Abstract
Adaptive designs (ADs) allow pre-planned changes to an ongoing trial without compromising the validity of conclusions and it is essential to distinguish pre-planned from unplanned changes that may also occur. The reporting of ADs in randomised trials is inconsistent and needs improving. Incompletely reported AD randomised trials are difficult to reproduce and are hard to interpret and synthesise. This consequently hampers their ability to inform practice as well as future research and contributes to research waste. Better transparency and adequate reporting will enable the potential benefits of ADs to be realised.This extension to the Consolidated Standards Of Reporting Trials (CONSORT) 2010 statement was developed to enhance the reporting of randomised AD clinical trials. We developed an Adaptive designs CONSORT Extension (ACE) guideline through a two-stage Delphi process with input from multidisciplinary key stakeholders in clinical trials research in the public and private sectors from 21 countries, followed by a consensus meeting. Members of the CONSORT Group were involved during the development process.The paper presents the ACE checklists for AD randomised trial reports and abstracts, as well as an explanation with examples to aid the application of the guideline. The ACE checklist comprises seven new items, nine modified items, six unchanged items for which additional explanatory text clarifies further considerations for ADs, and 20 unchanged items not requiring further explanatory text. The ACE abstract checklist has one new item, one modified item, one unchanged item with additional explanatory text for ADs, and 15 unchanged items not requiring further explanatory text.The intention is to enhance transparency and improve reporting of AD randomised trials to improve the interpretability of their results and reproducibility of their methods, results and inference. We also hope indirectly to facilitate the much-needed knowledge transfer of innovative trial designs to maximise their potential benefits. In order to encourage its wide dissemination this article is freely accessible on the BMJ and Trials journal websites.“To maximise the benefit to society, you need to not just do research but do it well” Douglas G Altman
Highlights
Background and 2a objectivesScientific background and explanation of rationale Specific objectives or hypotheses
Recruitment and 14ab Dates defining the periods of recruitment and follow- Dates defining the periods of recruitment and followadaptations up up, for each group
Specify what trial adaptation decisions were made in light of the pre-planned decision-making criteria and observed accrued data
Summary
Trial designDescription of trial design (such as parallel, factorial) including allocation ratio 3b«a3c«3bb Important changes to methods after trial commencement (such as eligibility criteria), with reasonsType of adaptive design used, with details of the preplanned trial adaptations and the statistical information informing the adaptationsImportant changes to the design or methods after trial commencement (such as eligibility criteria) outside the scope of the pre-planned adaptive design features, with reasons. Description of trial design (such as parallel, factorial) including allocation ratio 3b«a. 3c«3bb Important changes to methods after trial commencement (such as eligibility criteria), with reasons. Type of adaptive design used, with details of the preplanned trial adaptations and the statistical information informing the adaptations. Important changes to the design or methods after trial commencement (such as eligibility criteria) outside the scope of the pre-planned adaptive design features, with reasons
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