Evidence-based behavioral medicine: What is it and how do we achieve it? The standardized development method of the Japanese guidelines for cancer screening. Elusive search for effective provider interventions: a systematic review of provider interventions to increase adherence to evidence-based treatment for depression Editorial: Standards of Reporting: The CONSORT, QUORUM, and STROBE Guidelines Implementing PRISMA-P: recommendations for prospective authors A Pan-Canadian practice guideline: prevention, screening, assessment, and treatment of sleep disturbances in adults with cancer Moving forward toward standardizing analysis of quality of life data in randomized cancer clinical trials Management of Depression in Patients With Cancer: A Clinical Practice Guideline. Standardized Reporting of Clinical Practice Guidelines: A Proposal from the Conference on Guideline Standardization Part 3: Evidence evaluation process: 2010 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science with Treatment Recommendations. Adherence of randomized trials within children's surgical specialties published during 2000 to 2009 to standard reporting guidelines. Assessing the utility of the standards for reporting trials of acupuncture (STRICTA): a survey of authors. Adherence to published standards of reporting: a comparison of placebo-controlled trials published in English or German. Exercise for people with cancer: a clinical practice guideline. National Cancer Institute-sponsored Working Group guidelines for chronic lymphocytic leukemia: revised guidelines for diagnosis and treatment. Antibiotics in trauma and orthopedic surgery -- a primer of evidence-based recommendations. Clinical research in implant dentistry: study design, reporting and outcome measurements: consensus report of Working Group 2 of the VIII European Workshop on Periodontology. Abnormal uterine bleeding in pre-menopausal women. Trial registration and adherence to reporting guidelines in cardiovascular journals A Description of the Trials, Reviews, and Practice Guidelines Indexed in the PEDro Database Methods for Development of the European Commission Initiative on Breast Cancer Guidelines Guidelines for randomized clinical trial protocol content: a systematic review Description of a Chronic Heart Failure Service Model and Review of Pharmacotherapy in a District General Hospital in Comparison to Scottish Intercollegiate Guideline Network (SIGN) Guidelines.
The goal of evidence -based medicine is ultimately to improve patient outcomes and quality of care .  Systematic review s of the available published evidence are required to identify interventions that lead to improvements in behavior , health , and well-being . Authoritative literature review s depend on the quality of published research and research reports . The Consoli date d St and ards for Reporting Trials ( CONSORT ) Statement ( www.consort-statement.org ) was developed to improve the design and reporting of interventions involving r and omized clinical trials ( RCTs ) in medical journals . We describe the 22 CONSORT guidelines and explain their application to behavioral medicine research and to evidence -based practice . Additional behavioral medicine-specific guidelines ( e.g. , treatment adherence ) are also presented . Use of these guidelines by clinicians , educators , policymakers , and research ers who design , report , and evaluate or review RCTs will strengthen the research itself and accelerate efforts to apply behavioral medicine research to improve the processes and outcomes of behavioral medicine practice BACKGROUND To reduce cancer mortality , effective screening should be implemented properly . In Japan , the Research Group for Cancer Screening developed screening guidelines ; however , the development process was not well established . METHODS Based on the development processes of other guidelines , an original method , unique to Japan , was established to develop the Japanese cancer screening guidelines . RESULTS The guideline development process involved the following steps : topic selection , development of the analytic framework , systematic literature review , translation to recommendations , consultation and publication . Mortality reduction related to cancer screening was evaluated using both direct and indirect evidence . To select appropriate articles , an analytic framework for cancer screening program with key questions was developed . Direct evidence was defined as a single body of evidence that established the linkage between screening and health outcomes such as mortality and incidence . The use of indirect evidence to determine the level of evidence was limited to situations where test accuracy could be compared with that of a method whose evidence was supported by r and omized , controlled trials . Eight levels of evidence were defined based on the study design and quality . The benefits of each screening modality were determined based on the level of evidence according to the results of the systematic review . Balancing the benefits and harms , five grade s of recommendation were formulated for population -based and opportunistic screening . After organized consultations , three types of guidelines were published . CONCLUSION We developed a unique , st and ardized method for developing cancer screening guidelines in Japan . Based on this process , previously developed cancer screening guidelines have been revised Background Depression is a common mental health disorder for which clinical practice guidelines have been developed . Prior systematic review s have identified complex organizational interventions , such as collaborative care , as effective for guideline implementation ; yet , many healthcare delivery organizations are interested in less re source -intensive methods to increase provider adherence to guidelines and guideline -concordant practice s. The objective of this systematic review was to assess the effectiveness of  healthcare provider  interventions that aim to increase adherence to evidence -based treatment of depression in routine clinical practice . Methods We search ed five data bases through August 2017 using a comprehensive search strategy to identify English- language r and omized controlled trials ( RCTs ) in the quality improvement , implementation science , and behavior change literature that evaluated outpatient provider interventions , in the absence of practice re design efforts , to increase adherence to treatment guidelines or guideline -concordant practice s for depression . We used meta- analysis to summarize odds ratios , st and ardized mean differences , and incidence rate ratios , and assessed quality of evidence ( QoE ) using the GRADE approach . Results Twenty-two RCTs promoting adherence to clinical practice guidelines or guideline -concordant practice s met inclusion criteria . Studies evaluated diverse provider interventions , including distributing guidelines to providers , education/training such as academic detailing , and combinations of education with other components such as targeting implementation