Pub Date : 2024-10-21DOI: 10.1016/j.jclinepi.2024.111575
Nila A. Sathe , Colleen Ovelman , Naykky Singh Ospina , Omar Dewidar , Elizabeth A. Terhune , Damian K. Francis , Vivian Welch , Patricia C. Heyn , Tiffany Duque , Meera Viswanathan
<div><h3>Objectives</h3><div>To inform methods for centering racial health equity in syntheses, we explored (1) how syntheses that assess health-related interventions and explicitly address racial health inequities have engaged interest holders and (2) guidance for engaging racially and ethnically diverse interest holders.</div></div><div><h3>Study Design and Setting</h3><div>We systematically identified evidence syntheses (searches limited to January 1, 2020, through January 25, 2023) and guidance documents (no search date limits) for this overview. From syntheses we extracted data on engagement rationale and processes and extracted approaches suggested from guidance documents. We summarized findings qualitatively.</div></div><div><h3>Results</h3><div>Twenty-nine of the 157 (18%) eligible syntheses reported using engagement. Syntheses typically lacked robust detail on why and how to use and structure engagement and outcomes/effects of engagement, though syntheses involving Indigenous populations typically included more detail. When reported, engagement typically occurred in early and later synthesis phases. We did not identify guidance documents that specifically intended to provide guidance for engaging racially/ethnically diverse individuals in syntheses; some related guidance described broader equity considerations or engagement in general.</div></div><div><h3>Conclusion</h3><div>This review highlights gaps in understanding of the use of engagement in racial health equity-focused syntheses and in guidance specifically addressing engaging racially and ethnically diverse populations. Syntheses and guidance materials we identified reported limited data addressing the <em>whys, hows,</em> and <em>whats</em> (ie, rationale for, approaches to, resources needed and effects of) of engagement, and we lack information for understanding whether engagement makes a difference to the conduct and findings of syntheses and when and how engagement of specific populations may contribute to centering racial health equity. A more informed understanding of these issues, facilitated by prospective and retrospective descriptions of engagement of diverse interest holders, may help advance actionable guidance and reviews.</div></div><div><h3>Plain Language Summary</h3><div>We identified evidence syntheses (a kind of research that identifies and summarizes findings of individual studies or publications to address research questions) that looked at studies of interventions to improve differences in effects on health for racial or ethnic populations to see (1) if and how they incorporated perspectives of interest holders, people with an interest in the subject being studied; (2) what guidance for how to engage or involve racially or ethnically diverse interest holders exists. We found that 29 of 157 syntheses addressing interventions to improve differences in effects on health reported involving interest holders but typically did not provide much detail about how to inv
{"title":"Centering racial health equity in systematic reviews paper 6: engaging racially and ethnically diverse interest holders in evidence syntheses","authors":"Nila A. Sathe , Colleen Ovelman , Naykky Singh Ospina , Omar Dewidar , Elizabeth A. Terhune , Damian K. Francis , Vivian Welch , Patricia C. Heyn , Tiffany Duque , Meera Viswanathan","doi":"10.1016/j.jclinepi.2024.111575","DOIUrl":"10.1016/j.jclinepi.2024.111575","url":null,"abstract":"<div><h3>Objectives</h3><div>To inform methods for centering racial health equity in syntheses, we explored (1) how syntheses that assess health-related interventions and explicitly address racial health inequities have engaged interest holders and (2) guidance for engaging racially and ethnically diverse interest holders.</div></div><div><h3>Study Design and Setting</h3><div>We systematically identified evidence syntheses (searches limited to January 1, 2020, through January 25, 2023) and guidance documents (no search date limits) for this overview. From syntheses we extracted data on engagement rationale and processes and extracted approaches suggested from guidance documents. We summarized findings qualitatively.</div></div><div><h3>Results</h3><div>Twenty-nine of the 157 (18%) eligible syntheses reported using engagement. Syntheses typically lacked robust detail on why and how to use and structure engagement and outcomes/effects of engagement, though syntheses involving Indigenous populations typically included more detail. When reported, engagement typically occurred in early and later synthesis phases. We did not identify guidance documents that specifically intended to provide guidance for engaging racially/ethnically diverse individuals in syntheses; some related guidance described broader equity considerations or engagement in general.