Introducing the Adaptive designs CONSORT Extension (ACE) Statement to improve reporting of randomised trials that use an adaptive design (P-7)

Dimairo, Munya, Pallmann, Philip ORCID: https://orcid.org/0000-0001-8274-9696, Wason, James, Todd, Sue, Jaki, Thomas, Julious, Steven A., Mander, Adrian ORCID: https://orcid.org/0000-0002-0742-9040, Weir, Christopher J., Koenig, Franz, Walton, Marc K., Nicholl, Jon P., Coates, Elizabeth, Biggs, Katie, Hamasaki, Toshimitsu, Proschan, Michael A., Scott, John A., Ando, Yuki, Hind, Daniel and Altman, Douglas G. 2019. Introducing the Adaptive designs CONSORT Extension (ACE) Statement to improve reporting of randomised trials that use an adaptive design (P-7). Presented at: 5th International Clinical Trials Methodology Conference (ICTMC 2019), Brighton, UK, 6-9 October 2019. Trials. BioMed Central, -. 10.1186/s13063-019-3688-6

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Abstract

Background: The reporting of adaptive designs (ADs) in randomised trials is inconsistent and needs improving [1]. 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. Methods: 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 [1]. Delphi survey response rates were 94/143 (66%),114/156 (73%), and 79/143 (55%) in round one, two and across bothrounds, respectively. Members of the CONSORT Group were involved during the development process. Results: The resultant ACE checklist is comprised of 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 ACE guideline contains minimum essential reporting requirements and it applies to both frequentist and Bayesian ADs in randomised trials. Discussion: 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

Item Type:	Conference or Workshop Item (Paper)
Date Type:	Published Online
Status:	Published
Schools:	Centre for Trials Research (CNTRR)
Publisher:	BioMed Central
ISSN:	1745-6215
Date of First Compliant Deposit:	25 March 2020
Last Modified:	03 Dec 2022 02:08
URI:	https://orca.cardiff.ac.uk/id/eprint/129404

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