barriers . Results were heterogeneous and analyses comparing provider interventions with usual clinical practice did not indicate a statistically significant difference in guideline adherence across studies . There was some evidence that provider interventions improved individual outcomes such as medication prescribing and indirect comparisons indicated more complex provider interventions may be associated with more favorable outcomes . We did not identify types of provider interventions that were consistently associated with improvements across indicators of adherence and across studies . Effects on patients ’ health in these RCTs were inconsistent across studies and outcomes . Conclusions Existing RCTs describe a range of provider interventions to increase adherence to depression guidelines . Low QoE and lack of replication of specific intervention strategies across studies limited conclusions that can be drawn from the existing research . Continued efforts are needed to identify successful strategies to maximize the impact of provider interventions on increasing adherence to evidence -based treatment for depression . Trial registration PROSPERO record CRD42017060460 on St and ards of scientific reporting have evolved from the very beginning of scientific reporting . Virtually all journals now publish instructions for authors and most medical journals adhere to certain st and ards of publication . Such st and ards have been promoted by international groups such as the International Committee of Medical Journal Editors ( ICMJE ) and Committee on Publication Ethics ( COPE ) . The ICMJE has published general st and ards for crafting scientific articles : the “ Uniform Requirements for Manuscripts Su bmi tted to Biomedical Journals : Writing and Editing for Biomedical Publication ” [ 7 ] . These guidelines include suggestions not only for manuscript preparation , but also guidelines for ethical issues related to publishing . COPE , however , focuses on ethical issues [ 1 ] . CORR adheres to these guidelines ; authors may find links to these guidelines in our online Instructions for Authors . Such guidelines , as important as they are , lack sufficient detail to ensure all important information is included . Therefore , in addition to these general guidelines for preparing a manuscript , numerous international groups have published guidelines to ensure various sorts of studies contain all essential information . These include the CONSORT ( Consoli date d St and ards of Reporting Trials ) guidelines for r and omized trials [ 2 , 3 , 8 ] , QUORUM ( Quality of Reporting of Meta-analyses ) [ 6 ] and MOOSE ( Meta- analysis Of Observational Studies in Epidemiology ) [ 13 ] for meta-analyses , and STROBE ( Strengthening the Reporting of Observational Studies in Epidemiology ) for various sorts of observational studies ( the majority of clinical studies in surgical disciplines ) [ 12 , 15 ] . In essence , these guidelines tell investigators and authors what information is required to ensure readers ( and review ers ) can properly evaluate the study . Despite these st and ards , most reports of clinical studies lack such critical information . I suspect this is less by intent than lack of awareness of what information is required . In addition , although many journals , including CORR require a Level of Evidence [ 5 , 10 , 16 ] for studies involving patients , most clinical articles published in surgical journals have a relatively low level ; prospect i ve , r and omized trials are uncommon ( and often impractical ) , and even sufficiently large retrospective cohort studies to control for confounding variables may be unachievable for many conditions or treatments in single institutions . In the absence of high levels of evidence , systematic review s [ 9 , 11 , 17 ] and meta-analyses [ 4 ] have become increasingly common . My search of PubMed for articles limited to meta- analysis yielded 276 articles from 1950–1989 , 2116 from 1990–1994 , 3736 from 1995–1999 , 7920 from 2000–2004 , and 9313 from 2005 to 2009 . Most of these analyses undoubtedly collected information from lower level studies , thereby incurring the limitations of the individual studies . Virtually all systematic and meta-analyses we have recently published noted missing and variably reported data . In contrast to medical disciplines , surgical disciplines do not have the advantage of being able to conduct tightly design ed prospect i ve , r and omized , blinded , controlled trials . ( A PubMed search limited to r and omized controlled trials suggested The Journal of Bone and Joint Surgery and CORR had together published 556 RCTs and although I did not individually check these for quality , they reflect a small fraction of the articles both journals publish . ) For the foreseeable future , most of our information will arise from observational studies rather than prospect i ve trials . In this setting , it is especially important that each article contain all relevant information for future systematic review s and meta-analyses . The STROBE guidelines [ 12 ] provide authors with lists of critical information for reporting three sorts of observational studies : cohort ( longitudinal studies typically reporting outcomes of treatment in one or more cohorts ) , case-control ( studies identifying factors in outcomes ) , and cross-sectional studies ( studies to identify prevalence of factors or characteristics in a population at a single time ) . CORR now requires authors to adhere to CONSORT guidelines for r and omized clinical trials , QUORUM guidelines for meta-analyses , and STROBE guidelines for observational clinical studies . Authors will be able to download from our Instructions to Authors convenient templates for the various sorts of articles we publish ; these templates contain the information required . In addition , we request authors read and follow the guidelines in the Cochrane H and book for Systematic Review s of Interventions 4.2.6 [ 14 ] . Adherence to these st and ards will enhance our ability to answer key clinical questions in more definitive ways than we have in the past , and to answer more questions Systematic review s have become very popular . A recent estimate suggests that 22 new systematic review s are published daily [ 1 ] . One reason for this interest is that they serve many purpose s. For example , the influential Institute of Medicine has indicated that a systematic review is an essential component when developing clinical practice guidelines within the USA [ 2 ] . Some granting agencies are now advocating for the use of systematic review s as an evidence -based rationale for the conduct of a proposed r and omized trial [ 3 ] . And journals are now dem and ing the use of systematic review s to provide readers with context of the results of a clinical trial [ 4 ] . For systematic review s to be useful , they need to be reported in the highest possible quality thus facilitating their accurate use across a wide spectrum of stakeholders , including patients . Unfortunately , surveys of the published