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Cited by 58Statistical Methods in Clinical TrialsMeta-analysis and systematic reviewsDelphi Technique in Research

The DOI matches its Crossref record; 276 of the 278 references it cites were found in a registry or an index.

The adaptive designs CONSORT extension (ACE) statement: a checklist with explanation and elaboration guideline for reporting randomised trials that use an adaptive design

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Dimairo, Munyaradzi, Pallmann, Philip, Wason, James, Todd, Susan, Jaki, Thomas, Julious, Steven A., Mander, Adrian P., 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, Altman, Douglas G., on behalf of the ACE Consensus Group, Dimairo, Munyaradzi, Hamasaki, Toshimitsu, Todd, Susan, Weir, Christopher J., Mander, Adrian P., Wason, James, Koenig, Franz, Julious, Steven A., Hind, Daniel, Nicholl, Jon, Altman, Douglas G., Meurer, William J., Cates, Christopher, Sydes, Matthew, Jemiai, Yannis, Ashby, Deborah, Yap, Christina, Waldron-Lynch, Frank, Roger, James, Marsh, Joan, Collignon, Olivier, Lawrence, David J., Bunce, Catey, Parke, Tom, Gazzard, Gus, Coates, Elizabeth, Walton, Marc K., Hopewell, Sally, Pallmann, Philip, Jaki, Thomas, Biggs, Katie, Proschan, Michael A., Scott, John A., Ando, Yuki·2020·Trials
DOI 10.1186/s13063-020-04334-xPMC PMC7298968

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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

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Fig. 1 Adapted from Steg et al. [182]
Fig. 1 Adapted from Steg et al. [182]CC BY · PubMed Central
Fig. 2 Redrawn from Gilson et al. [260] Reused in accordance with the terms of Creative Commons Attribution 4.0 International License (https://creativecommons.org/licenses/by/4.0/). No changes to the original figure were made
Fig. 2 Redrawn from Gilson et al. [260] Reused in accordance with the terms of Creative Commons Attribution 4.0 International License (https://creativecommons.org/licenses/by/4.0/). No changes to the original figure were madeCC BY · PubMed Central
Fig. 3 Redrawn from Pallmann et al. [22] Reused in accordance with the terms of Creative Commons Attribution 4.0 International License (https://creativecommons.org/licenses/by/4.0/). No changes to the original figure were made
Fig. 3 Redrawn from Pallmann et al. [22] Reused in accordance with the terms of Creative Commons Attribution 4.0 International License (https://creativecommons.org/licenses/by/4.0/). No changes to the original figure were madeCC BY · PubMed Central

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Research works printed but not linked: 4

  1. Detry MA, Lewis RJ, Broglio KR, et al. Standards for the design, conduct, and evaluation of adaptive randomized clinical trials. 2012. https://www.pcori.org/assets/Standards-for-the-Design-Conduct-and-Evaluation-of-Adaptive-Randomized-Clinical-Trials.pdf.
  2. Hack N, Brannath W. Estimation in adaptive group sequential trials; 2011.
  3. Vandemeulebroecke M. An investigation of two-stage tests. Stat Sin. 2006;16:933–51.
  4. Wagenmakers E-J, Gronau QF, Stefan A, et al. A Bayesian perspective on the proposed FDA guidelines for adaptive clinical trials. 2018. https://www.bayesianspectacles.org/a-bayesian-perspective-on-the-proposed-fda-guidelines-for-adaptive-clinical-trials/.

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Authors
Dimairo, M., Pallmann, P., Wason, J., Todd, S., Jaki, T., Julious, S. A., Mander, A. P., Weir, C. J., Koenig, F., Walton, M. K., Nicholl, J. P., Coates, E., Biggs, K., Hamasaki, T., Proschan, M. A., Scott, J. A., Ando, Y., Hind, D., Altman, D. G., on behalf of the ACE Consensus Group, Dimairo, M., Hamasaki, T., Todd, S., Weir, C. J., Mander, A. P., Wason, J., Koenig, F., Julious, S. A., Hind, D., Nicholl, J., Altman, D. G., Meurer, W. J., Cates, C., Sydes, M., Jemiai, Y., Ashby, D., Yap, C., Waldron-Lynch, F., Roger, J., Marsh, J., Collignon, O., Lawrence, D. J., Bunce, C., Parke, T., Gazzard, G., Coates, E., Walton, M. K., Hopewell, S., Pallmann, P., Jaki, T., Biggs, K., Proschan, M. A., Scott, J. A., & Ando, Y.
Affiliations
  • University of Sheffield (GB)
  • University of Edinburgh (GB)
  • Newcastle University (GB)
  • Cardiff University (GB)
ORCID
Venue
Trials
Publisher
Springer Science and Business Media LLC
Published
2020-06-17
Volume
21
Issue
1
Pages
528-528
ISSN
1745-6215 (ISSN-L)
DOI
10.1186/s13063-020-04334-x
PMC
PMC7298968
OpenAlex
W3000741148
Cited by
58
References
278
Citations by year
2026: 1 · 2025: 17 · 2024: 14 · 2023: 6 · 2022: 8 · 2021: 7 · 2020: 5
FWCI
4.58
Type
journal article
Language
en
Open access
Licence
Locations
  • Trials (publishedVersion, cc-by)
  • Research Square (acceptedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • White Rose Research Online (University of Leeds, The University of Sheffield, University of York) (acceptedVersion)
  • ORCA Online Research @Cardiff (Cardiff University) (acceptedVersion)
  • Apollo (University of Cambridge) (submittedVersion, cc-by)
  • DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
  • Lancaster EPrints (Lancaster University) (submittedVersion)
  • UCL Discovery (University College London) (submittedVersion)
  • Edinburgh Research Explorer (University of Edinburgh) (submittedVersion, cc-by)
  • Apollo (cc-by)
Funders
  • Cancer Research UK (16895)
  • National Institute for Health and Care Research (DRF-2012-05-182, SRF-2015-08-001)
  • Department of Health and Social Care
  • University of Sheffield
  • Medical Research Council (NIHR-SRF-2015-08-001, MR/L004933/1, MR/L004933/2, MR/N028171/1, MC_UU_12023/24, MR/L004933/1-R/N/P/B1)
  • NIHR Academy (SRF-2015-08-001)
Topics
  • Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
  • Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
  • Social Sciences › Sociology and Political Science › Delphi Technique in Research
Keywords
adaptive design, CONSORT extension, reporting guidelines, randomised trials, research waste
MeSH terms
Delphi Technique, Humans, Periodicals as Topic, Publishing, Quality Control, Research Design, Reproducibility of Results, Randomized Controlled Trials as Topic, Guidelines as Topic, Consensus, Checklist

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