Journal of Clinical Epidemiology最新文献

{"title":"Corrigendum to “the inappropriateness of internal consistency testing and factor analysis for formative indicators: comment on Felicia et al, 2024” [Journal of Clinical Epidemiology 181 (2025) 111748]","authors":"Xin Meng , Daqiu Wang , Yan Huo , Wenhan Shang , Aiping Wang","doi":"10.1016/j.jclinepi.2025.111860","DOIUrl":"10.1016/j.jclinepi.2025.111860","url":null,"abstract":"","PeriodicalId":51079,"journal":{"name":"Journal of Clinical Epidemiology","volume":"184 ","pages":"Article 111860"},"PeriodicalIF":7.3,"publicationDate":"2025-06-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144322696","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":"Experiences and challenges faced by systematic review authors in using the GRADE approach: a qualitative study","authors":"Adriana Andrić ,&nbsp;Tina Poklepović Peričić ,&nbsp;Ružica Tokalić ,&nbsp;Ana Marušić ,&nbsp;Livia Puljak","doi":"10.1016/j.jclinepi.2025.111870","DOIUrl":"10.1016/j.jclinepi.2025.111870","url":null,"abstract":"<div><h3>Objectives</h3><div>This study aimed to gather feedback from systematic review authors on the use of the Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) approach and to explore potential barriers to its implementation.</div></div><div><h3>Study Design and Setting</h3><div>A qualitative study was conducted using semistructured interviews with principal investigators who are experienced in systematic review methodology and the use of the GRADE approach, about their experiences and challenges in using GRADE. Before the interview, all participants completed a structured questionnaire about their experience with GRADE and in conducting systematic reviews.</div></div><div><h3>Results</h3><div>Eleven of 41 invited experts participated in the study, offering detailed insights into the experiences and challenges of using GRADE. While the participants appreciated GRADE's structured approach to evaluating evidence, they highlighted several challenges, including its complexity, perceived subjectivity in grading, and the need for more practical guidance and examples. Barriers to GRADE use included difficulties in applying specific domains (primarily imprecision and indirectness), lack of adequate training, time constraints, motivational and attitudinal barriers, and financial limitations. The participants emphasized the importance of formal education, improved guidelines, and greater journal support to encourage GRADE adoption. They expressed mixed opinions on whether GRADE should be mandatory in all systematic reviews. While participants agreed on the need to promote GRADE, concerns were raised about its universal implementation potentially hindering research flexibility and innovation.</div></div><div><h3>Conclusion</h3><div>To enhance the use of GRADE, the research community should focus on improving training, developing more efficient tools, and striking a balance between standardization and scientific flexibility.</div></div><div><h3>Plain Language Summary</h3><div>GRADE is a tool to check how reliable and good the evidence is in research. This study looked at the challenges researchers face when using GRADE and their opinions on improving it. Researchers found GRADE valuable because it is well structured but noted it has issues such as being too complex, subjective, and needing clearer instructions. Other problems were the lack of training, not enough time and money, and low motivation. Researchers said that better training, clearer guidelines, and support from journals are needed to make GRADE easier to use.</div></div>","PeriodicalId":51079,"journal":{"name":"Journal of Clinical Epidemiology","volume":"185 ","pages":"Article 111870"},"PeriodicalIF":7.3,"publicationDate":"2025-06-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144369519","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":"Comparison of established comorbidity scores using administrative data of patients undergoing surgery or interventional procedures in Massachusetts","authors":"Elena Ahrens ,&nbsp;Dario von Wedel ,&nbsp;Simone Redaelli ,&nbsp;Theresa Tenge ,&nbsp;Luca J. Wachtendorf ,&nbsp;Ricardo Munoz-Acuna ,&nbsp;Guanqing Chen ,&nbsp;Maximilian S. Schaefer ,&nbsp;Denys Shay","doi":"10.1016/j.jclinepi.2025.111869","DOIUrl":"10.1016/j.jclinepi.2025.111869","url":null,"abstract":"<div><h3>Objectives</h3><div>Previous studies proposed comorbidity-based prediction tools to facilitate patient-level assessment of mortality risk, which are essential for confounder adjustment in epidemiologic studies. We compared established comorbidity indices using real-world administrative data of a broad surgical population.