literature indicate that the quality of reporting is not optimal . For example , there is evidence indicating that reporting biases , particularly selective outcome reporting , is prevalent . An early example of differences between outcomes reported in protocol s and the paired completed review was an examination of 47 Cochrane review s in which 43 ( 91 % ) contained a major change , such as the addition or deletion of outcomes  , between the protocol and the full publication [ 5 ] . More recently , in an examination of 485 Cochrane protocol - review pairs , 38 % ( 95 % CI 23 to 54 % ) were found to have discrepant outcomes ( i.e. , added , omitted , or changed the priority ) between the protocol and completed review [ 6 ] . The vast majority of these discrepancies were without attribution with more significant outcomes being up grade d or added . Whether or not , and to what extent , these examples reflect reporting biases is not clear . However , they represent inconsistencies that should be avoided by authors . The gold st and ard for identifying reporting biases is a comparison of the completed review with its paired protocol . Such an examination is difficult with systematic review s as too few of them report working from a protocol , although a growing number of funders are now requiring them . Perhaps , systematic review ers do not report or use protocol s because there has been little guidance on how to report them until recently . To help facilitate the use of reporting systematic review protocol s , the three of us and several colleagues developed Preferred Reporting Items for Systematic Review and Meta- Analysis Protocol s ( PRISMA -P ) [ 7 ] . This is a reporting guideline consisting of a 17-item checklist , to help prospect i ve authors in the preparation and reporting of a scientifically rigorous systematic review protocol . We also prepared a pedagogical explanation and elaboration document to facilitate its use [ 8 ] . Readers appear interested in the guidance . Since its publication a little more than a year ago , it has been downloaded about 45,000 times and cited ( Google scholar ) nearly 100 times . This journal and others have endorsed PRISMA -P. Here , we describe how the journal intends to implement it . All protocol su bmi ssions to the journal should use continuous line numbering in their manuscript . Authors should also include a completed PRISMA -P checklist indicating whether or not the requested item information is reported ( by completing the check mark ) . If the item is checked , authors should then specify the line number ( or range of line numbers ) where this information is described . Manuscripts accepted for publication will have the completed PRIMSA-P checklist ( on su bmi ssion ) included as an Appendix to their publication , which must be referenced within the main text ( Additional file 1 ) . Prospect i ve authors can download a Word version of the PRISMA -P checklist , which includes the two added columns , from the journal ’s website ( URL to be added)or the PRISMA website ( ttp://www . prisma -statement.org/Extensions/ Protocol s.aspx ) . If PRISMA -P was used to help report the protocol , it should be cited or the PRISMA -P URL ( http://www . prisma -statement.org/Extensions/ Protocol s.aspx ) on the PRISMA website should be reported . About half of what the journal publishes are protocol s of systematic review s. We want to ensure they are published to the highest possible quality . Endorsement and implementation of reporting guidelines appears to improve the completeness of reporting . For example , a systematic review examining the completeness of reporting in more than 16,000 r and omized trials in journals that endorsed the CONSORT statement , compared to journals that did not , found more complete reporting [ 9 ] . Similarly , examining 300 systematic review s published in February 2014 found that mention of PRISMA was associated with better reporting [ 1 ] . There is always a tension between an optimal implementation strategy and ensuring minimal barriers to su bmi ssion for prospect i ve authors . We believe the journal has achieved a good balance with this strategy . Protocol s su bmi tted for publication consideration from now on that do not include a completed checklist , including the two aforementioned columns , will be returned to the authors with instructions about the journal ’s systematic review protocol implementation strategy and invited to resu bmi t their continuously line numbered manuscript and appropriately completed checklist Purpose This study aims to provide recommendations on the optimal strategies and interventions for the prevention , screening , assessment , and management of  cancer-related sleep disturbance ( insomnia and insomnia syndrome ) in adult cancer population s. Methods A systematic search of the published health literature was conducted to identify r and omized controlled trials , clinical practice guidelines , systematic review s , and other guidance documents . The Sleep Disturbance Expert Panel [ comprised of nurses , psychologists , primary care physicians , oncologists , physicians specialized in sleep disturbances , research ers , and guideline method ologists ] review ed , discussed , and approved the final version of the guideline . Health care professionals across Canada were asked to provide feedback through an external review process . Results Three clinical practice guidelines and 12 r and omized controlled trials were identified as the evidence base . Overall , despite the paucity of evidence , the evidence and expert consensus suggest that it is important to screen and assess adult cancer patients for sleep disturbances using st and ardized screening tools on a routine basis . While prevention of sleep disturbance is the desired objective , cognitive behavioral therapies are effective in improving sleep outcomes . As part of the external review with 16 health care providers , 81 % indicated that they agreed with the recommendations as written . Conclusions Sleep difficulty is a prevalent problem in cancer population s that needs greater recognition by health professionals . Prevention , screening , assessment , and treatment strategies supported by the best available evidence are critical . Recommendations and care path algorithms for practice are offered Background There is currently a lack of consensus on how health-related quality of life and other patient-reported outcome measures in cancer r and omized clinical trials are analyzed and interpreted . This makes it difficult to compare results across r and omized controlled trials ( RCTs ) synthesize scientific research , and use that evidence to inform product labeling , clinical guidelines , and health policy . The Setting International St and ards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints Data for Cancer Clinical Trials ( SISAQOL ) Consortium aims to develop guidelines and recommendations to st and ardize analyses of patient-reported outcome data in cancer RCTs . Methods and Results Members from the SISAQOL Consortium