treatment avoids the discomfort , inconvenience and cost of monthly injections . TAKE HOME MESSAGE Our experience and the present analysis support the use of oral cobalamin therapy in clinical practice

IMPORTANCE OF THE FIELD Cobalamin ( vitamin B12 ) deficiency is particularly common in the elderly ( > 15 % ) . Management of cobalamin deficiency with cobalamin injections is well codified at present , but new routes of cobalamin administration ( oral and nasal ) are being studied , especially oral cobalamin therapy for food-cobalamin malabsorption . AREAS COVERED IN THIS REVIEW The objective of this review is to evaluate the efficacy of oral cobalamin treatment in elderly patients .

Oral cobalamin therapy for the treatment of patients with food-cobalamin malabsorption.

BACKGROUND The st and ard treatment for cobalamin ( vitamin B(12 ) ) deficiency involves regular intramuscular cobalamin injection . It has been suggested that oral cobalamin therapy may be effective for treating patients who have food-cobalamin malabsorption . SUBJECTS AND METHODS We prospect ively studied 10 patients with cobalamin deficiency and well-established food-cobalamin malabsorption who received 3000 microg or 5000 microg of oral crystalline cyanocobalamin once a week for at least 3 months . Complete blood counts and serum cobalamin , homocysteine , and folate levels were determined at baseline and after 3 months of treatment . Patients were reexamined after 6 months . RESULTS After 3 months of treatment , all patients had increased hemoglobin levels ( mean increase , 1.9 g/dL ; 95 % confidence interval : 0.9 to 3.9 g/dL;P < 0.01 compared with baseline ) and decreased erythrocyte cell volume ( mean decrease , 7.8 fL ; 95 % confidence interval : 0.9 to 16.5 fL;P<0.001 ) . However , 2 patients had only minor , if any , responses . Serum cobalamin levels were increased in all 8 patients in whom it was measured . CONCLUSION Our findings suggest that moderate doses of crystalline cyanocobalamin given orally may be an effective treatment for food-cobalamin malabsorption

The efficacy was particularly highlighted when looking at the marked improvement in serum vitamin B12 levels and hematological parameters , for example hemoglobin level , mean erythrocyte cell volume and reticulocyte count . Oral cobalamin treatment avoids the discomfort , inconvenience and cost of monthly injections . TAKE HOME MESSAGE Our experience and the present analysis support the use of oral cobalamin therapy in clinical practice

IMPORTANCE OF THE FIELD Cobalamin ( vitamin B12 ) deficiency is particularly common in the elderly ( > 15 % ) . Management of cobalamin deficiency with cobalamin injections is well codified at present , but new routes of cobalamin administration ( oral and nasal ) are being studied , especially oral cobalamin therapy for food-cobalamin malabsorption . AREAS COVERED IN THIS REVIEW The objective of this review is to evaluate the efficacy of oral cobalamin treatment in elderly patients .

The efficacy was particularly highlighted when looking at the marked improvement in serum vitamin B12 levels and hematological parameters , for example hemoglobin level , mean erythrocyte cell volume and reticulocyte count . Oral cobalamin treatment avoids the discomfort , inconvenience and cost of monthly injections . TAKE HOME MESSAGE Our experience and the present analysis support the use of oral cobalamin therapy in clinical practice

IMPORTANCE OF THE FIELD Cobalamin ( vitamin B12 ) deficiency is particularly common in the elderly ( > 15 % ) . Management of cobalamin deficiency with cobalamin injections is well codified at present , but new routes of cobalamin administration ( oral and nasal ) are being studied , especially oral cobalamin therapy for food-cobalamin malabsorption . AREAS COVERED IN THIS REVIEW The objective of this review is to evaluate the efficacy of oral cobalamin treatment in elderly patients .

Nasal absorption of hydroxocobalamin in healthy elderly adults.

AIMS To investigate the nasal absorption of hydroxocobalamin in 10 healthy elderly adults . METHODS In a cross-over study , blood sample s were collected before administration of the drug and after 10 , 20 , 30 , 40 , 60 , 120 , 180 and 240 min . The plasma cobalamin concentration was determined by competitive radioisotope binding technique . RESULTS The maximal plasma cobalamin concentration ( Cmax ) after nasal administration of 750 microg hydroxocobalamin was 1900 + /- 900 pmol l(-1 ) ( mean + /- s.d . ) . The maximal plasma cobalamin concentration was reached in 35 + /- 13 min ( t[max ] ) . The Cmax after nasal administration of 1500 microg hydroxocobalamin was 3500 + /- 2500 pmol l(-1 ) with a t(max ) of 28 + /- 16 min . Both the AUC(0,240 min ) and AUC(0,00 ) increased significantly with an increase of the dose from 750 microg to 1500 microg ( P = 0.037 and P = 0.028 , respectively ) . The nasal spray was well tolerated . No signs of irritation or local sensitivity were noted . CONCLUSIONS The nasal absorption of hydroxocobalamin in healthy elderly adults is rapid , high and well tolerated

The efficacy was particularly highlighted when looking at the marked improvement in serum vitamin B12 levels and hematological parameters , for example hemoglobin level , mean erythrocyte cell volume and reticulocyte count . Oral cobalamin treatment avoids the discomfort , inconvenience and cost of monthly injections . TAKE HOME MESSAGE Our experience and the present analysis support the use of oral cobalamin therapy in clinical practice

IMPORTANCE OF THE FIELD Cobalamin ( vitamin B12 ) deficiency is particularly common in the elderly ( > 15 % ) . Management of cobalamin deficiency with cobalamin injections is well codified at present , but new routes of cobalamin administration ( oral and nasal ) are being studied , especially oral cobalamin therapy for food-cobalamin malabsorption . AREAS COVERED IN THIS REVIEW The objective of this review is to evaluate the efficacy of oral cobalamin treatment in elderly patients .

The efficacy was particularly highlighted when looking at the marked improvement in serum vitamin B12 levels and hematological parameters , for example hemoglobin level , mean erythrocyte cell volume and reticulocyte count . Oral cobalamin treatment avoids the discomfort , inconvenience and cost of monthly injections . TAKE HOME MESSAGE Our experience and the present analysis support the use of oral cobalamin therapy in clinical practice

IMPORTANCE OF THE FIELD Cobalamin ( vitamin B12 ) deficiency is particularly common in the elderly ( > 15 % ) . Management of cobalamin deficiency with cobalamin injections is well codified at present , but new routes of cobalamin administration ( oral and nasal ) are being studied , especially oral cobalamin therapy for food-cobalamin malabsorption . AREAS COVERED IN THIS REVIEW The objective of this review is to evaluate the efficacy of oral cobalamin treatment in elderly patients .

Effective treatment of cobalamin deficiency with oral cobalamin.

Because cobalamin deficiency is routinely treated with parenteral cobalamin , we investigated the efficacy of oral therapy . We r and omly assigned 38 newly diagnosed cobalamin deficient patients to receive cyanocobalamin as either 1 mg intramuscularly on days 1 , 3 , 7 , 10 , 14 , 21 , 30 , 60 , and 90 or 2 mg orally on a daily basis for 120 days . Therapeutic effectiveness was evaluated by measuring hematologic and neurologic improvement and changes in serum levels of cobalamin ( normal , 200 to 900 pg/mL ) methylmalonic acid ( normal , 73 to 271 nmol/L ) , and homocysteine ( normal , 5.1 to 13.9 micromol/L ) . Five patients were subsequently found to have folate deficiency , which left 18 evaluable patients in the oral group and 15 in the parenteral group . Correction of hematologic and neurologic abnormalities was prompt and indistinguishable between the 2 groups . The mean pretreatment values for serum cobalamin , methylmalonic acid , and homocysteine were , respectively , 93 pg/mL , 3,850 nmol/L , and 37 . 2 micromol/L in the oral group and 95 pg/mL , 3,630 nmol/L , and 40.0 micromol/L in the parenteral therapy group . After 4 months of therapy , the respective mean values were 1,005 pg/mL , 169 nmol/L , and 10.6 micromol/L in the oral group and 325 pg/mL , 265 nmol/L , and 12.2 micromol/L in the parenteral group . The higher serum cobalamin and lower serum methylmalonic acid levels at 4 months posttreatment in the oral group versus the parenteral group were significant , with P < .0005 and P < .05 , respectively . In cobalamin deficiency , 2 mg of cyanocobalamin administered orally on a daily basis was as effective as 1 mg administered intramuscularly on a monthly basis and may be superior

The efficacy was particularly highlighted when looking at the marked improvement in serum vitamin B12 levels and hematological parameters , for example hemoglobin level , mean erythrocyte cell volume and reticulocyte count . Oral cobalamin treatment avoids the discomfort , inconvenience and cost of monthly injections . TAKE HOME MESSAGE Our experience and the present analysis support the use of oral cobalamin therapy in clinical practice

IMPORTANCE OF THE FIELD Cobalamin ( vitamin B12 ) deficiency is particularly common in the elderly ( > 15 % ) . Management of cobalamin deficiency with cobalamin injections is well codified at present , but new routes of cobalamin administration ( oral and nasal ) are being studied , especially oral cobalamin therapy for food-cobalamin malabsorption . AREAS COVERED IN THIS REVIEW The objective of this review is to evaluate the efficacy of oral cobalamin treatment in elderly patients .

The efficacy was particularly highlighted when looking at the marked improvement in serum vitamin B12 levels and hematological parameters , for example hemoglobin level , mean erythrocyte cell volume and reticulocyte count . Oral cobalamin treatment avoids the discomfort , inconvenience and cost of monthly injections . TAKE HOME MESSAGE Our experience and the present analysis support the use of oral cobalamin therapy in clinical practice

IMPORTANCE OF THE FIELD Cobalamin ( vitamin B12 ) deficiency is particularly common in the elderly ( > 15 % ) . Management of cobalamin deficiency with cobalamin injections is well codified at present , but new routes of cobalamin administration ( oral and nasal ) are being studied , especially oral cobalamin therapy for food-cobalamin malabsorption . AREAS COVERED IN THIS REVIEW The objective of this review is to evaluate the efficacy of oral cobalamin treatment in elderly patients .

Oral versus intramuscular cobalamin treatment in megaloblastic anemia: a single-center, prospective, randomized, open-label study.

BACKGROUND Cobalamin ( vitamin B12 ) deficiency , the most common cause of megaloblastic anemia , is treated with intramuscular ( IM ) cobalamin . It has been suggested by some investigators that oral ( p.o . ) cobalamin treatment may be as effective in the treatment of this condition , with the advantages of ease of administration and lower cost . OBJECTIVE This study assessed the effects and cost of p.o . versus i.m . cobalamin treatment in patients with megaloblastic anemia due to cobalamin deficiency . METHODS This was a 90-day , prospect i ve , r and omized , open-label study conducted at the Division of Hematology , Department of Internal Medicine , Adnan Menderes University Research and Practice Hospital ( Aydin , Turkey ) . Patients aged > or = 16 years with megaloblastic anemia due to cobalamin deficiency were r and omized to receive 1000-microg cobalamin p.o . once daily for 10 days ( p.o . group ) or 1000-microg cobalamin i.m . once daily for 10 days ( i.m . group ) . After 10 days , both treatments were administered once a week for 4 weeks , and after that , once a month for life . Patients were assessed for the presence of reticulocytosis between treatment days 5 and 10 until it was detected . Therapeutic effectiveness was assessed by measuring hematologic parameters on days 0 , 10 , 30 , and 90 and serum vitamin B12 concentration on days 0 and 90 . The Mini-Mental State Examination was used before and after the B12 therapy for cognitive function assessment and 125-Hz diapozone was used for vibration threshold testing . Neurologic sensory assessment , including soft-touch and pinprick examinations , was used to identify neuropathy at baseline and study end . Tolerability was assessed using laboratory tests and patient interview . Cost was assessed using the cost of the study drug and of the injection . RESULTS Sixty patients completed the study 26 in the p.o . group ( 16 men , 10 women ; mean [ SD ] age , 60 [ 15 ] years ) and 34 in the i.m . group ( 17 men , 17 women ; mean [ SD ] age , 64 [ 10 ] years ) . Reticulocytosis was observed in all patients . In the p.o . group , at days 30 and 90 , all hematologic parameters changed significantly versus day 0 ( mean hemoglobin levels increased [ both P<0.001 ] ; mean corpuscular volume decreased [ both P<0.001 ] ; mean white blood cell count increased [ day 30 , P<0.01 ; day 90 , P<0.001 ] ; and mean platelet count increased [ both P<0.001 ] ) . The mean serum vitamin B12 concentration increased significantly from day 0 to 90 ( P<0.001 ) . These hematologic parameters and the recovery patterns were similar between the 2 groups . Neurologic findings included sensitive peripheral neuropathy in 9 patients ( 15.0 % ) , alteration of cognitive function ( loss of memory , impaired concentration ) in 7 patients ( 11.7 % ) , and loss of sense of vibration in 5 patients ( 8.3 % ) . Neurologic improvement was detected in 7 of 9 patients ( 77.8 % ) in the p.o . group and 9 of 12 patients ( 75.0 % ) in the i.m . group at day 30 . CONCLUSIONS In this study of patients with megaloblastic anemia due to cobalamin deficiency , p.o . cobalamin treatment was as effective as i.m . cobalamin treatment . P.o . treatment also was better tolerated and less expensive compared with IM treatment . However , because of the small sample size and the short term of this study , further long-term studies are needed to determine the efficacy of p.o . cobalamin treatment

The efficacy was particularly highlighted when looking at the marked improvement in serum vitamin B12 levels and hematological parameters , for example hemoglobin level , mean erythrocyte cell volume and reticulocyte count . Oral cobalamin treatment avoids the discomfort , inconvenience and cost of monthly injections . TAKE HOME MESSAGE Our experience and the present analysis support the use of oral cobalamin therapy in clinical practice

IMPORTANCE OF THE FIELD Cobalamin ( vitamin B12 ) deficiency is particularly common in the elderly ( > 15 % ) . Management of cobalamin deficiency with cobalamin injections is well codified at present , but new routes of cobalamin administration ( oral and nasal ) are being studied , especially oral cobalamin therapy for food-cobalamin malabsorption . AREAS COVERED IN THIS REVIEW The objective of this review is to evaluate the efficacy of oral cobalamin treatment in elderly patients .

The efficacy was particularly highlighted when looking at the marked improvement in serum vitamin B12 levels and hematological parameters , for example hemoglobin level , mean erythrocyte cell volume and reticulocyte count . Oral cobalamin treatment avoids the discomfort , inconvenience and cost of monthly injections . TAKE HOME MESSAGE Our experience and the present analysis support the use of oral cobalamin therapy in clinical practice

IMPORTANCE OF THE FIELD Cobalamin ( vitamin B12 ) deficiency is particularly common in the elderly ( > 15 % ) . Management of cobalamin deficiency with cobalamin injections is well codified at present , but new routes of cobalamin administration ( oral and nasal ) are being studied , especially oral cobalamin therapy for food-cobalamin malabsorption . AREAS COVERED IN THIS REVIEW The objective of this review is to evaluate the efficacy of oral cobalamin treatment in elderly patients .

Oral cobalamin remains medicine's best kept secret.

A cross-sectional survey was conducted in order to describe the use of oral cobalamin among geriatricians , hematologists , and general practitioners , and to explore factors related to its use . The study population consisted of all geriatricians ( n = 138 ) and hematologists ( n = 317 ) listed in the Canadian Medical Directory plus a r and om sample of 307 general practitioners . The overall response rate was 40 % . Intramuscular and oral cobalamin was prescribed by 76 and 32 % of the respondents , respectively . Twenty seven percent reported using both oral and intramuscular cobalamin and 6 % reported using only oral cobalamin . Only 25 % of respondents indicated they were aware of a RCT demonstrating the efficacy of oral cobalamin prior to reading a synopsis of the study in the survey . After multivariate adjustment , only the belief that oral cobalamin was effective and certainty about who carried oral preparations remained independently associated with oral cobalamin use . Oral cobalamin has been shown to be an efficacious , cost efficient and safe method of treating cobalamin deficiency . Nonetheless , it is not used by the majority of physicians treating this condition . Strategies to promote the use of oral cobalamin should be directed at educating physicians of its efficacy and providing them with prescribing information on where it can be purchased

The efficacy was particularly highlighted when looking at the marked improvement in serum vitamin B12 levels and hematological parameters , for example hemoglobin level , mean erythrocyte cell volume and reticulocyte count . Oral cobalamin treatment avoids the discomfort , inconvenience and cost of monthly injections . TAKE HOME MESSAGE Our experience and the present analysis support the use of oral cobalamin therapy in clinical practice

IMPORTANCE OF THE FIELD Cobalamin ( vitamin B12 ) deficiency is particularly common in the elderly ( > 15 % ) . Management of cobalamin deficiency with cobalamin injections is well codified at present , but new routes of cobalamin administration ( oral and nasal ) are being studied , especially oral cobalamin therapy for food-cobalamin malabsorption . AREAS COVERED IN THIS REVIEW The objective of this review is to evaluate the efficacy of oral cobalamin treatment in elderly patients .

The efficacy was particularly highlighted when looking at the marked improvement in serum vitamin B12 levels and hematological parameters , for example hemoglobin level , mean erythrocyte cell volume and reticulocyte count . Oral cobalamin treatment avoids the discomfort , inconvenience and cost of monthly injections . TAKE HOME MESSAGE Our experience and the present analysis support the use of oral cobalamin therapy in clinical practice

IMPORTANCE OF THE FIELD Cobalamin ( vitamin B12 ) deficiency is particularly common in the elderly ( > 15 % ) . Management of cobalamin deficiency with cobalamin injections is well codified at present , but new routes of cobalamin administration ( oral and nasal ) are being studied , especially oral cobalamin therapy for food-cobalamin malabsorption . AREAS COVERED IN THIS REVIEW The objective of this review is to evaluate the efficacy of oral cobalamin treatment in elderly patients .

Oral cyanocobalamin supplementation in older people with vitamin B12 deficiency: a dose-finding trial.

BACKGROUND Supplementation with high doses of oral cobalamin is as effective as cobalamin administered by intramuscular injection to correct plasma markers of vitamin B(12 ) deficiency , but the effects of lower oral doses of cobalamin on such markers are uncertain . METHODS We conducted a r and omized , parallel-group , double-blind , dose-finding trial to determine the lowest oral dose of cyanocobalamin required to normalize biochemical markers of vitamin B(12 ) deficiency in older people with mild vitamin B(12 ) deficiency , defined as a serum vitamin B(12 ) level of 100 to 300 pmol/L ( 135 - 406 pg/mL ) and a methylmalonic acid level of 0.26 mumol/L or greater . We assessed the effects of daily oral doses of 2.5 , 100 , 250 , 500 , and 1000 mug of cyanocobalamin administered for 16 weeks on biochemical markers of vitamin B(12 ) deficiency in 120 people . The main outcome measure was the dose of oral cyanocobalamin that produced 80 % to 90 % of the estimated maximal reduction in the plasma methylmalonic acid concentration . RESULTS Supplementation with cyanocobalamin in daily oral doses of 2.5 , 100 , 250 , 500 , and 1000 mug was associated with mean reductions in plasma methylmalonic acid concentrations of 16 % , 16 % , 23 % , 33 % , and 33 % , respectively . Daily doses of 647 to 1032 mug of cyanocobalamin were associated with 80 % to 90 % of the estimated maximum reduction in the plasma methylmalonic acid concentration . CONCLUSION The lowest dose of oral cyanocobalamin required to normalize mild vitamin B(12 ) deficiency is more than 200 times greater than the recommended dietary allowance , which is approximately 3 mug daily

The efficacy was particularly highlighted when looking at the marked improvement in serum vitamin B12 levels and hematological parameters , for example hemoglobin level , mean erythrocyte cell volume and reticulocyte count . Oral cobalamin treatment avoids the discomfort , inconvenience and cost of monthly injections . TAKE HOME MESSAGE Our experience and the present analysis support the use of oral cobalamin therapy in clinical practice

IMPORTANCE OF THE FIELD Cobalamin ( vitamin B12 ) deficiency is particularly common in the elderly ( > 15 % ) . Management of cobalamin deficiency with cobalamin injections is well codified at present , but new routes of cobalamin administration ( oral and nasal ) are being studied , especially oral cobalamin therapy for food-cobalamin malabsorption . AREAS COVERED IN THIS REVIEW The objective of this review is to evaluate the efficacy of oral cobalamin treatment in elderly patients .

The efficacy was particularly highlighted when looking at the marked improvement in serum vitamin B12 levels and hematological parameters , for example hemoglobin level , mean erythrocyte cell volume and reticulocyte count . Oral cobalamin treatment avoids the discomfort , inconvenience and cost of monthly injections . TAKE HOME MESSAGE Our experience and the present analysis support the use of oral cobalamin therapy in clinical practice

IMPORTANCE OF THE FIELD Cobalamin ( vitamin B12 ) deficiency is particularly common in the elderly ( > 15 % ) . Management of cobalamin deficiency with cobalamin injections is well codified at present , but new routes of cobalamin administration ( oral and nasal ) are being studied , especially oral cobalamin therapy for food-cobalamin malabsorption . AREAS COVERED IN THIS REVIEW The objective of this review is to evaluate the efficacy of oral cobalamin treatment in elderly patients .

Efficacy of short-term oral cobalamin therapy for the treatment of cobalamin deficiencies related to food-cobalamin malabsorption: a study of 30 patients.