</div></div><div><h3>Conclusion</h3><div>This review highlights gaps in understanding of the use of engagement in racial health equity-focused syntheses and in guidance specifically addressing engaging racially and ethnically diverse populations. Syntheses and guidance materials we identified reported limited data addressing the <em>whys, hows,</em> and <em>whats</em> (ie, rationale for, approaches to, resources needed and effects of) of engagement, and we lack information for understanding whether engagement makes a difference to the conduct and findings of syntheses and when and how engagement of specific populations may contribute to centering racial health equity. A more informed understanding of these issues, facilitated by prospective and retrospective descriptions of engagement of diverse interest holders, may help advance actionable guidance and reviews.</div></div><div><h3>Plain Language Summary</h3><div>We identified evidence syntheses (a kind of research that identifies and summarizes findings of individual studies or publications to address research questions) that looked at studies of interventions to improve differences in effects on health for racial or ethnic populations to see (1) if and how they incorporated perspectives of interest holders, people with an interest in the subject being studied; (2) what guidance for how to engage or involve racially or ethnically diverse interest holders exists. We found that 29 of 157 syntheses addressing interventions to improve differences in effects on health reported involving interest holders but typically did not provide much detail about how to inv","PeriodicalId":51079,"journal":{"name":"Journal of Clinical Epidemiology","volume":"176 ","pages":"Article 111575"},"PeriodicalIF":7.3,"publicationDate":"2024-10-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142512535","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-10-19DOI: 10.1016/j.jclinepi.2024.111579
Richard Hooper, David Tovey, Andrea C Tricco, Areti Angeliki Veroniki
{"title":"What advice can we offer to authors? Reflections from the statisticians' bench.","authors":"Richard Hooper, David Tovey, Andrea C Tricco, Areti Angeliki Veroniki","doi":"10.1016/j.jclinepi.2024.111579","DOIUrl":"https://doi.org/10.1016/j.jclinepi.2024.111579","url":null,"abstract":"","PeriodicalId":51079,"journal":{"name":"Journal of Clinical Epidemiology","volume":" ","pages":"111579"},"PeriodicalIF":7.3,"publicationDate":"2024-10-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142631898","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 : 2024-10-18DOI: 10.1016/j.jclinepi.2024.111572
Danielle Pollock , Catrin Evans , Romy Menghao Jia , Lyndsay Alexander , Dawid Pieper , Érica Brandão de Moraes , Micah D.J. Peters , Andrea C. Tricco , Hanan Khalil , Christina M. Godfrey , Ashrita Saran , Fiona Campbell , Zachary Munn
Background and Objective
Scoping reviews are a type of evidence synthesis that aims to identify and map the breadth of evidence available on a particular topic, field, concept, or issue, within or across a defined context or contexts. Scoping reviews can contribute to clinical practice guideline development, policy making, reduce research waste by eliminating duplication of research effort, and be a precursor to a systematic review or inform further primary research. This article aims to provide a brief introduction of how to conduct and report scoping reviews.
Study Design and Setting
We will discuss the role and value of scoping reviews within the evidence synthesis ecosystem, the differences and similarities between these reviews and other types of evidence syntheses such as systematic reviews, mapping reviews, evidence and gap maps, and overviews, and how to overcome common challenges often associated in the conduct, reporting, and dissemination of scoping reviews.
Results
Scoping reviews have a role in the evidence ecosystem; however, we need to acknowledge their challenges.
Conclusion
Scoping reviews are a popular form of evidence synthesis, and further research is needed to provide clarity of current methodological challenges.
{"title":"“How-to”: scoping review?","authors":"Danielle Pollock , Catrin Evans , Romy Menghao Jia , Lyndsay Alexander , Dawid Pieper , Érica Brandão de Moraes , Micah D.J. Peters , Andrea C. Tricco , Hanan Khalil , Christina M. Godfrey , Ashrita Saran , Fiona Campbell , Zachary Munn","doi":"10.1016/j.jclinepi.2024.111572","DOIUrl":"10.1016/j.jclinepi.2024.111572","url":null,"abstract":"<div><h3>Background and Objective</h3><div>Scoping reviews are a type of evidence synthesis that aims to identify and map the breadth of evidence available on a particular topic, field, concept, or issue, within or across a defined context or contexts. Scoping reviews can contribute to clinical practice guideline development, policy making, reduce research waste by eliminating duplication of research effort, and be a precursor to a systematic review or inform further primary research. This article aims to provide a brief introduction of how to conduct and report scoping reviews.</div></div><div><h3>Study Design and Setting</h3><div>We will discuss the role and value of scoping reviews within the evidence synthesis ecosystem, the differences and similarities between these reviews and other types of evidence syntheses such as systematic reviews, mapping reviews, evidence and gap maps, and overviews, and how to overcome common challenges often associated in the conduct, reporting, and dissemination of scoping reviews.</div></div><div><h3>Results</h3><div>Scoping reviews have a role in the evidence ecosystem; however, we need to acknowledge their challenges.</div></div><div><h3>Conclusion</h3><div>Scoping reviews are a popular form of evidence synthesis, and further research is needed to provide clarity of current methodological challenges.</div></div>","PeriodicalId":51079,"journal":{"name":"Journal of Clinical Epidemiology","volume":"176 ","pages":"Article 111572"},"PeriodicalIF":7.3,"publicationDate":"2024-10-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142480174","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-10-18DOI: 10.1016/j.jclinepi.2024.111573
