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We find standards useful in everyday life and in science, although we do not always follow them. Adopting new standards can be expensive, so there may be a strong incentive to maintain the status quo rather than adopt new standards. The scientific community has many standards encompassing both doing clinical research and reporting it, including standards for design and measurement. Although existing research standards have improved both research and its reporting, we need to unify existing standards and to fill the gaps between steps throughout the research process. Existing gaps include implementation of standards and links between standards for study registration (to know about all studies undertaken), study protocols (to identify the preplanned study design and methods), data collection (to assess outcomes that are important and comparable across studies), dissemination of findings (to know the results of previous studies), data sharing (to make best use of existing data), and evidence synthesis (to draw appropriate conclusions from the body of evidence). The scientific community must work together to harmonize existing standards, to ensure that standards are kept up to date, to check that standards are followed, and to develop standards where they are still needed. A unified system of standards will make our work more reproducible. [ABSTRACT FROM AUTHOR]

An introduction is presented in which the editor discusses various reports within the issue on topics including the spread of the methods of meta-analysis, and the story of the "Smith and Glass Psychotherapy Meta-analysis."

Introduction: Choice of outcomes is critical for clinical trialists and systematic reviewers. It is currently unclear how systematic reviewers choose and pre-specify outcomes for systematic reviews. Our objective was to assess the completeness of pre-specification and comparability of outcomes in all Cochrane reviews addressing four common eye conditions. Methods: We examined protocols for all Cochrane reviews as of June 2013 that addressed glaucoma, cataract, age-related macular degeneration (AMD), and diabetic retinopathy (DR). We assessed completeness and comparability for each outcome that was named in ≥25% of protocols on those topics. We defined a completely-specified outcome as including information about five elements: domain, specific measurement, specific metric, method of aggregation, and time-points. For each domain, we assessed comparability in how individual elements were specified across protocols. Results: We identified 57 protocols addressing glaucoma (22), cataract (16), AMD (15), and DR (4). We assessed completeness and comparability for five outcome domains: quality-of-life, visual acuity, intraocular pressure, disease progression, and contrast sensitivity. Overall, these five outcome domains appeared 145 times (instances). Only 15/145 instances (10.3%) were completely specified (all five elements) (median = three elements per outcome). Primary outcomes were more completely specified than non-primary (median = four versus two elements). Quality-of-life was least completely specified (median = one element). Due to largely incomplete outcome pre-specification, conclusive assessment of comparability in outcome usage across the various protocols per condition was not possible. Discussion: Outcome pre-specification was largely incomplete; we encourage systematic reviewers to consider all five elements. This will indicate the importance of complete specification to clinical trialists, on whose work systematic reviewers depend, and will indirectly encourage comparable outcome choice to reviewers undertaking related research questions. Complete pre-specification could improve efficiency and reduce bias in data abstraction and analysis during a systematic review. Ultimately, more completely specified and comparable outcomes could make systematic reviews more useful to decision-makers. [ABSTRACT FROM AUTHOR]

A call for the papers that are unpublished years after completion due to distorted representation or other reasons is presented.

Clinical relevance: Systematic reviews and meta-analyses serve as a basis for decision-making and clinical practice guidelines and should be carried out using appropriate methodology to avoid incorrect inferences. Topic: We describe the characteristics, statistical methods used for meta-analyses, and citation patterns of all 21 glaucoma systematic reviews we identified pertaining to the effectiveness of prostaglandin analog eye drops in treating primary open-angle glaucoma, published between December 2000 and February 2012. Methods: We abstracted data, assessed whether appropriate statistical methods were applied in meta-analyses, and examined citation patterns of included reviews. Results: We identified two forms of problematic statistical analyses in 9 of the 21 systematic reviews examined. Except in 1 case, none of the 9 reviews that used incorrect statistical methods cited a previously published review that used appropriate methods. Reviews that used incorrect methods were cited 2.6 times more often than reviews that used appropriate statistical methods. We speculate that by emulating the statistical methodology of previous systematic reviews, systematic review authors may have perpetuated incorrect approaches to meta-analysis. Conclusions: The use of incorrect statistical methods, perhaps through emulating methods described in previous research, calls conclusions of systematic reviews into question and may lead to inappropriate patient care. We urge systematic review authors and journal editors to seek the advice of experienced statisticians before undertaking or accepting for publication a systematic review and meta-analysis. Financial Disclosure(s): The author(s) have no proprietary or commercial interest in any materials discussed in this article. [Copyright &y& Elsevier]

