Bayesian Analysis of Time-To-Event Data in a Cluster-Randomized Trial: Major Outcomes With Personalized Dialysate TEMPerature (MyTEMP) Trial.

Background: MyTEMP was a cluster-randomized trial to assess the effect of using a personalized cooler dialysate compared to standard temperature dialysate for potential cardiovascular benefits in patients receiving maintenance hemodialysis in Ontario, Canada.

Objective: To conduct Bayesian analyses of the MyTEMP trial, which sought to determine whether adopting a center-wide policy of personalized cooler dialysate is superior to a standard dialysate temperature of 36.5°C in reducing the risk of a composite outcome of cardiovascular-related deaths or hospitalizations.

Design: Secondary analysis of a parallel-group cluster-randomized trial.

Setting: In total, 84 dialysis centers in Ontario, Canada, were randomly allocated to the 2 groups.

Patients: Adult outpatients receiving in-center maintenance hemodialysis from dialysis centers participating in the trial.

Measurements: The primary composite outcome was cardiovascular-related death or hospital admission with myocardial infarction, ischemic stroke, or congestive heart failure during the 4-year trial period.

Methods: MyTEMP trial data were analyzed using Bayesian cause-specific parametric Weibull methods to model the survival time with 6 pre-defined reference priors of normal distributions on the log hazard ratio for the treatment effect (strongly enthusiastic, moderately enthusiastic, non-informative, moderately skeptical, skeptical, strongly skeptical). For each analysis, we reported the posterior mean, 2nd, 50th, and 98th percentiles of the treatment effects (hazard ratios) and 96% credible interval (CrI). We also reported the estimated posterior probabilities for different magnitudes of treatment effects.

Results: Regardless of priors, Bayesian analysis yielded consistent posterior means and a 96% CrI. The posterior distribution of the hazard ratio was concentrated between 0.95 and 1.05, indicating there was probably no substantial difference between the 2 trial arms.

Limitations: The interpretation of Bayesian methods highly depends on the prior distributions. In our study, the prior distributions were determined by 2 experts without a formal elicitation method. A formal elicitation is encouraged in future trials to better quantify experts' uncertainty about the treatment effect. In addition, we used cause-specific parametric Weibull methods to model survival time, as semi-parametric methods were not available in the standard Bayesian statistical software package at the time of analysis.

Conclusions: Our Bayesian analysis indicated that implementing personalized cooler dialysate as a center-wide policy is unlikely to yield meaningful benefits in reducing the composite outcome of cardiovascular-related deaths and hospitalizations, regardless of prior expectations, whether optimistic or skeptical, about the intervention's effectiveness.