Shi Wu Wen, Na Zeng, Daniel Krewski, Mark C Walker
{"title":"Letter to the Editor When results from clinical trials are different from observational studies.","authors":"Shi Wu Wen, Na Zeng, Daniel Krewski, Mark C Walker","doi":"10.1016/j.jclinepi.2024.111573","DOIUrl":"https://doi.org/10.1016/j.jclinepi.2024.111573","url":null,"abstract":"","PeriodicalId":51079,"journal":{"name":"Journal of Clinical Epidemiology","volume":" ","pages":"111573"},"PeriodicalIF":7.3,"publicationDate":"2024-10-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142480175","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 : 2024-10-17DOI: 10.1016/j.jclinepi.2024.111569
Carlos Zaror , Gonzalo Bravo-Soto , Maria Jose Oliveros , Pamela Burdiles , Wojtek Wiercioch , Itziar Etxeandia-Ikobaltzeta , Giselle Balaciano , Trinidad Sabalete , Ignacio Neumann , Holger J. Schünemann , David L. Streiner , Romina Brignardello-Petersen
Objectives
The PANELVIEW questionnaire identifies the strengths and weaknesses of the process and methods used for developing health guidelines from the guideline development group's perspective. To expand its use, PANELVIEW ideally should be available in different languages. We aimed to cross-culturally adapt PANELVIEW into Spanish and assess its acceptability, validity, and reliability.
Study Design and Setting
To translate and culturally adapt PANELVIEW to Spanish, we followed International Society for Pharmacoeconomics and Outcomes Research's Translation and Cultural Adaptation Good Practice Principles guidelines. The process consisted of 1) forward and back translation, 2) input from an expert panel, and 3) cognitive debriefing interviews. We assessed the content validity with experts in guideline development who rated instrument items for relevance to determine the item content validity index and scale content validity index (I-CVI and S-CVI). We tested the reliability with health guidelines panels from Spanish-speaking countries and measured internal consistency (Cronbach's alpha). We examined acceptability through the number of missing responses for each item.
Results
The content comparison between the back-translation and the original version showed that most items (24/34) were conceptually equivalent but with grammatical differences. Through the cognitive interviews, we identified six items with wording issues, ten with clarity issues, and two with applicability issues. I-CVI ranged from 0.77 to 1.00, with two items needing revision. S-CVI was 0.92, showing excellent content validity. The PANELVIEW Spanish version demonstrated very good reliability (Cronbach's alpha coefficient of 0.96). Panel members responded to all items, showing good acceptability.
Conclusion
The PANELVIEW Spanish version was conceptually equivalent to the original version and provided satisfactory evidence of acceptability, validity and reliability.
{"title":"Cross-cultural adaptation and validation to Spanish of the PANELVIEW instrument to evaluate the health guidelines development process","authors":"Carlos Zaror , Gonzalo Bravo-Soto , Maria Jose Oliveros , Pamela Burdiles , Wojtek Wiercioch , Itziar Etxeandia-Ikobaltzeta , Giselle Balaciano , Trinidad Sabalete , Ignacio Neumann , Holger J. Schünemann , David L. Streiner , Romina Brignardello-Petersen","doi":"10.1016/j.jclinepi.2024.111569","DOIUrl":"10.1016/j.jclinepi.2024.111569","url":null,"abstract":"<div><h3>Objectives</h3><div>The PANELVIEW questionnaire identifies the strengths and weaknesses of the process and methods used for developing health guidelines from the guideline development group's perspective. To expand its use, PANELVIEW ideally should be available in different languages. We aimed to cross-culturally adapt PANELVIEW into Spanish and assess its acceptability, validity, and reliability.</div></div><div><h3>Study Design and Setting</h3><div>To translate and culturally adapt PANELVIEW to Spanish, we followed International Society for Pharmacoeconomics and Outcomes Research's Translation and Cultural Adaptation Good Practice Principles guidelines. The process consisted of 1) forward and back translation, 2) input from an expert panel, and 3) cognitive debriefing interviews. We assessed the content validity with experts in guideline development who rated instrument items for relevance to determine the item content validity index and scale content validity index (I-CVI and S-CVI). We tested the reliability with health guidelines panels from Spanish-speaking countries and measured internal consistency (Cronbach's alpha). We examined acceptability through the number of missing responses for each item.</div></div><div><h3>Results</h3><div>The content comparison between the back-translation and the original version showed that most items (24/34) were conceptually equivalent but with grammatical differences. Through the cognitive interviews, we identified six items with wording issues, ten with clarity issues, and two with applicability issues. I-CVI ranged from 0.77 to 1.00, with two items needing revision. S-CVI was 0.92, showing excellent content validity. The PANELVIEW Spanish version demonstrated very good reliability (Cronbach's alpha coefficient of 0.96). Panel members responded to all items, showing good acceptability.</div></div><div><h3>Conclusion</h3><div>The PANELVIEW Spanish version was conceptually equivalent to the original version and provided satisfactory evidence of acceptability, validity and reliability.</div></div>","PeriodicalId":51079,"journal":{"name":"Journal of Clinical Epidemiology","volume":"176 ","pages":"Article 111569"},"PeriodicalIF":7.3,"publicationDate":"2024-10-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142480173","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 : 2024-10-16DOI: 10.1016/j.jclinepi.2024.111570