met in January 2017 to discuss relevant issues . Data from systematic review s of the current state of published research in patient-reported outcomes in cancer RCTs indicated a lack of clear reporting of research hypothesis and analytic strategies , and inconsistency in definitions of terms , including “ missing data , ” “ health-related quality of life , ” and “ patient-reported outcome . ” Based on the meeting proceedings , the Consortium will focus on three key priorities in the coming year : developing a taxonomy of research objectives , identifying appropriate statistical methods to analyze patient-reported outcome data , and determining best practice s to evaluate and deal with missing data . Conclusion The quality of the Consortium guidelines and recommendations are informed and enhanced by the broad Consortium membership which includes regulators , patients , clinicians , and academics PURPOSE This report up date s the Cancer Care Ontario Program in Evidence -Based Care guideline for the management of  depression in adult patients with cancer . This guideline covers pharmacologic , psychological , and collaborative care interventions , with a focus on integrating practical management tools to assist clinicians in delivering appropriate treatments for depression in patients with cancer . METHODS Recommendations were developed by synthesizing information from extant guidelines and review s and search ing for r and omized controlled trials from the date of data base inception ( 1964 for MEDLINE and 1974 for EMBASE ) to January 2015 . Quality assessment of guidelines and systematic review s were conducted by using the Appraisal of Guidelines for Research and Evaluation II ( AGREE II ) , Assessment of Multiple Systematic Review s ( AMSTAR ) , and Cochrane Risk of Bias tools . Final recommendations were developed through a st and ardized Program in Evidence -Based Care multidisciplinary expert and knowledge user review process . RESULTS Two high- quality relevant clinical practice guidelines , eight pharmacologic trials , nine psychological trials , and eight collaborative care intervention trials composed the evidence base upon which the recommendations were developed . Eight specific recommendations were made to establish a st and ard of care for the management of depression in patients with cancer . The recommendations and practical management tools were review ed as being well organized and helpful , although systemic barriers to implementation were identified . CONCLUSION This up date d guideline supports the previous general recommendation that patients with cancer who have depression may benefit from psychological and /or pharmacologic interventions , without evidence for the superiority of any specific treatment over another . New recommendations for a collaborative care model that incorporates a stepped care approach suggest that multidisciplinary mental health care restructuring may be required for optimal management of depression 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 > “ There are known knowns . These are things we know that we know . There are known unknowns . That is to say , there are things that we now know we do n't know . But there are also unknown unknowns . These are things we do not know we do n't know . ” > > —United States Secretary of Defense Donald Rumsfeld ( February 2002 ) > “ Thought is the wind , knowledge the sail , and mankind the vessel . ” > > August Hare ( 1792–1834 ) The international resuscitation community , under the auspices of the International Liaison Committee on Resuscitation ( ILCOR ) , has performed an exhaustive review of the published literature related to resuscitation and emergency cardiovascular care ( ECC ) . We had the opportunity to build on the detailed process developed over the past decade that facilitated the publication of the international consensus statement on therapeutic hypothermia1 and the Consensus on Cardiopulmonary Resuscitation ( CPR ) and ECC Science With Treatment Recommendations in 2005 (C2005).2 The overall process has been informed by the increasing evidence base behind good , systematic literature review s.3,4 There are , however , many questions that have never been addressed in a r and omized controlled trial , and much of the supporting scientific literature is at lower levels of evidence ( LOEs ) . In total , 356 worksheet authors from 29 countries throughout the world completed 411 worksheets on 277 topics . The information from these worksheets , with additional iterations from the writing groups and editorial board , makes up the evidence base from which the 2010 International Consensus on CPR and ECC Science with Treatment Recommendations ( CoSTR ) document is derived . As has been the process since the evidence evaluation for Guidelines 2000,5 volunteers from around the world were asked to perform systematic review s of the literature . These review s were conducted according to st and ardized instructions in completing the evidence worksheet template , and these worksheets were subsequently review ed in a detailed iterative process ( see www . ILCOR.org).6 A revised worksheet template ( based on that BACKGROUND R and omized clinical trials ( RCTs ) are uncommon in pediatric surgical specialties and the quality of reporting is unknown . Our primary purpose was to analyze published surgical RCTs involving children to measure adherence to the Consoli date d St and ards of Reporting Trials ( CONSORT ) guidelines . STUDY DESIGN Published RCTs from January 1 , 2000 through December 31 , 2009 were review ed . The trials were evaluated for the presence of 7 CONSORT guidelines and also grade d according to the Jadad scale . RESULTS Two hundred and twenty-eight trials were included . Five trials met all 7 CONSORT criteria ( 2 % ) and 53 had a Jadad score of ≥3 ( 23 % ) . Slightly more than 50 % of all trials specified primary outcomes and < 25 % described power calculations according to CONSORT . Adherence to CONSORT guidelines for allocation concealment , r and omization description , and attrition details was even lower . There were significant differences between surgical specialties with regard to CONSORT adherence to the majority of the guidelines . Pediatric general surgery had the largest number of published RCTs . Pediatric orthopaedic surgery had the highest proportion of trials with a Jadad score ≥3 ( 40 % ) . CONCLUSIONS Adherence to CONSORT guidelines is low across the spectrum of children 's surgical specialties , although significant differences do exist . Future RCTs in children 's surgical specialties should specifically focus on areas of low adherence to reporting guidelines OBJECTIVE To inform the potential revision of St and ards for Reporting Interventions in Controlled Trials of Acupuncture ( STRICTA ) , we sought the opinion of acupuncture trial authors and systematic review ers to rank the utility of the guidelines and asked trial authors about their experiences using them . DESIGN Question naires ranking STRICTA items and qualitative responses about experience using the