Journal of Clinical Epidemiology最新文献

{"title":"Accounting for differential exclusions in the Nordic-European initiative on colorectal cancer trial discloses stronger-than-reported effects of screening colonoscopy","authors":"Hermann Brenner ,&nbsp;Tim Holland-Letz ,&nbsp;Michael Hoffmeister ,&nbsp;Thomas Heisser","doi":"10.1016/j.jclinepi.2025.111669","DOIUrl":"10.1016/j.jclinepi.2025.111669","url":null,"abstract":"<div><h3>Objectives</h3><div>Recently, results on colorectal cancer (CRC) incidence and mortality reduction by the offer of screening colonoscopy were reported for the first time from a randomized controlled trial (RCT), the Nordic-European Initiative on Colorectal Cancer (NordICC) trial. Despite randomization, there was a substantially lower proportion of postrandomization exclusions of CRC cases due to cancer registry-recorded date of diagnosis before recruitment in the invited group than in the usual-care group. We aimed to evaluate the impact of such differential exclusions on the trial's effect estimates on CRC risk.</div></div><div><h3>Study Design and Setting</h3><div>We compared reported postrandomization exclusions of CRC cases due to cancer registry-recorded date of diagnosis, and we derived adjusted effect estimates on CRC risk accounting for the reported differential postrandomization exclusion of CRC cases in the invited group and the usual-care group.</div></div><div><h3>Results</h3><div>Reported postrandomization exclusion proportions of CRC cases were originally reported as 52/31,472 (0.17%) and 159/63,133 (0.25%) in the invited and usual-care group, respectively, (<em>P</em> &lt; .005) in an analysis, including participants from all four NordICCstudy countries and as 52/28,277 (0.20%) and 164/56,529 (0.29%) in the recent analysis of 10-year follow-up data from three of the countries (<em>P</em> = .018). Accounting for the differential exclusion proportions increased the estimated CRC risk reduction (95% CI) from originally reported 18% (7%–30%) to 25% (95% CI 13%–35%) in intention-to-screen analysis. Estimated reduction of CRC risk among screening attenders increased from originally reported 31% (17%–45%) to 50% (25%–69%) in adjusted per-protocol analysis.</div></div><div><h3>Conclusion</h3><div>Accounting for differential postrandomization exclusions of CRC cases leads to stronger-than-reported effect estimates in the so far only RCT on long-term effects of screening colonoscopy.</div></div>","PeriodicalId":51079,"journal":{"name":"Journal of Clinical Epidemiology","volume":"180 ","pages":"Article 111669"},"PeriodicalIF":7.3,"publicationDate":"2025-01-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142973157","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":"Assessing the scientific integrity of the collected work of one author or author group","authors":"Jeremy Nielsen ,&nbsp;Esmée M. Bordewijk ,&nbsp;Lyle C. Gurrin ,&nbsp;Siddharth Shivantha ,&nbsp;Madeline Flanagan ,&nbsp;Sue Liu ,&nbsp;May M. Linn ,&nbsp;Kelly X. Zhou ,&nbsp;Rik van Eekelen ,&nbsp;Nicholas J.L. Brown ,&nbsp;Jim Thornton ,&nbsp;Ben W. Mol","doi":"10.1016/j.jclinepi.2024.111603","DOIUrl":"10.1016/j.jclinepi.2024.111603","url":null,"abstract":"<div><h3>Objectives</h3><div>No published methods for research integrity review include both statistical techniques applied to groups of randomized trials and individual assessment of papers. We propose a method based on practical experience of investigating data integrity across the collected papers of an author or author group.</div></div><div><h3>Study Design and Setting</h3><div>We report our approach to investigating the collected papers of an author or author group suspected of academic misconduct.</div></div><div><h3>Results</h3><div>In the investigation of the work of an author or author group, we recommend a systematic search for the work of the involved authors in PubMed, Google Scholar, and the Retraction Watch database, as well as a search of trial registries for unpublished clinical trials. Summary information from studies should be tabulated to assess consistency between study registration, execution, and publication. Each paper should be investigated for unfeasible features of the governance, methodology, execution, results, and reporting of the study. Pairwise comparison of baseline and outcome tables between papers may reveal data duplication or unfeasibly large differences between baseline characteristics in similar studies. Assessment of baseline characteristics from multiple randomized trials using Carlisle’s method can determine whether the data are consistent with a properly executed randomization process, as can checking whether reported baseline characteristics follow expected patterns for random variables such as Benford’s law. If serious concerns are raised, a more thorough investigation should be performed by journals, publishers, and institutions.</div></div><div><h3>Conclusion</h3><div>These methods provide a systematic and reproducible way to assess the collected work of an author or group of authors.