The article presents an introduction to a report within the issue by R. M. Califf and colleagues concerning clinical studies registered in the ClinicalTrials.gov database of the U.S.

The article compares the effectiveness of hysterectomy and endometrial ablation in women with dysfunctional uterine bleeding in the United States. Results reveal that both endometrial ablation and hysterectomy are effective treatments in women with dysfunctional uterine bleeding. Hysterectomy was related to more adverse events and a significant number of patients receiving endometrial ablation had reoperation.

Each year, over 200,000 people are diagnosed with breast cancer in the United States. Although the use of biomarkers has the potential to guide preventive interventions and improve survival and quality of life, there have been few successes and many disappointments. In November 2005, the National Breast Cancer Coalition Fund convened a conference aimed at developing a patient-centred, strategic approach to breast cancer biomarker research. The consumers, clinicians, researchers, industry representatives and US regulators who served on the consensus panel developed a set of principles and recommendations to guide the field and ensure that biomarker research results in clinically important applications. [ABSTRACT FROM AUTHOR]

Abstract: Objective: To explore development of possible approaches leading to a sensitive and precise Medline search to identify observational studies of the association between oral contraceptives and breast cancer, an adverse event. Study Design and Setting: We compared the results of a series of Medline searches to a gold standard comprising 58 reports from a 1996 systematic review examining the relationship between oral contraceptives and the development of breast cancer. Sensitivity (the proportion of gold standard publications identified) and precision (the proportion of retrieved publications that were included in the gold standard) were calculated for each Medline search. Results: We identified all 58 articles when the search was not limited by terms related to oral contraceptives, but precision was less than 1% (58 of 6,120). Indexing was problematic when oral contraceptives or hormones were not mentioned in the title or abstract (n =8) or full text (n =2). Conclusion: Search strategies identifying all relevant studies were possible but arguably impractical; additional research is needed to generalize our findings. Authors and editors should ensure that all interventions and outcomes examined are reported and indexers should make sure they are indexed. Central registration of observational studies and all variables they examined should be considered to assure identification of studies examining adverse events associated with health interventions. [Copyright &y& Elsevier]

The Surgical Treatments Outcomes Project for Dysfunctional Uterine Bleeding (STOP-DUB) was a multicenter, randomized clinical trial that assessed the efficacy and effectiveness of hysterectomy versus endometrial ablation (EA) for dysfunctional uterine bleeding (DUB) in women for whom medical management has not provided relief. Resource centers included a coordinating center, a chair''s office, the American College of Obstetricians and Gynecologists, the Agency for Healthcare Research and Quality Project Office and 33 clinical centers in the United States and Canada. STOP-DUB enrolled: (1) eligible patients for whom medical treatment had not been successful and who were randomized to either hysterectomy or EA and (2) an observational cohort of patients who were “provisionally ineligible” or who were eligible but did not wish to be randomized. Enrollment began in October 1997 and ended in June 2001. The primary outcome addressed by the randomized trial was the impact of surgery on bleeding, pain, fatigue, and the major problem (symptom) that led the woman to seek treatment for her condition, measured 1 year following surgery. Additional outcomes included the impact of surgery at time points after 1 year; changes in quality of life, activity limitation, sexual functioning, and urinary incontinence; surgical complications; additional surgery; and resource utilization. The costs and the relative cost-effectiveness of the two surgeries were calculated. The main scientific objective for the observational study was to examine changes over time in terms of treatment selected, DUB-related symptoms, and quality of life. [Copyright &y& Elsevier]