BACKGROUND It has been suggested that oral cobalamin ( vitamin ( B12 ) ) therapy may be an effective therapy for treating cobalamin deficiencies related to food-cobalamin malabsorption . However , the duration of this treatment was not determined . PATIENTS AND METHOD In an open-label , nonplacebo study , we studied 30 patients with established cobalamin deficiency related to food-cobalamin malabsorption , who received between 250 and 1000 microg of oral crystalline cyanocobalamin per day for at least 1 month . ENDPOINTS Blood counts , serum cobalamin and homocysteine levels were determined at baseline and during the first month of treatment . RESULTS During the first month of treatment , 87 % of the patients normalized their serum cobalamin levels ; 100 % increased their serum cobalamin levels ( mean increase , + 167 pg/dl ; P < 0.001 compared with baseline ) ; 100 % had evidence of medullary regeneration ; 100 % corrected their initial macrocytosis ; and 54 % corrected their anemia . All patients had increased hemoglobin levels ( mean increase , + 0.6 g/dl ) and reticulocyte counts ( mean increase , + 35 x 10(6)/l ) and decreased erythrocyte cell volume ( mean decrease , 3 fl ; all P < 0.05 ) . CONCLUSION Our findings suggest that crystalline cyanocobalamin , 250 - 1000 microg/day , given orally for 1 month , may be an effective treatment for cobalamin deficiencies not related to pernicious anemia

The efficacy was particularly highlighted when looking at the marked improvement in serum vitamin B12 levels and hematological parameters , for example hemoglobin level , mean erythrocyte cell volume and reticulocyte count . Oral cobalamin treatment avoids the discomfort , inconvenience and cost of monthly injections . TAKE HOME MESSAGE Our experience and the present analysis support the use of oral cobalamin therapy in clinical practice

IMPORTANCE OF THE FIELD Cobalamin ( vitamin B12 ) deficiency is particularly common in the elderly ( > 15 % ) . Management of cobalamin deficiency with cobalamin injections is well codified at present , but new routes of cobalamin administration ( oral and nasal ) are being studied , especially oral cobalamin therapy for food-cobalamin malabsorption . AREAS COVERED IN THIS REVIEW The objective of this review is to evaluate the efficacy of oral cobalamin treatment in elderly patients .

The efficacy was particularly highlighted when looking at the marked improvement in serum vitamin B12 levels and hematological parameters , for example hemoglobin level , mean erythrocyte cell volume and reticulocyte count . Oral cobalamin treatment avoids the discomfort , inconvenience and cost of monthly injections . TAKE HOME MESSAGE Our experience and the present analysis support the use of oral cobalamin therapy in clinical practice

IMPORTANCE OF THE FIELD Cobalamin ( vitamin B12 ) deficiency is particularly common in the elderly ( > 15 % ) . Management of cobalamin deficiency with cobalamin injections is well codified at present , but new routes of cobalamin administration ( oral and nasal ) are being studied , especially oral cobalamin therapy for food-cobalamin malabsorption . AREAS COVERED IN THIS REVIEW The objective of this review is to evaluate the efficacy of oral cobalamin treatment in elderly patients .

Normalization of plasma vitamin B12 concentration by intranasal hydroxocobalamin in vitamin B12-deficient patients.

BACKGROUND & AIMS Patients with previous stomach and terminal ileum resections are often treated with intramuscular vitamin B12 injections . Disadvantages are , on a worldwide scale , the frequent need for medical personnel to administer injections and the sometimes painful way of application . This study was design ed to investigate the feasibility of intranasal hydroxocobalamin suppletion in cobalamin-deficient patients and to assess whether intranasal hydroxocobalamin application could be an alternative for intramuscular injection . METHODS Six patients with plasma cobalamin concentrations of < 200 ng/L were recruited . A dose of 1500 micrograms hydroxocobalamin was applied intranasally at days 0 , 14 , and 21 . Plasma cobalamin concentrations were determined 1 hour after hydroxocobalamin application and on days 0 , 7 , 21 , 28 , and 35 . RESULTS All patients showed substantial increase of cobalamin concentrations 1 hour after intranasal application . In these 6 patients , there was an eightfold increase of mean baseline cobalamin concentrations . All patients showed a sustained increase of baseline cobalamin concentrations 1 week after prior intranasal application of hydroxocobalamin . No side effects were noted . CONCLUSIONS Intranasal application of hydroxocobalamin in cobalamin-deficient patients results in fast nasal absorption and leads to sustained increase of baseline cobalamin concentrations

The efficacy was particularly highlighted when looking at the marked improvement in serum vitamin B12 levels and hematological parameters , for example hemoglobin level , mean erythrocyte cell volume and reticulocyte count . Oral cobalamin treatment avoids the discomfort , inconvenience and cost of monthly injections . TAKE HOME MESSAGE Our experience and the present analysis support the use of oral cobalamin therapy in clinical practice

IMPORTANCE OF THE FIELD Cobalamin ( vitamin B12 ) deficiency is particularly common in the elderly ( > 15 % ) . Management of cobalamin deficiency with cobalamin injections is well codified at present , but new routes of cobalamin administration ( oral and nasal ) are being studied , especially oral cobalamin therapy for food-cobalamin malabsorption . AREAS COVERED IN THIS REVIEW The objective of this review is to evaluate the efficacy of oral cobalamin treatment in elderly patients .

The efficacy was particularly highlighted when looking at the marked improvement in serum vitamin B12 levels and hematological parameters , for example hemoglobin level , mean erythrocyte cell volume and reticulocyte count . Oral cobalamin treatment avoids the discomfort , inconvenience and cost of monthly injections . TAKE HOME MESSAGE Our experience and the present analysis support the use of oral cobalamin therapy in clinical practice

IMPORTANCE OF THE FIELD Cobalamin ( vitamin B12 ) deficiency is particularly common in the elderly ( > 15 % ) . Management of cobalamin deficiency with cobalamin injections is well codified at present , but new routes of cobalamin administration ( oral and nasal ) are being studied , especially oral cobalamin therapy for food-cobalamin malabsorption . AREAS COVERED IN THIS REVIEW The objective of this review is to evaluate the efficacy of oral cobalamin treatment in elderly patients .

Hematological response to short-term oral cyanocobalamin therapy for the treatment of cobalamin deficiencies in elderly patients.

OBJECTIVES The aim of this trial was to demonstrate the efficacy of one month of oral cobalamin ( vitamin B12 ) therapy in elderly patients with cobalamin deficiency related to food-cobalamin malabsorption ( FCM ) . PATIENTS AND METHOD Twenty elderly patients ( mean age : 78+/-17 years ) with established cobalamin deficiency related to FCM were included in an open-label , non-r and omized , non-placebo trial . They were treated with a maximum of 1,000 microgram per day of oral crystalline cyanocobalamin for at least 1 month . Serum cobalamin levels ( primary endpoint ) , blood count abnormalities and reticulocytes count ( secondary endpoints ) were determined at baseline and during the first month of treatment . RESULTS 85 % of the patients normalized their serum cobalamin levels with a mean increase of+167 pg/ml ( p<0.001 compared with baseline ) . 100 % of the patients corrected their initial macrocytosis and 25 % their anemia ; 100 % of the patients had medullar regeneration with a mean increase of reticulocytes count of 32+/-11.3 x 106/l ( p=0.03 compared with baseline ) . CONCLUSIONS Our findings support the view that one month of oral crystalline cyanocobalamin is effective to correct serum vitamin B12 levels and to obtain hematological responses in elderly patients with cobalamin deficiency related to FCM

The efficacy was particularly highlighted when looking at the marked improvement in serum vitamin B12 levels and hematological parameters , for example hemoglobin level , mean erythrocyte cell volume and reticulocyte count . Oral cobalamin treatment avoids the discomfort , inconvenience and cost of monthly injections . TAKE HOME MESSAGE Our experience and the present analysis support the use of oral cobalamin therapy in clinical practice

IMPORTANCE OF THE FIELD Cobalamin ( vitamin B12 ) deficiency is particularly common in the elderly ( > 15 % ) . Management of cobalamin deficiency with cobalamin injections is well codified at present , but new routes of cobalamin administration ( oral and nasal ) are being studied , especially oral cobalamin therapy for food-cobalamin malabsorption . AREAS COVERED IN THIS REVIEW The objective of this review is to evaluate the efficacy of oral cobalamin treatment in elderly patients .

Based on the available trials , the evidence does not support the administration of oral immunoglobulin for the prevention of NEC . There are no r and omized controlled trials of oral IgA alone for the prevention of NEC

BACKGROUND Necrotizing enterocolitis ( NEC ) is the most common emergency involving the gastrointestinal tract occurring in the neonatal period . There have been published reports that suggest that oral immunoglobulins (Ig)A and IgG produce an immunoprotective effect in the gastrointestinal mucosa . OBJECTIVES To determine the effect of oral immunoglobulin on the incidence of necrotizing enterocolitis and other complications in preterm or low birth weight ( or both ) neonates .

GRADE guidelines: 4. Rating the quality of evidence--study limitations (risk of bias).

In the GRADE approach , r and omized trials start as high- quality evidence and observational studies as low- quality evidence , but both can be rated down if most of the relevant evidence comes from studies that suffer from a high risk of bias . Well-established limitations of r and omized trials include failure to conceal allocation , failure to blind , loss to follow-up , and failure to appropriately consider the intention-to-treat principle . More recently recognized limitations include stopping early for apparent benefit and selective reporting of outcomes according to the results . Key limitations of observational studies include use of inappropriate controls and failure to adequately adjust for prognostic imbalance . Risk of bias may vary across outcomes ( e.g. , loss to follow-up may be far less for all-cause mortality than for quality of life ) , a consideration that many systematic review s ignore . In deciding whether to rate down for risk of bias -- whether for r and omized trials or observational studies -- authors should not take an approach that averages across studies . Rather , for any individual outcome , when there are some studies with a high risk , and some with a low risk of bias , they should consider including only the studies with a lower risk of bias

Based on the available trials , the evidence does not support the administration of oral immunoglobulin for the prevention of NEC . There are no r and omized controlled trials of oral IgA alone for the prevention of NEC

BACKGROUND Necrotizing enterocolitis ( NEC ) is the most common emergency involving the gastrointestinal tract occurring in the neonatal period . There have been published reports that suggest that oral immunoglobulins (Ig)A and IgG produce an immunoprotective effect in the gastrointestinal mucosa . OBJECTIVES To determine the effect of oral immunoglobulin on the incidence of necrotizing enterocolitis and other complications in preterm or low birth weight ( or both ) neonates .

Based on the available trials , the evidence does not support the administration of oral immunoglobulin for the prevention of NEC . There are no r and omized controlled trials of oral IgA alone for the prevention of NEC

BACKGROUND Necrotizing enterocolitis ( NEC ) is the most common emergency involving the gastrointestinal tract occurring in the neonatal period . There have been published reports that suggest that oral immunoglobulins (Ig)A and IgG produce an immunoprotective effect in the gastrointestinal mucosa . OBJECTIVES To determine the effect of oral immunoglobulin on the incidence of necrotizing enterocolitis and other complications in preterm or low birth weight ( or both ) neonates .

Probiotic Effects on Late-onset Sepsis in Very Preterm Infants: A Randomized Controlled Trial

BACKGROUND AND OBJECTIVE : Late-onset sepsis frequently complicates prematurity , contributing to morbidity and mortality . Probiotics may reduce mortality and necrotizing enterocolitis ( NEC ) in preterm infants , with unclear effect on late-onset sepsis . This study aim ed to determine the effect of administering a specific combination of probiotics to very preterm infants on culture-proven late-onset sepsis . METHODS : A prospect i ve multicenter , double-blinded , placebo-controlled , r and omized trial compared daily administration of a probiotic combination ( Bifidobacterium infantis , Streptococcus thermophilus , and Bifidobacterium lactis , containing 1 × 109 total organisms ) with placebo ( maltodextrin ) in infants born before 32 completed weeks ’ gestation weighing < 1500 g. The primary outcome was at least 1 episode of definite late-onset sepsis . RESULTS : Between October 2007 and November 2011 , 1099 very preterm infants from Australia and New Zeal and were r and omized . Rates of definite late-onset sepsis ( 16.2 % ) , NEC of Bell stage 2 or more ( 4.4 % ) , and mortality ( 5.1 % ) were low in controls , with high breast milk feeding rates ( 96.9 % ) . No significant difference in definite late-onset sepsis or all-cause mortality was found , but this probiotic combination reduced NEC of Bell stage 2 or more ( 2.0 % versus 4.4 % ; relative risk 0.46 , 95 % confidence interval 0.23 to 0.93 , P = .03 ; number needed to treat 43 , 95 % confidence interval 23 to 333 ) . CONCLUSIONS : The probiotics B infantis , S thermophilus , and B lactis significantly reduced NEC of Bell stage 2 or more in very preterm infants , but not definite late-onset sepsis or mortality . Treatment with this combination of probiotics appears to be safe

Based on the available trials , the evidence does not support the administration of oral immunoglobulin for the prevention of NEC . There are no r and omized controlled trials of oral IgA alone for the prevention of NEC

BACKGROUND Necrotizing enterocolitis ( NEC ) is the most common emergency involving the gastrointestinal tract occurring in the neonatal period . There have been published reports that suggest that oral immunoglobulins (Ig)A and IgG produce an immunoprotective effect in the gastrointestinal mucosa . OBJECTIVES To determine the effect of oral immunoglobulin on the incidence of necrotizing enterocolitis and other complications in preterm or low birth weight ( or both ) neonates .

Based on the available trials , the evidence does not support the administration of oral immunoglobulin for the prevention of NEC . There are no r and omized controlled trials of oral IgA alone for the prevention of NEC

BACKGROUND Necrotizing enterocolitis ( NEC ) is the most common emergency involving the gastrointestinal tract occurring in the neonatal period . There have been published reports that suggest that oral immunoglobulins (Ig)A and IgG produce an immunoprotective effect in the gastrointestinal mucosa . OBJECTIVES To determine the effect of oral immunoglobulin on the incidence of necrotizing enterocolitis and other complications in preterm or low birth weight ( or both ) neonates .

Oral gentamicin therapy in the prevention of neonatal necrotizing enterocolitis. A controlled double-blind trial.

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

Based on the available trials , the evidence does not support the administration of oral immunoglobulin for the prevention of NEC . There are no r and omized controlled trials of oral IgA alone for the prevention of NEC

BACKGROUND Necrotizing enterocolitis ( NEC ) is the most common emergency involving the gastrointestinal tract occurring in the neonatal period . There have been published reports that suggest that oral immunoglobulins (Ig)A and IgG produce an immunoprotective effect in the gastrointestinal mucosa . OBJECTIVES To determine the effect of oral immunoglobulin on the incidence of necrotizing enterocolitis and other complications in preterm or low birth weight ( or both ) neonates .

Based on the available trials , the evidence does not support the administration of oral immunoglobulin for the prevention of NEC . There are no r and omized controlled trials of oral IgA alone for the prevention of NEC

BACKGROUND Necrotizing enterocolitis ( NEC ) is the most common emergency involving the gastrointestinal tract occurring in the neonatal period . There have been published reports that suggest that oral immunoglobulins (Ig)A and IgG produce an immunoprotective effect in the gastrointestinal mucosa . OBJECTIVES To determine the effect of oral immunoglobulin on the incidence of necrotizing enterocolitis and other complications in preterm or low birth weight ( or both ) neonates .

Prevention of Neonatal Necrotizing Enterocolitis

Small premature infants are often hypochlorhydric , and frequently their stomachs are colonized by enteric , gram-negative bacteria . We tested a hypothesis that gastric pH affected the colonization of the stomach with enteric bacteria and that this colonization was causally related to the risk or severity of necrotizing enterocolitis . A prospect i ve , double-blind study was conducted that compared a group of infants supplemented with 0.01–0.02 ml of 1 N HCl/ml of milk to a group with a similar supplement of water . Gastric pH , gastric enteric bacteria counts , and the incidence and severity of necrotizing enterocolitis were monitored . The median gastric pH of the HCl-supplemented group was lower ( 3.0 ) than controls ( 4.0 ) throughout the study ( p < 0.001 ) . The gastric enteric bacterial colonization rate and the quantitative bacterial counts were strongly correlated with gastric pH over 4 ( p < 0.001 ) . Somatic growth rates in infants in the HCl-supplemented group were equal to , or exceeded , those in the control group . There was 1 case of necrotizing entero-colitis among the 34 infants in the HCl-supplemented group and 8 cases among the 34 in the control group ( p = 0.02 ) . It appears that acidifying the feedings of small premature infants to a pH low enough to inhibit bacterial proliferation in the stomach significantly lowers the risk of necrotizing enterocolitis

Based on the available trials , the evidence does not support the administration of oral immunoglobulin for the prevention of NEC . There are no r and omized controlled trials of oral IgA alone for the prevention of NEC

BACKGROUND Necrotizing enterocolitis ( NEC ) is the most common emergency involving the gastrointestinal tract occurring in the neonatal period . There have been published reports that suggest that oral immunoglobulins (Ig)A and IgG produce an immunoprotective effect in the gastrointestinal mucosa . OBJECTIVES To determine the effect of oral immunoglobulin on the incidence of necrotizing enterocolitis and other complications in preterm or low birth weight ( or both ) neonates .

Based on the available trials , the evidence does not support the administration of oral immunoglobulin for the prevention of NEC . There are no r and omized controlled trials of oral IgA alone for the prevention of NEC

BACKGROUND Necrotizing enterocolitis ( NEC ) is the most common emergency involving the gastrointestinal tract occurring in the neonatal period . There have been published reports that suggest that oral immunoglobulins (Ig)A and IgG produce an immunoprotective effect in the gastrointestinal mucosa . OBJECTIVES To determine the effect of oral immunoglobulin on the incidence of necrotizing enterocolitis and other complications in preterm or low birth weight ( or both ) neonates .

Prevention of necrotizing enterocolitis in low-birth-weight infants by IgA-IgG feeding.

In a r and omized clinical trial , we evaluated the efficacy of an oral immunoglobulin preparation ( 73 percent IgA and 26 percent IgG ) in reducing the incidence of necrotizing enterocolitis in infants of low birth weight for whom breast milk from their mothers was not available . A total of 434 infants weighing between 800 and 2000 g were eligible for entry in the study . Of these , 255 were withdrawn - 234 during the first week of the study because breast milk from their mothers became available ( 123 in the treatment group and 111 in the control group ) , and 21 because of violations of protocol or because breast milk became available after the first week . The duration of follow-up was 28 days . Among the infants for whom breast milk did not become available during the study , there were no cases of necrotizing enterocolitis among the 88 receiving oral IgA-IgG , as compared with six cases among the 91 control infants ( P = 0.0143 ) . Of the infants withdrawn from the study , two assigned to the control group had necrotizing enterocolitis . We conclude that the oral administration of IgA-IgG may prevent the development of necrotizing enterocolitis in low-birth-weight infants

Based on the available trials , the evidence does not support the administration of oral immunoglobulin for the prevention of NEC . There are no r and omized controlled trials of oral IgA alone for the prevention of NEC

BACKGROUND Necrotizing enterocolitis ( NEC ) is the most common emergency involving the gastrointestinal tract occurring in the neonatal period . There have been published reports that suggest that oral immunoglobulins (Ig)A and IgG produce an immunoprotective effect in the gastrointestinal mucosa . OBJECTIVES To determine the effect of oral immunoglobulin on the incidence of necrotizing enterocolitis and other complications in preterm or low birth weight ( or both ) neonates .

Based on the available trials , the evidence does not support the administration of oral immunoglobulin for the prevention of NEC . There are no r and omized controlled trials of oral IgA alone for the prevention of NEC

BACKGROUND Necrotizing enterocolitis ( NEC ) is the most common emergency involving the gastrointestinal tract occurring in the neonatal period . There have been published reports that suggest that oral immunoglobulins (Ig)A and IgG produce an immunoprotective effect in the gastrointestinal mucosa . OBJECTIVES To determine the effect of oral immunoglobulin on the incidence of necrotizing enterocolitis and other complications in preterm or low birth weight ( or both ) neonates .

Mortality of necrotizing enterocolitis expressed by birth weight categories.

PURPOSE Low birth weight is the most important risk factor for developing necrotizing enterocolitis ( NEC ) . We aim ed to establish birth weight-based benchmarks for in-hospital mortality in neonates with NEC . METHODS Five hundred eleven centers belonging to the Vermont Oxford Network prospect ively evaluated 71,808 neonates with birth weight of 501 to 1500 g between January 2005 and December 2006 . The primary outcome variable was in-hospital mortality . RESULTS Birth weight was divided into 4 categories by 250-g increments . The NEC risk ( P < .001 ) and mortality ( P < .001 ) decreased with higher birth weight category . Necrotizing enterocolitis was associated with a significant odds ratio for death for each category ( P < .001 ) . Across groups , the odds ratio for NEC mortality increased with higher birth weight category ( category 1 = 1.6 vs category 4 = 9.9 ; P < .001 ) . CONCLUSION The in-hospital mortality rate of neonates with NEC remains high and is significantly related to birth weight category . Although the risk and absolute mortality of NEC decrease with higher birth weight , the odds ratios indicate that NEC has a relatively greater impact upon mortality at higher birth weight . These data afford birth weight-based mortality benchmarks that may be useful in assessing single center NEC outcomes and facilitating comparisons between centers

Based on the available trials , the evidence does not support the administration of oral immunoglobulin for the prevention of NEC . There are no r and omized controlled trials of oral IgA alone for the prevention of NEC

BACKGROUND Necrotizing enterocolitis ( NEC ) is the most common emergency involving the gastrointestinal tract occurring in the neonatal period . There have been published reports that suggest that oral immunoglobulins (Ig)A and IgG produce an immunoprotective effect in the gastrointestinal mucosa . OBJECTIVES To determine the effect of oral immunoglobulin on the incidence of necrotizing enterocolitis and other complications in preterm or low birth weight ( or both ) neonates .

