Journal of Clinical Epidemiology最新文献

{"title":"Manuscript peer review lacks an empirically derived definition: a scoping review of 139 sources identifies 37 characteristics.","authors":"Mehvish Masood, Ka Hin Tai, Julia Soto Rizzato, Janice Tufte, Michael Mittelman, Christine Von Raesfeld, Jessie McGowan, Alexandra Bodnaruc, Isabelle Boutron, Jocalyn Clark, Martin Offringa, Ludo Waltman, David Moher","doi":"10.1016/j.jclinepi.2026.112550","DOIUrl":"https://doi.org/10.1016/j.jclinepi.2026.112550","url":null,"abstract":"<p><strong>Objective: </strong>To summarize empirical definitions and characteristics of manuscript peer review in the literature.</p><p><strong>Study design and setting: </strong>Scoping review conducted according to JBI methodology. We searched eight bibliographic databases and 76 grey-literature sources for English-language publications from 1986 onward addressing manuscript peer review in biomedical and health sciences, social sciences, economics, and healthcare-aligned industries. Title/abstract and full-text screening, empirical-source identification, and study-characteristic extraction were supported by an artificial intelligence-enabled workflow with human verification. Extracted empirically derived definitions and characteristics were coded, deduplicated, and thematically synthesized..</p><p><strong>Results: </strong>Of 4,181 eligible sources, 139 reported findings informed by empirical studies. All 139 sources described one or more characteristics of manuscript peer review, but only one provided an empirically derived definition. We identified 37 unique characteristics, organized into six themes: function, motivation, process, assessment, characteristics, and shortcomings. The findings show that manuscript peer review is commonly described in terms of evaluating research quality and reporting, supporting editorial decision-making and manuscript improvement, and involving expectations of constructive, timely, professional, critical, principled, and confidential review. Empirical sources also identified substantial limitations, including inconsistent standards, unregulated discretion, limited impact on reporting quality, delays, reviewer shortages and workload, weak incentives, power imbalances, ethical concerns, and bias.</p><p><strong>Conclusions: </strong>This analysis identified a set of potential characteristics of manuscript peer review from empirical sources. These characteristics will be presented to Delphi study participants to support the development of a consensus definition of peer review. Achieving consensus in this area is expected to improve conceptual clarity, facilitate more consistent evaluation and comparison of peer review across fields, and inform future efforts to strengthen transparency and reform in scholarly publishing.</p><p><strong>Plain language summary: </strong>Peer review is the process in which people with relevant expertise assess a scholarly manuscript before, or sometimes after, it is published. It is intended to help editors decide whether a manuscript is suitable for publication and to help authors improve their work. Peer review is widely used across scholarly publishing, including research relevant to health care, but there is no single internationally accepted definition of what manuscript peer review is. We conducted a scoping review to identify how manuscript peer review has been defined and described in published research. A scoping review maps the available evidence on a topic rather than assess","PeriodicalId":51079,"journal":{"name":"Journal of Clinical Epidemiology","volume":" ","pages":"112550"},"PeriodicalIF":5.8,"publicationDate":"2026-10-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149170715","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":"Barriers and Strategies for Inclusive Clinical Trials: Focus Group Insights on Inclusivity, Diversity, Equity, and Accessibility.","authors":"Syamala Buragadda, Eva Friedman, Marie-Annick Clavel, Stuart Nicholls, David Collister, Léa-Mai Simard, Shannon M Ruzycki, Louise Pilote","doi":"10.1016/j.jclinepi.2026.112551","DOIUrl":"https://doi.org/10.1016/j.jclinepi.2026.112551","url":null,"abstract":"<p><strong>Background: </strong>Clinical trials are essential for advancing healthcare, yet they often underrepresent key populations, which can limit the applicability of findings to populations for whom interventions are intended and perpetuate inequities in the evidence base. In Canada, practical, context-specific resources to support inclusive trial design and conduct remain limited.</p><p><strong>Objective: </strong>To explore barriers, facilitators, and strategies related to equitable participation in Canadian clinical trials and to gather stakeholder input to inform development of an Inclusion, Diversity, Equity, and Accessibility (IDEA) toolkit for researchers.</p><p><strong>Methods: </strong>We conducted two in-person qualitative focus groups with 20 stakeholders, including researchers, healthcare providers, patient partners, Indigenous representatives, and other participants with lived or professional experience relevant to clinical-trial participation. Audio recordings were transcribed and analyzed in NVivo 15 using an inductive thematic-analysis approach.</p><p><strong>Results: </strong>Participants identified five barriers to inclusive participation: lack of trust; limited clinical-trial knowledge and health research literacy; language and communication challenges; logistical and regulatory challenges; and study burden and gatekeeping. Facilitators included community engagement, culturally relevant representation and outreach, multilingual and accessible materials, flexible and accessible trial delivery, and recruitment and retention supports. Stakeholders also identified priorities for a practical, modular Canadian IDEA toolkit.