Daytime sleepiness associated with lurasidone and quetiapine XR: results from a randomized double-blind, placebo-controlled trial in patients with schizophrenia The Comparative Effects of Risperidone Long-Acting Injection and Paliperidone Palmitate on Social Functioning in Schizophrenia: A 6-Month, Open-Label, Randomized Controlled Pilot Trial Computerized cognitive remediation training for schizophrenia: An open label, multi-site, multinational methodology study Proof-of-concept randomized controlled trial of pregnenolone in schizophrenia Multimedia consent for research in people with schizophrenia and normal subjects: a randomized controlled trial. Compensatory cognitive training for psychosis: effects in a randomized controlled trial. The efficacy of supported employment for middle-aged and older people with schizophrenia Randomized Placebo-Controlled Trial of a Selective Serotonin Reuptake Inhibitor in the Treatment of Nondepressed Tinnitus Subjects Combined cognitive remediation and functional skills training for schizophrenia: effects on cognition, functional competence, and real-world behavior. Clinical study and literature review of nasal irrigation. Neurocognitive individualized training versus social skills individualized training: A randomized trial in patients with schizophrenia A literature review on the representativeness of randomized controlled trial samples and implications for the external validity of trial results Real-world persistence and adherence with oral bisphosphonates for osteoporosis: a systematic review Neurocognitive and Self-efficacy Benefits of Cognitive Remediation in Schizophrenia: A Randomized Controlled Trial. The Cochrane Collaboration. Part 3: Evidence evaluation process: 2010 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science with Treatment Recommendations. Agreement about Identifying Patients Who Change over Time Healthcare professionals' intentions and behaviours: A systematic review of studies based on social cognitive theories Does EEG-neurofeedback improve neurocognitive functioning in children with attention-deficit/hyperactivity disorder? A systematic review and a double-blind placebo-controlled study. Effects of offering advance directives on quality adjusted life expectancy and psychological well-being among ill adults. Evaluation of a new method for librarian‐mediated literature searches for systematic reviews AMSTAR 2: a critical appraisal tool for systematic reviews that include randomised or non-randomised studies of healthcare interventions, or both Compliance with federal and state legislation by indoor tanning facilities in San Diego.
Objective The aim of this analysis was to compare the effects of 2 atypical antipsychotic agents , lurasidone ( 80 mg/d or 160 mg/d ) and quetiapine XR ( 600 mg/d ) , on daytime alertness , and to evaluate the effects of daytime sleepiness on treatment outcomes in patients with an acute exacerbation of schizophrenia . Methods Patients who met Diagnostic and Statistical Manual of Mental Disorders , 4th edition , text revision ( DSM-IV-TR ) criteria for schizophrenia were r and omized to 6 weeks of double-blind treatment with fixed doses of lurasidone 80 mg/d ( n = 125 ) , lurasidone 160 mg/d ( n = 121 ) , quetiapine XR 600 mg/d ( n = 119 ) , or placebo ( n = 121 ) , all dosed once daily in the evening , with food . Daytime sleepiness was assessed using the Epworth Sleepiness Scale ( ESS ) . Results Daytime sleepiness improved in the lurasidone and placebo-treated groups but worsened in the quetiapine XR treatment group when compared to placebo ( p = 0.001 ) and to either dose of lurasidone ( both p < 0.01 ) . Sedation associated with quetiapine XR treatment mediated an improvement in agitation [ assessed by the Positive and Negative Syndrome Scale — Excitement ( PANSS-EC ) subscale ] and a worsening in functional capacity [ assessed by the University of California – San Diego ( UCSD ) Performance-Based Skills Assessment —Brief Version ( UPSA-B ) total score ] ; these mediating relationships were not observed for the lurasidone or placebo treatment groups . Conclusion In this 6-week double-blind study , treatment with lurasidone 80 mg or 160 mg , administered once daily in the evening , was associated with a reduction in daytime sleepiness similar in magnitude to placebo , while quetiapine XR 600 mg/d was associated with a significant increase in daytime sleepiness , compared to both lurasidone dose groups and placebo . Daytime sleepiness was associated with improvement in agitation and worsening in functional capacity for quetiapine XR , but not lurasidone or placebo-treated patients Purpose : The aim of this study was to compare the effects of risperidone long-acting injection ( RLAI ) and paliperidone palmitate ( PP ) on non-acute-phase social functioning in patients with schizophrenia . Patients and Methods : In this 6-month pilot , open-label , r and omized controlled study , 30 patients with schizophrenia who had been treated with RLAI were r and omly allocated to the RLAI continuation group or switched to the PP group . Patients were evaluated at baseline and 6 months with the Social Functioning Scale ( SFS ) as the primary outcome variable and University of California San Diego Performance-Based Skills Assessment Brief ( UPSA-B ) , Social Emotional Cognition Task ( SECT ) , Positive and Negative Syndrome Scale ( PANSS ) , and Drug-Induced Extrapyramidal Symptoms Scale ( DIEPSS ) scores as secondary outcomes . Results : At baseline , the two groups did not significantly differ in demographic or clinical features . The two groups did not differ in total score changes for the UPSA-B , the SECT , the PANSS , and the DIEPSS . However , the total scores and the two subscales of the SFS , i.e. independence-competence and independence-performance , were more improved in the PP group compared to the RLAI group ( total scores , p = 0.038 ; competence , p = 0.001 , and performance , p = 0.007 , respectively ) . Conclusion : These results suggest that PP may improve the total social functioning , independent life competence , and performance as compared to the RLAI group . However , these results are preliminary and need independent replication in larger sample s before any definitive statement can be made A recent single-site study ( Fisher et al. , 2009 . Am J Psychiatry . 