Maja Pavić , Ružica Tokalić , Ana Marušić
<div><h3>Objectives</h3><div>To assess the completeness and concordance of reporting in registries and corresponding publications of interventional trials on targeted therapeutics for endocrine and metabolic disorders.</div></div><div><h3>Study Design and Setting</h3><div>We searched clinical trial registries in September 2022 for completed interventional trials of target therapeutics for endocrine and metabolic disorders registered from 2005 onwards. We used ClinicalTrials.gov and the World Health Organization International Clinical Trial Registration Platform registration requirements to extract data and assess the completeness of initial entry and final updates to trial registration and concordance with their published journal articles.</div></div><div><h3>Results</h3><div>Among 149 clinical trials included, 121 (81%) had corresponding publications. Missing mandatory registration data items were identified in 89 (67%) trials at the initial registration entry, 17 (13%) at the final registration update, and in 85 (77%) corresponding publications. All trials showed changes between initial registration entry and final registration update, and 98% showed changes from the initial registration entry to publication. Changes between initial registration entry and final registration update were most common in the categories ‘Completion date’ (92%), ‘Key secondary outcomes’ (82%), and ‘Date of first enrolment’ (70%). Changes between initial registration entry and publication were most common in categories ‘Sample size’ (91%), ‘Key inclusion and exclusion criteria’ (81%), ‘Key secondary outcomes’ (84%), and ‘Completion date’ (83%).</div></div><div><h3>Conclusion</h3><div>Despite the legal and journal registration requirements, the completeness and consistency of reporting mandatory data items in registries and corresponding publications regarding targeted therapeutics for endocrine and metabolic disorders are inadequate. Our findings raise questions about the integrity and reliability of clinical trials focusing on targeted therapeutics.</div></div><div><h3>Plain Language Summary</h3><div>This study evaluated the completeness of reporting of mandatory information about clinical trials of targeted therapies for endocrine and metabolic diseases in trial registries and published articles. Furthermore, we examined whether the information in trial registries aligns with what is reported in scientific journals. Our analysis focused on completed interventional trials registered from 2005 onwards using trial registries. We found that 67% of the included trials were missing mandatory information at the time of initial entry into registry, while 77% of the matching publications also lacked mandatory information. The most common discrepancies between the entry into registry and published data occurred in the mandatory categories of sample sizes and key inclusion and exclusion criteria for participants. Our findings highlight major gaps in how clinical trials for tar
{"title":"Poor registration and publication practices in clinical trials of targeted therapeutics for endocrine and metabolic diseases: an observational study","authors":"Maja Pavić , Ružica Tokalić , Ana Marušić","doi":"10.1016/j.jclinepi.2024.111570","DOIUrl":"10.1016/j.jclinepi.2024.111570","url":null,"abstract":"<div><h3>Objectives</h3><div>To assess the completeness and concordance of reporting in registries and corresponding publications of interventional trials on targeted therapeutics for endocrine and metabolic disorders.</div></div><div><h3>Study Design and Setting</h3><div>We searched clinical trial registries in September 2022 for completed interventional trials of target therapeutics for endocrine and metabolic disorders registered from 2005 onwards. We used ClinicalTrials.gov and the World Health Organization International Clinical Trial Registration Platform registration requirements to extract data and assess the completeness of initial entry and final updates to trial registration and concordance with their published journal articles.</div></div><div><h3>Results</h3><div>Among 149 clinical trials included, 121 (81%) had corresponding publications. Missing mandatory registration data items were identified in 89 (67%) trials at the initial registration entry, 17 (13%) at the final registration update, and in 85 (77%) corresponding publications. All trials showed changes between initial registration entry and final registration update, and 98% showed changes from the initial registration entry to publication. Changes between initial registration entry and final registration update were most common in the categories ‘Completion date’ (92%), ‘Key secondary outcomes’ (82%), and ‘Date of first enrolment’ (70%). Changes between initial registration entry and publication were most common in categories ‘Sample size’ (91%), ‘Key inclusion and exclusion criteria’ (81%), ‘Key secondary outcomes’ (84%), and ‘Completion date’ (83%).