Journal of Clinical Epidemiology最新文献

{"title":"Antimetric or semimetric research assessment reform is particularly risky for weak academic environments.","authors":"Livia Puljak, Rafael Leite Pacheco","doi":"10.1016/j.jclinepi.2026.112430","DOIUrl":"10.1016/j.jclinepi.2026.112430","url":null,"abstract":"<p><strong>Background and objectives: </strong>Research assessment is increasingly shifting from bibliometric indicators toward qualitative approaches intended to capture research quality more broadly. However, these reforms often assume strong governance, independent evaluators, and effective oversight. Such conditions may be less reliable in small or resource-constrained academic environments. This manuscript examines the potential risks of reducing reliance on standardized metrics in these settings and questions whether less metric-dependent assessment models can be applied universally.</p><p><strong>Study design and setting: </strong>This is a conceptual analysis and policy critique based on published meta-research, evaluation theory, and historical examples of problems in peer review and scientific gatekeeping.</p><p><strong>Results: </strong>Current initiatives to reduce the role of research metrics often assume institutions with strong governance, sufficiently large and independent pools of evaluators, and effective mechanisms for oversight. These conditions may not be present in smaller or more isolated academic environments, where academic inbreeding, limited resources for external reviewers, and close professional relationships can make independent evaluation difficult. In such settings, reducing the role of standardized and auditable indicators may give evaluators greater discretion and potentially increase opportunities for nepotism, patronage, or institutional bias. Qualitative assessment depends on several conditions working well at the same time; weaknesses in evaluator independence, competence, or oversight may undermine the reliability of the process. Quantitative indicators can also be manipulated, but such manipulation often produces data that can subsequently be examined, compared, and challenged.</p><p><strong>Conclusion: </strong>Research assessment reform should take institutional context into account rather than assuming that the same model will function equally well across academic systems. The effects of reducing reliance on quantitative indicators should be carefully evaluated in smaller and resource-constrained academic environments.</p>","PeriodicalId":51079,"journal":{"name":"Journal of Clinical Epidemiology","volume":" ","pages":"112430"},"PeriodicalIF":5.8,"publicationDate":"2026-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148609720","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":"Reply to the commentary on \"Estimating diagnostic accuracy under uncertainty about disease status: a sepsis case study\".","authors":"Kevin Jenniskens, Johannes B Reitsma","doi":"10.1016/j.jclinepi.2026.112432","DOIUrl":"10.1016/j.jclinepi.2026.112432","url":null,"abstract":"","PeriodicalId":51079,"journal":{"name":"Journal of Clinical Epidemiology","volume":" ","pages":"112432"},"PeriodicalIF":5.8,"publicationDate":"2026-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148609737","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":"Comment on \"Estimating diagnostic accuracy under uncertainty about disease status: a sepsis case study\".","authors":"Werner Vach","doi":"10.1016/j.jclinepi.2026.112431","DOIUrl":"10.1016/j.jclinepi.2026.112431","url":null,"abstract":"","PeriodicalId":51079,"journal":{"name":"Journal of Clinical Epidemiology","volume":" ","pages":"112431"},"PeriodicalIF":5.8,"publicationDate":"2026-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148594172","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":"Target audience and interest holder engagement in methods guidance development.","authors":"Ingrid Toews, Eva Rehfuess, Ani Movsisyan, Annabelle Bockey, Kolahta Asres Ioab, Signe Flottorp, Frode Forland, Jan Himmels, Christina Koscher-Kien, Brigitte Strahwald, Barbara Nussbaumer-Streit, Joerg J Meerpohl","doi":"10.1016/j.jclinepi.2026.112473","DOIUrl":"10.1016/j.jclinepi.2026.112473","url":null,"abstract":"","PeriodicalId":51079,"journal":{"name":"Journal of Clinical Epidemiology","volume":" ","pages":"112473"},"PeriodicalIF":5.8,"publicationDate":"2026-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148801278","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":"Author's reply to the letter to the editor: \"Target audience and interest holder engagement in methods guidance development\".","authors":"Malena Chiaborelli, Stefan Schandelmaier","doi":"10.1016/j.jclinepi.2026.112474","DOIUrl":"10.1016/j.jclinepi.2026.112474","url":null,"abstract":"","PeriodicalId":51079,"journal":{"name":"Journal of Clinical