Use of Condition-Specific Patient-Reported Outcome Measures in Clinical Trials among Patients with Wrist Osteoarthritis: A Systematic Review Editorial: an author's checklist for measure development and validation manuscripts. Can you believe what you read in the papers? Evidence regarding the utility of multiple mini-interview (MMI) for selection to undergraduate health programs: A BEME systematic review: BEME Guide No. 37 Effectiveness of interventions that assist caregivers to support people with dementia living in the community: a systematic review Development of core outcome sets for effectiveness trials of interventions to prevent and/or treat delirium (Del-COrS): study protocol Reducing patient delay with symptoms of acute coronary syndrome: a research protocol for a systematic review of previous interventions to investigate which behaviour change techniques are associated with effective interventions On the reliability and validity of manual muscle testing: a literature review The Pelvic Girdle Questionnaire: A Condition-Specific Instrument for Assessing Activity Limitations and Symptoms in People With Pelvic Girdle Pain The effectiveness of interventions to reduce undernutrition and promote eating in older adults with dementia: A systematic review Measuring quality of life in cosmetic surgery patients with a condition-specific instrument: the Derriford Scale. Effectiveness of interventions that assist caregivers to support people with dementia living in the community: a systematic review. Conducting and Reporting Case Series and Audits - Author Guidelines for Acupuncture in Medicine Common statistical errors in the design and analysis of subfertility trials. Reflecting peer-support groups in the prevention of stress and burnout: randomized controlled trial. A systematic review of trials evaluating success factors of interventions with computerised clinical decision support Assessing Care of Vulnerable Elders: Methods for Developing Quality Indicators The empirical status of empirically supported psychotherapies: assumptions, findings, and reporting in controlled clinical trials. Guidelines for the prevention of falls in people over 65 Systematic review of cognitive behavioural therapy for the management of headaches and migraines in adults Dietary fiber and the glycemic index: a background paper for the Nordic Nutrition Recommendations 2012 The Quality of Drug Studies Published in Symposium Proceedings A critical synthesis of literature on the promoting action on research implementation in health services (PARIHS) framework
Background . This paper aim ed to identify condition-specific patient-reported outcome measures used in clinical trials among people with wrist osteoarthritis and summarise empirical peer- review ed evidence supporting their reliability , validity , and responsiveness to change . Methods . A systematic review of r and omised controlled trials among people with wrist osteoarthritis was undertaken . Studies reporting reliability , validity , or responsiveness were identified using a systematic reverse citation trail audit procedure . Psychometric properties of the instruments were examined against predefined criteria and summarised . Results . Thirteen clinical trials met inclusion criteria . The most common patient-reported outcome was the disabilities of the arm , shoulder , and h and question naire ( DASH ) . The DASH , the  Michigan H and Outcomes Question naire ( MHQ ) , the  Patient Evaluation Measure ( PEM ) , and the  Patient-Reported Wrist Evaluation ( PRWE ) had evidence supporting their reliability , validity , and responsiveness . A post-hoc review of excluded studies revealed the AUSCAN Osteoarthritis H and Index as another suitable instrument that had favourable reliability , validity , and responsiveness . Conclusions . The DASH , MHQ , and AUSCAN Osteoarthritis H and Index instruments were supported by the most favourable empirical evidence for validity , reliability , and responsiveness . The PEM and PRWE also had favourable empirical evidence reported for these elements . Further psychometric testing of these instruments among people with wrist osteoarthritis is warranted A recent special issue of the Journal of Pediatric Psychology included papers focused on evidence -based assessment across several broad domains of assessment in pediatric psychology ( e.g. , adherence , pediatric pain , and quality of life ) . In one of these papers , Holmbeck et al. ( 2008 ) review ed strengths and limitations of existing measures of psychosocial adjustment and psychopathology , concluding that many measures lacked supporting psychometric data ( e.g. , basic indices of reliability and validity ) that would permit a complete evaluation of these measures . Given that measure development and validation papers are frequently published in JPP ( Brown , 2007 ) , it is important that we attend to guiding psychometric principles when developing and disseminating data on new measures to be employed with pediatric population s ( Nunnally & Bernstein , 1994 ) . Thus , the purpose of this paper is to present and describe a checklist for authors to use when su bmi tting measure development papers to JPP . This checklist is included in the Appendix and is also included at the following link on the JPP website : http://www.oxfordjournals.org/our_journals/jpepsy/for _ authors /measure%20development%20checklist.pdf Findings presented by Holmbeck et al. ( 2008 ) indicated that 34 of the 37 measures review ed met pre-established “ evidence -based assessment ” ( EBA ) criteria for “ well-established ” measures ( Cohen et al. , 2008 ) . To be considered “ well-established , ” a measure had to have been presented in at least two peer- review ed journal articles by different investigatory teams , have demonstrated adequate levels of reliability and validity , and be accompanied by supporting information ( e.g. , a measure manual ) . Although most measures that we review ed met these criteria , we also found that most of the 34 “ well-established ” measures were hampered by at least one major psychometric flaw and /or lacked important psychometric data . We concluded that a more fine-grained EBA classification system is needed . One important distinction in this literature relates to differences between empirically supported assessment and evidence -based assessment . This type of distinction was first discussed in the literature on clinical interventions ( e.g. , Spring , 2007 ) . An empirically supported intervention is one that has demonstrated efficacy in r and omized clinical trials or clinic-based effectiveness trials . An evidence -based intervention has empirical support in the manner just described , but also “ integrates research evidence , clinical expertise , and patient preferences and characteristics … empirically-supported treatments  ( ESTs )  are an important component of evidence -based practice ( EBP ) , but EBP can not be reduced to ESTs ” ( Spring , 2007 , p.611 ) . Applying these terms to the field of assessment and measure development efforts , an empirically supported assessment measure would be one that demonstrates satisfactory psychometric characteristics , broadly defined . To be evidence based , the measure should also demonstrate utility in clinical setting s , be useful in making diagnoses , be sensitive to treatment effects , and /or provide incremental validity above and beyond other similar measures . Although papers in the special issue of JPP frequently referred to “ evidence -based assessment ” ( Cohen et al. , 2009 ) , the articles included in the issue tended to evaluate the degree to which the measures were empirically-supported rather than evidence based . To be “ evidence -based , ” our review s would have needed to integrate an evaluation of clinical utility , diagnostic utility , and treatment sensitivity with the empirical psychometric data presented in each review . As noted , the published review s were more likely to focus on the latter rather than on the former . As suggested by Mash and Hunsley ( 2005 ) , detailed EBA profiles would provide a complete evaluation of evidence across each of several psychometric and clinical ly relevant dimensions , including : ( a ) internal consistency , ( b ) test – retest reliability , ( c ) the availability of normative data , ( d ) content validity , ( e ) construct validity , ( f ) convergent and discriminant validity , ( g ) criterion-related validity , ( h ) incremental validity , ( i ) clinical utility , ( j ) diagnostic utility , and ( k ) treatment sensitivity . The focus on incremental validity and clinical and diagnostic utility raises the bar from a focus on “ empirical support ” ( i.e. , where the focus would tend to be primarily on psychometric data ) to a broad focus on the “ evidence base ” for a measure . In developing the checklist that is the focus of this article , we attempted to provide a list of criteria relevant to establishing the evidence base ( and not just empirical support ) for a measure . In addition to shifting the focus from providing “ empirical support ” for a measure to providing an “ evidence base ” for our instruments , a checklist for measure development papers would permit JPP review ers to evaluate such papers in the same way that review ers of r and omized clinical trials make use of the Consoli date d St and ards of Reporting Trials ( CONSORT ) checklist and flowchart ( Altman et al. , 2001 ) . The CONSORT checklist contains reporting st and ards with respect to method ological features of and the manner in which results are reported in clinical trials . Moreover , authors are required to provide a flowchart that describes details of sample recruitment and attrition during the course of the study . Thus , a checklist for measure development papers would serve two interrelated purpose s : ( a ) it would provide guidance to authors as they embark on the measure development process and would provide a list of criteria authors can use as they develop an evidence base for their measures , and ( b ) it would begin to st and ardize the manner in which psychometric and other assessment -related data are presented in measure development papers for this journal . Before providing a more