</div></div><div><h3>Conclusion</h3><div>Despite the legal and journal registration requirements, the completeness and consistency of reporting mandatory data items in registries and corresponding publications regarding targeted therapeutics for endocrine and metabolic disorders are inadequate. Our findings raise questions about the integrity and reliability of clinical trials focusing on targeted therapeutics.</div></div><div><h3>Plain Language Summary</h3><div>This study evaluated the completeness of reporting of mandatory information about clinical trials of targeted therapies for endocrine and metabolic diseases in trial registries and published articles. Furthermore, we examined whether the information in trial registries aligns with what is reported in scientific journals. Our analysis focused on completed interventional trials registered from 2005 onwards using trial registries. We found that 67% of the included trials were missing mandatory information at the time of initial entry into registry, while 77% of the matching publications also lacked mandatory information. The most common discrepancies between the entry into registry and published data occurred in the mandatory categories of sample sizes and key inclusion and exclusion criteria for participants. Our findings highlight major gaps in how clinical trials for tar","PeriodicalId":51079,"journal":{"name":"Journal of Clinical Epidemiology","volume":"176 ","pages":"Article 111570"},"PeriodicalIF":7.3,"publicationDate":"2024-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142480178","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 : 2024-10-16DOI: 10.1016/j.jclinepi.2024.111568
Samuel Silva , Sareen Singh , Shazia Kashif , Rachel Ogilvie , Rafael Z. Pinto , Jill A. Hayden
<div><h3>Objectives</h3><div>The primary objectives were to describe characteristics of trial registration in the chronic low back pain (CLBP) field and assess the association of trial registration status (registered vs unregistered, prospectively registered vs retrospectively registered) with risk of bias, sufficient sample size, quality of reporting, and treatment effect estimates. Secondary objectives were to describe trial registration consistency with the final report and assess its association with risk of bias, sufficient sample size, and treatment effect estimates.</div></div><div><h3>Study Design and Setting</h3><div>A cross-sectional metaepidemiological study of trials included in a large Cochrane review on exercise treatments for CLBP. We extracted relevant trial and registration information and assessed trials’ risk of bias using the Cochrane Risk of Bias 1 tool. We performed descriptive analyses, logistic regressions, and subgroup meta-analyses.</div></div><div><h3>Results</h3><div>We included 361 trials, of which 23.3% were prospectively registered. Registered trials had lower risk of bias (odds ratio [OR] 0.6; 95% confidence interval [CI] 0.5, 0.7) and higher reporting quality (OR 1.6; 95% CI 1.4, 1.8) than unregistered trials. Prospectively registered trials were more likely to have low risk of reporting bias (OR 2.7; 95% CI 1.2, 6.5) and higher quality of reporting (OR 1.3; 95% CI 1.1, 1.6) than retrospectively registered trials. Trial registration status was not associated with effect estimates. Among prospectively registered trials, 64.3% clearly defined primary outcome(s) in their registration, 58.3% had consistent sample sizes, and 22.6% had no evidence of selective outcome reporting. Trials that clearly defined primary outcome(s) were more likely to report larger effect estimates for pain intensity (mean difference −15.8; 95% CI −22.7, −8.9 vs −6.0; 95% CI −10.6, −1.5; <em>Q</em> = 6.7, <em>P</em> = .01), although the difference was small, the 95% CIs overlapped, and no difference was found for functional limitations.</div></div><div><h3>Conclusion</h3><div>A small proportion of trials in the CLBP field were registered prospectively and many presented registration inconsistencies. Registered trials tend to have lower risk of bias and higher quality of reporting. Policies are needed to improve prospective registration and registration consistency in the field.</div></div><div><h3>Plain Language Summary</h3><div>Prospective trial registration is the practice of documenting the planned methods of a randomized controlled trial on a publicly available online platform (ie, website) before enrolling participants. Medical journals require trialists to prospectively register their trials to encourage the conduct of high-quality research and reduce the chance of trialists changing their research plan to report only positive or significant results (known as selective outcome reporting). We investigated whether trialists within the chro