</div></div><div><h3>Study Design and Setting</h3><div>Adult patients undergoing surgical or interventional procedures between January 2005 and June 2020 at a tertiary academic medical center in Massachusetts, USA, were included. The Elixhauser Comorbidity Index (van Walraven modification), Combined Comorbidity Score, and Charlson Comorbidity Index were compared regarding the prediction of 30-day mortality. Age and sex were included in all models. Discriminative ability was quantified by the area under the receiver operating characteristic curve (AUROC), and calibration was assessed using the Brier score and reliability plots.</div></div><div><h3>Results</h3><div>A total of 514,282 patients were included, of which 5849 (1.1%) died within 30 days. A model including age and sex alone had an AUROC of 0.73 (95% CI 0.72-0.74). The Elixhauser Comorbidity Index–based model showed the best discriminative ability with an AUROC of 0.86 (95% CI 0.86-0.87) compared to models, including the Combined Comorbidity Score (AUROC, 0.85 [95% CI 0.84-0.85]) and the Charlson Comorbidity Index (AUROC, 0.82 [95% CI 0.81-0.83], <em>P</em> &lt; .001, respectively). The Brier score was 0.011 for all scores. Overall, score performances were similar or improved after the implementation of the 10th Revision International Classification of Diseases (Clinical Modification) coding system. The primary findings were confirmed for in-hospital, 7-day, 90-day, 180-day, and 1-year mortality and when including score comorbidities as separate indicator variables (<em>P</em> &lt; .001, respectively). Patient and procedural characteristics were predictive of mortality (AUROC, 0.91 [95% CI 0.91-0.91]), with confirmatory findings and slightly improved performances when adding comorbidity scores (AUROC, 0.93 [95% CI 0.93-0.93] for the Elixhauser Comorbidity Index; AUROC, 0.93 [95% CI 0.93-0.93] for the Combined Comorbidity Score; AUROC, 0.92 [95% CI 0.92-0.93] for the Charlson Comorbidity Index, <em>P</em> &lt; .001, respectively).</div></div><div><h3>Conclusion</h3><div>All 3 comorbidity indices predicted mortality with excellent discrimination; however, they showed only slightly improved performance when incorporated into a model including patient and procedural characteristics. When surgical data are unavailable and in surgical setting–specific subgroups, the Elixhauser Comorbidity Index consistently performed best.</div></div>","PeriodicalId":51079,"journal":{"name":"Journal of Clinical Epidemiology","volume":"185 ","pages":"Article 111869"},"PeriodicalIF":7.3,"publicationDate":"2025-06-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144327667","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":"Clusters of post-acute COVID-19 symptoms: a latent class analysis across 9 databases and 7 countries","authors":"Kim López-Güell ,&nbsp;Martí Català ,&nbsp;Daniel Dedman ,&nbsp;Talita Duarte-Salles ,&nbsp;Raivo Kolde ,&nbsp;Raúl López-Blasco ,&nbsp;Álvaro Martínez ,&nbsp;Gregoire Mercier ,&nbsp;Alicia Abellan ,&nbsp;Johnmary T. Arinze ,&nbsp;Theresa Burkard ,&nbsp;Edward Burn ,&nbsp;Zara Cuccu ,&nbsp;Antonella Delmestri ,&nbsp;Dominique Delseny ,&nbsp;Sara Khalid ,&nbsp;Chungsoo Kim ,&nbsp;Ji-woo Kim ,&nbsp;Kristin Kostka ,&nbsp;Cora Loste ,&nbsp;Annika M. Jödicke","doi":"10.1016/j.jclinepi.2025.111867","DOIUrl":"10.1016/j.jclinepi.2025.111867","url":null,"abstract":"<div><h3>Objective</h3><div>Prior evidence has suggested the multisystem symptomatic manifestations of post-acute COVID-19 condition (PCC). Here we conducted a network cluster analysis of 24 World Health Organization–proposed symptoms to identify potential latent subclasses of PCC.