detailed overview of the checklist , it is important to note that this checklist is rather exhaustive ( see Appendix ) . As such , it represents what would “ ideally ” be expected for a measure development or validation manuscript rather than minimal criteria for such papers . No one paper can provide a complete evaluation of all important psychometric and clinical ly relevant dimensions that will establish once- and -for-all the evidence base for a measure . Instrument refinement is part of a measure development process that gradually builds an evidence base for a scale ( see Smith & McCarthy , 1995 , for suggestions on measure refinement ) . Indeed , the validation of any measure is a cumulative process that occurs across many different types of research studies and across research programs The number of reports of clinical trials grows by hundreds every week . However , this does not mean that people making decisions about healthcare are finding it easier to obtain reliable knowledge for these decisions . Some of the information is unreliable . Systematic review s are helping to resolve this by bringing together the research on a topic , appraising and summarising it . But the quality of these review s depends greatly on the quality of the studies , and this usually means the quality of their reports . If there are fundamental flaws within a study , such as the use of inappropriate ' r and omisation ' techniques in the context of review s of the effects of interventions , the review ers will not be able to fix these . Worse still , if they are not aware of underlying flaws , they might make incorrect judgements about the quality of the research in their review . A study by Wu and colleagues of ' r and omised trials ' from China provides a reminder of the cautious approach needed by users of scientific articles . They contacted the authors of more than 2000 research articles , which purported to be reports of r and omised trials ; and concluded that ten of every 11 studies cl aim ing to be a r and omised trial probably did not use r and om allocation . Better education of research ers , peer review ers and editors about what is , and is not , a properly r and omised trial is needed ; along with better reporting of the details for how participants were allocated to the different interventions . Systematic review ers must be cautious in making assumptions about the conduct of trials based on simple phrases about the trial methodology , rather than a full description of the methods actually used . It 's not that you ca n't believe anything that you read in the papers , just that you can not believe everything Abstract Background : In the 11 years since its development at McMaster University Medical School , the multiple mini-interview ( MMI ) has become a popular selection tool . We aim ed to systematic ally explore , analyze and synthesize the evidence regarding MMIs for selection to undergraduate health programs . Methods : The review protocol was peer- review ed and prospect ively registered with the Best Evidence Medical Education ( BEME ) collaboration . Thirteen data bases were search ed through 34 terms and their Boolean combinations . Seven key journals were h and - search ed since 2004 . The reference sections of all included studies were screened . Studies meeting the inclusion criteria were coded independently by two review ers using a modified BEME coding sheet . Extracted data were synthesized through narrative synthesis . Results : A total of 4338 citations were identified and screened , result ing in 41 papers that met inclusion criteria . Thirty-two studies report data for selection to medicine , six for dentistry , three for veterinary medicine , one for pharmacy , one for nursing , one for rehabilitation , and one for health science . Five studies investigated selection to more than one profession . MMIs used for selection to undergraduate health programs appear to have reasonable feasibility , acceptability , validity , and reliability . Reliability is optimized by including 7–12 stations , each with one examiner . The evidence is stronger for face validity , with more research needed to explore content validity and predictive validity . In published studies , MMIs do not appear biased against applicants on the basis of age , gender , or socio-economic status . However , applicants of certain ethnic and social background s did less well in a very small number of published studies . Performance on MMIs does not correlate strongly with other measures of noncognitive attributes , such as personality inventories and measures of emotional intelligence . Discussion : MMI does not automatically mean a more reliable selection process but it can do , if carefully design ed . Effective MMIs require careful identification of the noncognitive attributes sought by the program and institution . Attention needs to be given to the number of stations , the blueprint and examiner training . Conclusion : More work is required on MMIs as they may disadvantage groups of certain ethnic or social background s. There is a compelling argument for multi-institutional studies to investigate areas such as the relationship of MMI content to curriculum domains , graduate outcomes , and social missions ; relationships of applicants ’ performance on different MMIs ; bias in selecting applicants of minority groups ; and the long-term outcomes appropriate for studies of predictive validity Objectives The objective of this review was to assess the effectiveness of interventions that assist caregivers to provide support for people living with dementia in the community . Inclusion criteria Types of participants Adult caregivers who provide support for people with dementia living in the community ( non‐institutional care ) . Types of interventions Interventions design ed to support caregivers in their role such as skills training , education to assist in caring for a person living with dementia and support groups/programs . Interventions of formal approaches to care design ed to support caregivers in their role , care planning , case management and specially design ated members of the healthcare team ‐ for example dementia nurse specialist or volunteers trained in caring for someone with dementia . Types of studies This review considered any meta‐analyses , systematic review s , r and omised control trials , quasi‐experimental studies , cohort studies , case control studies and observational studies without control groups that addressed the effectiveness of interventions that assist caregivers to provide support for people living with dementia in the community . Search strategy The search sought to identify published studies from 2000 to 2005 through the use of electronic data bases . Only studies in English were considered for inclusion . The initial search was conducted of the data bases , CINAHL , MEDLINE and PsychINFO using search strategies adapted from the Cochrane Dementia and Cognitive Improvement Group . A second more extensive search was then conducted using the appropriate Medical Subject Headings ( MeSH ) and keywords for other available data bases . Finally , h and search ing of reference lists of articles retrieved and of core dementia , geriatric and psycho geriatric journals was undertaken . Assessment of quality Method ological quality of each of the articles was assessed by two independent review ers using appraisal checklist developed by the Joanna Briggs Institute and based on the work of the Cochrane Collaboration and Centre for Review s and Dissemination . Data collection and analysis St and ardised mean differences or weighted mean differences and their 95 % confidence intervals were calculated for each included study reported in the meta‐ analysis . Results from comparable groups of studies were pooled in statistical meta‐ analysis using Review Manager Software from the Cochrane Collaboration . Heterogeneity between combined studies was tested using st and ard chi‐square test . Where statistical pooling was not appropriate or possible , the findings are summarised in narrative form . Results A comprehensive search of relevant data bases , h and search ing and cross referencing found 685 articles that were assessed for relevance to the review . Eighty‐five papers appeared to meet the inclusion criteria based on title and abstract , and the full paper was retrieved . Of the 85 full papers review ed , 40 were accepted for inclusion , three were systematic review s , three were meta‐ analysis , and the remaining 34 were r and omised controlled trials . For the r and omised controlled trials that were able to be included in a meta‐ analysis , st and ardised mean differences or weighted mean differences and their 95 % confidence intervals were calculated for each . Results from comparable groups of studies were pooled in statistical meta‐ analysis using Review Manager Software and heterogeneity between combined studies was assessed by using the chi‐square test . Where statistical pooling was not appropriate or possible , the findings are summarised in narrative form . The results are discussed in two main sections . Firstly it was possible to assess the effectiveness of different types of caregiver interventions on the outcome categories of depression , health , subjective well‐being , self‐efficacy and burden . Secondly , results are reported by main outcome category . For each of these sections , meta‐ analysis was conducted where it was possible ; otherwise , a narrative summary describes the findings . Effectiveness of intervention type Four categories of intervention were included in the review ‐ psycho‐educational , support , multi‐component and other . Psycho‐educational Thirteen studies used  psycho‐educational interventions , and all but one showed positive results across a range of outcomes . Eight studies were entered in a meta‐ analysis . No significant impact of psycho‐educational interventions was found for the outcome categories of subjective well‐being , self‐efficacy or health . However , small but significant results were found for the categories of depression and burden . Support Seven studies discussed support only interventions and two of these showed significant results . These two studies were suitable for meta‐ analysis and demonstrated a small but significant improvement on caregiver burden . Multi‐component Twelve of the studies report multi‐component interventions and 10 of these report significant outcomes across a broad range of outcome measures including self‐efficacy , depression , subjective well‐being and burden . Unfortunately because of the heterogeneity of study design s and outcome measures , no meta‐ analysis was possible . Other interventions Other interventions included the use of exercise or nutrition which result ed in improvements in psychological distress and health benefits .  