4 papers · 1 filter
When do composite estimands answer non-causal questions?
Brennan C Kahan, Tra My Pham, Conor Tweed +1
Under a composite estimand strategy, the occurrence of the intercurrent event is incorporated into the endpoint definition, for instance by assigning a poor outcome value to patien…
Model-robust standardization in cluster-randomized trials
Fan Li, Jiaqi Tong, Xi Fang +3
In cluster-randomized trials, generalized linear mixed models and generalized estimating equations have conventionally been the default analytic methods for estimating the average…
Semiparametric principal stratification analysis beyond monotonicity
Jiaqi Tong, Brennan Kahan, Michael O. Harhay +1
Intercurrent events, common in clinical trials and observational studies, affect the existence or interpretation of final outcomes. Principal stratification addresses this challeng…
How to design a pre-specified statistical analysis approach to limit p-hacking in clinical trials: the Pre-SPEC framework
Brennan C Kahan, Gordon Forbes, Suzie Cro
Results from clinical trials can be susceptible to bias if investigators choose their analysis approach after seeing trial data, as this can allow them to perform multiple analyses…