</p><p><strong>Conclusion: </strong>This exploratory study identifies structural, relational, and operational factors that shape inclusive trial participation and provides context-informed priorities for an IDEA toolkit. The findings are not intended to represent all underserved communities, but they offer practical lessons that can be adapted across trial settings.</p>","PeriodicalId":51079,"journal":{"name":"Journal of Clinical Epidemiology","volume":" ","pages":"112551"},"PeriodicalIF":5.8,"publicationDate":"2026-10-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149149199","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":"Certainty may remain the best term for GRADE evidence ratings despite conceptual limitations: a commentary.","authors":"Arturo Martí-Carvajal, M Hassan Murad, Lars G Hemkens, Thomas Agoritsas, Tahira Devji, Prashanti Eachempati, Leticia Kawano-Dourado, Gordon Guyatt","doi":"10.1016/j.jclinepi.2026.112549","DOIUrl":"https://doi.org/10.1016/j.jclinepi.2026.112549","url":null,"abstract":"<p><strong>Background: </strong>The Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach initially described its ratings as confidence in an effect estimate. Current applications retain this focus while specifying the inference of interest, such as whether the true effect lies above or below a decision-relevant threshold. The terminology later changed from \"quality of evidence\" to \"certainty of evidence.\"</p><p><strong>Main argument: </strong>GRADE reports four ordered levels-high, moderate, low, and very low-of support for an outcome- and inference-specific conclusion. Ordinary English may give certainty an all-or-none state, but technical attributes permit gradation. We compare certainty, quality, confidence, strength, and trustworthiness through their strengths and limitations. None resolves the tension without adding another concern.</p><p><strong>Conclusion: </strong>In the absence of a superior alternative, certainty may remain the most practical term because it is established in guidance, teaching, software, and practice. It should be defined as an ordered judgment about support for a specified inference, not as proof.</p>","PeriodicalId":51079,"journal":{"name":"Journal of Clinical Epidemiology","volume":" ","pages":"112549"},"PeriodicalIF":5.8,"publicationDate":"2026-10-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149139288","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":"SERIES: living evidence syntheses in practice: methodology, standards, dissemination, and publication challenges. Paper 2: evaluating methodological compliance and reporting standards.","authors":"Ariadna Auladell-Rispau, Andrés Gempeler, Elisa Gutiérrez-Gómez, Josefina Bendersky, Francisca Verdugo-Paiva, Laura Trujillo, Camila Ávila, Gabriel Rada, Gerard Urrútia, María Ximena Rojas-Reyes","doi":"10.1016/j.jclinepi.2026.112546","DOIUrl":"10.1016/j.jclinepi.2026.112546","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background and objectives: &lt;/strong&gt;This is the second paper in a 3-part series assessing how living evidence synthesis (LES) products (systematic reviews, rapid reviews, network meta-analyses, overviews of reviews, and scoping reviews) are defined, implemented, reported, and updated over time. Here, we evaluate compliance to methodological and reporting standards and the consistency of application of key living review principles across updates.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;We conducted a methodological literature-based survey of any type of evidence syntheses that explicitly stated the use of a living evidence approach. All eligible LES were prospectively monitored by 2 years to capture all updates to achieve our assessment objectives. Adherence to conduction and reporting standards was assessed using the Bendersky's checklist, which compiles previously described living review requirements. In a post hoc analysis, we used a subsample of LES to assess compliance with the reporting elements included in the PRISMA 2024 extension for Living Systematic Reviews (PRISMA-LSR) extension.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Compliance with the Bendersky checklist was assessed in 119 baseline reports and up to 3 subsequent updates or surveillance reports per LES (93 reports). Baseline report compliance with general systematic review items was acceptable (&gt;70%), but living-specific reporting was limited: 52% reported a monitoring plan but &lt;30% reported most key elements, and only 5% specified discontinuation criteria. Among 73 updates, &lt;50% reported previous updates and 35.6% reported changes in monitoring; all reported changes in screening or selection frequency. Among 20 surveillance reports, 20.0% reported previous updates and none reported changes in monitoring. In 20 LES assessed using new PRISMA-LSR extension, compliance was 57.5% at baseline, declining to 40.7% and 42.3% in intermediate and final updates, respectively.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusion: &lt;/strong&gt;Despite growing adoption of the living evidence approach, substantial gaps remain in implementing and reporting living-specific standards. Update triggers, surveillance strategies, discontinuation criteria, and version control were frequently underreported, with PRISMA-LSR compliance declining over successive updates.