Case management and a computer aided support intervention provided mixed results . One cognitive behavioural therapy study reported a reduction in anxiety and positive impacts on patient behaviour . Effectiveness of interventions using specific outcome categories In addition to analysis by type of intervention it was possible to analyse results based on some outcome categories that were used across the studies . In particular the impact of interventions on  caregiver depression was available for meta‐ analysis from eight studies . This indicated that multi‐component and psycho‐educational interventions showed a small but significant positive effect on caregiver depression . Five studies using the outcome category of caregiver burden  were entered into a meta‐ analysis and findings indicated that there were no significant effects of any of interventions . No meta‐ analysis was possible for the outcome categories of health , self‐efficacy or subjective well‐being . Implication s for practice From this review there is evidence to support the use of well‐ design ed psycho‐educational or multi‐component interventions for caregivers of people with dementia who live in the community . Factors that appear to positively contribute to effective interventions are those which : Provide opportunities within the intervention for the person with dementia as well as the caregiver to be involved Encourage active participation in educational interventions for caregivers Offer individualised programs rather than group sessions Provide information on an ongoing basis , with specific information about services and coaching regarding their new role Target the care recipient particularly by reduction in behaviours Factors which do not appear to have benefit in interventions are those which : Simply refer caregivers to support groups Only provide self help material s Only offer peer Introduction Delirium is a common , serious and potentially preventable condition with devastating impact on the quality of life prompting a proliferation of interventional trials . Core outcome sets aim to st and ardise outcome reporting by identifying outcomes perceived fundamental for measurement in trials of a specific interest area . Our aim is to develop international consensus on two core outcome sets for trials of interventions to prevent and /or treat delirium , irrespective of study population . We aim to identify additional core outcomes specific to the critically ill , acutely hospitalised patients , palliative care and older adults . Methods and analysis We will conduct a systematic review of published and ongoing delirium trials ( 1980 onwards ) and  one-on-one interviews of patients who have experienced delirium and family members . These data will inform Delphi round 1 of a two-stage consensus process . In round 2 , we will provide participants their own response , summarised group responses and those of patient/family participants for rescoring . We will r and omise participants to receive feedback as proportion scoring the outcome as critical or as group mean responses . We will hold a consensus meeting using nominal group technique to finalise outcomes for inclusion . We will repeat the Delphi process and consensus meeting to select measures for each core outcome . We will recruit 240 Delphi participants giving us 80 % power to detect a 1.0–1.5 point ( 9-point scale ) difference by feedback method between rounds . We will analyse differences for subsequent scores , magnitude of opinion change , items retained and level of agreement . Ethics and dissemination We are obtaining research ethics approvals according to local governance . Participation will be voluntary and data deidentified . Support from three international delirium organisations will be instrumental in dissemination and core outcome set uptake . We will disseminate through peer- review ed open access publications and present at conferences selected to reach a wide range of knowledge users Introduction Delay to presentation with symptoms of acute coronary syndrome ( ACS ) is common meaning many fail to achieve optimal benefit from treatments . Interventions have had variable success in reducing delay . Evidence suggests inclusion of behaviour change techniques ( BCTs ) may improve effectiveness of interventions but this has not yet been systematic ally evaluated . Data from other time-critical conditions may be relevant . Methods and analysis A systematic review will be undertaken to identify which BCTs are associated with effective interventions to reduce patient delay ( or prompt rapid help-seeking ) among people with time-critical conditions ( eg , chest pain , ACS , lumps , stroke , cancer and meningitis ) . A systematic search of a wide range of data bases ( including Cochrane Library , MEDLINE , EMBASE , CINAHL , PsycInfo ) and grey literature will be undertaken to identify all relevant intervention studies ( r and omised controlled trials , controlled clinical trials and cohort studies ) . Two independent review ers will screen abstract s to identify relevant studies , apply inclusion criteria to full papers , assess method ological quality and extract data . Primary outcome measure Change in patient decision time BCTs reported in each of the included studies will be categorised and presented according to the latest reliable taxonomy . Results of included studies will be synthesis ed , exploring relationships between inclusion of each BCT and effectiveness of the overall intervention . Where possible , means and SDs for differences in delay time will be calculated and combined within meta-analyses to derive a st and ardised mean difference and 95 % CI . Analysis of ( 1 ) all time-critical and ( 2 ) ACS-only interventions will be undertaken . Ethics and dissemination No ethical issues are anticipated . Results will be su bmi tted for publication in a relevant peer- review ed journal INTRODUCTION A body of basic science and clinical research has been generated on the manual muscle test ( MMT ) since its first peer- review ed publication in 1915 . The aim of this report is to provide an historical overview , literature review , description , synthesis and critique of the reliability and validity of MMT in the evaluation of the musculoskeletal and nervous systems . METHODS Online re sources were search ed including Pubmed and CINAHL ( each from inception to June 2006 ) . The search terms manual muscle testing or manual muscle test were used . Relevant peer- review ed studies , commentaries , and review s were selected . The two review ers assessed data quality independently , with selection st and ards based on predefined method ologic criteria . Studies of MMT were categorized by research content type : inter- and intraexaminer reliability studies , and construct , content , concurrent and predictive validity studies . Each study was review ed in terms of its quality and contribution to knowledge regarding MMT , and its findings presented . RESULTS More than 100 studies related to MMT and the applied kinesiology chiropractic technique ( AK ) that employs  MMT  in its methodology were review ed , including studies on the clinical efficacy of MMT  in the diagnosis of patients with symptomatology . With regard to analysis there is evidence for good reliability and validity in the use of MMT for patients with neuromusculoskeletal dysfunction . The observational cohort studies demonstrated good external and internal validity , and the 12 r and omized controlled trials ( RCTs ) that were review ed show that MMT findings were not dependent upon examiner bias . CONCLUSION The MMT employed by chiropractors , physical therapists , and neurologists was shown to be a clinical ly useful tool , but its ultimate scientific validation and application requires testing that employs sophisticated research models in the areas of neurophysiology , biomechanics , RCTs , and statistical analysis Background No appropriate measures have been specifically developed for pelvic girdle pain ( PGP ) . There is a need for suitable outcome measures that are reliable and valid for people with PGP for use in research and clinical practice . Objective The objective of this study was to develop a condition-specific measure , the Pelvic Girdle Question naire ( PGQ ) , for use during pregnancy and postpartum . Design This was a methodology study . Methods Items were developed from a literature review and information from a focus group of people who consulted physical therapists for PGP .  