</div></div><div><h3>Study Design and Setting</h3><div>Individuals with a positive test of or diagnosed with SARS-CoV-2 after September 2020 and with at least 1 symptom within ≥90 to 365 days following infection were included. Subanalyses were conducted among people with ≥3 different symptoms. Summary characteristics were provided for each cluster. All analyses were conducted separately in 9 databases from 7 countries, including data from primary care, hospitals, national health claims and national health registries, allowing to compare clusters across the different healthcare settings.</div></div><div><h3>Results</h3><div>This study included 787,078 persons with PCC. Single-symptom clusters were common across all databases, particularly for joint pain, anxiety, depression and allergy. Complex clusters included anxiety-depression and abdominal-gastrointestinal symptoms.</div></div><div><h3>Conclusion</h3><div>Substantial heterogeneity within and between PCC clusters was seen across health-care settings. Current definitions of PCC should be critically reviewed to reflect this variety in clinical presentation.</div></div>","PeriodicalId":51079,"journal":{"name":"Journal of Clinical Epidemiology","volume":"185 ","pages":"Article 111867"},"PeriodicalIF":7.3,"publicationDate":"2025-06-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144303483","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":"Guidance for intervention fidelity in nondrug, nonsurgical trials: a scoping review","authors":"Fernando Sousa ,&nbsp;Mengda Zhu ,&nbsp;Melanie K. Farlie ,&nbsp;Terry Haines ,&nbsp;Belinda Borrelli ,&nbsp;Christopher Carroll ,&nbsp;Catherine Mathews ,&nbsp;Daniel C. Ribeiro ,&nbsp;Julie M. Fritz ,&nbsp;Martin Underwood ,&nbsp;Nadine E. Foster ,&nbsp;Sarah E. Lamb ,&nbsp;Zila M. Sanchez ,&nbsp;Peter Malliaras","doi":"10.1016/j.jclinepi.2025.111868","DOIUrl":"10.1016/j.jclinepi.2025.111868","url":null,"abstract":"<div><h3>Objectives</h3><div>Intervention fidelity is poorly reported in trials of nondrug, nonsurgical interventions. We aimed to review existing intervention fidelity guidance documents, assess their development methods, and synthesize their terminology, definitions, domains, and recommendations.</div></div><div><h3>Study Design and Setting</h3><div>We searched 6 databases from inception to September 2023 to identify documents describing explicit, actionable, and overarching recommendations on intervention fidelity. We supplemented this with backward citation searching in April 2024. Two reviewers independently screened titles, abstracts, and full texts. We conducted a qualitative content analysis, following JBI guidance, to extract and synthesize data on document characteristics, scope, methods, terminology, definitions, domains, and recommendations.</div></div><div><h3>Results</h3><div>After screening 7142 records from database searches and 1768 from citation searching, we included 73 documents. Most documents were unclear about the core methods used to develop recommendations (67/73, 92%), and only one document explicitly reported using consensus (1/73, 1%). We identified definitions of intervention fidelity across 6 categories and 7 intervention fidelity domain categories. Of these, only 2 (“provider delivery–related aspects” and “participant involvement–related aspects”) were reported in most documents (&gt;50%). We identified 81 recommendations across 10 categories, with only 14 being reported across more than half of the documents.</div></div><div><h3>Conclusion</h3><div>Existing documents providing recommendations on intervention fidelity reflect the evolving nature of the field, with consensus still needed on several aspects. The gaps and inconsistencies identified in this review emphasize the need for clearer, more systematic, and globally applicable guidelines. These findings will inform the development of ReFiND, an international, consensus-based reporting guideline for intervention fidelity in nondrug, nonsurgical trials.</div></div><div><h3>Plain Language Summary</h3><div>When studies are conducted to test how well an intervention works, it is key to evaluate the extent to which the intervention is delivered as planned. This is called intervention fidelity. We looked at 73 guides on how to check and report this. Most of these guides did not explain the methods used to decide what to include. The advice in these guides was often different from each other. As the field of intervention fidelity is still developing, many of these guides represent early attempts, where less structured methods were used before more organized approaches were established. This shows we need a global effort to create clear guidelines for reporting how well interventions are followed.