That it is not possible to find information about all initiated clinical trials is of international concern. This is a particular worry because scientists tend to publish their positive findings more often than their negative findings (publication bias). A comprehensive register of initiated clinical trials, with each trial assigned a unique identifier, would inform reviewers, physicians, and others (eg, consumers) about which trials had been started and directly address the problem of publication bias. Patients and their clinicians could also know which trials are open for enrollment, thus speeding medical advances. Individuals who participate in clinical trials typically provide consent in the belief that they are contributing to medical knowledge. But if the knowledge gained is never reported, the trust between patients and investigators and that between patients and research ethics review boards are both damaged. Ethical issues are of particular concern if industry is gaining financially from public involvement in trials, but refusing to reciprocate by making information from industry-sponsored trials generally available. All stakeholders—investigators, research organizations and institutions, journal editors, lawmakers, consumers, and others—must act now, together and in their own domains, to ensure comprehensive registration of clinical trials. [ABSTRACT FROM AUTHOR]

The Cochrane Collaboration has established a centralized database of controlled trials and other studies of health care interventions (called CENTRAL) that serves as the best available resource for all those preparing and maintaining systematic reviews or otherwise searching for trials. CENTRAL is available on The Cochrane Library. This article describes the history and methods of CENTRAL's development and the results of an analysis of the current composition of CENTRAL. As of September 2000, CENTRAL contained almost 300,000 citations to reports of trials, contributed mainly by Cochrane Groups and Centers around the world. Development of CENTRAL has been an ambitious, scholarly undertaking and has resulted in a valuable resource: CENTRAL includes citations to controlled trials that may not be indexed in MEDLINE, EMBASE, or other bibliographic databases; citations published internationally in many languages; and citations that are available only in conference proceedings or other hard-to-access sources. [ABSTRACT FROM AUTHOR]

Objective To develop and implement Project LEAD (leadership, education, and advocacy development), a science course for breast cancer activists. Population Students were breast cancer activists and other consumers, mainly affiliated with advocacy organizations in the United States of America. Setting Project LEAD is offered by the National Breast Cancer Coalition; the course takes place over 5 days and is offered 4 times a year, in various cities in the United States of America. Results The Project LEAD curriculum has developed over 5 years to include lectures, problem-based study groups, case studies, interactive critical appraisal sessions, a seminar by an ‘expert’ scientist, role play, and homework components. A core faculty has been valuable for evaluating and revising the course and has proved necessary to provide consistent high quality teaching. Course evaluations indicated that students gained critical appraisal skills, enhanced their knowledge and developed confidence in selected areas of basic science and epidemiology. Conclusions Project LEAD comprises a unique curriculum for training breast cancer activists in science and critical appraisal. Course evaluations indicate that students gain confidence and skills from the course. [ABSTRACT FROM AUTHOR]

Estimates the rate of full publication of the results of randomized clinical trials initially presented as abstracts at national ophthalmology meetings in 1988 and 1989. Comparison of data with similar studies and the association between selected study characteristics and full publication; Review of ophthalmology abstracts; Study selection; Data extraction and synthesis; Conclusions.

Presents a study to examine changes over time in the representation of women at the editorial level in United States epidemiology journals compared with the proportion of women authors and reviewers. Design and setting; Subjects; Main outcome measures; Results; Conclusions.

Examines the sensitivity and precision of Medline searching for randomized clinical trials in Baltimore, Maryland. Comparison between Medline searches and Gold standard of randomized clinical trials; Consideration of Gold standards in the meta-analysis; Demonstration of clinical trials for vision search.

