Journal of Clinical Epidemiology最新文献

{"title":"Prospective registration of trials: where we are, why, and how we could get better","authors":"Denis Mongin , Diana Buitrago-Garcia , Sami Capderou , Thomas Agoritsas , Cem Gabay , Delphine Sophie Courvoisier , Michele Iudici","doi":"10.1016/j.jclinepi.2024.111586","DOIUrl":"10.1016/j.jclinepi.2024.111586","url":null,"abstract":"<div><h3>Objectives</h3><div>Transparent trial conduct requires prospective registration of a randomized controlled clinical trial (RCT) before the enrollment of the first participant. We aimed to (1) estimate the proportion of RCTs that are prospectively registered and analyze the time trends and factors linked to registration timing and (2) assess the reasons for nonadherence to prospective registration and explore ways to improve compliance. We studied trials published in rheumatology as a case study.</div></div><div><h3>Study Design and Setting</h3><div>We searched for RCTs in rheumatology published between 2009 and 2022. We conducted a multivariable logistic regression to identify factors associated with prospective trial registration. We sent a survey to investigators of trials not prospectively registered, asking about reasons for nonadherence and potential solutions.</div></div><div><h3>Results</h3><div>We identified 1093 RCTs; 453 (41.4%) were not prospectively registered. Of these, 130 (11.9%) were not registered and 323 (29.5%) were retrospectively registered. Prospective registration increased by 3% annually (<em>P</em> < .001), with 13.3% (2 of 15) trials registered in 2009 to 73.2% (112 of 153) in 2022. In journals supporting the International Committee of Medical Journals Editors recommendations, 16% of trials published in 2022 were not prospectively registered. Prospective registration was associated with a larger sample size, multinational recruitment, and publication in higher impact journals. Investigators reported lack of knowledge or organizational problems as key reasons for retrospective registration. They suggested linking ethical approval to trial registration to ensure prospective registration.</div></div><div><h3>Conclusion</h3><div>Despite significant improvement, adherence to prospective registration remains unsatisfactory in rheumatology. Targeted strategies for journal editors, health-care professionals, and researchers may help improve trial registration.</div></div><div><h3>Plain Language Summary</h3><div>Randomized controlled clinical trials are a research type where people are randomly assigned to different treatments to see which works best. These treatments can include drugs, surgery, medical devices, or changes in behavior. The results obtained in RCTs are essential for the advance of medicine and for making medical decisions. Randomized controlled clinical trials need to be conducted in a transparent way to provide trustworthy information and avoid misleading findings. A key aspect of transparency is registering the study details and plan in a public repository before the trial starts. This not only requires researchers to plan their study in advance but also enables the scientific community to track any change in how the study is conducted. Although registration of RCTs is recommended, it is not compulsory. Questions remain about researchers’ compliance with prospective registration, and the factors that","PeriodicalId":51079,"journal":{"name":"Journal of Clinical Epidemiology","volume":"176 ","pages":"Article 111586"},"PeriodicalIF":7.3,"publicationDate":"2024-10-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142559370","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Networks of interventions with no closed loops are conceptually limited as a source of evidence.","authors":"Rafael Leite Pacheco, Rachel Riera","doi":"10.1016/j.jclinepi.2024.111584","DOIUrl":"10.1016/j.jclinepi.2024.111584","url":null,"abstract":"","PeriodicalId":51079,"journal":{"name":"Journal of Clinical Epidemiology","volume":" ","pages":"111584"},"PeriodicalIF":7.3,"publicationDate":"2024-10-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142559369","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Centering racial health equity in systematic reviews—paper 1: introduction to the series","authors":"Meera Viswanathan , Nila A. Sathe , Vivian Welch , Damian K. Francis , Patricia C. Heyn , Rania Ali , Tiffany Duque , Elizabeth A. Terhune , Jennifer S. Lin , Ana Beatriz Pizarro , Dru Riddle","doi":"10.1016/j.jclinepi.2024.111577","DOIUrl":"10.1016/j.jclinepi.2024.111577","url":null,"abstract":"<div><h3>Objectives</h3><div>Systematic reviews hold immense promise as tools to highlight evidence-based practices that can reduce or aim to eliminate racial health disparities. Currently, consensus on centering racial health equity in systematic reviews and other evidence synthesis products is lacking. Centering racial health equity implies concentrating or focusing attention on health equity in ways that bring attention to the perspectives or needs of groups that are typically marginalized.