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Development process of a consensus-driven CONSORT extension for randomised trials using an adaptive design

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Development process of a consensus-driven CONSORT extension for randomised trials using an adaptive design. / Dimairo, M.; Coates, E.; Pallmann, P.; Todd, S.; Julious, S.A.; Jaki, T.; Wason, J.; Mander, A.P.; Weir, C.J.; Koenig, F.; Walton, M.K.; Biggs, K.; Nicholl, J.; Hamasaki, T.; Proschan, M.A.; Scott, J.A.; Ando, Y.; Hind, D.; Altman, D.G.

In: BMC Medicine, Vol. 16, No. 1, 16.11.2018.

Research output: Contribution to Journal/MagazineJournal articlepeer-review

Harvard

Dimairo, M, Coates, E, Pallmann, P, Todd, S, Julious, SA, Jaki, T, Wason, J, Mander, AP, Weir, CJ, Koenig, F, Walton, MK, Biggs, K, Nicholl, J, Hamasaki, T, Proschan, MA, Scott, JA, Ando, Y, Hind, D & Altman, DG 2018, 'Development process of a consensus-driven CONSORT extension for randomised trials using an adaptive design', BMC Medicine, vol. 16, no. 1. https://doi.org/10.1186/s12916-018-1196-2

APA

Dimairo, M., Coates, E., Pallmann, P., Todd, S., Julious, S. A., Jaki, T., Wason, J., Mander, A. P., Weir, C. J., Koenig, F., Walton, M. K., Biggs, K., Nicholl, J., Hamasaki, T., Proschan, M. A., Scott, J. A., Ando, Y., Hind, D., & Altman, D. G. (2018). Development process of a consensus-driven CONSORT extension for randomised trials using an adaptive design. BMC Medicine, 16(1). https://doi.org/10.1186/s12916-018-1196-2

Vancouver

Author

Dimairo, M. ; Coates, E. ; Pallmann, P. ; Todd, S. ; Julious, S.A. ; Jaki, T. ; Wason, J. ; Mander, A.P. ; Weir, C.J. ; Koenig, F. ; Walton, M.K. ; Biggs, K. ; Nicholl, J. ; Hamasaki, T. ; Proschan, M.A. ; Scott, J.A. ; Ando, Y. ; Hind, D. ; Altman, D.G. / Development process of a consensus-driven CONSORT extension for randomised trials using an adaptive design. In: BMC Medicine. 2018 ; Vol. 16, No. 1.

Bibtex

@article{60923bfd9c264c098ec53fce34501044,
title = "Development process of a consensus-driven CONSORT extension for randomised trials using an adaptive design",
abstract = "Background: Adequate reporting of adaptive designs (ADs) maximises their potential benefits in the conduct of clinical trials. Transparent reporting can help address some obstacles and concerns relating to the use of ADs. Currently, there are deficiencies in the reporting of AD trials. To overcome this, we have developed a consensus-driven extension to the CONSORT statement for randomised trials using an AD. This paper describes the processes and methods used to develop this extension rather than detailed explanation of the guideline. Methods: We developed the guideline in seven overlapping stages: 1) Building on prior research to inform the need for a guideline; 2) A scoping literature review to inform future stages; 3) Drafting the first checklist version involving an External Expert Panel; 4) A two-round Delphi process involving international, multidisciplinary, and cross-sector key stakeholders; 5) A consensus meeting to advise which reporting items to retain through voting, and to discuss the structure of what to include in the supporting explanation and elaboration (E&E) document; 6) Refining and finalising the checklist; and 7) Writing-up and dissemination of the E&E document. The CONSORT Executive Group oversaw the entire development process. Results: Delphi survey response rates were 94/143 (66%), 114/156 (73%), and 79/143 (55%) in rounds 1, 2, and across both rounds, respectively. Twenty-seven delegates from Europe, the USA, and Asia attended the consensus meeting. The main checklist has seven new and nine modified items and six unchanged items with expanded E&E text to clarify further considerations for ADs. The abstract checklist has one new and one modified item together with an unchanged item with expanded E&E text. The E&E document will describe the scope of the guideline, the definition of an AD, and some types of ADs and trial adaptations and explain each reporting item in detail including case studies. Conclusions: We hope that making the development processes, methods, and all supporting information that aided decision-making transparent will enhance the acceptability and quick uptake of the guideline. This will also help other groups when developing similar CONSORT extensions. The guideline is applicable to all randomised trials with an AD and contains minimum reporting requirements. {\textcopyright} 2018 The Author(s).",
keywords = "Adaptive design, CONSORT extension, Flexible design, Randomised controlled trial, Reporting guidance, Reporting guideline, article, Asia, checklist, controlled study, decision making, Delphi study, Europe, human, human experiment, randomized controlled trial, writing",
author = "M. Dimairo and E. Coates and P. Pallmann and S. Todd and S.A. Julious and T. Jaki and J. Wason and A.P. Mander and C.J. Weir and F. Koenig and M.K. Walton and K. Biggs and J. Nicholl and T. Hamasaki and M.A. Proschan and J.A. Scott and Y. Ando and D. Hind and D.G. Altman",
year = "2018",
month = nov,
day = "16",
doi = "10.1186/s12916-018-1196-2",
language = "English",
volume = "16",
journal = "BMC Medicine",
issn = "1741-7015",
publisher = "BIOMED CENTRAL LTD",
number = "1",