Based on the available trials , the evidence does not support the administration of oral immunoglobulin for the prevention of NEC . There are no r and omized controlled trials of oral IgA alone for the prevention of NEC

BACKGROUND Necrotizing enterocolitis ( NEC ) is the most common emergency involving the gastrointestinal tract occurring in the neonatal period . There have been published reports that suggest that oral immunoglobulins (Ig)A and IgG produce an immunoprotective effect in the gastrointestinal mucosa . OBJECTIVES To determine the effect of oral immunoglobulin on the incidence of necrotizing enterocolitis and other complications in preterm or low birth weight ( or both ) neonates .

Breast milk and neonatal necrotising enterocolitis

In a prospect i ve multicentre study on 926 preterm infants formally assigned to their early diet , necrotising enterocolitis developed in 51 ( 5.5 % ) . Mortality was 26 % in stringently confirmed cases . In exclusively formula-fed babies confirmed disease was 6 - 10 times more common than in those fed breast milk alone and 3 times more common than in those who received formula plus breast milk . Pasteurised donor milk seemed to be as protective as raw maternal milk . Among babies born at more than 30 weeks ' gestation confirmed necrotising enterocolitis was rare in those whose diet included breast milk ; it was 20 times more common in those fed formula only . Other risk factors included very low gestational age , respiratory disease , umbilical artery catheterisation , and polycythaemia . In formula-fed but not breast-milk-fed infants , delayed enteral feeding was associated with a lower frequency of necrotising enterocolitis . With the fall in the use of breast milk in British neonatal units , exclusive formula feeding could account for an estimated 500 extra cases of necrotising enterocolitis each year . About 100 of these infants would die

Based on the available trials , the evidence does not support the administration of oral immunoglobulin for the prevention of NEC . There are no r and omized controlled trials of oral IgA alone for the prevention of NEC

BACKGROUND Necrotizing enterocolitis ( NEC ) is the most common emergency involving the gastrointestinal tract occurring in the neonatal period . There have been published reports that suggest that oral immunoglobulins (Ig)A and IgG produce an immunoprotective effect in the gastrointestinal mucosa . OBJECTIVES To determine the effect of oral immunoglobulin on the incidence of necrotizing enterocolitis and other complications in preterm or low birth weight ( or both ) neonates .

Based on the available trials , the evidence does not support the administration of oral immunoglobulin for the prevention of NEC . There are no r and omized controlled trials of oral IgA alone for the prevention of NEC

BACKGROUND Necrotizing enterocolitis ( NEC ) is the most common emergency involving the gastrointestinal tract occurring in the neonatal period . There have been published reports that suggest that oral immunoglobulins (Ig)A and IgG produce an immunoprotective effect in the gastrointestinal mucosa . OBJECTIVES To determine the effect of oral immunoglobulin on the incidence of necrotizing enterocolitis and other complications in preterm or low birth weight ( or both ) neonates .

Prevention of necrotizing enterocolitis in neonates at risk by oral administration of monomeric IgG.

Necrotizing enterocolitis ( NEC ) represents one of the major causes of morbidity in low-birth-weight ( LBW ) preterm infants . This r and omized clinical trial evaluated the efficacy of an oral immunoglobulin preparation ( containing monomeric IgG in a concentration of 90 % ) in reducing the incidence of NEC in infants of LBW for whom maternal breast milk was not available . One hundred and thirty-two formula-fed newborns with a birth weight less than or equal to 1,500 g or a gestational age less than or equal to 34 weeks were r and omly studied . Five hundred mg of IgG pro die , subdivided into 5 doses , were given orally to the test group of 65 neonates during the first 2 weeks of life . Although the number of infants included in this group is limited , the results of this study are encouraging : during the first 15 days after birth , none of the subjects developed NEC , while 4 cases were confirmed in the untreated control group . It , therefore , seems possible that oral monomeric IgG administration may prevent the development of NEC in LBW infants

Based on the available trials , the evidence does not support the administration of oral immunoglobulin for the prevention of NEC . There are no r and omized controlled trials of oral IgA alone for the prevention of NEC

BACKGROUND Necrotizing enterocolitis ( NEC ) is the most common emergency involving the gastrointestinal tract occurring in the neonatal period . There have been published reports that suggest that oral immunoglobulins (Ig)A and IgG produce an immunoprotective effect in the gastrointestinal mucosa . OBJECTIVES To determine the effect of oral immunoglobulin on the incidence of necrotizing enterocolitis and other complications in preterm or low birth weight ( or both ) neonates .

Based on the available trials , the evidence does not support the administration of oral immunoglobulin for the prevention of NEC . There are no r and omized controlled trials of oral IgA alone for the prevention of NEC

BACKGROUND Necrotizing enterocolitis ( NEC ) is the most common emergency involving the gastrointestinal tract occurring in the neonatal period . There have been published reports that suggest that oral immunoglobulins (Ig)A and IgG produce an immunoprotective effect in the gastrointestinal mucosa . OBJECTIVES To determine the effect of oral immunoglobulin on the incidence of necrotizing enterocolitis and other complications in preterm or low birth weight ( or both ) neonates .

Necrotizing enterocolitis prophylaxis: oral antibiotics and lyophilized enterobacteria vs oral immunoglobulins

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

Based on the available trials , the evidence does not support the administration of oral immunoglobulin for the prevention of NEC . There are no r and omized controlled trials of oral IgA alone for the prevention of NEC

BACKGROUND Necrotizing enterocolitis ( NEC ) is the most common emergency involving the gastrointestinal tract occurring in the neonatal period . There have been published reports that suggest that oral immunoglobulins (Ig)A and IgG produce an immunoprotective effect in the gastrointestinal mucosa . OBJECTIVES To determine the effect of oral immunoglobulin on the incidence of necrotizing enterocolitis and other complications in preterm or low birth weight ( or both ) neonates .

Based on the available trials , the evidence does not support the administration of oral immunoglobulin for the prevention of NEC . There are no r and omized controlled trials of oral IgA alone for the prevention of NEC

BACKGROUND Necrotizing enterocolitis ( NEC ) is the most common emergency involving the gastrointestinal tract occurring in the neonatal period . There have been published reports that suggest that oral immunoglobulins (Ig)A and IgG produce an immunoprotective effect in the gastrointestinal mucosa . OBJECTIVES To determine the effect of oral immunoglobulin on the incidence of necrotizing enterocolitis and other complications in preterm or low birth weight ( or both ) neonates .

Oral Probiotics Reduce the Incidence and Severity of Necrotizing Enterocolitis in Very Low Birth Weight Infants

Objective . We evaluated the efficacy of probiotics in reducing the incidence and severity of necrotizing enterocolitis ( NEC ) in very low birth weight ( VLBW ) infants . Patients and Methods . A prospect i ve , masked , r and omized control trial was conducted to evaluate the beneficial effects of probiotics in reducing the incidence and severity of NEC among VLBW ( < 1500 g ) infants . VLBW infants who started to fed enterally and survived beyond the seventh day after birth were eligible for the trial . They were r and omized into 2 groups after parental informed consents were obtained . The infants in the study group were fed with Infloran ( Lactobacillus acidophilus and Bifidobacterium infantis ) with breast milk twice daily until discharged . Infants in the control group were fed with breast milk alone . The clinicians caring for the infants were blinded to the group assignment . The primary outcome was death or NEC ( ≥ stage 2 ) . Results . Three hundred sixty-seven infants were enrolled : 180 in the study group and 187 in the control group . The demographic and clinical variables were similar in both groups . The incidence of death or NEC ( ≥ stage 2 ) was significantly lower in the study group ( 9 of 180 vs 24 of 187 ) . The incidence of NEC ( ≥ stage 2 ) was also significantly lower in the study when compared with the control group ( 2 of 180 vs 10 of 187 ) . There were 6 cases of severe NEC ( Bell stage 3 ) in the control group and none in the study group . None of the positive blood culture grew Lactobacillus or Bifidobacterium species . Conclusion . Infloran as probiotics fed enterally with breast milk reduces the incidence and severity of NEC in VLBW infants

Based on the available trials , the evidence does not support the administration of oral immunoglobulin for the prevention of NEC . There are no r and omized controlled trials of oral IgA alone for the prevention of NEC

BACKGROUND Necrotizing enterocolitis ( NEC ) is the most common emergency involving the gastrointestinal tract occurring in the neonatal period . There have been published reports that suggest that oral immunoglobulins (Ig)A and IgG produce an immunoprotective effect in the gastrointestinal mucosa . OBJECTIVES To determine the effect of oral immunoglobulin on the incidence of necrotizing enterocolitis and other complications in preterm or low birth weight ( or both ) neonates .

Based on the available trials , the evidence does not support the administration of oral immunoglobulin for the prevention of NEC . There are no r and omized controlled trials of oral IgA alone for the prevention of NEC

BACKGROUND Necrotizing enterocolitis ( NEC ) is the most common emergency involving the gastrointestinal tract occurring in the neonatal period . There have been published reports that suggest that oral immunoglobulins (Ig)A and IgG produce an immunoprotective effect in the gastrointestinal mucosa . OBJECTIVES To determine the effect of oral immunoglobulin on the incidence of necrotizing enterocolitis and other complications in preterm or low birth weight ( or both ) neonates .

Enteral human IgG for prevention of necrotising enterocolitis: a placebo-controlled, randomised trial

BACKGROUND Neonatal necrotising enterocolitis is a serious , commonly fatal disease in premature neonates . Although feeding with expressed breast milk and other good nursery practice s are partly protective , preventive measures are needed . Treating neonates enterally with a mixture of human IgA and IgG , prepared from donated blood , has been cl aim ed to protect against necrotising enterocolitis . However , no IgA preparation is available in Australia . Our aim , therefore , was to identify whether or not enteral IgG could prevent the disorder . METHODS We did a multicentre , double-blind , placebo- controlled trial . We r and omly assigned 768 infants to receive human IgG 1200 mg/kg daily , and 761 to receive placebo , for up to 28 days . Treatment began at the same time as enteral feeding . The primary outcome measure was the proportion of infants who developed definite necrotising enterocolitis during the trial , and any deaths that result ed from the disorder in the treatment and placebo groups . Analysis was on an intention-to-treat basis . FINDINGS 43 infants developed definite necrotising enterocolitis in the IgG group , ten of whom died . In the placebo group , 41 infants contracted the disorder and six died ( p=0.47 ) . 25 infants on IgG and 36 on placebo had suspect necrotising enterocolitis ( p=0.14 ) . INTERPRETATION Supplementation of enteral feeds with human IgG does not reduce necrotising enterocolitis

Based on the available trials , the evidence does not support the administration of oral immunoglobulin for the prevention of NEC . There are no r and omized controlled trials of oral IgA alone for the prevention of NEC

BACKGROUND Necrotizing enterocolitis ( NEC ) is the most common emergency involving the gastrointestinal tract occurring in the neonatal period . There have been published reports that suggest that oral immunoglobulins (Ig)A and IgG produce an immunoprotective effect in the gastrointestinal mucosa . OBJECTIVES To determine the effect of oral immunoglobulin on the incidence of necrotizing enterocolitis and other complications in preterm or low birth weight ( or both ) neonates .

Collectively , these studies provided some evidence to show that interventions by healthcare professionals improved the QOL medication compliance and calcium intake of patients but its effects on BMD , medication persistence , knowledge , and other lifestyle modifications were less conclusive .

Summary A systematic review was conducted to evaluate evidence concerning the effect of non-drug interventions by healthcare professionals on community-dwelling postmenopausal osteoporotic women . Evidence available indicates that such interventions are effective in improving the quality of life , medication compliance , and calcium intake , but effect on other outcomes is less conclusive . Introduction The purpose of this study is to conduct a systematic review to evaluate evidence concerning the effect of non-drug interventions by healthcare professionals on community-dwelling postmenopausal osteoporotic women .

Positive Effects of Physiotherapy on Chronic Pain and Performance in Osteoporosis

Abstract : The aim of this placebo-controlled , r and omized , single-masked study was to establish the effects of a 10-week ambulatory exercise programme for osteoporotic patients on pain , use of analgesics , functional status , quality of life , balance and muscle strength . Fifty-three ambulatory postmenopausal women with at least one spinal crush fracture and pains within the last 3 years were r and omized for physiotherapeutic training twice a week for 10 weeks or no training . The training included general training of balance and muscle strength , with stabilization of the lumbar spine . The participants were tested at baseline , week 5 and week 10 with a balance test , muscle strength test and question naires on pain , use of analgesics , functional status and quality of life . Twelve weeks after the supervised training had finished ( week 22 ) they answered the same question naires . The study groups were comparable at baseline . The training group had a significant reduction in use of analgesics ( p= 0.02 ) and pain level ( p= 0.01 ) during the training period . Distribution of functional score improved ; the improvement was reduced at week 22 . Quality of life score improved significantly throughout the study ( p= 0.0008 ) , even after week 22 . Balance improved non-significantly ( p= 0.08 ) . Quadriceps muscle strength improved significantly after 5 weeks ( p= 0.04 ) . Back extensor muscle strength improved almost significantly ( p= 0.09 ) . In conclusion , this training programme for osteoporotic patients improved balance and level of daily function and decreased experience of pain and use of analgesics . Quality of life was improved even beyond the active training period

Collectively , these studies provided some evidence to show that interventions by healthcare professionals improved the QOL medication compliance and calcium intake of patients but its effects on BMD , medication persistence , knowledge , and other lifestyle modifications were less conclusive .

Summary A systematic review was conducted to evaluate evidence concerning the effect of non-drug interventions by healthcare professionals on community-dwelling postmenopausal osteoporotic women . Evidence available indicates that such interventions are effective in improving the quality of life , medication compliance , and calcium intake , but effect on other outcomes is less conclusive . Introduction The purpose of this study is to conduct a systematic review to evaluate evidence concerning the effect of non-drug interventions by healthcare professionals on community-dwelling postmenopausal osteoporotic women .

Collectively , these studies provided some evidence to show that interventions by healthcare professionals improved the QOL medication compliance and calcium intake of patients but its effects on BMD , medication persistence , knowledge , and other lifestyle modifications were less conclusive .

Summary A systematic review was conducted to evaluate evidence concerning the effect of non-drug interventions by healthcare professionals on community-dwelling postmenopausal osteoporotic women . Evidence available indicates that such interventions are effective in improving the quality of life , medication compliance , and calcium intake , but effect on other outcomes is less conclusive . Introduction The purpose of this study is to conduct a systematic review to evaluate evidence concerning the effect of non-drug interventions by healthcare professionals on community-dwelling postmenopausal osteoporotic women .

Multidisciplinary patient education in groups increases knowledge on osteoporosis: A randomized controlled trial

Introduction : Specific pharmacological treatment reduces the incidence of fractures significantly in patients with osteoporosis . Unfortunately , compliance with such therapy is low in clinical practice and is inversely related to educational level . We hypothesized that patients ' knowledge of osteoporosis may be increased by a group-based multidisciplinary education programme . Methods : Three hundred patients , aged 45—81 years , recently diagnosed with osteoporosis and started on specific treatment , were r and omized to either the " school ' ' or " control ' ' group . Teaching was performed by nurses , physiotherapists , dieticians , and doctors , and design ed to increase the patient 's empowerment . The patient 's knowledge of osteoporosis was tested at study entry and at 3 months using a vali date d question naire . Results : At study entry , no differences in age or score ( 22 ( 18—24 ) ( median ( 25—75 percentiles ) ) vs. 22 ( 18—24 ) ) were seen between the school and control groups . The change in knowledge during the study , however , differed significantly between the two groups ( p<0.001 ) . In the school group , the increase in knowledge score correlated inversely with the level of education ; that is , the lower the education level , the higher the gain in knowledge during the course ( Rho=-0.25 , p<0.01 ) . Conclusions : A group-based multidisciplinary education programme significantly increases patients ' knowledge of the disease

Collectively , these studies provided some evidence to show that interventions by healthcare professionals improved the QOL medication compliance and calcium intake of patients but its effects on BMD , medication persistence , knowledge , and other lifestyle modifications were less conclusive .

Summary A systematic review was conducted to evaluate evidence concerning the effect of non-drug interventions by healthcare professionals on community-dwelling postmenopausal osteoporotic women . Evidence available indicates that such interventions are effective in improving the quality of life , medication compliance , and calcium intake , but effect on other outcomes is less conclusive . Introduction The purpose of this study is to conduct a systematic review to evaluate evidence concerning the effect of non-drug interventions by healthcare professionals on community-dwelling postmenopausal osteoporotic women .

Collectively , these studies provided some evidence to show that interventions by healthcare professionals improved the QOL medication compliance and calcium intake of patients but its effects on BMD , medication persistence , knowledge , and other lifestyle modifications were less conclusive .

Summary A systematic review was conducted to evaluate evidence concerning the effect of non-drug interventions by healthcare professionals on community-dwelling postmenopausal osteoporotic women . Evidence available indicates that such interventions are effective in improving the quality of life , medication compliance , and calcium intake , but effect on other outcomes is less conclusive . Introduction The purpose of this study is to conduct a systematic review to evaluate evidence concerning the effect of non-drug interventions by healthcare professionals on community-dwelling postmenopausal osteoporotic women .

Effect of community-based nutrition education intervention on calcium intake and bone mass in postmenopausal Vietnamese women.

OBJECTIVE To examine the effect of community-based nutrition education intervention on calcium intake and bone mass in Vietnamese postmenopausal women . DESIGN A controlled trial was conducted in two groups as intervention and control . The intervention group was given nutrition education during 18 months to improve calcium intake , while the control subjects had the usual diet . Calcium intake and bone mass were evaluated every 6 months . Bone mass was assessed by speed of sound ( SOS ) at calcaneus , referred to as quantitative ultrasound measurement . Anthropometric indices and serum parathyroid hormone ( PTH ) were determined at baseline and at the end of intervention . SETTING Two rural communes of Hai Duong province located in the Red River Delta in Vietnam . SUBJECTS A total of 140 women aged 55 - 65 years , who were more than 5 years postmenopausal and with low calcium intake ( < 400 mg/d ) , were recruited . After 18 months of intervention , 108 women completed the study . RESULTS Calcium intake in the intervention group had increased significantly ( P < 0.01 ) while it had no significant changes in controls . SOS values were not changed significantly in the intervention subjects while it decreased significantly by 0.5 % in the controls ( P < 0.01 ) . The intervention led to a decrease in serum PTH by 12 % ( P < 0.01 ) . In the controls , there was an increase in serum PTH by 32 % ( P < 0.001 ) . CONCLUSION Nutrition education intervention was effective in improving calcium intake and retarding bone loss in the studied subjects

Collectively , these studies provided some evidence to show that interventions by healthcare professionals improved the QOL medication compliance and calcium intake of patients but its effects on BMD , medication persistence , knowledge , and other lifestyle modifications were less conclusive .

Summary A systematic review was conducted to evaluate evidence concerning the effect of non-drug interventions by healthcare professionals on community-dwelling postmenopausal osteoporotic women . Evidence available indicates that such interventions are effective in improving the quality of life , medication compliance , and calcium intake , but effect on other outcomes is less conclusive . Introduction The purpose of this study is to conduct a systematic review to evaluate evidence concerning the effect of non-drug interventions by healthcare professionals on community-dwelling postmenopausal osteoporotic women .

Collectively , these studies provided some evidence to show that interventions by healthcare professionals improved the QOL medication compliance and calcium intake of patients but its effects on BMD , medication persistence , knowledge , and other lifestyle modifications were less conclusive .

Summary A systematic review was conducted to evaluate evidence concerning the effect of non-drug interventions by healthcare professionals on community-dwelling postmenopausal osteoporotic women . Evidence available indicates that such interventions are effective in improving the quality of life , medication compliance , and calcium intake , but effect on other outcomes is less conclusive . Introduction The purpose of this study is to conduct a systematic review to evaluate evidence concerning the effect of non-drug interventions by healthcare professionals on community-dwelling postmenopausal osteoporotic women .

Exercise therapy for osteoporosis: results of a randomised controlled trial.

OBJECTIVE : To define the effects of therapeutic exercise on bone density and back complaints . METHODS : A r and omised controlled trial with parallel groups was conducted in an outpatient clinic , Medical School , University of Vienna . Ninety two sedentary post-menopausal women with back problems were r and omly allocated to either exercise ( groups 1 and 2 ) or control ( group 3 , no exercise , n = 31 ) ; the exercise group was retrospectively subdivided into compliant ( group 1 , n = 27 ) and not fully compliant patients ( group 2 , n = 34 ) . Regular , initially supervised therapeutic exercise aim ed at restoring biomechanical function was performed for four years . Bone density in the forearm was measured by single photon absorptiometry at entry and after four years ; subjective back complaints were documented . RESULTS : A significant decrease in bone density was observed in groups 2 and 3 ; no change was noted in group 1 ; back complaints decreased in group 1 only . CONCLUSIONS : Sedentary postmenopausal women may benefit from regular long term therapeutic exercise in terms of subjective back complaints and slowed loss of bone mass

Collectively , these studies provided some evidence to show that interventions by healthcare professionals improved the QOL medication compliance and calcium intake of patients but its effects on BMD , medication persistence , knowledge , and other lifestyle modifications were less conclusive .

Summary A systematic review was conducted to evaluate evidence concerning the effect of non-drug interventions by healthcare professionals on community-dwelling postmenopausal osteoporotic women . Evidence available indicates that such interventions are effective in improving the quality of life , medication compliance , and calcium intake , but effect on other outcomes is less conclusive . Introduction The purpose of this study is to conduct a systematic review to evaluate evidence concerning the effect of non-drug interventions by healthcare professionals on community-dwelling postmenopausal osteoporotic women .

