Journal of clinical epidemiology · 2023
Meta-epidemiological review identified variable reporting and handling of time-to-event analyses in publications of trials included in meta-analyses of systematic reviews.
СтатьяПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Goldkuhle Marius, Hirsch Caroline, Iannizzi Claire, Bora Ana-Mihaela, Bender Ralf, van Dalen Elvira C, Hemkens Lars G, Trivella Marialene, Monsef Ina, Kreuzberger Nina, Skoetz Nicole
Аннотация
OBJECTIVES: Previous findings indicate limited reporting of systematic reviews with meta-analyses of time-to-event (TTE) outcomes. We assessed corresponding available information in trial publications included in such meta-analyses.
STUDY DESIGN AND SETTING: We extracted data from all randomized trials in pairwise, hazard ratio (HR)-based meta-analyses of primary outcomes and overall survival of 50 systematic reviews systematically identified from the Cochrane Database and Core Clinical Journals. Data on methods and characteristics relevant for TTE analysis of reviews, trials, and outcomes were extracted.
RESULTS: Meta-analyses included 235 trials with 315 trial analyses. Most prominently assessed was overall survival (91%). Definitions (61%), censoring reasons (41%), and follow-up specifications (56%) for trial outcomes were often missing. Available TTE data per trial were most frequently survival curves (83%), log-rank P values (76%), and HRs (72%). When trial TTE data recalculation was reported, reviews mostly specified HRs or P values (each 5%). Reviews primarily included intention-to-treat analyses (64%) and analyses not adjusted for covariates (25%). Except for missing outcome data, TTE-relevant trial characteristics, for example, informative censoring, treatment switching, and proportional hazards, were sporadically addressed in trial publications. Reporting limitations in trial publications translate to the review level.
CONCLUSION: TTE (meta)-analyses, in trial and review publications, need clear reporting standards.
STUDY DESIGN AND SETTING: We extracted data from all randomized trials in pairwise, hazard ratio (HR)-based meta-analyses of primary outcomes and overall survival of 50 systematic reviews systematically identified from the Cochrane Database and Core Clinical Journals. Data on methods and characteristics relevant for TTE analysis of reviews, trials, and outcomes were extracted.
RESULTS: Meta-analyses included 235 trials with 315 trial analyses. Most prominently assessed was overall survival (91%). Definitions (61%), censoring reasons (41%), and follow-up specifications (56%) for trial outcomes were often missing. Available TTE data per trial were most frequently survival curves (83%), log-rank P values (76%), and HRs (72%). When trial TTE data recalculation was reported, reviews mostly specified HRs or P values (each 5%). Reviews primarily included intention-to-treat analyses (64%) and analyses not adjusted for covariates (25%). Except for missing outcome data, TTE-relevant trial characteristics, for example, informative censoring, treatment switching, and proportional hazards, were sporadically addressed in trial publications. Reporting limitations in trial publications translate to the review level.
CONCLUSION: TTE (meta)-analyses, in trial and review publications, need clear reporting standards.