Face validity and content validity were assessed by classifying the items according to the World Health Organization 's International Classification of Functioning , Disability and Health . After a pilot study , the PGQ was administered to participants with clinical ly verified PGP by means of a postal question naire in 2 surveys . The first survey included 94 participants ( 52 pregnant ) , and the second survey included 87 participants ( 43 pregnant ) . Rasch analysis was used for item reduction , and the PGQ was assessed for unidimensionality , item fit , redundancy , and differential item functioning . Test-retest reliability was assessed with a r and om sample of 42 participants . Results The analysis result ed in a question naire consisting of 20 activity items and 5 symptom items on a 4-point response scale . The items in both subscales showed a good fit to the Rasch model , with acceptable internal consistency , satisfactory fit residuals , and no disordered threshold . Test-retest reliability showed high intraclass correlation coefficient estimates : .93 ( 95 % confidence interval=0.86–0.96 ) for the PGQ activity subscale and .91 ( 95 % confidence interval=0.84–0.95 ) for the PGQ symptom subscale . Limitations The PGQ should be compared with low back pain question naires as part of a concurrent evaluation of measurement properties , including validity and responsiveness to change . Conclusions The PGQ is the first condition-specific measure developed for people with PGP . The PGQ had acceptably high reliability and validity in people with PGP both during pregnancy and postpartum , it is simple to administer , and it is feasible for use in clinical practice Executive summary Background Older adults with dementia may have feeding difficulties for several reasons : they may experience deterioration in motor and cognitive skills making eating difficult , they may forget to eat , fail to recognise food or they may suffer from dysphagia . Food intake is often poor and malnutrition is common , leading to adverse health outcomes . This review specifically focussed on how best to promote and achieve ‘ normal ’ eating and feeding in older adults with dementia , in order that undernutrition and its consequences could be avoided . Review Objectives The aim was to identify and assess the effectiveness of interventions that encouraged eating and minimised risk of undernutrition in older adults with dementia . Types of Participants Adults over the age of sixty with dementia in any care setting ( who were not living independently ) . People receiving enteral tube feeding were excluded . Types of Interventions Any intervention that promoted dietary intake e.g. changes in practice of health care workers , family or volunteers , educational interventions , changes in food service . Types of Outcomes The primary outcomes were improvement in dietary intake and /or nutritional status . Measurements included : dietary intake , anthropometry , clinical outcomes , functional indicators . Types of Studies R and omised controlled trials , controlled trials and quasi‐experimental studies with a ‘ before and after ’ design . Search Strategy The search strategy aim ed to find both published and unpublished studies using a three‐step approach . Papers were limited to the English language and a date restriction of 1999 to 2009 was set . Critical appraisal Papers selected for retrieval were assessed by two independent review ers for method ological validity prior to inclusion in the review . Disagreements that arose between the review ers were resolved through discussion . Data Extraction For quantitative studies , data was extracted using a data extraction form developed to include specific details about the interventions , population s , study methods and outcomes of significance to the review question and specific objectives . This was based on the JBI data extraction tool from MAStARI and 2 review ers extracted data independently . Data synthesis Heterogeneity in study design s , interventions and outcomes meant meta‐ analysis was not possible . Findings were discussed in a narrative summary . Results The review included 11 studies . This included one RCT , 1 r and omised crossover study , 3 controlled non‐r and omised trials , 6 quasi‐experimental studies . None of the studies provided robust evidence , however there was moderate evidence ( Level 3 ) to support a Grade B recommendation for improvements in dietary intake and /or nutritional status with the following interventions : education of healthcare staff , simple environmental manipulations such as the use of high contrast tableware or small dining rooms , the introduction of something of interest such as an aquarium or background music , or the provision of feeding assistance , provision of enhanced menus , use of a de central ised food service , enhanced nutritional screening combined with increased dietetic time .  Conclusion There is moderate ( Level 3 ) evidence to support each of the interventions appraised in this review . Implication s for Practice There is moderate support that warrants consideration of the interventions listed above . Careful monitoring of weight of individual residents would help to determine the effectiveness of any such change in delivery of care . Implication s for Research Future research into interventions to improve eating and minimise undernutrition in older people with dementia should feature the following : inclusion of reliable outcome measures , full details of interventions , r and omisation of participants , inclusion of control groups , adequate sample sizes , longitudinal follow up , consideration of baseline demographics of intervention groups , and experimental design that allows the determination of the effectiveness of individual definable changes in delivery of care OBJECTIVE To assess the reliability , validity and sensitivity to change of the Derriford Scale , a quality of life instrument design ed to assess the distress and dysfunction experienced by people who are self-conscious about their physical appearance . SUBJECTS AND DESIGN Postal question naire survey of 656 cosmetic surgery patients recruited from new referral letters and plastic surgery waiting list reports . A total of 443 subjects completed and returned the question naire .  Of these respondents , 203 were sent a second question  naire to assess reproducibility , of whom 155 subjects responded . MAIN OUTCOME MEASURES Reliability was assessed in terms of internal consistency and reproducibility . Face , content and construct validity were also investigated . RESULTS The analyses led to mixed results . There was some evidence of internal consistency , but a number of items had low endorsement levels and there may be scope for reducing the overall size of the instrument . When assessed for reproducibility , the level of agreement between scores of individuals completing the question naire on two occasions was high , but an important systematic shift in responses was also detected . Correlations between the other health status measures and the Derriford Scale provided some evidence of construct validity . CONCLUSION In its present form the Derriford Scale has good descriptive value , but there are some measurement problems identified in this report that need to be addressed before the scale is taken up into general use OBJECTIVES The objective of this review was to assess the effectiveness of interventions that assist caregivers to provide support for people living with dementia in the community . INCLUSION CRITERIA Types of participants Adult caregivers who provide support for people with dementia living in the community ( non-institutional care).Types of interventions Interventions design ed to support caregivers in their role such as skills training , education to assist in caring for a person living with dementia and support groups/programs . Interventions of formal approaches to care design ed to support caregivers in their role , care planning , case management and specially design ated members of the healthcare team - for example dementia nurse specialist or volunteers trained in caring for someone with dementia . Types of studies This review considered any meta-analyses , systematic review s , r and omised control trials , quasi-experimental studies , cohort studies , case control studies and observational studies without control groups that addressed the effectiveness of interventions that assist caregivers to provide support for people living with dementia in the community . SEARCH STRATEGY The search sought to identify published studies from 2000 to 2005 through the use of electronic data bases . Only studies in English were considered for inclusion . The initial search was conducted of the data bases , CINAHL , MEDLINE and PsychINFO using search strategies adapted from the Cochrane Dementia and Cognitive Improvement Group . A second more extensive search was then conducted using the appropriate Medical Subject Headings ( MeSH ) and keywords for other available data bases . Finally , h and search ing of reference lists of articles retrieved and of core dementia , geriatric and psycho geriatric journals was undertaken . ASSESSMENT OF QUALITY Method ological quality of each of the articles was assessed by two independent review ers using appraisal checklist developed by the Joanna Briggs Institute and based on the work of the Cochrane Collaboration and Centre for Review s and Dissemination . DATA COLLECTION AND ANALYSIS St and ardised mean differences or weighted mean differences and their 95 % confidence intervals were calculated for each included study reported in the meta- analysis . Results from comparable groups of studies were pooled in statistical meta- analysis using Review Manager Software from the Cochrane Collaboration . Heterogeneity between combined studies was tested using st and ard chi-square test . Where statistical pooling was not appropriate or possible , the findings are summarised in narrative form . RESULTS A comprehensive search of relevant data bases , h and search ing and cross referencing found 685 articles that were assessed for relevance to the review . Eighty-five papers appeared to meet the inclusion criteria based on title and abstract , and the full paper was retrieved . Of the 85 full papers review ed , 40 were accepted for inclusion , three were systematic review s , three were meta- analysis , and the remaining 34 were r and omised controlled trials . For the r and omised controlled trials that were able to be included in a meta- analysis , st and ardised mean differences or weighted mean differences and their 95 % confidence intervals were calculated for each . Results from comparable groups of studies were pooled in statistical meta- analysis using Review Manager Software and heterogeneity between combined studies was assessed by using the chi-square test . Where statistical pooling was not appropriate or possible , the findings are summarised in narrative form . The results are discussed in two main sections . Firstly it was possible to assess the effectiveness of different types of caregiver interventions on the outcome categories of depression , health , subjective well-being , self-efficacy and burden . Secondly , results are reported by main outcome category . For each of these sections , meta- analysis was conducted