Collectively , these studies provided some evidence to show that interventions by healthcare professionals improved the QOL medication compliance and calcium intake of patients but its effects on BMD , medication persistence , knowledge , and other lifestyle modifications were less conclusive .

Summary A systematic review was conducted to evaluate evidence concerning the effect of non-drug interventions by healthcare professionals on community-dwelling postmenopausal osteoporotic women . Evidence available indicates that such interventions are effective in improving the quality of life , medication compliance , and calcium intake , but effect on other outcomes is less conclusive . Introduction The purpose of this study is to conduct a systematic review to evaluate evidence concerning the effect of non-drug interventions by healthcare professionals on community-dwelling postmenopausal osteoporotic women .

Efficacy of a Self-Management Program for Osteoporotic Subjects

Alp A , Kanat E , Yurtkuran M : Efficacy of a self-management program for osteoporotic subjects . Am J Phys Med Rehabil 2007;86:633–640 . Objective : This study is based on whether the self-management program choices For Better Bone Health is effective to promote behavioral strategies for improving bone health , life quality , pain perception , physical function , and balance in osteoporotic subjects . Design : In this single-blind , r and omized controlled study , a total of 50 sedentary women with postmenopausal and idiopathic osteoporosis were selected from the out patients of Atatürk Balneotherapy and Rehabilitation Center according to their physical activity level and T scores of dual-energy x-ray absorptiometry as the inclusion criteria . Fifty sedentary women with BMD T scores of −2.5 or lower were r and omized into two groups ( self-management group : group 1 ; and control group : group 2 ) and enrolled in a 6-mo study . Participants attended self-management class once a week for 5 wks . Evaluations were done at baseline , at the end of the fifth week , and at the sixth month . Pain-intensity evaluation by Visual Analogue Scale ( VAS ) , life- quality assessment s by SF-36 , balance testing by Sensitized Romberg Test ( SRT ) , and functional assessment by Timed Sit to St and test ( TSS ) and a simple question naire were the outcome measures . Results : When the groups were compared by change scores and percentages of change , improvements observed in pain intensity by VAS ( P < 0.001 ) , SF-36 Physical Function ( P < 0.001 ) , SF-36 Physical Role Limitations ( P < 0.001 ) , SF-36 Social Function ( P < 0.001 ) , SF-36 Mental Health ( P < 0.001 ) , SF-36 Vitality ( P < 0.01 ) , SF-36 Pain ( P < 0.001 ) , SF-36 General Health Perceptions ( P < 0.05 ) , SF-36 Emotional Role Limitations ( P < 0.01 ) , SRT eyes open ( P < 0.001 ) , SRT eyes closed ( P < 0.001 ) , and TSS ( P < 0.001 ) were determined to be superior in group 1 at the end of the sixth month . Seventy-four percent of patients in group 1 engaged in regular physical activities , and 92 % of them declared that they understood the purpose and benefits of medications and dietary calcium intake . Fifty-seven percent of them formed personal plans for preventing traumas , whereas 8 % of the subjects in group 2 experienced new falls but no fractures . Conclusion : It is determined that the self-management class led to improvements in functional , balance , and life- quality outcomes and to reductions in pain perception

Collectively , these studies provided some evidence to show that interventions by healthcare professionals improved the QOL medication compliance and calcium intake of patients but its effects on BMD , medication persistence , knowledge , and other lifestyle modifications were less conclusive .

Summary A systematic review was conducted to evaluate evidence concerning the effect of non-drug interventions by healthcare professionals on community-dwelling postmenopausal osteoporotic women . Evidence available indicates that such interventions are effective in improving the quality of life , medication compliance , and calcium intake , but effect on other outcomes is less conclusive . Introduction The purpose of this study is to conduct a systematic review to evaluate evidence concerning the effect of non-drug interventions by healthcare professionals on community-dwelling postmenopausal osteoporotic women .

Collectively , these studies provided some evidence to show that interventions by healthcare professionals improved the QOL medication compliance and calcium intake of patients but its effects on BMD , medication persistence , knowledge , and other lifestyle modifications were less conclusive .

Summary A systematic review was conducted to evaluate evidence concerning the effect of non-drug interventions by healthcare professionals on community-dwelling postmenopausal osteoporotic women . Evidence available indicates that such interventions are effective in improving the quality of life , medication compliance , and calcium intake , but effect on other outcomes is less conclusive . Introduction The purpose of this study is to conduct a systematic review to evaluate evidence concerning the effect of non-drug interventions by healthcare professionals on community-dwelling postmenopausal osteoporotic women .

Effects on function and quality of life of postoperative home-based physical therapy for patients with hip fracture.

OBJECTIVE To evaluate the effects of a 3-month home-based physical therapy ( PT ) program for patients with hip fracture after surgery . DESIGN R and omized controlled trial . SETTING Home . PARTICIPANTS Twenty-five patients recently discharged from an acute orthopedic department . INTERVENTIONS Patients were r and omized to the home-based PT group ( n=13 ) , where they received home-based PT 8 times from discharge to month 3 postdischarge , or to the control group ( n=12 ) . The home-based PT program included exercises for muscle strengthening , range of motion ( ROM ) , balance , and functional training . Patients in the control group were instructed to practice the exercise program given at bedside before discharge . MAIN OUTCOME MEASURES Patients were evaluated for hip ROM , strength , walking velocity , Harris hip score , and health-related quality of life ( HRQOL ) at the week of discharge and at 1 , 3 , and 6 months after discharge . RESULTS The baseline characteristics showed no difference between the 2 groups . Harris score of the home-based PT group progressed from 58.6+/-8.5 to 90.1+/-5.4 at month 3 , whereas Harris score of the control group progressed from 54.6+/-14.5 to 77.4+/-10.0 ( P<.01 ) . Scores of the psychologic domain of HRQOL for the home-based PT group were significantly better at month 1 ( P<.05 ) and month 3 ( P<.01 ) after discharge . Moreover , the physical domain score of the home-based PT group was also significantly better ( P<.05 ) at 3 months after discharge . CONCLUSIONS Home-based PT programs could help patients regain function and HRQOL earlier

Collectively , these studies provided some evidence to show that interventions by healthcare professionals improved the QOL medication compliance and calcium intake of patients but its effects on BMD , medication persistence , knowledge , and other lifestyle modifications were less conclusive .

Summary A systematic review was conducted to evaluate evidence concerning the effect of non-drug interventions by healthcare professionals on community-dwelling postmenopausal osteoporotic women . Evidence available indicates that such interventions are effective in improving the quality of life , medication compliance , and calcium intake , but effect on other outcomes is less conclusive . Introduction The purpose of this study is to conduct a systematic review to evaluate evidence concerning the effect of non-drug interventions by healthcare professionals on community-dwelling postmenopausal osteoporotic women .

Collectively , these studies provided some evidence to show that interventions by healthcare professionals improved the QOL medication compliance and calcium intake of patients but its effects on BMD , medication persistence , knowledge , and other lifestyle modifications were less conclusive .

Summary A systematic review was conducted to evaluate evidence concerning the effect of non-drug interventions by healthcare professionals on community-dwelling postmenopausal osteoporotic women . Evidence available indicates that such interventions are effective in improving the quality of life , medication compliance , and calcium intake , but effect on other outcomes is less conclusive . Introduction The purpose of this study is to conduct a systematic review to evaluate evidence concerning the effect of non-drug interventions by healthcare professionals on community-dwelling postmenopausal osteoporotic women .

Community-based exercise program reduces risk factors for falls in 65- to 75-year-old women with osteoporosis: randomized controlled trial.

BACKGROUND Exercise programs improve balance , strength and agility in elderly people and thus may prevent falls . However , specific exercise programs that might be widely used in the community and that might be " prescribed " by physicians , especially for patients with osteoporosis , have not been evaluated . We conducted a r and omized controlled trial of such a program design ed specifically for women with osteoporosis . METHODS We identified women 65 to 75 years of age in whom osteoporosis had been diagnosed by dual-energy X-ray absorptiometry in our hospital between 1996 and 2000 and who were not engaged in regular weekly programs of moderate or hard exercise . Women who agreed to participate were r and omly assigned to participate in a twice-weekly exercise class or to not participate in the class . We measured baseline data and , 20 weeks later , changes in static balance ( by dynamic posturography ) , dynamic balance ( by a timed figure-eight run ) and knee extension strength ( by dynamometry ) . RESULTS Of 93 women who began the trial , 80 completed it . Before adjustment for covariates , the intervention group tended to have greater , although nonsignificant , improvements in static balance ( mean difference 4.8 % , 95 % confidence interval [ CI ] -1.3 % to 11.0 % ) , dynamic balance ( mean difference 3.3 % , 95 % CI -1.7 % to 8.4 % ) and knee extension strength ( mean difference 7.8 % , 95 % CI -5.4 % to 21.0 % ) . Mean crude changes in the static balance score were -0.85 ( 95 % CI -2.91 to 1.21 ) for the control group and 1.40 ( 95 % CI -0.66 to 3.46 ) for the intervention group . Mean crude changes in figure-eight velocity ( dynamic balance ) were 0.08 ( 95 % CI 0.02 to 0.14 ) m/s for the control group and 0.14 ( 95 % CI 0.08 to 0.20 ) m/s for the intervention group . For knee extension strength , mean changes were -0.58 ( 95 % CI -3.02 to 1.81 ) kg/m for the control group and 1.03 ( 95 % CI -1.31 to 3.34 ) kg/m for the intervention group . After adjustment for age , physical activity and years of estrogen use , the improvement in dynamic balance was 4.9 % greater for the intervention group than for the control group ( p = 0.044 ) . After adjustment for physical activity , cognitive status and number of fractures ever , the improvement in knee extension strength was 12.8 % greater for the intervention group than for the control group ( p = 0.047 ) . The intervention group also had a 6.3 % greater improvement in static balance after adjustment for rheumatoid arthritis and osteoarthritis , but this difference was not significant ( p = 0.06 ) . INTERPRETATION Relative to controls , participants in the exercise program experienced improvements in dynamic balance and strength , both important determinants of risk for falls , particularly in older women with osteoporosis

Collectively , these studies provided some evidence to show that interventions by healthcare professionals improved the QOL medication compliance and calcium intake of patients but its effects on BMD , medication persistence , knowledge , and other lifestyle modifications were less conclusive .

Summary A systematic review was conducted to evaluate evidence concerning the effect of non-drug interventions by healthcare professionals on community-dwelling postmenopausal osteoporotic women . Evidence available indicates that such interventions are effective in improving the quality of life , medication compliance , and calcium intake , but effect on other outcomes is less conclusive . Introduction The purpose of this study is to conduct a systematic review to evaluate evidence concerning the effect of non-drug interventions by healthcare professionals on community-dwelling postmenopausal osteoporotic women .

Collectively , these studies provided some evidence to show that interventions by healthcare professionals improved the QOL medication compliance and calcium intake of patients but its effects on BMD , medication persistence , knowledge , and other lifestyle modifications were less conclusive .

Summary A systematic review was conducted to evaluate evidence concerning the effect of non-drug interventions by healthcare professionals on community-dwelling postmenopausal osteoporotic women . Evidence available indicates that such interventions are effective in improving the quality of life , medication compliance , and calcium intake , but effect on other outcomes is less conclusive . Introduction The purpose of this study is to conduct a systematic review to evaluate evidence concerning the effect of non-drug interventions by healthcare professionals on community-dwelling postmenopausal osteoporotic women .

Effects of extended outpatient rehabilitation after hip fracture: a randomized controlled trial.

CONTEXT Hip fractures are common in the elderly , and despite st and ard rehabilitation , many patients fail to regain their prefracture ambulatory or functional status . OBJECTIVE To determine whether extended outpatient rehabilitation that includes progressive resistance training improves physical function and reduces disability compared with low-intensity home exercise among physically frail elderly patients with hip fracture . DESIGN , SETTING , AND PATIENTS R and omized controlled trial conducted between August 1998 and May 2003 among 90 community-dwelling women and men aged 65 years or older who had had surgical repair of a proximal femur fracture no more than 16 weeks prior and had completed st and ard physical therapy . INTERVENTION Participants were r and omly assigned to 6 months of either supervised physical therapy and exercise training ( n = 46 ) or home exercise ( control condition ; n = 44 ) . MAIN OUTCOME MEASURES Primary outcome measures were total scores on a modified Physical Performance Test ( PPT ) , the Functional Status Question naire physical function subscale ( FSQ ) , and activities of daily living scales . Secondary outcome measures were st and ardized measures of skeletal muscle strength , gait , balance , quality of life , and body composition . Participants were evaluated at baseline , 3 months , and 6 months . RESULTS Changes over time in the PPT and FSQ scores favored the physical therapy group ( P = .003 and P = .01 , respectively ) . Mean change ( SD ) in PPT score for physical therapy was + 6.5 ( 5.5 ) points ( 95 % confidence interval [ CI ] , 4.6 - 8.3 ) , and for the control condition was + 2.5 ( 3.7 ) points ( 95 % CI , 1.4 - 3.6 points ) . Mean change ( SD ) in FSQ score for physical therapy was + 5.2 ( 5.4 ) points ( 95 % CI , 3.5 - 6.9 ) and for the control condition was + 2.9 ( 3.8 ) points ( 95 % CI , 1.7 - 4.0 ) . Physical therapy also had significantly greater improvements than the control condition in measures of muscle strength , walking speed , balance , and perceived health but not bone mineral density or fat-free mass . CONCLUSION In community-dwelling frail elderly patients with hip fracture , 6 months of extended outpatient rehabilitation that includes progressive resistance training can improve physical function and quality of life and reduce disability compared with low-intensity home exercise

Collectively , these studies provided some evidence to show that interventions by healthcare professionals improved the QOL medication compliance and calcium intake of patients but its effects on BMD , medication persistence , knowledge , and other lifestyle modifications were less conclusive .

Summary A systematic review was conducted to evaluate evidence concerning the effect of non-drug interventions by healthcare professionals on community-dwelling postmenopausal osteoporotic women . Evidence available indicates that such interventions are effective in improving the quality of life , medication compliance , and calcium intake , but effect on other outcomes is less conclusive . Introduction The purpose of this study is to conduct a systematic review to evaluate evidence concerning the effect of non-drug interventions by healthcare professionals on community-dwelling postmenopausal osteoporotic women .

Collectively , these studies provided some evidence to show that interventions by healthcare professionals improved the QOL medication compliance and calcium intake of patients but its effects on BMD , medication persistence , knowledge , and other lifestyle modifications were less conclusive .

Summary A systematic review was conducted to evaluate evidence concerning the effect of non-drug interventions by healthcare professionals on community-dwelling postmenopausal osteoporotic women . Evidence available indicates that such interventions are effective in improving the quality of life , medication compliance , and calcium intake , but effect on other outcomes is less conclusive . Introduction The purpose of this study is to conduct a systematic review to evaluate evidence concerning the effect of non-drug interventions by healthcare professionals on community-dwelling postmenopausal osteoporotic women .

Structural Model for Osteoporosis Preventing Behavior in Postmenopausal Women

Background : Osteoporosis prevention behaviors ( OPBs ) can prevent and delay bone deterioration ; dual-energy X-ray absorptiometry ( DXA ) scan can identify osteoporosis and provide personal osteoporosis risk information that may promote prevention behaviors . Objectives : This study was design ed to estimate relationships between receiving personal knowledge of bone mineral density ( gained through DXA scan ) , general knowledge of osteoporosis , health beliefs , and the two OPBs of calcium intake and weight-bearing exercise in healthy postmenopausal women 50 to 65 years . Methods : In this longitudinal , r and omized clinical trial ( including covariates ) , receipt of personal DXA information was manipulated by r and om assignment to the experimental or control group . The remaining antecedent and outcome variable measures were collected by question naire at three time points ( initial [ T1 ; pre-DXA ] , 6 months [ T2 ] , 12 months [ T3 ] ) and by bone density assessment from 203 women over an 18-month period in 2001 - 2003 . Results : The experimental manipulation ( DXA results ) had a direct positive effect ( & bgr ; = .23 , p < .05 ) on calcium intake at T2 , and indirectly at T3 through T2 . Women in the experimental group who were informed they had osteopenia or osteoporosis had a greater T1-T2 change in daily calcium intake than those with normal bone density ( & bgr ; = .23 , p < .05 ) . However , providing DXA results did not relate to change in exercise . Health beliefs and general osteoporosis knowledge predicted initial calcium and exercise levels ; there was tentative evidence that susceptibility beliefs partially mediate between DXA results and change in calcium intake . Discussion : Personal knowledge of DXA results was related significantly to increases in calcium intake in postmenopausal women , but not to exercise . Directions for further study are discussed

Collectively , these studies provided some evidence to show that interventions by healthcare professionals improved the QOL medication compliance and calcium intake of patients but its effects on BMD , medication persistence , knowledge , and other lifestyle modifications were less conclusive .

Summary A systematic review was conducted to evaluate evidence concerning the effect of non-drug interventions by healthcare professionals on community-dwelling postmenopausal osteoporotic women . Evidence available indicates that such interventions are effective in improving the quality of life , medication compliance , and calcium intake , but effect on other outcomes is less conclusive . Introduction The purpose of this study is to conduct a systematic review to evaluate evidence concerning the effect of non-drug interventions by healthcare professionals on community-dwelling postmenopausal osteoporotic women .

Collectively , these studies provided some evidence to show that interventions by healthcare professionals improved the QOL medication compliance and calcium intake of patients but its effects on BMD , medication persistence , knowledge , and other lifestyle modifications were less conclusive .

Summary A systematic review was conducted to evaluate evidence concerning the effect of non-drug interventions by healthcare professionals on community-dwelling postmenopausal osteoporotic women . Evidence available indicates that such interventions are effective in improving the quality of life , medication compliance , and calcium intake , but effect on other outcomes is less conclusive . Introduction The purpose of this study is to conduct a systematic review to evaluate evidence concerning the effect of non-drug interventions by healthcare professionals on community-dwelling postmenopausal osteoporotic women .

What is the impact of osteoporosis education and bone mineral density testing for postmenopausal women in a managed care setting?

Objective To assess whether osteoporosis education , with and without bone mineral density ( BMD ) testing , increases the initiation of lifestyle changes and pharmaceutical treatment to prevent osteoporosis . Design A total of 508 women , aged 54–65 , from a large managed care organization who were not on osteoporosis prevention therapy participated in an intervention study . Participants were r and omly assigned to either an education class on osteoporosis ( n = 301 ) or education plus BMD ( n = 207 ) . A control group of 187 women receiving no intervention were also surveyed to serve as comparison . Group differences and differences based on BMD test result were compared 6 months after education regarding self-reported changes in health behaviors using & khgr;2 tests and logistic regression analyses . Results Of the 508 intervention participants , 455 ( 90 % ) responded to the follow-up survey . Initiation of hormone replacement therapy was reported by 9 % , with 5 % reporting starting alendronate . More than half reported changes in diet , exercise , or calcium intake . Forty-three percent increased their vitamin D intake . There were no significant group differences in behavior except with regard to pharmaceutical therapy ; subjects with education plus BMD were three times more likely than those receiving education only to report starting hormone replacement therapy ( p = 0.004 ) . Low BMD scores were associated with increasing vitamin D intake ( p = 0.03 ) and starting medication ( p = 0.001 ) . Women in the intervention groups were significantly more likely to report modifying their diet ( p < 0.001 ) , calcium ( p < 0.01 ) , and vitamin D intake ( p < 0.0001 ) than women in the control group , not exposed to education . Conclusion Education regarding osteoporosis prevention seems to encourage women to make lifestyle changes . The inclusion of BMD testing enhances the likelihood that women will consider pharmaceutical therapy

Collectively , these studies provided some evidence to show that interventions by healthcare professionals improved the QOL medication compliance and calcium intake of patients but its effects on BMD , medication persistence , knowledge , and other lifestyle modifications were less conclusive .

Summary A systematic review was conducted to evaluate evidence concerning the effect of non-drug interventions by healthcare professionals on community-dwelling postmenopausal osteoporotic women . Evidence available indicates that such interventions are effective in improving the quality of life , medication compliance , and calcium intake , but effect on other outcomes is less conclusive . Introduction The purpose of this study is to conduct a systematic review to evaluate evidence concerning the effect of non-drug interventions by healthcare professionals on community-dwelling postmenopausal osteoporotic women .

Collectively , these studies provided some evidence to show that interventions by healthcare professionals improved the QOL medication compliance and calcium intake of patients but its effects on BMD , medication persistence , knowledge , and other lifestyle modifications were less conclusive .

Summary A systematic review was conducted to evaluate evidence concerning the effect of non-drug interventions by healthcare professionals on community-dwelling postmenopausal osteoporotic women . Evidence available indicates that such interventions are effective in improving the quality of life , medication compliance , and calcium intake , but effect on other outcomes is less conclusive . Introduction The purpose of this study is to conduct a systematic review to evaluate evidence concerning the effect of non-drug interventions by healthcare professionals on community-dwelling postmenopausal osteoporotic women .

