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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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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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“Extensions to CONSORT have been developed to tackle the methodological issues associated with reporting different types of trial designs, data, and interventions.”
From CONSORT 2025 statement: Updated guideline for reporting randomised trials (2025) · cites this paper as [33]
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“Extensions to CONSORT have been developed to tackle the methodological issues associated with reporting different types of trial designs, data, and interventions.”
From CONSORT 2025 statement: updated guideline for reporting randomised trials (2025) · cites this paper as [33]
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Cites
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Thrombectomy 6 to 24 Hours after Stroke with a Mismatch between Deficit and Infarct
Nogueira, R. G., Jadhav, A. P., Haussen, D. C., Bonafé, A., Budzik, R. F., Bhuva, P., Yavagal, D. R., Ribó, M., Cognard, C., Hanel, R. A., et al. (2017) · New England Journal of Medicine · doi:10.1056/nejmoa1706442 · Cited by 5,667
CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials
Schulz, K. F., Altman, D. G., Moher, D., & for the CONSORT Group* (2010) · Annals of Internal Medicine · doi:10.7326/0003-4819-152-11-201006010-00232 · Cited by 3,824
Self-citationConsort 2010 statement: extension to cluster randomised trials
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Self-citationA Multiple Testing Procedure for Clinical Trials
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Self-citation
Research works printed but not linked: 4
- 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.
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Cited by
Sorted by citations
CONSORT 2025 statement: updated guideline for reporting randomised trials
Hopewell, S., Chan, A.-W., Collins, G. S., Hróbjartsson, A., Moher, D., Schulz, K. F., Tunn, R., Aggarwal, R., Berkwits, M., Berlin, J. A., et al. (2025) · BMJ · doi:10.1136/bmj-2024-081123 · Cited by 1,195
Self-citationCONSORT 2025 statement: updated guideline for reporting randomised trials
Hopewell, S., Chan, A.-W., Collins, G. S., Hróbjartsson, A., Moher, D., Schulz, K. F., Tunn, R., Aggarwal, R., Berkwits, M., Berlin, J. A., et al. (2025) · The Lancet · doi:10.1016/s0140-6736(25)00672-5 · Cited by 510
Self-citationHopewell, S., Chan, A., Collins, P. G. S., Hróbjartsson, A., Moher, D., Schulz, K. F., Tunn, R., Aggarwal, R., Berkwits, M., Berlin, J. A., et al. (2025) · JAMA · doi:10.1001/jama.2025.4347 · Cited by 444
Self-citationCONSORT 2025 statement: updated guideline for reporting randomized trials
Hopewell, S., Chan, A., Collins, P. G. S., Hróbjartsson, A., Moher, D., Schulz, K. F., Tunn, R., Aggarwal, R., Berkwits, M., Berlin, J. A., et al. (2025) · Nature Medicine · doi:10.1038/s41591-025-03635-5 · Cited by 332
“Examples of extensions for trial designs include recommendations for adaptive designs 33 , cluster trials 34 , crossover trials 35 , early phase trials 36 , factorial trials 37 , non-inferiority and equivalence trials 38 , pragmatic trials 39 , multi-arm trials 40 , n-of-1 trials 41 , pilot and…”
Self-citationLuchini, C., Veronese, N., Nottegar, A., Shin, J. I., Gentile, G., Granziol, U., Soysal, P., Alexinschi, O., Smith, L., & Solmi, M. (2020) · Pharmaceutical Statistics · doi:10.1002/pst.2068 · Cited by 249
“transparency and improving the report of adaptive-design randomized trials, to increase both the interpretability of their results and reproducibility of their methods, results, and inference.(25)”
Method
Metadata
- 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
- Published
- 2020-06-17
- Volume
- 21
- Issue
- 1
- Pages
- 528-528
- ISSN
- 1745-6215 (ISSN-L)
- 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
- gold
- doi.org
- 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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