where it was possible ; otherwise , a narrative summary describes the findings . EFFECTIVENESS OF INTERVENTION TYPE Four categories of intervention were included in the review - psycho-educational , support , multi-component and other . Psycho-educational Thirteen studies used  psycho-educational interventions  , and all but one showed positive results across a range of outcomes . Eight studies were entered in a meta- analysis . No significant impact of psycho-educational interventions was found for the outcome categories of subjective well-being , self-efficacy or health . However , small but significant results were found for the categories of depression and burden . Support Seven studies discussed support only interventions and two of these showed significant results . These two studies were suitable for meta- analysis and demonstrated a small but significant improvement on caregiver burden . Multi-component Twelve of the studies report multi-component interventions and 10 of these report significant outcomes across a broad range of outcome measures including self-efficacy , depression , subjective well-being and burden . Unfortunately because of the heterogeneity of study design s and outcome measures , no meta- analysis was possible . Other interventions Other interventions included the use of exercise or nutrition which result ed in improvements in psychological distress and health benefits . Case management and a computer aided support intervention provided mixed results . One cognitive behavioural therapy study reported a reduction in anxiety and positive impacts on patient behaviour . EFFECTIVENESS OF INTERVENTIONS USING SPECIFIC OUTCOME CATEGORIES In addition to analysis by type of intervention it was possible to analyse results based on some outcome categories that were used across the studies . In particular the impact of interventions on caregiver depression was available for meta- analysis from eight studies . This indicated that multi-component and psycho-educational interventions showed a small but significant positive effect on caregiver depression . Five studies using the outcome category of caregiver burden  were entered into a meta- analysis and findings indicated that there were no significant effects of any of interventions . No meta- analysis was possible for the outcome categories of health , self-efficacy or subjective well-being . IMPLICATION S FOR PRACTICE From this review there is evidence to support the use of well- design ed psycho-educational or multi-component interventions for caregivers of people with dementia who live in the community . Factors that appear to positively contribute to effective interventions are those which : Factors which do not appear to have benefit in interventions are those which This article aims to give guidance on the conduct and reporting of case series and audits of acupuncture , based on common problems that have arisen in the past . This type of project , and particularly the prospect i ve case series or pre- post-intervention study , may give valuable evidence of the overall effectiveness of acupuncture for example in different situations and in different conditions and provides one step in the research pathway before generating an hypothesis . The project should be design ed with the aim of reducing bias as much as possible . Careful and detailed planning is essential for the project to produce worthwhile results that readers can evaluate and replicate . Ethical issues should be considered and formal approval may be necessary . The patient group should be recruited systematic ally and baseline data obtained . The treatment given should be systematic and decisions to change or end treatment made explicit . The outcome should be measured in ways that are known to be reliable and valid . Musculoskeletal problems can be evaluated with scales for pain and confirmed by measuring one other symptom such as stiffness or one other aspect such as bothersomeness . Global change scores also provide supporting information , and the MYMOP ( Measure Yourself Medical Outcome Profile ) measure is popular when patients with different conditions are included . The design of question naires for beliefs and attitudes is a specialised area that should not be attempted without expert help . Adverse events should also be recorded . Analysis of the data and the best way of summarising and presenting the results are also discussed BACKGROUND The quality of clinical trials has received increasing attention with the growth of evidence -based medicine and systematic review s. We aim ed to identify whether errors and omissions commonly encountered when undertaking Cochrane review s in this field are still passing peer review . METHODS We undertook a review of trials published in 2001 by two major journals . We selected from Medline only trials in which authors compared pregnancy rates under two interventions by allocating women to different groups . RESULTS We identified 39 trials meeting our criteria . Six trials were fatally flawed by design , either by inappropriate use of a cross-over design or by systematic allocation described by the authors as ' r and om ' . Only six reports cl aim ed to apply the intention-to-treat principle , and the principle was misunderstood by four of these . Only five trials reported live birth rates sufficiently to allow valid meta- analysis . Most trials ( 82 % ) included at least one ' unit of analysis ' error . CONCLUSIONS We selected simple trials from respected journals , assuming that our sample would represent trials of highest method ological quality in the field . Nevertheless , the st and ards of design , analysis and reporting of many subfertility trials are not sufficient to allow reliable interpretation of results , or inclusion in meta-analyses AIM This paper is a report of a study to test the effect of participating in a reflecting peer-support group on self-reported health , burnout and on perceived changes in work conditions . BACKGROUND Stress-related conditions are one of the most common causes for long-term sick-leave . There is limited evidence for the effectiveness of person-directed interventions aim ed at reducing stress levels in healthcare workers . Prior research in the relationship between support and burnout show somewhat inconsistent results . METHOD A r and omized controlled trial with peer-support groups as the intervention was conducted with 660 healthcare workers scoring above the 75th percentile on the exhaustion dimension of the Oldenburg Burnout Inventory . One hundred and fifty-one ( 22.9 % ) agreed to participate . The intervention started in 2002 with 51 participants ( 96.1 % were women ) , 80 of whom constituted the control group .  Potential differences in outcome measures 12 months after the intervention were compared using ancova , and data collected was completed in 2004 . Qualitative content analyses were used to analyse reported experiences from group participation . RESULTS Statistically significant intervention effects were found for general health , perceived quantitative dem and s at work , participation and development opportunities at work and in support at work . Seven categories of experiences from participating were identified : talking to others in a similar situation , knowledge , sense of belonging , self-confidence , structure , relief of symptoms and behavioural change . CONCLUSION Peer-support groups using a problem-based method could be a useful and comparatively inexpensive tool in alleviating work-related stress and burnout Background Computerised clinical decision support ( CDS ) can potentially better inform decisions , and it can help with the management of information overload . It is perceived to be a key component of a learning health care system . Despite its increasing implementation worldwide , it remains uncertain why the effect of CDS varies and which factors make CDS more effective . Objective To examine which factors make CDS strategies more effective on a number of outcomes , including adherence to recommended practice , patient outcome measures , economic measures , provider or patient satisfaction , and medical decision quality . Methods We identified r and omised controlled trials , non-r and omised trials , and controlled before- and -after studies that directly compared CDS implementation with a given factor to CDS without that factor by search ing CENTRAL , MEDLINE , EMBASE , and CINAHL and checking reference lists of relevant studies . We considered CDS with any objective for any condition in any healthcare setting . We included CDS interventions that were either displayed on screen or provided on paper and that were directed at healthcare professionals or targeted at both professionals and patients . The review ers screened the potentially relevant studies in duplicate . They extracted data and assessed risk of bias in independent pairs or individually followed by a double check by another review er . We summarised results using medians and interquartile ranges and rated our certainty in the evidence using the GRADE system . Results We identified 66 head-to-head trials that we synthesis ed across 14 comparisons of CDS intervention factors . Providing CDS automatically versus on dem and led to large improvements in adherence . Displaying CDS on-screen versus on paper led to moderate improvements and making CDS more versus less patient-specific improved adherence modestly . When CDS interventions were combined with professional-oriented strategies , combined with patient-oriented strategies , or combined with staff-oriented strategies , then adherence improved slightly . Providing CDS to patients slightly increased adherence versus CDS aim ed at the healthcare provider only . Making CDS advice more explicit and requiring users to respond to the advice made little or no difference . The CDS intervention factors made little or no difference to patient outcomes . The results for economic outcomes and satisfaction outcomes were sparse . Conclusion Multiple factors may affect the success of CDS interventions . CDS may be more effective when the advice is provided automatically and displayed on-screen and when the suggestions are more patient-specific . CDS interventions