</div></div><div><h3>Study Design and Setting</h3><div>This Cochrane US Network team and colleagues, with the guidance of a steering committee, sought to understand the views of varied interest holders through semistructured interviews and conducted evidence syntheses addressing (1) definitions of racial health equity, (2) logic models and frameworks to centering racial health equity, (3) interventions to reduce racial health inequities, and (4) interest holder engagement in evidence syntheses. Our methods and teams include a primarily American and Canadian lens; however, findings and insights derived from this work are applicable to any region in which racial or ethnic discrimination and disparities in care due to structural causes exist.</div></div><div><h3>Results</h3><div>In this series, we explain why centering racial health equity matters and what gaps exist and may need to be prioritized. The interviews and systematic reviews identified numerous gaps to address racial health equity that require changes not merely to evidence synthesis practices but also to the underlying evidence ecosystem. These changes include increasing representation, establishing foundational guidance (on definitions and causal mechanisms and models, building a substantive evidence base on racial health equity, strengthening methods guidance, disseminating and implementing results, and sustaining new practices).</div></div><div><h3>Conclusion</h3><div>Centering racial health equity requires consensus on the part of key interest holders. As part of the next steps in building consensus, the manifold gaps identified by this series of papers need to be prioritized. Given the resource constraints, changes in norms around systematic reviews are most likely to occur when evidence-based standards for success are clearly established and the benefits of centering racial health equity are apparent.</div></div><div><h3>Plain Language Summary</h3><div>Racial categories are not based on biology, but racism has negative biological effects. People from racial or ethnic minority groups have often been left out of research and ignored in systematic reviews. Systematic reviews often help clinicians and policymakers with evidence-based decisions. Centering racial health equity in systematic reviews will help clinicians and policymakers to improve outcomes for people from racial or ethnic minority groups. We conducted interviews and a series of four systematic reviews on definitions, logic models and","PeriodicalId":51079,"journal":{"name":"Journal of Clinical Epidemiology","volume":"176 ","pages":"Article 111577"},"PeriodicalIF":7.3,"publicationDate":"2024-10-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142548827","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Centering racial health equity in systematic reviews paper 3: a systematic review of definitions for “racial health equity” and related terms within health-related articles","authors":"Elizabeth A. Terhune ,&nbsp;Mahederemariam Bayleyegn Dagne ,&nbsp;Christi Piper ,&nbsp;Ana B. Pizarro ,&nbsp;Miriam Barsoum ,&nbsp;Anita Rizvi ,&nbsp;Damian K. Francis ,&nbsp;Meera Viswanathan ,&nbsp;Nila A. Sathe ,&nbsp;Vivian Welch ,&nbsp;Tiffany Duque ,&nbsp;Dru Riddle ,&nbsp;Robert W. Turner II ,&nbsp;Tamara A. Baker ,&nbsp;Patricia C. Heyn","doi":"10.1016/j.jclinepi.2024.111580","DOIUrl":"10.1016/j.jclinepi.2024.111580","url":null,"abstract":"<div><h3>Objectives</h3><div>To systematically evaluate definitions of “racial health equity” (RHE) and related terms within health-related academic literature.</div></div><div><h3>Study Design and Setting</h3><div>We systematically evaluated definitions of RHE and related terms within health-related academic articles. Articles published in English were included, and no date restrictions were imposed.