The well-being questionnaire: evidence for a three-factor structure with 12 items (W-BQ12). The nuts and bolts of PROSPERO: an international prospective register of systematic reviews Good intentions and received wisdom are not enough Best Practice in Systematic Reviews: The Importance of Protocols and Registration Health-Related Quality of Life, Treatment Satisfaction, and Costs Associated With Intraperitoneal Versus Subcutaneous Insulin Administration in Type 1 Diabetes Monitoring of Individual Needs in Diabetes (MIND)-2 Optimizing Insulin Glargine Plus One Injection of Insulin Glulisine in Type 2 Diabetes in the ELEONOR Study Diagnosis and treatment of primary myelodysplastic syndromes in adults: recommendations from the European LeukemiaNet. Reliability and validity of the Thai version of the WHO-Five Well-Being Index in primary care patients. Screening for depression in elderly Indian population Evaluation of the Quality of Prognosis Studies in Systematic Reviews The WHO (Ten) Well-Being Index: validation in diabetes. The Pelvic Girdle Questionnaire: A Condition-Specific Instrument for Assessing Activity Limitations and Symptoms in People With Pelvic Girdle Pain Part 3: Evidence evaluation process: 2010 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science with Treatment Recommendations. The Cochrane Collaboration. Interactive electronic teaching (ISIS): has the future started? Evaluation of community-based oral health promotion and oral disease prevention--WHO recommendations for improved evidence in public health practice. Rehabilitation after myocardial infarction trial (RAMIT): multi-centre randomised controlled trial of comprehensive cardiac rehabilitation in patients following acute myocardial infarction Systematic Reviews of Diagnostic Test Accuracy Quality of life and psychological well-being in GH-treated, adult PWS patients: a longitudinal study. A literature review on the representativeness of randomized controlled trial samples and implications for the external validity of trial results Effects of a health examination programme on quality of life and subjective well-being Transparent Development of the WHO Rapid Advice Guidelines
BACKGROUND The Well-being Question naire ( W-BQ ) has been design ed to measure psychological well-being in people with a chronic somatic illness and is recommended by the World Health Organization for widespread use . However , studies into the factor structure of this instrument are still limited and their findings are inconsistent . This study aim ed to investigate the factor structure of the Dutch version of the W-BQ . METHODS A cross-validation design was used . A total of 1472 people with diabetes completed the W-BQ  and were r and omly assigned to group A or B. In group A ( N = 736 ) , exploratory factor analyses were conducted . Group B ( N = 736 ) was split up into four subgroups of male or female patients with type 1 or type 2 diabetes . In these subgroups , confirmatory factor analyses were employed to test the model(s ) developed in group A and the two models described in the literature ( four-factor model with 22 items and a three-factor model with 12 items ) . RESULTS Exploratory factor analyses yielded a three-factor model with 21 items ( negative well-being , energy and positive well-being ) . In the subgroups of group B confirmatory factor analyses only accepted the three-factor model with 12 items . This factor solution was stable across gender , type of diabetes and level of education . CONCLUSIONS The best description of the factor structure of the Dutch translation of the W-BQ was given by a three-factor solution with 12 items ( W-BQ12 ) , measuring positive well-being ( four items ) , negative well-being ( four items ) and energy ( four items ) Background Following publication of the PRISMA statement , the UK Centre for Review s and Dissemination ( CRD ) at the University of York in Engl and began to develop an international prospect i ve register of systematic review s with health-related outcomes . The objectives were to reduce unplanned duplication of review s and provide transparency in the review process , with the aim of minimizing reporting bias . Methods An international advisory group was formed and a consultation undertaken to establish the key items necessary for inclusion in the register and to gather views on various aspects of functionality . This article describes the development of the register , now called PROSPERO , and the process of registration . Results PROSPERO offers free registration and free public access to a unique prospect i ve register of systematic review s across all areas of health from all around the world . The dedicated web-based interface is electronically search able and available to all prospect i ve registrants . At the moment , inclusion in PROSPERO is restricted to systematic review s of the effects of interventions and strategies to prevent , diagnose , treat , and monitor health conditions , for which there is a health-related outcome .Ideally , registration should take place before the research ers have started formal screening against inclusion criteria but review s are eligible as long as they have not progressed beyond the point of completing data extraction .The required data set captures the key attributes of review design as well as the administrative details necessary for registration .Su bmi tted registration forms are checked against the scope for inclusion in PROSPERO and for clarity of content before being made publicly available on the register , rejected , or returned to the applicant for clarification . The public records include an audit trail of major changes to planned methods , details of when the review has been completed , and links to result ing publications when provided by the authors . Conclusions There has been international support and an enthusiastic response to the principle of prospect i ve registration of protocol s for systematic review s and to the development of PROSPERO .In October 2011 , PROSPERO contained 200 records of systematic review s being undertaken in 26 countries around the world on a diverse range of interventions There is a common view among social and public health scientists that there is an evidence -based medicine ( EBM ) juggernaut , a powerful , naive , and overweening attempt to impose an inappropriately narrow and medical model of experimentation onto a complex social world . We have both frequently come across hostility among social scientists , and public health or health promotion practitioners or theorists , to attempts to apply EBM principles ( for example , systematic review s or experimental design s ) in social or public health setting s ( for example , sex education in schools , health promotion campaigns , or community development1 ) . We believe such hostility to be misplaced , and to be based on a number of misconceptions . The first misconception is that systematic review s and experimental design s have a wholly biomedical provenance . As Ann Oakley has pointed out , the use of experimental design s was well established in United States by the 1930s , and from the early 1960s to early 1980s there were many r and omised experiments for evaluating public policy interventions in United States , these being considered the optimum