Abstract. Investigations in which statistically significant differences between treatment groups have not been observed are less likely than others to be reported in scientific journals. In clinical research, this selective suppression of "negative" results may lead to the adoption of ineffective or hazardous treatments. In an attempt to obtain information about unpublished trials in perinatal medicine, letters were sent to 42 000 obstetricians and pediatricians in 18 countries. As a result, we were notified of 395 unpublished randomized trials. Only 18 of the trials had been completed more than 2 years before the survey, a period during which at least 2300 reports of perinatal trials had been published. Of the 395 unpublished trials, 125 had ceased recruitment within the 2 years prior to the survey, 193 were actively recruiting at the time of the survey, and 59 were about to begin recruitment. It was concluded that publication bias will not be addressed successfully by attempts to obtain information about unpublished trials retrospectively. However, since the response rate to our request for details about ongoing and planned trials was good, prospective registration of trials at inception appears to be a feasible approach to reducing publication bias and its adverse consequences. An additional merit of prospective registration of clinical trials is that it should reduce unnecessary duplication (as opposed to necessary replication) in research and promote more effective collaboration. [ABSTRACT FROM AUTHOR]

Studies the publication bias and risk factors for its occurrence. Historical aspects of publication bias; Evidence for publication bias; Role of journal editors and study quality in publication bias; Discussion of findings.

The author reflects on the comparative effectiveness research that covers primary research studies and primary research synthesis such as systematic reviews and meta-analyses. He relates that metabias is an associated differences for nonprocess-related factors and being used to create treatment recommendations and practice guidelines. According to the study conducted by A. Dechartes and colleagues, 26% larger effect size reported in single versus multicenter trials.

A letter to the editor is presented in response to the article regarding the changes of the U.S. Preventive Services Task Force on its breast cancer screening recommendation.

Context: Studies have shown that reports from clinical trials with statistically significant results tend to be submitted and published more rapidly than reports from studies with null or nonsignficant findings. Methods: We wanted to determine whether manuscripts reporting positive results from controlled clinical trials are published more quickly than those reporting negative results. We tracked manuscripts from submission to [JAMA] until the publication decision. We classified results as positive if a statistically significant difference was reported for the primary outcome. Manuscripts were further classified according to indicators of methodologic quality and other study characteristics. We included manuscripts if they were submitted from February 1996 through August 1999, reported results of a prospective study in which participants were assigned to a treatment or comparison group, used statistical tests to compare differences between groups, and were accepted for publication. Results: One hundred thirty-three manuscripts met our inclusion criteria, 78 (59%) reported positive results, 51 (38%) reported negative results. We were unable to classify the direction of results for 4 articles (3%). The time interval between submission and publication was not associated with positive results: median time between submission and publication was 7.8 months for reports with positive vs 7.6 months for reports with negative results (P = .44). Time to publication also was not associated with any marker of study quality or study characteristic. Conclusions: Among 133 published controlled trials, time to publication was not associated with statistical significance, methodologic quality, or other study characteristics. [ABSTRACT FROM AUTHOR]

Context: It is not known whether articles with group authorship (ie, with a research group name listed as the author) are difficult to identify or whether use of group authorship may lead to problems with citation. Methods: To examine ways in which reports of controlled trials with group authorship are indexed and citations counted in bibliographic databases, we conducted a cross-sectional study in January 2000. We identified 47 controlled trials funded by the National Eye Institute and 285 associated articles. Between January and August 2000, we searched PubMed and Science Citation Index (SCI) and recorded the citation practices for these articles. Our main outcome measures were ways in which trial reports were listed in PubMed and SCI and number of citations to each report by type of authorship. Results: Of the 285 published reports identified, 126 (44%) had group authorship, 109 (38%) had modified group authorship (listing individual names plus the name of the research group), and 50 (18%) had named authors only. In PubMed, no group authors were listed in the author field (per MEDLINE rules); in SCI, group-authored reports generally were incorrectly attributed (first name on investigator list [35.3%], first name on writing committee [25.5%], contact name [16.7%], anonymous [16.7%], and other [5.9%]). Using the SCI general search, we identified citations to 16.7% of group-authored reports, compared with citations to 96.9% of reports with modified group authorship and 93.9% of citations to reports with named authors only. Other systematic search methods found that more than 98% of group-authored reports actually had been cited and that group-authored reports were cited more than other reports. Conclusions: Indexing systems are not optimally adapted to group authorship. We recommend that indexing services change their practices to include group authors in the author field to help correct the problem. [ABSTRACT FROM AUTHOR]