guidelines . SAMPLE The authors of 38 r and omized controlled acupuncture trials r and omly selected from a systematic search of those published in 2004 and 2005 were contacted with a question naire . Authors of 14 Cochrane acupuncture systematic review s or protocol s published in the same time frame were also sent a question naire . RESULTS Fifty-four percent ( 54 % ) ( 28/52 ) of the sample responded . Among the trial authors , 58 % ( 11/19 ) used STRICTA to help guide their writing , but more than half of these reported that the editing process had removed some or all of the STRICTA-specific items . STRICTA was seen as a helpful reference , but authors requested that some items be clarified . Respondents tended to rank the utility of STRICTA  highly overall , but five items in particular were not highly valued ; three of these pertained to details on the trial acupuncturists ' background . Authors flagged potential difficulties of reporting unusual trial design s in the current format of STRICTA . CONCLUSIONS Authors of acupuncture trials and systematic review s believe that STRICTA contributes to the reporting of acupuncture interventions and rate it highly . Because very few acupuncture studies are published in STRICTA-adopting journals , the editing process for journals unaware of the guidelines may be responsible for deleting acupuncture intervention-specific items . Several items remain unclear , and the relevance of STRICTA to some trial design s is question ed . A review of STRICTA is warranted to clarify and reconsider items , and targeted promotion to non-complementary and alternative medicine journals should be considered CONTEXT Although st and ards of reporting r and omized controlled trials are well established internationally , essential study elements continue to be omitted , which hampers interpretation and systematic review of r and omized controlled trials . OBJECTIVE To identify deficiencies in the quality of reporting of placebo-controlled r and omized trials published in German or English . DESIGN Observational study comparing 32 German- and 89 English- language reports of placebo-controlled trials with parallel design , published by the same group of authors between 1985 and 1994 . MAIN OUTCOME MEASURE High reporting quality , defined as adherence to published st and ards and measured by an 18-item scale based on 2 st and ard guidelines . RESULTS The mean quality score was 8.4 ( SD , 3.0 ; range , 1 - 16 ) of 18 . The difference of the mean quality scores between English- language reports compared with German- language reports was small ( 0.27 ; 95 % confidence interval , -0.97 to 1.52 ) . More articles reported clinical aspects than trial methods or statistics . CONCLUSION There is room for improvement in the reporting of placebo-controlled r and omized trials for both English and German reports BACKGROUND Development of this guideline was undertaken by the Exercise for People with Cancer Guideline Development Group , a group organized by Cancer Care Ontario 's Program in Evidence -Based Care ( pebc ) . The purpose of the guideline was to provide guidance for clinicians with respect to exercise for patients living with cancer , focusing on the benefits of specific types of exercise , recommendations about screening requirements for new referrals , and safety concerns . METHODS Consistent with the pebc 's st and ardized approach , a systematic search was conducted for existing guidelines , and systematic literature search es were performed in medline and embase for both systematic review s and primary literature . Content and methodology experts performed an internal review , which was followed by an external review by targeted experts and intended users . RESULTS The search identified three guidelines , eighteen systematic review s , and twenty-nine r and omized controlled trials with relevance to the topic . The present guideline provides recommendations for the duration , frequency , and intensity of exercise appropriate for people living with cancer . It also provides recommendations for pre-exercise assessment , safety concerns , and delivery models . CONCLUSIONS There is sufficient evidence to show that exercise provides benefits in quality of life and muscular and aerobic fitness for people with cancer both during and after treatment , and that it does not cause harm . The present guideline is intended to support the Canadian Society for Exercise Physiology 's Canadian physical activity guidelines . The recommendations are intended for clinicians and institutions treating cancer patients in Ontario , and for policymakers and program planners involved in the delivery of exercise programs for cancer patients N 1988 , THE National Cancer Institute-sponsored Working Group ( NCI-WC ) on chronic lymphocytic leukemia ( CLL ) published guidelines for the design and conduct of clinical trials in CLL with two major objectives : first , to facilitate comparisons of results of clinical trials in CLL by providing st and ardized eligibility , response , and toxicity criteria ; and , second , to encourage a framework on which to evaluate new scientific studies related to our increasing underst and ing of the biology and immunology of this disease . ' These guidelines were rapidly adopted by the majority of the clinical trials community , and were also used by the Food and Drug Administration during its evaluation process for the approval of fludarabine . The differences between these guidelines and those subsequently published by the International Working Group on CLL ( IWCLL ) , which were general- practice recommendations ' are listed in Table 1 . For diagnosis , the NCI-WC requires a lymphocyte count of 5 X loy & which is lower than the 10 X 109/L required by the IWCLL , unless the lymphocytes are B cells and the bone marrow is involved . To be considered a complete remission ( CR ) , the NCI-WC criteria specify that less than 30 % lymphocytes must be present in the bone marrow , with a recommendation that the clinical significance of lymphoid nodules be assessed prospect ively ( Table 1 ) ; the IWCLL allows focal infiltrates or nodules in the bone marrow aspirate and biopsy for CR . The IWCLL uses a shift in clinical stage as the sole index of partial remission ( PR ) , whereas the NCI-WC provides more specific criteria and recommends validation of the relevance of stage shift . The major differences were the well-defined criteria in the NCI guidelines regarding when to initiate therapy , hematologic toxicity , and other important components for clinical trials design . The purpose of this report is to present those revisions as considered necessary in view of advances in the past 8 years . Many of these revisions evolved as the guidelines were used in a systematic fashion in large clinical trials and , also , with the experience following the use of newer , more effective agents , such as fludarabine . " ' Although this report will focus on those changes recommended by the NCI-sponsored CLL Working Group , it will include sufficient details from the original guidelines