title: Accounting for competing risks in randomized controlled trials: a review and recommendations for improvement.
abstract: In studies with survival or time-to-event outcomes, a competing risk is an event whose occurrence precludes the occurrence of the primary event of interest. Specialized statistical methods must be used to analyze survival data in the presence of competing risks. We conducted a review of randomized controlled trials with survival outcomes that were published in high-impact general medical journals. Of 40 studies that we identified, 31 (77.5%) were potentially susceptible to competing risks. However, in the majority of these studies, the potential presence of competing risks was not accounted for in the statistical analyses that were described. Of the 31 studies potentially susceptible to competing risks, 24 (77.4%) reported the results of a Kaplan-Meier survival analysis, while only five (16.1%) reported using cumulative incidence functions to estimate the incidence of the outcome over time in the presence of competing risks. The former approach will tend to result in an overestimate of the incidence of the outcome over time, while the latter approach will result in unbiased estimation of the incidence of the primary outcome over time. We provide recommendations on the analysis and reporting of randomized controlled trials with survival outcomes in the presence of competing risks. © 2017 The Authors. Statistics in Medicine published by John Wiley & Sons Ltd.
authors.affiliation: Institute for Clinical Evaluative Sciences, Toronto, Ontario, Canada.|Institute of Health Management, Policy and Evaluation, University of Toronto, Toronto, Ontario, Canada.|Schulich Heart Research Program, Sunnybrook Research Institute, Toronto, Ontario, Canada.
authors.forename: Peter C
authors.initials: PC
authors.lastname: Austin
authors.affiliation: Department of Biostatistics, University of North Carolina, Chapel Hill, NC, U.S.A.|Department of Statistics and Operations Research, University of North Carolina, Chapel Hill, NC, U.S.A.
authors.forename: Jason P
authors.initials: JP
authors.lastname: Fine
mesh_terms: D003627:Data Interpretation, Statistical; D006801:Humans; D058996:Quality Improvement; D016032:Randomized Controlled Trials as Topic / Q000379:methods / Q000592:standards; D012307:Risk Factors; D013223:Statistics as Topic; D016019:Survival Analysis
keywords: RCT; competing risks; randomized controlled trial; survival analysis; systematic review