Development process of a consensus-driven CONSORT extension for randomised trials using an adaptive design.

ABSTRACT:

Background

Adequate reporting of adaptive designs (ADs) maximises their potential benefits in the conduct of clinical trials. Transparent reporting can help address some obstacles and concerns relating to the use of ADs. Currently, there are deficiencies in the reporting of AD trials. To overcome this, we have developed a consensus-driven extension to the CONSORT statement for randomised trials using an AD. This paper describes the processes and methods used to develop this extension rather than detailed explanation of the guideline.

Methods

We developed the guideline in seven overlapping stages: 1) Building on prior research to inform the need for a guideline; 2) A scoping literature review to inform future stages; 3) Drafting the first checklist version involving an Extern

SUBMITTER: Dimairo M 

PROVIDER: S-EPMC6238302 | biostudies-literature | 2018 Nov

REPOSITORIES: biostudies-literature