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Plain language summary: &lt;/strong&gt;A systematic review is a structured method of research that identifies, evaluates, and summarizes all relevant studies addressing a specific question. Its goal is to synthesize evidence transparently and rigorously to produce a clear overall conclusion. Living systematic reviews (LSRs) are a type of systematic review designed to be continuously updated as new evidence emerges. This approach is used to generate a broader set of products, known as living evidence synthesis (LES), intended to support timely clinical and policy decisions based on the most up-to-date evidence. However, the \"living\" label does not always ensure that a re","PeriodicalId":51079,"journal":{"name":"Journal of Clinical Epidemiology","volume":" ","pages":"112546"},"PeriodicalIF":5.8,"publicationDate":"2026-10-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149118275","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":"Addressing Limited Evidence in Guideline Development.","authors":"Andrea J Darzi, Emily Sirotich, Saifur R Chowdhury, Donald M Arnold, Gordon Guyatt","doi":"10.1016/j.jclinepi.2026.112548","DOIUrl":"https://doi.org/10.1016/j.jclinepi.2026.112548","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Evidence-based guidelines are essential to optimize healthcare decision-making, yet in contexts such as rare diseases, emerging conditions, or specific subpopulations, direct evidence to estimate the magnitude of intervention effects may be minimal or absent. In these situations, guideline panels must formulate recommendations despite very low certainty evidence on benefits and harms. To address this dilemma, we explore three strategies that guideline panels may implement.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;The first involves systematic recollection of expert clinical experiences, a structured, timely, and resource-efficient method to capture expert clinical experience. However, it is prone to the limitations of member recall and biases arising from clinicians' enthusiasm for particular interventions. The second involves leveraging patient registries, which may generate evidence comparable to well-conducted observational studies but are limited by data availability, quality (e.g., missing information), and representativeness. In particular, failure to capture key prognostic variables for adjusted analyses may result in very high risk of bias. The third approach involves conducting a multisite retrospective cohort study, which can generate direct evidence with merits of accurate and comprehensive data collection. It does, however, require extensive coordination, time, resources and may have missing data.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Discussion: &lt;/strong&gt;These approaches can help address evidence gaps by providing estimates of intervention effects closely aligned with the clinical question. Each method has, however, important methodological and practical limitations and is likely to generate only very low certainty evidence. Nevertheless, when transparently applied within established frameworks such as GRADE, these strategies can support the development of more informed and actionable recommendations in settings with limited evidence.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Plain language summary: &lt;/strong&gt;Why did we do this study? Healthcare guidelines are based on research showing the benefits and harms of different treatments. However, for rare diseases, emerging conditions, or specific groups of patients, there may be little or no relevant published research about how well treatments work or what harms they cause. Clinicians still need guidance, and guideline panels still need to make recommendations in these situations. We therefore explored three strategies that panels can use to help address these evidence gaps. What did we find? We explored three approaches. First, panels can systematically collect and summarize experts' clinical experiences. Second, they can use information from patient registries. Third, researchers can collect data from patient charts from several healthcare centres. Each approach can provide information that is closely related to the clinical question and may help estimate the benefits and harms of an intervention. What are the com","PeriodicalId":51079,"journal":{"name":"Journal of Clinical Epidemiology","volume":" ","pages":"112548"},"PeriodicalIF":5.8,"publicationDate":"2026-10-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149118272","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":"Chatbot Health Advice Studies: what are they, how are they evolving in health care, and how do we respond?","authors":"Bright Huo, Gary S Collins, Giovanni E Cacciamani, Aaron Yu, Gordon Guyatt","doi":"10.1016/j.jclinepi.2026.112424","DOIUrl":"10.1016/j.jclinepi.2026.112424","url":null,"abstract":"","PeriodicalId":51079,"journal":{"name":"Journal of Clinical Epidemiology","volume":" ","pages":"112424"},"PeriodicalIF":5.8,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148498358","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":"Response to: Mansmann U. Missing patient-reported outcome data replacements require clearer models and mechanisms.","authors":"Hamza Khan","doi":"10.1016/j.jclinepi.2026.112425","DOIUrl":"10.1016/j.jclinepi.2026.112425","url":null,"abstract":"","PeriodicalId":51079,"journal":{"name":"Journal