</div></div>","PeriodicalId":51079,"journal":{"name":"Journal of Clinical Epidemiology","volume":"185 ","pages":"Article 111868"},"PeriodicalIF":7.3,"publicationDate":"2025-06-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144303484","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":"Public availability of randomized clinical trial protocols: a repeated meta-research study","authors":"Christof Manuel Schönenberger ,&nbsp;Malena Chiaborelli ,&nbsp;Ala Taji Heravi ,&nbsp;Lukas Kübler ,&nbsp;Pooja Gandhi ,&nbsp;Zsuzsanna Kontár ,&nbsp;Julia Hüllstrung ,&nbsp;Mona Elalfy ,&nbsp;Jan Glasstetter ,&nbsp;Dmitry Gryaznov ,&nbsp;Belinda von Niederhäusern ,&nbsp;Anette Blümle ,&nbsp;Jason W. Busse (Prof.) ,&nbsp;Szimonetta Lohner ,&nbsp;Sally Hopewell (Prof.) ,&nbsp;Alexandra Griessbach ,&nbsp;Matthias Briel (Prof.) ,&nbsp;Benjamin Speich","doi":"10.1016/j.jclinepi.2025.111865","DOIUrl":"10.1016/j.jclinepi.2025.111865","url":null,"abstract":"<div><h3>Objectives</h3><div>Making protocols of randomized clinical trials (RCTs) publicly available is important for the trustworthiness and quality of medical research. In a previous study assessing 326 RCTs with ethical approval in 2012, only 36% had a publicly available protocol. We aimed to generate current evidence on the availability of RCT protocols and to evaluate changes over time.</div></div><div><h3>Study Design and Setting</h3><div>Using a representative sample of RCTs approved in 2016 in Switzerland, Canada, Germany, and the United Kingdom, we investigated the number of available protocols by searching PubMed, Google Scholar, trial registries, and Google. Up to June 2024, we systematically searched for (i) protocols available as peer-reviewed publications, (ii) protocols attached to trial registries, and (iii) protocols shared with result publications of RCTs. We used multivariable logistic regression to examine the association of protocol availability with trial characteristics such as sample size, drug vs nondrug interventions, multicenter vs single-center status, and RCT approval in 2016 vs 2012.</div></div><div><h3>Results</h3><div>Of the 347 included RCTs, 228 (66%) had an available protocol. Forty-three percent (150/347) of the protocols were available as files on trial registries, 26% (91/347) as supplementary material to result publication, and 23% (81/347) as peer-reviewed publications. Protocol availability improved over time in industry trials (83.4% in 2016 vs 34.6% in 2012). Protocol availability for nonindustry trials remained low (46.4% 2016 vs 38.1% 2012). Multicenter trials (206/256; 77.7% vs single-center trials 22/82; 26.8%) and larger sample size (&gt;500 participants 68/77; 88.3%, 100-500 participants 131/191; 68.6%, &lt;100 participants 29/79; 36.7%) showed higher protocol availability.</div></div><div><h3>Conclusion</h3><div>The availability of protocols increased in RCTs approved in 2016 compared to RCTs from 2012. This was mainly driven by industry sponsored trials. Efforts to further improve protocol availability should be continued, especially in nonindustry sponsored RCTs.</div></div>","PeriodicalId":51079,"journal":{"name":"Journal of Clinical Epidemiology","volume":"185 ","pages":"Article 111865"},"PeriodicalIF":7.3,"publicationDate":"2025-06-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144295345","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Editors’ Choice: July 2025","authors":"Andrea C. Tricco,&nbsp;David Tovey","doi":"10.1016/j.jclinepi.2025.111866","DOIUrl":"10.1016/j.jclinepi.2025.111866","url":null,"abstract":"","PeriodicalId":51079,"journal":{"name":"Journal of Clinical Epidemiology","volume":"183 ","pages":"Article 111866"},"PeriodicalIF":7.3,"publicationDate":"2025-06-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144279836","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":"Where are the harms? Underreporting of adverse events in clinical trials