{"title":"Many randomized trials in a large systematic review were not registered and had evidence of selective outcome reporting: a metaepidemiological study","authors":"Samuel Silva , Sareen Singh , Shazia Kashif , Rachel Ogilvie , Rafael Z. Pinto , Jill A. Hayden","doi":"10.1016/j.jclinepi.2024.111568","DOIUrl":"10.1016/j.jclinepi.2024.111568","url":null,"abstract":"<div><h3>Objectives</h3><div>The primary objectives were to describe characteristics of trial registration in the chronic low back pain (CLBP) field and assess the association of trial registration status (registered vs unregistered, prospectively registered vs retrospectively registered) with risk of bias, sufficient sample size, quality of reporting, and treatment effect estimates. Secondary objectives were to describe trial registration consistency with the final report and assess its association with risk of bias, sufficient sample size, and treatment effect estimates.</div></div><div><h3>Study Design and Setting</h3><div>A cross-sectional metaepidemiological study of trials included in a large Cochrane review on exercise treatments for CLBP. We extracted relevant trial and registration information and assessed trials’ risk of bias using the Cochrane Risk of Bias 1 tool. We performed descriptive analyses, logistic regressions, and subgroup meta-analyses.</div></div><div><h3>Results</h3><div>We included 361 trials, of which 23.3% were prospectively registered. Registered trials had lower risk of bias (odds ratio [OR] 0.6; 95% confidence interval [CI] 0.5, 0.7) and higher reporting quality (OR 1.6; 95% CI 1.4, 1.8) than unregistered trials. Prospectively registered trials were more likely to have low risk of reporting bias (OR 2.7; 95% CI 1.2, 6.5) and higher quality of reporting (OR 1.3; 95% CI 1.1, 1.6) than retrospectively registered trials. Trial registration status was not associated with effect estimates. Among prospectively registered trials, 64.3% clearly defined primary outcome(s) in their registration, 58.3% had consistent sample sizes, and 22.6% had no evidence of selective outcome reporting. Trials that clearly defined primary outcome(s) were more likely to report larger effect estimates for pain intensity (mean difference −15.8; 95% CI −22.7, −8.9 vs −6.0; 95% CI −10.6, −1.5; <em>Q</em> = 6.7, <em>P</em> = .01), although the difference was small, the 95% CIs overlapped, and no difference was found for functional limitations.</div></div><div><h3>Conclusion</h3><div>A small proportion of trials in the CLBP field were registered prospectively and many presented registration inconsistencies. Registered trials tend to have lower risk of bias and higher quality of reporting. Policies are needed to improve prospective registration and registration consistency in the field.</div></div><div><h3>Plain Language Summary</h3><div>Prospective trial registration is the practice of documenting the planned methods of a randomized controlled trial on a publicly available online platform (ie, website) before enrolling participants. Medical journals require trialists to prospectively register their trials to encourage the conduct of high-quality research and reduce the chance of trialists changing their research plan to report only positive or significant results (known as selective outcome reporting). We investigated whether trialists within the chro","PeriodicalId":51079,"journal":{"name":"Journal of Clinical Epidemiology","volume":"176 ","pages":"Article 111568"},"PeriodicalIF":7.3,"publicationDate":"2024-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142480176","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-10-11DOI: 10.1016/j.jclinepi.2024.111566
Perrine Janiaud , Lars G. Hemkens
Background and Objectives
Over half a century ago, the terms “pragmatic” and “explanatory” were introduced to biomedicine by Schwartz and Lellouch, presenting two distinct conceptual approaches to trial design. Today, we frequently say that there are pragmatic trials and there are explanatory trials. Pragmatic trials inform decision-making in practice, and explanatory trials aim to understand the mechanism of an intervention. They are often perceived as diametral extremes of a continuum. In this commentary, we argue that with the digitalization of health care and clinical research, ways for modern trial designs were paved and new avenues opened, and that there is no such continuum.
Methods, Results and Conclusions
Since the groundbreaking work of Schwartz and Lellouch, new approaches and methods have become available that allow researchers to address pragmatic and explanatory questions in parallel in the same trial. Emerging availability of routinely collected “real-world” data, development of decentralized trial techniques, and creation of digital biomarkers allow to observe health outcomes with minimal or no interference in real-world care. This overcomes previous limitations to studying mechanisms of interventions in routine care and makes the idea of a continuum obsolete. We argue that pragmatism and explanatorism need to be understood as two distinct but compatible conceptual dimensions to open new perspectives for using novel technologies to design the most informative clinical trials and make better clinical and regulatory decisions. We base our argument on an analysis of the concept of a continuum and highlight its limitations. We review key trial design features and introduce a new concept that sees explanatory design features as fundamental, invasive or noninvasive, or sufficient or insufficient. We describe their impact on pragmatism and explanatorism and show how multidimensional pragmatic explanatory trials that are most useful are possible today.
