Systematic Review: Inspiratory Muscle Training in Patients with Chronic Obstructive Pulmonary Disease: The State of the Evidence Comparison of tools for assessing the methodological quality of primary and secondary studies in health technology assessment reports in Germany Development of a core outcome set for disease modification trials in mild to moderate dementia: a systematic review, patient and public consultation and consensus recommendations. A checklist to evaluate a report of a nonpharmacological trial (CLEAR NPT) was developed using consensus. Society for Immunotherapy of Cancer consensus statement on immunotherapy for the treatment of bladder carcinoma Society for Immunotherapy of Cancer consensus statement on immunotherapy for the treatment of bladder carcinoma. Guidelines for randomized clinical trial protocol content: a systematic review Recommended Measures for the Assessment of Cognitive and Physical Performance in Older Patients with Dementia: A Systematic Review Reliability of the PEDro scale for rating quality of randomized controlled trials. Assessing Care of Vulnerable Elders: Methods for Developing Quality Indicators Standardized Reporting of Clinical Practice Guidelines: A Proposal from the Conference on Guideline Standardization
Purpose : The purpose of the present review was to assess the quality of evidence in the literature regarding the specific benefits of inspiratory muscle training ( IMT ) with an emphasis on training intensity and the relationships between changes in inspiratory muscle function and other clinical outcome measures . Methods : Articles were found by search ing CINAHL , PubMed , Medline via First Search , and ProQuest data bases . Articles used in the review were r and omized trials of IMT vs. sham IMT or no intervention  , published in English in a peer‐ review ed journal , included patients with chronic obstructive pulmonary disease ( COPD ) , and specified the intensity of training . The quality of the studies was evaluated by 2 independent review ers using the method ological rigor scale described by Medlicott and Harris as well as Sackett 's levels of evidence . Fifteen articles met the inclusion criteria and were used in this review . Results : Consistent improvements in maximal inspiratory pressures ( ranging from ‐11 to ‐30 cm H2O ) and inspiratory muscle endurance were found . Improvements in dyspnea and health‐related quality of life were also observed . Inspiratory muscle training may result in improved exercise tolerance as measured using walking tests . High‐intensity IMT result ed in improved training efficiency with respect to inspiratory muscle strength , but evidence of the effect of high‐intensity IMT on other clinical outcomes is lacking . Conclusion : Despite research spanning decades , there are numerous limitations in the literature regarding IMT . IMT appears to improve dyspnea , waking test distance , and health‐related quality of life in individuals with COPD , but it is not clear whether this improvement is mediated through improved inspiratory muscle strength and endurance . This review discussed several considerations critical to the design of future trials Health care policy background Findings from scientific studies form the basis for evidence -based health policy decisions . Scientific background Quality assessment s to evaluate the credibility of study results are an essential part of health technology assessment reports and systematic review s. Quality assessment tools ( QAT ) for assessing the study quality examine to what extent study results are systematic ally distorted by confounding or bias ( internal validity ) . The tools can be divided into checklists , scales and component ratings . Research questions What QAT are available to assess the quality of interventional studies or studies in the field of health economics , how do they differ from each other and what conclusions can be drawn from these results for quality assessment s ? Methods A systematic search of relevant data bases from 1988 onwards is done , supplemented by screening of the references , of the HTA reports of the German Agency for Health Technology Assessment ( DAHTA ) and an internet search . The selection of relevant literature , the data extraction and the quality assessment are carried out by two independent review ers . The substantive elements of the QAT are extracted using a modified criteria list consisting of items and domains specific to r and omized trials , observational studies , diagnostic studies , systematic review s and health economic studies . Based on the number of covered items and domains , more and less comprehensive QAT are distinguished . In order to exchange experiences regarding problems in the practical application of tools , a workshop is hosted . Results A total of eight systematic method ological review s is identified as well as 147 QAT : 15 for systematic review s , 80 for r and omized trials , 30 for observational studies , 17 for diagnostic studies and 22 for health economic studies . The tools vary considerably with regard to the content , the performance and quality of operationalisation . Some tools do not only include the items of internal validity but also the items of quality of reporting and external validity . No tool covers all elements or domains . Design -specific generic tools are presented , which cover most of the content criteria . Discussion The evaluation of QAT by using content criteria is difficult , because there is no scientific consensus on the necessary elements of internal validity , and not all of the generally accepted elements are based on empirical evidence . Comparing QAT with regard to contents neglects the operationalisation of the respective parameters , for which the quality and precision are important for transparency , replicability , the correct assessment and interrater reliability . QAT , which mix items on the quality of reporting and internal validity , should be avoided . Conclusions There are different , design -specific tools available which can be preferred for quality assessment , because of its wider coverage of substantive elements of internal validity . To minimise the subjectivity of the assessment , tools with a detailed and precise operationalisation of the individual elements should be applied . For health economic studies , tools should be developed and complemented with instructions , which define the appropriateness of the criteria . Further research is needed to identify study characteristics that influence the internal validity of studies BACKGROUND There is currently no disease-modifying treatment available to halt or delay the progression of the disease pathology in dementia . An agreed core set of the best-available and most appropriate outcomes for disease modification would facilitate the design of trials and ensure consistency across disease modification trials , as well as making results comparable and meta-analysable in future trials . OBJECTIVES To agree a set of core outcomes for disease modification trials for mild to moderate dementia with the UK dementia research community and patient and public involvement ( PPI ) . DATA SOURCES We included disease modification trials with quantitative outcomes of efficacy from ( 1 ) references from related systematic review s in workstream 1 ; ( 2 ) search es of the Cochrane Dementia and Cognitive Improvement Group study register , Cochrane Central Register of Controlled Trials , Cumulative Index to Nursing and Allied Health Literature , EMBASE , Latin American and Caribbean Health Sciences Literature and PsycINFO on 11 December 2015 , and clinical trial registries [ International St and ard R and omised Controlled Trial Number ( IS RCT N ) and clinical trials.gov ] on 22 and 29 January 2016 ; and ( 3 ) h and - search es of reference lists of relevant systematic review s from data base search es . REVIEW METHODS The project consisted of four workstreams . ( 1 ) We obtained related core outcome sets and work from co-applicants . ( 2 ) We systematic ally review ed published and ongoing disease modification trials to identify the outcomes used in different domains . We extracted outcomes used in each trial , recording how many used each outcome and with how many participants . We divided outcomes into the domains measured and search ed for validation data . ( 3 ) We consulted with PPI participants about recommended outcomes . ( 4 ) We presented all the synthesis ed information at a conference attended by the wider body of National Institute for Health Research ( NIHR ) dementia research ers to reach consensus on a core set of outcomes . RESULTS We included 149 papers from the 22,918 papers screened , referring to 125 individual trials . Eighty-one outcomes were used across trials , including 72 scales [ 31 cognitive , 12 activities of daily living ( ADLs ) , 10 global , 16 neuropsychiatric and three quality of life ] and nine biological techniques . We consulted with 18 people for PPI . The conference decided that only cognition and biological markers are core measures of disease modification . Cognition should be measured by the Mini Mental State Examination ( MMSE ) or the Alzheimer 's Disease Assessment Scale - Cognitive subscale ( ADAS-Cog ) , and brain changes through structural magnetic resonance imaging ( MRI ) in a subset of participants . All other domains are important but not core . We recommend using the Neuropsychiatric Inventory for neuropsychiatric symptoms : the Disability Assessment for Dementia for ADLs , the Dementia Quality of Life Measure for quality of life and the Clinical Dementia Rating scale to measure dementia globally . LIMITATIONS Most of the trials included participants with Alzheimer 's disease , so recommendations may not apply to other types of dementia . We did not conduct economic analyses . The PPI consultation was limited to members of the Alzheimer 's Society Research Network . CONCLUSIONS Cognitive outcomes and biological markers form the core outcome set for future disease modification trials , measured by the  MMSE or ADAS-Cog , and structural MRI in a subset of participants . FUTURE WORK We envisage that the core set may be superseded in the future , particularly for other types of dementia . There is a need to develop an algorithm to compare scores on the MMSE and ADAS-Cog . STUDY REGISTRATION The project was registered with Core Outcome Measures in Effectiveness Trials [ www.comet-initiative.org/ studies /details/819 ? result = true ( accessed 7 April 2016 ) ] . The systematic review protocol is registered as PROSPERO CRD42015027346 . FUNDING The National Institute for