166 ( 7 ) 805 - 11 ) showed that repeated training with the Brain Fitness Program ( BFP )  improved performance on a battery of neuropsychological tasks . If replicated these data suggest an important non-pharmacological method for ameliorating cognitive impairment in schizophrenia . Our study evaluated the BFP training effects in an open-label , multi-site , multinational clinical trial . Fifty-five stable adult patients with schizophrenia on regular antipsychotic medication completed ≥ 32 BFP training sessions over 8 - 10 weeks . Training effects on cognitive performance and functional capacity outcome measures were measured using CogState ® schizophrenia battery , UCSD Performance based Skills Assessment ( UPSA-2 ) and Cognitive Assessment Interview ( CAI )  . BFP training showed a large and significant treatment effect on a training exercise task ( auditory processing speed ) , however this effect did not generalize to improved performance on independent CogState ® assessment . There were no significant effects on UPSA-2 or CAI scores . Our study demonstrated the feasibility of implementing BFP training in a multi-site study . However , BFP training did not show significant treatment effects on cognitive performance or functional capacity outcome measures despite showing large and significant effects on a training exercise Rationale Pre clinical and clinical data suggest that pregnenolone may be a promising therapeutic in schizophrenia .  Pregnenolone is neuroprotective and enhances learning and memory , myelination , and microtubule polymerization . Treatment with pregnenolone elevates allopregnanolone ( a neurosteroid that enhances GABAA receptor responses ) and pregnenolone sulfate ( a positive NMDA receptor modulator ) . Pregnenolone could thus potentially mitigate GABA dysregulation and /or NMDA receptor hypofunction in schizophrenia via metabolism to other neurosteroids . Objective The objective of this study is to conduct a r and omized controlled trial of adjunctive pregnenolone in schizophrenia . Methods Following a placebo lead-in , 120 participants were r and omized to pregnenolone or placebo for 8 weeks ( Institute for Mental Health , Singapore ) . Primary endpoints were changes in MATRICS Consensus Cognitive Battery ( MCCB ) composite scores ( cognitive symptoms ) , UCSD Performance-based Skills Assessment —Brief ( UPSA-B ) composite scores ( functional capacity ) , and Scale for Assessment of Negative Symptoms ( SANS ) total scores ( negative symptoms ) . A modified intent-to-treat analysis approach was utilized . Results No significant changes compared to placebo were demonstrated in composite MCCB scores . In contrast , participants r and omized to pregnenolone ( n = 56 ) demonstrated greater improvements in functional capacity ( UPSA-B composite changes ) compared to placebo ( n = 55 ) , p = 0.03 . Pregnenolone was also superior to placebo in the communication subscale of the UPSA-B ( p < 0.001 ) . Serum pregnenolone changes post-treatment were correlated with UPSA-B composite score changes in females ( rs = 0.497 , p < 0.042 , n = 17 ) but not in males . Mean total SANS scores were very low at baseline and did not improve further post-treatment . Pregnenolone was well-tolerated . Conclusions Pregnenolone improved functional capacity in participants with schizophrenia , but did not improve cognitive symptoms over an 8-week treatment period . Neurosteroid changes correlated with functional improvements in female participants . Neurosteroid interventions may exhibit promise as new therapeutic leads for schizophrenia Limitations of printed , text-based , consent forms have long been documented and may be particularly problematic for persons at risk for impaired decision-making capacity , such as those with schizophrenia . We conducted a r and omized controlled comparison of the effectiveness of a multimedia vs routine consent procedure ( augmented with a 10-minute control video presentation ) as a means of enhancing comprehension among 128 middle-aged and older persons with schizophrenia and 60 healthy comparison subjects . The primary outcome measure was manifest decisional capacity ( underst and ing , appreciation , reasoning , and expression of choice ) for participation in a ( hypothetical ) clinical drug trial , as measured with the MacArthur Competence Assessment Tool for Clinical Research ( MacCAT-CR ) and the University of California San Diego ( UCSD ) Brief Assessment for Capacity to Consent ( UBACC ) . The MacCAT-CR and UBACC were administered by research assistants kept blind to consent condition . Additional assessment s included st and ardized measures of psychopathology and cognitive functioning . Relative to patients in the routine consent condition , schizophrenia patients receiving multimedia consent had significantly better scores on the UBACC and on the MacCAT-CR underst and ing and expression of choice subscales and were significantly more likely to be categorized as being capable to consent than those in the routine consent condition ( as categorized with several previously established criteria ) . Among the healthy subjects , there were few significant effects of consent condition . These findings suggest that multimedia consent procedures may be a valuable consent aid that should be considered for use when enrolling participants at risk for impaired decisional capacity , particularly for complex and /or high-risk research protocol OBJECTIVE Treatments for the cognitive impairments of schizophrenia are urgently needed . We developed and tested a 12-week , group-based , manualized , compensatory cognitive training intervention targeting prospect i ve memory , attention , learning/memory , and executive functioning . The intervention focused on compensatory strategies , such as calendar use , self-talk , note taking , and a 6-step problem-solving method , and did not require computers . METHOD In a r and omized controlled trial , 69 out patients with DSM-IV primary psychotic disorders were assigned to receive st and ard pharmacotherapy alone or compensatory cognitive training + st and ard pharmacotherapy for 12 weeks . Assessment s of neuropsychological performance and functional capacity ( primary outcomes ) and psychiatric symptom severity , quality of life , social skills performance , cognitive insight , and self-reported everyday functioning ( secondary outcomes ) were administered at baseline , posttreatment , and 3-month follow-up . Data were collected between September 2003 and August 2009 . RESULTS Hierarchical linear modeling analyses demonstrated significant compensatory cognitive training-associated effects on attention at follow-up ( P = .049 ) , verbal memory at posttreatment and follow-up ( P values ≤ .039 ) , and functional capacity ( University of California , San Diego Performance-based Skills Assessment ) at follow-up ( P = .004 ) . The compensatory cognitive training group also differentially improved