design . Much of the early literature on experimental design s ( including blinding ) came from the social sciences , as a response to the perceived need to be able to make valid causal inferences.2 The second misconception is that the “ real world ” is too complex , messy , It is now just over six years [ 1 ] since many medical journals began requiring that trials be registered before considering the trial report for publication . Such a policy was set up explicitly to reduce what was considered to be widespread bias in favor of publication of ‘ ‘ positive ’ ’ trials and to ensure that all clinical trials be made public prior to participant enrollment . Given the importance of clinical trials for estimating the efficacy and safety of interventions , and their role in approval of new drugs and devices , such a policy seemed uncontroversial . Although it is known that some trials still go unregistered , there are strong incentives ( such as journal publication ) and , in some countries legally enforceable m and ates , for authors to register these studies before enrolling patients . The existence and widespread uptake of trial registration helps research ers , patients , and funders underst and how many trials are being undertaken and which interventions are being evaluated . It also allows studies to be traced from inception through to completion and publication [ 2 ] . However , well-conducted systematic review s — overviews of health care interventions that use a predefined , explicit methodology to find and synthesize all the relevant evidence —are generally considered higher-caliber evidence than are individual trials in decision-making for clinical practice and health policy . The superiority given to such review s derives from key aspects inherent to the process of carrying out a systematic review . This study type , if done properly , allows the review to come closer to estimating the true effect of an intervention than any single study can , for two main reasons . First , such review s collect and synthesize all relevant studies ; second , review s appraise each included study for risk of bias . However , there is increasing evidence of the existence of publication bias for systematic review s. A recent survey [ 3 ] indicates that nonpublication of completed studies may be as much of a problem for systematic review s as it is for trials . Other analyses [ 4,5 ] point to the existence of discrepancies between systematic review protocol s and the published report , with one study [ 5 ] showing that the outcomes included in published systematic review s may be biased toward ‘ ‘ positive ’ ’ findings . It is crucially important , therefore , that if the evidence from these studies is to be incorporated into clinical practice , the review is as rigorous and as fully reported as possible . For example , it should be obvious to readers whether there was a prespecified protocol for the review , that deviations are noted , and whether outcomes from the review are reported according to the original study plan . Increased clarity surrounding systematic review conduct and reporting would be possible if the protocol s for systematic review s , just like those for trials , were registered [ 6,7 ] . Systematic review s conducted under the auspices of the Cochrane Collaboration are registered early , at the protocol development stage . This registration helps minimize bias in the conduct and reporting of the review , reduce duplication of effort between groups , and keep systematic review s up date d. However , until now no overarching registry open to all research ers , worldwide , has existed for recording the existence and development of systematic review s from inception through to completion . This month , the Centre for Review s and Dissemination ( University of York , UK ) , supported by the UK National Institutes of Health Research and in collaboration with an international advisory group , announces PROSPERO , its international Prospect i ve Register of Ongoing Systematic Review s. Following months of public consultation , with many hundreds of respondents from 34 countries providing input on the proposed registration process and minimum data set , PROSPERO is now open for business [ 8 ] . Registration is free , is available to anyone around the world , and generates a unique identifying number for each registered systematic review , which can ( and should ) be reported in any publications that arise from the study . Investigators should use the registry to record the existence of the protocol for a planned or ongoing systematic review of health care interventions even before screening studies for inclusion in the systematic review . A minimum data set specifies the key items that are required for a systematic review to be meaningfully registered . Key data items include a statement of the research question , patients and population , study intervention(s ) and outcomes ; criteria for inclusion and exclusion of studies in the systematic review ; outline of search strategy ; and methods to assess risk of bias and for analysis of studies included in the systematic review . With a clear system in place for registration of new and ongoing systematic review s , PLoS Medicine announces its support for this initiative . The journal wishes to promote best practice in the conduct and reporting of systematic review s. Best practice includes registration during the protocol phase in PROSPERO or other appropriate registry , conduct of the review in accordance with a fully developed protocol , and reporting in line with the PRISMA guidelines [ 9 ] . PLoS Medicine and other PLoS journals will now start OBJECTIVE To investigate the effects of continuous intraperitoneal insulin infusion ( CIPII ) compared with subcutaneous insulin on health-related quality of life ( HRQOL ) and treatment satisfaction , and to perform a cost analysis in type 1 diabetes . RESEARCH DESIGN AND METHODS We used an open-label , prospect i ve , crossover , r and omized , 16-month study ( N = 24 ) .  HRQOL and patient satisfaction were assessed with question naires ( the 36-item short-form health survey [ SF-36 ] , the World Health Organization-Five Well-Being Index [ WHO-5 ] , and the Diabetes Treatment Satisfaction Question naire [ DTSQ ] ) . Direct costs  of CIPII and continuous subcutaneous insulin infusion ( CSII ) were compared . RESULTS Question naire scores were higher with CIPII than with subcutaneous therapy . Yearly direct pump- and procedure-associated costs  for CIPII were estimated at € 10,910 compared with € 4,810 for CSII . CONCLUSIONS Apart from improving glycemic control , CIPII improved HRQOL and treatment satisfaction compared with subcutaneous insulin . Direct pump- and procedure-associated costs are considerably higher for CIPII , however OBJECTIVE To test the effects of implementing computer-assisted Monitoring of Individual Needs in Diabetes ( MIND ) in routine diabetes care on psychological status and glycemic control , identify predictors of poor psychological outcomes , and evaluate care providers ’ experiences . RESEARCH DESIGN AND METHODS The MIND procedure was implemented as part of the annual review in diabetes clinics across eight countries in a prospect i ve observational study with a 1-year follow-up . MIND