Journal of Clinical Epidemiology最新文献

{"title":"Associations of hypothetical early intensive in-hospital rehabilitation with activities of daily living after hip fracture surgery in patients with and without dementia: emulating a randomized controlled trial using medical claims data","authors":"Takaaki Ikeda ,&nbsp;Upul Cooray ,&nbsp;Ryutaro Matsugaki ,&nbsp;Yuta Suzuki ,&nbsp;Michiaki Takagi ,&nbsp;Keiji Muramatsu ,&nbsp;Kiyohide Fushimi ,&nbsp;Masayasu Murakami ,&nbsp;Ken Osaka ,&nbsp;Shinya Matsuda","doi":"10.1016/j.jclinepi.2024.111550","DOIUrl":"10.1016/j.jclinepi.2024.111550","url":null,"abstract":"<div><h3>Objectives</h3><div>To investigate the impact of early intensive in-hospital rehabilitation, initiated within 2 days of surgery and lasting up to 7 days, on the recovery of activities of daily living in patients with and without dementia.</div></div><div><h3>Study Design and Setting</h3><div>Medical claims data from 925 hospitals in Japan were analyzed. We enrolled patients aged ≥50 years who underwent hip fracture surgery within 2 days of admission between April 1, 2018, and December 31, 2019. Low- (20 minutes per day starting on day 2), highest- (60 minutes per day starting on day 1), and gradually increasing (20 minutes on day 1, 40 minutes on days 2–4, and 60 minutes per day thereafter) intensity regimens were used as exposures. The outcomes were Barthel Index (BI) scores at 14 and 30 days postoperatively. For per-protocol analysis, a target trial emulation framework with the sequential doubly robust estimator was used.</div></div><div><h3>Results</h3><div>Among patients without dementia (<em>N</em> = 11,461), no significant differences in BI scores were observed at 14 days postoperatively across regimens. At 30 days postoperatively, significant differences in BI scores were noted between highest- and low-intensity regimens and between gradually increasing intensity and low-intensity regimens, with additive BI scores of 15.2 (95% CI, 10.7–19.7) and 14.7 (95% CI, 9.2–20.2), respectively. In patients with dementia (<em>N</em> = 14,302), significant differences in BI scores were noted at 14 days postoperatively between highest- and low-intensity regimens and between gradually increasing intensity and low-intensity regimens, with additive BI scores of 8.7 (95% CI, 5.2–12.2) and 10.7 (95% CI, 5.8–15.6), respectively. At 30 days postoperatively, a significant difference in BI scores was observed between gradually increasing intensity and low-intensity regimens, with an additive BI score of 17.9 (95% CI, 11.3–24.5).</div></div><div><h3>Conclusion</h3><div>Early intensive in-hospital rehabilitation is highly relevant and beneficial for dementia patients.</div></div>","PeriodicalId":51079,"journal":{"name":"Journal of Clinical Epidemiology","volume":"176 ","pages":"Article 111550"},"PeriodicalIF":7.3,"publicationDate":"2024-10-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142395027","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":"What should journals do to prevent the publication of methodologically flawed systematic reviews?","authors":"KM Saif-Ur-Rahman","doi":"10.1016/j.jclinepi.2024.111493","DOIUrl":"10.1016/j.jclinepi.2024.111493","url":null,"abstract":"","PeriodicalId":51079,"journal":{"name":"Journal of Clinical Epidemiology","volume":"174 ","pages":"Article 111493"},"PeriodicalIF":7.3,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141890820","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":"Long list of conflicts of interest in industry-funded drug trials are counterproductive and opaque for readers","authors":"Sophie Leducq,&nbsp;Richard Barlow,&nbsp;Arabella Baker,&nbsp;Mikolaj Swiderski,&nbsp;Hywel C. Williams","doi":"10.1016/j.jclinepi.2024.111491","DOIUrl":"10.1016/j.jclinepi.2024.111491","url":null,"abstract":"","PeriodicalId":51079,"journal":{"name":"Journal of Clinical Epidemiology","volume":"174 ","pages":"Article 111491"},"PeriodicalIF":7.3,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141890818","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":"Analysis of risk of bias assessments in a sample of intervention systematic reviews, Part II: focus on risk of bias tools reveals few meet current appraisal standards","authors":"Kat Kolaski ,&nbsp;Mike Clarke ,&nbsp;Lynne Romeiser Logan","doi":"10.1016/j.jclinepi.2024.111460","DOIUrl":"10.1016/j.jclinepi.2024.111460","url":null,"abstract":"&lt;div&gt;&lt;h3&gt;Objectives&lt;/h3&gt;&lt;div&gt;Risk of bias (RoB) assessment is a critical part of any systematic review (SR). There are multiple tools available for assessing RoB of the studies included in a SR. The conduct of these assessments in intervention SRs are addressed by three items in AMSTAR-2, considered the preferred tool for critically appraising an intervention SR. This study focuses attention on item 9, which assesses the ability of a RoB tool to adequately address sources of bias, particularly in randomized trials (RCTs) and nonrandomized studies of interventions (NRSI). Our main objective is to report the detailed results of our examination of both Cochrane and non-Cochrane RoB tools and distinguish those that meet AMSTAR-2 item 9 appraisal standards.