Does an educational leaflet improve self-reported adherence to therapy in osteoporosis? The OPTIMA study

Introduction Adherence to treatment in osteoporosis remains poor . The aim of this study was to evaluate the effects of an educational leaflet on adherence to medication and to assess the association between adherence and health-related quality of life ( HRQOL ) . Methods A naturalistic , observational , multi-center , prospect i ve study of 12 months ’ follow-up was performed . Consecutive post-menopausal women aged 50 years to 86 years starting treatment with raloxifene according to daily practice were enrolled from 126 primary care offices in Spain . The women were assigned to two study groups . Group A received an educational leaflet with general information about osteoporosis ; group B followed current practice . To assess adherence to medication and HRQOL , the Morisky test and the EuroQoL question naire were administered . A total of 745 post-menopausal women ( group A , n=366 ; group B n=379 ) , with a mean age of 62 years , were included . Results Most patients in both study groups showed high adherence to raloxifene at the 3-month visit : 56.3 % vs 62.7 % for groups A and B , respectively ; this proportion at the 12-month visit was 47.4 % ( P=0.15 ) and 52.5 % ( P=0.02 ) , respectively . At baseline , “ pain/discomfort ” was the dimension showing the highest percentage of women reporting problems : 86.4 % vs 83.2 % in groups A and B , respectively ( P=0.22 ) . HRQOL improved in both groups throughout the study , with an overall mean increment in the EuroQoL visual analog scale ( EQ VAS ) of 9.2 at 12 months ( P<0.01 ) . Correlations between adherence and HRQOL were weak . After receiving an educational leaflet , young post-menopausal women suffering osteoporosis did not show improvement in adherence to therapy . HRQOL improved at 12-month follow-up under treatment . Conclusion No consistent correlation between adherence and HRQOL was found

Collectively , these studies provided some evidence to show that interventions by healthcare professionals improved the QOL medication compliance and calcium intake of patients but its effects on BMD , medication persistence , knowledge , and other lifestyle modifications were less conclusive .

Summary A systematic review was conducted to evaluate evidence concerning the effect of non-drug interventions by healthcare professionals on community-dwelling postmenopausal osteoporotic women . Evidence available indicates that such interventions are effective in improving the quality of life , medication compliance , and calcium intake , but effect on other outcomes is less conclusive . Introduction The purpose of this study is to conduct a systematic review to evaluate evidence concerning the effect of non-drug interventions by healthcare professionals on community-dwelling postmenopausal osteoporotic women .

Collectively , these studies provided some evidence to show that interventions by healthcare professionals improved the QOL medication compliance and calcium intake of patients but its effects on BMD , medication persistence , knowledge , and other lifestyle modifications were less conclusive .

Summary A systematic review was conducted to evaluate evidence concerning the effect of non-drug interventions by healthcare professionals on community-dwelling postmenopausal osteoporotic women . Evidence available indicates that such interventions are effective in improving the quality of life , medication compliance , and calcium intake , but effect on other outcomes is less conclusive . Introduction The purpose of this study is to conduct a systematic review to evaluate evidence concerning the effect of non-drug interventions by healthcare professionals on community-dwelling postmenopausal osteoporotic women .

Effect of low-intensity back exercise on quality of life and back extensor strength in patients with osteoporosis: a randomized controlled trial

Summary R and omized controlled study in 80 postmenopausal women with osteoporosis was conducted to investigate the effect of a home-based , simple , low-intensity exercise . Low-intensity back-strengthening exercise was effective in improving the quality of life and back extensor strength . Introduction and hypothesisBack-strengthening exercise is effective in increasing back extensor strength and decreasing risk of vertebral fractures . We hypothesized that a home-based , simple , low-intensity exercise could enhance back extensor strength and improve the quality of life and /or spinal range of motion in postmenopausal women in a short-term follow-up . Methods Eighty postmenopausal women with osteoporosis were r and omly assigned to a control group ( n = 38 ) or an exercise group ( n = 42 ) . Subjects were instructed to lift their upper trunk from a prone position antigravity and maintain the neutral position . Isometric back extensor strength , spinal range of motion , and scores for quality of life were evaluated at baseline and 4 months . Results Back extensor strength significantly increased both in the exercise group ( 26 % ) and in the control group ( 11 % ) . Scores for quality of life increased in the exercise group ( 7 % ) , whereas it remained unchanged in the control group ( 0 % ) . There was a significant difference in quality of life score between the groups ( p = 0.012 ) . Conclusions Low-intensity back-strengthening exercise was effective in improving the quality of life and back extensor strength in patients with osteoporosis

Collectively , these studies provided some evidence to show that interventions by healthcare professionals improved the QOL medication compliance and calcium intake of patients but its effects on BMD , medication persistence , knowledge , and other lifestyle modifications were less conclusive .

Summary A systematic review was conducted to evaluate evidence concerning the effect of non-drug interventions by healthcare professionals on community-dwelling postmenopausal osteoporotic women . Evidence available indicates that such interventions are effective in improving the quality of life , medication compliance , and calcium intake , but effect on other outcomes is less conclusive . Introduction The purpose of this study is to conduct a systematic review to evaluate evidence concerning the effect of non-drug interventions by healthcare professionals on community-dwelling postmenopausal osteoporotic women .

Collectively , these studies provided some evidence to show that interventions by healthcare professionals improved the QOL medication compliance and calcium intake of patients but its effects on BMD , medication persistence , knowledge , and other lifestyle modifications were less conclusive .

Summary A systematic review was conducted to evaluate evidence concerning the effect of non-drug interventions by healthcare professionals on community-dwelling postmenopausal osteoporotic women . Evidence available indicates that such interventions are effective in improving the quality of life , medication compliance , and calcium intake , but effect on other outcomes is less conclusive . Introduction The purpose of this study is to conduct a systematic review to evaluate evidence concerning the effect of non-drug interventions by healthcare professionals on community-dwelling postmenopausal osteoporotic women .

Effect of monitoring bone turnover markers on persistence with risedronate treatment of postmenopausal osteoporosis.

CONTEXT Persistence with osteoporosis treatment is poor but is important for maximum benefit . OBJECTIVE The objective of the study was to assess the impact of physician reinforcement using bone turnover markers ( BTMs ) on persistence with risedronate treatment . DESIGN AND SETTING This was a 1-yr multinational prospect i ve , open-label , blinded study in 171 osteoporosis centers in 21 countries . PATIENTS A total of 2382 postmenopausal women ( 65 - 80 yr old ) with spine/hip T-score -2.5 or less or T-score -1.0 or less with a low-trauma fracture . INTERVENTION Intervention included calcium 500 mg/d , vitamin D 400 IU/d , and risedronate 5 mg/d for 1 yr . Centers were r and omized to reinforcement ( RE+ ) or no reinforcement ( RE- ) . At 13 and 25 wk , reinforcement based on urinary N-telopeptide of type I collagen change from baseline was provided to the RE+ patients using the following response categories : good ( > 30 % decrease ) , stable ( -30 % to + 30 % change ) , or poor ( > 30 % increase ) . MAIN OUTCOME MEASURES Persistence assessed with electronic drug monitors was measured . RESULTS In the overall efficacy population ( n=2302 ) , persistence was unexpectedly high and was similar for both groups ( RE- , 77 % ; RE+ , 80 % ; P=0.160 ) . A significant relationship between the type of message and persistence was observed ( P=0.017 ) . Compared with RE- , intervention based on a good BTM response was associated with a significant improvement in persistence [ hazard ratio ( HR ) 0.71 ; 95 % confidence interval ( CI ) 0.53 - 0.95 ] . Persistence was unchanged ( HR 1.02 ; 95 % CI 0.74 - 1.40 ) or lower ( HR 2.22 ; 95 % CI 1.27 - 3.89 ) when reinforcement was based on a stable or poor BTM response , respectively . Reinforcement was associated with a lower incidence of new radiologically determined vertebral fractures ( odds ratio 0.4 ; 95 % CI , 0.2 - 1.0 ) . CONCLUSIONS Reinforcement using BTMs influences persistence with treatment in postmenopausal women with osteoporosis , depending on the BTM response observed

Collectively , these studies provided some evidence to show that interventions by healthcare professionals improved the QOL medication compliance and calcium intake of patients but its effects on BMD , medication persistence , knowledge , and other lifestyle modifications were less conclusive .

Summary A systematic review was conducted to evaluate evidence concerning the effect of non-drug interventions by healthcare professionals on community-dwelling postmenopausal osteoporotic women . Evidence available indicates that such interventions are effective in improving the quality of life , medication compliance , and calcium intake , but effect on other outcomes is less conclusive . Introduction The purpose of this study is to conduct a systematic review to evaluate evidence concerning the effect of non-drug interventions by healthcare professionals on community-dwelling postmenopausal osteoporotic women .

Collectively , these studies provided some evidence to show that interventions by healthcare professionals improved the QOL medication compliance and calcium intake of patients but its effects on BMD , medication persistence , knowledge , and other lifestyle modifications were less conclusive .

Summary A systematic review was conducted to evaluate evidence concerning the effect of non-drug interventions by healthcare professionals on community-dwelling postmenopausal osteoporotic women . Evidence available indicates that such interventions are effective in improving the quality of life , medication compliance , and calcium intake , but effect on other outcomes is less conclusive . Introduction The purpose of this study is to conduct a systematic review to evaluate evidence concerning the effect of non-drug interventions by healthcare professionals on community-dwelling postmenopausal osteoporotic women .

A multifaceted intervention to improve treatment of osteoporosis in postmenopausal women with wrist fractures: a cluster randomized trial

Summary In a cluster r and omized trial , we evaluated the effect of a multifaceted intervention ( directed at both patient and primary care physician ) on the rates of testing and treatment of osteoporosis in postmenopausal women within six months of their wrist fracture . Compared to usual care , women in the intervention practice s were three times more likely to receive bone mineral density testing and prescribed osteoporosis treatments . Introduction Postmenopausal women with wrist fractures are at increased risk of future fragility fractures , yet they frequently do not receive evaluation and treatment for osteoporosis . We set out to evaluate a multifaceted intervention design ed to improve management of osteoporosis in older women with recent wrist fractures . Methods Cluster r and omized trial of 270 women cared for in 119 primary care practice s. We recruited postmenopausal women with an acute wrist fracture from the emergency departments of hospitals in southeastern Ontario , Canada . Family practice s were r and omly assigned to either the intervention or usual care . The intervention consisted of a mailed reminder with a summary of treatment guidelines and letter sent to the primary care physician , in addition to an educational package and letter to the women . The primary outcome was the proportion of women prescribed osteoporosis therapy within 6 months of their fracture . Results The mean age of women was 69(10.9 ) years . The intervention increased the proportion of women started on osteoporosis medications ( 28 % vs. 10 % ) of controls , adjusted OR 3.45 , 95 % CI , 1.58–7.56 , p = 0.002 ) and the proportion who had a bone mineral density ( BMD ) test ( 53.3 % vs. 26 % ) of controls , OR 3.38 , 95 % CI , 1.83–6.26 , p < 0.001 ) . In addition to the intervention , having a female physician was a predictor of increased testing and treatment rates . Conclusion A multifaceted intervention significantly improved rates of osteoporosis treatment and BMD testing in postmenopausal women with wrist fractures

Collectively , these studies provided some evidence to show that interventions by healthcare professionals improved the QOL medication compliance and calcium intake of patients but its effects on BMD , medication persistence , knowledge , and other lifestyle modifications were less conclusive .

Summary A systematic review was conducted to evaluate evidence concerning the effect of non-drug interventions by healthcare professionals on community-dwelling postmenopausal osteoporotic women . Evidence available indicates that such interventions are effective in improving the quality of life , medication compliance , and calcium intake , but effect on other outcomes is less conclusive . Introduction The purpose of this study is to conduct a systematic review to evaluate evidence concerning the effect of non-drug interventions by healthcare professionals on community-dwelling postmenopausal osteoporotic women .

Collectively , these studies provided some evidence to show that interventions by healthcare professionals improved the QOL medication compliance and calcium intake of patients but its effects on BMD , medication persistence , knowledge , and other lifestyle modifications were less conclusive .

Summary A systematic review was conducted to evaluate evidence concerning the effect of non-drug interventions by healthcare professionals on community-dwelling postmenopausal osteoporotic women . Evidence available indicates that such interventions are effective in improving the quality of life , medication compliance , and calcium intake , but effect on other outcomes is less conclusive . Introduction The purpose of this study is to conduct a systematic review to evaluate evidence concerning the effect of non-drug interventions by healthcare professionals on community-dwelling postmenopausal osteoporotic women .

The impact of monitoring on adherence and persistence with antiresorptive treatment for postmenopausal osteoporosis: a randomized controlled trial.

Long-term adherence and persistence with any therapy are very poor ( approximately 50 % ) . Adherence to therapy is defined as the percentage of prescribed medication taken , and persistence is defined as continuing to take prescribed medication . We examined whether monitoring by nursing staff could enhance adherence and persistence with antiresorptive therapy and whether presenting information on response to therapy provided additional benefit . In addition we evaluated the impact of monitoring on treatment efficacy . Seventy-five postmenopausal women with osteopenia were r and omized to 1 ) no monitoring , 2 ) nurse-monitoring , or 3 ) marker-monitoring . All subjects were prescribed raloxifene . At 12 , 24 , and 36 wk , the nursing staff review ed subjects in the monitored ( nurse-monitoring or marker-monitoring ) groups using a predefined protocol . The marker-monitored group were also presented a graph of response to therapy using percentage change in urinary N-telopeptide of type I collagen ( uNTX ) , a bone resorption marker , at each visit . Biological response to therapy at 1 yr was determined using the percent change in bone mineral density ( BMD ) and uNTX . Treatment adherence and persistence were assessed using electronic monitoring devices . Survival analysis showed that the monitored group increased cumulative adherence to therapy by 57 % compared with no monitoring ( P = 0.04 ) . There was a trend for the monitored group to persist with therapy for 25 % longer compared with no monitoring ( P = 0.07 ) . Marker measurements did not improve adherence or persistence to therapy compared with nurse-monitoring alone . Adherence at 1 yr was correlated with percent change in hip ( BMD ) ( r = 0.28 ; P = 0.01 ) and percent change in uNTX ( r = -0.36 ; P = 0.002 ) . In conclusion , monitoring of patients increased adherence to therapy by 57 % at 1 yr . Increased adherence to therapy increased the effectiveness of raloxifene therapy determined using surrogate end points

Collectively , these studies provided some evidence to show that interventions by healthcare professionals improved the QOL medication compliance and calcium intake of patients but its effects on BMD , medication persistence , knowledge , and other lifestyle modifications were less conclusive .

Summary A systematic review was conducted to evaluate evidence concerning the effect of non-drug interventions by healthcare professionals on community-dwelling postmenopausal osteoporotic women . Evidence available indicates that such interventions are effective in improving the quality of life , medication compliance , and calcium intake , but effect on other outcomes is less conclusive . Introduction The purpose of this study is to conduct a systematic review to evaluate evidence concerning the effect of non-drug interventions by healthcare professionals on community-dwelling postmenopausal osteoporotic women .

Collectively , these studies provided some evidence to show that interventions by healthcare professionals improved the QOL medication compliance and calcium intake of patients but its effects on BMD , medication persistence , knowledge , and other lifestyle modifications were less conclusive .

Summary A systematic review was conducted to evaluate evidence concerning the effect of non-drug interventions by healthcare professionals on community-dwelling postmenopausal osteoporotic women . Evidence available indicates that such interventions are effective in improving the quality of life , medication compliance , and calcium intake , but effect on other outcomes is less conclusive . Introduction The purpose of this study is to conduct a systematic review to evaluate evidence concerning the effect of non-drug interventions by healthcare professionals on community-dwelling postmenopausal osteoporotic women .

Efficacy of home-based exercise for improving quality of life among elderly women with symptomatic osteoporosis-related vertebral fractures

This r and omized controlled trial was design ed to investigate the effect of a 6-month home-based exercise program versus control ( usual activities ) on quality of life for postmenopausal women with osteoporosis who had at least one vertebral fracture . Twelve-month assessment s of outcomes were completed to determine if women would continue exercising with minimal supervision and if benefit could be sustained . The home exercise program followed a " lifestyle exercise " approach where participants completed exercises 60 min per day , 3 days a week and could complete exercises in small periods of time throughout the day . Exercise activities included stretching , strength training and aerobics ( i.e. walking ) . Participants were assessed at baseline , 6 months , and 12 months using the Osteoporosis Quality of Life Question naire ( OQLQ ) , the Sickness Impact Profile ( SIP ) , a balance test , and the Timed Up And Go test . Bone mineral density was assessed at baseline and 12 months for both the lumbar spine and femoral neck . Quality of life ( OQLQ ) improved over 6 months in the exercise group compared to the control group in the domains of symptoms ( P=0.003 ) , emotion ( P=0.01 ) and leisure ( P=0.03 ) . Results from the balance test indicated a greater effect in the exercise group over 12 months ( P<0.05 ) . There were no significant differences between groups in measures of Timed Up and Go , SIP at 6 and 12 months , and femoral neck and lumbar spine bone mineral density at 12 months . Home-based exercise with minimal supervision improves quality of life in elderly women with vertebral fractures . Future research is needed to determine if home exercise programs reduce falls and fall-related injuries in the elderly

Collectively , these studies provided some evidence to show that interventions by healthcare professionals improved the QOL medication compliance and calcium intake of patients but its effects on BMD , medication persistence , knowledge , and other lifestyle modifications were less conclusive .

Summary A systematic review was conducted to evaluate evidence concerning the effect of non-drug interventions by healthcare professionals on community-dwelling postmenopausal osteoporotic women . Evidence available indicates that such interventions are effective in improving the quality of life , medication compliance , and calcium intake , but effect on other outcomes is less conclusive . Introduction The purpose of this study is to conduct a systematic review to evaluate evidence concerning the effect of non-drug interventions by healthcare professionals on community-dwelling postmenopausal osteoporotic women .

Collectively , these studies provided some evidence to show that interventions by healthcare professionals improved the QOL medication compliance and calcium intake of patients but its effects on BMD , medication persistence , knowledge , and other lifestyle modifications were less conclusive .

Summary A systematic review was conducted to evaluate evidence concerning the effect of non-drug interventions by healthcare professionals on community-dwelling postmenopausal osteoporotic women . Evidence available indicates that such interventions are effective in improving the quality of life , medication compliance , and calcium intake , but effect on other outcomes is less conclusive . Introduction The purpose of this study is to conduct a systematic review to evaluate evidence concerning the effect of non-drug interventions by healthcare professionals on community-dwelling postmenopausal osteoporotic women .

Results of a 10 week community based strength and balance training programme to reduce fall risk factors: a randomised controlled trial in 65–75 year old women with osteoporosis

Objective —To test the efficacy of a community based 10 week exercise intervention to reduce fall risk factors in women with osteoporosis . Methods —Static balance was measured by computerised dynamic posturography ( Equitest ) , dynamic balance by timed figure of eight run , and knee extension strength by dynamometry . Subjects were r and omised to exercise intervention ( twice weekly Osteofit classes for 10 weeks ) or control groups . Results —The outcome in 79 participants ( 39 exercise , 40 control ) who were available for measurement 10 weeks after baseline measurement is reported . After confounding factors had been controlled for , the exercise group did not make significant gains compared with their control counterparts , although there were consistent trends toward greater improvement in all three primary outcome measures . Relative to the change in control subjects , the exercise group improved by 2.3 % in static balance , 1.9 % in dynamic balance , and 13.9 % in knee extension strength . Conclusions —A 10 week community based physical activity intervention did not significantly reduce fall risk factors in women with osteoporosis . However , trends toward improvement in key independent risk factors for falling suggest that a study with greater power may show that these variables can be improved to a level that reaches statistical significance

Collectively , these studies provided some evidence to show that interventions by healthcare professionals improved the QOL medication compliance and calcium intake of patients but its effects on BMD , medication persistence , knowledge , and other lifestyle modifications were less conclusive .

Summary A systematic review was conducted to evaluate evidence concerning the effect of non-drug interventions by healthcare professionals on community-dwelling postmenopausal osteoporotic women . Evidence available indicates that such interventions are effective in improving the quality of life , medication compliance , and calcium intake , but effect on other outcomes is less conclusive . Introduction The purpose of this study is to conduct a systematic review to evaluate evidence concerning the effect of non-drug interventions by healthcare professionals on community-dwelling postmenopausal osteoporotic women .

Collectively , these studies provided some evidence to show that interventions by healthcare professionals improved the QOL medication compliance and calcium intake of patients but its effects on BMD , medication persistence , knowledge , and other lifestyle modifications were less conclusive .

Summary A systematic review was conducted to evaluate evidence concerning the effect of non-drug interventions by healthcare professionals on community-dwelling postmenopausal osteoporotic women . Evidence available indicates that such interventions are effective in improving the quality of life , medication compliance , and calcium intake , but effect on other outcomes is less conclusive . Introduction The purpose of this study is to conduct a systematic review to evaluate evidence concerning the effect of non-drug interventions by healthcare professionals on community-dwelling postmenopausal osteoporotic women .

Effectiveness of a falls-and-fracture nurse coordinator to reduce falls: a randomized, controlled trial of at-risk older adults.

OBJECTIVES To assess the effectiveness of a community-based falls- and -fracture nurse coordinator and multifactorial intervention in reducing falls in older people . DESIGN R and omized , controlled trial . SETTING Screening for previous falls in family practice followed by community-based intervention . PARTICIPANTS Three hundred twelve community-living people aged 75 and older who had fallen in the previous year . INTERVENTION Home-based nurse assessment of falls- and -fracture risk factors and home hazards , referral to appropriate community interventions , and strength and balance exercise program . Control group received usual care and social visits . MEASUREMENTS Primary outcome was rate of falls over 12 months . Secondary outcomes were muscle strength and balance , falls efficacy , activities of daily living , self-reported physical activity level , and quality of life ( Medical Outcomes Study 36-item Short Form Question naire ) . RESULTS Of the 3,434 older adults screened for falls , 312 ( 9 % ) from 19 family practice s were enrolled and r and omized . The average age was 81+/-5 , and 69 % ( 215/312 ) were women . The incidence rate ratio for falls for the intervention group compared with the control group was 0.96 ( 95 % confidence interval=0.70 - 1.34 ) . There were no significant differences in secondary outcomes between the two groups . CONCLUSION This nurse-led intervention was not effective in reducing falls in older people who had fallen previously . Implementation and adherence to the fall-prevention measures was dependent on referral to other health professionals working in their usual clinical practice . This may have limited the effectiveness of the interventions

Collectively , these studies provided some evidence to show that interventions by healthcare professionals improved the QOL medication compliance and calcium intake of patients but its effects on BMD , medication persistence , knowledge , and other lifestyle modifications were less conclusive .

