Pub Date : 2025-12-12DOI: 10.1016/j.jclinepi.2025.112103
Elizabeth A. Terhune , Mahederemariam Bayleyegn Dagne , Miriam Barsoum , Meera Viswanathan , Rania Ali , Vivian Welch , Ana B. Pizarro , Nila Sathe , Tiffany Duque , Damian Francis , Anita Rizvi , Dru Riddle , Robert W. Turner II , Tamara A. Baker , Patricia C. Heyn
Objectives
The current literature lacks an established and adoptable definition of “racial health equity.” This study aimed to catalog and evaluate, via thematic analyses, definitions and terminology related to racial health equity across the specific studies from the Robert Wood Johnson Foundation and Cochrane-US (United States) (RWJF-Cochrane) “Centering Racial Health Equity in Systematic Reviews” project and to propose a working definition based on study findings.
Study Design and Setting
We employed an integrative review framework to analyze current definitions of racial health equity terms identified within published studies from the RWJF-Cochrane project. Definitions of racial health equity were identified via dual reviewer screening of all identified studies and interview transcripts, which included recent systematic reviews (published since 2020), theoretical and conceptual health literature, and listening exercises with interest holders involved in systematic reviews addressing health equity. Identified definitions were analyzed via thematic coding using the Braun and Clarke framework.
Results
We reviewed 157 systematic reviews, 29 interviews, and 16 articles related to racial health equity for the presence of racial health equity definitions. This review resulted in 32 definitions of racial health equity from theoretical and conceptual health literature (n = 16) and interest holder transcripts (n = 16). No systematic reviews contained definitions of racial health equity. Retrieved definitions emphasize equality in health or health care, including outcomes, processes, or care; themes of discrimination in health-care settings; and acknowledgments of the intersections of social determinants of health with health equity. Definitions varied on the role of improving health-care access in achieving racial health equity. A working definition of racial health equity is proposed using common themes identified across definitions.
Conclusion
Our findings highlight that a clear and consistent definition of racial health equity will assist researchers, practitioners, and policymakers with developing metrics and interventions aimed at reducing racial health inequities. Thus, we propose a working definition for racial health equity, which emphasizes 1) fairness and justice in health, 2) equality in health outcomes and access across racialized groups, 3) a recognition that social consequences of one's race and/or ethnicity may influence health or the quality of health care received. We also note areas of variability in understandings that require further discussion.
{"title":"Defining racial health equity: an integrative analysis of terminology and conceptualizations","authors":"Elizabeth A. Terhune , Mahederemariam Bayleyegn Dagne , Miriam Barsoum , Meera Viswanathan , Rania Ali , Vivian Welch , Ana B. Pizarro , Nila Sathe , Tiffany Duque , Damian Francis , Anita Rizvi , Dru Riddle , Robert W. Turner II , Tamara A. Baker , Patricia C. Heyn","doi":"10.1016/j.jclinepi.2025.112103","DOIUrl":"10.1016/j.jclinepi.2025.112103","url":null,"abstract":"<div><h3>Objectives</h3><div>The current literature lacks an established and adoptable definition of “racial health equity.” This study aimed to catalog and evaluate, via thematic analyses, definitions and terminology related to racial health equity across the specific studies from the Robert Wood Johnson Foundation and Cochrane-US (United States) (RWJF-Cochrane) “Centering Racial Health Equity in Systematic Reviews” project and to propose a working definition based on study findings.</div></div><div><h3>Study Design and Setting</h3><div>We employed an integrative review framework to analyze current definitions of racial health equity terms identified within published studies from the RWJF-Cochrane project. Definitions of racial health equity were identified via dual reviewer screening of all identified studies and interview transcripts, which included recent systematic reviews (published since 2020), theoretical and conceptual health literature, and listening exercises with interest holders involved in systematic reviews addressing health equity. Identified definitions were analyzed via thematic coding using the Braun and Clarke framework.