Epidemiology","volume":" ","pages":"112474"},"PeriodicalIF":5.8,"publicationDate":"2026-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148801159","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":"CONSORT at 30 years: history, evolution, and impact of a reporting guideline for randomized controlled trials - Part 1.","authors":"David Moher, Sally Hopewell, Isabelle Boutron, An-Wen Chan, Asbjørn Hróbjartsson, Kenneth F Schulz","doi":"10.1016/j.jclinepi.2026.112577","DOIUrl":"https://doi.org/10.1016/j.jclinepi.2026.112577","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;The Consolidated Standards of Reporting Trials (CONSORT) Statement was developed to improve the transparency and completeness of reporting randomized controlled trials (RCTs). Since its first publication in 1996, CONSORT has become the international standard for reporting RCTs and has influenced the development of reporting guidelines across health research.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;This article describes the history, evolution, and impact of CONSORT from its beginnings in the early 1990s to the publication of CONSORT 2025. It draws on published reports, historical records and contributions from original developers and current members of the CONSORT and SPIRIT Executive group.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Concerns regarding the poor reporting of RCTs, and the limitations this imposed for critical appraisal, systematic reviews and their ability to inform clinical practice guidelines, motivated the development of structured reporting guidance. Independent initiatives by the SORT Group in Ottawa and the Asilomar Working Group led to the production of the original CONSORT Statement in 1996, which introduced a checklist and participant flow diagram for reporting RCTs. Subsequent updates in 2001, 2010, and 2025 refined and expanded the guidance in response to emerging methodological evidence and user feedback. CONSORT also stimulated the creation of extensions addressing specific trial designs, interventions, and reporting issues, as well as related initiatives including SPIRIT, QUOROM, STARD, and the EQUATOR Network.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusion: &lt;/strong&gt;Over three decades, CONSORT has become the international standard for reporting RCTs, endorsed by leading journals and editorial organizations worldwide. Evidence suggests that journal endorsement of CONSORT improves reporting completeness, although adherence remains inconsistent. Continued innovation, harmonization with related initiatives, and improved implementation strategies are still required to ensure transparent, reproducible, and trustworthy reporting of RCTs in the future.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Plain language summary: &lt;/strong&gt;Randomized controlled trials are important studies that help determine whether health treatments and other interventions work. However, if trial reports leave out key details about what researchers did and what they found, clinicians, patients, policy-makers, and other researchers cannot judge the results properly or use them confidently. This article describes the 30-year history of the CONSORT Statement, an international guideline designed to help researchers report randomized trials clearly and completely. CONSORT began in the mid-1990s, when two groups of researchers and journal editors independently developed proposals to improve poor reporting of trials. They combined their work, publishing the first CONSORT Statement in 1996. It included a checklist and a participant flow diagram to show how people moved through a trial. CONSORT ha","PeriodicalId":51079,"journal":{"name":"Journal of Clinical Epidemiology","volume":" ","pages":"112577"},"PeriodicalIF":5.8,"publicationDate":"2026-10-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149301996","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":"Informing sample size and power calculations for clone-censor-weight analyses: a Monte Carlo simulation study of the variance inflation factor relative to the underlying target trial.","authors":"Peter C Austin","doi":"10.1016/j.jclinepi.2026.112576","DOIUrl":"https://doi.org/10.1016/j.jclinepi.2026.112576","url":null,"abstract":"<p><strong>Background: </strong>Clone-censor-weighting (CCW) is a causal inference method used in target trial emulation in settings in which the time of application of the treatment occurs during follow-up. An important component of study design is determining the sample size required for a specified level of statistical power or to determine the statistical power associated with a specific sample size. Determining statistical power is relatively straightforward for the underlying randomized controlled trial (RCT) that one is emulating. In contrast, conducting power and sample size calculations for observational studies that employ CCW is not straightforward because the analysis incorporates inverse probability of censoring weights, which are only known at the analysis phase, and not during the design phase.