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. 2015 American Heart Association/American Stroke Association Focused Update of the 2013 Guidelines for the Early Management of Patients With Acute Ischemic Stroke Regarding Endovascular Treatment: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association Systematic review of exercise effects on health outcomes in women with breast cancer. A survey on prevention of surgical infections in operating theaters. Effectiveness of Different Commercial Chlorhexidine-Based Mouthwashes After Periodontal and Implant Surgery: A Systematic Review Improving the reporting of randomised trials: the CONSORT Statement and beyond. A methodological survey of the analysis, reporting and interpretation of Absolute Risk ReductiOn in systematic revieWs (ARROW): a study protocol The International Society for Traumatic Stress Studies New Guidelines for the Prevention and Treatment of Posttraumatic Stress Disorder: Methodology and Development Process. Preoperative or postoperative therapy for stage II or III rectal cancer: an updated practice guideline. An international registry of systematic-review protocols Preoperative or postoperative therapy for resectable oesophageal cancer: an updated practice guideline. Driving up the Quality and Relevance of Research Through the Use of Agreed Core Outcomes Prevention of cervical cancer in HIV-seropositive women from developing countries: a systematic review protocol Quality of Reporting of Randomized Clinical Trials in Tai Chi Interventions—A Systematic Review Guidelines for Improving Entry Into and Retention in Care and Antiretroviral Adherence for Persons With HIV: Evidence-Based Recommendations From an International Association of Physicians in AIDS Care Panel European Respiratory Society guidelines for the management of adult bronchiectasis Nonoperative Management or ‘Watch and Wait’ for Rectal Cancer with Complete Clinical Response After Neoadjuvant Chemoradiotherapy: A Critical Appraisal Texting and Mobile Phone App Interventions for Improving Adherence to Preventive Behavior in Adolescents: A Systematic Review Management of Immune-Related Adverse Events in Patients Treated With Immune Checkpoint Inhibitor Therapy: American Society of Clinical Oncology Clinical Practice Guideline. The identification of bias in studies of the diagnostic performance of imaging modalities. Changing preventive practice: a controlled trial on the effects of outreach visits to organise prevention of cardiovascular disease. Mapping randomized controlled trials of treatments for eczema - The GREAT database (The Global Resource of Eczema Trials: a collection of key data on randomized controlled trials of treatments for eczema from 2000 to 2010) Improving the quality of reporting in randomised controlled trials. Dietary and physical activity strategies to prevent type 2 diabetes in South Asian adults: protocol for a systematic review Effectiveness of electronic guideline-based implementation systems in ambulatory care settings - a systematic review Promoting research use in speech and language therapy: a cluster randomized controlled trial to compare the clinical effectiveness and costs of two training strategies CONSORT and QUOROM guidelines for reporting randomized clinical trials and systematic reviews. Reports of clinical trials should begin and end with up-to-date systematic reviews of other relevant evidence: a status report. Single‐subject research design: recommendations for levels of evidence and quality rating Sugammadex: when should we be giving it? What Comparative Effectiveness Research Is Needed? A Framework for Using Guidelines and Systematic Reviews to Identify Evidence Gaps and Research Priorities Improving antiretroviral therapy adherence in resource‐limited settings at scale: a discussion of interventions and recommendations Completeness of reporting of trials published in languages other than English: implications for conduct and reporting of systematic reviews Diagnosis and treatment of autoimmune hepatitis. Improving Pediatric Asthma Control Among Minority Children Participating in Medicaid: Providing Practice Redesign Support to Deliver a Chronic Care Model Helping patients help themselves: A systematic review of self-management support strategies in primary health care practice Evaluating the role of quality assessment of primary studies in systematic reviews of cancer practice guidelines Mobile Phone Apps for Smoking Cessation: Quality and Usability Among Smokers With Psychosis Evidence-based medicine and the challenge of low back pain: where are we now? Effectiveness of disseminating consensus management recommendations for ulcer bleeding: a cluster randomized trial Two-year migration results of the ReCap hip resurfacing system—a radiostereometric follow-up study of 23 hips Effect of using reporting guidelines during peer review on quality of final manuscripts submitted to a biomedical journal: masked randomised trial A Systematic Evaluation of the Impact of STRICTA and CONSORT Recommendations on Quality of Reporting for Acupuncture Trials Tibial component fixation in porous- and hydroxyapatite-coated total knee arthroplasty: a radiostereo metric evaluation of migration and inducible displacement after 5 years. The role of endoscopy in the evaluation and treatment of patients with biliary neoplasia. American Society of Clinical Oncology guideline recommendations for sentinel lymph node biopsy in early-stage breast cancer. Systematic review of outcome measures in pediatric eosinophilic esophagitis treatment trials Methodology and reporting of randomised controlled trials. Evaluation and Treatment of Functional Constipation in Infants and Children: Evidence-Based Recommendations From ESPGHAN and NASPGHAN The Role of High-Dose Chemotherapy and Stem-Cell Transplantation in Patients with Multiple Myeloma: A Practice Guideline of the Cancer Care Ontario Practice Guidelines Initiative Systematic Reviews of Diagnostic Test Accuracy The Surgical Infection Society guidelines on antimicrobial therapy for intra-abdominal infections: evidence for the recommendations. The CROWN Initiative: journal editors invite researchers to develop core outcomes in women's health Uses and misuses of the STROBE statement: bibliographic study Comprehensive evidence-based clinical practice guidelines for ventilator-associated pneumonia: diagnosis and treatment. Reporting of prognostic markers: current problems and development of guidelines for evidence-based practice in the future
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 Purpose — The aim of this guideline is to provide a focused up date of the current recommendations for the  endovascular  treatment of  acute ischemic stroke . When there is overlap , the recommendations made here supersede those of previous guidelines . Methods — This focused up date analyzes results from 8 r and omized , clinical trials of endovascular treatment and other relevant data published since 2013 . It is not intended to be a complete literature review from the date of the previous guideline publication but rather to include pivotal new evidence that justifies changes in current recommendations . Members of the writing committee were appointed by the American Heart Association/American Stroke Association Stroke Council ’s Scientific Statement Oversight Committee and the American Heart Association/American Stroke Association Manuscript Oversight Committee . Strict adherence to the American Heart Association conflict of interest policy was maintained throughout the consensus process . Recommendations follow the American Heart Association/American Stroke Association methods of classifying the level of certainty of the treatment effect and the class of evidence . Prerelease review of the draft guideline was performed by 6 expert peer review ers and by the members of the Stroke Council Scientific Statement Oversight Committee and Stroke Council Leadership Committee . Results — Evidence -based guidelines are presented for the selection of patients with acute ischemic stroke for endovascular treatment , for the endovascular procedure , and for systems of care to facilitate endovascular treatment . Conclusions — Certain endovascular procedures have been demonstrated to provide clinical benefit in selected patients with acute ischemic stroke . Systems of care should be organized to facilitate the delivery of this care PURPOSE Exercise is commonly recommended to women after breast cancer surgery , yet it is difficult for patients and health professionals to adopt safe and beneficial types and modes of exercise . Thus studies on exercise interventions targeting women with breast cancer treatment were systematic ally review ed . METHODS The review process and quality assessment of the studies followed the guideline of the National Evidence -based Healthcare Collaborating Agency . Relevant studies were obtained from electronic data bases , and two trained review ers independently analyzed the studies . Of the 902 articles sorted , 11 were selected . Then , quality assessment for each study was carried out with the Scottish Intercollegiate Guideline Network ( SIGN ) checklist . RESULTS Seven different types of  exercise interventions were identified from 3 quasi-experimental and 8 r and omized controlled trial studies . The interventions varied in duration from several days to 13 weeks , and tended to show significant effects on psychological outcomes and upper body functions within a short-term period and were effective in alleviating lymphedema at a longer 1-year point . Supervised , professional intervention had significant effects on health indicators and a higher adherence rate . CONCLUSION Well- design ed exercises are effective and beneficial for improving women 's physical , physiological , and psychological health outcomes after breast cancer treatment as well as to facilitate changes in exercise behaviors . The feasibility of applying intervention protocol s , efficiency of interventions , and strengths of exercise protocol s should be further examined BACKGROUND It is well known that surgical site infections ( SSIs ) contribute significantly to the cost of nosocomial infections . Although many guidelines and recommendations exist , research has demonstrated that practice s for preventing SSIs in operating theaters ( OT ) vary . AIM The purpose of this study was to describe the current infection control practice s for SSIs , formerly called surgical wound infections , in OTs , and compare these findings with evidence -based practice guidelines . METHODS In order to accomplish the purpose , a prospect i ve , cross-sectional descriptive survey was conducted . Data were collected by interviewing the charge nurses in 24 OTs of 11 hospitals in the city of Izmir , Turkey . The results were tabulated and compared with an evidence -based guideline . RESULTS Data showed that there is a lack of adherence to the guideline . The most compliant areas to the guideline were h and /forearm antisepsis and the use of surgical gowns and drapes . IMPLICATION S It is suggested that increased compliance to infection control guidelines for surgical infections in OTs would facilitate providing best practice and evidence -based care . There is a need for further research to determine why there is a difference between what is practice d and what guidelines indicate should be practice Objectives : The aim of the present study was to review the effectiveness , side effects , and patient acceptance of different concentrations and formulation of chlorhexidine-based mouthwashes used after periodontal and implant surgery . Material s and Methods : The PRISMA guideline was adopted in the search strategy using electronic data bases PubMed and MEDLINE to identify r and omized and case – control prospect i ve studies on humans written in English language and published up to September 2017 . Results : A total of 10 articles were selected for a total of 344 patients . Because of the significant heterogeneity of the outcome measures , meta- analysis was not performed , and the data were summarized in a table . A positive relationship between the use of chlorhexidine  and reduction of plaque was found , demonstrating the effectiveness of the substance in terms of antisepsis and decrease of inflammation after periodontal and implant surgery . Conclusion : Chlorhexidine is recognized as the primary agent for plaque control and the gold st and ard in preventing infection , although the presence of largely known side effects would affect patient compliance . Future research should be directed at finding chlorhexidine formulation with negligible adverse effects , without compromising or even increasing its effectiveness as the antiseptics and antiplaque agent An extensive and growing number of review s of the published literature demonstrate that health research publications have frequent deficiencies . Of particular concern are poor reports of r and omised trials , which make it difficult or impossible for readers to assess how the research was conducted , to evaluate the reliability of the findings , or to place them in the context of existing research evidence . As a result , published reports of trials often can not be used by clinicians to inform patient care or to inform public health policy , and the data can not be included in systematic review s. Reporting guidelines are design ed to identify the key information that research ers should include in a report of their research . We describe the history of reporting guidelines for r and omised trials culminating in the CONSORT Statement in 1996 . We detail the subsequent development and extension of CONSORT and consider related initiatives aim ed at improving the reliability of the medical research literature Background Clinicians , providers and guideline panels use absolute effects to weigh the advantages and downsides of treatment alternatives . Relative measures have the potential to mislead readers . However , little is known about the reporting of absolute measures in systematic review s. The objectives of our study are to determine the proportion of systematic review s that report absolute measures of effect for the most important outcomes , and ascertain how they are analyzed , reported and interpreted . Methods / design We will conduct a method ological survey of systematic review s published in 2010 . We will conduct a 1:1 stratified r and om sampling of Cochrane vs. non-Cochrane systematic review s. We will calculate the proportion of systematic review s reporting at least one absolute estimate of effect for the most patient-important outcome for the comparison of interest . We will conduct multivariable logistic regression analyses with the reporting of an absolute estimate of effect as the dependent variable and pre-specified study characteristics as the independent variables . For systematic review s reporting an absolute estimate of effect , we will document the methods used for the analysis , reporting and interpretation of the absolute estimate . Discussion Our method ological survey will inform current practice s regarding reporting of absolute estimates in systematic review s. Our findings may influence recommendations on reporting , conduct and interpretation of absolute estimates . Our results are likely to be of interest to systematic review authors , funding agencies , clinicians , guideline developers and journal editors Over the last two decades , treatment guidelines have become major aids in the delivery of evidence -based care and improvement of clinical outcomes . The International Society for Traumatic Stress Studies ( ISTSS ) produced the first guidelines for the prevention and treatment of posttraumatic stress disorder ( PTSD ) in 2000 and published its latest recommendations , along with position papers on complex PTSD ( CPTSD ) , in November 2018 . A rigorous methodology was developed and followed ; scoping questions were posed , systematic review s were undertaken , and 361 r and omized controlled trials were included according to the a priori agreed inclusion criteria . In total , 208 meta-analyses were conducted and used to generate 125 recommendations ( 101 for adults and 24 for children and adolescents ) for specific prevention and treatment interventions , using an agreed definition of clinical importance and recommendation setting algorithm . There were eight strong , eight st and ard , five low effect , 26 emerging evidence , and 78 insufficient evidence to recommend recommendations . The inclusion of separate scoping questions on treatments for complex presentations of PTSD was considered but decided against due to definitional issues and the virtual absence of studies specifically design ed to clearly answer possible scoping questions in this area . Narrative review s were undertaken and position papers prepared ( one for adults and one for children and adolescents ) to consider the current issues around CPTSD and make recommendations to facilitate further research . This paper describes the methodology and results of the ISTSS Guideline process and considers the interpretation and implementation of the recommendations AIMS Uncertainty remains regarding the optimal therapy for patients with stage II or III rectal cancer . Systematic review s and practice guidelines on preoperative and postoperative therapy for rectal cancer were published by the Gastrointestinal Cancer Disease Site Group in 2003 and 2000 , respectively . The systematic review s were up date d and revised and new recommendations for preoperative and postoperative therapy were developed based on the up date d body of evidence . The following research questions were addressed : After appropriate preoperative staging tests , should patients with resectable clinical stage II or III rectal cancer be offered preoperative radiotherapy ( with or without chemotherapy ) ? What is the role of postoperative radiotherapy and /or chemotherapy for patients with resected stage II or III rectal cancer who have not received preoperative radiotherapy  , in terms of improving survival and delaying local recurrence ? MATERIAL S AND METHODS The MEDLINE , EMBASE and Cochrane Library data bases , as well as meeting proceedings from the American Society of Clinical Oncology , were search ed for reports of r and omised controlled trials and meta-analyses comparing preoperative or postoperative therapy with surgery alone or other preoperative or postoperative therapy for stage II or III rectal cancer . The draft practice guideline and systematic review s were distributed through a mailed survey to 129 health care providers in Ontario for review . RESULTS Systematic review s on preoperative and postoperative therapy for rectal cancer were developed . On the basis of the evidence contained in these review s , the Gastrointestinal Cancer Disease Site Group drafted recommendations . Of the 33 practitioners who responded to the mailed survey , 97 % agreed with the draft recommendations as stated , 88 % agreed that the report should be approved as a practice guideline and 94 % indicated that they were likely to use the guideline in their own practice . CONCLUSIONS Preoperative chemoradiotherapy is preferred , compared with st and ard fractionation preoperative radiotherapy alone , to decrease local recurrence .  