combined with other strategies probably also improves adherence . Providing CDS directly to patients may also positively affect adherence . The certainty of the evidence was low to moderate for all factors . Trial registration PROSPERO , Quality of care can be measured by using either processes or outcomes . Each method has its strengths and limitations ( 1 ) . With the concurrence of the Assessing Care of Vulnerable Elders ( ACOVE ) Policy Advisory Committee [ 2 ] , we chose to assess the care of vulnerable elders by using processes rather than outcomes . We did so because 1 ) processes are a more efficient measure of quality ; 2 ) for most conditions there are insufficient information in the medical record and a paucity of vali date d models to adequately adjust outcomes for differences in case mix between providers ; and 3 ) ultimately , processes of care are amenable to direct action by providers . To be a valid measure of quality , a health care process must be strongly linked to an outcome that is important to patients . Ideally , high- quality published studies would link performance of all such processes to outcomes ; however , few health care processes are supported by high- quality evidence ( 3 ) . Even when a process is supported by strong evidence from r and omized clinical trials , the inclusion and exclusion criteria of the clinical trials leave the evidence directly applicable to only a narrow group of patients ( 4 , 5 ) . This is particularly true for vulnerable elders , who are typically excluded from clinical trials ( 6 ) . Therefore , as we developed the ACOVE quality indicators , we used expert opinion to interpret the available evidence for applicability to vulnerable elders . Our methods entailed a literature review and several levels of expert opinion ( Figure ) , which we explain in detail . Figure . Assessing  Care of Vulnerable Elders ( ACOVE ) method for developing quality indicators for vulnerable elders . Methods Development of Draft Process Indicators  For each ACOVE condition that we selected for quality improvement in vulnerable elders ( 2 ) , we identified a content expert , who worked as a team with another project member knowledgeable about systematic review s and quality indicator development . Together , the content expert and project member developed potential quality indicators from existing guidelines , review criteria , and expert opinion . Because practice guidelines and existing quality indicators are seldom referenced in the traditional scientific data bases , we used various search strategies to locate these material s. In addition to search ing MEDLINE , we search ed the following sources : CONQUEST 1.1 ( A Computerized Needs-Oriented Quality Measurement Evaluation System ) ( 7 ) ; DEMPAQ : A Project to Develop and Evaluate Methods to Promote Ambulatory Care Quality ( 8) ; Directory of Clinical Practice Guidelines ( 9 ) ; Guide to Clinical Preventive Services ( 10 ) ; HEDIS 3.0 : Health Plan Employer Data and Information Set ( 11 ) ; National Guideline Clearinghouse ( 12 ) ; National Library of Health Care Indicators ( 13 ) ; and The Medical Outcomes & Guidelines Source book ( 14 ) . We also h and search ed the tables of contents of all issues of The Journal of the American Medical Association and Medical Care published April through November 1998 for relevant practice guidelines and quality indicators . Furthermore , we requested practice guidelines and quality indicators from the following agencies and organizations : Administration on Aging ( AOA ) ; Agency for Health Care Policy and Research (AHCPR)now known as Agency for Healthcare Research and Quality ( AHRQ ) ; Centers for Disease Control and Prevention ( CDC ) ; Department of Health and Human Services ( DHHS ) ; Department of Veterans Affairs ; Foundation for Accountability ( FACCT ) ; Health Care Financing Administration ( HCFA ) ; HCFA/Connecticut Peer Review Organization ; Joint Commission on Accreditation of Healthcare Organizations ( JCAHO ) ; National Committee for Quality Assurance ( NCQA ) ; and National Institutes of Health ( NIH ) . By using the quality indicators identified through this process , as well as using expert opinion and existing guidelines , the content expert developed 20 to 30 preliminary quality indicators for further review . Potential indicators were constructed in an IFTHENBECAUSE format : IF refers to the clinical characteristics that describe persons eligible for the quality indicator ; THEN indicates the actual process that should or should not be performed ; and BECAUSE refers to the expected health impact if the indicator is performed . For example , IF a vulnerable elder has heart failure with an ejection fraction of 40 % or less , THEN an angiotensin-converting enzyme ( ACE ) inhibitor should be offered BECAUSE treatment with ACE inhibitors improves longevity . We circulated this initial set of potential quality indicators to other clinical experts for their review . On the basis of review ers ' comments , we narrowed down the initial set to the 10 to 25 most promising indicators for future development . Review of Scientific Literature Next , we assessed the published evidence supporting a link between the process specified in each quality indicator and patient outcomes . To do so , we performed a systematic review on each quality indicator by using the essence of the Cochrane Collaboration 's methods (15)except that we used a single review er to screen and assess studies . With the assistance of a reference librarian , we electronically search ed MEDLINE , EMBASE , The Cochrane Data base of Systematic Review s , HealthSTAR , Ageline , and other specialized data bases on a condition-specific basis by using keywords and free-text terms to identify potentially relevant studies . For most conditions , the search es were not restricted by language . The content expert review ed the retrieved citations by using a three-step process : First , the titles were review ed for possibly relevant studies ; the abstract s associated with the titles that passed the first round of screening were then review ed ; and , finally , the full articles of abstract s that passed the second round of screening were review ed . Abstract s and articles were not masked for review . To be accepted , titles and abstract s had to contain information indicating that the full article probably reported evidence on the potential relationship between the process in question and better outcomes in humans . We excluded animal studies , letters , review articles , and other articles that did not report original data . In review ing full articles , we gave priority to evidence from studies with the strongest design s that were relevant to the potential quality indicator being examined . In general , this meant that we chose r and omized clinical trials for questions about the efficacy or effectiveness of interventions and prospect i ve cohort studies to answer questions about risk or prognosis . We considered such evidence to be direct evidence , and we judged direct evidence in elderly persons to be the strongest level of evidence available . In the absence of direct evidence in elderly persons , we performed search es for direct evidence in other groups . Indirect evidence that from less rigorous design sin elderly or nonelderly persons was review ed if the available direct evidence was insufficient . When both direct evidence and indirect evidence were lacking , we included the statements of authoritative bodies ( for example , specialty societies , National Institutes of Health consensus development conferences , or Agency for Health Care Policy and Research practice guidelines ) . After review ing all of the relevant articles , the content expert prepared a monograph detailing each of the quality indicators and summaries of the evidence supporting them . This monograph was sent to one or more peer review ers , who were asked to assess the quality of the monograph according to the following guidelines : 1 ) Is the review complete in terms of both the proposed quality criteria and the evidence ? 2 ) Is the review fair ( that is , is the presentation of the evidence unbiased ) ? The authors subsequently revised the monographs on the basis of review ers ' comments in a manner analogous to the response to a critique of a journal article : Each comment was addressed in turn , and the author provided an appropriate revision or stated the reason why he or she believed that no revision was indicated . Expert Panels We convened two multidisciplinary groups , each composed of 12 clinical experts , to interpret the supporting evidence detailed in the monographs and to select quality indicators for further consideration . Each panel of experts considered a separate set of ACOVE conditions . Table 1 lists the members of the panels and the conditions they considered . Table 1 . ACOVE Expert Panels To assess the expert opinions of the panelists , we used a modified version of the R AND /UCLA Appropriateness Method ( 16 , 17 ) . In brief , the method entails two rounds of anonymous ratings on a riskbenefit scale ranging from 1 to 9 and a face-to-face group discussion between rounds . Each panelist has equal weight in determining the final ratings . The reproducibility of the R AND /UCLA Appropriateness Method is consistent with that of well-accepted diagnostic tests , such as the interpretation of coronary angiography and screening mammography ( 18 ) . It also has content , construct , and predictive validity ( 5 , 17 , 19 , 20 ) . In this application of the method , we sent each panelist the proposed quality indicators and the relevant condition-specific monographs . We asked the panelists to assess the validity of each proposed indicator on a scale of 1 to 9 , in which 1 was definitely not valid and 9 was definitely valid . We considered an indicator to be valid if 1 ) adequate scientific evidence or professional consensus supported a link between the process specified by the indicator and a health benefit to the patient ; 2 ) a physician or health plan with high rates of adherence to the indicator would be considered a higher- quality provider ; and 3 ) the physician or health plan influenced a majority of factors