so that the reader would find it a complete document by itself without having to refer to the older version Systematic review s and meta-analyses published in recent years have allowed drafting of evidence -based guidelines for antibiotic prophylaxis in orthopedic and trauma surgery . It is important to recognize the limitations of the recommendations derived from the available body of evidence . Since some of the most relevant r and omized controlled clinical trials were performed more than 20 years ago , it is sometimes difficult to apply the data to today 's clinical practice . In establishing consensus guidelines , it could prove difficult to identify areas for improvement through further research and better compliance . Although recommendations for optimized treatment of orthopedic implant infections are not currently based on first-class evidence , there are very promising new concepts emerging in this field , and we are awaiting more data and decisive conclusions from larger clinical trials AIMS The objective of this working group was to assess and make specific recommendations to improve the quality of reporting of clinical research in implant dentistry and discuss ways to reach a consensus on choice of outcomes . MATERIAL AND METHODS Discussion s were informed by three systematic review s on quality of reporting of observational studies ( case series , case-control and cohort ) and experimental research ( r and omized clinical trials ) . An additional systematic review provided information on choice of outcomes and analytical methods . In addition , an open survey among all workshop participants was utilized to capture a consensus view on the limits of currently used survival and success-based outcomes as well as to identify domains that need to be captured by future outcome systems . RESULTS The Workshop attempted to clarify the characteristics and the value in dental implant research of different study design s. In most areas , measurable quality improvements over time were identified . The Workshop recognized important aspects that require continued attention by clinical research ers , funding agencies and peer review ers to decrease potential bias . With regard to choice of outcomes , the limitations of currently used systems were recognized . Three broad outcome domains that need to be captured by future research were identified : ( i ) patient reported outcome measures , ( ii ) peri-implant tissue health and ( iii ) performance of implant supported restorations . Peri-implant tissue health can be measured by marginal bone level changes and soft tissue inflammation and can be incorporated in time to event analyses . CONCLUSIONS The Workshop recommended that collaboration between clinicians and epidemiologists/ clinical trials specialists should be encouraged . Aspects of design aim ed at limitation of potential bias should receive attention by clinical research ers , funding agencies and journal editors . Adherence to appropriate reporting guidelines such as STROBE and CONSORT are necessary st and ards . Research on outcome measure domains is an area of top priority and should urgently inform a proper process leading to a consensus on outcome measures in dental implant research BACKGROUND Abnormal uterine bleeding is the direct cause of a significant health care burden for women , their families , and society as a whole . Up to 30 % of women will seek medical assistance for this problem during their reproductive years . This guideline replaces previous clinical guidelines on the topic and is aim ed to enable health care providers with the tools to provide the latest evidence -based care in the diagnosis and the medical and surgical management of this common problem . OBJECTIVE To provide current evidence -based guidelines for the diagnosis and management of  abnormal uterine bleeding ( AUB ) among women of reproductive age . OUTCOMES Outcomes evaluated include the impact of AUB on quality of life and the results of interventions including medical and surgical management of AUB . METHODS Members of the guideline committee were selected on the basis of individual expertise to represent a range of practical and academic experience in terms of location in Canada , type of practice , subspecialty expertise , and general gynaecology background . The committee review ed relevant evidence in the English medical literature including published guidelines . Recommendations were established as consensus statements . The final document was review ed and approved by the Executive and Council of the SOGC . RESULTS This document provides a summary of up-to- date evidence regarding diagnosis , investigations , and medical and surgical management of AUB . The result ing recommendations may be adapted by individual health care workers when serving women with this condition . CONCLUSIONS Abnormal uterine bleeding is a common and sometimes debilitating condition in women of reproductive age . St and ardization of related terminology , a systematic approach to diagnosis and investigation , and a step-wise approach to intervention is necessary . Treatment commencing with medical therapeutic modalities followed by the least invasive surgical modalities achieving results satisfactory to the patient is the ultimate goal of all therapeutic interventions . EVIDENCE Published literature was retrieved through search es of MEDLINE and the Cochrane Library in March 2011 using appropriate controlled vocabulary ( e.g. uterine hemorrhage , menorrhagia ) and key words ( e.g. menorrhagia , heavy menstrual bleeding , abnormal uterine bleeding ) . Results were restricted to systematic review s , r and omized control trials/controlled clinical trials , and observational studies written in English and published from January 1999 to March 2011 . Search es were up date d on a regular basis and incorporated in the guideline to February 2013 . Grey ( unpublished ) literature was identified through search ing the websites of health technology assessment and health technology-related agencies , clinical practice guideline collection s , clinical trial registries , and national and international medical specialty societies . VALUES The quality of evidence in this document was rated using the criteria described in the Report of the Canadian Task Force on Preventive Health Care ( Table ) . BENEFITS , HARMS , AND COSTS Implementation of the guideline recommendations will improve the health and well-being of women with abnormal uterine bleeding , their families , and society . The economic cost of implementing these guidelines in the Canadian health care system was not considered Objective This study investigated the policies of cardiac and cardiovascular system journals concerning clinical trial registration and guideline adoption to underst and how frequently journals use these mechanisms to improve transparency , trial reporting and overall study quality . Methods We selected the top 20 ( by impact factor ) journals cited in the subcategory ‘ Cardiac and Cardiovascular Systems ’ of the Exp and ed Science Citation Index of the 2014 Journal Citation Reports to extract journal policies concerning the 17 guidelines we identified . In addition , trial and systematic review registration adherence statements were extracted . 