Dechartres and colleagues' examination of the association between publication characteristics and treatment effect estimates suggests that reporting biases are threatening our understanding of the truth in clinical evidence. The editorialists discuss the findings and propose strategies to increase the certainty that the body of evidence on which we base health-related decisions is correct. [ABSTRACT FROM AUTHOR]

Examines the importance of randomized controlled trials in guiding decisions about health care in Great Britain. Efforts of Archie Cochrane; Assessment of the effects of health care; Difference of effects of care and biases or chance.

The author reflects on the controversy brought by the 2009 U.S. Preventive Services Task Force (USPSTF) recommendations on breast cancer screening. Topics discussed include the passage of a law in the middle of the 2009 recommendations which requires private insurers to cover the procedures for the USPSTF issued grade A or B recommendations, the updated recommendations of the USPSTF, and the concerns whether the copayment for mammograms would be required under the updated recommendations.

The article discusses health care reform in the U.S. and approaches to assessing reform needs. The article refers to the U.S. Patient Protection and Affordable Care Act. The article notes controversial aspects of evidence-based health care while noting the need for systematic review of existing research in advance of initiating other research efforts.

A response by S. Swaroop Vedula and colleagues to a letter to the editor about their article "Outcome Reporting in Industry-Sponsored Trials of Gabapentin for Off-Label Use," in the November 12, 2009 issue is presented.

The article focuses on the publication bias against negative results from clinical trials in the U.S. Accordingly, the assessment of the number of meeting abstracts that turned into full papers reveals that a trial proving a benefit of a drug or device has much greater chance of full publication than does a trial which is showing no benefit. Moreover, publications of trials sanctioned by institutional review boards are often characterized by selective outcome reporting.

Discusses mammographic screening for women aged 40-49 years. Reference to the data from 14 years of follow-up in the Edinburgh Trial and the mortality findings from 16 years of follow-up in the United Kingdom Trial of Early Detection of Breast Cancer in this issue; Criticism about the studies; Consideration of cost to society and to women; Chance of false positives; Need for education and research on this issue.

A correction to the article "Shaping the future of biomarker research," by M. Carolina Hinestrosa and colleagues that was published in the previous issue is presented.

This article focuses on evidence-based medicine and how the term arose. Evidence-based medicine has been used in the treatment of breast cancer, premature babies, asthma and in halting the use of diethylstilbestrol to prevent miscarriage. Its use in the conservation of public health resources is mentioned. The future of evidence-based medicine is discussed.

Presents a letter to the editor about marketing strategies used by the U.S. pharmaceutical industry.

Presents a letter to the editor in response to a report by von Elm and colleagues on patterns of duplicate publication. Idea that prospective registration of controlled trials encourage transparency and address publication bias; The need for an international register system.

Presents a letter to the editor in response to an article about the problems of publication bias in a comprehensive register of clinical trials.