in negative symptom severity at posttreatment and follow-up ( P values ≤ .025 ) and subjective quality of life at follow-up ( P = .002 ) . CONCLUSIONS Compensatory cognitive training , a low-tech , brief intervention , has the potential to improve not only cognitive performance but also functional skills , negative symptoms , and self-rated quality of life in people with psychosis . TRIAL REGISTRATION Clinical Trials.gov identifier : NCT01521026 OBJECTIVE Supported employment is the evidence -based treatment of choice for assisting individuals with severe mental illness to achieve competitive employment , but few supported employment programs specifically target older clients with psychiatric illness . The purpose of this study was to evaluate the efficacy of supported employment for middle-aged or older people with schizophrenia . METHOD Participants included 58 out patients with schizophrenia or schizoaffective disorder aged 45 or older who were recruited from a community mental health clinic . Participants were r and omly assigned to receive Individual Placement and Support ( IPS ; the manualized version of supported employment ) or conventional vocational rehabilitation ( CVR ) for one year , and completed assessment s at baseline , six months , and twelve months . RESULTS IPS was superior to CVR on nearly all work outcome measures , including attainment of competitive employment , weeks worked , and wages earned . Fifty-seven percent of IPS participants worked competitively , compared with 29 % of CVR participants ; 70 % of IPS participants obtained any paid work , compared with 36 % of CVR participants . Within the IPS group , better baseline functional capacity ( as measured by the UCSD Performance Based Skills Assessment ) and more recent employment were modestly associated with better work outcomes . CONCLUSIONS Middle-aged and older adults with schizophrenia are good c and i date s for supported employment services Objective : To assess the efficacy of a selective serotonin reuptake inhibitor ( paroxetine ) for relief of tinnitus . Design : One hundred twenty tinnitus sufferers participated in a r and omized double-blind placebo-controlled trial . Paroxetine or placebo was increased to a maximally tolerated dose ( up to 50 mg/day ) , and patients were treated for a total of 31 days at the maximal dose . Methods : Patients with chronic tinnitus were recruited from our university-based specialty clinic by referral from otolaryngologists and audiologists in the local community and by advertisement . Patients with psychotic or substance use disorders or suicidal ideation were excluded , as were those using psychoactive medications  ( this result ed in only 1 subject with major depression in the study ) or any other medications that interact with paroxetine and those with inability to hear at one ’s tinnitus sensation level . Fifty-eight percent of patients were male , 92 % were Caucasian , and the average age was 57 . Outcomes Measures : Tinnitus matching , the Tinnitus H and icap Question naire , the question : How severe ( bothered , aggravating ) is your tinnitus ? Quality of Well-Being and other psychological question naires . Results : Paroxetine was not statistically superior to placebo on the following tinnitus measures ( tinnitus matching , 5- or 10-db drop , Tinnitus H and icap Question naire , quality of well-being measures , how severe , how bothered , positive change ) . There was a significant improvement in the single item question , How aggravating is your tinnitus ? for those in the paroxetine group compared with the placebo group . Conclusions : These results suggest that the majority of individuals in this study did not benefit from paroxetine in a consistent fashion . Further work remains to be done to determine if subgroups of patients ( e.g. , those who tolerate higher doses , those who are depressed ) may benefit . UCSD = University of California , San Diego OBJECTIVE Cognitive remediation is an efficacious treatment for schizophrenia and , when used within broader psychosocial treatments , improves transfer to real-world behavior change . The authors examined whether cognitive remediation effectively generalizes to functional competence and real-world functioning as a st and alone treatment and when combined with a functional skills treatment . METHOD Out patients with schizophrenia ( N=107 ) were r and omly assigned to receive cognitive remediation , functional adaptation skills training , or combined treatment , with cognitive remediation preceding functional skills training .  Clinical symptoms , neurocognition , social competence , functional competence , and case-manager-rated real-world behavior were assessed at baseline , at end of treatment , and at a 12-week durability assessment . RESULTS Neurocognition improved , with durable effects , after cognitive remediation but not after functional skills training . Social competence improved both with functional skills training and with combined treatment but not with cognitive remediation alone . Improvements in functional competence were greater and more durable with combined treatment . Cognitive remediation alone did not produce significant improvements in real-world behavior , but when combined with functional skills training , statistically significant improvements from baseline to end of treatment and follow-up were observed in community or household activities and work skills . Number-needed-to-treat analyses suggest that as few as three cases are required for treatment to induce a meaningful improvement in functional skills . CONCLUSIONS In a short intervention , cognitive remediation produced robust improvements in neurocognition . Generalization to functional competence and real-world behavior was more likely when supplemental skills training and cognitive remediation were combined OBJECTIVES /HYPOTHESIS Nasal disease , including chronic rhinosinusitis and allergic rhinitis , is a significant source of morbidity . Nasal irrigation has been used as an adjunctive treatment of sinonasal disease . However , despite an abundance of anecdotal reports , there has been little statistical evidence to support its efficacy . The objective of this study was to determine the efficacy of the use of pulsatile hypertonic saline nasal irrigation in the treatment of sinonasal disease . STUDY DESIGN A prospect i ve controlled clinical study . METHODS Two hundred eleven patients from the University of California , San Diego ( San Diego , CA ) Nasal Dysfunction Clinic with sinonasal disease ( including allergic rhinitis , aging rhinitis , atrophic rhinitis , and postnasal drip ) and 20 