</div></div><div><h3>Results</h3><div>We reviewed 157 systematic reviews, 29 interviews, and 16 articles related to racial health equity for the presence of racial health equity definitions. This review resulted in 32 definitions of racial health equity from theoretical and conceptual health literature (<em>n</em> = 16) and interest holder transcripts (<em>n</em> = 16). No systematic reviews contained definitions of racial health equity. Retrieved definitions emphasize equality in health or health care, including outcomes, processes, or care; themes of discrimination in health-care settings; and acknowledgments of the intersections of social determinants of health with health equity. Definitions varied on the role of improving health-care access in achieving racial health equity. A working definition of racial health equity is proposed using common themes identified across definitions.</div></div><div><h3>Conclusion</h3><div>Our findings highlight that a clear and consistent definition of racial health equity will assist researchers, practitioners, and policymakers with developing metrics and interventions aimed at reducing racial health inequities. Thus, we propose a working definition for racial health equity, which emphasizes 1) fairness and justice in health, 2) equality in health outcomes and access across racialized groups, 3) a recognition that social consequences of one's race and/or ethnicity may influence health or the quality of health care received. We also note areas of variability in understandings that require further discussion.</div></div>","PeriodicalId":51079,"journal":{"name":"Journal of Clinical Epidemiology","volume":"190 ","pages":"Article 112103"},"PeriodicalIF":5.2,"publicationDate":"2025-12-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145758359","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}
Pub Date : 2025-12-12DOI: 10.1016/j.jclinepi.2025.112105
Eibhlín Looney , Moira Duffy , Dimity Dutch , Victoria Brown , John Browne , Declan Devane , Janas M. Harrington , Catherine Hayes , Brittany J. Johnson , Patricia M. Kearney , Jamie J. Kirkham , Patricia Leahy-Warren , Andrew W. Murphy , Sarah Redsell , Anna Lene Seidler , Helen Skouteris , Darren Dahly , Karen Matvienko-Sikar
Background and Objective
Heterogeneity in what and how outcomes are measured in childhood obesity prevention trials limits evidence synthesis and evaluation of intervention effectiveness. Core Outcome Sets (COS) and Core Outcome Measurement Sets (COMS) can standardize measurement and reporting across trials, but only if they are used by trialists. This study examined trialists’ awareness and attitudes toward two childhood obesity–related COS and factors influencing their use; characteristics of Outcome Measurement Instruments (OMIs) used in childhood obesity prevention trials; and how trialists choose these OMIs.
Methods
An online, international, cross-sectional survey was conducted including trialists engaged in designing and/or conducting childhood obesity prevention trials in children aged 0–5 years. Trialists were recruited via peer-reviewed publications, the Transforming Obesity Prevention for CHILDren Collaboration and professional contacts. The survey examined trialist characteristics, awareness, and use of existing COS, OMI characteristics, and factors influencing trialist selection of OMIs. Quantitative data were analyzed descriptively; qualitative data were analyzed using content analysis.
Results
The majority of the 46 trialists who completed the survey were senior-career researchers (61%; n = 28), with 1 to 38 years' experience in childhood obesity prevention trials. Seventy percent (n = 32) were familiar with COS in general; 84% (n = 26) of these were familiar with one or both childhood obesity–related COS. These trialists' COS use was limited by perceived participant burden, cost, and lack of knowledge; availability of guidelines, and resources facilitated COS use. Trialists favored measuring outcomes using existing (83%; n = 38) and adapted (80%; n = 37) questionnaires, and anthropometric measures (80%; n = 37). Quantitative and qualitative data indicated that measurement properties (eg, reliability, validity), cost, perceived burden, ease of use, and feasibility were the most important factors influencing trialists’ OMI choice.
Conclusion
Trialists’ awareness and use of childhood obesity–related COS is positive, and may be enhanced through provision of guidance and resources to support COS and COMS use. Development of COMS should consider trialist-reported factors related to feasibility and measurement properties. Such considerations can enhance COS and COMS use in trials, reducing outcome heterogeneity, and improving evaluation of intervention effectiveness to prevent childhood obesity.