Background: Systematic reviews of interventions provide a summary of the evidence available on intervention effectiveness and harm. Cochrane systematic reviews (CSRs) have been published electronically in the Cochrane Database of Systematic Reviews (CDSR) since 1994, and co-publication (publication of a Cochrane review in another journal) has been allowed since that time, as long as the co-publishing journal has agreed to the arrangement. Although standards for co-publication were established in 2008, the frequency of co-publication and adherence to the standards have remained largely unexamined. Our objective was to examine the frequency of co-publication of Cochrane Eyes and Vision Group (CEVG) reviews, adherence to the co-publication policy, the relative numbers of citations of the two modes of publishing, and differences in times cited in CSRs with and without a co-publication. Methods: We identified all CEVG reviews published by May 30, 2014 in The Cochrane Library. Using keywords from the title, author names, and "Cochrane Eyes and Vision Group", we searched Google Scholar, Web of Science, Scopus, and PubMed databases to identify possible co-publications. We also emailed contact authors of all identified CEVG reviews to ask them whether they had published their CSR elsewhere. We compared each co-publication to the corresponding CEVG review for adherence to the Cochrane Policy Manual (dated June 10, 2014). We recorded the number of times each CEVG review and each co-publication had been cited by others according to Google Scholar, Web of Science, and Scopus, as of June 11, 2014. Results: We identified 117 CEVG reviews; 19 had been co-published in 22 articles. Adherence to Cochrane policy on co-publication was moderate, with all authors complying with at least one of four requirements we addressed. Co-publications were cited more often than the corresponding CEVG reviews; CEVG reviews with at least one co-publication were cited approximately twice as often as CEVG reviews without a co-publication. The number of citations varied considerably depending on whether the CEVG review had a co-publication or not. Conclusions: The findings support encouraging co-publication while maintaining the primacy of the Cochrane systematic review. Support for co-publication may be tempered by other factors such as the possibility that CEVG reviews with a co-publication covered more clinically important and timely topics than those without a co-publication. Assuming that citations are a valid measure of dissemination effectiveness, the 15-year CEVG experience with co-publication of systematic reviews suggests that Cochrane authors should be encouraged to co-publish in traditional medical journals. [ABSTRACT FROM AUTHOR]

Background: Details about the type of analysis (e.g., intent to treat [ITT]) and definitions (i.e., criteria for including participants in the analysis) are necessary for interpreting a clinical trial's findings. Our objective was to compare the description of types of analyses and criteria for including participants in the publication (i.e., what was reported) with descriptions in the corresponding internal company documents (i.e., what was planned and what was done). Trials were for off-label uses of gabapentin sponsored by Pfizer and Parke-Davis, and documents were obtained through litigation. Methods and Findings: For each trial, we compared internal company documents (protocols, statistical analysis plans, and research reports, all unpublished), with publications. One author extracted data and another verified, with a third person verifying discordant items and a sample of the rest. Extracted data included the number of participants randomized and analyzed for efficacy, and types of analyses for efficacy and safety and their definitions (i.e., criteria for including participants in each type of analysis). We identified 21 trials, 11 of which were published randomized controlled trials, and that provided the documents needed for planned comparisons. For three trials, there was disagreement on the number of randomized participants between the research report and publication. Seven types of efficacy analyses were described in the protocols, statistical analysis plans, and publications, including ITT and six others. The protocol or publication described ITT using six different definitions, resulting in frequent disagreements between the two documents (i.e., different numbers of participants were included in the analyses). Conclusions: Descriptions of analyses conducted did not agree between internal company documents and what was publicly reported. Internal company documents provide extensive documentation of methods planned and used, and trial findings, and should be publicly accessible. Reporting standards for randomized controlled trials should recommend transparent descriptions and definitions of analyses performed and which study participants are excluded. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the impact of having breast cancer survivors with advocacy experience (consumers) participate as voting members of scientific review panels for proposals on breast cancer research. As major stakeholders, patients and other consumer advocates sought inclusion in all decision-making processes affecting funding of disease-targeted research. Method: Cross-sectional analysis of assigned proposal scores ranging from 5.0 (acceptable) to 1.0 (outstanding); before (prepanel) and after (postpanel) opinion questionnaires. Forty-six panels reviewed 2206 proposals for the Fiscal Year 1995 Department of Defense (DOD) Breast Cancer Research Program. Analyses were limited to the 42 panels scheduled to meet on site and the 2190 proposals scored by both participant groups. There were 85 consumers and 638 scientists. The main outcome measures were proposal merit scores (raw, overall, and participant-specific means) and opinions concerning perceived benefits and drawbacks of consumer involvement. Results: In general, the voting patterns of consumers were similar to those of scientists. Final proposal scores were the same as those that would have been obtained without consumer voting for 76.2% of the proposals, more favorable for 15.2% of the proposals, and less favorable for 8.6% of the proposals. For all but 13 proposals, the difference was ±0.1. Prepanel opinions regarding consumer involvement were generally positive. Prepanel and postpanel comparisons almost always showed that significantly greater proportions of participants had positive postpanel opinions than had negative postpanel opinions. Having consumers on review panels was reported to be beneficial (83.9% and 98.2% for scientists and consumers, respectively) and to not have drawbacks (74.7% and 87.3%, respectively). Conclusions: Our results support continued participation of consumers in our peer review process. The DOD program can serve as a model for other research programs considering consumer involvement. [ABSTRACT FROM AUTHOR]