that determine adherence to the indicator ( such as smoking cessation ) . Each panelist was instructed to rate each potential quality indicator for validity and return the ratings to us before the face-to-face This article provides a critical review of the assumptions and findings of studies used to establish  psychotherapies  as empirically supported . The attempt to identify empirically supported therapies ( ESTs ) imposes particular assumptions on the use of r and omized controlled trial ( RCT ) methodology that appear to be valid for some disorders and treatments ( notably exposure-based treatments of specific anxiety symptoms ) but substantially violated for others . Meta-analytic studies support a more nuanced view of treatment efficacy than implied by a dichotomous judgment of supported versus unsupported . The authors recommend changes in reporting practice s to maximize the clinical utility of RCTs , describe alternative method ologies that may be useful when the assumptions underlying EST methodology are violated , and suggest a shift from validating treatment packages to testing intervention strategies and theories of change that clinicians can integrate into empirically informed therapies General practice p 994 Older people frequently fall . This is a serious public health problem , with a substantial impact on health and healthcare costs.1 These guidelines translate trial evidence about prevention of falls into recommendations that can be implemented in different setting s , with the aim of reducing the rate of falls and injurious falls in people over 65 ( see boxes 2 3 ) . # # # # Summary points Multifaceted interventions reduce falls in older people ( those over 65 ) Home assessment of older people at risk of falls without referral or direct intervention is not recommended Assessment of high risk residents in nursing homes with relevant referral is effective Evidence from well design ed single trials shows that assessment and modification of risk factors of older people who have presented to an accident and emergency department after a fall and the provision of hip protectors in residents of nursing homes are effective We up date d two previous systematic review s to include any new evidence up to March 1998 . 4 5 We electronically search ed Medline for all r and omised controlled trials and systematic review s by using the terms fall(s ) , accidental falls , fracture , elderly , aged , older , and senior . We followed up relevant references in papers , and we contacted research ers in prevention of falls for information about other trial evidence and about studies from journals not catalogued by the National Library of Medicine . For inclusion , studies had to be r and omised controlled trials of interventions design ed to minimise or prevent exposure to the risk factors for falling ( or fracture ) in people aged 65 years or over living in either community or residential care . Outcomes had to include the number of people who had fallen or the number of falls or fractures . We excluded drug or dietary treatments for the prevention of fractures . Trials that fulfilled the inclusion criteria were review ed and summarised Aim : This systematic review aim ed to establish if cognitive behavioural therapy ( CBT ) can reduce the physical symptoms of chronic headache and migraines in adults . Methods : Evidence from search es of eight data bases was systematic ally sought , appraised and synthesis ed . Screening of title and abstract s was conducted independently by two review ers . Full papers were screened , data extracted and quality assessed by one review er and checked by a second . Data were synthesis ed narratively by intervention due to the heterogeneity of the studies . The inclusion criteria specified r and omised controlled trials with CBT as an intervention in adults suffering from chronic headaches/migraines not associated with an underlying pathology/medication overuse .  CBT was judged on the basis of authors describing the intervention as CBT . The diagnosis of the condition had to be clinician verified . Studies had to include a comparator and employ headache/migraine-specific outcomes such as patient-reported headache days . Results : Out of 1126 screened titles and abstract s and 20 assessed full papers , 10 studies met the inclusion criteria of the review . Some studies combined CBT with another intervention , as well as employing varying numbers of comparators . CBT was statistically significantly more effective in improving some headaches-related outcomes in CBT comparisons with waiting lists ( three studies ) , in combination with relaxation compared with relaxation only ( three studies ) or antidepressant medication ( one study ) , with no statistically significant differences in three studies . Conclusions : The findings of this review were mixed , with some studies providing evidence in support of the suggestion that people experiencing headaches or migraines can benefit from CBT , and that CBT can reduce the physical symptoms of headache and migraines . However , methodology inadequacies in the evidence base make it difficult to draw any meaningful conclusions or to make any recommendations The aim of this study is to review recent data on dietary fiber ( DF ) and the glycemic index ( GI ) , with special focus on studies from the Nordic countries regarding cardiometabolic risk factors , type 2 diabetes , cardiovascular disease , cancer , and total mortality . In this study , recent guidelines and scientific background papers or up date s on older reports on DF and GI published between 2000 and 2011 from the US , EU , WHO , and the World Cancer Research Fund were review ed , as well as prospect i ve cohort and intervention studies carried out in the Nordic countries . All of the reports support the role for fiber-rich foods and DF as an important part of a healthy diet . All of the five identified Nordic papers found protective associations between high intake of DF and health outcomes ; lower risk of cardiovascular disease , type 2 diabetes , colorectal and breast cancer . None of the reports and few of the Nordic papers found clear evidence for the GI in prevention of risk factors or diseases in healthy population s , although association was found in sub-groups , e.g. overweight and obese individuals and suggestive for prevention of type 2 diabetes . It was concluded that DF is associated with decreased risk of different chronic diseases and metabolic conditions . There is not enough evidence that choosing foods with low GI will decrease the risk of chronic diseases in the population overall . However , there is suggestive evidence that ranking food based on their GI might be of use for overweight and obese individuals . Issues regarding methodology , validity and practicality of the GI remain to be clarified For physicians , pharmacists , pharmacologists , and others , the medical literature is a key source of information about prescription drugs [ 1 , 2 ] . The medical literature on drugs includes articles from peer- review ed journals , non-peer- review ed ( controlled circulation or throwaway ) journals , and the published proceedings of symposia [ 3 , 4 ] . Symposia are a rapidly growing and potentially major means of disseminating information about drugs . In the clinical journals with the highest circulation rates , the number of symposia published increased from 83 during 1972 - 1977 to 307 during 1984 - 1989 . Approximately half of these symposia were on pharmaceutical topics [ 4 ] . Symposia can be valuable sources of information about drugs , but evidence suggests that they can also be used to market drugs and other interventions , especially if they are industry sponsored . Approximately 70 % of symposia on pharmaceutical topics are sponsored by drug companies [ 3 , 4 ] . Among symposia , sponsorship by a single drug company is associated with promotional characteristics that include a focus on a single drug , misleading titles , use of br and names , and lack of peer review [ 4 ] . Other studies indicate that clinical trials , including those published in symposia , are more likely to favor a new drug therapy if they are funded by the pharmaceutical industry than if they are not [ 5 , 6 ] . Although physicians often report that the peer- review ed literature is one of their main sources of drug information , industry sources of information can sometimes have a stronger influence on prescribing behavior [ 2 ] . Thus , if symposia sponsored by drug companies are a growing source of information about drugs for pharmacists and physicians , assessing the quality of the articles in these symposia is important . We compared the method ologic quality and relevance of drug studies published in symposia sponsored by single drug companies with those of studies that were published in symposia that had other sponsors or in the peer- review ed parent journals . We also assessed whether a methods section was present , because such a section is necessary for evaluating quality . Finally , we tested whether drug industry support of research was associated with study outcome . Methods A symposium is a collection of papers published as a separate issue or as a special section in a regular issue of a medical journal [ 4 ] . We defined original clinical drug articles as articles that 1 ) appeared to present original data from studies done in humans [ that is , articles that had at least one table or figure that was not acknowledged to have been reprinted from another source ] and 2 ) did not specifically state that they were review s [ 4 ] . Selection of Articles We identified original clinical drug articles that had a section describing the study methods , because such a section is needed to assess the quality of an article . Using a computer-generated list of r and om numbers from 1 to 625 , we r and omly selected symposia from 625 symposia that had been identified for a previous study [ 4 ] . We had data on the type of sponsorship of publication for each symposium . From each selected symposium , we r and omly selected one original clinical drug article that had a methods section . We continued selecting symposia until we had enough articles ( n = 127 ) according to the sample