investigating targeted therapy for endocrine and metabolic disorders: an observational study","authors":"Maja Pavić ,&nbsp;Shelly Pranić ,&nbsp;Ana Marušić","doi":"10.1016/j.jclinepi.2025.111861","DOIUrl":"10.1016/j.jclinepi.2025.111861","url":null,"abstract":"&lt;div&gt;&lt;h3&gt;Objectives&lt;/h3&gt;&lt;div&gt;This study aimed to assess the completeness and consistency of adverse event (AE) reporting in &lt;span&gt;&lt;span&gt;&lt;em&gt;ClinicalTrials.gov&lt;/em&gt;&lt;/span&gt;&lt;svg&gt;&lt;path&gt;&lt;/path&gt;&lt;/svg&gt;&lt;/span&gt; and corresponding peer-reviewed publications for clinical trials investigating targeted therapeutics for endocrine and metabolic disorders.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Study Design and Setting&lt;/h3&gt;&lt;div&gt;On September 12, 2022, a search of &lt;span&gt;&lt;span&gt;&lt;em&gt;ClinicalTrials.gov&lt;/em&gt;&lt;/span&gt;&lt;svg&gt;&lt;path&gt;&lt;/path&gt;&lt;/svg&gt;&lt;/span&gt; was conducted to identify completed interventional trials investigating targeted therapeutics for the treatment of endocrine and metabolic disorders registered after September 1, 2009. The main outcome was the completeness of AE reporting in &lt;span&gt;&lt;span&gt;&lt;em&gt;ClinicalTrials.gov&lt;/em&gt;&lt;/span&gt;&lt;svg&gt;&lt;path&gt;&lt;/path&gt;&lt;/svg&gt;&lt;/span&gt; and corresponding peer-reviewed journal articles. The completeness of registry reporting for serious AEs (SAEs) and other AEs (OAEs) was also assessed, as well as the all-cause mortality (ACM) data for trials with a primary completion date after January 18, 2017. In addition, the study examined the concordance in AE reporting between the two sources.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Results&lt;/h3&gt;&lt;div&gt;Out of 7405 trials identified in the &lt;span&gt;&lt;span&gt;&lt;em&gt;ClinicalTrials.gov&lt;/em&gt;&lt;/span&gt;&lt;svg&gt;&lt;path&gt;&lt;/path&gt;&lt;/svg&gt;&lt;/span&gt; registry, 92 met the inclusion criteria. All trials reported SAEs and OAEs in the registry, and all eligible trials reported ACM data. In the corresponding peer-reviewed journal publications, SAEs were reported for 86% of trials, OAEs for 91%, and ACM data for 64% of eligible trials. Among the trials with complete AE reporting in &lt;span&gt;&lt;span&gt;&lt;em&gt;ClinicalTrials.gov&lt;/em&gt;&lt;/span&gt;&lt;svg&gt;&lt;path&gt;&lt;/path&gt;&lt;/svg&gt;&lt;/span&gt; and journal publications, 38% showed discrepancies in the number of participants experiencing SAEs, 86% for OAEs, and 36% for ACM data. In addition, 18% of journal articles used different terminology for reporting of AEs compared to the registry, and 60% applied different frequency thresholds.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Conclusion&lt;/h3&gt;&lt;div&gt;Our analysis revealed significant discrepancies between registry data and journal articles regarding AE reporting in clinical trials investigating targeted therapy for endocrine and metabolic disorders. Greater efforts are needed to enhance transparency and harmonization in AE reporting, ensuring accurate risk communication and informed clinical decision-making.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Plain Language Summary&lt;/h3&gt;&lt;div&gt;Accurate reporting of adverse events (AEs) in clinical trials is essential for evaluating the safety of new therapeutics. This study assessed whether safety data reported in clinical trials investigating treatments for endocrine and metabolic disorders were consistently presented in &lt;span&gt;&lt;span&gt;&lt;em&gt;ClinicalTrials.gov&lt;/em&gt;&lt;/span&gt;&lt;svg&gt;&lt;path&gt;&lt;/path&gt;&lt;/svg&gt;&lt;/span&gt; and corresponding journal publications. A total of 92 completed clinical trials registered on &lt;span&gt;&lt;span&gt;&lt;em&gt;ClinicalTrials.gov&lt;/em&gt;&lt;/span&gt;&lt;s","PeriodicalId":51079,"journal":{"name":"Journal of Clinical Epidemiology","volume":"185 ","pages":"Article 111861"},"PeriodicalIF":7.3,"publicationDate":"2025-06-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144250715","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":"Prevalence of patient and public involvement in child health randomized controlled trials and impact on research quality, loss to follow-up, and