encompasses well-being ( World Health Organization Five Well-Being Index [ WHO-5 ] ) , diabetes-related distress ( Problem Areas in Diabetes [ PAID ] ) , a Life Event Inventory , and the patient ’s agenda for their consultation . Medical data and agreed case-management actions were retrieved from the charts . RESULTS Of the total 1,567 patients , 891 patients ( 57 % ) were monitored at a 1-year follow-up . Twenty-eight percent of the patients screened positive for depression and /or diabetes distress at baseline and considered cases , 17 % of whom were receiving psychological care . Cases were significantly more often female and had type 2 diabetes and worse glycemic control compared with noncases . Clinical ly relevant improvements in WHO-5 and PAID were observed over time in cases , irrespective of referral ( effects sizes 0.59 and 0.48 , respectively ; P < 0.0001 ) . Glycemic control did not change . Female sex , life events , and concomitant chronic diseases were predictors of poor psychological outcomes . MIND was well received by patients and staff . CONCLUSIONS MIND appears suitable for screening and discussion of emotional distress as part of the annual review . Broader dissemination in diabetes care is recommendable , but sustainability will depend on reimbursement and availability of support services OBJECTIVE To determine the functional health status and treatment satisfaction in patients with type 2 diabetes from the Evaluation of Lantus Effect ON Optimization of use of single dose Rapid insulin ( ELEONOR ) study that investigated whether a telecare program helps optimization of basal insulin glargine with one bolus injection of insulin glulisine . RESEARCH DESIGN AND METHODS Functional health status and treatment satisfaction were investigated using the 36-Item Short-Form ( SF-36 ) Health Survey , the World Health Organization Well-Being Question naire ( WBQ ) , and the Diabetes Treatment Satisfaction Question naire . RESULTS Of 291 r and omized patients , 238 completed the study ( telecare : 114 ; self-monitoring blood glucose : 124 ) . Significant improvements were detected in most SF-36 domains , in WBQ depression and anxiety scores , and in treatment satisfaction , without differences between study groups . CONCLUSIONS An insulin regimen that substantially improves metabolic control , while minimizing the risk of hypoglycemia , can positively affect physical and psychologic well-being and treatment satisfaction irrespective of the educational support system used Within the myelodysplastic syndrome ( MDS ) work package of the European LeukemiaNet , an Expert Panel was selected according to the framework elements of the National Institutes of Health Consensus Development Program . A systematic review of the literature was performed that included indexed original papers , indexed review s and educational papers , and abstract s of conference proceedings . Guidelines were developed on the basis of a list of patient- and therapy-oriented questions , and recommendations were formulated and ranked according to the supporting level of evidence . MDSs should be classified according to the 2008 World Health Organization criteria . An accurate risk assessment requires the evaluation of not only disease-related factors but also of those related to extrahematologic comorbidity . The assessment of individual risk enables the identification of fit patients with a poor prognosis who are c and i date s for up-front intensive treatments , primarily allogeneic stem cell transplantation . A high proportion of MDS patients are not eligible for potentially curative treatment because of advanced age and /or clinical ly relevant comorbidities and poor performance status . In these patients , the therapeutic intervention is aim ed at preventing cytopenia-related morbidity and preserving quality of life . A number of new agents are being developed for which the available evidence is not sufficient to recommend routine use . The inclusion of patients into prospect i ve clinical trials is strongly recommended AIMS Because of the high patient load in Thail and , we need a practical measurement to help primary physicians detect depression . This study aim ed to examine the reliability and validity of the Thai version of the World Health Organization-Five Well-Being Index  ( WHO-5-T ) , which is short and easy to use as a screening tool for major depression in primary care patients . METHODS The English version of the WHO-Five Well-Being Index was translated into Thai . Back-translations , cross-cultural adaptation and field testing of the pre-final version with final adjustments were performed accordingly . The WHO-5-T was administered r and omly to 300 patients in our primary care clinic . Then the patients were further assessed using the  Mini International Neuropsychiatric Interview  and the  Hamilton Rating Scale for Depression  as the gold st and ard of diagnosis and symptom severity , respectively . RESULTS Completed data were obtained from 274 respondents . Their mean age was 44.6 years [ st and ard deviation ( SD ) = 14.7 ] and 73.7 % of them were female . The mean WHO-5-T score was 14.32 ( SD = 5.26 ) . The WHO-5-T had a satisfactory internal consistency ( Cronbach 's alpha = 0.87 ) and showed moderate convergent validity with the Hamilton Rating Scale for Depression ( r = -0.54 ; P < 0.001 ) . The optimal cut-off score of the WHO-5-T < 12 revealed a sensitivity of 0.89 and a specificity of 0.71 in detecting depression . The area under the curve in this study was 0.86 ( SD = 0.03 , 95 % confidence interval 0.81 to 0.89 ) . CONCLUSIONS The Thai version of the WHO-Five Well-Being Index was found to be a reliable and valid self- assessment to screen for major depression in primary care setting at a cut-off point of < 12 Background : The point prevalence of depressive disorders in the elderly population in India varies from 13 to 25 % . Since the World Health Organization ( five ) Well-being Index ( 1998 version ) is simple and easy to administer , an attempt is made to evaluate the Indian version of this instrument to identify depression in the elderly Indian community . Objectives : ( 1 ) To determine the prevalence of depression among the elderly population of rural areas of Udupi district , Karnataka , India . ( 2 ) To determine the validity and reliability of WHO ( five ) Well-being Index ( 1998 version ) as a screening instrument to identify depressive disorders in elderly population in this Indian setting . Material s and Methods : This cross-sectional study was conducted over a period of eight months ( from March 1 to October 31 , 2002 ) in the three taluks of Udupi , Kundapura , and Karkala ; belonging to the Udupi district of South India . We selected 627 people in the age group of 60 years and above for the study . Simple r and om sampling , without replacement method , using the probability proportionate to size ( PPS ) technique was used . The WHO ( five ) well-being index ( 1998 version ) was vali date d against the major International Classification of Diseases and Related Health Problems 10th Revision ( ICD-10 ) depression inventory of mastering depression in primary care version 2.2 . Proportions and their 95 % confidence intervals were calculated and Kappa statistics was applied to determine the