</p><p><strong>Methods: </strong>Monte Carlo simulations (270 scenarios varying sample size, treatment prevalence, threshold for defining early treatment, and covariate-treatment odds ratios) were used to estimate the variance inflation factor (VIF) of a CCW analysis compared to the underlying target RCT, across two estimands: the risk difference and the relative risk.</p><p><strong>Results: </strong>In settings with 10 baseline covariates, the use of a CCW design tended to result in more precise estimation of risk differences and relative risks compared to the underlying RCT when the magnitude of confounding was low to moderate. The magnitude of the VIF depended on treatment prevalence, sample size, the time horizon at which risk was estimated, and the strength of the baseline covariates' association with treatment initiation. In secondary simulations, it was observed that the VIF comparing a CCW design to the underlying RCT tended to increase as the number of baseline covariates increased.</p><p><strong>Conclusions: </strong>Researchers designing CCW studies can use the simulation results and the accompanying R code, available in a public GitHub repository, to obtain study-specific VIF estimates for incorporation into a priori power calculations.</p>","PeriodicalId":51079,"journal":{"name":"Journal of Clinical Epidemiology","volume":" ","pages":"112576"},"PeriodicalIF":5.8,"publicationDate":"2026-10-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149301993","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":"Statistical Pitfalls in Large Language Model Evaluation: A Practical Guide to Study Design and Analysis.","authors":"Hadi Vahedi, Ali Jafarizadeh","doi":"10.1016/j.jclinepi.2026.112581","DOIUrl":"https://doi.org/10.1016/j.jclinepi.2026.112581","url":null,"abstract":"<p><strong>Background: </strong>Studies evaluating large language models in medicine increasingly follow a common design in which a fixed set of clinical questions is posed to several sources, such as different language models, clinicians, or patient-education resources. The responses are then scored for outcomes including accuracy, completeness, readability, or similar measures. Because each source answers the same set of questions, the resulting observations are inherently paired: the question functions as the repeated unit across sources. Despite this structure, many studies analyze the resulting data using statistical procedures that assume independent observations.</p><p><strong>Discussion: </strong>Treating paired observations as independent introduces a mismatch between the study design and the statistical analysis. In evaluations where multiple sources respond to the same questions, the responses are naturally correlated because they are influenced by shared characteristics of the question, such as difficulty or ambiguity. Ignoring this dependence can reduce statistical power and distort the nominal type I error rate. These issues arise when commonly used independent-sample procedures, including the Mann-Whitney test, the Kruskal-Wallis test, one-way analysis of variance, or unpaired t-tests, are applied to datasets generated from identical question sets. The appropriate analytical framework instead treats the question as the unit of pairing. Methods designed for repeated or paired observations, such as the Friedman test or repeated-measures analysis of variance for overall comparisons, followed by paired contrasts using the Wilcoxon signed-rank test or paired t-tests with appropriate multiplicity correction, provide analyses that align with the underlying design. Effect sizes and regression approaches that account for the paired structure, including mixed-effects models with question treated as a random effect, may further strengthen inference. Recognizing the repeated-measures nature of these evaluations provides a straightforward path toward more statistically coherent analyses.</p>","PeriodicalId":51079,"journal":{"name":"Journal of Clinical Epidemiology","volume":" ","pages":"112581"},"PeriodicalIF":5.8,"publicationDate":"2026-10-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149302019","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":"Best Practice Methods for Living Evidence Synthesis in Health Care: An International Modified Delphi Survey.","authors":"Melanie M Golob, Jonathan Livingstone-Banks, Per Olav Vandvik, Maria Michaels, Rebecca Hodder, Zachary Munn, James Thomas, Irbaz Bin Riaz, Gabriel Rada, Gordon Guyatt, David Nunan","doi":"10.1016/j.jclinepi.2026.112574","DOIUrl":"https://doi.org/10.1016/j.jclinepi.2026.112574","url":null,"abstract":"<p><strong>Objective: </strong>Living evidence syntheses (LES) represent continual updates for an important topic for decision-making where there is uncertainty in the evidence. Whereas best practices for traditional evidence syntheses in health care are well established, they are not for LES. This study aimed to establish globally relevant consensus statements for considering, conducting, publishing, and implementing LES in health care.