of Clinical Epidemiology","volume":" ","pages":"112425"},"PeriodicalIF":5.8,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148563645","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":"Evaluating the accuracy of full text and serial screening by one vs two independent reviewers: part 2 of a meta-research study of rapid review methodological trade-offs.","authors":"Melissa Corso, Lauren Ead, Ginny Brunton, Stefano Negrini, Andrea C Tricco, Pierre Côté","doi":"10.1016/j.jclinepi.2026.112542","DOIUrl":"10.1016/j.jclinepi.2026.112542","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Objectives: &lt;/strong&gt;We aimed to determine the accuracy of one vs two reviewers for full-text screening and serial screening (title/abstract and full text). We also determined the inter-rater reliability, post-test probability (PTP), false positive and negative rates, and sources of misclassification.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Study design and setting: &lt;/strong&gt;One reviewer screened full-text articles from three systematic reviews evaluating interventions (acupuncture, education, and transcutaneous electrical nerve stimulation [TENS]) for chronic low back pain. We combined these results with titles and abstracts screened by the same reviewer to assess serial screening accuracy (screening title and abstracts, then full-text studies). Outcomes were compared to consensus decisions from two independent reviewers. We computed sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) with 95% confidence intervals (CIs). Inter-rater reliability (Cohen's kappa) and positive PTP for serial screening were calculated. Rates and reasons for misclassification were examined. A sensitivity analysis of English studies explored the impact of AI-assisted translation of non-English studies.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;A total of 120, 92, and 91 studies were screened for the acupuncture, education, and TENS reviews, respectively. Compared with two reviewers, the sensitivity of single reviewer full-text screening ranged from 62% to 88%, specificity from 84% to 96%, PPV from 70% to 77%, and NPV from 89% to 97%. Kappa ranged from 0.61 to 0.73. Single-reviewer sensitivity for serial screening ranged from 62% to 81%, specificity from 98% to 100%, PPV from 68% to 71%, and NPV was 99%. Kappa ranged from 0.67 to 0.73. Positive PTP ranged from 42.7% to 63.5%. Misclassifications were mostly due to interpretation of the population, interventions, or comparators. There were no or small differences in the estimates with overlap of CIs between English and all language analyses.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusion: &lt;/strong&gt;The accuracy of one vs two reviewers may be reduced in serial screening, resulting in missed and falsely included studies, ranging across reviews. Therefore, there is uncertainty around whether a single reviewer can correctly select relevant studies. However, the impact on rapid review results is unknown. Although overall agreement is substantial, reporting sensitivity and specificity can provide insight into classifications between reviewers. Carefully defining the population, intervention, and comparators in screening is required and highlights the need for improved reporting in trials.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Plain language summary: &lt;/strong&gt;Systematic reviews use two steps to choose which studies should be included in the synthesis. Each step is typically done by two people, but using one reviewer can save time and money. This study investigated how one reviewer compares to two reviewers when deciding which studies to include in a review. ","PeriodicalId":51079,"journal":{"name":"Journal of Clinical Epidemiology","volume":" ","pages":"112542"},"PeriodicalIF":5.8,"publicationDate":"2026-09-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149076626","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 Impact of Prospective versus Retrospective Study Design on Diagnostic Test Accuracy in Medical Imaging: A Meta-epidemiological Study.","authors":"Punit Sevak, Giang Trung Pham, Elio Arruzza, Arian Bhatia, Minh-Son To, Samuel White","doi":"10.1016/j.jclinepi.2026.112538","DOIUrl":"https://doi.org/10.1016/j.jclinepi.2026.112538","url":null,"abstract":"<p><strong>Background and objectives: </strong>Diagnostic test accuracy (DTA) estimates may be influenced by whether data are collected prospectively or retrospectively, but previous meta-epidemiological evaluations across diverse diagnostic tests have reported inconsistent findings. Radiology provides a distinctive context because imaging tests are often based on protocolised acquisition and stored image datasets. We evaluated whether prospective versus retrospective study design was associated with reported sensitivity and specificity in radiology DTA studies. Secondary analyses examined study-level factors as contextual contributors to heterogeneity.</p><p><strong>Methods: </strong>We included systematic reviews with meta-analyses published in radiology-related journals during the five years preceding the search date and containing at least 10 primary medical imaging DTA studies. Primary studies were classified as prospective or retrospective according to design labels reported in the included reviews. Complete 2 × 2 contingency-table data were extracted. A Bayesian three-level bivariate generalised linear mixed model jointly modelled sensitivity and specificity using binomial likelihoods while accounting for clustering of primary studies within systematic reviews. Effects were reported as posterior mean logit differences with 95% credible intervals, comparing retrospective with prospective studies.