disease-free control subjects were enrolled . Patients irrigated their nasal cavities using hypertonic saline delivered by a Water Pik device using a commercially available nasal adapter twice daily for 3 to 6 weeks . Patients rated nasal disease-specific symptoms and completed a self-administered quality of well-being question naire before intervention and at follow-up . RESULTS Patients who used nasal irrigation for the treatment of sinonasal disease experienced statistically significant improvements in 23 of the 30 nasal symptoms queried . Improvement was also measured in the global assessment of health status using the Quality of Well-Being scale . CONCLUSIONS Nasal irrigation is effective in improving symptoms and the health status of patients with sinonasal disease Rehabilitation programs integrating cognitive remediation ( CR ) and psychosocial rehabilitation are often implemented as they seem to yield greater improvements in functional outcome than st and alone treatment approaches . Mechanisms underlying synergistic effects of combining CR with psychosocial interventions are not fully understood . Disentangling the relative contribution of each component of integrated programs might improve underst and ing of underlying mechanisms . In the present study we compared the efficacy of two components of our rehabilitation program [ the Neurocognitive Individualized Training ( NIT ) and the Social Skills Individualized Training ( SSIT ) ] . Seventy-two patients with schizophrenia or schizoaffective disorder were r and omly assigned to one of two treatment groups . Changes in cognitive , psychopathological and real-world functioning indices after 6 and 12 months were compared between the two groups . After both 6 and 12 months , NIT produced an improvement of attention , verbal memory and perseverative aspects of executive functioning , while SSIT produced a worsening of visuo-spatial memory and attention and no significant effect on the other cognitive domains . As to the real-world functioning , NIT produced a significant improvement of interpersonal relationships , while SSIT yielded a significant improvement of QLS instrumental role subscale . According to our findings , cognitive training is more effective than social skills training on several cognitive domains and indices of real-world functioning relevant to subject 's relationships with other people . Integrated approaches might target different areas of functional impairment but should be planned carefully and individually to fully exploit the synergistic potential R and omized controlled trials ( RCTs ) are conducted under idealized and rigorously controlled conditions that may compromise their external validity . A literature review was conducted of published English language articles that reported the findings of studies assessing external validity by a comparison of the patient sample included in RCTs reporting on pharmaceutical interventions with patients from everyday clinical practice . The review focused on publications in the fields of cardiology , mental health , and oncology . A range of data bases were interrogated ( MEDLINE ; EMBASE ; Science Citation Index ; Cochrane Methodology Register ) . Double- abstract review and data extraction were performed as per protocol specifications . Out of 5,456 de-duplicated abstract s , 52 studies met the inclusion criteria ( cardiology , n = 20 ; mental health , n = 17 ; oncology , n = 15 ) . Studies either performed an analysis of the baseline characteristics ( demographic , socioeconomic , and clinical parameters ) of RCT -enrolled patients compared with a real-world population , or assessed the proportion of real-world patients who would have been eligible for RCT inclusion following the application of RCT inclusion /exclusion criteria . Many of the included studies concluded that RCT sample s are highly selected and have a lower risk profile than real-world population s , with the frequent exclusion of elderly patients and patients with co-morbidities . Calculation of in eligibility rates in individual studies showed that a high proportion of the general disease population was often excluded from trials . The majority of studies ( n = 37 [ 71.2 % ] ) explicitly concluded that RCT sample s were not broadly representative of real-world patients and that this may limit the external validity of the RCT . Authors made a number of recommendations to improve external validity . Findings from this review indicate that there is a need to improve the external validity of RCTs such that physicians treating patients in real-world setting s have the appropriate evidence on which to base their clinical decisions . This goal could be achieved by trial design modification to include a more representative patient sample and by supplementing RCT evidence with data generated from observational studies . In general , a thoughtful approach to clinical evidence generation is required in which the trade-offs between internal and external validity are considered in a holistic and balanced manner Objectives This study examined patient adherence and persistence to oral bisphosphonates for the treatment of osteoporosis in real-world setting s. Methods A systematic review was completed according to the Preferred Reporting Items for Systematic Review s and Meta-Analyses . Medical Literature Analysis and Retrieval System Online ( MEDLINE ) , Cumulative Index to Nursing and Allied Health Literature ( CINAHL ) , Allied and Complementary Medicine Data base ( AMED ) , Data base of Abstract s of Review s of Effects ( DARE ) , Health Technology Assessment ( HTA ) and National Health Service Economic Evaluation Data base NHS EED ) data bases were search ed for studies published in English language up to April 2018 . Prospect i ve and retrospective observational studies that used prescription cl aim data bases or hospital medical records to examine patient adherence and persistence to oral bisphosphonate treatment among adults with osteoporosis were included . The Newcastle – Ottawa quality assessment scale ( NOS ) was used to assess the quality of included studies . Results The search yielded 540 published studies , of which 89 were deemed relevant and were included in this review . The mean age of patients included within the studies ranged between 53 to 80.8 years , and the follow-up varied from 3 months to 14 years . The mean persistence of oral bisphosphonates for 6 months , 1 year and 2 years ranged from 34.8 % to 71.3 % , 17.7 % to 74.8 % and 12.9 % to 72.0 % , respectively . The mean medication possession ratio ranged from 28.2 % to 84.5 % , 23 % to 50 % , 27.2 % to 46 % over 