</div></div><div><h3>Results</h3><div>We found 20 original articles containing relevant definitions out of 1816 retrieved articles, thirteen of which were published from 2020 to 2023. Themes used in the definitions varied; racism (<em>n</em> = 12) and quality of healthcare (<em>n</em> = 10) were the most common. Additional themes, including social hierarchy or marginalization, discrimination, justice, unmet social needs, and historical events were described within some definitions. Eleven of the included manuscripts defined race as a social construct.</div></div><div><h3>Conclusion</h3><div>This study depicts RHE as an emerging concept with limited consensus on racism, quality of health, and social determinants of health as important underlying frameworks. To center equity efforts and actions under a workable and shared vision, we recommend continued discussions regarding underlying meanings of RHE concepts and propose establishing a definition that promotes unity across health fields and prevents ambiguity.</div></div>","PeriodicalId":51079,"journal":{"name":"Journal of Clinical Epidemiology","volume":"176 ","pages":"Article 111580"},"PeriodicalIF":7.3,"publicationDate":"2024-10-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142570111","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Centering racial health equity in systematic reviews paper 2: themes from semistructured interviews","authors":"Rania Ali ,&nbsp;Carmen Daniel ,&nbsp;Tiffany Duque ,&nbsp;Nila Sathe ,&nbsp;Ana Beatriz Pizarro ,&nbsp;Alexander Rabre ,&nbsp;Danielle Henderson ,&nbsp;Janelle Armstrong-Brown ,&nbsp;Damian K. Francis ,&nbsp;Vivian Welch ,&nbsp;Patricia C. Heyn ,&nbsp;Omar Dewidar ,&nbsp;Anita Rizvi ,&nbsp;Meera Viswanathan","doi":"10.1016/j.jclinepi.2024.111574","DOIUrl":"10.1016/j.jclinepi.2024.111574","url":null,"abstract":"<div><h3>Objectives</h3><div>In the context of profound and persistent racial health inequities, we sought to understand how to define racial health equity in the context of systematic reviews and how to staff, conduct, disseminate, sustain, and evaluate systematic reviews that address racial health equity.</div></div><div><h3>Study Design and Setting</h3><div>The study consisted of virtual, semistructured interviews followed by structured coding and qualitative analyses using NVivo.</div></div><div><h3>Results</h3><div>Twenty-nine individuals, primarily United States–based, including patients, community representatives, systematic reviewers, clinicians, guideline developers, primary researchers, and funders, participated in this study. These interest holders brought up systems of power, injustice, social determinants of health, and intersectionality when conceptualizing racial health equity. They also emphasized including community members with lived experience in review teams. They suggested making changes to systematic review scope, methods, and eligible evidence (such as adapting review methods to include racial health equity considerations in prioritizing topics for reviews, formulating key questions and searches, and specifying outcomes) and broadening evidence to include designs that address implementation and access. Interest holders noted that sustained efforts to center racial health equity in systematic reviews require resources, time, training, and demonstrating value to funders.</div></div><div><h3>Conclusion</h3><div>Interest holders identified changes to the funding, staffing, conduct, dissemination, and implementation of systematic reviews to center racial health equity. Action on these steps requires clear standards for success, an evidence base to support transformative changes, and consensus among interest holders on the way forward.</div></div>","PeriodicalId":51079,"journal":{"name":"Journal of Clinical Epidemiology","volume":"176 ","pages":"Article 111574"},"PeriodicalIF":7.3,"publicationDate":"2024-10-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142512527","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Exposure misclassification: an “immortal time” bias in observational studies of training load and injury","authors":"Chinchin Wang ,&nbsp;Jay S. Kaufman ,&nbsp;Ian Shrier","doi":"10.1016/j.jclinepi.2024.111581","DOIUrl":"10.1016/j.jclinepi.2024.111581","url":null,"abstract":"<div><h3>Background</h3><div>Several observational studies of the relationship between training load and injury have found increased risks of injury at low loads. These associations are expected because load is often assessed at the end of the injury follow-up period. As such, athletes who get injured earlier in the follow-up period will have systematically lower loads than athletes who get injured later in the follow-up period.