Health Research Health Technology Assessment programme BACKGROUND AND OBJECTIVE To develop a checklist of items measuring the quality of reports of r and omized clinical trials ( RCTs ) assessing nonpharmacological treatments ( NPTs ) . STUDY DESIGN AND SETTING The Delphi consensus method was used to select and reduce the number of items in the checklist . A total of 154 individuals were invited to participate : epidemiologists and statisticians involved in the field of methodology of RCTs ( n = 55 ) , members of the Cochrane Collaboration ( n = 41 ) , and clinicians involved in planning NPT clinical trials ( n = 58 ) . Participants ranked on a 10-point Likert scale whether an item should be included in the checklist . RESULTS Fifty-five experts ( 36 % ) participated in the survey . They were experienced in systematic review s ( 68 % were involved in the Cochrane Collaboration ) and in planning RCTs ( 76 % ) . Three rounds of the Delphi method were conducted to achieve consensus . The final checklist contains 10 items and 5 subitems , with items related to the st and ardization of the intervention , care provider influence , and additional measures to minimize the potential bias from lack of blinding of participants , care providers , and outcome assessors . CONCLUSIONS This tool can be used to critically appraise the medical literature , design NPT studies , and assess the quality of trial reports included in systematic review The st and ard of care for most patients with non-muscle-invasive bladder cancer ( NMIBC ) is immunotherapy with intravesical Bacillus Calmette-Guérin ( BCG ) , which activates the immune system to recognize and destroy malignant cells and has demonstrated durable clinical benefit . Urologic best- practice guidelines and consensus reports have been developed and strengthened based on data on the timing , dose , and duration of therapy from r and omized clinical trials , as well as by critical evaluation of criteria for progression . However , these reports have not penetrated the community , and many patients do not receive appropriate therapy . Additionally , several immune checkpoint inhibitors have recently been approved for treatment of metastatic disease . The approval of immune checkpoint blockade for patients with platinum-resistant or -ineligible metastatic bladder cancer has led to considerations of exp and ed use for both advanced and , potentially , localized disease . To address these issues and others surrounding the appropriate use of immunotherapy for the treatment of bladder cancer , the Society for Immunotherapy of Cancer ( SITC ) convened a Task Force of experts , including physicians , patient advocates , and nurses , to address issues related to patient selection , toxicity management , clinical endpoints , as well as the combination and sequencing of therapies . Following the st and ard approach established by the Society for other cancers , a systematic literature review and analysis of data , combined with consensus voting was used to generate guidelines . Here , we provide a consensus statement for the use of immunotherapy in patients with bladder cancer , with plans to up date these recommendations as the field progresses The st and ard of care for most patients with non-muscle-invasive bladder cancer ( NMIBC ) is immunotherapy with intravesical Bacillus Calmette-Guérin ( BCG ) , which activates the immune system to recognize and destroy malignant cells and has demonstrated durable clinical benefit . Urologic best- practice guidelines and consensus reports have been developed and strengthened based on data on the timing , dose , and duration of therapy from r and omized clinical trials , as well as by critical evaluation of criteria for progression . However , these reports have not penetrated the community , and many patients do not receive appropriate therapy . Additionally , several immune checkpoint inhibitors have recently been approved for treatment of metastatic disease . The approval of immune checkpoint blockade for patients with platinum-resistant or -ineligible metastatic bladder cancer has led to considerations of exp and ed use for both advanced and , potentially , localized disease . To address these issues and others surrounding the appropriate use of immunotherapy for the treatment of bladder cancer , the Society for Immunotherapy of Cancer ( SITC ) convened a Task Force of experts , including physicians , patient advocates , and nurses , to address issues related to patient selection , toxicity management , clinical endpoints , as well as the combination and sequencing of therapies . Following the st and ard approach established by the Society for other cancers , a systematic literature review and analysis of data , combined with consensus voting was used to generate guidelines . Here , we provide a consensus statement for the use of immunotherapy in patients with bladder cancer , with plans to up date these recommendations as the field progresses Background All r and omized clinical trials ( RCTs ) require a protocol ; however , numerous studies have highlighted protocol deficiencies . Reporting guidelines may improve the content of research reports and , if developed using robust methods , may increase the utility of reports to stakeholders . The objective of this study was to systematic