{"title":"Modern trials are most useful when they are pragmatic and explanatory – there is no continuum","authors":"Perrine Janiaud , Lars G. Hemkens","doi":"10.1016/j.jclinepi.2024.111566","DOIUrl":"10.1016/j.jclinepi.2024.111566","url":null,"abstract":"<div><h3>Background and Objectives</h3><div>Over half a century ago, the terms “pragmatic” and “explanatory” were introduced to biomedicine by Schwartz and Lellouch, presenting two distinct conceptual approaches to trial design. Today, we frequently say that there are pragmatic trials and there are explanatory trials. Pragmatic trials inform decision-making in practice, and explanatory trials aim to understand the mechanism of an intervention. They are often perceived as diametral extremes of a continuum. In this commentary, we argue that with the digitalization of health care and clinical research, ways for modern trial designs were paved and new avenues opened, and that there is no such continuum.</div></div><div><h3>Methods, Results and Conclusions</h3><div>Since the groundbreaking work of Schwartz and Lellouch, new approaches and methods have become available that allow researchers to address pragmatic and explanatory questions in parallel in the same trial. Emerging availability of routinely collected “real-world” data, development of decentralized trial techniques, and creation of digital biomarkers allow to observe health outcomes with minimal or no interference in real-world care. This overcomes previous limitations to studying mechanisms of interventions in routine care and makes the idea of a continuum obsolete. We argue that pragmatism and explanatorism need to be understood as two distinct but compatible conceptual dimensions to open new perspectives for using novel technologies to design the most informative clinical trials and make better clinical and regulatory decisions. We base our argument on an analysis of the concept of a continuum and highlight its limitations. We review key trial design features and introduce a new concept that sees explanatory design features as fundamental, invasive or noninvasive, or sufficient or insufficient. We describe their impact on pragmatism and explanatorism and show how multidimensional pragmatic explanatory trials that are most useful are possible today.</div></div>","PeriodicalId":51079,"journal":{"name":"Journal of Clinical Epidemiology","volume":"176 ","pages":"Article 111566"},"PeriodicalIF":7.3,"publicationDate":"2024-10-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142480177","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 : 2024-10-09DOI: 10.1016/j.jclinepi.2024.111549
Lisa Parker , Stephanie Boughton , Lisa Bero , Jennifer A. Byrne
Paper mills are fraudulent organizations that make money by writing fake manuscripts and offering authorship slots for sale to academic customers. Mill activity differs in scale to individual academic misconduct: many thousands of fake paper mill manuscripts have been successfully published in peer-reviewed journals. Despite this, paper mill activity is still relatively unrecognized outside the publishing industry. We discuss what is known about paper mill operations and how publishers, independent organizations, and individuals are working to prevent and detect mill activity. Research readers can also have a part to play in paper mill detection, and we provide detail on what to look out for.
{"title":"Paper mill challenges: past, present, and future","authors":"Lisa Parker , Stephanie Boughton , Lisa Bero , Jennifer A. Byrne","doi":"10.1016/j.jclinepi.2024.111549","DOIUrl":"10.1016/j.jclinepi.2024.111549","url":null,"abstract":"<div><div>Paper mills are fraudulent organizations that make money by writing fake manuscripts and offering authorship slots for sale to academic customers. Mill activity differs in scale to individual academic misconduct: many thousands of fake paper mill manuscripts have been successfully published in peer-reviewed journals. Despite this, paper mill activity is still relatively unrecognized outside the publishing industry. We discuss what is known about paper mill operations and how publishers, independent organizations, and individuals are working to prevent and detect mill activity. Research readers can also have a part to play in paper mill detection, and we provide detail on what to look out for.</div></div>","PeriodicalId":51079,"journal":{"name":"Journal of Clinical Epidemiology","volume":"176 ","pages":"Article 111549"},"PeriodicalIF":7.3,"publicationDate":"2024-10-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142401889","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-10-09DOI: 10.1016/j.jclinepi.2024.111548
Liping Guo , Xin Xing , Junjie Ren , Xinyu Huang , Sarah Miller , Howard White , Kehu Yang
Objectives
To evaluate and compare the reporting quality of observational systematic reviews and meta-analyses (OSRMA) published in Chinese- and English-language social science journals using the Meta-analyses Of Observational Studies in Epidemiology guideline.
Study Design and Setting
We searched the Social Science Core Index via Web of Science and the Chinese Social Science Core Index via China National Knowledge Infrastructure databases for OSRMAs published from 2012 to 2022 (before December 2022). The process of literature search, selection, and data extraction were performed double blind.