</p><p><strong>Study design and setting: </strong>A modified Delphi consensus process was conducted. Potential participants were identified through a prior survey, workshop, and targeted outreach based on expertise and representation across global organizations producing or supporting LES. Three modified Delphi rounds were administered using JISC Online Surveys between January and April 2025. Participants rated 23 statements on a five-point Likert scale. Consensus was defined as ≥80% agreement ('Agree' or 'Strongly Agree') with ≥85% panel response rate required per round. Qualitative feedback guided iterative statement revision. Draft statements were informed by an overview of living systematic reviews, a living evidence survey plus workshop activity, and an ongoing living critical interpretive synthesis of LES. Statements expanded upon the living methodology reporting guidance published by the PRISMA-LSR group to include other considerations for LES.</p><p><strong>Results: </strong>The Delphi panel comprised 29 experts from around the world, with 27 (93%) completing round 1, 26 (90%) round 2, and 27 (93%) completing round 3. Nineteen of 22 final statements achieved consensus: 12 on conduct (including set up and maintenance of living mode as well as funding and resources), 2 on reporting, 4 on publishing, and 1 on implementation/appraisal. Final statements included ways to enable the living mode, such as version history; authoring tools; collaboration; unit of update; transparency; communication; publication considerations; and digital and technological considerations.</p><p><strong>Conclusion: </strong>This study presents the first expert consensus-based best-practice statements for considering, conducting, publishing, and implementing LES in health care. These statements can help align global processes, improve transparency, and promote sustainability. But there is still more to be done to accomplish these objectives, requiring that groups collaborate to embrace digital tools, adopt interoperability standards, and create effective appraisal tools.</p>","PeriodicalId":51079,"journal":{"name":"Journal of Clinical Epidemiology","volume":" ","pages":"112574"},"PeriodicalIF":5.8,"publicationDate":"2026-10-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149302073","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":"Methods for evaluating living guidelines: Early guidance based on practical experience.","authors":"Tanya Millard, Anneliese Synnot, Samantha Chakraborty, Kelvin Hill, Ella Zomer, Eng Joo Tan, Tari Turner","doi":"10.1016/j.jclinepi.2026.112573","DOIUrl":"https://doi.org/10.1016/j.jclinepi.2026.112573","url":null,"abstract":"<p><strong>Objectives: </strong>To provide guidance for designing and conducting process and impact evaluations for living guidelines; drawing on the practical experiences of the Australian Living Evidence Collaboration (ALEC) and its member groups.</p><p><strong>Methods: </strong>In this paper, we describe and reflect upon the methods for evaluating living guidelines, providing practical advice drawing on our experiences conducting diverse evaluations of three living guidelines developed by the ALEC and its member groups - the Australian and New Zealand Clinical Guidelines for Stroke Management, the Australian Guidelines for the Clinical Care of people with COVID-19, and the Australian Pregnancy and Postnatal Care guidelines. We describe and outline preliminary methods for 1) process evaluations to assess and refine living guideline processes and outputs as guideline development is underway; and 2) impact evaluations to explore if and how living guidelines are being used, their value and the impacts they are having. Our guidance includes economic evaluations to assess the economic costs and benefits of developing and maintaining living guidelines.</p><p><strong>Conclusion: </strong>Process and impact evaluations have been pivotal in underpinning improvements in the ALEC living guideline methods and processes, including the format, content and dissemination of the living guidelines, and our engagement with key stakeholders. Conducting thorough evaluations throughout the cycle of living guideline development and maintenance provides crucial information about the facilitators and enablers, strengths and weaknesses in the process of living guideline production and implementation. The methods described here can be tailored by guideline development programs and applied to evaluate living guidelines across diverse topics and settings.</p>","PeriodicalId":51079,"journal":{"name":"Journal of Clinical Epidemiology","volume":" ","pages":"112573"},"PeriodicalIF":5.8,"publicationDate":"2026-10-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149289861","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}