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Study Design and Setting&lt;/h3&gt;&lt;div&gt;We identified critical appraisal tools reported in a sample of 126 SRs reporting on interventions for persons with cerebral palsy published from 2014 to 2021. Eligible tools were those that had been used to assess the primary studies included in these SRs and for which assessment results were reported in enough detail to allow appraisal of the tool. We identified the version of the tool applied as original, modified, or novel and established the applicable study designs as intended by the tools’ developers. We then evaluated the potential ability of these tools to assess the four sources of bias specified in AMSTAR-2 item 9 for RCTs and NRSI. We adapted item 9 to appraise tools applied to single-case experimental designs, which we also encountered in this sample of SRs.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Results&lt;/h3&gt;&lt;div&gt;Most of the eligible tools are recognized by name in the published literature and were applied in the original or modified form. Modifications were applied with considerable variability across the sample. Of the 37 tools we examined, those judged to fully meet the appraisal standards for RCTs included all the Cochrane tools, the original and modified Downs and Black Checklist, and the quality assessment standard for a cross-over study by Ding et al; for NRSI, these included all the Cochrane tools, the original and modified Downs and Black Checklist, and the Research Triangle Institute item bank on Risk of Bias and Precision of Observational Studies for NRSI. In general, tools developed for a specific study design were judged to meet the appraisal standards fully or partially for that design. These results suggest it is unlikely that a single tool will be adequate by AMSTAR-2 item 9 appraisal standards for an intervention SR that includes studies of various designs.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Conclusion&lt;/h3&gt;&lt;div&gt;To our knowledge, this is the first resource providing SR authors with practical information about the appropriateness and adequacy of RoB tools by the appraisal standards specified in AMSTAR-2 item 9 for RCTs and NRSI. We propose similar methods for appraisal of tools applied to single-case experimental design. We encourage authors to seek co","PeriodicalId":51079,"journal":{"name":"Journal of Clinical Epidemiology","volume":"174 ","pages":"Article 111460"},"PeriodicalIF":7.3,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141724954","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: October 2024","authors":"Andrea C. Tricco,&nbsp;David Tovey","doi":"10.1016/j.jclinepi.2024.111554","DOIUrl":"10.1016/j.jclinepi.2024.111554","url":null,"abstract":"","PeriodicalId":51079,"journal":{"name":"Journal of Clinical Epidemiology","volume":"174 ","pages":"Article 111554"},"PeriodicalIF":7.3,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142433648","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":"Estimates for diagnostic accuracy of rapid antigen tests for SARS-CoV-2 in systematic reviews are consistently similar despite poor methodological rigor: a methodological overview","authors":"Vivienne C. Bachelet ,&nbsp;Francisca J. Lizana ,&nbsp;Catalina O. Andrades ,&nbsp;Belén Carroza ,&nbsp;Leandro R.A. González ,&nbsp;Paula Munita ,&nbsp;Luana Wosiack ,&nbsp;Nicolás Meza","doi":"10.1016/j.jclinepi.2024.111547","DOIUrl":"10.1016/j.jclinepi.2024.111547","url":null,"abstract":"<div><h3>Objectives</h3><div>To evaluate the design, conduct, and analysis of systematic reviews on the diagnostic accuracy of rapid antigen tests for SARS-CoV-2 during the COVID-19 pandemic.</div></div><div><h3>Study Design and Setting</h3><div>We did a methodological overview of systematic reviews on diagnostic test accuracy, exploring methodological rigor, risk of bias and potential factors of between-review variability.</div></div><div><h3>Results</h3><div>Of the 31 included reviews, 30 provided summary statistics for sensitivity and 29 for specificity. Summary sensitivities ranged from 56.2% to 91.1%, with a median of 71.5% (IQR 68.3%–76.6%) and a mean of 72.7% with a 7.2 SD. Reported summary specificity estimates were consistently high: median 99.5% (IQR 99%–99.9%) and a mean of 99.3% with a 0.9 SD. We found methodological shortcomings in the systematic reviews, with a majority showing critically low confidence in quality and a high risk of bias.