1 year , 2 years and 3 years , respectively . All studies included scored between 6 to 8 out of 9 on the NOS . The determinants of adherence and persistence to oral bisphosphonates included geographic residence , marital status , tobacco use , educational status , income , hospitalisation , medication type and dosing frequency . Conclusions While a number of studies reported high levels of persistence and adherence , the findings of this review suggest that patient persistence and adherence with  oral bisphosphonates  medications was poor and reduced notably over time . Overall , adherence was suboptimal . To maximise adherence and persistence to oral bisphosphonates , it is important to consider possible determinants , including characteristics of the patients OBJECTIVES The aim of this study was to evaluate the impact of computer-assisted " drill- and - strategy " cognitive remediation ( CR ) for community-dwelling individuals with schizophrenia on cognition , everyday self-efficacy , and independent living skills . METHODS Fifty-six people with schizophrenia or schizoaffective disorder were r and omized into CR or computer game ( CG ) playing ( control ) , and offered twenty 1-hr individual sessions in a group setting over 10 weeks . Measures of cognition , psychopathology , self-efficacy , quality of life , and independent living skills were conducted at baseline , end-group and 3 months following intervention completion . RESULTS Forty-three participants completed at least 10 sessions and the end-group assessment . Linear mixed-effect analyses among completers demonstrated a significant interaction effect for global cognition favoring CR ( p=.028 ) . CR-related cognitive improvement was sustained at 3-months follow-up . At end-group , 17 ( 77 % ) CR completers showed a reliable improvement in at least one cognitive domain . A significant time effect was evident for self-efficacy ( p=.028 ) with both groups improving over time , but no significant interaction effect was observed . No significant effects were found for other study outcomes , including the functional measure . CONCLUSIONS Computer-assisted drill- and - strategy CR in schizophrenia improved cognitive test performance , while participation in both CR and CG playing promoted enhancements in everyday self-efficacy . Changes in independent living skills did not appear to result from CR , however . Adjunctive psychosocial rehabilitation is likely necessary for improvements in real-world community functioning to be achieved . ( JINS , 2018 , 24 , 549 - 562 ) Twenty years ago , you could read all the literature in your field , said reference librarian Kathy Robbins , PhD , MLIS , scanning shelf after shelf of medical journals at the University of Minnesota Bio-Medical Library in Minneapolis . Now , 6000 journal articles are published each day . Merely keeping up with this torrent of information in one 's own specialty is difficult enough . Synthesizing and applying the knowledge to patient care verges on the impossible without some sort of guidance . Fortunately , this guidance is available . Bringing the fruits of new research to the bedside takes at least four levels of review , said Brian Haynes , MD , PhD , professor and chair of the department of clinical epidemiology at McMaster University in Hamilton , Ontario , Canada . Publications such as ACP Journal Club ( of which Haynes is the editor ) collect relevant trials ; the Cochrane Collaboration synthesizes studies of a given research question ; Evidence -Based Medicine Review s integrates the material ; and Clinical Evidence from the British Medical Journal organizes the information according to clinical topic areas , bringing the material closer to practitioners . The goal of the Cochrane Collaboration is to improve the quality of decisions in health care by preparing , maintaining , and promoting the accessibility of systematic review s of the effects of health care interventions . The Cochrane Collaboration has consistently used r and omized , controlled trials ( RCTs ) as the principal focus of its review s. For medical research , The Cochrane Collaboration is a good place to start , said Robbins . If the answer is there , you save time , because the Collaboration has already done the work of search ing journals . The Cochrane Collaboration and Evidence -Based Medicine The Cochrane Collaboration , which is almost a decade old , has a special flavor because its members receive no financial compensation for their contributions . Another noteworthy aspect of the Collaboration is its origin , which stems from the inspiration of one person . Archibald L. Cochrane was a charismatic British epidemiologist whose call for a hard look at how to tell which interventions did more harm than good inspired the formation of a worldwide consortium that prepares systematic review s of r and omized clinical trials . Both evidence -based medicine and the Cochrane Collaboration have roots in the same soil , said Haynes . The origins were n't spontaneous on either side of the Atlantic , said Haynes . Public investment in health care research after World War II had finally produced results that had gone from the laboratory to r and omized , controlled trials . At that point , there was still a gap between evidence and practice . Closing that gap meant knowing which interventions worked and how well . At McMaster , this led to work by Haynes and David Sackett , joined by Alvan Feinstein at Yale , and others , in what was then called critical appraisal of medical literature . ( According to Haynes , the term evidence -based medicine was not introduced until 1991 in an article by Gordon Guyatt in ACP Journal Club . ) In Britain , similar impulses led to the Cochrane Collaboration . Archie Cochrane : A History Kay Dickersin , PhD , codirector of the Collaboration 's New Engl and Center , has written that Archie Cochrane was one of the first to advance the notion that health services must be evaluated on the basis of scientific evidence rather than on clinical impression , anecdotal experience , expert opinion , or tradition .  Cochrane was born in Scotl and in 1909 , graduated from the University of Cambridge , and studied medicine at University Hospital in London . He joined the Royal Army Medical Corps in 1939 and was taken prisoner in 1941 when the German army overran British forces defending the Greek isl and of Crete .  