{"title":"Factors influencing use and choice of Core Outcome Sets and Outcome Measurement Instruments in trials of interventions to prevent childhood obesity: a mixed-methods survey","authors":"Eibhlín Looney , Moira Duffy , Dimity Dutch , Victoria Brown , John Browne , Declan Devane , Janas M. Harrington , Catherine Hayes , Brittany J. Johnson , Patricia M. Kearney , Jamie J. Kirkham , Patricia Leahy-Warren , Andrew W. Murphy , Sarah Redsell , Anna Lene Seidler , Helen Skouteris , Darren Dahly , Karen Matvienko-Sikar","doi":"10.1016/j.jclinepi.2025.112105","DOIUrl":"10.1016/j.jclinepi.2025.112105","url":null,"abstract":"<div><h3>Background and Objective</h3><div>Heterogeneity in what and how outcomes are measured in childhood obesity prevention trials limits evidence synthesis and evaluation of intervention effectiveness. Core Outcome Sets (COS) and Core Outcome Measurement Sets (COMS) can standardize measurement and reporting across trials, but only if they are used by trialists. This study examined trialists’ awareness and attitudes toward two childhood obesity–related COS and factors influencing their use; characteristics of Outcome Measurement Instruments (OMIs) used in childhood obesity prevention trials; and how trialists choose these OMIs.</div></div><div><h3>Methods</h3><div>An online, international, cross-sectional survey was conducted including trialists engaged in designing and/or conducting childhood obesity prevention trials in children aged 0–5 years. Trialists were recruited via peer-reviewed publications, the Transforming Obesity Prevention for CHILDren Collaboration and professional contacts. The survey examined trialist characteristics, awareness, and use of existing COS, OMI characteristics, and factors influencing trialist selection of OMIs. Quantitative data were analyzed descriptively; qualitative data were analyzed using content analysis.</div></div><div><h3>Results</h3><div>The majority of the 46 trialists who completed the survey were senior-career researchers (61%; <em>n</em> = 28), with 1 to 38 years' experience in childhood obesity prevention trials. Seventy percent (<em>n</em> = 32) were familiar with COS in general; 84% (<em>n</em> = 26) of these were familiar with one or both childhood obesity–related COS. These trialists' COS use was limited by perceived participant burden, cost, and lack of knowledge; availability of guidelines, and resources facilitated COS use. Trialists favored measuring outcomes using existing (83%; <em>n</em> = 38) and adapted (80%; <em>n</em> = 37) questionnaires, and anthropometric measures (80%; <em>n</em> = 37). Quantitative and qualitative data indicated that measurement properties (eg, reliability, validity), cost, perceived burden, ease of use, and feasibility were the most important factors influencing trialists’ OMI choice.</div></div><div><h3>Conclusion</h3><div>Trialists’ awareness and use of childhood obesity–related COS is positive, and may be enhanced through provision of guidance and resources to support COS and COMS use. Development of COMS should consider trialist-reported factors related to feasibility and measurement properties. Such considerations can enhance COS and COMS use in trials, reducing outcome heterogeneity, and improving evaluation of intervention effectiveness to prevent childhood obesity.</div></div>","PeriodicalId":51079,"journal":{"name":"Journal of Clinical Epidemiology","volume":"191 ","pages":"Article 112105"},"PeriodicalIF":5.2,"publicationDate":"2025-12-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145758311","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}
Pub Date : 2025-12-11DOI: 10.1016/j.jclinepi.2025.112104
Gowri Gopalakrishna
Research integrity is foundational to clinical epidemiology, particularly in an increasingly transparent scientific landscape. As the field of research integrity navigates the evolving demands of open science, data transparency, and collaborative research, it must also grapple with the influence systemic challenges, such as research fairness and diversity, equity, and inclusion (DEI), have on research quality. This Key Concepts article provides a concise overview of research integrity for clinical epidemiologists. It summarizes key principles in research integrity and the emerging overlap with open science, research fairness, and DEI in upholding the integrity of epidemiological research. Practical guidance is provided at every stage of the research lifecycle—from preparing a research proposal to study protocol development and data collection to publication and dissemination of research findings. It addresses how these overlapping concepts demonstrate that research integrity is not merely about methodological rigor, but is a scientific imperative that requires a broader definition of research integrity to produce high-quality research that is responsible and inclusive.