Summary A systematic review was conducted to evaluate evidence concerning the effect of non-drug interventions by healthcare professionals on community-dwelling postmenopausal osteoporotic women . Evidence available indicates that such interventions are effective in improving the quality of life , medication compliance , and calcium intake , but effect on other outcomes is less conclusive . Introduction The purpose of this study is to conduct a systematic review to evaluate evidence concerning the effect of non-drug interventions by healthcare professionals on community-dwelling postmenopausal osteoporotic women .

Collectively , these studies provided some evidence to show that interventions by healthcare professionals improved the QOL medication compliance and calcium intake of patients but its effects on BMD , medication persistence , knowledge , and other lifestyle modifications were less conclusive .

Summary A systematic review was conducted to evaluate evidence concerning the effect of non-drug interventions by healthcare professionals on community-dwelling postmenopausal osteoporotic women . Evidence available indicates that such interventions are effective in improving the quality of life , medication compliance , and calcium intake , but effect on other outcomes is less conclusive . Introduction The purpose of this study is to conduct a systematic review to evaluate evidence concerning the effect of non-drug interventions by healthcare professionals on community-dwelling postmenopausal osteoporotic women .

Tailored Interventions to Enhance Osteoporosis Prevention in Women

PURPOSE The purpose of this pilot study was to determine if tailored nursing interventions based on personal knowledge of bone mineral density from a dual-energy x-ray absorptiometry cause increases in knowledge of osteoporosis , health beliefs , or osteoporosis-prevention behaviors in postmenopausal women 50–65 years of age , 6 months after the intervention . METHOD The design for this pilot study was a two group quasi-experimental design . The treatment group received a tailored intervention ; the control group did not . Outcome data were gathered at 6 months after dual-energy x-ray absorptiometry . The tailored intervention was design ed and given to each woman via telephone using her dual-energy x-ray absorptiometry results and osteoporosis question naire data that addressed her knowledge of osteoporosis and osteoporosis-prevention behaviors of calcium intake , exercise , smoking , and alcohol use . A written mailed copy of the intervention followed the telephone interview . Six months after the intervention , the women were mailed another osteoporosis question naire to determine if the tailored intervention made a difference in the outcome variables . SAMPLE A total 124 women between the ages of 50 and 65 ( 101 control , 23 treatment ) comprised the sample . RESULTS There was no difference in knowledge between groups . On the average , there were significantly more perceived barriers to calcium in the tailored group ( mean = 13.48 ) than in the nontailored group ( mean = 11.55 ) ( t = 2.147 ; df = 122 ; p = .034 ) . There were significantly more perceived barriers to exercise in the tailored group ( mean = 14.39 ) than in the nontailored group ( mean = 12.21 ) ( t = .144 ; df = 122 ; p = .034 ) . Daily calcium intake increased in both the tailored and the nontailored groups . The tailored intervention increased women 's daily calcium intake from 614.28 to 1039.10 mg ( t = −2.896 ; df = 22 ; p = .008 ) . The nontailored group daily calcium intake increased from 587.91 to 916.30 mg ( t = −3.541 ; df = 100 ; p = .001 ) ; there was no significant difference between the groups . Weight-bearing exercise behaviors decreased from 96.04 minutes to 59.2 minutes in the tailored group but increased slightly in the nontailored group from 81.47 to 87.26 minutes of exercise . CONCLUSION Tailored interventions increased women 's perceived barriers to calcium and exercise . Both groups increased calcium intake . The mixed findings of increased perception of barriers to calcium and exercise and decreased exercise behaviors indicate the need for further study . This important intervention has implication s for orthopaedic nurses and healthcare professionals involved in health promotion and prevention of osteoporosis

Collectively , these studies provided some evidence to show that interventions by healthcare professionals improved the QOL medication compliance and calcium intake of patients but its effects on BMD , medication persistence , knowledge , and other lifestyle modifications were less conclusive .

Summary A systematic review was conducted to evaluate evidence concerning the effect of non-drug interventions by healthcare professionals on community-dwelling postmenopausal osteoporotic women . Evidence available indicates that such interventions are effective in improving the quality of life , medication compliance , and calcium intake , but effect on other outcomes is less conclusive . Introduction The purpose of this study is to conduct a systematic review to evaluate evidence concerning the effect of non-drug interventions by healthcare professionals on community-dwelling postmenopausal osteoporotic women .

Collectively , these studies provided some evidence to show that interventions by healthcare professionals improved the QOL medication compliance and calcium intake of patients but its effects on BMD , medication persistence , knowledge , and other lifestyle modifications were less conclusive .

Summary A systematic review was conducted to evaluate evidence concerning the effect of non-drug interventions by healthcare professionals on community-dwelling postmenopausal osteoporotic women . Evidence available indicates that such interventions are effective in improving the quality of life , medication compliance , and calcium intake , but effect on other outcomes is less conclusive . Introduction The purpose of this study is to conduct a systematic review to evaluate evidence concerning the effect of non-drug interventions by healthcare professionals on community-dwelling postmenopausal osteoporotic women .

Multifaceted intervention to improve diagnosis and treatment of osteoporosis in patients with recent wrist fracture: a randomized controlled trial

Background : Older patients who experience a fragility fracture are at high risk of future fractures but are rarely tested or treated for osteoporosis . We developed a multifaceted intervention directed at older patients with wrist fractures ( in the form of telephone-based education ) and their physicians ( in the form of guidelines endorsed by opinion leaders , supported by reminders ) to improve the quality of osteoporosis care . Methods : In a r and omized controlled trial with blinded ascertainment of outcomes , we compared our intervention with usual care ( provision of printed educational material s to patients ) . Eligible patients were those older than 50 years of age who had experienced a wrist fracture and were seen in emergency departments and fracture clinics ; we excluded those who were already being treated for osteoporosis . The primary outcome was bisphosphonate treatment within 6 months after the fracture . Secondary outcomes included bone mineral density testing , “ appropriate care ” ( consisting of bone mineral density testing with treatment if bone mass was low ) and quality of life . Results : We screened 795 patients for eligibility and r and omly assigned 272 to the intervention ( 137 patients ) or control ( 135 patients ) group . The median age was 60 years ; 210 ( 77 % ) of the subjects were women , and 130 ( 48 % ) reported a previous fracture as an adult . Six months after the fracture , 30 ( 22 % ) of the intervention patients , as compared with 10 ( 7 % ) of the control patients , were receiving bisphosphonate therapy for osteoporosis ( adjusted relative risk [ RR ] 2.6 , 95 % confidence interval [ CI ] 1.3–5.1 , p = 0.008 ) . Intervention patients were more likely than control patients to undergo bone mineral density testing ( 71/137 [ 52 % ] v. 24/135 [ 18 % ] ; adjusted RR 2.8 , 95 % CI 1.9–4.2 , p < 0.001 ) and to receive appropriate care ( 52/137 [ 38 % ] v. 15/135 [ 11 % ] ; adjusted RR 3.1 , 95 % CI 1.8–5.3 , p < 0.001 ) . There were no differences between the groups in other outcomes . One patient died , and 4 others experienced recurrent fracture . Interpretation : A multifaceted intervention directed at high-risk patients and their physicians substantially increased rates of testing and treatment for osteoporosis . Nevertheless , more than half of the patients in the intervention group were not receiving appropriate care 6 months after their fracture , which suggests that additional strategies should be explored . ( Clinical Trials.gov trial register no. NCT00152321 .

Collectively , these studies provided some evidence to show that interventions by healthcare professionals improved the QOL medication compliance and calcium intake of patients but its effects on BMD , medication persistence , knowledge , and other lifestyle modifications were less conclusive .

Summary A systematic review was conducted to evaluate evidence concerning the effect of non-drug interventions by healthcare professionals on community-dwelling postmenopausal osteoporotic women . Evidence available indicates that such interventions are effective in improving the quality of life , medication compliance , and calcium intake , but effect on other outcomes is less conclusive . Introduction The purpose of this study is to conduct a systematic review to evaluate evidence concerning the effect of non-drug interventions by healthcare professionals on community-dwelling postmenopausal osteoporotic women .

Collectively , these studies provided some evidence to show that interventions by healthcare professionals improved the QOL medication compliance and calcium intake of patients but its effects on BMD , medication persistence , knowledge , and other lifestyle modifications were less conclusive .

Summary A systematic review was conducted to evaluate evidence concerning the effect of non-drug interventions by healthcare professionals on community-dwelling postmenopausal osteoporotic women . Evidence available indicates that such interventions are effective in improving the quality of life , medication compliance , and calcium intake , but effect on other outcomes is less conclusive . Introduction The purpose of this study is to conduct a systematic review to evaluate evidence concerning the effect of non-drug interventions by healthcare professionals on community-dwelling postmenopausal osteoporotic women .

A randomized, prospective study of the effects of Tai Chi Chun exercise on bone mineral density in postmenopausal women.

OBJECTIVE To evaluate the potential benefits of programmed Tai Chi Chun ( TCC ) exercise on the weight-bearing bones of early postmenopausal women . DESIGN Age-matched and r and omized prospect i ve intervention . SETTING University medical school . PARTICIPANTS One hundred thirty-two healthy postmenopausal women ( mean age , 54.0+/-3.5y ) within 10 years of menopause onset were recruited and r and omized into the TCC exercise group ( n=67 ) or the sedentary control group ( n=65 ) . INTERVENTION Supervised TCC exercise was performed by the TCC group for 45 minutes a day , 5 days a week , for 12 months ; control subjects retained a sedentary life style . Main outcome measures Bone mineral density ( BMD ) was measured in the lumbar spine and proximal femur by using dual-energy x-ray absorptiometry and in the distal tibia by using multislice peripheral quantitative computed tomography ( pQCT ) . All BMD measurements were repeated after 12 months in both groups . Fracture rate was also documented . RESULTS Baseline measurements showed homogeneity in age , anthropometric variables , and menstruation status between the TCC and control groups . Exactly 81.6 % of the subjects in the TCC group and 83.1 % of subjects in the control group completed the 12-month follow-up study . BMD measurements revealed a general bone loss in both TCC and sedentary control subjects at all measured skeletal sites , but with a reportedly slower rate in the TCC group . A significant 2.6- to 3.6-fold retardation of bone loss ( P<.01 ) was found in both trabecular and cortical compartments of the distal tibia in the TCC group as compared with the controls , as measured by pQCT . A total of 4 fracture cases were documented during follow-up , including 3 subjects in the control group and 1 in the TCC group . CONCLUSIONS This is the first prospect i ve and r and omized study to show that a programmed TCC exercise intervention is beneficial for retarding bone loss in weight-bearing bones in early postmenopausal women . Long-term follow-up is needed to substantiate the role of TCC exercise in the prevention of osteoporosis and its related fracture

Collectively , these studies provided some evidence to show that interventions by healthcare professionals improved the QOL medication compliance and calcium intake of patients but its effects on BMD , medication persistence , knowledge , and other lifestyle modifications were less conclusive .

Summary A systematic review was conducted to evaluate evidence concerning the effect of non-drug interventions by healthcare professionals on community-dwelling postmenopausal osteoporotic women . Evidence available indicates that such interventions are effective in improving the quality of life , medication compliance , and calcium intake , but effect on other outcomes is less conclusive . Introduction The purpose of this study is to conduct a systematic review to evaluate evidence concerning the effect of non-drug interventions by healthcare professionals on community-dwelling postmenopausal osteoporotic women .

Collectively , these studies provided some evidence to show that interventions by healthcare professionals improved the QOL medication compliance and calcium intake of patients but its effects on BMD , medication persistence , knowledge , and other lifestyle modifications were less conclusive .

Summary A systematic review was conducted to evaluate evidence concerning the effect of non-drug interventions by healthcare professionals on community-dwelling postmenopausal osteoporotic women . Evidence available indicates that such interventions are effective in improving the quality of life , medication compliance , and calcium intake , but effect on other outcomes is less conclusive . Introduction The purpose of this study is to conduct a systematic review to evaluate evidence concerning the effect of non-drug interventions by healthcare professionals on community-dwelling postmenopausal osteoporotic women .

Use of a case manager to improve osteoporosis treatment after hip fracture: results of a randomized controlled trial.

BACKGROUND Patients who survive hip fracture are at high risk of recurrent fractures , but rates of osteoporosis treatment 1 year after sustaining a fracture are less than 10 % to 20 % . We have developed an osteoporosis case manager intervention . The case manager educated patients , arranged bone mineral density tests , provided prescriptions , and communicated with primary care physicians . The intervention was compared with usual care in a r and omized controlled trial . METHODS We recruited from all hospitals that participate in the Capital Health system ( Alberta , Canada ) , including patients 50 years or older who had sustained a hip fracture and excluding those who were receiving osteoporosis treatment or who lived in a long-term care facility . Primary outcome was bisphosphonate therapy 6 months after fracture ; secondary outcomes included bone mineral density testing , appropriate care ( bone mineral density testing and treatment if bone mass was low ) , and intervention costs . RESULTS We screened 2219 patients and allocated 220 , as follows : 110 to the intervention group and 110 to the control group . Median age was 74 years , 60 % were women , and 37 % reported having had previous fractures . Six months after hip fracture , 56 patients in the intervention group ( 51 % ) were receiving bisphosphonate therapy compared with 24 patients in the control group ( 22 % ) ( adjusted odds ratio , 4.7 ; 95 % confidence interval , 2.4 - 8.9 ; P < .001 ) . Bone mineral density tests were performed in 88 patients in the intervention group ( 80 % ) vs 32 patients in the control group ( 29 % ) ( P < .001 ) . Of the 120 patients who underwent bone mineral density testing , 25 ( 21 % ) had normal bone mass . Patients in the intervention group were more likely to receive appropriate care than were patients in the control group ( 67 % vs 26 % ; P < .001 ) . The average intervention cost was $ 50.00 per patient . CONCLUSION For a modest cost , a case manager was able to substantially increase rates of osteoporosis treatment in a vulnerable elderly population at high risk of future fractures

Collectively , these studies provided some evidence to show that interventions by healthcare professionals improved the QOL medication compliance and calcium intake of patients but its effects on BMD , medication persistence , knowledge , and other lifestyle modifications were less conclusive .

Summary A systematic review was conducted to evaluate evidence concerning the effect of non-drug interventions by healthcare professionals on community-dwelling postmenopausal osteoporotic women . Evidence available indicates that such interventions are effective in improving the quality of life , medication compliance , and calcium intake , but effect on other outcomes is less conclusive . Introduction The purpose of this study is to conduct a systematic review to evaluate evidence concerning the effect of non-drug interventions by healthcare professionals on community-dwelling postmenopausal osteoporotic women .

Our case study successfully enabled us to address the four feasibility metrics , and we provide new information on management feasibility ( i.e. estimate data completeness and estimate data entry ) and scientific outcomes feasibility ( i.e. determining data collection material s appropriateness ) . Conclusion Our review highlights the existing research and provides a case study which assesses important metrics of study feasibility .

Background Much research has been undertaken to establish the important benefits of physical activity in persons with multiple sclerosis ( MS ) . There is disagreement regarding the strength of this research , perhaps because the majority of studies on physical activity and its benefits have not undergone initial and systematic feasibility testing . We aim to address the feasibility processes that have been examined within the context of physical activity interventions in MS .

A tutorial on pilot studies: the what, why and how

Pilot studies for phase III trials - which are comparative r and omized trials design ed to provide preliminary evidence on the clinical efficacy of a drug or intervention - are routinely performed in many clinical areas . Also commonly know as " feasibility " or " vanguard " studies , they are design ed to assess the safety of treatment or interventions ; to assess recruitment potential ; to assess the feasibility of international collaboration or coordination for multicentre trials ; to increase clinical experience with the study medication or intervention for the phase III trials . They are the best way to assess feasibility of a large , expensive full-scale study , and in fact are an almost essential pre-requisite . Conducting a pilot prior to the main study can enhance the likelihood of success of the main study and potentially help to avoid doomed main studies . The objective of this paper is to provide a detailed examination of the key aspects of pilot studies for phase III trials including : 1 ) the general reasons for conducting a pilot study ; 2 ) the relationships between pilot studies , proof-of-concept studies , and adaptive design s ; 3 ) the challenges of and misconceptions about pilot studies ; 4 ) the criteria for evaluating the success of a pilot study ; 5 ) frequently asked questions about pilot studies ; 7 ) some ethical aspects related to pilot studies ; and 8) some suggestions on how to report the results of pilot investigations using the CONSORT format

Our case study successfully enabled us to address the four feasibility metrics , and we provide new information on management feasibility ( i.e. estimate data completeness and estimate data entry ) and scientific outcomes feasibility ( i.e. determining data collection material s appropriateness ) . Conclusion Our review highlights the existing research and provides a case study which assesses important metrics of study feasibility .

Background Much research has been undertaken to establish the important benefits of physical activity in persons with multiple sclerosis ( MS ) . There is disagreement regarding the strength of this research , perhaps because the majority of studies on physical activity and its benefits have not undergone initial and systematic feasibility testing . We aim to address the feasibility processes that have been examined within the context of physical activity interventions in MS .

Our case study successfully enabled us to address the four feasibility metrics , and we provide new information on management feasibility ( i.e. estimate data completeness and estimate data entry ) and scientific outcomes feasibility ( i.e. determining data collection material s appropriateness ) . Conclusion Our review highlights the existing research and provides a case study which assesses important metrics of study feasibility .

Background Much research has been undertaken to establish the important benefits of physical activity in persons with multiple sclerosis ( MS ) . There is disagreement regarding the strength of this research , perhaps because the majority of studies on physical activity and its benefits have not undergone initial and systematic feasibility testing . We aim to address the feasibility processes that have been examined within the context of physical activity interventions in MS .

The distinction between randomized clinical trials (RCTs) and preliminary feasibility and pilot studies: what they are and are not.

Feasibility and pilot studies play an important role in the preliminary planning of a proposed full-size r and omized clinical trial ( RCT ) . In essence , feasibility studies are used to help develop trial interventions or outcome measures , whereas pilot studies replicate , in miniature , a planned full-size RCT . However , the terms used for these preliminary studies are sometimes considered synonymous , and in practice may overlap considerably or be combined . The important issue is not the distinction between these : the important distinction is between such preliminary studies and a proper RCT . J Orthop Sports Phys Ther 2014;44(8):555–558 .

Our case study successfully enabled us to address the four feasibility metrics , and we provide new information on management feasibility ( i.e. estimate data completeness and estimate data entry ) and scientific outcomes feasibility ( i.e. determining data collection material s appropriateness ) . Conclusion Our review highlights the existing research and provides a case study which assesses important metrics of study feasibility .

Background Much research has been undertaken to establish the important benefits of physical activity in persons with multiple sclerosis ( MS ) . There is disagreement regarding the strength of this research , perhaps because the majority of studies on physical activity and its benefits have not undergone initial and systematic feasibility testing . We aim to address the feasibility processes that have been examined within the context of physical activity interventions in MS .

Our case study successfully enabled us to address the four feasibility metrics , and we provide new information on management feasibility ( i.e. estimate data completeness and estimate data entry ) and scientific outcomes feasibility ( i.e. determining data collection material s appropriateness ) . Conclusion Our review highlights the existing research and provides a case study which assesses important metrics of study feasibility .

Background Much research has been undertaken to establish the important benefits of physical activity in persons with multiple sclerosis ( MS ) . There is disagreement regarding the strength of this research , perhaps because the majority of studies on physical activity and its benefits have not undergone initial and systematic feasibility testing . We aim to address the feasibility processes that have been examined within the context of physical activity interventions in MS .

Nuts and bolts of conducting feasibility studies.

Many factors can affect the successful implementation and validity of intervention studies . A primary purpose of feasibility and pilot studies is to assess the potential for successful implementation of the proposed main intervention studies and to reduce threats to the validity of these studies . This article describes a typology to guide the aims of feasibility and pilot studies design ed to support the development of r and omized controlled trials and provides an example of the studies underlying the development of one rehabilitation trial . The purpose of most feasibility and pilot studies should be to describe information and evidence related to the successful implementation and validity of a planned main trial . Null hypothesis significance testing is not appropriate for these studies unless the sample size is properly powered . The primary tests of the intervention effectiveness hypotheses should occur in the main study , not in the studies that are serving as feasibility or pilot studies

Our case study successfully enabled us to address the four feasibility metrics , and we provide new information on management feasibility ( i.e. estimate data completeness and estimate data entry ) and scientific outcomes feasibility ( i.e. determining data collection material s appropriateness ) . Conclusion Our review highlights the existing research and provides a case study which assesses important metrics of study feasibility .

Background Much research has been undertaken to establish the important benefits of physical activity in persons with multiple sclerosis ( MS ) . There is disagreement regarding the strength of this research , perhaps because the majority of studies on physical activity and its benefits have not undergone initial and systematic feasibility testing . We aim to address the feasibility processes that have been examined within the context of physical activity interventions in MS .

Our case study successfully enabled us to address the four feasibility metrics , and we provide new information on management feasibility ( i.e. estimate data completeness and estimate data entry ) and scientific outcomes feasibility ( i.e. determining data collection material s appropriateness ) . Conclusion Our review highlights the existing research and provides a case study which assesses important metrics of study feasibility .