Preoperative chemoradiotherapy is also preferred , compared with a postoperative approach , to decrease local recurrence and adverse effects . For patients with relative contraindications to chemotherapy in the preoperative period , an acceptable alternative is preoperative radiotherapy alone followed by surgery .  Patients with resected stage II or III rectal cancer who have not received preoperative radiotherapy  should be offered postoperative therapy with concurrent chemoradiotherapy plus fluoropyrimidine-based chemotherapy Support for prospect i ve registration of protocol s for systematic review s has been gathering momentum . The PRISMA statement , a guideline for reporting systematic review s and meta-analyses of studies that evaluate health-care interventions , advocates registration . Well-conducted systematic review s are accepted as the best- quality evidence to inform policy and practice , and the dramatic upward trend in the number of systematic review s published annually ( fi gure ) is set to continue . However , there is currently no single facility for identifying this type of research in advance of the appearance of the results of the review . There is concern about and evidence of publication and selective outcome -reporting biases associated with systematic review s. An open registry of review s captured at the protocol stage would facilitate good practice in systematic review s by providing transparency of the review process and outcomes . Discrepancies between the methods of the published review and those planned in the registered protocol could be more readily identifi ed . Registration might also encourage full publication of the review ’s fi ndings and transparency in changes to methods that could bias fi ndings . In both the prevention and revelation of potential bias , registration should improve quality and increase confi dence that policy or practice informed by the fi ndings of systematic review s are indeed drawing on best- quality evidence . A registry of protocol s of systematic review s could assist those planning new review s and updating existing ones . Easy access to information about ongoing review s should help to optimise the use of fi nite re sources by enabling funding and commissioning agencies to avoid unnecessary duplication and encourage collaboration . A comprehensive registry could also create opportunities for method ological and other research , both within and across disciplines . Existing access to systematic - review protocol s is limited to the outputs of individual organisations , such as the Cochrane and Campbell Collaborations and the Joanna Briggs Institute . The National Public Health Service for Wales is piloting an All Wales Systematic Review s Register , but , up to now , there has been no central ised comprehensive registry of systematic - review protocol s. We are developing an international facility to register the details of ongoing systematic review s in health and social care . Our registry is being established with the existing platform and infrastructure that supports the Data base of Abstract s of Review s of Eff ects ( DARE ) , the NHS Economic Evaluations Data base ( NHS EED ) and the Health Technology Assessment ( HTA ) data base produced by the Centre for Review s and Dissemination . The initial scope of the registry will be limited to systematic review s of the eff ectiveness of health interventions . However , the longterm aim is for the registry to include details of all ongoing systematic review s with a health-related outcome in the broadest sense . Ultimately , inclusion will encompass systematic review s of health-care interventions , and review s of the social determinants of health , of service delivery , and of risk factors and genetic associations . Our web-based registry will off er free public access , be electronically search able , and open to all prospect i ve registrants . Registration will require the provision of a minimum data set , the completeness of which will be checked automatically before registration . After acceptance , the registry ’s entry and protocol for the review , if available , will be loaded on the data base as a permanent entry and a unique identifi cation number issued . An audit trail for any amendments to the information will be available within the record . Links to result ing publications will be added . These provisions ensure that the registry will match the relevant criteria required of clinical trials registries AIMS Oesophageal cancer is an aggressive disease and the optimal therapy for patients with resectable tumours remains unclear . A systematic review and companion practice guideline were published in 2004 ; however , new evidence has become available since the publication of the original report . An up date of the literature search and a revision of the recommendations were undertaken to incorporate the new data . The following research question was addressed : should patients with resectable oesophageal cancer receive preoperative or postoperative therapy together with surgery ? The outcomes of interest were survival , adverse effects and quality of life . MATERIAL S AND METHODS The literature search of the original systematic review was up date d to April 2007 . MEDLINE , EMBASE , Cochrane Library and abstract s from the American Society of Clinical Oncology and the American Society for Therapeutic Radiology and Oncology were search ed for reports of r and omised controlled trials and meta-analyses comparing preoperative or postoperative therapy with surgery alone or other preoperative or postoperative therapy . After the completion of the draft systematic review and practice guideline , the report was distributed through a mailed survey to 133 health care providers in Ontario for review and feedback . RESULTS The up date d literature search yielded eight new r and omised controlled trial reports and seven new meta- analysis reports for consideration , together with the evidence review ed in the original review publication . Of the 31 practitioners who responded to the mailed survey , 80 % agreed with the draft recommendations as stated , 83 % agreed that the report should be approved as a practice guideline and 86 % indicated that they would probably use the guideline in their own practice . CONCLUSIONS Preoperative cisplatin-based chemotherapy plus radiotherapy is recommended as the preferred modality for the management of surgically resectable patients with oesophageal cancer .  Preoperative cisplatin-based chemotherapy alone is an alternative choice for the management of these patients There is a growing recognition that insufficient attention has been paid to the selection of the outcomes to measure in clinical trials and clinical audit . Outcomes need to be relevant to patients , clinicians , purchasers and policy-makers if the findings of research are to influence practice and future research . In addition , st and ardization of outcomes is needed to combine data from different studies to allow evidence synthesis and to compare data sets . Inconsistent choice of outcome measures means that many meta-analyses are unable to include data from all the relevant studies . For example , the five most accessed Cochrane review s in 2009 , together with the top cited review in that year , all described inconsistencies in the outcomes reported in eligible trials . A call for the st and ardization of outcomes is a regular conclusion of systematic review s. Furthermore , outcome reporting bias , defined as the bias arising from selecting outcomes for publication based on the results , affects many r and omized trials and ‘ is an under-recognized problem that affects the conclusions in a substantial proportion of Cochrane review s ’ . That bias is likely to affect systematic review s more widely as well as affecting individual studies when considered on their own . Similar problems occur with clinical audit , highlighting the importance of establishing national audits that use and report the same outcomes for all participants . All these issues could be addressed with the development and application of agreed st and ardized sets of outcomes that have been termed ‘ core outcome sets ’ . These should be measured and reported , as a minimum , in all relevant clinical trials and national clinical audits for a specific condition . Adopting a core outcome set does not imply that a particular study , review or audit should be restricted to only those outcomes . Rather , the expectation is that , as a minimum , core outcomes will always be collected and reported to allow the results of trials to be compared , contrasted and combined as appropriate . The adoption of core outcomes would have implication s across all areas of research in health and health care , reduce heterogeneity between trials , and lead to research that is more likely to have measured relevant outcomes . Importantly , they would enhance the value of evidence synthesis by reducing the risk of outcome reporting bias and ensuring that all trials contribute usable information . In addition , they will increase the efficiency and value of research . An important rationale for core outcome sets is that outcomes currently reported for trials do not consistently reflect endpoints that are meaningful for patients . Examples exist where trials failed to include all outcomes important to patients and where involvement of patients has identified an outcome that might not have been considered by practitioners on their own . Despite increasing recognition of the importance of incorporating patients ’ opinions , their involvement has been limited . Recent regulatory guidance in the USA requires documented evidence of patient input during the development of instruments to measure  patient reported outcomes ( PROs ) . However , measurement of PROs in clinical trials is hampered by the multiplicity and heterogeneity of tools currently available . Many generic , disease and domain-specific instruments have been developed and vali date d , each containing multiple scales and items . As a result , synthesis of PRO data from trials is difficult and review s aim ing to summarize treatment effect according to PROs may fail . There is synergy between the development of core outcome sets for trials and work to select up to seven outcomes that are important to patients for inclusion in Summary of Findings tables in systematic review s. Developed by the GRADE group ( http://www . grade workinggroup.org ) , Cochrane review s have featured such tables since 2008 , and they play a key role in presenting research in guidelines , such as those produced by the World Health Organization ( WHO ) . The development of core outcome sets needs to be accelerated and undertaken in ways that maximize efficiency . The COMET ( Core Outcome Measures in Effectiveness Trials , http://www.comet-initiative.org ) Initiative in the UK brings together research ers interested in the development and application of core outcome sets . These include key participants in a collaboration of research ers in rheumatology who have done the most notable work to date in this area . The COMET Initiative was launched in January 2010 , with a second meeting in July 2011 . Attendees included trialists , systematic review ers , patients , clinicians , journal editors , research funders , policy-makers , people responsible for trials registries and regulators . Data on individual studies , both published and ongoing , are being included in a free , publically available internet-based re source . This will be up date d periodically , to minimize the risk of duplication . Seventy-eight published or ongoing studies have already been entered into the repository . In addition , published review s of outcomes used in clinical trials or studies examining patients ’ views , will be entered Background Over 85 % of cervical cancer cases and deaths occur in developing countries . HIV-seropositive women are more likely to develop precancerous lesions that lead to cervical cancer than HIV-negative women . However , the literature on cervical cancer prevention in seropositive women in developing countries has not been review ed . The aim of this study is to systematic ally review cervical cancer prevention modalities available for HIV-seropositive women in developing countries . Methods / design This protocol was developed by following the Preferred Reporting Items for Systematic Review s and Meta-Analyses Protocol s ( PRISMA -P ) statement , and the systematic review will be reported in accordance with the PRISMA guidelines . Embase , MEDLINE , PubMed , CINAHL and Cochrane Library will be search ed from inception up to date of final search , and additional studies will be located through citation and reference list tracking . Eligible studies will be r and omised controlled trials , prospect i ve and retrospective cohort studies , case-control and cross-sectional studies carried out in developing countries . Studies will be included if they are published in English and examine cervical cancer prevention modalities in HIV-seropositive women . Results will be summarised in tables and , where appropriate , combined using meta- analysis . Discussion This review will address the gap in evidence by systematic ally review ing the published literature on the different prevention modalities being used to prevent  cervical cancer in HIV-seropositive women in developing countries . The findings may be used to inform evidence -based guidelines for prevention of cervical cancer in seropositive women as well as future research . Systematic review registration PROSPERO CRD42017054678 Objectives . To evaluate the reporting quality of published r and omized clinical trials ( RCTs ) in the Tai Chi literature following the publication of the CONSORT guidelines in 2001 . Data Sources . The OVID MEDLINE and PUBMED data bases . Review Methods . To survey the general characteristics of Tai Chi RCTs in the literature , we included any report if ( i ) it was an original report of the trial ; ( ii ) its design was RCT ; ( iii ) one of the treatments being tested was Tai Chi ; and ( iv ) it was in English . In addition , we assessed the reporting quality of RCTs that were published between 2002 and 2007 , using a modified CONSORT checklist of 40 items . The adequate description of Tai Chi interventions in these trials was examined against a 10-item checklist adapted from previous review s. Results . The search yielded 31 Tai Chi RCTs published from 2002 to 2007 and only 11 for 1992–2001 . Among trials published during 2002–2007 , the most adequately reported criteria were related to background , participant eligibility and interpretation of the study results . Nonetheless , the most poorly reported items were associated with r and omization allocation concealment , implementation of r and omization and the definitions of period of recruitment and follow-up . In addition , only 23 % of RCTs provided adequate details of Tai Chi intervention used in the trials . Conclusion . The findings in this review indicated that the reporting quality of Tai Chi intervention trials is sub-optimal . Substantial improvement is required to meet the CONSORT guidelines and allow assessment of the quality of evidence . We believe that not only investigators , but also journal editors , review ers and funding agencies need to follow the CONSORT guidelines to improve the st and