reliability of the screening instrument . P value<0.05 was considered statistically significant . Results : The prevalence of depression in elderly population was determined to be 21.7 % ( 95 % CI = 18.4 - 24.9 ) . The Indian version of WHO-five well-being index ( 1998 version ) showed a sensitivity of 97.0 % , specificity of 86.4 % , positive predictive value of 66.3 % and an overall accuracy of 0.89 . The Kappa statistics showed significantly high reliability of k = 0.71 . Conclusion : The Indian version of " WHO ( five ) Well-being Index ( 1998 version ) " was found to be an effective instrument for identifying depression in elderly Indian community Prognosis studies are investigations of future events or the evaluation of associations between risk factors and health outcomes in population s of patients ( 1 ) . The results of such studies improve our underst and ing of the clinical course of a disease and assist clinicians in making informed decisions about how best to manage patients . Prognostic research also informs the design of intervention studies by helping define subgroups of patients who may benefit from a new treatment and by providing necessary information about the natural history of a disorder ( 2 ) . There has recently been a rapid increase in the use of systematic review methods to synthesize the evidence on research questions related to prognosis . It is essential that investigators conducting systematic review s thoroughly appraise the method ologic quality of included studies to be confident that a study 's design , conduct , analysis , and interpretation have adequately reduced the opportunity for bias ( 3 , 4 ) . Caution is warranted , however , because inclusion of method ologically weak studies can threaten the internal validity of a systematic review ( 4 ) . This follows abundant empirical evidence that inadequate attention to biases can cause invalid results and inferences ( 5 - 9 ) . However , there is limited consensus on how to appraise the quality of prognosis studies ( 1 ) . A useful framework to assess bias in such studies follows the basic principles of epidemiologic research ( 10 , 11 ) . We focus on 6 areas of potential bias : study participation , study attrition , prognostic factor measurement , confounding measurement and account , outcome measurement , and analysis . The main objectives of our review of review s are to describe methods used to assess the quality of prognosis studies and to describe how well current practice s assess potential biases . Our secondary objective is to develop recommendations to guide future quality appraisal , both within single studies of prognostic factors and within systematic review s of the evidence . We hope this work facilitates future discussion and research on biases in prognosis studies and systematic review s. Methods Literature Search and Study Selection We identified systematic review s of prognosis studies by search ing MEDLINE ( 1966 to October 2005 ) using the search strategy recommended by McKibbon and colleagues ( 12 ) . This strategy combines broad search terms for systematic review s ( systematic review .mp ; meta- analysis .mp ) and a sensitive search strategy for prognosis studies ( cohort , incidence , mortality , follow-up studies , prognos * , predict * , or course ) . We also search ed the reference lists of included review s and method ologic papers to identify other relevant publications . We restricted our search to English- language publications . One review er conducted the search and selected the studies . Systematic review s , defined as review s of published studies with a comprehensive search and systematic selection , were included if they assessed the method ologic quality of the included studies by using 1 or more explicit criteria . We excluded studies if they were meta-analyses of independent patient data only , if their primary goal was to investigate the effectiveness of an intervention or specific diagnostic or screening tests , or if they included studies that were not done on humans . Data Extraction and Synthesis Individual items included in the quality assessment of the systematic review s were recorded as they were reported in the publication ( that is , the information that would be available to readers and future review ers ) . We review ed journal Web sites and contacted the authors of the systematic review s for additional information when authors made such an offer in their original papers . When review s assessed different study design s by using different sets of quality items , we extracted only those items used to assess cohort studies . We constructed a comprehensive list of distinct items that the review s used to assess the quality of their included studies . The full text of each review was screened . All items used by the review authors to assess the quality of studies were extracted into a computerized spreadsheet by 1 review er . Two experienced review ers , a clinical epidemiologist and an epidemiologist , independently synthesized the quality items extracted from the prognosis review s to determine how well the systematic review s assessed potential biases . We did this in 3 steps : 1 ) identified distinct concepts or domains addressed by the quality items ; 2 ) grouped each extracted quality item into the appropriate domain or domains ; and 3 ) identified the domains necessary to assess potential biases in prognosis studies . We then used this information to assess how well the review s ' quality assessment included items from the domains necessary to assess potential biases . After completing each of the first 3 steps , the review ers met to attempt to reach a consensus . The consensus process involved each review er presenting his or her observations and results , followed by discussion and debate . A third review er was available in cases of persistent disagreement or uncertainty . In the first step , all domains addressed by the quality items were identified . The first review er iteratively and progressively defined the domains as items were extracted from the included review s. The second review er defined domains from a r and om list of all extracted quality items . Limited guidance was provided to the review ers so that their assessment s and definitions of domains would be independent . The review ers agreed on a final set of domains that adequately and completely defined all of the extracted items . In the second step , review ers independently grouped each extracted item into the appropriate domains . Review ers considered each extracted item by asking , What is each particular quality item addressing ? or What are the review 's authors getting at with the particular quality assessment item ? . Items were grouped into the domain or domains that best represented the concepts being addressed . For example , the extracted items at least 80 % of the group originally identified was located for follow-up and follow-up was sufficiently complete or does n't jeopardize validity were each independently classified by both review ers as assessing the domain completeness of follow-up adequate , whereas the extracted item quantification and description of all subjects lost to follow-up was classified as assessing the domain completeness of follow-up described . In the third step , we identified the domains necessary to assess potential biases . Each review er considered the ability of the identified domains to adequately address , at least in part , 1 of the following 6 potential biases : 1 ) study participation , 2 ) study attrition , 3 ) prognostic factor measurement , 4 ) confounding measurement and account , 5 ) outcome measurement , and 6 ) analysis . Domains were considered to adequately address part of the framework if information garnered from that domain would inform the assessment of potential bias . For example , both review ers judged that the identified domain study population represents source population or population of interest assessed potential bias in a prognosis study , whereas the domain research question definition did not , although the latter is an important consideration in assessing the inclusion of studies in a systematic review . Finally , on the basis of our previous ratings , we looked at whether each review included items from the domains necessary to assess the 6 potential biases . We calculated the frequency of systematic review s by assessing each potential bias and the number of review s that adequately assessed bias overall . From this systematic synthesis , we developed recommendations for improving quality appraisal in future systematic review s of prognosis studies . We used Microsoft Access and Excel 2002 ( Microsoft Corp. , Redmond , Washington ) for data management and SAS for Windows , version 9.1 ( SAS Institute , Inc. , Cary , North Carolina ) for descriptive statistics . Role of the Funding Sources The funding sources , the Canadian Institutes of Health Research , the Canadian Chiropractic Research Foundation , the Ontario Chiropractic Association , and the Ontario Ministry of Health and Long Term Care , did not have a role in the collection , analysis , or interpretation of the data or in the decision to su bmi t the manuscript for publication . Results We identified 1384 potentially relevant articles . Figure 1 shows a flow chart of studies that were included and excluded . Figure 2 shows the number of review s identified by year of publication . We excluded 131 systematic review s of prognosis studies that did not seem to include any quality assessment of the included studies ; this represented 44 % of prognosis review s. We included 163 review s of prognosis studies in our analysis ( 13 - 175 ) . The most common topics were cancer ( 15 % ) , musculoskeletal disorders and rheumatology ( 13 % ) , cardiovascular ( 10 % ) , neurology ( 10 % ) , and obstetrics ( 10 % ) . Other review s included a wide range of health and health care topics . Sixty-three percent of the review s investigated the association between a specific prognostic factor and a particular outcome ; the remainder investigated multiple prognostic factors or models . The number of primary studies included in each systematic review ranged from 3 to 167 ( median , 18 [ interquartile range , 12 to 31 ] ) . A complete description of the included review s is available from the authors on request . Figure 1 . Flow diagram of inclusion and exclusion criteria of systematic review s. Figure 2 . Number of systematic review s of prognosis studies identified over time . Quality Items One hundred fifty-three review s provided adequate detail to allow extraction of quality items . Eight hundred eighty-two distinct quality items were extracted from the review s. Most review s developed their own set of quality items , with only a few applying criteria from previous review s. Most quality items BACKGROUND In a European trial in 8 countries , the subjective well-being of patients on alternative forms of treatment for insulin-dependent diabetes was compared using the 28-item WHO Well-Being Question naire , covering four dimensions of depression , anxiety , energy and positive well-being . The objective of the analysis reported here has been to identify the items of the WHO question naire which belong to an overall index of negative and positive well-being . METHODS Adult patients at 10 study centres in 8 countries who had been on insulin for at least 2 years were invited to participate in a r and omised , cross-over trial to compare insulin pump treatment with injection therapy . At each phase , patients completed questions on well-being and general health . Internal validity of the well-being index was evaluated by Cronbach 's alpha and Loevinger 's and Mokken 's homogeneity coefficients , as well as factor analysis . External validity was evaluated by comparisons with results of the general assessment questions and by the ability to discriminate between the alternative forms of treatment . RESULTS 358 patients had sufficient data for analysis . Ten items were found to constitute a valid index of well-being with respect to internal and external validity . Coefficients of homogeneity were acceptable and there was evidence for both concurrent and discriminant validity . CONCLUSIONS The WHO ( Ten ) well-being index includes negative and positive aspects of well-being in a single uni-dimensional scale . Its advantage lies in its ability to show overall change along the continuum of well-being , thus facilitating comparisons between patient groups and treatments . It is not specific to diabetes , and therefore may be useful as a disease-independent index of well-being in a broad range of health care studies 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 > “ 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 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 Medical education of hypertensives as well as of other asymptomatic cardiovascular risk patients requires individualized , interactive and attractive strategies . Electronic teaching set up in hospital or clinic setting s opens the way of the future , saving time and allowing more advantageous use of caretakers . ISIS ( Initiation Sanitaire Informatisee et Scenarisee ) , a French computer assisted program for cardiovascular risk patients , combines a scientific information , divided in 12 sequential but independent modules , with a recreative imaginary trip in the world of ancient Egypt . To test the impact of this tool on patient health information retention , 158 hypertensives hospitalized in a day-hospital clinic were r and omized into an  intervention or ISIS group ( IG , n = 79 ) and a control group ( CG , n = 79 ) . Both groups received cardiovascular education through st and ard means . In addition , IG patients underwent a 30 to 60 min session on the computer .  