ally identify and review RCT protocol guidelines , to assess their characteristics and methods of development , and to compare recommendations . Methods We conducted a systematic review of indexed literature ( MEDLINE , EMBASE and the Cochrane Methodology Register from inception to September 2010 ; reference lists ; related article features ; forward citation search ing ) and a targeted search of supplementary sources , including a survey of major trial funding agencies in six countries . Records were eligible if they described a content guideline in English or French relevant to RCT protocol s. Guidelines were excluded if they specified content for protocol s for trials of specific procedures or conditions or were intended to assess trial quality . We extracted guideline characteristics and methods . Content was mapped for a subset of guidelines that described development methods or had institutional endorsement . Results Forty guidelines published in journals , books and institutional reports were included in the review ; seven were specific to RCT protocol s. Only eight ( 20 % ) described development methods which included informal consensus methods , pilot testing and formal validation ; no guideline described all of these methods . No guideline described formal consensus methods or a systematic retrieval of empirical evidence to inform its development . The guidelines included a median of 23 concepts per guideline ( interquartile range ( IQR ) = 14 to 34 ; range = 7 to 109 ) . Among the subset of guidelines ( n = 23 ) for which content was mapped , approximately 380 concepts were explicitly addressed ( median concepts per guideline IQR = 31 ( 24,80 ) ; range = 16 to 150 ) ; most concepts were addressed in a minority of guidelines . Conclusions Existing guidelines for RCT protocol content varied substantially in their recommendations . Few reports described the methods of guideline development , limiting comparisons of guideline validity . Given the importance of protocol s to diverse stakeholders , we believe a systematic ally developed , evidence -informed guideline for clinical trial protocol s is needed Aim / Goal : To recommend a set of neuropsychological and physical exercise tests for research ers to assess cognition and physical fitness in clinical trials with older patients with dementia ; to create consensus , decrease heterogeneity , and improve research quality . Methods : A literature search ( 2005–2011 ) yielded 89 r and omized controlled trials . To provide information on test recommendations the frequency of test use , effect size of the test outcome , study quality , and psychometric properties of tests were analyzed . Results : Fifty-nine neuropsychological tests ( cognitive domains : global cognition , executive functioning , memory , and attention ) and 10  exercise tests ( physical domains : endurance capacity , muscle strength , balance , and mobility ) were found . Conclusion : The Severe Impairment Battery , Mini Mental State Examination , and Alzheimer Disease Assessment Scale – cognitive subscale were recommended to measure global cognition . The Verbal Fluency Test Category/Letters , Clock Drawing Test , and Trail Making Test-B were recommended to measure executive functioning . No specific memory test could be recommended . The Digit Span Forward , Digit Span Backward , and Trail Making Test-A were recommended to measure attention . As physical exercise tests , the Timed Up and Go and Six Meter Walk for mobility , the Six Minute Walk Distance for endurance capacity , and the Tinetti Balance Scale were recommended BACKGROUND AND PURPOSE Assessment of the quality of r and omized controlled trials ( RCTs ) is common practice in systematic review s. However , the reliability of data obtained with most quality assessment scales has not been established . This report describes 2 studies design ed to investigate the reliability of data obtained with the Physiotherapy Evidence Data base ( PEDro ) scale developed to rate the quality of RCTs evaluating physical therapist interventions . METHOD In the first study , 11 raters independently rated 25 RCTs r and omly selected from the PEDro data base . In the second study , 2 raters rated 120 RCTs r and omly selected from the PEDro data base , and disagreements were resolved by a third rater ; this generated a set of individual rater and consensus ratings . The process was repeated by independent raters to create a second set of individual and consensus ratings . Reliability of ratings of PEDro scale items was calculated using multirater kappas , and reliability of the total ( summed ) score was calculated using intraclass correlation coefficients ( ICC [ 1,1 ] ) . RESULTS The kappa value for each of the 11 items ranged from.36 to.80 for individual assessors and from.50 to.79 for consensus ratings generated by groups of 2 or 3 raters . The ICC for the total score was.56 ( 95 % confidence interval=.47-.65 ) for ratings by individuals , and the ICC for consensus ratings was.68 ( 95 % confidence interval=.57-.76 ) . DISCUSSION AND CONCLUSION The reliability of ratings of PEDro scale items varied from " fair " to " substantial , " and the reliability of the total PEDro score was " fair " to " good . 