Importance: Extenuating circumstances can trigger unplanned changes to randomized trials and introduce methodological, ethical, feasibility, and analytical challenges that can potentially compromise the validity of findings. Numerous randomized trials have required changes in response to the COVID-19 pandemic, but guidance for reporting such modifications is incomplete.Objective: As a joint extension for the CONSORT and SPIRIT reporting guidelines, CONSERVE (CONSORT and SPIRIT Extension for RCTs Revised in Extenuating Circumstances) aims to improve reporting of trial protocols and completed trials that undergo important modifications in response to extenuating circumstances.Evidence: A panel of 37 international trial investigators, patient representatives, methodologists and statisticians, ethicists, funders, regulators, and journal editors convened to develop the guideline. The panel developed CONSERVE following an accelerated, iterative process between June 2020 and February 2021 involving (1) a rapid literature review of multiple databases (OVID Medline, OVID EMBASE, and EBSCO CINAHL) and gray literature sources from 2003 to March 2021; (2) consensus-based panelist meetings using a modified Delphi process and surveys; and (3) a global survey of trial stakeholders.Findings: The rapid review yielded 41 673 citations, of which 38 titles were relevant, including emerging guidance from regulatory and funding agencies for managing the effects of the COVID-19 pandemic on trials. However, no generalizable guidance for all circumstances in which trials and trial protocols might face unanticipated modifications were identified. The CONSERVE panel used these findings to develop a consensus reporting guidelines following 4 rounds of meetings and surveys. Responses were received from 198 professionals from 34 countries, of whom 90% (n = 178) indicated that they understood the concept definitions and 85.4% (n = 169) indicated that they understood and could use the implementation tool. Feedback from survey respondents was used to finalize the guideline and confirm that the guideline's core concepts were applicable and had utility for the trial community. CONSERVE incorporates an implementation tool and checklists tailored to trial reports and trial protocols for which extenuating circumstances have resulted in important modifications to the intended study procedures. The checklists include 4 sections capturing extenuating circumstances, important modifications, responsible parties, and interim data analyses.Conclusions and Relevance: CONSERVE offers an extension to CONSORT and SPIRIT that could improve the transparency, quality, and completeness of reporting important modifications to trials in extenuating circumstances such as COVID-19. [ABSTRACT FROM AUTHOR]

Studies the peer review of summary reports of controlled trials. Materials used in the study; Assessment of methodological quality and authors' judgments of study results; Results of the study; Discussion of findings.

The protocol of a clinical trial serves as the foundation for study planning, conduct, reporting, and appraisal. However, trial protocols and existing protocol guidelines vary greatly in content and quality. This article describes the systematic development and scope of SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013, a guideline for the minimum content of a clinical trial protocol. The 33-item SPIRIT checklist applies to protocols for all clinical trials and focuses on content rather than format. The checklist recommends a full description of what is planned; it does not prescribe how to design or conduct a trial. By providing guidance for key content, the SPIRIT recommendations aim to facilitate the drafting of high-quality protocols. Adherence to SPIRIT would also enhance the transparency and completeness of trial protocols for the benefit of investigators, trial participants, patients, sponsors, funders, research ethics committees or institutional review boards, peer reviewers, journals, trial registries, policymakers, regulators, and other key stakeholders. [ABSTRACT FROM AUTHOR]

Presents principles for internationally recognized principles for clinical trial registration. Importance of registering trials to make sure all results are publicly available and that ethical obligations to participants are met; Evidence of selective reporting of results of clinical trials; Defense for the registering of all types of trials; Concerns over the release of commercially sensitive information and intellectual property contained in trial protocols; Concerns over the use of unpublished results that are not peer reviewed.