Cochrane spent the rest of the war in prisoner-of-war camps in Greece and Germany , often as the only medical officer serving thous and s of fellow prisoners . Some of the prisoners in the camp in Greece developed edema in their legs , which Cochrane hypothesized was a form of beriberi caused by vitamin B deficiency . He divided his patients into two groups and added yeast to the diet of one group . The intervention worked , and he then persuaded German army officials at the camp to provide yeast to all inmates . It was , Cochrane wrote , his first , worst , and most successful trial ( Cochrane AL . Br Med J [ Clin Res Ed ] . 1984;289:1726 - 7 ) . Later in Germany , when caring for prisoners with tuberculosis , he lamented the lack of hard evidence on whether and when to perform pneumothorax or thoracoplasty . These experiences and observations inspired a postwar career in epidemiology . After the war , Cochrane returned to London and studied statistics under Bradford Hill ( who would publish the first major r and omized clinical trial , on streptomycin to treat pulmonary tuberculosis , in 1948 ) . Cochrane settled in Cardiff , Wales , where over the next 20 years , he studied the epidemiology of tuberculosis and pneumoconiosis . In 1972 , Cochrane published Effectiveness and Efficiency : R and om Reflections on Health Services , in which he argued that r and omized clinical trials could separate valuable interventions from harmful or useless ones . Seven years later , he wrote : It is surely a great criticism of our profession that we have not organized a critical summary , by specialty or subspecialty , adapted periodically , of all relevant r and omized , controlled trials . Cochrane was especially critical of obstetrics and gynecology , which had failed to evaluate properly new innovations in the field ( such as the move to universal hospital delivery for childbirth and the introduction of Papanicolaou smears for cancer screening of the cervix ) before widespread introduction . Iain Chalmers , an obstetrician in Cardiff who knew Cochrane and his work , found Cochrane 's ideas compelling . If one is going to make rational use of limited re sources for health care , one needs to know which of the many things that people are doing within health care have been shown in reliable research studies to be more likely to do good than harm , said Chalmers recently . And the search for and analysis of the evidence needed to provide this information base should be systematic . The First RCT Registry Thus inspired , Chalmers set out in 1974 to create a comprehensive register of all r and omized clinical trials in perinatal medicine ( pregnancy through postpartum day 28 ) . At the time , a MEDLINE search might have retrieved barely half of all trials published after 1965 . Chalmers directed a team of volunteers in h and search ing 50 journals , going as far back as 1940 . They accumulated 3500 trial reports , and their compilation result ed in the publication in 1985 of A Classified Bibliography of Controlled Trials in Perinatal Medicine , 19401984 . Rapid progress in the field , however , meant that the volume was out of date almost immediately after it was printed , said Dickersin . A regularly up date d , electronic version first appeared in 1988a harbinger of later storage and distribution systems ( Dickersin K , Manheimer E. Clin Obstet Gynecol . 1998;41:315 - 31 ) . Further analytic work by Chalmers and others based on this bibliographic material yielded several volumes on perinatal medicine , including a 350-page paperback , Guide to Effective Care in Pregnancy and Childbirth , that presented the conclusions of the full versions in ways immediately useful to women using the maternity services . The systematic review s that were initially published on paper in three books were then kept up to date in a semi-annual electronic publication called The Oxford Data base of Perinatal Trials . Birth of the Cochrane Collaboration In 1993 , Chalmers and an international group of about 70 others jointly announced the formation of the Cochrane Collaboration to prepare , maintain , and disseminate systematic review s of the effects of health care interventions . Dickersin was the principal U.S. representative at the inaugural meeting . The Collaboration 's systematic review s entail exhaustive literature search es and the selection and analysis of studies based on explicit , prespecified criteria , sometimes , but not always , using meta-analyses , which are formal , mathematical combinations of numerical results . With the traditional review article , there are no guidelines about how to do it and no transparency for the reader . You ca n't tell if they 've really plowed through the literature or just picked over their file cabinets , said Dickersin , now associate professor of community health at Brown University School of Medicine in Providence , Rhode Isl and . Meta-analyses , to be good , must be of high quality and appropriate . Sometimes they may lump data together from both r and omized and observational trials or exhibit other biases . When poor meta-analyses are associated with systematic review s , people may assume guilt by association . Clinical practice guidelines may be an outgrowth of systematic review s , but they should be done by different peopleclinicians and professional organizations , she said . How Cochrane Works The Collaboration is made up of review groups , centers , fields , methods groups , and the consumer network . The review groups search for , collect , and analyze RCTs relating to specific health conditions . The 15 centers that constitute the Collaboration are geographically dispersed across 13 countries . In addition to coordinating the review activities within their region , each center also performs specialized functions . The San Francisco Center , for instance , advises on the electronic feedback and peer- review system . An elected 12-member steering group oversees the entire organization , supported by a small secretariat based in Oxford . The real work of the Collaboration takes place in the review groups , building on the model established by Chalmers ' work on perinatal medicine . Initiative for review s generally comes from members who suggest topics to the groups , explained Lisa A. Bero , PhD , associate professor of health policy studies > “ There are known knowns . These are things we know that we know . There are known unknowns . That is to say , there are things that we now know we do n't know . But there are also unknown unknowns . These are things we do not know we do n't know . ” > > —United States Secretary of Defense Donald Rumsfeld ( February 2002 ) > “ Thought is the wind , knowledge the sail , and mankind the vessel . ” > > August Hare ( 1792–1834 ) The international resuscitation community , under the auspices of the International Liaison Committee on