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 Evidence -based clinical practice guidelines can reduce the delivery of inappropriate care and support the introduction of new knowledge into clinical practice ( 1 - 3 ) . In many cases , guidelines encapsulate the most current knowledge about best practice s. Rigorously developed guidelines can translate complicated research findings into actionable recommendations for clinical care ( 4 ) . Over the past decade , a plethora of guidelines has been created and published by a multitude of organizations at substantial cost . Despite the enormous energies invested in guideline authoring , the quality of individual guidelines varies considerably . In its l and mark report , the Institute of Medicine ( IOM ) defined 8 desirable attributes of clinical practice guidelines : validity , reliability and reproducibility , clinical applicability , clinical flexibility , clarity , documentation , development by a multidisciplinary process , and plans for review ( 5 ) . However , critical information that would attest to validity or would document fulfillment of the other IOM criteria is regularly absent from published guidelines . In an evaluation of 279 guidelines developed by U.S. medical specialty societies , Shaneyfelt and colleagues ( 6 ) found that guidelines published in the peer- review ed medical literature do not adhere to established method ologic st and ards . Likewise , Grilli and colleagues ( 7 ) found that of 431 guidelines produced by specialty societies , 82 % did not apply explicit criteria to grade the scientific evidence that supported their recommendations , 87 % did not report whether a systematic literature search was performed , and 67 % did not describe the type of professionals involved in guideline development . Systematic review s of guidelines for drug therapy ( 8) , management of depression ( 9 ) , and osteoporosis ( 10 ) have confirmed marked variation in quality . Both nonadherence to method ologic st and ards and failure to document development activities contribute to this variation . We convened the Conference on Guideline St and ardization ( COGS ) to define a st and ard for guideline reporting that would promote guideline quality and facilitate implementation . The proposed st and ard provides a checklist of components necessary for evaluation of validity and usability . The checklist is intended to minimize the quality defects that arise from failure to include essential information and to promote development of recommendation statements that are more easily implemented . In contrast to other instruments that have been developed for post hoc evaluation of guideline quality , the COGS checklist is intended to be used prospect ively by developers to improve their product by improving documentation . The COGS panel used a systematic and rigorous process to define content of the proposed st and ard and to achieve consensus . The COGS panel also included a wide variety of perspectives , deliberately bringing together representatives from medical specialty societies , government agencies , and private groups that develop guidelines ; journal editors and the National Guideline Clearinghouse ( NGC ) , which disseminate guidelines ; guideline implementers , including managed care representatives and informaticians ; and academicians . Methods We actively sought people with diverse background s from wide-ranging geographic areas to participate in the meeting . Selection criteria for participants were 1 ) activity in a wide variety of guidelines initiatives , 2 ) recognition as leaders in their field , and 3 ) willingness to collaborate . To maximize interaction , the number of participants in the Conference was limited . We set as a task for the panelists the specification and definition of a set of necessary guideline components that should be considered for reporting in all evidence -based practice guidelines . We defined necessary items as those that establish the validity of the guideline recommendations or facilitate practical application of the recommendations . We noted that many additional items might be considered appropriate components in guidelines , but sought to define a minimal set of essential elements . We assembled a list of c and i date guideline components from the IOM Provisional Instrument for Assessing Clinical Guidelines ( 5 ) , the NGC ( 11 ) , and the Guideline Elements Model ( 12 ) , a hierarchical model of guideline content that was created from a systematic review of published guideline descriptions . These items were supplemented with items highlighted in the literature , for example , structured abstract ( 13 ) and conflict of interest ( 14 ) . We applied a modified Delphi approach to help focus group discussion . This approach has been widely applied for evaluation of expert opinion on appropriateness ( 15 ) and medical necessity ( 16 ) , for policy development ( 17 ) , and for prioritization ( 18 ) . The technique has been described in detail ( 19 ) . In brief , after we secured agreement to participate in the COGS panel , we gave all participants a bibliography of re sources regarding guideline quality and its appraisal , guideline implementation , and the modified Delphi consensus development approach . Panelists were asked to rate their agreement with the statement that [ Item name ] is a necessary component of practice guidelines on a 