{"title":"Research integrity in clinical epidemiology: core concepts and contemporary challenges","authors":"Gowri Gopalakrishna","doi":"10.1016/j.jclinepi.2025.112104","DOIUrl":"10.1016/j.jclinepi.2025.112104","url":null,"abstract":"<div><div>Research integrity is foundational to clinical epidemiology, particularly in an increasingly transparent scientific landscape. As the field of research integrity navigates the evolving demands of open science, data transparency, and collaborative research, it must also grapple with the influence systemic challenges, such as research fairness and diversity, equity, and inclusion (DEI), have on research quality. This <em>Key Concepts</em> article provides a concise overview of research integrity for clinical epidemiologists. It summarizes key principles in research integrity and the emerging overlap with open science, research fairness, and DEI in upholding the integrity of epidemiological research. Practical guidance is provided at every stage of the research lifecycle—from preparing a research proposal to study protocol development and data collection to publication and dissemination of research findings. It addresses how these overlapping concepts demonstrate that research integrity is not merely about methodological rigor, but is a scientific imperative that requires a broader definition of research integrity to produce high-quality research that is responsible and inclusive.</div></div>","PeriodicalId":51079,"journal":{"name":"Journal of Clinical Epidemiology","volume":"191 ","pages":"Article 112104"},"PeriodicalIF":5.2,"publicationDate":"2025-12-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145752446","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}
Pub Date : 2025-12-08DOI: 10.1016/j.jclinepi.2025.112098
Shannon M. Ruzycki , Kirstie C. Lithgow , Claire Song , Sarah Taylor , Abinaya Subramanian , Miriam Li , Stephanie Happ , Mark Shea , Debby Oladimeji , Wayne Clark , Dean A. Fergusson , Sarina R. Isenberg , Patricia Li , Sangeeta Mehta , Stuart G. Nicholls , Courtney L. Pollock , Louise Pilote , Amity E. Quinn , Syamala Buragadda , David Collister
<div><h3>Objectives</h3><div>To describe the demographic and social identities of participants in contemporary Canadian randomized clinical trials (RCTs).</div></div><div><h3>Study Design and Setting</h3><div>A meta-epidemiologic study included published reports of phase 2 and 3 RCTs that exclusively recruited adults living in Canada and were registered on ClinicalTrials.gov between January 1, 2010, and December 31, 2019. Study design and participant demographics were abstracted from eligible articles in duplicate using frameworks for understanding participant diversity such as PROGRESS-PLUS.</div></div><div><h3>Results</h3><div>We identified 118 RCTs with 17,387 participants. Most reported participant sex (<em>n</em> = 105, 89.0%), few reported gender (<em>n</em> = 12, 10.2%), and none reported both. Among articles reporting sex, there were 11,066 female (63.6%), 5402 male (32.8%), and one intersex (<0.1%) participants. There were 477 women (54.1%) and 404 men (45.9%) participants. No studies reported gender diverse participants. When excluding studies that only recruited one sex and/or gender, 51.8% of participants were male (<em>n</em> = 4774/9219) and 47.5% were men (<em>n</em> = 446/850). Race and/or ethnicity was reported for 4124 participants (23.7%) in 31 of 118 (26.3%) of RCTs; of these, 72.0% were White (<em>n</em> = 2969), 2.7% were Black (<em>n</em> = 113), and 0.2% were Indigenous (<em>n</em> = 7). Eligibility criteria related to specific PROGRESS-PLUS factors were rare except for cognition (<em>n</em> = 42, 35.6%), substance use (<em>n</em> = 25, 21.7%), pregnancy (<em>n</em> = 29, 24.5%), breastfeeding (<em>n</em> = 16, 13.6%), and older age (<em>n</em> = 26, 22.0%).</div></div><div><h3>Conclusion</h3><div>The data are encouraging regarding representation of female and women participants in Canadian trials. Due to underreporting of other identities, we cannot identify additional groups who may be underrepresented. Work to improve reporting of race and/or ethnicity, among other identities, is needed.</div></div><div><h3>Plain Language Summary</h3><div>Clinical trials tell us what drugs and procedures are helpful for patients. In certain specialties, like cancer and heart disease, clinical trials are made up mostly of men, White people, and younger people. This means that the results of these trials may be different for other groups of people, especially older people, women, and racialized people, who are more likely to have these diseases. We looked at the demographic identities of all participants in 118 Canadian clinical trials that were done between 2010 and 2019. Of the 17,387 participants, there were 11,066 female, 5402 male, 477 women, 404 men, and one intersex participant. We could find the race and/or ethnicity for only 4124 participants in 31 of the trials. Most participants (72.0%) were White, and only 2.7% were Black and 0.2% were Indigenous. These results tell us that reporting of identities in Canadian clinical trial