Cardiovascular knowledge was tested by a nurse administering a st and ardized 28-item question naire before and two months after education . Retesting was done by telephone interview . A total of 138 completed question naires ( 69 from each group ) were analyzed . Overall mean cardiovascular knowledge score before education ( 14.3 + /- 4.2 , range 4 - 25 ) improved significantly after education ( 3.7 + /- 3.5 , p = 0.0001 ) . This improvement was more important in the IG than the CG ( 3.8 + /- 3.6 vs 2.4 + /- 3.2 respectively , p = 0.02 ) , especially in hypertensives having a known disease for more than six months . Isis is now available in two language s : French and English . Patients ' satisfaction and the conclusion of this comparative trial encourage confirmation of these first results in other French or English speaking population s , in order to test the long term effects of structured electronic teaching sessions on health behaviour , and to promote a wide use of computers and multimedia communication in hypertension control programs Systematic evaluation is an integral part of the organisation and delivery of community oral health care programmes , ensuring the effectiveness of these community-based interventions . As for general health promotion programmes the common problems from effectiveness review s of oral health interventions relate to the quality and validity of programme evaluations . Problems identified mostly refer to the quality of outcome measures , short-term timescales to assess change , inadequate evaluation method ologies and inappropriate evaluation of programme implementation and processes . It remains a challenge to oral health professionals to integrate community oral health programmes into a wider health agenda . Public health research focusing on the development of evaluation method ologies has identified a variety of issues including the importance of using pluralistic evaluation approaches ( quantitative and /or qualitative ) , limitations of the r and omised controlled trial ( RCT ) design for evaluation of public health interventions , the need to match evaluation methods with the nature of intervention , development of outcome measures appropriate for the nature of intervention , importance of developing workforce capacity in evaluation techniques , and the need for development of partnerships between health practitioners and academics in conducting evaluations . In June 2003 , the WHO Oral Health Programme at Headquarters organised a two-day workshop to take forward the development and documentation of the evaluation of oral health promotion and oral disease prevention programmes . The aims of the workshop were to : ( 1 ) identify common problems and challenges in evaluating community-based  oral health interventions ; ( 2 ) explore developments in the evaluation approaches in public health ; ( 3 ) share experiences in evaluating oral health intervention programmes implemented at national or community levels in developing and developed countries and ( 4 ) develop guidelines for quality evaluation of national and community oral health programmes . Twenty-two invitees from 15 countries attended in addition to WHO staff . The first day was devoted to presentations of oral health promotion and oral disease prevention programmes from around the world . During the second day , WHO staff at Headquarters in Geneva discussed aspects of evaluation of public health programmes . Two working groups were formed to discuss agreed topics , and the reports from their deliberations , together with the general discussion , result ed in the presentation of emerging key issues and recommendations . In summary , it was agreed that evaluation of oral health promotion and disease prevention programmes should integrate , whenever possible , with general health programmes . While the design and advantages of RCTs in clinical evaluations are well documented , the relevance of this design in evaluation of community oral disease preventive programmes and oral health promotion programmes are much less clearly defined . Subsequently , the conduct of such programmes may be inappropriately evaluated in systematic review s. There is a need for more research into appropriate immediate , interim and ultimate outcome measures , as well as process evaluation , an assessment that is poorly understood and practised less often than outcome evaluation . Guidance on potential design , conduct , and especially the evaluation , of community oral disease prevention programmes and oral health promotion programmes should be developed and up date d regularly . WHO Collaborating Centres could have a role in promoting good practice , training and collaboration between teams throughout the world . Centres undertaking systematic review s should consider the guidelines given in the proposed WHO document when defining their evaluation criteria Background It is widely believed that cardiac rehabilitation following acute myocardial infa rct ion ( MI ) reduces mortality by approximately 20 % . This belief is based on systematic review s and meta-analyses of mostly small trials undertaken many years ago . Clinical management has been transformed in the past 30–40 years and the findings of historical trials may have little relevance now . Objectives The principal objective was to determine the effect of cardiac rehabilitation , as currently provided , on mortality , morbidity and health-related quality of life in patients following MI . The secondary objectives included seeking programmes that may be more effective and characteristics of patients who may benefit more . Design , setting , patients , outcome measures A multi-centre r and omised controlled trial in representative hospitals in Engl and and Wales compared 1813 patients referred to comprehensive cardiac rehabilitation programmes or discharged to ‘ usual care ’ ( without referral to rehabilitation ) .  The primary outcome measure was all-cause mortality at 2 years . The secondary measures were morbidity , health service use , health-related quality of life , psychological general well-being and lifestyle cardiovascular risk factors at 1 year . Patient entry ran from 1997 to 2000 , follow-up of secondary outcomes to 2001 and of vital status to 2006 . A parallel study compared 331 patients in matched ‘ elective ’ rehabilitation and ‘ elective ’ usual care ( without rehabilitation ) hospitals . Results There were no significant differences between patients referred to rehabilitation and controls in mortality at 2 years ( RR 0.98 , 95 % CI 0.74 to 1.30 ) or after 7–9 years ( 0.99 , 95 % CI 0.85 to 1.15 ) , cardiac events , seven of eight domains of the health-related quality of life scale ( ‘ Short Form 36 ’ , SF36 ) or the psychological general well-being scale . Rehabilitation patients reported slightly less physical activity . No differences between groups were reported in perceived overall quality of cardiac aftercare . Data from the ‘ elective ’ hospitals comparison concurred with these findings . Conclusion In this trial , comprehensive rehabilitation following MI had no important effect on mortality , cardiac or psychological morbidity , risk factors , health-related quality of life or activity . This finding is consistent with systematic review s of all trials reported since 1983 . The value of cardiac rehabilitation as practised in the UK is open to question Diagnosis is a critical component of health care , and clinicians , policymakers , and patients routinely face a range of questions regarding diagnostic tests . They want to know whether testing improves outcome ; what test to use , purchase , or recommend in practice guidelines ; and how to interpret test results . Well- design ed  diagnostic test accuracy studies can help in making these decisions , provided that they transparently and fully report their participants , tests , methods , and results as facilitated , for example , by the STARD ( St and ards for Reporting of Diagnostic Accuracy ) statement ( 1 ) . That 25-item checklist was published in many journals