Background Much research has been undertaken to establish the important benefits of physical activity in persons with multiple sclerosis ( MS ) . There is disagreement regarding the strength of this research , perhaps because the majority of studies on physical activity and its benefits have not undergone initial and systematic feasibility testing . We aim to address the feasibility processes that have been examined within the context of physical activity interventions in MS .

Pragmatic exercise intervention in people with mild to moderate multiple sclerosis: a randomised controlled feasibility study.

BACKGROUND People with Multiple Sclerosis ( PwMS ) are less physically active than the general population and pragmatic approaches design ed to equip them with the skills and confidence to participate in long-term physical activity are required . OBJECTIVE The objective of this study was to determine the feasibility of a pragmatic exercise intervention in PwMS . METHODS A voluntary sample of 30 PwMS ( male n = 4 , female n = 26 ; mean age = 40 years ; range = 24 - 49 years ) , with mild to moderate disability ( EDSS ≤ 5.5 ) , were recruited from eligible participants attending outpatient clinics . A total of 28 participants were r and omised to a 10 week pragmatic exercise intervention ( 2 × supervised and 1 × home-based session per week ) or usual care . Clinical , functional and quality of life ( MSQoL-54 ) outcomes were assessed at baseline , immediately and 3 months after the intervention . RESULTS Attrition was low ( 2 participants lost to immediate follow-up and 4 participants lost to 3 month follow-up ) , with high compliance rates ( > 75 % of all sessions ) . The intervention group achieved progression of exercise volume ( 24.3 ± 7.0 to 30.9 ± 5.5 min per session ) , intensity ( 60.4 ± 8.8 to 67.7 ± 6.9 % HR max ) and training impulse ( min × average HR = training impulse/load [ arbitrary units ; AU ] ) ( 2600 ± 1105 to 3210 ± 1269AU ) during the intervention , whilst significantly increasing(P = 0.050 ) their physical composite score ( MSQOL-54 ) at 10 weeks and readiness to exercise ( P = 0.003 ) at 3 months compared with usual care . CONCLUSION This pragmatic intervention was feasible for PwMS , but further research is needed to assess its long-term impact on physical activity behaviour

Our case study successfully enabled us to address the four feasibility metrics , and we provide new information on management feasibility ( i.e. estimate data completeness and estimate data entry ) and scientific outcomes feasibility ( i.e. determining data collection material s appropriateness ) . Conclusion Our review highlights the existing research and provides a case study which assesses important metrics of study feasibility .

Background Much research has been undertaken to establish the important benefits of physical activity in persons with multiple sclerosis ( MS ) . There is disagreement regarding the strength of this research , perhaps because the majority of studies on physical activity and its benefits have not undergone initial and systematic feasibility testing . We aim to address the feasibility processes that have been examined within the context of physical activity interventions in MS .

Our case study successfully enabled us to address the four feasibility metrics , and we provide new information on management feasibility ( i.e. estimate data completeness and estimate data entry ) and scientific outcomes feasibility ( i.e. determining data collection material s appropriateness ) . Conclusion Our review highlights the existing research and provides a case study which assesses important metrics of study feasibility .

Background Much research has been undertaken to establish the important benefits of physical activity in persons with multiple sclerosis ( MS ) . There is disagreement regarding the strength of this research , perhaps because the majority of studies on physical activity and its benefits have not undergone initial and systematic feasibility testing . We aim to address the feasibility processes that have been examined within the context of physical activity interventions in MS .

Participant recruitment into a randomised controlled trial of exercise therapy for people with multiple sclerosis

Background The success of a clinical trial is often dependant on whether recruitment targets can be met in the required time frame . Despite an increase in research into the benefits of exercise in people with multiple sclerosis ( PwMS ) , no trial has reported detailed data on effective recruitment strategies for large-scale r and omised controlled trials . The main purpose of this report is to provide a detailed outline of recruitment strategies , rates and estimated costs in the Exercise Intervention for Multiple Sclerosis ( ExIMS ) trial to identify best practice s for future trials involving multiple sclerosis ( MS ) patient recruitment . Methods The ExIMS research ers recruited 120 PwMS to participate in a 12-week exercise intervention . Participants were r and omly allocated to either exercise or usual-care control groups . Participants were sedentary , aged 18–65 years and had Exp and ed Disability Status Scale scores of 1.0–6.5 . Recruitment strategies included attendance at MS outpatient clinics , consultant mail-out and trial awareness-raising activities . Results A total of 120 participants were recruited over the course of 34 months . To achieve this target , 369 potentially eligible and interested participants were identified . A total of 60 % of participants were recruited via MS clinics , 29.2 % from consultant mail-outs and 10.8 % through trial awareness . The r and omisation yields were 33.2 % , 31.0 % and 68.4 % for MS clinic , consultant mail-outs and trial awareness strategies , respectively . The main reason for in eligibility was being too active ( 69.2 % ) , whilst for eligible participants the most common reason for non-participation was the need to travel to the study site ( 15.8 % ) . Recruitment via consultant mail-out was the most cost-effective strategy , with MS clinics being the most time-consuming and most costly . Conclusions To reach recruitment targets in a timely fashion , a variety of methods were employed . Although consultant mail-outs were the most cost-effective recruitment strategy , use of this method alone would not have allowed us to obtain the predetermined number of participants in the required time period , thus leading to costly extensions of the project or failure to reach the number of participants required for sufficient statistical power . Thus , a multifaceted approach to recruitment is recommended for future trials . Trial registration International St and ard R and omised Controlled Trial Registry number : IS RCT N41541516 ; date registered : 5 February 2009

Our case study successfully enabled us to address the four feasibility metrics , and we provide new information on management feasibility ( i.e. estimate data completeness and estimate data entry ) and scientific outcomes feasibility ( i.e. determining data collection material s appropriateness ) . Conclusion Our review highlights the existing research and provides a case study which assesses important metrics of study feasibility .

Background Much research has been undertaken to establish the important benefits of physical activity in persons with multiple sclerosis ( MS ) . There is disagreement regarding the strength of this research , perhaps because the majority of studies on physical activity and its benefits have not undergone initial and systematic feasibility testing . We aim to address the feasibility processes that have been examined within the context of physical activity interventions in MS .

Our case study successfully enabled us to address the four feasibility metrics , and we provide new information on management feasibility ( i.e. estimate data completeness and estimate data entry ) and scientific outcomes feasibility ( i.e. determining data collection material s appropriateness ) . Conclusion Our review highlights the existing research and provides a case study which assesses important metrics of study feasibility .

Background Much research has been undertaken to establish the important benefits of physical activity in persons with multiple sclerosis ( MS ) . There is disagreement regarding the strength of this research , perhaps because the majority of studies on physical activity and its benefits have not undergone initial and systematic feasibility testing . We aim to address the feasibility processes that have been examined within the context of physical activity interventions in MS .

Feasibility study design and methods for Project GEMS: Guidelines for Exercise in Multiple Sclerosis.

The Guidelines for Exercise in Multiple Sclerosis ( GEMS ) program is a r and omized controlled trial ( RCT ) examining the feasibility and efficacy of a home-based exercise training program based on recent physical activity guidelines and principles of behavior change for improving symptoms and health-related quality of life ( HRQOL ) in adults with multiple sclerosis ( MS ) . The primary aim is to assess program feasibility in the four domains of process ( e.g. , recruitment , retention , and adherence ) , re sources ( e.g. , communication , staff requirements , and monetary costs ) , management ( e.g. , time and accuracy in data collection /entry , and reporting of adverse events ) and scientific outcomes ( e.g. , safety , burden , participant feedback and efficacy/ outcomes ) . The trial will recruit individuals with mild-to-moderate MS-related disability across the United States who will be r and omized into intervention or waitlist control conditions . All participants will complete home-based assessment s ( including wearing an accelerometer for 7 days and completion of a question naire booklet ) prior to and upon completion of the 4-month program . Participants in the intervention will receive a 4-month home-based exercise program emphasizing aerobic and resistance training . Participants will be provided with exercise equipment , a DVD , a manual and a log-book . The exercise program will be supplemented with periodic newsletters in the mail highlighting principles of behavior change , and video-chats with an exercise specialist to provide motivation and social accountability . This trial serves to inform development of Phase II and III RCTs which can determine the actual efficacy and effectiveness of home-based exercise based on the MS-specific physical activity guidelines for improving symptoms and HRQOL

Our case study successfully enabled us to address the four feasibility metrics , and we provide new information on management feasibility ( i.e. estimate data completeness and estimate data entry ) and scientific outcomes feasibility ( i.e. determining data collection material s appropriateness ) . Conclusion Our review highlights the existing research and provides a case study which assesses important metrics of study feasibility .

Background Much research has been undertaken to establish the important benefits of physical activity in persons with multiple sclerosis ( MS ) . There is disagreement regarding the strength of this research , perhaps because the majority of studies on physical activity and its benefits have not undergone initial and systematic feasibility testing . We aim to address the feasibility processes that have been examined within the context of physical activity interventions in MS .

Our case study successfully enabled us to address the four feasibility metrics , and we provide new information on management feasibility ( i.e. estimate data completeness and estimate data entry ) and scientific outcomes feasibility ( i.e. determining data collection material s appropriateness ) . Conclusion Our review highlights the existing research and provides a case study which assesses important metrics of study feasibility .

Background Much research has been undertaken to establish the important benefits of physical activity in persons with multiple sclerosis ( MS ) . There is disagreement regarding the strength of this research , perhaps because the majority of studies on physical activity and its benefits have not undergone initial and systematic feasibility testing . We aim to address the feasibility processes that have been examined within the context of physical activity interventions in MS .

Defining Feasibility and Pilot Studies in Preparation for Randomised Controlled Trials: Development of a Conceptual Framework

We describe a framework for defining pilot and feasibility studies focusing on studies conducted in preparation for a r and omised controlled trial . To develop the framework , we undertook a Delphi survey ; ran an open meeting at a trial methodology conference ; conducted a review of definitions outside the health research context ; consulted experts at an international consensus meeting ; and review ed 27 empirical pilot or feasibility studies . We initially adopted mutually exclusive definitions of pilot and feasibility studies . However , some Delphi survey respondents and the majority of open meeting attendees disagreed with the idea of mutually exclusive definitions . Their viewpoint was supported by definitions outside the health research context , the use of the terms ‘ pilot ’ and ‘ feasibility ’ in the literature , and participants at the international consensus meeting . In our framework , pilot studies are a subset of feasibility studies , rather than the two being mutually exclusive . A feasibility study asks whether something can be done , should we proceed with it , and if so , how . A pilot study asks the same questions but also has a specific design feature : in a pilot study a future study , or part of a future study , is conducted on a smaller scale . We suggest that to facilitate their identification , these studies should be clearly identified using the terms ‘ feasibility ’ or ‘ pilot ’ as appropriate . This should include feasibility studies that are largely qualitative ; we found these difficult to identify in electronic search es because research ers rarely used the term ‘ feasibility ’ in the title or abstract of such studies . Investigators should also report appropriate objectives and methods related to feasibility ; and give clear confirmation that their study is in preparation for a future r and omised controlled trial design ed to assess the effect of an intervention

Our case study successfully enabled us to address the four feasibility metrics , and we provide new information on management feasibility ( i.e. estimate data completeness and estimate data entry ) and scientific outcomes feasibility ( i.e. determining data collection material s appropriateness ) . Conclusion Our review highlights the existing research and provides a case study which assesses important metrics of study feasibility .

Background Much research has been undertaken to establish the important benefits of physical activity in persons with multiple sclerosis ( MS ) . There is disagreement regarding the strength of this research , perhaps because the majority of studies on physical activity and its benefits have not undergone initial and systematic feasibility testing . We aim to address the feasibility processes that have been examined within the context of physical activity interventions in MS .

Our case study successfully enabled us to address the four feasibility metrics , and we provide new information on management feasibility ( i.e. estimate data completeness and estimate data entry ) and scientific outcomes feasibility ( i.e. determining data collection material s appropriateness ) . Conclusion Our review highlights the existing research and provides a case study which assesses important metrics of study feasibility .

Background Much research has been undertaken to establish the important benefits of physical activity in persons with multiple sclerosis ( MS ) . There is disagreement regarding the strength of this research , perhaps because the majority of studies on physical activity and its benefits have not undergone initial and systematic feasibility testing . We aim to address the feasibility processes that have been examined within the context of physical activity interventions in MS .

The feasibility and short-term benefits of Blue Prescription: a novel intervention to enable physical activity for people with multiple sclerosis

Purpose : Participation in physical activity for people with Multiple sclerosis ( MS ) is important but can be difficult to sustain long-term . Facilitators for long-term adherence include choice over activity and control over level of engagement , coupled with support , advice and encouragement from a physiotherapist . This is the basis of Blue Prescription , a novel physiotherapy approach aim ed at optimising long-term adherence with physical activity . We evaluated the feasibility and short-term benefits of Blue Prescription in people with MS . Methods : Twenty-seven people with MS ( mean age : 51 ± 11 years , with a range of MS type and disability ) were assessed at baseline and immediately post-intervention with the MS Impact Scale , MS Self-efficacy Scale , and European Quality of Life Question naire . Change in outcomes were analysed with Wilcoxon signed ranks tests . Results : All participants , irrespective of level of disability , were able to choose a physical activity and to engage in it . The physical component MS Impact Scale score significantly improved by a median change of 6.5 ( 95 % CI = −10.5 to −2.0 ; p = 0.007 ; effect size = 0.38 ) . There were no other significant changes in outcomes . Conclusion : Blue Prescription appears feasible and potentially beneficial , particularly in reducing the negative impacts of MS upon individuals , and thus warrants further evaluation . Implication s for Rehabilitation Facilitators for long-term adherence for disabled people include choice over activity and control over level of engagement , coupled with support , advice and encouragement from a physiotherapist . Blue Prescription is a physiotherapy approach aim ed at optimising long-term adherence with physical activity for people with multiple sclerosis . Blue Prescription appears to reduce the negative impacts of multiple sclerosis upon individuals

Our case study successfully enabled us to address the four feasibility metrics , and we provide new information on management feasibility ( i.e. estimate data completeness and estimate data entry ) and scientific outcomes feasibility ( i.e. determining data collection material s appropriateness ) . Conclusion Our review highlights the existing research and provides a case study which assesses important metrics of study feasibility .

Background Much research has been undertaken to establish the important benefits of physical activity in persons with multiple sclerosis ( MS ) . There is disagreement regarding the strength of this research , perhaps because the majority of studies on physical activity and its benefits have not undergone initial and systematic feasibility testing . We aim to address the feasibility processes that have been examined within the context of physical activity interventions in MS .

Our case study successfully enabled us to address the four feasibility metrics , and we provide new information on management feasibility ( i.e. estimate data completeness and estimate data entry ) and scientific outcomes feasibility ( i.e. determining data collection material s appropriateness ) . Conclusion Our review highlights the existing research and provides a case study which assesses important metrics of study feasibility .

Background Much research has been undertaken to establish the important benefits of physical activity in persons with multiple sclerosis ( MS ) . There is disagreement regarding the strength of this research , perhaps because the majority of studies on physical activity and its benefits have not undergone initial and systematic feasibility testing . We aim to address the feasibility processes that have been examined within the context of physical activity interventions in MS .

Feasibility and effects of a group kickboxing program for individuals with multiple sclerosis: a pilot report.

BACKGROUND AND PURPOSE Balance and mobility impairments are common in persons with multiple sclerosis ( MS ) . The primary purpose of this pilot program was to evaluate the feasibility and the effects of group kickboxing on balance and mobility in individuals with MS . METHODS Four individuals with relapsing-remitting or secondary progressive MS participated in a group kickboxing program two times per week for 8 weeks . Outcome measures included the Berg Balance Scale ( BBS ) , Dynamic Gait Index ( DGI ) , Timed Up and Go ( TUG ) , walking speed and the Activities Specific Balance Confidence Scale ( ABC ) . RESULTS Following training , 3 of 4 participants had improvements in BBS performance . All participants demonstrated improvements in the DGI . Changes in the TUG , ABC , and walking speed were more variable . CONCLUSION Group kickboxing appears to be a feasible exercise activity for individuals with MS and may lead to improvement in select measures of balance . Further investigation may be warranted

Our case study successfully enabled us to address the four feasibility metrics , and we provide new information on management feasibility ( i.e. estimate data completeness and estimate data entry ) and scientific outcomes feasibility ( i.e. determining data collection material s appropriateness ) . Conclusion Our review highlights the existing research and provides a case study which assesses important metrics of study feasibility .

Background Much research has been undertaken to establish the important benefits of physical activity in persons with multiple sclerosis ( MS ) . There is disagreement regarding the strength of this research , perhaps because the majority of studies on physical activity and its benefits have not undergone initial and systematic feasibility testing . We aim to address the feasibility processes that have been examined within the context of physical activity interventions in MS .

Our case study successfully enabled us to address the four feasibility metrics , and we provide new information on management feasibility ( i.e. estimate data completeness and estimate data entry ) and scientific outcomes feasibility ( i.e. determining data collection material s appropriateness ) . Conclusion Our review highlights the existing research and provides a case study which assesses important metrics of study feasibility .

Background Much research has been undertaken to establish the important benefits of physical activity in persons with multiple sclerosis ( MS ) . There is disagreement regarding the strength of this research , perhaps because the majority of studies on physical activity and its benefits have not undergone initial and systematic feasibility testing . We aim to address the feasibility processes that have been examined within the context of physical activity interventions in MS .

CONSORT 2010 statement: extension to randomised pilot and feasibility trials

The Consoli date d St and ards of Reporting Trials ( CONSORT ) statement is a guideline design ed to improve the transparency and quality of the reporting of r and omised controlled trials ( RCTs ) . In this article we present an extension to that statement for r and omised pilot and feasibility trials conducted in advance of a future definitive RCT . The checklist applies to any r and omised study in which a future definitive RCT , or part of it , is conducted on a smaller scale , regardless of its design ( eg , cluster , factorial , crossover ) or the terms used by authors to describe the study ( eg , pilot , feasibility , trial , study ) . The extension does not directly apply to internal pilot studies built into the design of a main trial , non-r and omised pilot and feasibility studies , or phase II studies , but these studies all have some similarities to r and omised pilot and feasibility studies and so many of the principles might also apply . The development of the extension was motivated by the growing number of studies described as feasibility or pilot studies and by research that has identified weaknesses in their reporting and conduct . We followed recommended good practice to develop the extension , including carrying out a Delphi survey , holding a consensus meeting and research team meetings , and piloting the checklist . The aims and objectives of pilot and feasibility r and omised studies differ from those of other r and omised trials . Consequently , although much of the information to be reported in these trials is similar to those in r and omised controlled trials ( RCTs ) assessing effectiveness and efficacy , there are some key differences in the type of information and in the appropriate interpretation of st and ard CONSORT reporting items . We have retained some of the original CONSORT statement items , but most have been adapted , some removed , and new items added . The new items cover how participants were identified and consent obtained ; if applicable , the prespecified criteria used to judge whether or how to proceed with a future definitive RCT ; if relevant , other important unintended consequences ; implication s for progression from pilot to future definitive RCT , including any proposed amendments ; and ethical approval or approval by a research review committee confirmed with a reference number . This article includes the 26 item checklist , a separate checklist for the abstract , a template for a CONSORT flowchart for these studies , and an explanation of the changes made and supporting examples . We believe that routine use of this proposed extension to the CONSORT statement will result in improvements in the reporting of pilot trials . Editor ’s note : In order to encourage its wide dissemination this article is freely accessible on the BMJ and Pilot and Feasibility Studies journal websites

Our case study successfully enabled us to address the four feasibility metrics , and we provide new information on management feasibility ( i.e. estimate data completeness and estimate data entry ) and scientific outcomes feasibility ( i.e. determining data collection material s appropriateness ) . Conclusion Our review highlights the existing research and provides a case study which assesses important metrics of study feasibility .

Background Much research has been undertaken to establish the important benefits of physical activity in persons with multiple sclerosis ( MS ) . There is disagreement regarding the strength of this research , perhaps because the majority of studies on physical activity and its benefits have not undergone initial and systematic feasibility testing . We aim to address the feasibility processes that have been examined within the context of physical activity interventions in MS .

Our case study successfully enabled us to address the four feasibility metrics , and we provide new information on management feasibility ( i.e. estimate data completeness and estimate data entry ) and scientific outcomes feasibility ( i.e. determining data collection material s appropriateness ) . Conclusion Our review highlights the existing research and provides a case study which assesses important metrics of study feasibility .

Background Much research has been undertaken to establish the important benefits of physical activity in persons with multiple sclerosis ( MS ) . There is disagreement regarding the strength of this research , perhaps because the majority of studies on physical activity and its benefits have not undergone initial and systematic feasibility testing . We aim to address the feasibility processes that have been examined within the context of physical activity interventions in MS .