{"title":"Participant diversity and inclusive trial design: a meta-epidemiologic study of Canadian randomized clinical trials","authors":"Shannon M. Ruzycki , Kirstie C. Lithgow , Claire Song , Sarah Taylor , Abinaya Subramanian , Miriam Li , Stephanie Happ , Mark Shea , Debby Oladimeji , Wayne Clark , Dean A. Fergusson , Sarina R. Isenberg , Patricia Li , Sangeeta Mehta , Stuart G. Nicholls , Courtney L. Pollock , Louise Pilote , Amity E. Quinn , Syamala Buragadda , David Collister","doi":"10.1016/j.jclinepi.2025.112098","DOIUrl":"10.1016/j.jclinepi.2025.112098","url":null,"abstract":"<div><h3>Objectives</h3><div>To describe the demographic and social identities of participants in contemporary Canadian randomized clinical trials (RCTs).</div></div><div><h3>Study Design and Setting</h3><div>A meta-epidemiologic study included published reports of phase 2 and 3 RCTs that exclusively recruited adults living in Canada and were registered on ClinicalTrials.gov between January 1, 2010, and December 31, 2019. Study design and participant demographics were abstracted from eligible articles in duplicate using frameworks for understanding participant diversity such as PROGRESS-PLUS.</div></div><div><h3>Results</h3><div>We identified 118 RCTs with 17,387 participants. Most reported participant sex (<em>n</em> = 105, 89.0%), few reported gender (<em>n</em> = 12, 10.2%), and none reported both. Among articles reporting sex, there were 11,066 female (63.6%), 5402 male (32.8%), and one intersex (<0.1%) participants. There were 477 women (54.1%) and 404 men (45.9%) participants. No studies reported gender diverse participants. When excluding studies that only recruited one sex and/or gender, 51.8% of participants were male (<em>n</em> = 4774/9219) and 47.5% were men (<em>n</em> = 446/850). Race and/or ethnicity was reported for 4124 participants (23.7%) in 31 of 118 (26.3%) of RCTs; of these, 72.0% were White (<em>n</em> = 2969), 2.7% were Black (<em>n</em> = 113), and 0.2% were Indigenous (<em>n</em> = 7). Eligibility criteria related to specific PROGRESS-PLUS factors were rare except for cognition (<em>n</em> = 42, 35.6%), substance use (<em>n</em> = 25, 21.7%), pregnancy (<em>n</em> = 29, 24.5%), breastfeeding (<em>n</em> = 16, 13.6%), and older age (<em>n</em> = 26, 22.0%).</div></div><div><h3>Conclusion</h3><div>The data are encouraging regarding representation of female and women participants in Canadian trials. Due to underreporting of other identities, we cannot identify additional groups who may be underrepresented. Work to improve reporting of race and/or ethnicity, among other identities, is needed.</div></div><div><h3>Plain Language Summary</h3><div>Clinical trials tell us what drugs and procedures are helpful for patients. In certain specialties, like cancer and heart disease, clinical trials are made up mostly of men, White people, and younger people. This means that the results of these trials may be different for other groups of people, especially older people, women, and racialized people, who are more likely to have these diseases. We looked at the demographic identities of all participants in 118 Canadian clinical trials that were done between 2010 and 2019. Of the 17,387 participants, there were 11,066 female, 5402 male, 477 women, 404 men, and one intersex participant. We could find the race and/or ethnicity for only 4124 participants in 31 of the trials. Most participants (72.0%) were White, and only 2.7% were Black and 0.2% were Indigenous. These results tell us that reporting of identities in Canadian clinical trial","PeriodicalId":51079,"journal":{"name":"Journal of Clinical Epidemiology","volume":"191 ","pages":"Article 112098"},"PeriodicalIF":5.2,"publicationDate":"2025-12-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145727093","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}
Pub Date : 2025-12-08DOI: 10.1016/j.jclinepi.2025.112100
Gina Bantle, Julia Stadelmaier, Maria Petropoulou, Joerg J Meerpohl, Lukas Schwingshackl
{"title":"Response to letter to the editor \"Most methodological characteristics do not exaggerate effect estimates in nutrition randomized trials: findings from a metaepidemiological study\".","authors":"Gina Bantle, Julia Stadelmaier, Maria Petropoulou, Joerg J Meerpohl, Lukas Schwingshackl","doi":"10.1016/j.jclinepi.2025.112100","DOIUrl":"10.1016/j.jclinepi.2025.112100","url":null,"abstract":"","PeriodicalId":51079,"journal":{"name":"Journal of Clinical Epidemiology","volume":" ","pages":"112100"},"PeriodicalIF":5.2,"publicationDate":"2025-12-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145727089","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}
Pub Date : 2025-12-04DOI: 10.1016/j.jclinepi.2025.112097
R. Guelimi , C. Choudhary , C. Ollivier , Q. Beytout , Q. Samaran , A. Mubuangankusu , A. Chaimani , E. Sbidian , S. Afach , L. Le Cleach
Objectives
This study was conducted within a large Cochrane living systematic review (SR) on psoriasis treatments with the aim to evaluate the inter-rater agreement of the Cochrane risk of bias tool 2 (RoB-2) tool, to compare its RoB judgments with the original RoB-1, and to explore the impact of changes in RoB judgment between the two tools on the Cochrane network meta-analysis’ (NMA) results.
Study Design and Setting
This study was conducted within the 2025 update of a living Cochrane review on systemic treatments for psoriasis. Four pairs of assessors used RoB-2 to evaluate the RoB of 193 randomized controlled trials for two primary outcomes: Psoriasis Area Severity Index (PASI) 90 (reflecting clear or almost clear skin) and serious adverse events (SAEs). Inter-rater reliability (IRR) was calculated using Cohen's kappa. RoB-2 judgments for 147 trials (PASI 90) and 154 trials (SAEs) were compared to the previous RoB-1 assessments from the Cochrane 2023 update. The impact of using RoB-2 vs. RoB-1 judgments on the NMA's results was explored through sensitivity analyses, with calculation of ratio of risk ratios (RRRs) between the analyses for each treatment effect.
