Statistical methods to adjust for the effects on intervention compliance in randomized clinical trials where precision treatment rules are being developed.

ABSTRACT:

Background

Heterogeneity of treatment effects (HTEs) can occur because of either differential treatment compliance or differential treatment effectiveness. This distinction is important, as it has action implications, but it is unclear how to distinguish these two possibilities statistically in precision treatment analysis given that compliance is not observed until after randomization. We review available statistical methods and illustrate a recommended method in secondary analysis in a trial focused on HTE.

Methods

The trial randomized n = 880 anxious and/or depressed university students to guided internet-delivered cognitive behavioral therapy (i-CBT) or treatment-as-usual (TAU) and evaluated joint remission. Previously reported analyses documented superiority of i-CBT bu

SUBMITTER: Zainal NH 

PROVIDER: S-EPMC11711205 | biostudies-literature | 2025 Mar

REPOSITORIES: biostudies-literature