</div></div><div><h3>Conclusion</h3><div>Despite significant methodological flaws in the reviews, the diagnostic accuracy estimates for rapid antigen tests were characterized by a strong central tendency, highlighting the importance of large sample sizes and broad participant representation. This study suggests the need for further research in diagnostic test accuracy assessments of rigor and risk of bias in systematic reviews.</div></div>","PeriodicalId":51079,"journal":{"name":"Journal of Clinical Epidemiology","volume":"176 ","pages":"Article 111547"},"PeriodicalIF":7.3,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142367241","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":"A review of health equity considerations in cochrane reviews of lifestyle interventions for cardiovascular health in adults","authors":"Moriasi Nyanchoka ,&nbsp;Omolola Titilayo Alade ,&nbsp;Jennifer Petkovic ,&nbsp;Tiffany Duque ,&nbsp;L. Susan Wieland","doi":"10.1016/j.jclinepi.2024.111546","DOIUrl":"10.1016/j.jclinepi.2024.111546","url":null,"abstract":"<div><h3>Objectives</h3><div>Cardiovascular disease (CVD) is the leading cause of global disease burden and rising health-care costs. Systematic reviews (SRs) rigorously evaluate evidence on health interventions' effects and guide personal, clinical, and policy decision-making. Health equity is the absence of avoidable and unfair differences in health between groups within a population. Assessing equity in lifestyle interventions for cardiovascular health is important due to persisting health inequities in CVD burden and access to interventions. We aim to explore how health equity considerations are addressed in Cochrane SRs of lifestyle interventions for cardiovascular health.</div></div><div><h3>Study Design and Setting</h3><div>This is a methodological review of Cochrane SRs of lifestyle interventions for cardiovascular health using the PROGRESS-Plus framework. PROGRESS-Plus stands for Place of residence, Race/ethnicity/culture/language, Occupation, Gender/sex, Religion, Education, Socioeconomic status, and Social capital, while “Plus” stands for additional factors associated with discrimination and exclusion such as age, disability, and comorbidity. Using predefined selection criteria, two authors independently screened all Cochrane reviews published in the Cochrane Database of Systematic Reviews (CDSR) between August 2017 and December 2022. PROGRESS-Plus factors in the SRs were sought in the Summary of Findings (SoF) table, Methods/Inclusion criteria, Methods/Subgroup analyses, Results/Included studies, Results/Subgroup analyses, and Discussion/Overall completeness and applicability of evidence.</div></div><div><h3>Results</h3><div>We included 36 SRs published by 10 Cochrane groups, addressing 11 health conditions with mostly dietary and exercise interventions. The most common PROGRESS-Plus factors assessed were gender/sex, age, and comorbidity. PROGRESS-Plus factors were most addressed in the inclusion criteria (64%), the discussion (75%), and the included studies (92%) sections of the SRs. Only 33% of SoF tables referenced PROGRESS-Plus. Sixty-nine percent of the included SRs planned for subgroup analyses across one or more PROGRESS-Plus factors, but only 43% of SRs conducted subgroup analyses, suggesting limited reporting of PROGRESS-Plus factors in primary studies.</div></div><div><h3>Conclusion</h3><div>Equity factors are not sufficiently addressed in Cochrane reviews of lifestyle interventions for cardiovascular health. Low reporting of PROGRESS-Plus factors in implications for practice and research sections of Cochrane SRs limit equity-focused guidance for current clinical practice, public health interventions, and future research.</div></div>","PeriodicalId":51079,"journal":{"name":"Journal of Clinical Epidemiology","volume":"176 ","pages":"Article 111546"},"PeriodicalIF":7.3,"publicationDate":"2024-09-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142331897","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The performance of prognostic models depended on the choice of missing value imputation algorithm: a simulation study","authors":"Manja Deforth ,&nbsp;Georg Heinze ,&nbsp;Ulrike Held","doi":"10.1016/j.jclinepi.2024.111539","DOIUrl":"10.1016/j.jclinepi.2024.111539","url":null,"abstract":"&lt;div&gt;&lt;h3&gt;Objectives&lt;/h3&gt;&lt;div&gt;The development of clinical prediction models is often impeded by the occurrence of missing values in the predictors. Various methods for imputing missing values before modeling have been proposed. Some of them are based on variants of multiple imputations by chained equations, while others are based on single imputation. These methods may include elements of flexible modeling or machine learning algorithms, and for some of them user-friendly software packages are available. The aim of this study was to investigate by simulation if some of these methods consistently outperform others in performance measures of clinical prediction models.