Resuscitation ( ILCOR ) , has performed an exhaustive review of the published literature related to resuscitation and emergency cardiovascular care ( ECC ) . We had the opportunity to build on the detailed process developed over the past decade that facilitated the publication of the international consensus statement on therapeutic hypothermia1 and the Consensus on Cardiopulmonary Resuscitation ( CPR ) and ECC Science With Treatment Recommendations in 2005 (C2005).2 The overall process has been informed by the increasing evidence base behind good , systematic literature review s.3,4 There are , however , many questions that have never been addressed in a r and omized controlled trial , and much of the supporting scientific literature is at lower levels of evidence ( LOEs ) . In total , 356 worksheet authors from 29 countries throughout the world completed 411 worksheets on 277 topics . The information from these worksheets , with additional iterations from the writing groups and editorial board , makes up the evidence base from which the 2010 International Consensus on CPR and ECC Science with Treatment Recommendations ( CoSTR ) document is derived . As has been the process since the evidence evaluation for Guidelines 2000,5 volunteers from around the world were asked to perform systematic review s of the literature . These review s were conducted according to st and ardized instructions in completing the evidence worksheet template , and these worksheets were subsequently review ed in a detailed iterative process ( see www . ILCOR.org).6 A revised worksheet template ( based on that Background . Preference-based measures of health-related quality of life all use the same dead = 0.00 to perfect health = 1.00 scale , but there are substantial differences among measures . Objective . The objective was to examine agreement in classifying patients as better , stable , or worse . Methods . The EQ-5D , Health Utilities Index Mark 2 and Mark 3 , Quality of Well-Being – Self-Administered scale , Short-Form 36 ( Short-Form 6D ) , and disease-targeted measures were administered prospect ively in 2 clinical cohorts . The study was conducted at academic medical centers : University of California , Los Angeles ; University of California , San Diego ; University of Wisconsin – Madison ; and University of Southern California . Patients undergoing cataract extraction surgery with lens replacement completed the 25-item National Eye Institute Visual Function Question naire ( NEI-VFQ-25 ) .  Patients newly referred to congestive heart failure specialty clinics completed the Minnesota Living with Heart Failure Question naire ( MLHF ) . In both cohorts , subjects completed surveys at baseline and at 1 and 6 months . The NEI-VFQ-25 and MLHF were used as gold st and ards to assign patients to categories of change . Agreement was assessed using κ . Results . There were 376 cataract patients recruited . Complete data for baseline and the 1-month follow-up were available on all measures for 210 cases . Using criteria specified by Altman , agreement was poor for 6 of 9 pairs of comparisons and fair for 3 pairs . There were 160 heart failure patients recruited . Complete data for baseline and the 6-month follow-up were available for 86 cases . Agreement was negligible for 5 pairs and fair for 1 . The study was conducted on selected patients at a few academic medical centers . Conclusions . The results underscore the lack of interchangeability among different preference-based measures Background There is an important gap between the implication s of clinical research evidence and the routine clinical practice of healthcare professionals . Because individual decisions are often central to adoption of a clinical -related behaviour , more information about the cognitive mechanisms underlying behaviours is needed to improve behaviour change interventions targeting healthcare professionals . The aim of this study was to systematic ally review the published scientific literature about factors influencing health professionals ' behaviours based on social cognitive theories . These theories refer to theories where individual cognitions/thoughts are viewed as processes intervening between observable stimuli and responses in real world situations . Methods We search ed psycINFO , MEDLINE , EMBASE , CIHNAL , Index to theses , PROQUEST dissertations and theses and Current Contents for articles published in English only . We included studies that aim ed to predict healthcare professionals ' intentions and behaviours with a clear specification of relying on a social cognitive theory . Information on percent of explained variance ( R2 ) was used to compute the overall frequency-weighted mean R2 to evaluate the efficacy of prediction in several context s and according to different method ological aspects . The cognitive factors most consistently associated with prediction of healthcare professionals ' intention and behaviours were documented . Results Seventy eight studies met the inclusion criteria . Among these studies , 72 provided information on the determinants of intention and 16 prospect i ve studies provided information on the determinants of behaviour . The theory most often used as reference was the Theory of Reasoned Action ( TRA ) or its extension the Theory of Planned Behaviour ( TPB ) . An overall frequency-weighted mean R2 of 0.31 was observed for the prediction of behaviour ; 0.59 for the prediction of intention . A number of moderators influenced the efficacy of prediction ; frequency-weighted mean R2 varied from 0.001 to 0.58 for behaviour and 0.19 to 0.81 for intention . Conclusion Our results suggest that the TPB appears to be an appropriate theory to predict behaviour whereas other theories better capture the dynamic underlying intention . In addition , given the variations in efficacy of prediction , special care should be given to method ological issues , especially to better define the context of behaviour performance BACKGROUND The number of placebo-controlled r and omized studies relating to EEG-neurofeedback and its effect on neurocognition in attention-deficient/hyperactivity disorder ( ADHD ) is limited . For this reason , a double blind , r and omized , placebo-controlled study was design ed to assess the effects of  EEG-neurofeedback  on neurocognitive functioning in children with ADHD , and a systematic review on this topic was performed . METHODS Forty-one children ( 8 - 15 years ) with a DSM-IV-TR diagnosis of ADHD were r and omly allocated to EEG-neurofeedback or placebo-neurofeedback treatment for 30 sessions , twice a week . Children were stratified by age , electrophysiological