</div></div><div><h3>Objective</h3><div>In this commentary, we identify this problem as a type of exposure misclassification occurring from the misalignment of exposure measurement and start of follow-up. This methodological issue has previously been recognized in other areas of epidemiology as “immortal time bias.”</div></div><div><h3>Results and Conclusion</h3><div>Similar to immortal time bias, exposure misclassification bias can be prevented by aligning the measurement of load with the start of follow-up for injury.</div></div>","PeriodicalId":51079,"journal":{"name":"Journal of Clinical Epidemiology","volume":"176 ","pages":"Article 111581"},"PeriodicalIF":7.3,"publicationDate":"2024-10-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142512536","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Centering racial health equity in systematic reviews paper 5: a methodological overview of methods and interventions","authors":"Vivian Welch ,&nbsp;Omar Dewidar ,&nbsp;Anita Rizvi ,&nbsp;Mostafa Bondok ,&nbsp;Yuewen Pan ,&nbsp;Hind Sabri ,&nbsp;Adedeji Irefin ,&nbsp;Elizabeth Ghogomu ,&nbsp;Elizabeth A. Terhune ,&nbsp;Damian K. Francis ,&nbsp;Ana Beatriz Pizarro ,&nbsp;Tiffany A. Duque ,&nbsp;Patricia C. Heyn ,&nbsp;Dru Riddle ,&nbsp;Nila A. Sathe ,&nbsp;Meera Viswanathan","doi":"10.1016/j.jclinepi.2024.111576","DOIUrl":"10.1016/j.jclinepi.2024.111576","url":null,"abstract":"<div><h3>Objectives</h3><div>We aim to (1) evaluate the methods used in systematic reviews of interventions focused on racialized populations to improve racial health equity and (2) examine the types of interventions evaluated for advancing racial health equity in systematic reviews.</div></div><div><h3>Study Design and Setting</h3><div>We searched MEDLINE, Cochrane, and Campbell databases for reviews evaluating interventions focused on racialized populations to mitigate racial health inequities, published from January 2020 to January 2023.</div></div><div><h3>Results</h3><div>We analyzed 157 reviews on racialized populations. Only 22 (14%) reviews addressed racism's role in driving racial health inequities related to the review question. Eleven percent (7) of reviews considered intersectionality when conceptualizing racial inequities. Two-thirds (105, 67%) provided descriptive summaries of included studies rather than synthesizing them. Among those that quantified effect sizes, 54% (21) used biased synthesis methods like vote counting. The most common method assessed was tailoring interventions to meet the needs of racialized populations. Reviews mainly focused on assessing interventions to reduce racial disparities rather than enhancing structural opportunities for racialized populations.</div></div><div><h3>Conclusion</h3><div>Reviews for racial health equity could be improved by enhancing methodologic quality, defining the role of racism in the question, using reliable analytical methods, and assessing process and implementation outcomes. More focus is needed on assessing structural interventions to improve opportunities for racialized populations and prioritize these issues in political and social agendas.</div></div>","PeriodicalId":51079,"journal":{"name":"Journal of Clinical Epidemiology","volume":"176 ","pages":"Article 111576"},"PeriodicalIF":7.3,"publicationDate":"2024-10-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142512534","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"13-Year colorectal cancer risk after lower-quality, higher-quality and no screening colonoscopy: a cohort study","authors":"Sarina Schwarz ,&nbsp;Malte Braitmaier ,&nbsp;Christian Pox ,&nbsp;Bianca Kollhorst ,&nbsp;Vanessa Didelez ,&nbsp;Ulrike Haug","doi":"10.1016/j.jclinepi.2024.111571","DOIUrl":"10.1016/j.jclinepi.2024.111571","url":null,"abstract":"<div><h3>Objectives</h3><div>A lower-quality colonoscopy has been shown to be less effective in reducing colorectal cancer (CRC) incidence than a higher-quality colonoscopy, but the comparison with no-screening colonoscopy (noSC) is lacking. We aimed to compare the 13-year risk of developing CRC between persons with I) a higher-quality screening colonoscopy (higherQualSC), II) a lower-quality screening colonoscopy (lowerQualSC), and III) without a screening colonoscopy.