Managing clustering effects and learning effects in the design and analysis of randomised surgical trials: a review of existing guidance.

ABSTRACT:

Background

The complexities associated with delivering randomised surgical trials, such as clustering effects, by centre or surgeon, and surgical learning, are well known. Despite this, approaches used to manage these complexities, and opinions on these, vary. Guidance documents have been developed to support clinical trial design and reporting. This work aimed to identify and examine existing guidance and consider its relevance to clustering effects and learning curves within surgical trials.

Methods

A review of existing guidelines, developed to inform the design and analysis of randomised controlled trials, is undertaken. Guidelines were identified using an electronic search, within the Equator Network, and by a targeted search of those endorsed by leading UK funding bodie

SUBMITTER: Conroy EJ 

PROVIDER: S-EPMC9552436 | biostudies-literature | 2022 Oct

REPOSITORIES: biostudies-literature