ards of research and strengthen the evidence base for Tai Chi and for complementary and alternative medicine DESCRIPTION After HIV diagnosis , timely entry into HIV medical care and retention in that care are essential to the provision of effective antiretroviral therapy ( ART ) . Adherence to ART is among the key determinants of successful HIV treatment outcome and is essential to minimize the emergence of drug resistance . The International Association of Physicians in AIDS Care convened a panel to develop evidence -based recommendations to optimize entry into and retention in care and ART adherence for people with HIV . METHODS A systematic literature search was conducted to produce an evidence base restricted to r and omized , controlled trials and observational studies with comparators that had at least 1 measured biological or behavioral end point . A total of 325 studies met the criteria . Two review ers independently extracted and coded data from each study using a st and ardized data extraction form . Panel members drafted recommendations based on the body of evidence for each method or intervention and then grade d the overall quality of the body of evidence and the strength for each recommendation . RECOMMENDATIONS Recommendations are provided for monitoring entry into and retention in care , interventions to improve entry and retention , and monitoring of and interventions to improve ART adherence . Recommendations cover ART strategies , adherence tools , education and counseling , and health system and service delivery interventions . In addition , they cover specific issues pertaining to pregnant women , incarcerated individuals , homeless and marginally housed individuals , and children and adolescents , as well as substance use and mental health disorders . Recommendations for future research in all areas are also provided Bronchiectasis in adults is a chronic disorder associated with poor quality of life and frequent exacerbations in many patients . There have been no previous international guidelines . The European Respiratory Society guidelines for the management of adult bronchiectasis describe the appropriate investigation and treatment strategies determined by a systematic review of the literature . A multidisciplinary group representing respiratory medicine , microbiology , physiotherapy , thoracic surgery , primary care , methodology and patients considered the most relevant clinical questions ( for both clinicians and patients ) related to management of bronchiectasis . Nine key clinical questions were generated and a systematic review was conducted to identify published systematic review s , r and omised clinical trials and observational studies that answered these questions . We used the GRADE approach to define the quality of the evidence and the level of recommendations . The result ing guideline addresses the investigation of underlying causes of bronchiectasis , treatment of exacerbations , pathogen eradication , long term antibiotic treatment , anti-inflammatories , mucoactive drugs , bronchodilators , surgical treatment and respiratory physiotherapy . These recommendations can be used to benchmark quality of care for people with bronchiectasis across Europe and to improve outcomes . The publication of the first ERS guidelines for bronchiectasis Background There is increasing interest in nonoperative management ( NOM ) for rectal cancer with complete clinical response ( cCR ) after neoadjuvant chemoradiation ( nCRT ) . Objective The aim of this systematic review was to summarize the available data on NOM , with the intention of formulating st and ardized protocol s on which to base future investigations . Methods A systematic review following the Preferred Reporting Items for Systematic Review s and Meta-Analyses ( PRISMA ) guidelines was conducted . A highly sensitive literature search identified all relevant studies published between January 2004 and December 2016 . Data extraction and quality assessment was performed independently by two authors , and resolved by consensus with a third review er . Results In total , 15 studies , including 920 patients , met the inclusion criteria ; 575 ( 62.5 % ) of these patients underwent NOM after cCR , with the remaining patients forming a surgical control group . The weighted mean follow-up was 39.4 ( 12.7 ) months in the NOM group and 39.8 ( 5.1 ) months in the surgery group . The pooled regrowth rate in the NOM group was 21.3 % at a mean of 15.6 ( 7.0 ) months . Surgical salvage was possible and was undertaken in 93.2 % of these patients . Overall survival in the NOM group was 91.7 % , while disease-free survival was 82.7 % . For the comparison proctectomy group , pooled rates of local recurrence , overall survival , and disease-free survival were 8.4 , 92.4 , and 87.5 % , respectively . Conclusion NOM may be a feasible option for surgically eligible rectal cancer patients with cCR after nCRT . Before such a strategy can be widely implemented , further prospect i ve data are required with st and ardized definitions , diagnostic criteria , and management protocol s , with an emphasis on shared patient – provider decision making and patient-centered outcomes Background Many preventable behaviors contribute to adolescent mortality and morbidity . Non-adherence to preventive measures represents a challenge and has been associated with worse health outcomes in this population . The widespread use of electronic communication technologies by adolescents , particularly the use of text messaging ( short message service , SMS ) and mobile phones , presents new opportunities to intervene on risk and preventive risk behavior , but little is known about their efficacy . Objective This study aim ed to systematic ally evaluate evidence for the efficacy of text messaging and mobile phone app interventions to improve adherence to preventive behavior among adolescents and describe intervention approaches to inform intervention development . Methods This review covers literature published between 1995 and 2015 . Search es included PubMed , Embase , CENTRAL , PsycINFO , CINAHL , INSPEC , Web of Science , Google Scholar , and additional data bases . The search strategy sought articles on text messaging and mobile phone apps combined with adherence or compliance , and adolescents and youth . An additional h and search of related themes in the Journal of Medical Internet Research was also conducted . Two review ers independently screened titles and abstract s , assessed full-text articles , and extracted data from articles that met inclusion criteria . Included studies reflect original research —experimental or preexperimental design s with text messaging or mobile phone app interventions —targeting adherence to preventive behavior among adolescents ( 12 - 24 years old ) . The preferred reporting items of systematic review s and meta-analyses ( PRISMA ) guidelines were followed for reporting results , and findings were critically appraised against the Oxford Centre for Evidence -based Medicine criteria . Results Of 1454 records , 19 met inclusion criteria , including text messaging ( n=15 ) and mobile phone apps ( n=4 ) . Studies targeted clinic attendance , contraceptive use , oral health , physical activity and weight management , sun protection , human papillomavirus ( HPV ) vaccination , smoking cessation , and sexual health .  Most studies were performed in the United States ( 47 % , 9/19 ) , included younger adolescents ( 63 % , 12/19 ) , and had sample size < 100 ( 63 % , 12/19 ) . Although most studies were r and omized controlled trials ( RCTs ; 58 % , 11/19 ) , only 5 followed an intent-to-treat analysis . Only 6 of 19 studies ( 32 % ) incorporated a theoretical framework in their design . Most studies reported good feasibility with high acceptability and satisfaction . About half of the included studies ( 42 % , 8/19 ) demonstrated significant improvement in preventive behavior with moderate st and ardized mean differences . As early efforts in this field to establish feasibility and initial efficacy , most studies were low to moderate in quality . Studies varied in sample size and methods of preventive behavior adherence or outcome assessment , which prohibited performing a meta- analysis . Conclusions Despite the promising feasibility and acceptability of text messaging and mobile phone apps in improving preventive behavior among adolescents , overall findings were modest in terms of efficacy . Further research evaluating the efficacy , effectiveness , and cost-effectiveness of these intervention approaches in promoting preventive behavior among adolescents is needed Purpose To increase awareness , outline strategies , and offer guidance on the recommended management of immune-related adverse events in patients treated with immune checkpoint inhibitor ( ICPi ) therapy .  Methods A multidisciplinary , multi-organizational panel of experts in medical oncology , dermatology , gastroenterology , rheumatology , pulmonology , endocrinology , urology , neurology , hematology , emergency medicine , nursing , trialist , and advocacy was convened to develop the clinical practice guideline . Guideline development involved a systematic review of the literature and an informal consensus process . The systematic review focused on guidelines , systematic review s and meta-analyses , r and omized controlled trials , and case series published from 2000 through 2017 . Results The systematic review identified 204 eligible publications . Much of the evidence consisted of systematic review s of observational data , consensus guidelines , case series , and case reports . Due to the paucity of high- quality evidence on management of immune-related adverse events , recommendations are based on expert consensus . Recommendations Recommendations for specific organ system-based toxicity diagnosis and management are presented . While management varies according to organ system affected , in general , ICPi therapy should be continued with close monitoring for grade 1 toxicities , with the exception of some neurologic , hematologic , and cardiac toxicities .  ICPi therapy may be suspended for most grade 2 toxicities , with consideration of resuming when symptoms revert to grade 1 or less . Corticosteroids may be administered . Grade 3 toxicities generally warrant suspension of ICPis and the initiation of high-dose corticosteroids ( prednisone 1 to 2 mg/kg/d or methylprednisolone 1 to 2 mg/kg/d ) . Corticosteroids should be tapered over the course of at least 4 to 6 weeks . Some refractory cases may require infliximab or other immunosuppressive therapy . In general , permanent discontinuation of ICPis is recommended with grade 4 toxicities , with the exception of endocrinopathies that have been controlled by hormone replacement . Additional information is available at www.asco.org/supportive-care- guidelines and www.asco.org/ guidelines wiki The dem and for evidence -based healthcare is increasing nationally and internationally and it is equally necessary in both diagnostic and therapeutic practice . Evidence may be collected and combined by means of a systematic literature review of published and unpublished data on a well-defined topic . The output of such review s is then available to guide health policy , influence good practice or direct research . Published guidelines are available on the performance of systematic review s , especially those of r and omized controlled trials . Although there is an extensive literature base of research data in diagnostic imaging there are few such trials , but it is still possible to perform systematic review s. With the alternative study design s encountered it is important to be aware of the main threats to study validity . In this paper the biases likely to be encountered in studies of diagnostic performance are review ed , with particular reference to diagnostic imaging tests . The biases are sub-divided into three categories . The first category is patient selection and covers the validity of generalizing results beyond the study population . The other two , concerning study design and execution and the interpretation of results , affect the likely validity of the results of a study . An underst and ing of these factors is an essential prerequisite for those undertaking or using a systematic literature review in the field of diagnostic imaging . The definitions form the foundations of a defensible review protocol OBJECTIVES : To assess the effects of outreach visits by trained nurse facilitators  on the organisation of services used to prevent cardiovascular disease . To identify the characteristics of general practice s that determined success . DESIGN : A non-r and omised controlled trial of two methods of implementing guidelines to organise prevention of cardiovascular disease : an innovative outreach visit method compared with a feedback method . The results in both groups were compared with data from a control group . SETTING AND SUBJECTS : 95 general practice s in two regions in The Netherl and s. INTERVENTIONS : Trained nurse facilitators visited practice s , focusing on solving problems in the organisation of prevention . They applied a four step model in each practice . The number of visits depended on the needs of the practice team . The feedback method consisted of the provision of a feedback report with advice specific to each practice and st and ardised instructions . MAIN OUTCOME MEASURES : The proportion of practice s adhering to 10 different guidelines . Guidelines were on the detection of patients at risk , their follow up , the registration of preventive activities , and teamwork within the practice . RESULTS : Outreach visits were more effective than feedback in implementing guidelines to organise prevention . Within the group with outreach visits , the increase in the number of practice s adhering to the guidelines was significant for six out of 10 guidelines . Within the feedback group , a comparison of data before and after intervention showed no significant differences . Partnerships and practice s with a computer changed more . CONCLUSION : Outreach visits by trained nurse facilitators proved to be effective in implementing guidelines within general practice s , probably because their help was practical and design ed for the individual practice , guided by the wishes and capabilities of the practice team Background Massive duplication of effort occurs when research ers all over the world undertake extensive search es for r and omized controlled trials when preparing systematic review s , when developing evidence -based guidelines and when applying for research funding for eczema treatments . Such duplication wastes valuable re sources . Search ing for r and omized controlled trials of eczema is a laborious task involving scrutiny of thous and s of individual references from diverse electronic data bases in order to obtain a few papers of interest . Clinicians and patients who wish to find out more about a particular treatment are at risk of missing the relevant evidence if they are not trained in electronic bibliographic search ing . Systematic review s can not be relied upon to comprehensively inform current optimal eczema treatments due to incomplete coverage and because many may be out of date .An international , publically available and comprehensive re source which brings together all r and omized controlled trials on eczema treatment using a highly sensitive search has the potential to release more filtered knowledge about patient care to those who need it most and to significantly shorten the duration and costs of many clinical eczema research and guideline projects . DescriptionThe G lobal R e source of E czemA T rials brings together information on all r and omized controlled trials of eczema treatments published from the beginning of 2000 up to the end of 2010 and will be up date d every month . We search ed the Cochrane Central Register of Controlled Trials in The Cochrane Library and the Cochrane Skin Group Specialised Register , MEDLINE , EMBASE , LILACS , AMED and CINHAL data bases . We included 268 RCTs ( 24th March 2011 ) covering over 70 different treatment interventions .The structure of the Global Re source of Eczema Trials allows the user as much , or as little , specificity when retrieving information on trials as they wish , in an easy to use format . For each trial , the data base gives the citation for the published report and also provides enough information to enable a user to decide whether the trial is worth further scrutiny . Conclusions The Global Re source of Eczema Trials has been created to facilitate knowledge mobilization into healthcare and to reduce wastage of research time through unnecessary duplication . The collective time saved by research groups around the world can now be used to make strides in optimising the treatment of eczema , in order to further benefit people with eczema . The data base can be accessed free of charge at http://www.great data Wound-care journals contain abundant reports of trials , but not all report a satisfactory methodology . Systematic review s of wound-care trials have highlighted many areas for improvement , and the National Institute for Clinical Excellence ( NICE ) guidelines recommend that primary research in the field of pressure ulcer prevention should adhere more closely to current