300 r and omised controlled trials published in 2016 in the top 20 journals were search ed for clinical trial registry numbers and CONSORT diagrams . Results Of the 19 cardiac and cardiovascular system journals included in our analysis , eight journals ( 42 % ) did not require or recommend trial or review registration . Seven ( 37 % ) did not recommend or require a single guideline within their instructions to authors . Consoli date d St and ards for Reporting Trials guidelines ( 10/19 , 53 % ) were recommended or required most often . Of the trials surveyed , 122/285 ( 42.8 % ) published a CONSORT diagram in their manuscript , while 236/292 ( 80.8 % ) published a trial registry number . Discussion Cardiac and cardiovascular system journals infrequently require , recommend or enforce the use of reporting guidelines . Furthermore , too few require or enforce the use of clinical trial registration . Cardiology journal editors should consider guideline adoption due to their potential to limit bias and increase transparency This perspective provides an overview of the r and omized controlled trials , systematic review s , and evidence -based clinical practice guidelines in physical therapy . Data from the Physiotherapy Evidence Data base ( PEDro ) are used to describe key events in the history of physical therapy research and the growth of evidence of effects of interventions used in the various subdisciplines of physical therapy . The 11,494 records that were identified reveal a rich history of physical therapy research dating back to the first trial in 1929 . Most of the r and omized controlled trials , systematic review s , and evidence -based clinical practice guidelines in physical therapy have been published since the year 2000 . This rapid growth presents a challenge for physical therapists who want to keep up to date in clinical practice In December 2003 , the European Council identified best practice as key for ensuring development of high- quality cancer-screening programs . To support national policies on cancer control , the European Union institutions progressed several initiatives on cancer . The European Commission ( EC ) Initiative on Breast Cancer ( ECIBC ) is the most recent of these projects and the most implementation driven . Within this initiative , the European Guidelines for Breast Cancer Screening and Diagnosis ( in short , European Breast Guidelines ) are being developed ( http://ecibc.jrc.ec.europa.eu/ ) . Guidelines are approaches to generally improve prevention , diagnosis , treatment , and follow-up of diseases , overcoming inappropriate variations by providing recommendations for best care . The new era of guidelines promises recommendations that are based on the best available evidence summarized in systematic review s while providing the necessary flexibility needed to individualize decisions . The best methods for development of practice guidelines have experienced intense elaboration and attention during the past decades ( 17 ) . The impetus for this attention has been the change from expert- or consensus-based to evidence -based health care recommendations . Although this change in terminology should express the shift from un systematic development of guidelines to systematic and trustworthy recommendations , it is often misunderstood and misconstrued as meaning that experts are now meaningless in the process or as if consensus through discussion is a matter of the past . Neither is correct . Experts from various disciplines and consensus as a result of deliberation remain a mainstay of health care guideline development ( 810 ) . These experts are responsible for prioritization of questions that should be addressed in guidelines ; judgments that result from interpretation of evidence , including the rating of the certainty of the available evidence ; and decisions about how the judgments on the different criteria bear on recommendations . What has changed over time in guideline development are the rules , the structure and explicitness of the process , and the guideline product . Indeed , review s of guideline development methodology and how guidelines can be improved have led to more structured and documented processes that allow a reduction of bias and provide balanced views of appropriately composed guideline panels ( 2 , 5 , 6 ) . Core components for trustworthy guideline development ( 13 , 5 , 7 , 11 ) include that guidelines be developed by a knowledgeable , multidisciplinary panel of experts and representatives from key affected groups ; be based on a systematic review of the existing evidence ; consider important patient subgroups and patient preferences as appropriate ; be based on an explicit and transparent process that minimizes distortions , biases , and conflicts of interest ( 12 ) ; provide a clear explanation of the logical relationships between alternative care options and health outcomes and provide ratings of both the quality of evidence and the strength of the recommendations ( 1316 ) ; and be reconsidered and revised as appropriate when important new evidence warrants modifications . In addition , greater transparency in linking the considered research evidence and the recommendations , as well as the requirement of making structured expert judgments , represents a shift in the guideline development paradigm ( 5 , 11 , 1719 ) . At the same time , developing guidelines for a large number of member states and those that aim to adapt the guidelines poses challenges , such as the feasibility of implementing strategies that may exist in some member countries but not others ( for example , organized population -based screening in Italy but not Greece ) . Addressing these challenges requires considerations that extend beyond strictly clinical efforts in guideline development and mastering the many factors that influence recommendations and their implementation . This article describes the rationale , methods , and processes the ECIBC has adopted to develop the European Breast Guidelines in the context of evolving international st and ards . It also describes an innovative approach to presenting , disseminating , and accelerating implementation of recommendations . Guideline Methodology and Development To adhere to the core requirements for guideline development , the EC has taken several steps . First , it selected , via an open call ( https://ecibc.jrc.ec.europa.eu/ guidelines -team ) , a panel with broad representation of expertise , knowledge , and background , which includes patients , health care professionals , epidemiologists , guideline method ologists , and others ( Appendix ) . These individuals voluntarily participate in the ECIBC and compose the guidelines development group ( GDG ) . Second , it ensured that all recommendations were supported by systematic review s of the evidence conducted by independent scientists from Cochrane