</div></div><div><h3>Study Design and Setting</h3><div>A health-care database (∼20% of the German population) was used to emulate a target trial with three arms: higherQualSC vs lowerQualSC vs noSC at baseline. The quality of screening colonoscopy was categorized based on the polyp detection rate of the examining physician (cut-off: 21.8%). We included persons aged 55–69 years at average CRC risk and CRC screening naïve at baseline. We estimated adjusted cumulative CRC incidence over 13 years of follow-up.</div></div><div><h3>Results</h3><div>The higherQualSC arm comprised 142,960 persons, the lowerQualSC arm 62,338 persons, and the noSC arm 124,040 persons. The adjusted 13-year CRC risk was 1.77% in the higherQualSC arm, 2.09% in the lowerQualSC arm, and 2.74% in the noSC arm. Compared to the noSC arm, the adjusted relative risk was 0.76 (95% CI: 0.70–0.84) in the lowerQualSC arm and 0.65 (95% CI: 0.60–0.69) in the higherQualSC arm.</div></div><div><h3>Conclusion</h3><div>Our study shows that a lowerQualSC is also effective in reducing CRC incidence compared to noSC. However, the effect is about one-third less than that of a higherQualSC.</div></div>","PeriodicalId":51079,"journal":{"name":"Journal of Clinical Epidemiology","volume":"176 ","pages":"Article 111571"},"PeriodicalIF":7.3,"publicationDate":"2024-10-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142512526","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"David Sackett Young Investigator Award, Peer Reviewer of the Year Award, and Peer Reviewer Acknowledgment","authors":"","doi":"10.1016/j.jclinepi.2024.111582","DOIUrl":"10.1016/j.jclinepi.2024.111582","url":null,"abstract":"","PeriodicalId":51079,"journal":{"name":"Journal of Clinical Epidemiology","volume":"176 ","pages":"Article 111582"},"PeriodicalIF":7.3,"publicationDate":"2024-10-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142696150","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"GRADE Notes 4: how to use GRADE when there is “no” evidence? A case study of using unpublished registry data","authors":"Ibrahim K. El Mikati ,&nbsp;Brandy Begin ,&nbsp;Dagmara Borzych-Duzalka ,&nbsp;Alicia M. Neu ,&nbsp;Troy Richardson ,&nbsp;Rebecca G. Same ,&nbsp;Franz Schaefer ,&nbsp;Bradley A. Warady ,&nbsp;Reem A. Mustafa","doi":"10.1016/j.jclinepi.2024.111578","DOIUrl":"10.1016/j.jclinepi.2024.111578","url":null,"abstract":"<div><h3>Objectives</h3><div>Trustworthy guidelines rely on systematic reviews of the best available published evidence. The GRADE (Grading of Recommendations Assessment, Development, and Evaluation) Working Group has provided guidance about developing evidence-based recommendations when published direct evidence is lacking. In this article, we provide a case example as an alternate solution to generate primary data using registries prior to collecting expert evidence.</div></div><div><h3>Study Design and Setting</h3><div>When direct published literature was absent, a team of clinical and statistical expertise can utilize registries, when available, for primary data generation in a way that allows for answering clinically important questions.</div></div><div><h3>Results</h3><div>Out of 54 questions prioritized by a guideline development for the prevention and management of peritoneal dialysis-associated infections in children, 25 questions had no evidence to inform them. The use of unpublished registry data served as a primary source of information to answer 12 of the 25 questions and provided additional information for nine questions for which at least one published study was available.</div></div><div><h3>Conclusion</h3><div>This article extends our previous GRADE note for scenarios of “no” evidence, highlighting the value of generating primary evidence using unpublished registry data when relevant registries and resources allow. This approach can be of particular value when addressing conditions that are rare or from populations that are considered vulnerable, while emphasizing the importance of being transparent regarding the reporting of raw data and the analysis plan in the event of reporting unpublished work.</div></div>","PeriodicalId":51079,"journal":{"name":"Journal of Clinical Epidemiology","volume":"177 ","pages":"Article 111578"},"PeriodicalIF":7.3,"publicationDate":"2024-10-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142512537","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}