Managing clustering effects and learning effects in the design and analysis of multicentre randomised trials: a survey to establish current practice.

ABSTRACT:

Background

Patient outcomes can depend on the treating centre, or health professional, delivering the intervention. A health professional's skill in delivery improves with experience, meaning that outcomes may be associated with learning. Considering differences in intervention delivery at trial design will ensure that any appropriate adjustments can be made during analysis. This work aimed to establish practice for the allowance of clustering and learning effects in the design and analysis of randomised multicentre trials.

Methods

A survey that drew upon quotes from existing guidelines, references to relevant publications and example trial scenarios was delivered. Registered UK Clinical Research Collaboration Registered Clinical Trials Units were invited to participate.

SUBMITTER: Conroy EJ 

PROVIDER: S-EPMC7251810 | biostudies-literature | 2020 May

REPOSITORIES: biostudies-literature