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Study Design and Setting&lt;/h3&gt;&lt;div&gt;We simulated development and validation cohorts by mimicking observed distributions of predictors and outcome variable of a real data set. In the development cohorts, missing predictor values were created in 36 scenarios defined by the missingness mechanism and proportion of noncomplete cases. We applied three imputation algorithms that were available in R software (R Foundation for Statistical Computing, Vienna, Austria): mice, aregImpute, and missForest. These algorithms differed in their use of linear or flexible models, or random forests, the way of sampling from the predictive posterior distribution, and the generation of a single or multiple imputed data set. For multiple imputation, we also investigated the impact of the number of imputations. Logistic regression models were fitted with the simulated development cohorts before (full data analysis) and after missing value generation (complete case analysis), and with the imputed data. Prognostic model performance was measured by the scaled Brier score, &lt;em&gt;c&lt;/em&gt;-statistic, calibration intercept and slope, and by the mean absolute prediction error evaluated in validation cohorts without missing values. Performance of full data analysis was considered as ideal.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Results&lt;/h3&gt;&lt;div&gt;None of the imputation methods achieved the model's predictive accuracy that would be obtained in case of no missingness. In general, complete case analysis yielded the worst performance, and deviation from ideal performance increased with increasing percentage of missingness and decreasing sample size. Across all scenarios and performance measures, aregImpute and mice, both with 100 imputations, resulted in highest predictive accuracy. Surprisingly, aregImpute outperformed full data analysis in achieving calibration slopes very close to one across all scenarios and outcome models. The increase of mice's performance with 100 compared to five imputations was only marginal. The differences between the imputation methods decreased with increasing sample sizes and decreasing proportion of noncomplete cases.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Conclusion&lt;/h3&gt;&lt;div&gt;In our simulation study, model calibration was more affected by the choice of the imputation method than model discrimination. While difference","PeriodicalId":51079,"journal":{"name":"Journal of Clinical Epidemiology","volume":"176 ","pages":"Article 111539"},"PeriodicalIF":7.3,"publicationDate":"2024-09-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142331900","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}

{"title":"Simultaneous evaluation of the imprecision and inconsistency domains of GRADE can be performed using prediction intervals","authors":"M. Hassan Murad ,&nbsp;Rebecca L. Morgan ,&nbsp;Yngve Falck-Ytter ,&nbsp;Reem A. Mustafa ,&nbsp;Shahnaz Sultan ,&nbsp;Philipp Dahm ,&nbsp;Madelin R. Siedler ,&nbsp;Osama Altayar ,&nbsp;Perica Davitkov ,&nbsp;Syed Arsalan Ahmed Naqvi ,&nbsp;Irbaz Bin Riaz ,&nbsp;Zhen Wang ,&nbsp;Lifeng Lin","doi":"10.1016/j.jclinepi.2024.111543","DOIUrl":"10.1016/j.jclinepi.2024.111543","url":null,"abstract":"<div><h3>Objectives</h3><div>To explore the use of prediction interval (PI) for the simultaneous evaluation of the imprecision and inconsistency domains of Grading of Recommendations, Assessment, and Evaluation using stakeholder-provided decision thresholds.</div></div><div><h3>Study Design and Setting</h3><div>We propose transforming the PI of a meta-analysis from a relative risk scale to an absolute risk difference using an appropriate baseline risk. The transformed PI is compared to stakeholder-provided thresholds on an absolute scale. We applied this approach to a large convenience sample of meta-analyses extracted from the Cochrane Database of Systematic Reviews and compared it against the traditional approach of rating imprecision and inconsistency separately using confidence intervals and statistical measures of heterogeneity, respectively. We used empirically derived thresholds following Grading of Recommendations, Assessment, and Evaluation guidance.