Background: There is broad recognition of the importance of evidence in informing clinical decisions. When information from all studies included in a systematic review ("review") does not contribute to a meta-analysis, decision-makers can be frustrated. Our objectives were to use the field of eyes and vision as a case study and examine the extent to which authors of Cochrane reviews conducted meta-analyses for their review's pre-specified main outcome domain and the reasons that some otherwise eligible studies were not incorporated into meta-analyses.Methods: We examined all completed systematic reviews published by Cochrane Eyes and Vision, as of August 11, 2017. We extracted information about each review's outcomes and, using an algorithm, categorized one outcome as its "main" outcome. We calculated the percentage of included studies incorporated into meta-analyses for any outcome and for the main outcome. We examined reasons for non-inclusion of studies into the meta-analysis for the main outcome.Results: We identified 175 completed reviews, of which 125 reviews included two or more studies. Across these 125 reviews, the median proportions of studies incorporated into at least one meta-analysis for any outcome and for the main outcome were 74% (interquartile range [IQR] 0-100%) and 28% (IQR 0-71%), respectively. Fifty-one reviews (41%) could not conduct a meta-analysis for the main outcome, mostly because fewer than two included studies measured the outcome (21/51 reviews) or the specific measurements for the outcome were inconsistent (16/51 reviews).Conclusions: Outcome choice during systematic reviews can lead to few eligible studies included in meta-analyses. Core outcome sets and improved reporting of outcomes can help solve some of these problems. [ABSTRACT FROM AUTHOR]

Women comprise about half of senior epidemiologists, but little is known about whether they are also viewed as leaders (i.e., authorities) in the field. We believe editorial roles are markers of leadership in a field. Our objective was to describe the distribution of gender across authorship of editorials published in 5 high-impact epidemiology journals over the past 8 years. We included editorials and commentaries published in American Journal of Epidemiology , European Journal of Epidemiology , Epidemiology , International Journal of Epidemiology , and Journal of Clinical Epidemiology between 2010 and 2017. We classified genders of all authors as woman, man, or unknown and computed the proportions of women editorial authors over all journals and according to position (e.g., first author). Only 31% (682/2,228) of all editorial authors and 36% (524/1,477) of unique editorial authors (i.e., counting each editorial author name only once) were women. We identified 1,180 editorials; 594 had sole authors, 24% (141/594) of whom were women, and 586 had 2 or more authors, 31% (184/586) of which had women as first authors. If women are underrepresented as editorial authors across epidemiology journals (e.g., as a marker of epidemiology leadership), the situation merits immediate correction. [ABSTRACT FROM AUTHOR]

Data for individual trials included in systematic reviews may be available in multiple sources. For example, a single trial might be reported in 2 journal articles and 3 conference abstracts. Because of differences across sources, source selection can influence the results of systematic reviews. We used our experience in the Multiple Data Sources in Systematic Reviews (MUDS) study, and evidence from previous studies, to develop practical guidance for using multiple data sources in systematic reviews. We recommend the following: (1) Specify which sources you will use. Before beginning a systematic review, consider which sources are likely to contain the most useful data. Try to identify all relevant reports and to extract information from the most reliable sources. (2) Link individual trials with multiple sources. Write to authors to determine which sources are likely related to the same trials. Use a modified Preferred Reporting Items for Systematic Reviews and Meta‐analyses (PRISMA) flowchart to document both the selection of trials and the selection of sources. (3) Follow a prespecified protocol for extracting trial characteristics from multiple sources. Identify differences among sources, and contact study authors to resolve differences if possible. (4) Prespecify outcomes and results to examine in the review and meta‐analysis. In your protocol, describe how you will handle multiple outcomes within each domain of interest. Look for outcomes using all eligible sources. (5) Identify which data sources were included in the review. Consider whether the results might have been influenced by data sources used. (6) To reduce bias, and to reduce research waste, share the data used in your review. [ABSTRACT FROM AUTHOR]