9-point scale . Rating an item with a 9 indicated strong agreement with the statement that this item was necessary . Rating an item with a 1 indicated strong disagreement with the statement and suggested that the item was absolutely unnecessary in a guideline . A rating of 5 indicated neutrality or indifference . We developed a password-protected Web site that panelists used to complete the first round of ratings online before the meeting . Online rating permitted accurate and efficient data capture and analysis . For each item , the median rating and the disagreement index ( defined as the Interpercentile Range divided by the Interpercentile Range Adjusted for Symmetry ) were calculated ( 19 ) . The disagreement index , which can be calculated for panels of any size , describes the dispersion of ratings more effectively than the mean absolute deviation from the median . Index values greater than 1 indicate disagreement . We displayed summary statistics for each item on a form that was individualized for each panelist . The COGS meeting was held on 26 and 27 April 2002 in New Haven , Connecticut . In a colloquy facilitated by 2 of the authors , each c and i date item was discussed to ensure that all participants agreed on its definition and potential contribution to the COGS checklist and to highlight empirical evidence of its value . When appropriate , additional items were added to the list . The group determined that in the second round of ratings , it would be valuable to rate each item 's necessity on 2 subscales : necessity to establish validity and necessity for practical application . The participants then rated each item on these 2 dimensions . Analysis We tallied the median score and the disagreement index for each item . We retained items with median scores of 7 or higher and disagreement indexes less than 1.0 on either scale as necessary guideline components on the checklist . To interpret necessity , the 9-point scale is divided into 3 ranges : items scoring 1 to 3 are considered unnecessary , items scoring 4 to 6 are neutral , and items scoring 7 to 9 are considered necessary ( 20 ) . In this study , the threshold of 7 was chosen because it represented the lowest rating at which the participants indicated that an item was necessary for inclusion in guidelines . Pilot Review To field test the proposed checklist , we surveyed organizations that were active in guideline development . We identified all organizations that met the NGC Web site criteria for guideline display on 12 July 2002 . From that list , we selected organizations that had developed 10 or more guidelines displayed on the NGC Web site . We excluded 1 ) organizations that participated in development of the COGS checklist [ because of potential bias ] and 2 ) government agencies and organizations based outside the United States ( for logistic reasons ) . A draft COGS checklist and a brief survey were sent to the people identified as being responsible for guideline development at each eligible organization . Results All 23 panelists su bmi tted first- and second-round ballots . During the discussion , participants suggested consideration of 10 new items in the second round of balloting and refined definitions of several items . Thirty-six discrete items were considered necessary to establish guideline validity ; they received ratings of 7 or greater and had disagreement indexes of less than 1 . Twenty-four items were considered necessary for practical application of the guideline , each with a disagreement index less than 1 . Several items were rated necessary on both dimensions . Overall , 44 discrete items were considered necessary . Closely related items were then consoli date d into 18 topics to create the COGS checklist for reporting clinical guidelines ( Table ) . Appendix Tables 1 and 2 present a complete listing of all items rated and their scores . Table . The COGS Checklist for Reporting Clinical Practice Guidelines Appendix Table 1 . Items Ranked Necessary for Guideline Validity , Median Ratings , Distribution of Ratings by Tertiles , and Disagreement Index Appendix Table 2 . Items Ranked Necessary for Guideline Usability , Median Ratings , Distribution of Ratings by Tertiles , and Disagreement Index Twenty-two organizations met eligibility criteria for evaluation of the draft checklist , and all completed the survey ( 100 % response rate ) . Sixteen organizations ( 73 % ) responded that they believed the checklist would be helpful for creating more comprehensive practice guidelines , and an additional 2 organizations ( 9 % ) responded that it might be helpful . Nineteen respondents ( 86 % ) indicated that documenting the proposed items would fit within their organizations ' guideline development methods . Fifteen ( 68 % ) stated that they would use the proposed checklist in guideline
RESULTS We found that none of the 19 instruments have sufficiently comprehensive reporting of measurement or feasibility performance as would be required by regulatory authorities .
INTRODUCTION In an accompanying study we reported on the content of several activity rating scales that have been used for muscle disease .
To further aid in achieving consensus we conducted a systematic review to assess the quality of the 19 activity rating scales  design ed specifically for muscle disease .