and is now adopted by more than 200 scientific journals worldwide . As in other areas of science , systematic review s and meta- analysis of accuracy studies can be used to obtain more precise estimates when small studies addressing the same test and patients in the same setting are available . Review s can also be useful to establish whether and how scientific findings vary by particular subgroups , and may provide summary estimates with a stronger generalizability than estimates from a single study . Systematic review s may help identify the risk for bias that may be present in the original studies and can be used to address questions that were not directly considered in the primary studies , such as comparisons between tests . The Cochrane Collaboration is the largest international organization preparing , maintaining , and promoting systematic review s to help people make well-informed decisions about health care ( 2 ) . The Collaboration decided in 2003 to make preparations for including systematic review s of diagnostic test accuracy in their Cochrane Data base of Systematic Review s. To enable this , a working group ( Appendix ) . was formed to develop methodology , software , and a h and book The first diagnostic test accuracy review was published in the Cochrane Data base in October 2008 . In this paper , we review recent method ological developments concerning problem formulation , location of literature , quality assessment , and meta- analysis of diagnostic accuracy studies by using our experience from the work on the Cochrane H and book . The information presented here is based on the recent literature and up date s previously published guidelines by Irwig and colleagues ( 3 ) . Definition of the Objectives of the Review Diagnostic test accuracy refers to the ability of a test to distinguish between patients with disease ( or more generally , a specified target condition ) and those without . In a study of test accuracy , the results of the test under evaluation , the index test , are compared with those of the reference st and ard determined in the same patients . The reference st and ard is an agreed-on and accurate method for identifying patients who have the target condition . Test results are typically categorized as positive or negative for the target condition . By using such binary test outcomes , the accuracy is most often expressed as the test 's sensitivity ( the proportion of patients with positive results on the reference st and ard that are also positive on the index test ) and specificity ( the proportion of patients with negative results on the reference st and ard that are also negative on the index test ) . Other measures have been proposed and are in use ( 46 ) . It has long been recognized that test accuracy is not a fixed property of a test . It can vary between patient subgroups , with their spectrum of disease , with the clinical setting , or with the test interpreters and may depend on the results of previous testing . For this reason , inclusion of these elements in the study question is essential . In order to make a policy decision to promote use of a new index test , evidence is required that using the new test increases test accuracy over other testing options , including current practice , or that the new test has equivalent accuracy but offers other advantages ( 79 ) . As with the evaluation of interventions , systematic review s need to include comparative analyses between alternative testing strategies and should not focus solely on evaluating the performance of a test in isolation . In relation to the existing situation , 3 possible roles for a new test can be defined : replacement , triage , and add-on ( 7 ) . If a new test is to replace an existing test , then comparing the accuracy of both tests on the same population and with the same reference st and ard provides the most direct evidence . In triage , the new test is used before the existing test or testing pathway , and only patients with a particular result on the triage test continue the testing pathway . When a test is needed to rule out disease in patients who then need no further testing , a test that gives a minimal proportion of falsenegative results and thus a relatively high sensitivity should be used . Triage tests may be less accurate than existing ones , but they have other advantages , such as simplicity or low cost . A third possible role of a new test is add-on . The new test is then positioned after the existing testing pathway to identify false-positive or false-negative results after the existing pathway . The review should provide data to assess the incremental change in accuracy made by adding the new test . An example of a replacement question can be found in a systematic review of the diagnostic accuracy of urinary markers for primary bladder cancer ( 10 ) . Clinicians may use cytology to triage patients before they undergo invasive cystoscopy  , the reference st and ard for bladder cancer . Because cytology combines high specificity with low sensitivity ( 11 ) , the goal of the review was to identify a tumor marker with sufficient accuracy to either replace cytology or be used in addition to cytology . For a marker to replace cytology , it has to achieve equally high specificity with improved sensitivity . New markers that are sensitive but not specific may have roles as adjuncts to conventional testing . The review included studies in which the test under evaluation ( several different tumor markers and cytology ) was evaluated against cystoscopy or histopathology . Included studies compared 1 or more of the markers , cytology only , or a combination of markers and cytology . Although information on accuracy can help clinicians make decisions about tests , good diagnostic accuracy is a desirable but not sufficient condition for the effectiveness of a test ( 8) . To demonstrate that using a new test does more good than harm to patients tested , r and omized trials of test- and -treatment strategies and review s of such trials may be necessary . However , with the possible exception of screening , in most cases , such r and omized trials are not available and systematic review s of test accuracy may provide the most useful evidence available to guide clinical and health policy decision making and use as input for decision and cost-effectiveness analysis ( 12 ) . Identification and Selection of Studies Identifying test accuracy studies is more difficult than search ing for r and omized trials ( 13 ) . There is not a clear , unequivocal keyword or indexing term for an accuracy study in literature data bases comparable with the term r and omized , controlled trial . The Medical Subject Heading sensitivity and specificity may look suitable but is inconsistently applied in most electronic bibliographic data bases . Furthermore , data on diagnostic test accuracy may be hidden in studies that did not have test accuracy estimation as their primary objective . This complicates the efficient identification of diagnostic test accuracy studies in electronic data bases , such as MEDLINE . Until indexing systems properly code studies of test accuracy , search ing for them will remain challenging and may require additional manual search es , such as screening reference lists . In the development