method ological st and ards in terms of conduct and reporting . The CONSORT tool was developed to help achieve these improvements in the design and reporting of r and omised controlled trials ( RCTs ) Introduction Type 2 diabetes ( T2D ) is a major health concern among population s of South Asian ethnicity . Although dietary and physical activity interventions may reduce the risk of T2D , the effectiveness has been moderate among South Asians . This might ( in part ) be because this subgroup follows strategies that were originally developed for interventions among other population s. Therefore , this review aims to assess the evidence for the current dietary and physical activity strategies recommended in T2D prevention intervention studies and guidelines for South Asians . Methods and analysis Included will be all studies and guidelines on dietary and /or physical activity strategies to prevent T2D in adult South Asians . Two review ers will search online data bases from their start until the present date for published and unpublished experimental/quasiexperimental studies , with at least an abstract in English . References of identified articles and key review s will be screened for additional studies . Guidelines will be identified by search es in online data bases and websites of public organisations . Finally , expert consultations will be held to supplement any missing information . Trial quality will be assessed with the Quality Assessment Tool for Quantitative Studies Data , and guidelines with the Appraisal of Guidelines for Research & Evaluation II . Data on the strategies recommended , targeting and evidence on effectiveness will be extracted by two review ers and presented in tabular and narrative forms . Recommendations will be compared with the National Institute for Health and Care Excellence guidelines [ PH35 ] . Overall findings on  dietary and physical activity recommendations , as well as findings for specific subgroups ( eg , by sex ) , will be discussed . Ethics and dissemination Ethics assessment is not required . Start date : 1 January 2016 , finishing and reporting date 31 July 2016 . Results will be published in a peer- review ed scientific journal , the project report of EuroDHYAN ( www.eurodhyan.eu ) and in a PhD dissertation . Trial registration number The protocol is registered with the International Prospect i ve Register of Systematic Review s ( PROSPERO ) registration number CRD42015027067 Background Electronic guideline -based decision support systems have been suggested to successfully deliver the knowledge embedded in clinical practice guidelines . A number of studies have already shown positive findings for decision support systems such as drug-dosing systems and computer-generated reminder systems for preventive care services . Methods A systematic literature search ( 1990 to December 2008 ) of the English literature indexed in the Medline data base , Embase , the Cochrane Central Register of Controlled Trials , and CRD ( DARE , HTA and NHS EED data bases ) was conducted to identify evaluation studies of electronic multi-step guideline implementation systems in ambulatory care setting s. Important inclusion criterions were the multidimensionality of the guideline ( the guideline needed to consist of several aspects or steps ) and real-time interaction with the system during consultation . Clinical decision support systems such as one-time reminders for preventive care for which positive findings were shown in earlier review s were excluded . Two comparisons were considered : electronic multidimensional guidelines versus usual care ( comparison one ) and electronic multidimensional guidelines versus other guideline implementation methods ( comparison two ) . Results Twenty-seven publications were selected for analysis in this systematic review . Most design s were cluster r and omized controlled trials investigating process outcomes more than patient outcomes . With success defined as at least 50 % of the outcome variables being significant , none of the studies were successful in improving patient outcomes . Only seven of seventeen studies that investigated process outcomes showed improvements in process of care variables compared with the usual care group ( comparison one ) . No incremental effect of the electronic implementation over the distribution of paper versions of the guideline was found , neither for the patient outcomes nor for the process outcomes ( comparison two ) . Conclusions There is little evidence at the moment for the effectiveness of an increasingly used and commercialised instrument such as electronic multidimensional guidelines . After more than a decade of development of numerous electronic systems , research on the most effective implementation strategy for this kind of guideline -based decision support systems is still lacking . This conclusion implies a considerable risk towards inappropriate investments in ineffective implementation interventions and in suboptimal care Objective : To evaluate the clinical and cost effectiveness of two training strategies to promote the use of research evidence in speech and language therapy ( SLT ) management  of poststroke dysphagia . Design : Pragmatic , cluster r and omized trial . Setting : Seventeen SLT departments in north-west Engl and . Participants : Two SLTs from each department received training and cascaded information across their department . Process of care was measured from the notes of 708 patients with acute poststroke dysphagia across eight departments allocated to training strategy A , and 762 patients across nine departments in strategy B. Interventions : Strategy A : training on the critical appraisal of published research papers and practice guidelines . Strategy B : strategy A plus training on management of change in clinical practice . Main outcome measures : Pre- and post-training adherence to practice guidelines in poststroke dysphagia management , based on a review of case notes . Incremental cost of increased adherence to clinical guidelines . Results : Departments ' practice differed in adherence to guidelines . Departments changed following training ( F=2.22 , df 16 , 1436 , p=0.004 ) . The effect of training strategy on clinical practice was not significant . Strategy B departments engaged in more activities relating to research use following training than strategy A. Total costs of training averaged £ 2001 , t2892 , $ 3886 ( SD £ 502 , t726 , $ 975 ) for strategy A and £ 3366 , t4866 , $ 6537 ( SD £ 2121 , t3066 , $ 4119 ) for strategy B. Conclusions : Training in research implementation in addition to critical appraisal and guideline introduction is associated with increased dissemination activities and awareness of research information , but not with changes in clinical practice within six months of training . The department in which SLTs work influences their use of research . The process of poststroke dysphagia management can be measured using a tool developed from practice guidelines As practitioners strive to improve the delivery of patient care , it is increasingly important that they find it easier to identify studies with the highest level of evidence . Once found , there must be some assurance that the studies were carried out satisfactorily and the methodology was sound . To assist in meeting this challenge , the Consoli date d St and ards of Reporting Trials ( CONSORT ) guidelines were developed by a team of dedicated journal editors , epidemiologists , and statisticians . They determined the st and ards for authors reporting the findings of controlled clinical trials . CONSORT comprises a checklist and a flow diagram ( Figs 1 and 2 ) to help improve the quality of reports of r and omized controlled trials ( RCTs ) . It offers a st and ard way for research ers to report their findings . The checklist includes items , based on evidence , that should be addressed in the report ; the flow diagram gives readers a clear picture of the progress of all participants in the trial , from the time they are r and omized until the end of their involvement . The intent is to make the experimental process transparent , flawed or not , so that users of the data can more appropriately evaluate the validity for their purpose s. The key elements start when the research er su bmi ts an article for review and completes the st and ardized forms . The completed checklist should accompany the manuscript through the review process and identify the page on which each item is addressed . The completed flow diagram should appear as a figure in the manuscript . Nearly a year ago , the AJO-DO m and ated a structured abstract with each su bmi ssion ; this is one of the first items on the CONSORT checklist . There are good reasons for this change and for all other requests listed . According to Sharma and Harrison , “ the quality of information provided in journals with structured abstract s is greater than in those with nonstructured abstract s. ” These authors concluded that the quality of information in an abstract improves when a journal changes to a structured format . OBJECTIVE Scientific and ethical justification for new clinical trials requires them to have been design ed in the light of scientifically defensible assessment s of relevant previous research . Reliable interpretation of the results of new clinical trials entails setting them in the context of up date s of the review s upon which they were deemed scientifically and ethically justifiable . We have shown previously that most reports of r and omized trials published in five general medical journals in May 1997 and in May 2001 failed to set their results in the context of the findings from similar research . In the current study , we assess whether there had been progress in this respect in 2005 and also investigate the extent to which reports begin by referring to systematic review s providing the justification for the new research reported . DESIGN Assessment of the Introduction and Discussion sections in all reports of r and omized trials published during May 2005 in five general medical journals . SETTING Reports of r and omized trials in five general medical journals . PARTICIPANTS Annals of Internal Medicine , BMJ , JAMA , Lancet and New Engl and Journal of Medicine . INTERVENTIONS None . MAIN OUTCOME MEASURES The inclusion or mention of one or more systematic review s in the Introduction or Discussion section of each report assessed . RESULTS We found 18 reports of r and omized trials . The Introduction sections referred to systematic review s in five ( 27 % ) of these reports . None of the discussion sections of the 15 reports of trials that were not the first published trials to address the question studied placed the results of the new trial in the context of an up date d systematic review of other research . Although reference was made to relevant systematic review s in five of these 15 reports , there was no integration - quantitative or qualitative - of the results of the new trials in an up date of these review s. In the remaining ten reports there was no evidence that any systematic attempt had been made to set the new results in the context of previous trials . CONCLUSIONS There is no evidence of progress between 1997 and 2005 in the proportion of reports of trials published in general medical journals which discussed new results within the context of up-to- date systematic review s of relevant evidence from other controlled trials . Although the proportion of trials referring to systematic review s in Discussion sections has increased , the majority of reports continued to fail even to do this . Similarly , most research ers appear not to have considered a systematic review when design ing their trial . Research ers and journal editors do a disservice to the interests of the public and others involved in healthcare decision-making by acquiescing in this situation The aim of this article is to present a set of evidence levels , accompanied by 14 quality or rigor questions , to foster a critical review of published single‐subject research articles . In developing these guidelines , we review ed levels of evidence and quality /rigor criteria that are in wide use for group research design s , e.g. r and omized controlled trials , such as those developed by the Treatment Outcomes Committee of the American Academy for Cerebral Palsy and Developmental Medicine . We also review ed method ological articles on how to conduct and critically evaluate single‐subject research design s ( SSRDs ) . We then subjected the quality questions to interrater agreement testing and refined them until acceptable agreement was reached . We recommend that these guidelines be implemented by clinical research ers who plan to conduct single‐subject research or who incorporate SSRD studies into systematic review s , and by clinicians who aim to practise evidence ‐based medicine and who wish to critically review pediatric single‐subject research 2011 ; 14 : 371–380 . 6 . Senn S , Gavini F , Magrez D , Scheen A. Issues in performing a network meta analysis . Statistical Methods in Medical Research 2013 ; 22 : 169–89 . 7 . Salanti G , Higgins JP , Ades A , Ioannidis JP . Evaluation of networks of r and omized trials . Statistical Methods in Medical Research 2008 ; 17 : 279– 301 . 8 . Song F , Clark A , Bachmann MO , Maas J. Simulation evaluation of statistical properties  of methods for indirect and mixed treatment comparisons . BMC Medical Research Methodology 2012 ; 12 : 1–14 . 9 . Jansen JP , Naci H. Is network meta- analysis as valid as st and ard pairwise meta- analysis ? It all depends on the distribution of effect modifers . BMC Medicine 2013 ; 11 : 1 . 10 . The Guidelines Manual . London : National Institute for Health and Clinical Excellence . 2012 . https://www . nice.org.uk/process/pmg6/chapter/6 review ing-the- evidence ( accessed 27/ 05/2017 ) . 11 . Kanters S , Ford N , Druyts E , et al. Use of network meta- analysis  in clinical guidelines . Bulletin of the World Health Organization 2016 ; 94 : 782–4 . 12 . Kiefer C , Sturtz S , Bender R. Indirect comparisons and network meta-analyses : estimation of effects in the absence of head-to-head trials . Deutsches € Arzteblatt International 2015 ; 112 : 803–8 . 13 . Imberger G , Gluud C , Boylan J , Wetterslev J. Systematic review s of anesthesiologic interventions reported as statistically significant : problems with power , precision , and type 1 error protection . Anesthesia and Analgesia 2015 ; 121 : 1611–22 . 14 . Afshari A , Wetterslev J , Smith AF . Can systematic review s with sparse data be trusted ? Anaesthesia 2017 ; 72 : 12–6 . 15 . Jakobsen JC , Wetterslev J , Lange T , Gluud C. Viewpoint : taking into account risks of r and om errors when analysing multiple outcomes in systematic review s. Cochrane Data base of Systematic Review s 2016 ; 3 : ED000111 . 16 . Jakobsen JC , Wetterslev J , Winkel P , Lange T , Gluud C. Thresholds for statistical and clinical significance in systematic review s with meta-analytic methods . BMC Medical Research Methodology 2014 ; 14 : 120 . 17 . Wetterslev J , Jakobsen JC , Gluud C. Trial Sequential Analysis in systematic review s with meta- analysis . BMC Medical Research Methodology 2017 ; 17 : 39 . 18 . Smith AF , Carlisle JC . Review s , systematic review s and Anaesthesia . Anaesthesia 2015 ; 70 : 644–70 . 19 . Cook TM , Kelly FE . The Difficult Airway Society 2015 guidelines and the sacred cows of routine airway management . Anaesthesia 2016 ; 71 : 466–7 . 20 . Schmitz S , Adams R , Walsh C. Incorporating data from various trial design s into a mixed treatment comparison model . Statistics in Medicine 2013 ; 32 : 2935–49 . 21 . Marshall SD , P and it JJ . Radical evolution : the 2015 Difficult Airway Society guidelines for managing unanticipated difficult or failed tracheal intubation . Anaesthesia 2016 ; 71 : 131–7 . 22 . Black AE , Flynn PE , Smith HL , Thomas ML , Wilkinson KA . Association of Pediatric Anaesthetists of Great Britain and Irel and . Development of a guideline for the management of the unanticipated difficult airway in pediatric practice . Pediatric Anaesthesia 2015 ; 25 : 346–62 . 23 . Hagberg CA , Gabel JC , Connis RT . Difficult Airway Society 2015 guidelines for the management of unanticipated difficult intubation in adults : not just another algorithm . British Journal of Anaesthesia 2015 ; 115 : 812–4 . 24 . Martin-Castro C , Montero A.  Flexible laryngeal mask as an alternative to reinforced tracheal tube for upper chest , head and neck oncoplastic surgery . European Journal of Anaesthesiology 2008 ; 25 : 261–6 . 25 . Maclennan A , Smith AF . An analysis of critical incidents relevant to paediatric anaesthesia reported to the UK National Reporting and Learning System , 2006 - 2008 . Pediatric Anesthesia 2011 ; 21 : 841–7 . 