</p><p><strong>Results: </strong>We included 50 reviews comprising 790 primary studies, of which 332 (42.0%) were prospective and 458 (58.0%) were retrospective. Design-effect estimates were small for sensitivity (posterior mean logit difference 0.13; 95% CrI -0.07 to 0.32) and specificity (-0.05; 95% CrI -0.27 to 0.17), with both credible intervals including zero. Substantial heterogeneity was observed at the review and primary-study levels. In contextual secondary analyses, higher prevalence was associated with higher sensitivity and lower specificity, while larger sample size was associated with higher specificity. All remaining coefficients had credible intervals including zero.</p><p><strong>Conclusions: </strong>In this sample of radiology DTA studies, we found no clear evidence that prospective versus retrospective study design was associated with reported sensitivity or specificity after accounting for clustering within systematic reviews. These findings support assessing specific sources of bias, study conduct and imaging context rather than relying on prospective and retrospective classification alone. Whether design-related effects vary according to diagnostic-test characteristics, including standardisation and operator dependence, requires direct evaluation across other diagnostic fields.</p>","PeriodicalId":51079,"journal":{"name":"Journal of Clinical Epidemiology","volume":" ","pages":"112538"},"PeriodicalIF":5.8,"publicationDate":"2026-09-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149076567","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":"AI Clinical Trials Registered on ClinicalTrials.gov Showed Persistent Misalignment with Global Disease Burden, 2010-2026.","authors":"Kohl Kirby, Caden Forbes, Tanner Livsey, Nick Camasso, Ryan Langerman, Noah Calvert, Matt Vassar","doi":"10.1016/j.jclinepi.2026.112543","DOIUrl":"https://doi.org/10.1016/j.jclinepi.2026.112543","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;To determine whether artificial intelligence (AI) clinical trial activity aligns with global disease burden, and whether the 2023 launch of a global AI health equity initiative was associated with a reorientation of research priorities.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Study design and setting: &lt;/strong&gt;We conducted a cross-sectional metaresearch study mapping 2,771 AI clinical trials registered on ClinicalTrials.gov between 2010 and 2026 to Global Burden of Disease (GBD) Level 3 disease causes, quantifying mismatch between trial allocation and burden across three metrics: disability-adjusted life years (DALYs), deaths, and prevalence.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Log-log regression of trial count on global DALYs returned a slope of 0.31, indicating that a 10-fold increase in disease burden was associated with only a 2.0-fold increase in AI trial activity against an expected slope of 1.0 under proportional allocation. Slopes for deaths (0.56) and prevalence (0.14) showed similar subproportional patterns. Fifty-six of 160 GBD Level 3 causes (35.0%) had no AI trials identified by our title-based search criteria across the entire study period, collectively representing 14.4% of global DALYs; diarrheal diseases alone carried 56.5 million DALYs with zero trials. Among causes with at least one trial, inflammatory bowel disease (mismatch ratio 12.94), non-melanoma skin cancer (12.41), and alopecia areata (19.06, n = 2 trials) were among the most over-represented relative to their burden. Neonatal disorders (0.05), malaria (0.02), and tuberculosis (0.10) were the most under-represented. Mismatch patterns were broadly consistent across burden metrics (DALY vs. deaths Spearman r = 0.77; DALY vs. prevalence r = 0.60). To assess whether the July 2023 launch of the Global Initiative on AI for Health (GI-AI4H) by WHO, ITU, and WIPO was associated with a reorientation of research priorities, we compared mismatch ratios before and after July 5, 2023. Among 75 eligible causes, 32 (42.7%) experienced worsened mismatch and 43 (57.3%) improved; however, the largest shifts reflected reductions in extreme over-representation among already heavily researched conditions rather than gains for high-burden neglected ones.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusion: &lt;/strong&gt;AI clinical trial activity remains substantially misaligned with global disease burden. No observable reorientation toward high-burden neglected conditions was detected in registration data following the establishment of a formal international equity mandate.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Plain language summary: &lt;/strong&gt;Artificial intelligence is increasingly used in medical research, but it is unclear whether AI clinical trials focus on the diseases that cause the most harm worldwide. We looked at every AI-related clinical trial registered on the website ClinicalTrials.gov between 2010 and 2026 and compared how many trials existed for each disease against how much illness, death, and disability that disease causes globa","PeriodicalId":51079,"journal":{"name":"Journal of Clinical Epidemiology","volume":" ","pages":"112543"},"PeriodicalIF":5.8,"publicationDate":"2026-09-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149076555","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}