state of arousal , and medication use . Neurocognitive tests of attention , executive functioning , working memory , and time processing were administered before and after treatment . Research ers , teachers , children and their parents , with the exception of the neurofeedback-therapist , were all blind to treatment assignment . Outcome measures were the changes in neurocognitive performance before and after treatment . CLINICAL TRIAL REGISTRATION www . clinical trials.gov : NCT00723684 . RESULTS No significant treatment effect on any of the neurocognitive variables was found . A systematic review of the current literature also did not find any systematic beneficial effect of EEG-neurofeedback on neurocognitive functioning . CONCLUSION Overall , the existing literature and this study fail to support any benefit of neurofeedback on neurocognitive functioning in ADHD , possibly due to small sample sizes and other study limitations Two hundred and four patients from various clinical services at the San Diego Veterans ' Administration Medical Center and the University of California , San Diego Medical Center were r and omly assigned to either experimental ( offered the opportunity to execute an Advance Directive regarding the level of care they wanted to receive if incapacitated ) or control ( no Advance Directive offered ) conditions . Patients were given a baseline interview and re-interviewed at specific intervals ( 3 months , 6 months , 1 year and 2 years after baseline , and every 6 months thereafter ) . Outcome measures included the Qualitty of Well-being Scale , a measure of health status , and the General Well-being Index , a measure of psychological well-being . All differences between the health status and psychological well-being of experimental and control groups 3.5 years after the r and omization were non-significant . Method ological implication s of including mortality as part of the outcomes are discussed Objective To evaluate and vali date the time of completion and results of a new method of search ing for systematic review s , the exhaustive search method ( ESM ) , using a pragmatic comparison . Methods Single‐line search strategies were prepared in a text document . Term completeness was ensured with a novel optimization technique . Macros in MS Word converted the syntaxes between data bases and interfaces almost automatically . We compared search characteristics , such as number of search terms and data bases , and outcomes , such as number of included and retrieved references and precision , from ESM search es and other Dutch academic hospitals identified by search ing PubMed for systematic review s published between 2014 and 2016 . We compared time to perform the ESM with a secondary comparator of recorded search times from published literature and contact with authors to acquire unpublished data . Results We identified 73 published Erasmus MC systematic review s and 258 published by other Dutch academic hospitals meeting our criteria . We pooled search time data from 204 other systematic review s. The ESM search es differed by using 2 times more data bases , retrieving 44 % more references , including 20 % more studies in the final systematic review , but the time needed for the search was 8 % of that of the control group . Similarities between methods include precision and the number of search terms . Conclusions The evaluated similarities and differences suggest that the ESM is a highly efficient way to locate more references meeting the specified selection criteria in systematic review s than traditional search methods . Further prospect i ve research is required The number of published systematic review s of studies of healthcare interventions has increased rapidly and these are used extensively for clinical and policy decisions . Systematic review s are subject to a range of biases and increasingly include non-r and omised studies of interventions . It is important that users can distinguish high quality review s. Many instruments have been design ed to evaluate different aspects of review s , but there are few comprehensive critical appraisal instruments . AMSTAR was developed to evaluate systematic review s of r and omised trials . In this paper , we report on the updating of AMSTAR and its adaptation to enable more detailed assessment of systematic review s that include r and omised or non-r and omised studies of healthcare interventions , or both . With moves to base more decisions on real world observational evidence we believe that AMSTAR 2 will assist decision makers in the identification of high quality systematic review s , including those based on non-r and omised studies of healthcare interventions BACKGROUND The prevalence rates of both skin cancers and indoor tanning among the US population are high and have increased substantially in recent years . Low compliance by indoor tanning facilities with safety regulations may place consumers at greater risk of skin and ocular damage . OBJECTIVE This study quantified the level of compliance by  indoor tanning facilities  with selected federal and state regulations and recommendations . METHODS  Tanning facilities ( N = 54 ) in San Diego County , California , were visited by a confederate posing as a prospect i ve customer . Compliance with 13 regulations/ recommendations were assessed by either direct query or observation of the presence/absence of signs and warning labels . Operators ' responses to 5 risk-based questions also were noted . RESULTS No facility complied with all 13 regulations/ recommendations . Compliance with 3 protective eyewear regulations was high ( 89%-100 % ) . In contrast , compliance with  maximum tanning frequency recommendations  ( approximately 6 % ) and parental consent regulations  ( approximately 43 % ) was disturbingly low . CONCLUSION The investigators recommend instituting m and atory , comprehensive training for operators , as well as systematic compliance monitoring with enforcement of penalties for noncompliance
Conclusion The SLOF was the most often used functional measure and had the strongest observed correlation with the UPSA .
Although knowledge gaps remain , evidence from this review indicates that there is a quantitative relationship between functional capacity and real-world outcomes in individuals with schizophrenia
Objective To perform a systematic review of the published literature to evaluate how functional capacity , as measured by the University of California at San Diego ( UCSD ) Performance-based Skills Assessment ( UPSA ) , relates to other functional measures and real-world outcomes among individuals with schizophrenia .