Results
For the RoB-2 overall judgment, the IRR was fair for PASI 90 (kappa = 0.37) and moderate for SAEs (kappa = 0.46). IRR varied between domains (from kappa = 0.33, to kappa = 0.65), with lower IRR found for domains 2, 3, and 5. Significant discrepancies were found between RoB-1 and RoB-2 judgments. Compared to RoB-1, RoB-2 rated a smaller proportion of results as low risk for both PASI 90 (36% vs 58%) and SAEs (13% vs 58%) and a higher proportion as high risk for SAEs (55% vs 29%). For PASI 90, 66/147 (45%) studies showed switches between different judgments, including 18 extreme switches either from low to high or from high to low RoB. For SAEs, 93/154 (60%) studies underwent switches between different judgments, with 32 extreme switches occurring exclusively from low to high RoB. Sensitivity analyses excluding high-risk trials showed moderate impact on the NMA efficacy results (median RRR = 0.92, interquartile range (IQR), 0.91–0.92), but wider changes for SAEs (median RRR = 1.07, IQR, 0.97–1.15).
Conclusion
The transition to RoB-2 in a large Cochrane SR revealed fair-to-moderate inter-rater agreement, underscoring the need for consensus among reviewers. The shift from RoB-1 to RoB-2 led to changes in risk-of-bias judgments in our review. Although the impact on the NMA results was pronounced for SAEs, the changes in results were limited for our efficacy outcome PASI 90.
{"title":"Comparison between risk of bias-1 and risk of bias-2 tool and impact on network meta-analysis results—A case study from a living Cochrane review on psoriasis","authors":"R. Guelimi , C. Choudhary , C. Ollivier , Q. Beytout , Q. Samaran , A. Mubuangankusu , A. Chaimani , E. Sbidian , S. Afach , L. Le Cleach","doi":"10.1016/j.jclinepi.2025.112097","DOIUrl":"10.1016/j.jclinepi.2025.112097","url":null,"abstract":"<div><h3>Objectives</h3><div>This study was conducted within a large Cochrane living systematic review (SR) on psoriasis treatments with the aim to evaluate the inter-rater agreement of the Cochrane risk of bias tool 2 (RoB-2) tool, to compare its RoB judgments with the original RoB-1, and to explore the impact of changes in RoB judgment between the two tools on the Cochrane network meta-analysis’ (NMA) results.</div></div><div><h3>Study Design and Setting</h3><div>This study was conducted within the 2025 update of a living Cochrane review on systemic treatments for psoriasis. Four pairs of assessors used RoB-2 to evaluate the RoB of 193 randomized controlled trials for two primary outcomes: Psoriasis Area Severity Index (PASI) 90 (reflecting clear or almost clear skin) and serious adverse events (SAEs). Inter-rater reliability (IRR) was calculated using Cohen's kappa. RoB-2 judgments for 147 trials (PASI 90) and 154 trials (SAEs) were compared to the previous RoB-1 assessments from the Cochrane 2023 update. The impact of using RoB-2 vs. RoB-1 judgments on the NMA's results was explored through sensitivity analyses, with calculation of ratio of risk ratios (RRRs) between the analyses for each treatment effect.</div></div><div><h3>Results</h3><div>For the RoB-2 overall judgment, the IRR was fair for PASI 90 (kappa = 0.37) and moderate for SAEs (kappa = 0.46). IRR varied between domains (from kappa = 0.33, to kappa = 0.65), with lower IRR found for domains 2, 3, and 5. Significant discrepancies were found between RoB-1 and RoB-2 judgments. Compared to RoB-1, RoB-2 rated a smaller proportion of results as low risk for both PASI 90 (36% vs 58%) and SAEs (13% vs 58%) and a higher proportion as high risk for SAEs (55% vs 29%). For PASI 90, 66/147 (45%) studies showed switches between different judgments, including 18 extreme switches either from low to high or from high to low RoB. For SAEs, 93/154 (60%) studies underwent switches between different judgments, with 32 extreme switches occurring exclusively from low to high RoB. Sensitivity analyses excluding high-risk trials showed moderate impact on the NMA efficacy results (median RRR = 0.92, interquartile range (IQR), 0.91–0.92), but wider changes for SAEs (median RRR = 1.07, IQR, 0.97–1.15).</div></div><div><h3>Conclusion</h3><div>The transition to RoB-2 in a large Cochrane SR revealed fair-to-moderate inter-rater agreement, underscoring the need for consensus among reviewers. The shift from RoB-1 to RoB-2 led to changes in risk-of-bias judgments in our review. Although the impact on the NMA results was pronounced for SAEs, the changes in results were limited for our efficacy outcome PASI 90.</div></div>","PeriodicalId":51079,"journal":{"name":"Journal of Clinical Epidemiology","volume":"190 ","pages":"Article 112097"},"PeriodicalIF":5.2,"publicationDate":"2025-12-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145696458","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}
Pub Date : 2025-12-03DOI: 10.1016/j.jclinepi.2025.112092
Matthew J. Valente , Biwei Cao , Daniëlle D.B. Holthuijsen , Martijn J.L. Bours , Simone J.P.M. Eussen , Matty P. Weijenberg , Judith J.M. Rijnhart
Objectives
Ratio variables (eg, body mass index (BMI), cholesterol ratios, and metabolite ratios) are widely used as exposure variables in epidemiologic studies on cause-and-effect. While statisticians have emphasized the importance of including main effects of the variables that make up a ratio variable in regression models, main effects are still often omitted in practice. The objective of this study is to demonstrate the impact of omitting main effects from regression models with a ratio variable as the focal exposure on bias in the effect estimates and type I error rates.