dissemination","authors":"Sadia Akbar ,&nbsp;Cornelia M. Borkhoff ,&nbsp;Nayantara Hattangadi ,&nbsp;Francine Buchanan ,&nbsp;Isabella Miklaucic ,&nbsp;Patricia C. Parkin ,&nbsp;Colin Macarthur","doi":"10.1016/j.jclinepi.2025.111858","DOIUrl":"10.1016/j.jclinepi.2025.111858","url":null,"abstract":"&lt;div&gt;&lt;h3&gt;Objectives&lt;/h3&gt;&lt;div&gt;Patient and public involvement (PPI) in randomized controlled trials (RCTs) is hypothesized to enhance research quality, participant enrollment and retention, and uptake of findings. However, there are few empirical data on the impact of PPI in child health RCTs. Our objective was to compare research quality, loss to follow-up, and dissemination for child health RCTs with PPI in the research process (PPI+) with trials that did not (PPI−).&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Study Design and Setting&lt;/h3&gt;&lt;div&gt;In this bibliometric analysis, all child health intervention reviews in the Cochrane Library of Systematic Reviews between 2021 and 2023 were identified. One RCT from each eligible systematic review was randomly selected, generating a sample of 199 individual trials. Two independent reviewers classified trials as PPI+ or PPI− and collected data on variables of interest.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Results&lt;/h3&gt;&lt;div&gt;Only 12/199 RCTs (6%) reported PPI in the research process. Percent lost to follow-up was higher in PPI+ trials compared to PPI− trials among noncluster RCTs (15% vs. 5%; &lt;em&gt;P&lt;/em&gt; = .03), but lower for cluster RCTs (0% vs. 2%, respectively; &lt;em&gt;P&lt;/em&gt; = .05). Research quality was similar for PPI+ and PPI− trials (42% vs. 29%, respectively, were rated as “good/fair”; &lt;em&gt;P&lt;/em&gt; = .34). Both academic and nonacademic measures of dissemination were modestly higher for PPI+ trials compared with PPI− trials. Specifically, PlumX Captures per year (bookmarks, favorites, readers, follows) were higher for PPI+ trials compared with PPI− trials (18.2 vs. 11.9, respectively; &lt;em&gt;P&lt;/em&gt; = .02).&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Conclusion&lt;/h3&gt;&lt;div&gt;PPI was infrequent among child health RCTs. Research quality was similar for PPI+ and PPI- trials. PPI may modestly enhance dissemination of research findings. The lack of standardized reporting of PPI leads to inconsistency in describing involvement, potential misclassification of PPI in research, and prevents the definitive analysis of the impact of PPI. Improved reporting of PPI in child health RCTs is needed.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Plain Language Summary&lt;/h3&gt;&lt;div&gt;Patient and public involvement (PPI) in health research refers to researchers working together with patients and other members of the public on any or all aspects of a research study. For our study, we compared research quality, loss to follow-up, and dissemination (ie, sharing of research findings) for child health randomized controlled trials (RCTs) with PPI in the research process with trials without PPI. We searched the Cochrane Library of Systematic Reviews for all child health intervention reviews published between 2021 and 2023 and randomly selected one RCT from each systematic review, creating a sample of 199 individual trials. Two reviewers classified trials as PPI+ or PPI− and collected data on variables of interest. We found that PPI in child health RCTs was uncommon (12/199, 6%), but PPI+ RCTs had similar research quality and improved diss","PeriodicalId":51079,"journal":{"name":"Journal of Clinical Epidemiology","volume":"184 ","pages":"Article 111858"},"PeriodicalIF":7.3,"publicationDate":"2025-06-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144227467","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Editors' Choice June 2025","authors":"David Tovey,&nbsp;Andrea C. Tricco","doi":"10.1016/j.jclinepi.2025.111854","DOIUrl":"10.1016/j.jclinepi.2025.111854","url":null,"abstract":"","PeriodicalId":51079,"journal":{"name":"Journal of Clinical Epidemiology","volume":"182 ","pages":"Article 111854"},"PeriodicalIF":7.3,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144222833","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}