</div></div><div><h3>Plain Language Summary</h3><div>It is increasingly accepted that papers reporting on clinical studies may contain fraudulent or falsified data, often multiple papers by a single author or author group. Based on our experience assessing the research integrity of collections of papers by one author or author group, we present an approach to these investigations that combines published statistical methods with pragmatic assessment of study feasibility. This will help journals and publishers better identify groups of potentially untrustworthy studies.</div></div>","PeriodicalId":51079,"journal":{"name":"Journal of Clinical Epidemiology","volume":"180 ","pages":"Article 111603"},"PeriodicalIF":7.3,"publicationDate":"2025-01-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142973158","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":"Research participation effects and where to find them: a systematic review of studies on alcohol","authors":"Katarina Ulfsdotter Gunnarsson,&nbsp;Elizabeth S. Collier,&nbsp;Marcus Bendtsen","doi":"10.1016/j.jclinepi.2025.111668","DOIUrl":"10.1016/j.jclinepi.2025.111668","url":null,"abstract":"<div><h3>Objectives</h3><div>The term ‘research participation effects’ (RPEs) is intended to capture features and artifacts of study design that may affect measured outcomes in ways that introduce bias into research findings, impacting inference and outcome validity. This systematic review aims to identify which RPEs have been studied in the context of alcohol research and provide an overview of estimates of RPEs on self-reported alcohol consumption.</div></div><div><h3>Study Design and Setting</h3><div>This systematic review summarizes the available evidence on RPEs in alcohol research.</div></div><div><h3>Results</h3><div>Twenty-seven reports were included in the review. The reports included randomized controlled trials (RCTs), studies-within-a-trial, between-subjects experiments, and qualitative investigations. A range of RPEs were addressed as follows: assessment reactivity (<em>N</em> = 15), being randomized to a waiting list control group (<em>N</em> = 3), the impact of obtaining informed consent (<em>N</em> = 2), experimentally induced social desirability (<em>N</em> = 3), and the Hawthorne effect, either specifically by name (<em>N</em> = 2, one quantitative, one qualitative) or described as general RPE presence (<em>N</em> = 2). The literature provided proportionally stronger evidence in favor of assessment reactivity and waiting list designs affecting alcohol outcomes, contrary to obtaining informed consent or inducing social desirability.</div></div><div><h3>Conclusion</h3><div>Variation in study quality, terminology, and outcome measures hinder comprehensive understanding and discussion of RPEs at present. Improved knowledge of RPEs and their potential long-term consequences in alcohol research, including a unified lexicon, would enhance trial design and improve the certainty of evidence in alcohol research.</div></div>","PeriodicalId":51079,"journal":{"name":"Journal of Clinical Epidemiology","volume":"179 ","pages":"Article 111668"},"PeriodicalIF":7.3,"publicationDate":"2025-01-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142973159","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":"Answers to comments by Jonas Schmidt, Casper Urth Pedersen, and Sisse Helle Njor","authors":"Philippe Autier,&nbsp;Karsten Juhl Jørgensen,&nbsp;Henrik Støvring","doi":"10.1016/j.jclinepi.2024.111588","DOIUrl":"10.1016/j.jclinepi.2024.111588","url":null,"abstract":"","PeriodicalId":51079,"journal":{"name":"Journal of Clinical Epidemiology","volume":"177 ","pages":"Article 111588"},"PeriodicalIF":7.3,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142565172","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":"Corrigendum to ‘Identification of homelessness using health administrative data in Ontario, Canada following a national coding mandate: a validation study’ [Journal of Clinical Epidemiology 172 (2024) 111430]","authors":"Lucie Richard ,&nbsp;Brooke Carter ,&nbsp;Rosane Nisenbaum ,&nbsp;Michael Liu ,&nbsp;Stephen W. Hwang","doi":"10.1016/j.jclinepi.2024.111615","DOIUrl":"10.1016/j.jclinepi.2024.111615","url":null,"abstract":"","PeriodicalId":51079,"journal":{"name":"Journal of Clinical Epidemiology","volume":"177 ","pages":"Article 111615"},"PeriodicalIF":7.3,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142820178","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":"The influence of intervention fidelity on treatment effect estimates in clinical trials of complex interventions: a metaepidemiological study","authors":"Arsenio Páez ,&nbsp;David Nunan ,&nbsp;Peter McCulloch ,&nbsp;David Beard","doi":"10.1016/j.jclinepi.2024.111610","DOIUrl":"10.1016/j.jclinepi.2024.111610","url":null,"abstract":"&lt;div&gt;&lt;h3&gt;Background and Objective&lt;/h3&gt;&lt;div&gt;Randomized clinical trials (RCTs) provide the most reliable estimates of treatment effectiveness for therapeutic interventions. However, flaws in their design and conduct may bias treatment effect estimates, leading to overestimation or underestimation of the true intervention effect. This is especially relevant for complex interventions, such as those in rehabilitation, which are multifaceted and tailored for individual patients or providers, leading to variations in delivery and treatment effects. To assess whether poor intervention fidelity, the faithfulness of the intervention delivered in an RCT to what was intended in the trial protocol, influences (biases) estimates of treatment effects derived from meta-analysis of rehabilitation RCTs.