of a comprehensive search strategy , review authors can use search strings that refer to the test(s ) under evaluation , the target condition , and the patient description or a subset of these . For tests with a clear name that are used for a single purpose , search ing for publications in which those tests are mentioned may suffice . For other review s , adding the patient description may be necessary , although this is also often poorly indexed . A search strategy in MEDLINE should contain both Medical Subject Headings and free text words . A search strategy for articles about tests for bladder cancer , for example , should include as many synonyms for bladder cancer as possible in the search strategy , including neoplasm , carcinoma , transitional cell , and hematuria . Several method ological electronic search filters for diagnostic test accuracy studies have been developed , each attempting to restrict the search to articles that are most likely to be test accuracy studies ( 1316 ) . These filters rely on indexing terms for research methodology and text words used in reporting results , but they often miss relevant studies and are unlikely to decrease the number of articles one needs to screen . Therefore , they are not recommended for systematic review s ( 17 , 18 ) . The incremental value of search ing in language s other than English and in the gray literature has not yet been fully investigated . In systematic review s of intervention studies , publication bias is an important and well-studied form of bias in which the decision to report and publish studies is linked to their findings . For clinical trials , the magnitude and determinants of publication bias have been identified by tracing the publication history of cohorts of trials review ed by ethics committees and research boards ( 19 ) . A consistent observation has been that studies with significant results are more likely to be published than studies with nonsignificant findings ( 19 ) . Investigating publication bias for diagnostic tests is problematic , because many studies are done without ethical review or study registration ; therefore , identification of cohorts of studies from registration to final publication status BACKGROUND Prader-Willi syndrome ( PWS ) is a congenital alteration of chromosome pair 15 . It is characterized by short stature , muscular hypotonia , hyperphagia , obesity , behavioural and emotional disturbances , hypogonadism and partial Growth Hormone ( GH ) deficiency . The aim of this study was to assess the long-term effect of GH treatment on the psychological well-being and Quality of Life ( QoL ) in an adult PWS group . METHODS A total of 13 PWS patients , their diagnosis confirmed by genetic tests , and their parents were recruited for this study . The participants were administered the 36-Items Short Form Health Survey ( SF-36 ) and the Psychological General Well-Being Index ( PGWBI ) , for the assessment of QoL and psychological well-being , at the beginning of GH treatment , and at following intervals of 6 , 12 and 24 months . Modified versions of the same question naires were given to the parents . RESULTS Significant improvement with respect to the baseline was found , on both scales , in the evaluation of both physical and psychological well-being , although the parents ' evaluation was less optimistic than that of the patients . CONCLUSION Our findings suggest that the amelioration of QoL and psychological status is sustained in patients who continue GH treatment 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 The effects on quality of life and psychological well-being of a health examination programme in a branch of Swedish industry were studied by means of question naires in 124 white-collar workers . They were asked to answer two question naires , one before and the other one month after the examination ( the Nottingham Health Profile ( NHP ) and the Psychological General Well-being Schedule ( PGWB ) ) . Both are well-known and well-documented st and ard question naires used for estimating quality of life and degree of subjective well-being . The answers were compared with those of a control group comprising other white-collar workers in the same industry , of the same sex and age but who did not participate in the health examination  and who were asked to complete the same question naires twice . The group that had participated in the health examination did not differ generally from the control group with respect to intra-individual differences as studied in the question naires on the two occasions . This indicates that no deterioration of quality of life or of psychological well-being was experienced by the participants in the health examination Emerging health problems require rapid advice . We describe the development and pilot testing of a systematic , transparent approach used by the World Health Organization ( WHO ) to develop rapid advice guidelines in response to requests from member states confronted with uncertainty about the pharmacological management of avian influenza A ( H5N1 ) virus infection . We first search ed for systematic review s of r and omized trials of treatment and prevention of seasonal influenza and for non-trial evidence on H5N1 infection , including case reports and animal and in vitro studies . A panel of clinical experts , clinicians with experience in treating patients with H5N1 , influenza research ers , and method ologists was convened for a two-day meeting . Panel members review ed the evidence prior to the meeting and agreed on the process . It took one month to put together a team to prepare the evidence profiles ( i.e. , summaries of the evidence on important clinical and policy questions ) , and it took the team only five weeks to prepare and revise the evidence profiles and to prepare draft guidelines prior to the panel meeting . A draft manuscript for publication was prepared within 10 days following the panel meeting . Strengths of the process include its transparency and the short amount of time used to prepare these WHO guidelines . The process could be improved by shortening the time required to commission evidence profiles . Further development is needed to facilitate stakeholder involvement , and evaluate and ensure the guideline 's usefulness
The review demonstrated that the WHO-5 has high clinimetric validity , can be used as an outcome measure balancing the wanted and unwanted effects of treatments , is a sensitive and specific screening tool for depression and its applicability across study fields is very high .
Conclusions : The WHO-5 is a short question naire consisting of 5 simple and non-invasive questions , which tap into the subjective well-being of the respondents .
The scale has adequate validity both as a screening tool for depression and as an outcome measure in clinical trials and has been applied successfully across a wide range of study fields
Background : The 5-item World Health Organization Well-Being Index ( WHO-5 ) is among the most widely used question naires assessing subjective psychological well-being .
Since its first publication in 1998 , the WHO-5 has been translated into more than 30 language s and has been used in research studies all over the world .
We now provide a systematic review of the literature on the WHO-5 .