26 . P and it JJ , Popat MT , Cook TM , et al. The Difficult Airway Society ‘ ADEPT ’ Guidance on selecting airway devices : the basis of a strategy for equipment evaluation . Anaesthesia 2011 ; 66 : 726–37 The authors developed and tested a framework for identifying evidence gaps and prioritizing comparative effectiveness research by using a combination of clinical practice guidelines and systematic review s. In phase 1 of the project , reported elsewhere , 45 clinical questions on the management of primary open-angle glaucoma were derived from practice guidelines and prioritized by using a 2-round Delphi survey of clinicians . On the basis of the clinicians ' responses , 9 questions were classified as high-priority . In phase 2 , reported here , systematic review s that addressed the 45 clinical questions were identified . The review s were classified as at low , high , or unclear risk of bias , and evidence gaps ( in which no systematic review was at low risk of bias ) were identified . The following comparative effectiveness research agenda is proposed : Two of the 9 high-priority questions require new primary research ( such as a r and omized , controlled trial ) and 4 require a new systematic review . The utility and limitations of the framework and future adaptations are discussed Abstract Introduction : Successful population ‐level antiretroviral therapy ( ART ) adherence will be necessary to realize both the clinical and prevention benefits of antiretroviral scale‐up and , ultimately , the end of AIDS . Although many people living with HIV are adhering well , others struggle and most are likely to experience challenges in adherence that may threaten virologic suppression at some point during lifelong therapy . Despite the importance of ART adherence , supportive interventions have generally not been implemented at scale . The objective of this review is to summarize the recommendations of clinical , research , and public health experts for scalable ART adherence interventions in re source ‐limited setting s. Methods : In July 2015 , the Bill and Melinda Gates Foundation convened a meeting to discuss the most promising ART adherence interventions for use at scale in re source ‐limited setting s. This article summarizes that discussion with recent up date s. It is not a systematic review , but rather provides practical considerations for programme implementation based on evidence from individual studies , systematic review s , meta‐analyses , and the World Health Organization Consoli date d Guidelines for HIV , which include evidence from r and omized controlled trials in low‐ and middle‐income countries . Interventions are categorized broadly as education and counselling ; information and communication technology‐enhanced solutions ; healthcare delivery restructuring ; and economic incentives and social protection interventions . Each category is discussed , including descriptions of interventions , current evidence for effectiveness , and what appears promising for the near future . Approaches to intervention implementation and impact assessment are then described . Results and discussion : The evidence base is promising for currently available , effective , and scalable ART adherence interventions for re source ‐limited setting s. Numerous interventions build on existing health care infrastructure and leverage available re sources . Those most widely studied and implemented to date involve peer counselling , adherence clubs , and short message service ( SMS ) . Many additional interventions could have an important impact on ART adherence with further development , including st and ardized counselling through multi‐media technology , electronic dose monitoring , de central ized and differentiated models of care , and livelihood interventions . Optimal targeting and tailoring of interventions will require improved adherence measurement . Conclusions : The opportunity exists today to address and resolve many of the challenges to effective ART adherence , so that they do not limit the potential of ART to help bring about the end of AIDS BACKGROUND Lately , the number of systematic review s published has increased substantially . Many systematic review s exclude trials published in language s other than English . However , there is little empirical evidence to support this action . We looked for differences in the completeness of reporting between trials published in other language s and those published in English , to see whether the exclusion of trials published in other language s is justified . METHODS We compared completeness of reporting , design characteristics , and analytical approaches of 133 r and omised controlled trials ( RCTs ) published in English between 1989 and 1994 and 96 published in French , German , Italian , or Spanish during the same time . RCTs were identified by h and search ing of journals ( seven in English and six in the other language s ) . FINDINGS We found no significant differences between trials published in English and other- language trials for any single item in the completeness of reporting scale ( r and omisation , double-blinding , withdrawals ) , or for the overall score ( percentage of maximum possible score 51.0 % for trials in English , 46.2 % for trials in other language s ; 95 % CI for difference -1.1 to 10.5 ) . Other- language trials were more likely than English- language trials to have adult participants , to use two or more interventions , and to compare two or more active treatments without an untreated control group . Trials in other language s were less likely to report a clearly prespecified primary outcome or any rationale for sample size estimation . INTERPRETATION These results provide evidence for inclusion of all trial reports , irrespective of the language in which they are published , in systematic review s. Their inclusion is likely to increase precision and may reduce systematic errors . We hope that our findings will prove useful to those developing guidelines and policies for the conduct of reporting of systematic review These guidelines provide a data -supported approach to the diagnosis and management of patients with autoimmune hepatitis . They are based on the following : ( 1 ) a formal review and analysis of the published world literature on autoimmune hepatitis ( 914 articles ) ( Medline Search from 1966 - 2002 ; the search term was autoimmune hepatitis ) ; ( 2 ) recommendations developed and published by the International Autoimmune Hepatitis Group ; ( 3 ) concepts developed at the AASLD Single Topic Conference on autoimmune hepatitis in September 1999 ; and ( 4 ) 40 years of combined experience by both authors in the clinical and laboratory investigation and care for patients with this disease . The guidelines , intended for use by physicians , are meant to be flexible , in contrast to “ st and ards of care , ” which are inflexible policies to be followed in almost every case . They have been developed in a manner consistent with the American Association for the Study of Liver Diseases ’ Policy Statement on Development and Use of Practice Guidelines . Specific recommendations are based on relevant published information . In an attempt to st and ardize recommendations , the Practice Guidelines Committee of the American Association for the Study of Liver Diseases modified the categories of the Infectious Diseases Society of America ’s Quality St and ards . These categories are reported with each recommendation , using the Roman numerals I through IV to determine the quality of evidence upon which the recommendations are based . The categories are as follows : I , evidence from multiple well- design ed r and omized controlled trials , each involving a number of participants to be of sufficient statistical power ; II , evidence from at least one large , well- design ed clinical trial with or without r and omization , from cohort or case-control analytic studies , or from well- design ed meta- analysis ; III , evidence based on clinical experience , descriptive studies , or reports of expert committees ; and IV , not rated Background . Asthma , a leading chronic disease of children , currently affects about 6.2 million ( 8.5 % ) children in the United States . Despite advances in asthma research and availability of increasingly effective therapy , many children do not receive appropriate medications to control the disease , have overreliance on reliever medication , and lack systematic follow-up care . The situation is even worse for poor inner-city and minority children who have significantly worse asthma rates , severity , and outcomes . National Asthma Education and Prevention Program Guidelines recommend a multimodal , chronic care approach . Objective . The authors assessed the effectiveness of practice re design and computerized provider feedback in improving both practitioner adherence to National Asthma Education and Prevention Program Guidelines ( NAEPP ) , and patient outcomes in 295 poor minority children across four Federally Qualified Health Centers ( FQHC ) . Methods . In a nonr and omized , two-group ( intervention versus comparison ) , two-phase trial , all sites were provided re design support to provide quarterly well-asthma visits using structured visit forms , community health workers for outreach and follow-up , a Web-based disease registry for tracking and scheduling , and a provider education package . Intervention sites were given an additional Web-based , computerized patient-specific provider feedback system that produced a guideline -driven medication assessment prompt . Results . Logistic regression results showed that providers at intervention sites were more than twice as likely on average to prescribe guideline -appropriate medications after exposure to our feedback system during the Phase I enrollment period than providers at comparison sites ( exp(B ) = 2.351 , confidence interval [ CI ] = 1.315–4.204 ) . In Phase II ( the postenrollment visit period ) , hierarchical linear models ( HLMs ) and latent growth curves were used to show that asthma control improved significantly by .19 ( SE = .05 ) on average for each of the remaining four visits ( about 11 % of a st and ard deviation ) , and improved even more for patients at intervention sites . These results show that implementation of practice re design support guided by a pediatric chronic care model can improve provider adherence to treatment guidelines as well as patients ’ asthma control . Conclusions . The addition of patient-specific feedback for providers results in quicker adoption of guideline recommendations and potentially greater improvements in asthma control compared to the basic practice re design support alone Background Primary health professionals are well positioned to support the delivery of patient self-management in an evidence -based , structured capacity . A need exists to better underst and the active components required for effective self-management support , how these might be delivered within primary care , and the training and system changes that would subsequently be needed . Objectives ( 1 ) To examine self-management support interventions in primary care on health outcomes for a wide range of diseases compared to usual st and ard of care ; and ( 2 ) To identify the effective strategies that facilitate positive clinical and humanistic outcomes in this setting . Method A systematic review of r and omized controlled trials evaluating self-management support interventions was conducted following the Cochrane h and book & PRISMA guidelines . Published literature was systematic ally search ed from inception to June 2019 in PubMed , Scopus and Web of Science . Eligible studies assessed the effectiveness of individualized interventions with follow-up , delivered face-to-face to adult patients with any condition in primary care , compared with usual st and ard of care . Matrices were developed that mapped the evidence and components for each intervention . The method ological quality of included studies were appraised . Results 6,510 records were retrieved . 58 studies were included in the final qualitative synthesis . Findings reveal a structured patient-provider exchange is required in primary care ( including a one-on-one patient-provider consultation , ongoing follow up and provision of self-help material s ) . Interventions should be tailored to patient needs and may include combinations of strategies to improve a patient ’s disease or treatment knowledge ; independent monitoring of symptoms , encouraging self-treatment through a personalized action plan in response worsening symptoms or exacerbations , psychological coping and stress management strategies , and enhancing responsibility in medication adherence and lifestyle choices . Follow-up may include tailored feedback , monitoring of progress with respect to patient set healthcare goals , or honing problem-solving and decision-making skills . Theoretical models provided a strong base for effective SMS interventions . Positive outcomes for effective SMS included improvements in clinical indicators , health-related quality of life , self-efficacy ( confidence to self-manage ) , disease knowledge or control . An SMS model has been developed which sets the foundation for the design and evaluation of practical strategies for the construct of self-management support interventions in primary healthcare practice . Conclusions These findings provide primary care professionals with evidence -based strategies and structure to deliver SMS in practice . For this collaborative partnership approach to be more widely applied , future research should build on these findings for optimal SMS service design and upskilling healthcare providers to effectively support patients in this collaborative process Background The purpose of this study was to evaluate the role of study quality assessment of primary studies in cancer practice guidelines . Methods Reliable and valid study quality  assessment scales were sought and applied to published reports of trials included in systematic review s of cancer guidelines . Sensitivity analyses were performed to evaluate the relationship between quality scores and pooled odds ratios ( OR ) for mortality and need for blood transfusion .  Results Results found that that whether trials were classified as high or low quality depended on the scale used to assess them . Although the results of the sensitivity analyses found some variation in the ORs observed , the confidence intervals ( CIs ) of the pooled effects from each of the analyses of high quality trials overlapped with the CI of the pooled odds of all trials . Quality score was not predictive of pooled ORs studied here . Conclusions Had sensitivity analyses based on study quality been conducted prospect ively , it is highly unlikely that different conclusions would have been found or that different clinical recommendations would have emerged in the guidelines Background Smoking is one of the top preventable causes of mortality in people with psychotic disorders such as schizophrenia .  Cessation treatment improves abstinence outcomes , but access is a barrier . Mobile phone apps are one way to increase access to cessation treatment ; however , whether they are usable by people with psychotic disorders , who often have special learning needs , is not known . Objective Research ers review ed 100 r and omly selected apps for smoking cessation to rate them based on US guidelines for nicotine addiction treatment and to categorize them based on app functions . We aim ed to test the usability and usefulness of the top-rated apps in 21 smokers with psychotic disorders . Methods We identified 766 smoking cessation apps and r and omly selected 100 for review . Two independent review ers rated each app with the Adherence Index to US Clinical Practice Guideline for Treating Tobacco Use and Dependence . Then , smokers with psychotic disorders evaluated the top 9 apps within a usability testing protocol . We analyzed quantitative results using descriptive statistics and t tests . Qualitative data were open-coded and analyzed for themes . Results Regarding adherence to practice guidelines , most of the r and omly sample d smoking cessation apps scored poorly—66 % rated lower than 10 out of 100 on the Adherence Index ( Mean 11.47 , SD 11.8 ) . Regarding usability , three common usability problems emerged : text-dense content , abstract symbols on the homepage , and subtle directions to edit features . Conclusions In order for apps to be effective and usable for this population , developers should utilize a balance of text and simple design that facilitate ease of navigation and content comprehension that will help people learn quit smoking skills Low  back pain  has long been described as a challenge for both primary care physicians and specialists . Management of  low back pain  has also been criticized as frequently arbitrary , inappropriate , or ineffective . Contributing factors have been an inadequate evidence base and a need for more rigorous appraisal s of the available literature . Evidence -based medicine , an approach to clinical problem solving , is predicated on the premise that high- quality health care will result from practice s consistent with the best evidence . In contrast to the traditional medical paradigm that placed a heavy reliance on expert opinion , authority , and un systematic clinical observations , evidence -based medicine emphasizes the need for rigorous critical appraisal s of the scientific literature to inform medical decision making . Evidence -based medicine places strong weight on the requirement for valid studies , particularly r and omized controlled trials , to appropriately evaluate the effectiveness of health care interventions . Because of the rapidly increasing volume of medical literature , however , most clinicians are unable to keep up-to- date with all the new data . Two types of preprocessed evidence that can aid busy clinicians in medical decision making are systematic review s and evidence -based clinical practice guidelines . Like primary studies , systematic review s and clinical practice guidelines must adhere to high method ologic st and ards to reduce error and bias . As in other areas of medicine , the approach to the management of low back pain has been positively affected by the availability of more clinical trials and better use of critical appraisal techniques to evaluate and apply research findings . In addition to more rigorous primary studies , an increasing number of high- quality systematic review s and evidence -based clinical practice guidelines for low back pain are also available . Although some research gaps and method ologic shortcomings persist , the richer evidence base has greatly improved our underst and ing of what does and does not work for low back pain . Despite these advances , the best available evidence often does not inform everyday clinical decisions for low back pain . Nonetheless , there is widespread agreement that adherence to evidence -based practice will help improve low back pain patient outcomes and reduce arbitrary variations in care . This article review s basic principles of evidence -based medicine , discusses evidence -based medicine in the context of low back pain management , and summarizes some useful evidence -based medicine re sources Background : International guidelines for the management of nonvariceal upper gastrointestinal bleeding have not been widely adopted in clinical practice . We sought to determine whether a national , multifaceted intervention could improve adherence to guidelines , especially for patients at high risk of nonvariceal upper gastrointestinal bleeding . Methods : In this r and omized trial , we stratified hospitals by region and size and allocated sites to either the control or experimental group . Health care workers in the experimental group were given published guidelines , generic algorithms , stratification scoring systems and written reminders and attended multidisciplinary guideline education groups and case-based workshops . These interventions were implemented over a 12-month period after r and omization , with performance feedback and benchmarking . The primary outcome of adherence rates to key guidelines in endoscopic and pharmacologic management , determined by chart review , was adjusted according to site characteristics and possible within-site dependencies . We also report the rates of adherence to other recommendations . Results : Forty-three sites were r and omized to the experimental ( n = 21 ) or control ( n = 22 ) groups . In our primary analysis , we compared patients before ( experimental group : n = 402 patients ; control group : n = 424 patients ) and after ( experimental group : n = 361 patients ; control group : n = 389 patients ) intervention . Patient-level analysis revealed no significant difference in adherence rates to the guidelines after the intervention ( experimental group : 9.8 % ; control group : 4.8 % ; p = 0.99 ) after adjustment for the rate of adherence before the intervention ( experimental group : 13.2 % ; control group : 7.1 % ) . The adherence rates to other guidelines were similar and decreased over time , varying between 5 % and 93 % . Interpretation : This national knowledge translation – based trial suggests poor adherence to guidelines on nonvariceal upper gastrointestinal bleeding . Adherence was not improved by an educational intervention , which highlights both the complexity and poor predictability of attempting to alter the behaviour of health care providers ( Trial registration : Clinical Trials.gov , no. MCT-88113 ) There has been renewed interest for metal-on-metal hip resurfacing due to improved design and manufacturing of implants , better material s , and enhanced implant fixation . In contrast to conventional total hip replacements , only a few clinical hip resurfacing trials using radiostereometry ( RSA ) have been reported , and solely for the Birmingham hip resurfacing arthroplasty . The purpose of this RSA trial was to describe the migration pattern of a  new hip resurfacing system ( ReCap ) within the first two years after primary surgery . Twenty-six patients underwent total hip replacement .  The patients were followed-up for up to 24 months and were evaluated with the use of radiostereometric measurements .  The prosthesis showed mean translations and rotation close to zero . Maximum translation was seen along the transverse axis in the medial direction ( 0.13 mm ) . No statistically significant translation or rotation was seen at two-years follow-up , ( t-test , p < 0.05 , translation or rotation ) Objective To investigate the effect of an additional review based on reporting guidelines such as STROBE and CONSORT on quality of manuscripts . Design Masked r and omised trial . Population Original research manuscripts su bmi tted to the Medicina Clínica journal from May 2008 to April 2009 and considered suitable for publication . Intervention Control group : conventional peer review s alone . Intervention group : conventional review plus an additional review looking for missing items from reporting guidelines . Outcomes Manuscript quality , assessed with a 5 point Likert scale ( primary : overall quality ; secondary : average quality of specific items in paper ) . Main analysis compared groups as allocated , after adjustment for baseline factors ( analysis of covariance ) ; sensitivity analysis compared groups as review ed . Adherence to review er suggestions assessed with Likert scale . Results Of 126 consecutive papers receiving conventional review  , 34 were not suitable for publication . The remaining 92 papers were allocated to receive conventional review s alone ( n=41 ) or additional review s ( n=51 ) . Four papers assigned to the conventional review group deviated from protocol ; they received an additional review based on reporting guidelines . We saw an improvement in manuscript quality in favour of the additional review group ( comparison as allocated , 0.25 , 95 % confidence interval –0.05 to 0.54 ; as review ed , 0.33 , 0.03 to 0.63 ) . More papers with additional review s than with conventional review s alone improved from baseline ( 22 ( 43 % ) v eight ( 20 % ) , difference 23.6 % ( 3.2 % to 44.0 % ) , number needed to treat 4.2 ( from 2.3 to 31.2 ) , relative risk 2.21 ( 1.10 to 4.44 ) ) . Authors in the additional review group adhered more to suggestions from conventional review s than to those from additional review s ( average increase 0.43 Likert points ( 0.19 to 0.67 ) ) . Conclusions Additional review s based on reporting guidelines improve manuscript quality , although the observed effect was smaller than hypothesised and not definitively demonstrated . Authors adhere more to suggestions from conventional review s than to those from additional review s , showing difficulties in adhering to high method ological st and ards at the latest research phases . To boost paper quality and impact , authors should be aware of future requirements of reporting guidelines at the very beginning of their study . Trial registration and protocol Although registries do not include trials of peer review , the protocol design was su bmi tted to sponsored research projects ( Instituto de Salud Carlos III , PI081903 ) Background We investigated whether there had been an improvement in quality of reporting for r and omised controlled trials of acupuncture since the publication of the STRICTA and CONSORT statements . We conducted a before- and -after study , comparing ratings for quality of reporting following the publication of both STRICTA and CONSORT recommendations . Methodology and Principal Findings Ninety peer review ed journal articles reporting the results of acupuncture trials were selected at r and om from a wider sample frame of 266 papers . Papers published in three distinct time periods ( 1994–1995 , 1999–2000 and 2004–2005 ) were compared . Assessment criteria were developed directly from CONSORT and STRICTA checklists . Papers were independently assessed for quality of reporting by two assessors , one of whom was blind to information which could have introduced systematic bias ( e.g. date of publication ) . We detected a statistically significant increase in the reporting of CONSORT items for papers published in each time period measured . We did not , however , find a difference between the number of STRICTA items reported in journal articles published before and 3 to 4 years following the introduction of STRICTA recommendations . Conclusions and Significance The results of this study suggest that general st and ards of reporting for acupuncture trials have significantly improved since the introduction of the CONSORT statement in 1996 , but that quality in reporting details specific to acupuncture interventions has yet to change following the more recent introduction of STRICTA recommendations . Wider targeting and revision of the guidelines is recommended A total of 51 knees ( 45 patients ) with osteoarthrosis were stratified in a r and omized study to receive a hydroxyapatite-coated Freeman-Samuelson ( FS HA ) or a porous-coated Miller-Galante II ( MG II ) uncemented total knee arthroplasty . Repeated clinical , radiographic  , and  radiostereometric analysis (  RSA ) evaluations of the tibial components were done for 5 years . The clinical outcome was equal at the 5-year follow-up ( mean Hospital for Special Surgery score , 93 ) . St and ard radiographs displayed more zones around the tibial stem in the MG II group . RSA revealed that the FS HA components migrated less ( smaller maximum total point motion and maximum subsidence ) after 5 years and showed less inducible displacements at the 1-year follow-up . The stability of the implants obtained is equal to or better than cemented implants after 5 years . Key words : knee prosthesis , cementless , hydroxyapatite , radiostereometry , inducible displacement d t m n d m e D m This is one of a series of statements discussing the use of GI endoscopy in common clinical situations . The St and ards of Practice Committee of the American Society for Gastrointestinal Endoscopy ( ASGE ) prepared this text . This guideline is an up date of a previous ASGE guideline published in 2005.1 In preparing this guideline , a search of the medical literature was performed by using PubMed . Additional references were obtained from the bibliographies of the identified articles and from recommendations of expert consultants . When few or no data exist from well- design ed prospect i ve trials , emphasis is given to results from large series and reports from recognized experts . Guidelines for appropriate use of endoscopy are based on a critical review of the available data and expert consensus at the time that the guidelines are drafted . Further controlled clinical studies may be needed to clarify aspects of this guideline . This guideline may be revised as necessary to account for changes in technology , new data , or other aspects of clinical practice . The recommendations are based on review ed studies and are grade d on the strength of the supporting evidence ( Table 1).2 The trength of individual recommendations is based on both he aggregate evidence quality and an assessment of the nticipated benefits and harms . Weaker recommendaions are indicated by phrases such as “ We suggest , ” hereas stronger recommendations are typically stated as We recommend . ” This guideline is intended to be an educational device o provide information that may assist endoscopists in roviding care to patients . This guideline is not a rule and hould not be construed as establishing a legal st and ard of are or as encouraging , advocating , requiring , or discourging any particular treatment . Clinical decisions in any articular case involve a complex analysis of the patient ’s ondition and available courses of action . Therefore , clincal considerations may lead an endoscopist to take a ourse of action that varies from these guidelines PURPOSE To develop a guideline for the use of sentinel node biopsy ( SNB ) in early stage breast cancer . METHODS An American Society of Clinical Oncology ( ASCO ) Expert Panel conducted a systematic review of the literature available through February 2004 on the use of SNB in early-stage breast cancer . The panel developed a guideline for clinicians and patients regarding the appropriate use of a sentinel lymph node identification and sampling procedure from hereon referred to as SNB . The guideline was review ed by selected experts in the field and the ASCO Health Services Committee and was approved by the ASCO Board of Directors . RESULTS The literature review identified one published prospect i ve r and omized controlled trial in which SNB was compared with axillary lymph node dissection ( ALND ) , four limited meta-analyses , and 69 published single-institution and multicenter trials in which the test performance of SNB was evaluated with respect to the results of ALND ( completion axillary dissection ) . There are currently no data on the effect of SLN biopsy on long-term survival of patients with breast cancer . However , a review of the available evidence demonstrates that , when performed by experienced clinicians , SNB appears to be a safe and acceptably accurate method for identifying early-stage breast cancer without involvement of the axillary lymph nodes . CONCLUSION SNB is an appropriate initial alternative to routine staging ALND for patients with early-stage breast cancer with clinical ly negative axillary nodes . Completion ALND remains st and ard treatment for patients with axillary metastases identified on SNB . Appropriately identified patients with negative results of SNB , when done under the direction of an experienced surgeon , need not have completion ALND . Isolated cancer cells detected by pathologic examination of the SLN with use of specialized techniques are currently of unknown clinical significance . Although such specialized techniques are often used , they are not a required part of SLN evaluation for breast cancer at this time . Data suggest that SNB is associated with less morbidity than ALND , but the comparative effects of these two approaches on tumor recurrence or patient survival are unknown Abstract Background Heterogeneity has been noted in the selection and reporting of disease-specific , pediatric outcomes in r and omized controlled trials ( RCTs ) . The consequence is invalid results or difficulty comparing results across trials . The primary objective of this systematic review was to assess primary outcome and outcome measure selection and reporting , in pediatric eosinophilic esophagitis ( EoE ) treatment trials . As secondary objectives , we compared trial disease definition to established concensus guidelines , and the efficacy of current EoE treatments . Methods We search ed MEDLINE , EMBASE , The Cochrane Library , Cochrane Central Register of Controlled Trials ( CENTRAL ) , and CINAHL since 2001 . We also search ed clinical trial registries ( portal.nihr.ac.uk ; clinical trials.gov ; is rct n.com ; and anzctr.org.au ) and references of included studies . We included RCTs of EoE treatment in patients 0–18 years . Two authors independently assessed articles . Results Eleven studies met inclusion criteria . All identified primary outcomes , however , of 9 unique primary outcomes , only 2 were used in more than one study . In total , 25 unique primary and secondary outcome measures were employed for pediatric EoE treatment trials . Measurement properties and rationale for their selection was rarely provided . Uptake of consensus-based diagnostic criteria was 25 % in trials initiated after 2011 . Due to the small number and heterogeneity of studies obtained , no meta- analysis of treatment efficacy could be undertaken . This SR was limited to exclusively pediatric RCTs . Conclusions The results of this study confirm the need for a st and ardized set of core outcomes that are universally reported in pediatric EoE trials . Consistent disease definition and st and ardized outcome reporting will facilitate meta-analyses across similar trials and inform future clinical decision-making . Systematic review registration number A systematic review of the literature will fail to provide information needed for evidence -based medicine ( EBM ) if the design , execution and reporting of individual trials do not adhere to strict guidelines . Experience gained while conducting systematic literature review s have revealed serious shortcomings in current literature . These limitations pertain to r and omisation , blinding , outcome assessment s and data reporting . The principles related to these issues are discussed with solutions and improvements provided Background : Constipation is a pediatric problem commonly encountered by many health care workers in primary , secondary , and tertiary care . To assist medical care providers in the evaluation and management of children with functional constipation  , the North American Society for Pediatric Gastroenterology , Hepatology , and Nutrition and the European Society for Pediatric Gastroenterology , Hepatology , and Nutrition were charged with the task of developing a uniform document of evidence -based guidelines . Methods : Nine