Results
We identified 634 OSRMAs, of which 349 were in English-language journals and 285 in Chinese-language journals. The mean reporting completeness rate was 54.6%, and reviews in English had higher reporting completeness than those in Chinese (55.2% vs 53.9%). All the reviews reported well on background, method, and conclusion, with average reporting rates of 68.1%, 65.2%, and 88.8%, respectively. However, the reporting of search strategy was ignored, with an average rate of 42.9% for reviews in English and 25.8% for reviews in Chinese, especially on the qualifications of searchers, effort to include all available studies, search software used, handling unpublished studies, and contact with authors. The reporting transparency of these reviews was statistically significantly influenced by multiple review factors, including the language of journals, year of publication, the number of authors, the reporting guideline followed, and the declaration of funding source.
Conclusion
OSRMAs in social science demonstrate low reporting quality, especially in Chinese-language journals. We suggest adapting the Meta-analyses Of Observational Studies in Epidemiology guideline to the social science context and promoting its use among researchers and reviewers in this field.
目的采用流行病学观察性研究荟萃分析(MOOSE)指南,评估和比较中英文社会科学期刊上发表的观察性系统综述和荟萃分析(OSRMA)的报告质量:我们通过 Web of Science检索了《社会科学核心索引》(SSCI),并通过中国国家知识基础设施(CNKI)数据库检索了《中文社会科学核心索引》(CSSCI),以查找2012年至2022年(2022年12月之前)发表的OSRMA。文献检索、筛选和数据提取过程均采用双盲法:我们发现了634篇OSRMA,其中349篇发表在英文期刊上,285篇发表在中文期刊上。平均报告完整率为 54.6%,英文综述的报告完整率高于中文综述(55.2% 对 53.9%)。所有综述都很好地报告了背景、方法和结论,平均报告率分别为 68.1%、65.2% 和 88.8%。然而,英文综述的平均报告率为 42.9%,中文综述的平均报告率为 25.8%,尤其是关于检索者的资质、纳入所有可用研究的努力、所使用的检索软件、未发表研究的处理以及与作者的联系等方面的报告被忽视。这些综述的报告透明度在统计学上受多种综述因素的显著影响,包括期刊语言、发表年份、作者人数、遵循的报告指南以及资金来源声明:结论:社会科学领域的OSRMA报告质量较低,尤其是中文期刊。我们建议调整 MOOSE 指南,使其适用于社会科学领域,并在该领域的研究人员和审稿人中推广使用。
{"title":"The reporting completeness of observational systematic reviews and meta-analysis in social science could be improved: a cross-sectional survey","authors":"Liping Guo , Xin Xing , Junjie Ren , Xinyu Huang , Sarah Miller , Howard White , Kehu Yang","doi":"10.1016/j.jclinepi.2024.111548","DOIUrl":"10.1016/j.jclinepi.2024.111548","url":null,"abstract":"<div><h3>Objectives</h3><div>To evaluate and compare the reporting quality of observational systematic reviews and meta-analyses (OSRMA) published in Chinese- and English-language social science journals using the Meta-analyses Of Observational Studies in Epidemiology guideline.</div></div><div><h3>Study Design and Setting</h3><div>We searched the Social Science Core Index via Web of Science and the Chinese Social Science Core Index via China National Knowledge Infrastructure databases for OSRMAs published from 2012 to 2022 (before December 2022). The process of literature search, selection, and data extraction were performed double blind.</div></div><div><h3>Results</h3><div>We identified 634 OSRMAs, of which 349 were in English-language journals and 285 in Chinese-language journals. The mean reporting completeness rate was 54.6%, and reviews in English had higher reporting completeness than those in Chinese (55.2% vs 53.9%). All the reviews reported well on background, method, and conclusion, with average reporting rates of 68.1%, 65.2%, and 88.8%, respectively. However, the reporting of search strategy was ignored, with an average rate of 42.9% for reviews in English and 25.8% for reviews in Chinese, especially on the qualifications of searchers, effort to include all available studies, search software used, handling unpublished studies, and contact with authors. The reporting transparency of these reviews was statistically significantly influenced by multiple review factors, including the language of journals, year of publication, the number of authors, the reporting guideline followed, and the declaration of funding source.</div></div><div><h3>Conclusion</h3><div>OSRMAs in social science demonstrate low reporting quality, especially in Chinese-language journals. We suggest adapting the Meta-analyses Of Observational Studies in Epidemiology guideline to the social science context and promoting its use among researchers and reviewers in this field.</div></div>","PeriodicalId":51079,"journal":{"name":"Journal of Clinical Epidemiology","volume":"176 ","pages":"Article 111548"},"PeriodicalIF":7.3,"publicationDate":"2024-10-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142395028","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}