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Methods&lt;/h3&gt;&lt;div&gt;In this metaepidemiological study of 19 meta-analyses and 204 RCTs published between 2010 and 2020, we evaluated the difference in intervention effects between RCTs in which intervention fidelity was monitored and those in which it was absent. We also conducted random-effects metaregression to measure associations between intervention fidelity, risk of bias, study sample size, and treatment effect estimates.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Results&lt;/h3&gt;&lt;div&gt;There was a linear relationship between fidelity and treatment effect sizes across RCTs, even after adjusting for risk of bias and study sample size. Higher degrees of fidelity were associated with smaller but more precise treatment effect estimates (d = −0.23 95% CI: −0.38, −0.74). Lower or absent fidelity was associated with larger, less precise estimates. Adjusting for fidelity reduced pooled treatment effect estimates in 4 meta-analyses from moderate to small or from small to no negligible or no effect, highlighting how poor fidelity can bias meta-analyses’ results.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Conclusion&lt;/h3&gt;&lt;div&gt;Poor or absent intervention fidelity in RCTs may lead to overestimation of observed treatment effects, skewing the conclusions from individuals studies and systematic reviews with meta-analyses when pooled. Caution is needed when interpreting the results of complex intervention RCTs when fidelity is not monitored or is monitored but not reported.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Plain Language Summary&lt;/h3&gt;&lt;div&gt;Patients, the public, and health-care providers rely on clinical trials for information about how effective treatments are when making decisions about health care. However, the way that clinical trials are conducted may alter the evidence that clinical trials provide about how effective interventions truly are. In this study, we investigated whether how closely health-care providers monitor how they deliver rehabilitation treatments to patients in clinical studies, and how closely those treatments match the treatment that the researchers had planned, influences the results of those studies. We found that when researchers or health-care providers don’t closely monitor how they deliver treatm","PeriodicalId":51079,"journal":{"name":"Journal of Clinical Epidemiology","volume":"177 ","pages":"Article 111610"},"PeriodicalIF":7.3,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142631895","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,&nbsp;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":"177 ","pages":"Article 111584"},"PeriodicalIF":7.3,"publicationDate":"2025-01-01","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":"The methods adopted by Autier et al do not support their conclusions","authors":"Jonas Schmidt,&nbsp;Casper Urth Pedersen,&nbsp;Sisse Helle Njor","doi":"10.1016/j.jclinepi.2024.111587","DOIUrl":"10.1016/j.jclinepi.2024.111587","url":null,"abstract":"","PeriodicalId":51079,"journal":{"name":"Journal of Clinical Epidemiology","volume":"177 ","pages":"Article 111587"},"PeriodicalIF":7.3,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142565174","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":"Editors’ Choice January 2025","authors":"Andrea C. Tricco,&nbsp;David Tovey","doi":"10.1016/j.jclinepi.2024.111647","DOIUrl":"10.1016/j.jclinepi.2024.111647","url":null,"abstract":"","PeriodicalId":51079,"journal":{"name":"Journal of Clinical Epidemiology","volume":"177 ","pages":"Article 111647"},"PeriodicalIF":7.3,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143140897","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":"Corrigendum to ‘Avoiding searching for outcomes called for additional search strategies: a study of cochrane review searches’ [Journal of Clinical Epidemiology, 149 (2022) 83-88]","authors":"Tove Faber Frandsen ,&nbsp;Michael Friberg Bruun Nielsen ,&nbsp;Mette Brandt Eriksen","doi":"10.1016/j.jclinepi.2024.111604","DOIUrl":"10.1016/j.jclinepi.2024.111604","url":null,"abstract":"","PeriodicalId":51079,"journal":{"name":"Journal of Clinical Epidemiology","volume":"177 ","pages":"Article 111604"},"PeriodicalIF":7.3,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142677477","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}