Home > Research > Publications & Outputs > The Adaptive designs CONSORT Extension (ACE) st...

Links

Text available via DOI:

View graph of relations

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

Research output: Contribution to journalJournal articlepeer-review

Published

Standard

The Adaptive designs CONSORT Extension (ACE) statement : a checklist with explanation and elaboration guideline for reporting randomised trials that use an adaptive design. / 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.; Group, ACE Consensus.

In: BMJ, Vol. 369, m115, 17.06.2020.

Research output: Contribution to journalJournal articlepeer-review

Harvard

Dimairo, M, Pallmann, P, Wason, J, Todd, S, Jaki, T, Julious, SA, Mander, AP, Weir, CJ, Koenig, F, Walton, MK, Nicholl, JP, Coates, E, Biggs, K, Hamasaki, T, Proschan, MA, Scott, JA, Ando, Y, Hind, D, Altman, DG & Group, ACEC 2020, 'The Adaptive designs CONSORT Extension (ACE) statement: a checklist with explanation and elaboration guideline for reporting randomised trials that use an adaptive design', BMJ, vol. 369, m115. https://doi.org/10.1136/bmj.m115

APA

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., & Group, ACE. C. (2020). The Adaptive designs CONSORT Extension (ACE) statement: a checklist with explanation and elaboration guideline for reporting randomised trials that use an adaptive design. BMJ, 369, [m115]. https://doi.org/10.1136/bmj.m115

Vancouver

Author

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. ; Group, ACE Consensus. / The Adaptive designs CONSORT Extension (ACE) statement : a checklist with explanation and elaboration guideline for reporting randomised trials that use an adaptive design. In: BMJ. 2020 ; Vol. 369.

Bibtex

@article{40e8b96674c44fd999d920eff75e28eb,
title = "The Adaptive designs CONSORT Extension (ACE) statement: a checklist with explanation and elaboration guideline for reporting randomised trials that use an adaptive design",
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.",
keywords = "adaptive clinical trial, article, checklist, consensus, controlled study, Delphi study, human, practice guideline, private sector, randomized controlled trial, reproducibility",
author = "M. Dimairo and P. Pallmann and J. Wason and S. Todd and T. Jaki and S.A. Julious and A.P. Mander and C.J. Weir and F. Koenig and M.K. Walton and J.P. Nicholl and E. Coates and K. Biggs and T. Hamasaki and M.A. Proschan and J.A. Scott and Y. Ando and D. Hind and D.G. Altman and Group, {ACE Consensus}",
year = "2020",
month = jun,
day = "17",
doi = "10.1136/bmj.m115",
language = "English",
volume = "369",
journal = "BMJ",
issn = "0959-8138",
publisher = "British Medical Association",

}

RIS

TY - JOUR

T1 - The Adaptive designs CONSORT Extension (ACE) statement

T2 - a checklist with explanation and elaboration guideline for reporting randomised trials that use an adaptive design

AU - Dimairo, M.

AU - Pallmann, P.

AU - Wason, J.

AU - Todd, S.

AU - Jaki, T.

AU - Julious, S.A.

AU - Mander, A.P.

AU - Weir, C.J.

AU - Koenig, F.

AU - Walton, M.K.

AU - Nicholl, J.P.

AU - Coates, E.

AU - Biggs, K.

AU - Hamasaki, T.

AU - Proschan, M.A.

AU - Scott, J.A.

AU - Ando, Y.

AU - Hind, D.

AU - Altman, D.G.

AU - Group, ACE Consensus

PY - 2020/6/17

Y1 - 2020/6/17

N2 - 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.

AB - 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.

KW - adaptive clinical trial

KW - article

KW - checklist

KW - consensus

KW - controlled study

KW - Delphi study

KW - human

KW - practice guideline

KW - private sector

KW - randomized controlled trial

KW - reproducibility

U2 - 10.1136/bmj.m115

DO - 10.1136/bmj.m115

M3 - Journal article

VL - 369

JO - BMJ

JF - BMJ

SN - 0959-8138

M1 - m115

ER -