size estimates described below . We also calculated the proportion of articles in the selected symposia , overall and by type of sponsorship , that had methods sections . Quality Assessment We compared the quality of original clinical drug articles published in symposia sponsored by single drug companies with that of similar articles published in symposia that had other sponsors and in the peer- review ed parent journals . Sample Size Estimates We estimated the sample size needed to test the association between the independent variable type of sponsorship of publication and the main outcome measure , method ologic quality score . For a three-group comparison , a minimum sample of 108 symposium articles was needed to detect a minimum effect size of 0.10 ( on a scale of 0 to 1 ) , with an value of 0.05 and a value of 0.80 , and st and ard deviation of quality scores of 0.18 based on previous results [ 7 ] . To compare articles from symposia sponsored by single pharmaceutical companies with articles from the peer- review ed parent journals , we estimated that we would need 45 symposia articles and 45 journal articles ; this estimate was the result of sample size calculations done using the variables described above . Because date of publication , journal , and therapeutic class of drug could have confounded the association between source of publication and quality [ 8 - 10 ] , we matched each symposium article to an article from the parent journal by using these characteristics , as described previously [ 7 ] . Our sample of symposium articles contained 50 articles sponsored by single drug companies , but 5 articles published in Transplantation Proceedings were excluded from this analysis because no parent journal is associated with that publication . Instruments We used previously developed instruments to measure the method ologic quality of articles ( defined as the minimization of systematic bias and the consistency of conclusions with results ) and non method ologic indices of quality , such as clinical relevance and generalizability . Both instruments were valid and reliable and have been published elsewhere [ 7 ] . Four review ers independently assessed each article : Two used the method ologic quality instrument , and two used the clinical relevance instrument . We derived  method ologic quality and clinical relevance scores for each article by using a previously described scoring system [ 7 ] . Each score was between 0 ( lowest quality ) and 1 ( highest quality ) and was the average of the scores of the two review ers . Two clinical pharmacologists with extensive research experience in the health sciences did the method ologic quality assessment . For the clinical relevance instrument , three pairs of review ers with clinical experience in general internal medicine and research experience in the health sciences each assessed one third of the articles . Each pair of review ers review ed the articles in the same r and omized order . For both instruments , review ers were trained as described previously [ 7 ] . For the quality assessment s , each review er worked independently , was blinded as to whether an article had been published in a symposium , and was given photocopies of articles from which author names , institution names , journal names , date s , and all other reference information had been obliterated . Review ers were unaware of our hypotheses and the purpose of their review ing , and they were paid for their work . None of the review ers were known to us or knew of our previous work before the study . We assessed the inter-rater reliability of quality scores by using the Kendall coefficient of concordance ( W ) with adjustment for tied ranks [ 11 ] and the intraclass correlation ( R ; treating both review ers and articles as r and om effects [ 12 ] ) . Inter-rater reliability of quality scores was high ( for method ologic quality scores : W equals 0.85 , R equals 0.74 [ 95 % CI , 0.67 to 0.80 ] ; for clinical relevance scores : W equals 0.77 , R equals 0.56 [ CI , 0.44 to 0.65 ] ) . Drug Company Support and Study Outcome For each article , one of us determined whether a drug company had supported the research and whether the article 1 ) reported an outcome favorable to the drug of interest , 2 ) did not report an outcome favorable to the drug of interest , or 3 ) did not test a hypothesis . The drug of interest ( as defined from the perspective of the authors , according to Gotzsche [ 13 ] ) was the newest drug if two or more drugs were studied . We defined research as having had drug company support if the article that reported the research acknowledged either that a drug company had provided funding or drugs or that any of the authors were employed by a drug company . We determined drug company support solely on the basis of information in the paper . If an article did not test a hypothesis , it was excluded from this analysis . We classified the remaining articles as favorable or unfavorable using Gotzsche 's definitions [ 13 ] . An article was favorable if the drug that seemed to be of primary interest to the authors had the same effect as the comparison drug or drugs but with less pronounced side effects , had a better effect without more pronounced side effects , or was preferred more often by patients when the effect and side-effect evaluations were combined . All other articles were considered not favorable . The conclusions of the authors were taken at face value , even if they conflicted with the study results . To test inter-rater reliability , the other author independently assessed a subset of the articles ( n = 90 ) . Agreement in classifying articles as favorable or not favorable was 85 % . Statistical Analyses Because method ologic quality and relevance scores were distributed normally ( Shapiro-Wilk test ) , we analyzed differences between groups ( type of sponsorship of publication ) by using parametric one-way analysis of variance followed by the Tukey test for multiple comparisons or two-way analysis of variance ( total error rate , 0.05 ) . We compared matched groups ( symposium articles and peer- review ed parent journal articles ) by using the paired t-test ( two-tailed equals 0.05 ) . To analyze categorical data on the outcome of studies , we tested for differences in proportions between groups by using the chi-square statistic . For tests of significance , we used an value of 0.05 . All hypothesis tests were two-sided . Results Presence of a Method Section To obtain 127 original clinical drug articles for quality assessment , we had to select 213 symposia containing a total of 5041 articles . The proportions of articles that reported original data but contained no methods sections were 4 % overall ( 195 of 5041 ) , 10 % ( 108 of 1064 ) in the symposia sponsored by single drug companies Background The Promoting Action on Research Implementation in  Health Services framework  , or PARIHS , is a conceptual framework that posits key , interacting elements that influence successful implementation of evidence -based practice s. It has been widely cited and used as the basis for empirical work ; however , there has not yet been a literature review to examine how the framework has been used in implementation projects and research . The purpose of the present article was to critically review and synthesize the literature on PARIHS to underst and how it has been used and operationalized , and to highlight its strengths and limitations . Methods We conducted a qualitative , critical synthesis of peer- review ed PARIHS literature published through March 2009 . We synthesized findings through a three-step process using semi-structured data abstract ion tools and group consensus . Results Twenty-four articles met our inclusion criteria : six core concept articles from original PARIHS authors , and eighteen empirical articles ranging from case reports to quantitative studies . Empirical articles generally used PARIHS as an organizing framework for analyses . No studies used PARIHS prospect ively to design implementation strategies , and there was generally a lack of detail about how variables were measured or mapped , or how conclusions were derived . Several studies used findings to comment on the framework in ways that could help refine or vali date it . The primary issue identified with the framework was a need for greater conceptual clarity regarding the definition of sub-elements and the nature of dynamic relationships . Strengths identified included its flexibility , intuitive appeal , explicit acknowledgement of the outcome of ' successful implementation , ' and a more expansive view of what can and should constitute ' evidence . ' Conclusions While we found studies reporting empirical support for PARIHS , the single greatest need for this and other implementation models is rigorous , prospect i ve use of the framework to guide implementation projects . There is also need to better explain derived findings and how interventions or measures are mapped to specific PARIHS elements ; greater conceptual discrimination among sub-elements may be necessary first . In general , it may be time for the implementation science community to develop consensus guidelines for reporting the use and usefulness of theoretical frameworks within implementation studies
The DASH , the  Michigan H and Outcomes Question naire ( MHQ ) , the  Patient Evaluation Measure ( PEM ) , and the  Patient-Reported Wrist Evaluation ( PRWE ) had evidence supporting their reliability , validity , and responsiveness .
A post-hoc review of excluded studies revealed the AUSCAN Osteoarthritis H and Index as another suitable instrument that had favourable reliability , validity , and responsiveness .
The DASH , MHQ , and AUSCAN Osteoarthritis H and Index instruments were supported by the most favourable empirical evidence for validity , reliability , and responsiveness .
The PEM and PRWE also had favourable empirical evidence reported for these elements .
This paper aim ed to identify condition-specific patient-reported outcome measures used in clinical trials among people with wrist osteoarthritis and summarise empirical peer- review ed evidence supporting their reliability , validity , and responsiveness to change .