</div></div><div><h3>Results</h3><div>The convenience sample consisted of 2516 meta-analyses (median of 7 studies per meta-analysis; interquartile range: 5–11). The main analysis showed the percentage of meta-analyses in which both approaches had the same number of certainty levels rated down was 59%. The PI approach led to more levels of rating down (lower certainty) in 27% and to fewer levels of rating down (higher certainty) in 14%. Multiple sensitivity analyses using different thresholds showed similar results, but the PI approach had particularly increased width with a larger number of included studies and higher I² values.</div></div><div><h3>Conclusion</h3><div>Using the PI for simultaneous evaluation of imprecision and inconsistency seems feasible and logical but can lead to lower certainty ratings. The PI-based approach requires further testing in future systematic reviews and guidelines using context-specific thresholds and evidence-to-decision criteria.</div></div><div><h3>Plain Language Summary</h3><div>The prediction interval (PI) addresses both the imprecision and inconsistency domains of certainty. In this study, we applied this PI approach to simultaneously judge both domains and compared this to the traditional approach of making these separate judgments. The 2 approaches had moderate agreement. The PI-based approach requires further testing in future systematic reviews and guidelines using context-specific thresholds and evidence-to-decision criteria.</div></div>","PeriodicalId":51079,"journal":{"name":"Journal of Clinical Epidemiology","volume":"175 ","pages":"Article 111543"},"PeriodicalIF":7.3,"publicationDate":"2024-09-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142331899","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":"A cross-sectional study assessing visual abstracts of randomized trials revealed inadequate reporting and high prevalence of spin","authors":"Melissa Duran ,&nbsp;Isabelle Boutron ,&nbsp;Sally Hopewell ,&nbsp;Hillary Bonnet ,&nbsp;Stephanie Sidorkiewicz","doi":"10.1016/j.jclinepi.2024.111544","DOIUrl":"10.1016/j.jclinepi.2024.111544","url":null,"abstract":"<div><h3>Objectives</h3><div>Visual abstracts (VAs) lack study-specific reporting guidelines and are increasingly used as stand-alone sources in medical research dissemination although not designed for this purpose. Therefore, our objectives were to describe 1) completeness of reporting in VAs and corresponding written abstracts (WAs) of randomized controlled trials (RCTs), and 2) the extent and type of spin (ie, any reporting pattern that could distort result interpretation and mislead readers) in VAs and WAs of RCTs with a statistically nonsignificant primary outcome.</div></div><div><h3>Study Design and Setting</h3><div>We conducted a cross-sectional study evaluating VAs and WAs of RCTs published between January 1, 2021, and March 3, 2023. We searched MEDLINE via PubMed for reports of RCTs published in the 15 highest impact factor journals from six medical fields (among which 34 journals producing VAs of RCTs were identified). One reviewer identified primary reports of RCTs published with a VA and randomly selected a maximum of 10 reports from each journal to avoid overrepresentation. The completeness of reporting assessment was based on the Consolidated Standards of Reporting Trials extension for abstracts. Spin was explored using a standardized spin classification for RCTs with statistically nonsignificant primary outcome results. Both assessments were conducted in duplicate, with discussion until consensus in case of discrepancy.</div></div><div><h3>Results</h3><div>A random sample of 253 reports from 34 journals was identified. The information provided in VAs was frequently incomplete: primary outcome identification, primary outcome results, and harms were respectively described or displayed in only 47% (<em>n</em> = 116/247), 30% (<em>n</em> = 75/247), and 35% (<em>n</em> = 88/253). Reporting was slightly better for some items in WAs, although still unsatisfactory. Among trials with nonsignificant primary outcome results (<em>n</em> = 101), 57% (<em>n</em> = 58) of the VAs and 55% (<em>n</em> = 56) of the WAs exhibited at least 1 type of spin. Posthoc analyses showed VAs produced by journal editors of high-impact general medical journals were more complete and more accurate than those produced by specialty journals or authors.</div></div><div><h3>Conclusion</h3><div>The information conveyed in VAs was frequently incomplete and inaccurate, highlighting the urgent need to refer to appropriate specific reporting guidelines to avoid misinterpretation by readers.</div></div>","PeriodicalId":51079,"journal":{"name":"Journal of Clinical Epidemiology","volume":"176 ","pages":"Article 111544"},"PeriodicalIF":7.3,"publicationDate":"2024-09-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142331896","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}