Accounting for competing risks in randomized controlled trials: a review and recommendations for improvement

Peter C. Austin, Jason P. Fine

Research output: Research - peer-reviewArticle

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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.

LanguageEnglish (US)
Pages1203-1209
Number of pages7
JournalStatistics in Medicine
Volume36
Issue number8
DOIs
StatePublished - Apr 15 2017

Fingerprint

Randomized Controlled Trial
Competing Risks
Recommendations
Review
Randomized Controlled Trials
Incidence
Survival Analysis
Cumulative Incidence Function
Kaplan-Meier
Unbiased Estimation
Survival Data
Statistical method
Tend
Estimate
Kaplan-Meier Estimate

Keywords

  • competing risks
  • randomized controlled trial
  • RCT
  • survival analysis
  • systematic review

ASJC Scopus subject areas

  • Epidemiology
  • Statistics and Probability

Cite this

Accounting for competing risks in randomized controlled trials : a review and recommendations for improvement. / Austin, Peter C.; Fine, Jason P.

In: Statistics in Medicine, Vol. 36, No. 8, 15.04.2017, p. 1203-1209.

Research output: Research - peer-reviewArticle

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