Iberoamricathe systematic review team (SRT)following st and ard Cochrane Collaboration methods ( 20 , 21 ) . Third , because this is a women-centered initiative , we included women advocates in the GDG as full voting guideline group members . We separately considered important subgroups of women during recommendation development ( for example , different age groups ) , and we specifically focused on evidence that supports best ways of communicating this information to women to inform their decisions . Fourth , we applied EC conflict of interest rules ( http://ecibc.jrc.ec.europa.eu/rules ) , which are consistent with international recommendations , and used GRADE ( Grading of Recommendations Assessment , Development and Evaluation ) Evidence to Decision ( EtD ) frameworks to minimize the influence of competing interests on the recommendations ( 12 , 17 , 18 ) . These EtD frameworks help guideline panels use evidence in a structured , transparent way to inform decisions with a series of criteria , such as anticipated harms and benefits of the options considered , the certainty of the evidence for those effects , and the costs and feasibility of the options , to help them reach their decision . Fifth , using the GRADE approach to guideline development and its EtD frameworks , we focused our questions and recommendations on outcomes that matter to women and provided a rating of the certainty or quality of evidence and the strength of recommendations that is widely accepted as the reference st and ard ( Figures 1 and 2 ) . Sixth , our evidence review s are up to date when the recommendations are formulated , and we engage in international stakeholder feedback to ensure that recommendations remain timely and relevant to public health and clinical practice . The ECIBC is committed to review ing and updating the recommendations as required when new evidence becomes available . The general process is explained in Figure 3 and is based on the Guidelines International NetworkMcMaster Guideline Development Checklist ( https://hei grade .mcmaster.ca/ guideline -development/using-checklist ) ( 5 ) . Figure 1 . According to GRADE , certainty , quality , strength of evidence , or confidence in the estimate of effect is determined on the basis of a systematic review of the evidence for each outcome ( based on the domains risk of bias , indirectness , imprecision , inconsistency , and publication bias that lower certainty and , usually only for nonr and omized studies , large effects , doseresponse relations and opposing plausible residual confounding that may increase the certainty ) . For recommendations , the overall certainty is determined across outcomes based on the lowest certainty outcome among those critical for decision making for the specific context . The guidelines development group applies the GRADE Evidence -to-Decision frameworks to make recommendations that are made available on the European Commission Web site . ( Reproduced from reference 15 , with permission from Schnemann HJ . ) . GRADE = Grading of Recommendations Assessment , Development and Evaluation . Figure 2 . GRADE EtD frameworks . The GRADE EtD frameworks as available in the GRADE pro software ( www . grade pro.org ) . They help with structuring the entire guideline process into 4 sections and support the conduct of guideline group meetings , presentation , and implementation . They clarify the perspective that is taken by the guideline panel or decision maker and the type of question that is asked in the question section . The section on assessment includes the criteria if the problem is a priority , the balance of health benefits and harms , values and preferences related to the outcomes , cost , re sources and cost-effectiveness , equity , acceptability , and feasibility . Conclusions provide the decision or recommendation with a justification and implementation , as well as research considerations . The presentation function supports the conduct of guideline group meetings and facilitates the output of EtD frameworks to other implementation tools , such as Web sites , h and -held apps , and interactive decision aids . EtD = Evidence to Decision ; GRADE = Grading of Recommendations Assessment , Development and Evaluation ; HTA = health technology assessment ; PICO = population , intervention , comparators , and outcomes . Figure 3 . Approach to guideline development used by the European Commission Initiative on Breast Cancer . The European Commission JRC has oversight of the organization , budgeting , planning , and training . The JRC also manages conflicts of interest , documents all aspects of the work , and manages the membership and group processes . The guideline development group and JRC formulate the questions and work with the systematic review team on identifying and assessing the evidence . The guidelines development group is responsible for developing the recommendations . The JRC is responsible for most other aspects as described in the figure under dissemination , implementation , and updating . JRC = Joint Research Centre ; PICO = population , intervention , comparator , and outcomes . ( Reproduced with adaptation to the JRC process from 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 Background The Scottish Intercollegiate Guidelines Network ( SIGN ) guideline 95 on the management of  chronic heart failure ( CHF ) was published in February 2007 , superseding SIGN guideline 35 of February 1999 . The guideline promotes evidence based management of CHF . Aims To describe an existing service model and to review our level of concordance with SIGN guidelines . Methods We describe a model of a CHF service based in a district general hospital ( DGH ) in Scotl and . We conducted a retrospective review on consecutive new referrals between August and November 2002 , and a prospect i ve review of new attendances between September 2005 and January 2006 . Results In 2002 and 2005/6 , 49 and 45 patients were review ed respectively , with 26 and 28 patients showing left ventricular systolic dysfunction on echocardiography . Median ages of patients were 81 and 79 years respectively .  Angiotensin Converting Enzyme Inhibitor ( ACEI ) or Angiotensin II Receptor Blocker ( AIIRB ) therapy  was in use in 23 ( 88.5 % ) and 24 ( 85.7 % ) patients respectively . The use of β-blockers , digoxin and spironolactone  was shown to have improved between both review s. Conclusions We have been able to demonstrate an improving level of concordance with SIGN guidelines in a district general hospital ( DGH ) heart failure service model run by care of the elderly physicians and supported by specialist nurses
INTERPRETATION The guidelines have improved method ological reporting in RSA studies , but adherence to these guidelines is still relatively low .
BACKGROUND AND PURPOSE Guidelines for st and ardization of  radiostereometry ( RSA )  of implants were published in 2005 to facilitate comparison of outcomes between various research groups .
In this systematic review , we determined how well studies have adhered to these guidelines .