CONSORT 2010 statement: extension to randomised pilot and feasibility trials

The Consoli date d St and ards of Reporting Trials ( CONSORT ) statement is a guideline design ed to improve the transparency and quality of the reporting of r and omised controlled trials ( RCTs ) . In this article we present an extension to that statement for r and omised pilot and feasibility trials conducted in advance of a future definitive RCT . The checklist applies to any r and omised study in which a future definitive RCT , or part of it , is conducted on a smaller scale , regardless of its design ( eg , cluster , factorial , crossover ) or the terms used by authors to describe the study ( eg , pilot , feasibility , trial , study ) . The extension does not directly apply to internal pilot studies built into the design of a main trial , non-r and omised pilot and feasibility studies , or phase II studies , but these studies all have some similarities to r and omised pilot and feasibility studies and so many of the principles might also apply . The development of the extension was motivated by the growing number of studies described as feasibility or pilot studies and by research that has identified weaknesses in their reporting and conduct . We followed recommended good practice to develop the extension , including carrying out a Delphi survey , holding a consensus meeting and research team meetings , and piloting the checklist . The aims and objectives of pilot and feasibility r and omised studies differ from those of other r and omised trials . Consequently , although much of the information to be reported in these trials is similar to those in r and omised controlled trials ( RCTs ) assessing effectiveness and efficacy , there are some key differences in the type of information and in the appropriate interpretation of st and ard CONSORT reporting items . We have retained some of the original CONSORT statement items , but most have been adapted , some removed , and new items added . The new items cover how participants were identified and consent obtained ; if applicable , the prespecified criteria used to judge whether or how to proceed with a future definitive RCT ; if relevant , other important unintended consequences ; implication s for progression from pilot to future definitive RCT , including any proposed amendments ; and ethical approval or approval by a research review committee confirmed with a reference number . This article includes the 26 item checklist , a separate checklist for the abstract , a template for a CONSORT flowchart for these studies , and an explanation of the changes made and supporting examples . We believe that routine use of this proposed extension to the CONSORT statement will result in improvements in the reporting of pilot trials . Editor ’s note : In order to encourage its wide dissemination this article is freely accessible on the BMJ and Pilot and Feasibility Studies journal websites

Our case study successfully enabled us to address the four feasibility metrics , and we provide new information on management feasibility ( i.e. estimate data completeness and estimate data entry ) and scientific outcomes feasibility ( i.e. determining data collection material s appropriateness ) . Conclusion Our review highlights the existing research and provides a case study which assesses important metrics of study feasibility .

Background Much research has been undertaken to establish the important benefits of physical activity in persons with multiple sclerosis ( MS ) . There is disagreement regarding the strength of this research , perhaps because the majority of studies on physical activity and its benefits have not undergone initial and systematic feasibility testing . We aim to address the feasibility processes that have been examined within the context of physical activity interventions in MS .

Our case study successfully enabled us to address the four feasibility metrics , and we provide new information on management feasibility ( i.e. estimate data completeness and estimate data entry ) and scientific outcomes feasibility ( i.e. determining data collection material s appropriateness ) . Conclusion Our review highlights the existing research and provides a case study which assesses important metrics of study feasibility .

Background Much research has been undertaken to establish the important benefits of physical activity in persons with multiple sclerosis ( MS ) . There is disagreement regarding the strength of this research , perhaps because the majority of studies on physical activity and its benefits have not undergone initial and systematic feasibility testing . We aim to address the feasibility processes that have been examined within the context of physical activity interventions in MS .

Design and analysis of pilot studies: recommendations for good practice.

Pilot studies play an important role in health research , but they can be misused , mistreated and misrepresented . In this paper we focus on pilot studies that are used specifically to plan a r and omized controlled trial ( RCT ) . Citing examples from the literature , we provide a method ological framework in which to work , and discuss reasons why a pilot study might be undertaken . A well-conducted pilot study , giving a clear list of aims and objectives within a formal framework will encourage method ological rigour , ensure that the work is scientifically valid and publishable , and will lead to higher quality RCTs . It will also safeguard against pilot studies being conducted simply because of small numbers of available patients

Our case study successfully enabled us to address the four feasibility metrics , and we provide new information on management feasibility ( i.e. estimate data completeness and estimate data entry ) and scientific outcomes feasibility ( i.e. determining data collection material s appropriateness ) . Conclusion Our review highlights the existing research and provides a case study which assesses important metrics of study feasibility .

Background Much research has been undertaken to establish the important benefits of physical activity in persons with multiple sclerosis ( MS ) . There is disagreement regarding the strength of this research , perhaps because the majority of studies on physical activity and its benefits have not undergone initial and systematic feasibility testing . We aim to address the feasibility processes that have been examined within the context of physical activity interventions in MS .

Our case study successfully enabled us to address the four feasibility metrics , and we provide new information on management feasibility ( i.e. estimate data completeness and estimate data entry ) and scientific outcomes feasibility ( i.e. determining data collection material s appropriateness ) . Conclusion Our review highlights the existing research and provides a case study which assesses important metrics of study feasibility .

Background Much research has been undertaken to establish the important benefits of physical activity in persons with multiple sclerosis ( MS ) . There is disagreement regarding the strength of this research , perhaps because the majority of studies on physical activity and its benefits have not undergone initial and systematic feasibility testing . We aim to address the feasibility processes that have been examined within the context of physical activity interventions in MS .

A task-oriented circuit training in multiple sclerosis: a feasibility study

Background The aim of this study was to evaluate the safety , feasibility and preliminary effects of a high-intensity rehabilitative task-oriented circuit training ( TOCT ) in a sample of multiple sclerosis ( MS ) subjects on walking competency , mobility , fatigue and health-related quality of life ( HRQoL ) . Methods 24 MS subjects ( EDSS 4.89 ± 0.54 , 17 female and 7 male , 52.58 ± 11.21 years , MS duration 15.21 ± 8.68 years ) have been enrolled and r and omly assigned to 2 treatment groups : ( i ) experimental group received 10 TOCT sessions over 2 weeks ( 2 hours/each session ) followed by a 3 months home exercise program , whereas control group did not receive any specific rehabilitation intervention . A feasibility patient-reported question naire was administered after TOCT . Functional outcome measures were : walking endurance ( Six Minute Walk Test ) , gait speed ( 10 Meter Walk Test ) , mobility ( Timed Up and Go test ) and balance ( Dynamic Gait Index ) . Furthermore , self-reported question naire of motor fatigue ( Fatigue Severity Scale ) , walking ability ( Multiple Sclerosis Walking Scale – 12 ) and health-related quality of life ( Multiple Sclerosis Impact Scale – 29 ) were included . Subjects ’ assessment s were delivered at baseline ( T0 ) , after TOCT ( T1 ) and 3 months of home-based exercise program ( T2 ) . Results After TOCT subjects reported a positive global rating on the received treatment . At 3 months , we found a 58.33 % of adherence to the home-exercise program . After TOCT , walking ability and health-related quality of life were improved ( p < 0.05 ) with minor retention after 3 months . The control group showed no significant changes in any variables . Conclusions This two weeks high-intensity task-oriented circuit class training followed by a three months home-based exercise program seems feasible and safe in MS people with moderate mobility impairments ; moreover it might improve walking abilities . Trial registration

Our case study successfully enabled us to address the four feasibility metrics , and we provide new information on management feasibility ( i.e. estimate data completeness and estimate data entry ) and scientific outcomes feasibility ( i.e. determining data collection material s appropriateness ) . Conclusion Our review highlights the existing research and provides a case study which assesses important metrics of study feasibility .

Background Much research has been undertaken to establish the important benefits of physical activity in persons with multiple sclerosis ( MS ) . There is disagreement regarding the strength of this research , perhaps because the majority of studies on physical activity and its benefits have not undergone initial and systematic feasibility testing . We aim to address the feasibility processes that have been examined within the context of physical activity interventions in MS .

Our case study successfully enabled us to address the four feasibility metrics , and we provide new information on management feasibility ( i.e. estimate data completeness and estimate data entry ) and scientific outcomes feasibility ( i.e. determining data collection material s appropriateness ) . Conclusion Our review highlights the existing research and provides a case study which assesses important metrics of study feasibility .

Background Much research has been undertaken to establish the important benefits of physical activity in persons with multiple sclerosis ( MS ) . There is disagreement regarding the strength of this research , perhaps because the majority of studies on physical activity and its benefits have not undergone initial and systematic feasibility testing . We aim to address the feasibility processes that have been examined within the context of physical activity interventions in MS .

Long-term benefits of exercising on quality of life and fatigue in multiple sclerosis patients with mild disability: a pilot study

Objective : To determine if exercise benefits patients with multiple sclerosis . Design : R and omized controlled trial . Setting s : Participants exercised at home and also attended exercise classes held in a hospital physiotherapy gym . Subjects : Thirty patients , diagnosed and independently mobile , were recruited in the Dublin area . Intervention : For three months , classes were held twice-weekly and participants exercised independently once-weekly . The control group was monitored monthly and management remained unchanged . Measurements : Measurements were taken at baseline , three and six months . The Modified Fatigue Impact Scale ( MFIS ) , Multiple Sclerosis Impact Scale-29 ( MSIS-29 ) and Functional Assessment of Multiple Sclerosis ( FAMS ) were used to measure fatigue and quality of life ( QOL ) . Heart rate ( HR ) and the Borg 's Rating of Perceived Exertion ( RPE ) were recorded during an incremental exercise test . The change from baseline scores between groups was compared using the Mann — Whitney U-test . Results : Twenty-four participants completed the programme ( n = 12 in each group ) . Based on the change in scores at three months , the exercise group had significantly greater improvements in exercise capacity ( HR : —14 [ -18.5 , -2.5 ] versus 0.5 [ -4 , 5.5 ] , P= 0.009 ) , QOL ( FAMS : 23 [ 9.5 , 42.5 ] versus -3.5 [ -16 , 5 ] , P=0.006 ) and fatigue ( MFIS : -13 [ -20 , -3 ] versus 1 [ -4 , 4.5 ] , P=0.02 ) . At six months , the difference in change scores remained significant for FAMS ( 19 [ 14 , 31 ] versus -4.5 [ -25 , 8 ] , P=0.002 ) and MFIS ( -8.5 [ -19.5 , -1 ] versus 0.5 [ -2.5 , 6.5 ] , P=0.02 ) only . Conclusions : A three-month exercise programme improved participants ' exercise capacity , QOL and fatigue , with the improvements in QOL and fatigue lasting beyond the programme

Our case study successfully enabled us to address the four feasibility metrics , and we provide new information on management feasibility ( i.e. estimate data completeness and estimate data entry ) and scientific outcomes feasibility ( i.e. determining data collection material s appropriateness ) . Conclusion Our review highlights the existing research and provides a case study which assesses important metrics of study feasibility .

Background Much research has been undertaken to establish the important benefits of physical activity in persons with multiple sclerosis ( MS ) . There is disagreement regarding the strength of this research , perhaps because the majority of studies on physical activity and its benefits have not undergone initial and systematic feasibility testing . We aim to address the feasibility processes that have been examined within the context of physical activity interventions in MS .

Our case study successfully enabled us to address the four feasibility metrics , and we provide new information on management feasibility ( i.e. estimate data completeness and estimate data entry ) and scientific outcomes feasibility ( i.e. determining data collection material s appropriateness ) . Conclusion Our review highlights the existing research and provides a case study which assesses important metrics of study feasibility .

Background Much research has been undertaken to establish the important benefits of physical activity in persons with multiple sclerosis ( MS ) . There is disagreement regarding the strength of this research , perhaps because the majority of studies on physical activity and its benefits have not undergone initial and systematic feasibility testing . We aim to address the feasibility processes that have been examined within the context of physical activity interventions in MS .

Cost effectiveness of a pragmatic exercise intervention (EXIMS) for people with multiple sclerosis: economic evaluation of a randomised controlled trial

Background : Exercise is a safe , non-pharmacological adjunctive treatment for people with multiple sclerosis but cost-effective approaches to implementing exercise within health care setting s are needed . Objective : The objective of this paper is to assess the cost effectiveness of a pragmatic exercise intervention in conjunction with usual care compared to usual care only in people with mild to moderate multiple sclerosis . Methods : A cost-utility analysis of a pragmatic r and omised controlled trial over nine months of follow-up was conducted . A total of 120 people with multiple sclerosis were r and omised ( 1:1 ) to the intervention or usual care . Exercising participants received 18 supervised and 18 home exercise sessions over 12 weeks . The primary outcome for the cost utility analysis was the incremental cost per quality -adjusted life year ( QALY ) gained , calculated using utilities measured by the EQ-5D question naire . Results : The incremental cost per QALY of the intervention was £ 10,137 per QALY gained compared to usual care . The probability of being cost effective at a £ 20,000 per QALY threshold was 0.75 , rising to 0.78 at a £ 30,000 per QALY threshold . Conclusion : The pragmatic exercise intervention is highly likely to be cost effective at current established thresholds , and there is scope for it to be tailored to particular sub-groups of patients or services to reduce its cost impact

Our case study successfully enabled us to address the four feasibility metrics , and we provide new information on management feasibility ( i.e. estimate data completeness and estimate data entry ) and scientific outcomes feasibility ( i.e. determining data collection material s appropriateness ) . Conclusion Our review highlights the existing research and provides a case study which assesses important metrics of study feasibility .

Background Much research has been undertaken to establish the important benefits of physical activity in persons with multiple sclerosis ( MS ) . There is disagreement regarding the strength of this research , perhaps because the majority of studies on physical activity and its benefits have not undergone initial and systematic feasibility testing . We aim to address the feasibility processes that have been examined within the context of physical activity interventions in MS .

Our case study successfully enabled us to address the four feasibility metrics , and we provide new information on management feasibility ( i.e. estimate data completeness and estimate data entry ) and scientific outcomes feasibility ( i.e. determining data collection material s appropriateness ) . Conclusion Our review highlights the existing research and provides a case study which assesses important metrics of study feasibility .

Background Much research has been undertaken to establish the important benefits of physical activity in persons with multiple sclerosis ( MS ) . There is disagreement regarding the strength of this research , perhaps because the majority of studies on physical activity and its benefits have not undergone initial and systematic feasibility testing . We aim to address the feasibility processes that have been examined within the context of physical activity interventions in MS .

Exercise in the community for people with minimal gait impairment due to MS: an assessor-blind randomized controlled trial

Background : While there is an increasing body of evidence supporting the efficacy of exercise in people with multiple sclerosis ( MS ) , additional information on the effectiveness of combining aerobic and resistance training , and yoga is required . Objectives : This study evaluated the effectiveness of community exercise interventions for people with MS having minimal gait impairment . Methods : A multi-centred , block-r and omised , assessor-blinded , controlled trial was conducted . Participants were r and omised in groups of eight to physiotherapist (PT)-led exercise ( n = 80 ) , yoga ( n = 77 ) , fitness instructor (FI)-led exercise ( n = 86 ) and they took part in weekly community-based group exercise sessions . Those in the control group were asked not to change of their exercise habits ( n = 71 ) . The primary outcome was the Multiple Sclerosis Impact Scale ( MSIS ) 29v2 physical component , measured before and after the 10-week intervention . Secondary outcomes were the MSIS 29v2 psychological component , the Modified Fatigue Impact Scale ( MFIS ) and the 6-Minute Walk Test ( 6MWT ) . Results : The group x time interaction approached significance for the MSIS-29v2 physical component ( f = 2.48 , p = 0.061 ) and MFIS total ( f = 2.50 , p = 0.06 ) , and it was significant for the MFIS physical subscale ( f = 4.23 , p = 0.006 ) . All three exercise interventions led to a statistically significant improvement on the MSIS-29 psychological component and both the MFIS total and physical subscales , which were greater than the control ( p < 0.05 ) . Only the PT-led and FI-led interventions significantly improved the MSIS-29 physical and 6MWT to levels greater than the control ( p < 0.05 ) . Conclusions : This study provides evidence for the positive effect of exercise on the physical impact of MS and fatigue . The group nature of the classes may have contributed to the positive effects seen on the psychological impact of MS

Our case study successfully enabled us to address the four feasibility metrics , and we provide new information on management feasibility ( i.e. estimate data completeness and estimate data entry ) and scientific outcomes feasibility ( i.e. determining data collection material s appropriateness ) . Conclusion Our review highlights the existing research and provides a case study which assesses important metrics of study feasibility .

Background Much research has been undertaken to establish the important benefits of physical activity in persons with multiple sclerosis ( MS ) . There is disagreement regarding the strength of this research , perhaps because the majority of studies on physical activity and its benefits have not undergone initial and systematic feasibility testing . We aim to address the feasibility processes that have been examined within the context of physical activity interventions in MS .

Our case study successfully enabled us to address the four feasibility metrics , and we provide new information on management feasibility ( i.e. estimate data completeness and estimate data entry ) and scientific outcomes feasibility ( i.e. determining data collection material s appropriateness ) . Conclusion Our review highlights the existing research and provides a case study which assesses important metrics of study feasibility .

Background Much research has been undertaken to establish the important benefits of physical activity in persons with multiple sclerosis ( MS ) . There is disagreement regarding the strength of this research , perhaps because the majority of studies on physical activity and its benefits have not undergone initial and systematic feasibility testing . We aim to address the feasibility processes that have been examined within the context of physical activity interventions in MS .

Effect of Aerobic Training on Walking Capacity and Maximal Exercise Tolerance in Patients With Multiple Sclerosis: A Randomized Crossover Controlled Study

Background and Purpose Physical deconditioning is involved in the impaired exercise tolerance of patients with multiple sclerosis ( MS ) , but data on the effects of aerobic training ( AT ) in this population are scanty . The purpose of this study was to compare the effects of an 8-week AT program on exercise capacity — in terms of walking capacity and maximum exercise tolerance , as well as its effects on fatigue and health-related quality of life — as compared with neurological rehabilitation ( NR ) in subjects with MS . Subjects and Methods Nineteen subjects ( 14 female , 5 male ; mean age [X̄±SD]=41±8 years ) with mild to moderate disability secondary to MS participated in a r and omized crossover controlled study . Eleven subjects ( 8 female , 3 male ; mean age [X̄±SD]=44±6 years ) completed the study . Results After AT , but not NR , the subjects ’ walking distances and speeds during a self-paced walk were significantly improved , as were their maximum work rate , peak oxygen uptake , and oxygen pulse during cardiopulmonary exercise tests . The increases in peak oxygen uptake and maximum work rate , but not in walking capacity , were significantly higher after AT , as compared with after NR . Additionally , the subjects who were most disabled tended to benefit more from AT . There were no differences between AT and NR in effects on fatigue , and the results showed that AT may have partially affected health-related quality of life . Discussion and Conclusion The results suggest that AT is more effective than NR in improving maximum exercise tolerance and walking capacity in people with mild to moderate disability secondary to MS

Our case study successfully enabled us to address the four feasibility metrics , and we provide new information on management feasibility ( i.e. estimate data completeness and estimate data entry ) and scientific outcomes feasibility ( i.e. determining data collection material s appropriateness ) . Conclusion Our review highlights the existing research and provides a case study which assesses important metrics of study feasibility .

Background Much research has been undertaken to establish the important benefits of physical activity in persons with multiple sclerosis ( MS ) . There is disagreement regarding the strength of this research , perhaps because the majority of studies on physical activity and its benefits have not undergone initial and systematic feasibility testing . We aim to address the feasibility processes that have been examined within the context of physical activity interventions in MS .

Our case study successfully enabled us to address the four feasibility metrics , and we provide new information on management feasibility ( i.e. estimate data completeness and estimate data entry ) and scientific outcomes feasibility ( i.e. determining data collection material s appropriateness ) . Conclusion Our review highlights the existing research and provides a case study which assesses important metrics of study feasibility .

Background Much research has been undertaken to establish the important benefits of physical activity in persons with multiple sclerosis ( MS ) . There is disagreement regarding the strength of this research , perhaps because the majority of studies on physical activity and its benefits have not undergone initial and systematic feasibility testing . We aim to address the feasibility processes that have been examined within the context of physical activity interventions in MS .

Fall risk and incidence reduction in high risk individuals with multiple sclerosis: a pilot randomized control trial

Objective : To determine the feasibility of three fall prevention programs delivered over 12 weeks among individuals with multiple sclerosis : ( A ) a home-based exercise program targeting physiological risk factors ; ( B ) an educational program targeting behavioral risk factors ; and ( C ) a combined exercise- and -education program targeting both factors . Design : R and omized controlled trial . Setting : Home-based training with assessment s at research laboratory . Participants : A total of 103 individuals inquired about the investigation . After screening , 37 individuals with multiple sclerosis who had fallen in the last year and ranged in age from 45–75 years volunteered for the investigation . A total of 34 participants completed post assessment following the 12-week intervention . Intervention : Participants were r and omly assigned into one of four conditions : ( 1 ) wait-list control ( n = 9 ) ; ( 2 ) home-based exercise ( n = 11 ) ; ( 3 ) education ( n = 9 ) ; or ( 4 ) a combined exercise and education ( n = 8) group . Measures : Before and after the 12-week interventions , participants underwent a fall risk assessment as determined by the physiological profile assessment and provided information on their fall prevention behaviors as indexed by the Falls Prevention Strategy Survey . Participants completed falls diaries during the three-months postintervention . Results : A total of 34 participants completed postintervention testing . Procedures and processes were found to be feasible . Overall , fall risk scores were lower in the exercise groups ( 1.15 SD 1.31 ) compared with the non-exercise groups ( 2.04 SD 1.04 ) following the intervention ( p < 0.01 ) . There was no group difference in fall prevention behaviors ( p > 0.05 ) . Conclusions : Further examination of home-based exercise/education programs for reducing falls in individuals with multiple sclerosis is warranted . A total of 108 participants would be needed in a larger r and omized controlled trial . Clinical Trials.org #

Our case study successfully enabled us to address the four feasibility metrics , and we provide new information on management feasibility ( i.e. estimate data completeness and estimate data entry ) and scientific outcomes feasibility ( i.e. determining data collection material s appropriateness ) . Conclusion Our review highlights the existing research and provides a case study which assesses important metrics of study feasibility .

Background Much research has been undertaken to establish the important benefits of physical activity in persons with multiple sclerosis ( MS ) . There is disagreement regarding the strength of this research , perhaps because the majority of studies on physical activity and its benefits have not undergone initial and systematic feasibility testing . We aim to address the feasibility processes that have been examined within the context of physical activity interventions in MS .