Study Design and Setting
We demonstrated the impact of omitting main effects in three steps. First, we showed the connection between regression models with ratio variables and regression models with product terms, which are well-understood by epidemiologists. Second, we estimated models with and without main effects of a ratio variable using a real-life data example. Third, we performed a simulation study to demonstrate the impact of omitting main effects on bias and type I error rates.
Results
We showed the impact of omitting main effects in regression models with ratio terms. In the real-life example, the ratio term was only statistically significantly associated with the outcome when omitting main effects. The simulation study results indicated that the omission of main effects often leads to biased effect estimates and inflated type I error rates.
Conclusion
Regression models with a ratio term as an exposure variable need to include main effects to avoid bias in the effect estimates and inflated type I error rates.
{"title":"Omission of main effects from regression models with a ratio variable as the focal exposure can result in bias and inflated type I error rates","authors":"Matthew J. Valente , Biwei Cao , Daniëlle D.B. Holthuijsen , Martijn J.L. Bours , Simone J.P.M. Eussen , Matty P. Weijenberg , Judith J.M. Rijnhart","doi":"10.1016/j.jclinepi.2025.112092","DOIUrl":"10.1016/j.jclinepi.2025.112092","url":null,"abstract":"<div><h3>Objectives</h3><div>Ratio variables (eg, body mass index (BMI), cholesterol ratios, and metabolite ratios) are widely used as exposure variables in epidemiologic studies on cause-and-effect. While statisticians have emphasized the importance of including main effects of the variables that make up a ratio variable in regression models, main effects are still often omitted in practice. The objective of this study is to demonstrate the impact of omitting main effects from regression models with a ratio variable as the focal exposure on bias in the effect estimates and type I error rates.</div></div><div><h3>Study Design and Setting</h3><div>We demonstrated the impact of omitting main effects in three steps. First, we showed the connection between regression models with ratio variables and regression models with product terms, which are well-understood by epidemiologists. Second, we estimated models with and without main effects of a ratio variable using a real-life data example. Third, we performed a simulation study to demonstrate the impact of omitting main effects on bias and type I error rates.</div></div><div><h3>Results</h3><div>We showed the impact of omitting main effects in regression models with ratio terms. In the real-life example, the ratio term was only statistically significantly associated with the outcome when omitting main effects. The simulation study results indicated that the omission of main effects often leads to biased effect estimates and inflated type I error rates.</div></div><div><h3>Conclusion</h3><div>Regression models with a ratio term as an exposure variable need to include main effects to avoid bias in the effect estimates and inflated type I error rates.</div></div>","PeriodicalId":51079,"journal":{"name":"Journal of Clinical Epidemiology","volume":"190 ","pages":"Article 112092"},"PeriodicalIF":5.2,"publicationDate":"2025-12-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145688599","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}
Pub Date : 2025-12-03DOI: 10.1016/j.jclinepi.2025.112093
Adrian Martinez-De la Torre , Polina Leshetkina , Ogie Ahanor , Roxanne Maritz
Background
To examine how functioning-related outcomes in Phase III pharmacological clinical trials for rheumatoid arthritis (RA) align with the International Classification of Functioning, Disability and Health (ICF) Brief Core Set, and to identify which domains of functioning are most frequently represented.