clinical questions addressing diagnostic , therapeutic , and prognostic topics were formulated . A systematic literature search was performed from inception to October 2011 using Embase , MEDLINE , the Cochrane Data base of Systematic Review s and Cochrane Central Register of Controlled Clinical Trials , and PsychInfo data bases . The approach of the  Grading of Recommendations Assessment , Development and Evaluation  was applied to evaluate outcomes . For therapeutic questions , quality of evidence was assessed using the Grading of Recommendations , Assessment , Development , and Evaluation system . Grading the quality of evidence for the other questions was performed according to the classification system of the Oxford Centre for Evidence -Based Medicine . During 3 consensus meetings , all recommendations were discussed and finalized . The group members voted on each recommendation , using the nominal voting technique . Expert opinion was used where no r and omized controlled trials were available to support the recommendation . Results : This evidence -based guideline provides recommendations for the evaluation and treatment of  children with functional constipation  to st and ardize and improve their quality of care . In addition , 2 algorithms were developed , one for the infants < 6 months of age and the other for older infants and children . Conclusions : This document is intended to be used in daily practice and as a basis for further clinical research . Large well- design ed clinical trials are necessary with regard to diagnostic evaluation and treatment After more than three decades of clinical trials testing various st and ard-dose chemotherapy regimens , the disease course of patients with multiple myeloma has not changed appreciably . Conventional chemotherapy can provide effective palliation but is not curative ( 1 ) . Case series have described encouraging results in patients with myeloma undergoing allogeneic or autologous bone marrow or peripheral blood stem-cell transplantation ( 2 ) . Other studies of transplantation , including r and omized trials , have been reported in the past 6 years ( 3 , 4 ) . To facilitate decisions about treatment options , practice guidelines have been developed for use by health care providers and consumers . In Ontario , Canada , cancer treatments and policies are led by a state-funded organization , Cancer Care Ontario . To help derive treatment options , Cancer Care Ontario has developed the Program in Evidence -Based Care , which includes the Practice Guidelines Initiative . Disease Site Groups ( DSGs ) , which comprise physicians , epidemiologists , and consumers , develop guidelines through a systematic process that involves assessment of evidence , consensus , and a validation process involving practitioners from across the province . Guideline topics are chosen through a prioritization process that includes the burden of illness , availability of evidence , perceived variation in practice , the potential to affect treatment decisions , and re source utilization . The Hematology DSG noted that the use of transplantation for patients with myeloma varied among practice s across the province . Variability in practice and emerging evidence of higher quality made this a priority topic for guideline development . To approach this topic , the DSG addressed the following questions : What is optimal st and ard-dose chemotherapy for patients with myeloma ? In terms of survival , is  peripheral blood stem-cell  or  marrow transplantation better than conventional chemotherapy ? What is the relative efficacy of autologous versus allogeneic transplantation ? What specifics of the transplantation process can be recommended ? When should transplantation be performed ? Who should ( or should not ) receive a transplant ? Methods Overview of Guideline Development This guideline was developed by the Cancer Care Ontario Practice Guidelines Initiative ( CCOPGI ) using the methods of the Practice Guidelines Development Cycle ( 5 ) . Members of the CCOPGI 's Hematology DSG selected , review ed , and interpreted the evidence . This DSG comprises 25 members , including hematologists , medical and radiation oncologists , an epidemiologist , and 2 lay representatives . Several of the physician members have background training in epidemiology ; 8 hematologists regularly perform stem-cell transplantation in clinical practice . The DSG 's draft recommendations were circulated through a mailed survey to hematologists and medical or radiation oncologists in Ontario for feedback and involvement in a consensus process . Responses were used to guide the reformatting of the draft into the final guideline recommendations . The Practice Guidelines Co-ordinating Committee ( PGCC ) , which ensures consistency of guideline development across the DSGs of various tumor sites , approved the guideline . The CCOPGI has a st and ardized process to up date each guideline report ; the current guideline was up date d and review ed by the PGCC in October 2000 . Literature Search Strategy We search ed the MEDLINE , CANCERLIT , and Cochrane Library data bases for literature published from 1992 to December 1997 and subsequently up date d the search in October 1998 , June 1999 , and April 2000 . For the search es , we combined multiple myeloma ( as a Medical Subject Heading [ MeSH ] and text word ) with bone marrow transplantation ( MeSH and text word ) and drug therapy ( MeSH ) . Then , we combined these terms with the search terms for the following study design s : practice guidelines ; systematic review s or meta-analyses ; review s ; r and omized , controlled trials ; controlled clinical trials ; and comparative studies . In addition , we search ed the PubMed and Physician Data Query ( PDQ ) ( www.cancer.gov/ search / clinical _ trials/ ) data bases and review ed relevant conference proceedings ( American Society of Hematology , 1997 to 1999 , and American Society of Clinical Oncology , 1999 to 2000 ) , article bibliographies , and personal files . To address the issue of optimal chemotherapy , we performed an additional search of the same data bases using the term multiple myeloma ( MeSH ) combined with r and omized , controlled trials ( MeSH ) and the text word r and om in the title . Inclusion Criteria We selected study reports meeting one of the three following criteria : r and omized trial or meta- analysis of therapy for patients with myeloma that reported survival or quality -of-life outcomes ; nonr and omized comparative trial that addressed transplantation strategy , including a contemporaneous control group , and that reported survival or quality -of-life outcomes ; or economic evaluation that addressed transplantation strategy . Because of insufficient data on the specifics of the transplantation process and the patients who would be most likely to benefit from transplantation , we performed a second search , which identified data from noncomparative case-series studies . Data Extraction and Interpretative Summary Three members of the DSG , including an epidemiologist , determined eligibility of the articles and abstract s obtained from the literature search . The lead DSG member for this guideline extracted and summarized relevant data according to the guideline question addressed . The DSG members then review ed the summarized data and key articles . The DSG met formally three to four times annually ; at these meetings , the members method ologically assessed the articles , interpreted the data , and debated specific points in an attempt to reach a consensus . Synthesizing the Evidence Because all of the nine r and omized trials on transplantation addressed different questions , we did not statistically pool the data . DSG Consensus Process Through an iterative process that included debate at formal meetings and circulation of draft recommendations , we considered the implication s of the appraised data for each guideline question . With this process , attempts were made to reach consensus ; when this was impossible , minority opinions were recorded . Approval by each member of the DSG was required before circulation of the draft version for practitioner feedback and su bmi ssion of the final guideline to the PGCC . Practitioner Feedback To obtain practitioner feedback , we mailed a survey to 211 practitioners in Ontario ( 94 hematologists , 93 medical oncologists , and 24 radiation oncologists ) . The survey consisted of st and ardized items asking the practitioner to rate the quality of each draft guideline and to judge whether the draft recommendations should serve as a practice guideline . Written comments were invited . Follow-up reminders were sent at 2 weeks ( by postcard ) and 4 weeks ( entire package ) . After exclusion of 18 retired practitioners , 137 of 193 practitioners ( 71 % ) responded ; 90 of 137 respondents ( 66 % ) indicated that the guideline was relevant to their practice . Approval of the draft guideline was strong among these 90 practitioners : 91 % agreed or strongly agreed that the summary of the evidence was acceptable , 87 % agreed with the draft recommendations , and 81 % approved of the recommendations as a practice guideline . Thirty-nine respondents provided written comments ; these comments were , like the other responses , incorporated in the final guideline . Results Sixty-six reports met the criteria for inclusion and are categorized in Table 1 . In each section below , we describe the studies , summarize results , and describe the guideline development . Table 1 . Evidence Included in This Practice Guideline Report What Is Optimal St and ard-Dose Chemotherapy  for Patients with Multiple Myeloma ? To properly compare transplantation with conventional chemotherapy , we must define optimal conventional chemotherapy . We identified 30 r and omized trials comparing therapies in previously untreated patients . Four meta-analyses ( 6 - 9 ) evaluated these data . The Myeloma Trialists ' Collaborative Group ( 7 ) compared combination chemotherapy with melphalan plus prednisone in a meta- analysis of 27 trials . Twenty of these trials supplied individual-patient data . No difference in survival was detected . The proportional reduction in the annual odds of death was 1.5 % in favor of combination chemotherapy ( 95 % CI , 8 % to 5 % ; P > 0.2 ) , with an odds ratio ( OR ) of 0.99 ( CI , 0.93 to 1.05 ) . An earlier literature -based meta- analysis ( 6 ) of 18 trials also failed to detect a survival difference between groups ( OR , 1.04 [ CI , 0.90 to 1.19 ] ; P > 0.2 ) . Two meta-analyses evaluated interferon for multiple myeloma . An overview of 24 r and omized trials published in abstract form ( 8) demonstrated that interferon improved recurrence-free survival by 6 months and improved 3-year overall survival by 4 % . Another meta- analysis ( 9 ) measured survival by a unique measure called the mean lifetime survival . This meta- analysis found no difference in survival rate between the group receiving interferon and the group not receiving interferon ( 3.9 vs. 3.4 years , respectively ; P = 0.095 ) . Guideline Recommendation Multiagent chemotherapy or melphalan plus prednisone is appropriate therapy for a control group in a comparison of transplantation versus st and ard-dose therapy . The addition of interferon is unlikely to influence outcomes in the control group . In Terms of Survival , Is Autologous Peripheral Blood Stem-Cell or Bone Marrow Transplantation Better than Conventional Chemotherapy ? We review ed two r and omized and three nonr and omized comparisons ( Table 2 ) . Attal and colleagues ( 3 ) r and omly assigned 200 previously untreated patients younger than 65 years of age with stage II or III ( 40 ) myeloma to conventional chemotherapy or to a strategy that included autologous bone marrow transplantation . Patients were r and omly Diagnosis is a critical component of health care , and clinicians , policymakers , and patients routinely face a range of questions regarding diagnostic tests . They want to know whether testing improves outcome ; what test to use , purchase , or recommend in practice guidelines ; and how to interpret test results . Well- design ed  diagnostic test accuracy studies can help in making these decisions , provided that they transparently and fully report their participants , tests , methods , and results as facilitated , for example , by the STARD ( St and ards for Reporting of Diagnostic Accuracy ) statement ( 1 ) . That 25-item checklist was published in many journals and is now adopted by more than 200 scientific journals worldwide . As in other areas of science , systematic review s and meta- analysis of accuracy studies can be used to obtain more precise estimates when small studies addressing the same test and patients in the same setting are available . Review s can also be useful to establish whether and how scientific findings vary by particular subgroups , and may provide summary estimates with a stronger generalizability than estimates from a single study . Systematic review s may help identify the risk for bias that may be present in the original studies and can be used to address questions that were not directly considered in the primary studies , such as comparisons between tests . The Cochrane Collaboration is the largest international organization preparing , maintaining , and promoting systematic review s to help people make well-informed decisions about health care ( 2 ) . The Collaboration decided in 2003 to make preparations for including systematic review s of diagnostic test accuracy in their Cochrane Data base of Systematic Review s. To enable this , a working group ( Appendix ) . was formed to develop methodology , software , and a h and book The first diagnostic test accuracy review was published in the Cochrane Data base in October 2008 . In this paper , we review recent method ological developments concerning problem formulation , location of literature , quality assessment , and meta- analysis of diagnostic accuracy studies by using our experience from the work on the Cochrane H and book . The information presented here is based on the recent literature and up date s previously published guidelines by Irwig and colleagues ( 3 ) . Definition of the Objectives of the Review Diagnostic test accuracy refers to the ability of a test to distinguish between patients with disease ( or more generally , a specified target condition ) and those without . In a study of test accuracy , the results of the test under evaluation , the index test , are compared with those of the reference st and ard determined in the same patients . The reference st and ard is an agreed-on and accurate method for identifying patients who have the target condition . Test results are typically categorized as positive or negative for the target condition . By using such binary test outcomes , the accuracy is most often expressed as the test 's sensitivity ( the proportion of patients with positive results on the reference st and ard that are also positive on the index test ) and specificity ( the proportion of patients with negative results on the reference st and ard that are also negative on the index test ) . Other measures have been proposed and are in use ( 46 ) . It has long been recognized that test accuracy is not a fixed property of a test . It can vary between patient subgroups , with their spectrum of disease , with the clinical setting , or with the test interpreters and may depend on the results of previous testing . For this reason , inclusion of these elements in the study question is essential . In order to make a policy decision to promote use of a new index test , evidence is required that using the new test increases test accuracy over other testing options , including current practice , or that the new test has equivalent accuracy but offers other advantages ( 79 ) . As with the evaluation of interventions , systematic review s need to include comparative analyses between alternative testing strategies and should not focus solely on evaluating the performance of a test in isolation . In relation to the existing situation , 3 possible roles for a new test can be defined : replacement , triage , and add-on ( 7 ) . If a new test is to replace an existing test , then comparing the accuracy of both tests on the same population and with the same reference st and ard provides the most direct evidence . In triage , the new test is used before the existing test or testing pathway , and only patients with a particular result on the triage test continue the testing pathway . When a test is needed to rule out disease in patients who then need no further testing , a test that gives a minimal proportion of falsenegative results and thus a relatively high sensitivity should be used . Triage tests may be less accurate than existing ones , but they have other advantages , such as simplicity or low cost . A third possible role of a new test is add-on . The new test is then positioned after the existing testing pathway to identify false-positive or false-negative results after the existing pathway . The review should provide data to assess the incremental change in accuracy made by adding the new test . An example of a replacement question can be found in a systematic review of the diagnostic accuracy of urinary markers for primary bladder cancer ( 10 ) . Clinicians may use cytology to