Study Design and Setting
RA is a chronic autoimmune disease and a major cause of disability worldwide. While Phase III randomized controlled trials (RCTs) remain the gold standard for evaluating pharmacological treatments, they often rely on clinical and laboratory endpoints and overlook how therapies affect patients’ functioning. The International Classification of Functioning, Disability and Health (ICF) provides a standardized, patient-centered framework to assess functioning across key domains. A scoping review was conducted in accordance with the JBI methodology for scoping reviews and reported following PRISMA-ScR guidelines. Literature was searched in MEDLINE, EMBASE, and ClinicalTrials.gov from 2010 to 2025. Phase III RCTs evaluating pharmacological interventions in adult patients with RA were included. Functioning-related outcomes were extracted and mapped to ICF categories using standardized linking rules.
Results
Of 852 records screened, 91 met the inclusion criteria. Functioning was frequently assessed through patient-reported outcomes and composite clinical measures. The most commonly linked ICF categories were related to pain and joint mobility within the body functions domain, walking and carrying out daily activities within the activities and participation domain, and joint structures of the shoulder, upper, and lower limbs within body structures. Despite the broad representation, none of the studies explicitly used the ICF framework.
Conclusion
Functioning is often assessed in RA phase III RCTs, but only implicitly and without reference to the ICF framework. Explicitly integrating the ICF could bring greater standardization, comparability, and patient-centeredness in outcome measurement in pharmacological trials, not only in RA but across chronic conditions.
{"title":"Integrating and standardizing functioning outcomes in rheumatoid arthritis pharmacological trials: a scoping review informed by the International Classification of Functioning, Disability and Health (ICF)","authors":"Adrian Martinez-De la Torre , Polina Leshetkina , Ogie Ahanor , Roxanne Maritz","doi":"10.1016/j.jclinepi.2025.112093","DOIUrl":"10.1016/j.jclinepi.2025.112093","url":null,"abstract":"<div><h3>Background</h3><div>To examine how functioning-related outcomes in Phase III pharmacological clinical trials for rheumatoid arthritis (RA) align with the International Classification of Functioning, Disability and Health (ICF) Brief Core Set, and to identify which domains of functioning are most frequently represented.</div></div><div><h3>Study Design and Setting</h3><div>RA is a chronic autoimmune disease and a major cause of disability worldwide. While Phase III randomized controlled trials (RCTs) remain the gold standard for evaluating pharmacological treatments, they often rely on clinical and laboratory endpoints and overlook how therapies affect patients’ functioning. The International Classification of Functioning, Disability and Health (ICF) provides a standardized, patient-centered framework to assess functioning across key domains. A scoping review was conducted in accordance with the JBI methodology for scoping reviews and reported following PRISMA-ScR guidelines. Literature was searched in MEDLINE, EMBASE, and ClinicalTrials.gov from 2010 to 2025. Phase III RCTs evaluating pharmacological interventions in adult patients with RA were included. Functioning-related outcomes were extracted and mapped to ICF categories using standardized linking rules.</div></div><div><h3>Results</h3><div>Of 852 records screened, 91 met the inclusion criteria. Functioning was frequently assessed through patient-reported outcomes and composite clinical measures. The most commonly linked ICF categories were related to pain and joint mobility within the body functions domain, walking and carrying out daily activities within the activities and participation domain, and joint structures of the shoulder, upper, and lower limbs within body structures. Despite the broad representation, none of the studies explicitly used the ICF framework.</div></div><div><h3>Conclusion</h3><div>Functioning is often assessed in RA phase III RCTs, but only implicitly and without reference to the ICF framework. Explicitly integrating the ICF could bring greater standardization, comparability, and patient-centeredness in outcome measurement in pharmacological trials, not only in RA but across chronic conditions.</div></div>","PeriodicalId":51079,"journal":{"name":"Journal of Clinical Epidemiology","volume":"190 ","pages":"Article 112093"},"PeriodicalIF":5.2,"publicationDate":"2025-12-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145688644","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}
Pub Date : 2025-12-01DOI: 10.1016/j.jclinepi.2025.112072
David Tovey, Andrea C. Tricco
{"title":"Editors’ Choice December 2025","authors":"David Tovey, Andrea C. Tricco","doi":"10.1016/j.jclinepi.2025.112072","DOIUrl":"10.1016/j.jclinepi.2025.112072","url":null,"abstract":"","PeriodicalId":51079,"journal":{"name":"Journal of Clinical Epidemiology","volume":"188 ","pages":"Article 112072"},"PeriodicalIF":5.2,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145693692","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}
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