triage patients before they undergo invasive cystoscopy  , the reference st and ard for bladder cancer . Because cytology combines high specificity with low sensitivity ( 11 ) , the goal of the review was to identify a tumor marker with sufficient accuracy to either replace cytology or be used in addition to cytology . For a marker to replace cytology , it has to achieve equally high specificity with improved sensitivity . New markers that are sensitive but not specific may have roles as adjuncts to conventional testing . The review included studies in which the test under evaluation ( several different tumor markers and cytology ) was evaluated against cystoscopy or histopathology . Included studies compared 1 or more of the markers , cytology only , or a combination of markers and cytology . Although information on accuracy can help clinicians make decisions about tests , good diagnostic accuracy is a desirable but not sufficient condition for the effectiveness of a test ( 8) . To demonstrate that using a new test does more good than harm to patients tested , r and omized trials of test- and -treatment strategies and review s of such trials may be necessary . However , with the possible exception of screening , in most cases , such r and omized trials are not available and systematic review s of test accuracy may provide the most useful evidence available to guide clinical and health policy decision making and use as input for decision and cost-effectiveness analysis ( 12 ) . Identification and Selection of Studies Identifying test accuracy studies is more difficult than search ing for r and omized trials ( 13 ) . There is not a clear , unequivocal keyword or indexing term for an accuracy study in literature data bases comparable with the term r and omized , controlled trial . The Medical Subject Heading sensitivity and specificity may look suitable but is inconsistently applied in most electronic bibliographic data bases . Furthermore , data on diagnostic test accuracy may be hidden in studies that did not have test accuracy estimation as their primary objective . This complicates the efficient identification of diagnostic test accuracy studies in electronic data bases , such as MEDLINE . Until indexing systems properly code studies of test accuracy , search ing for them will remain challenging and may require additional manual search es , such as screening reference lists . In the development of a comprehensive search strategy , review authors can use search strings that refer to the test(s ) under evaluation , the target condition , and the patient description or a subset of these . For tests with a clear name that are used for a single purpose , search ing for publications in which those tests are mentioned may suffice . For other review s , adding the patient description may be necessary , although this is also often poorly indexed . A search strategy in MEDLINE should contain both Medical Subject Headings and free text words . A search strategy for articles about tests for bladder cancer , for example , should include as many synonyms for bladder cancer as possible in the search strategy , including neoplasm , carcinoma , transitional cell , and hematuria . Several method ological electronic search filters for diagnostic test accuracy studies have been developed , each attempting to restrict the search to articles that are most likely to be test accuracy studies ( 1316 ) . These filters rely on indexing terms for research methodology and text words used in reporting results , but they often miss relevant studies and are unlikely to decrease the number of articles one needs to screen . Therefore , they are not recommended for systematic review s ( 17 , 18 ) . The incremental value of search ing in language s other than English and in the gray literature has not yet been fully investigated . In systematic review s of intervention studies , publication bias is an important and well-studied form of bias in which the decision to report and publish studies is linked to their findings . For clinical trials , the magnitude and determinants of publication bias have been identified by tracing the publication history of cohorts of trials review ed by ethics committees and research boards ( 19 ) . A consistent observation has been that studies with significant results are more likely to be published than studies with nonsignificant findings ( 19 ) . Investigating publication bias for diagnostic tests is problematic , because many studies are done without ethical review or study registration ; therefore , identification of cohorts of studies from registration to final publication status Revised guidelines for the use of antimicrobial therapy in patients with intra-abdominal infections were recently developed by the Therapeutic Agents Committee of the Surgical Infection Society ( Mazuski et al. , Surg Infect 2002;3:161 - 173 ) . These were based , insofar as possible , on evidence published over the past decade . The objective of this document is to describe the process by which the Committee identified and review ed the published literature utilized to develop the recommendations and to summarize the results of those review s. English- language articles published between 1990 and 2000 related to antimicrobial therapy for intra-abdominal infections were identified by a systematic MEDLINE search and an examination of references included in recent review articles . If current literature with regard to a specific issue was lacking , relevant articles published prior to 1990 were identified . All prospect i ve r and omized controlled trials , as well as other articles selected by the Committee , were evaluated individually and collectively . Data with regard to patient numbers , types of infections , and results of interventions were abstract ed . Studies were categorized according to their design , and all included trials were grade d according to quality . On the basis of this evidence , the Committee formulated recommendations for antimicrobial therapy for intra-abdominal infections and grade d those recommendations . After receiving comments from invited review ers and the general membership of the Society , the guidelines were finalized and su bmi tted to the Council of the Surgical Infection Society for approval . The final recommendations related to the selection of patients needing therapeutic antimicrobials , acceptable antimicrobial regimens , duration of antimicrobial use , and the identification and treatment of higher-risk patients . Although numerous publications pertaining to these topics were identified , but nearly all of the prospect i ve r and omized controlled trials represented comparisons of different antimicrobial regimens for the treatment of intra-abdominal infections . A few prospect i ve trials evaluated the need for  therapeutic antimicrobial therapy  in patients with peritoneal contamination following abdominal trauma . The quality of these prospect i ve trials was highly variable . Many did not limit enrollment to patients with complicated intra-abdominal infections , lacked blinding of treatment assignment , did not provide a complete description of the criteria used to determine therapeutic success or failure , failed to identify the reasons why patients were excluded from analysis , or did not include an intention-to-treat analysis . For many issues , no prospect i ve r and omized controlled trials were encountered , and guidelines had to be formulated using evidence from studies with historical controls or uncontrolled data , or on the basis of expert Clinical trials , systematic review s , and guidelines compare beneficial and non-beneficial outcomes following interventions . Often , however , various studies on a particular topic do not address the same outcomes , making it difficult to draw clinical ly useful conclusions when a group of studies is looked at as a whole.1 This problem was recently thrown into sharp focus by a systematic review of interventions for preterm birth prevention , which found that among 103 r and omized trials , no fewer than 72 different outcomes were reported.2 There is a growing recognition among clinical research ers that this variability undermines consistent synthesis of the evidence , and that what is needed is an agreed st and ardized collection of outcomes —a “ core outcomes set”—for all trials in a specific clinical area.1 Recognizing that the current inconsistency is a serious hindrance to progress in our specialty , the editors of over 50 journals related to women ’s health have come together to support The CROWN ( CoRe Outcomes in WomeN ’s health ) Initiative ( ► Table 1 ) . Development of consensus is required around a set of welldefined , relevant , and feasible outcomes for all trials concerning particular obstetric and gynaecologic health conditions , such as preterm birth , incontinence , infertility , and menstrual problems . With somany subspecialties involved , this is no easy task . Duplication of effort can be avoided by working with the Core Outcome Measures in Effectiveness  Trials ( COMET ) Initiative , which is working toward core data sets for all medical specialties.3 Production of trustworthy core outcome sets will require engagement with patients , healthcare professionals , research ers , industry , and regulators , and the employment of scientifically robust consensus methods .1 The data for these core outcome sets , once agreed upon , should be collected in trials and reported in publications as st and ard practice in the future . Journal editors now invite research ers to take the lead in beginning this work . What will we do as editors to support them and their colleagues ? First , we are drawing wide attention toThe CROWN Initiative by publishing this editorial in the journals listed below . We shall ensure that the global research community , which includes our many review ers , is aware of the need for core outcome sets . Su bmi ssions which describe development of core outcome sets , if deemed acceptable after peer review , will be effectively disseminated . Our collaboration is not for enforcing harmony at the expense of innovation . To quote from the COMET home page ( www.comet-initiative.org ) : “ The existence or use of a core outcome set does not imply that outcomes in a particular trial should be restricted to those in the relevant core outcome set . Rather , there is an expectation that the core outcomes will be collected and reported , making it easier for the results of trials to be compared , contrasted and combined as appropriate ; while research ers continue to explore other outcomes as well . ” We also expect that as new or superior ways of capturing outcomes emerge , core outcome sets will themselves need updating . Table 1 Aims of The CROWN Objectives Appropriate reporting is central to the application of findings from research to clinical practice . The Strengthening the Reporting of Observational Studies in Epidemiology ( STROBE ) recommendations consist of a checklist of 22 items that provide guidance on the reporting of cohort , case – control and cross-sectional studies , in order to facilitate critical appraisal and interpretation of results . STROBE was published in October 2007 in several journals including The Lancet , BMJ , Annals of Internal Medicine and PLoS Medicine . Within the framework of the revision of the STROBE recommendations , the authors examined the context and circumstances in which the STROBE statement was used in the past . Design The authors search ed the Web of Science data base in August 2010 for articles which cited STROBE and examined a r and om sample of 100 articles using a st and ardised , piloted data extraction form . The use of STROBE in observational studies and systematic review s ( including meta-analyses ) was classified as appropriate or inappropriate . The use of STROBE to guide the reporting of observational studies was considered appropriate . Inappropriate uses included the use of STROBE as a tool to assess the method ological quality of studies or as a guideline on how to design and conduct studies . Results The authors identified 640 articles that cited STROBE . In the r and om sample of 100 articles , about half were observational studies ( 32 % ) or systematic review s ( 19 % ) . Comments , editorials and letters accounted for 15 % , method ological articles for 8 % , and recommendations and narrative review s for 26 % of articles . Of the 32 observational studies , 26 ( 81 % ) made appropriate use of STROBE , and three uses ( 10 % ) were considered inappropriate . Among 19 systematic review s , 10 ( 53 % ) used STROBE inappropriately as a tool to assess study quality . Conclusions The STROBE reporting recommendations are frequently used inappropriately in systematic review s and meta-analyses as an instrument to assess the method ological quality of observational studies BACKGROUND Ventilator-associated pneumonia ( VAP ) is an important cause of morbidity and mortality in ventilated critically ill patients . Despite a large amount of research evidence , the optimal diagnostic and treatment strategies for VAP remain controversial . PURPOSE The aim of this study was to develop evidence -based clinical practice guidelines for the diagnosis and treatment of VAP . Data sources include Medline , EMBASE , Cumulative Index to Nursing and Allied Health Literature , and the Cochrane Data base of Systematic Review s and Register of Controlled Trials . STUDY SELECTION The authors systematic ally search ed for all relevant r and omized controlled trials and systematic review s on the diagnosis and treatment of VAP in mechanically ventilated adults that were published from 1980 to October 1 , 2006 . DATA EXTRACTION Independently and in duplicate , the panel critically appraised each published trial . The effect size , confidence intervals , and homogeneity of the results were scored using predefined definitions . The full guideline development panel arrived at a consensus for scores on safety , feasibility , and economic issues . LEVELS OF EVIDENCE Based on the scores for each topic , the following statements of recommendation were used : recommend , consider , do not recommend , and no recommendation because of insufficient or conflicting evidence . DATA SYNTHESIS For the diagnosis of VAP in immunocompetent patients , we recommend that endotracheal aspirates with nonquantitative cultures be used as the initial diagnostic strategy . When there is a suspicion of VAP , we recommend empiric antimicrobial therapy ( in contrast to delayed or culture directed therapy ) and appropriate single agent antimicrobial therapy for each potential pathogen as empiric therapy for VAP . Choice of antibiotics should be based on patient factors and local resistance patterns . We recommend that an antibiotic discontinuation strategy be used in patients who are treated of suspected VAP . For patients who receive adequate initial antibiotic therapy , we recommend 8 days of antibiotic therapy . We do not recommend nebulized endotracheal tobramycin or intratracheal instillation of tobramycin for the treatment of VAP . CONCLUSION We present evidence -based recommendations for the diagnosis and treatment of VAP . Implementation of these recommendations into clinical practice may lessen the morbidity and mortality of patients who develop VAP Prognostic markers help to stratify patients for treatment by identifying patients with different risks of outcome ( e.g. recurrence of disease ) , and are important tools in the management of cancer and many other diseases . Systematic review and meta-analytical approaches to identifying the most valuable prognostic markers are needed because ( sometimes conflicting ) evidence relating to markers is often published across a number of studies . To investigate the practicality of this approach , an empirical investigation of a systematic review of  tumour markers for neuroblastoma was performed ; 260 studies of prognostic markers were identified , which considered 130 different markers . The reporting of these studies was often inadequate , in terms of both statistical analysis and presentation , and there was considerable heterogeneity for many important clinical /statistical factors . These problems restricted both the extraction of data and the meta- analysis of results from the primary studies , limiting feasibility of the evidence -based approach . Guidelines for reporting the results of primary prognostic marker studies in cancer , and other diseases , are given in order to facilitate both the interpretation of individual studies and the undertaking of systematic review s , meta- analysis and , ultimately , evidence -based practice . General availability of full individual patient data is a necessary step forward and would overcome the majority of problems encountered , including poorly reported summary statistics and variability in cutoff level , outcome assessed and adjustment factors used . It would also limit the problem of reporting bias , although publication bias will remain a concern until studies are prospect ively registered . Such changes in practice would help important evidence -based review s to be conducted in order to establish the most appropriate prognostic markers for clinical use , which should ultimately improve patient care
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 .