}

RIS

TY - JOUR

T1 - Development process of a consensus-driven CONSORT extension for randomised trials using an adaptive design

AU - Dimairo, M.

AU - Coates, E.

AU - Pallmann, P.

AU - Todd, S.

AU - Julious, S.A.

AU - Jaki, T.

AU - Wason, J.

AU - Mander, A.P.

AU - Weir, C.J.

AU - Koenig, F.

AU - Walton, M.K.

AU - Biggs, K.

AU - Nicholl, J.

AU - Hamasaki, T.

AU - Proschan, M.A.

AU - Scott, J.A.

AU - Ando, Y.

AU - Hind, D.

AU - Altman, D.G.

PY - 2018/11/16

Y1 - 2018/11/16

N2 - Background: Adequate reporting of adaptive designs (ADs) maximises their potential benefits in the conduct of clinical trials. Transparent reporting can help address some obstacles and concerns relating to the use of ADs. Currently, there are deficiencies in the reporting of AD trials. To overcome this, we have developed a consensus-driven extension to the CONSORT statement for randomised trials using an AD. This paper describes the processes and methods used to develop this extension rather than detailed explanation of the guideline. Methods: We developed the guideline in seven overlapping stages: 1) Building on prior research to inform the need for a guideline; 2) A scoping literature review to inform future stages; 3) Drafting the first checklist version involving an External Expert Panel; 4) A two-round Delphi process involving international, multidisciplinary, and cross-sector key stakeholders; 5) A consensus meeting to advise which reporting items to retain through voting, and to discuss the structure of what to include in the supporting explanation and elaboration (E&E) document; 6) Refining and finalising the checklist; and 7) Writing-up and dissemination of the E&E document. The CONSORT Executive Group oversaw the entire development process. Results: Delphi survey response rates were 94/143 (66%), 114/156 (73%), and 79/143 (55%) in rounds 1, 2, and across both rounds, respectively. Twenty-seven delegates from Europe, the USA, and Asia attended the consensus meeting. The main checklist has seven new and nine modified items and six unchanged items with expanded E&E text to clarify further considerations for ADs. The abstract checklist has one new and one modified item together with an unchanged item with expanded E&E text. The E&E document will describe the scope of the guideline, the definition of an AD, and some types of ADs and trial adaptations and explain each reporting item in detail including case studies. Conclusions: We hope that making the development processes, methods, and all supporting information that aided decision-making transparent will enhance the acceptability and quick uptake of the guideline. This will also help other groups when developing similar CONSORT extensions. The guideline is applicable to all randomised trials with an AD and contains minimum reporting requirements. © 2018 The Author(s).

AB - Background: Adequate reporting of adaptive designs (ADs) maximises their potential benefits in the conduct of clinical trials. Transparent reporting can help address some obstacles and concerns relating to the use of ADs. Currently, there are deficiencies in the reporting of AD trials. To overcome this, we have developed a consensus-driven extension to the CONSORT statement for randomised trials using an AD. This paper describes the processes and methods used to develop this extension rather than detailed explanation of the guideline. Methods: We developed the guideline in seven overlapping stages: 1) Building on prior research to inform the need for a guideline; 2) A scoping literature review to inform future stages; 3) Drafting the first checklist version involving an External Expert Panel; 4) A two-round Delphi process involving international, multidisciplinary, and cross-sector key stakeholders; 5) A consensus meeting to advise which reporting items to retain through voting, and to discuss the structure of what to include in the supporting explanation and elaboration (E&E) document; 6) Refining and finalising the checklist; and 7) Writing-up and dissemination of the E&E document. The CONSORT Executive Group oversaw the entire development process. Results: Delphi survey response rates were 94/143 (66%), 114/156 (73%), and 79/143 (55%) in rounds 1, 2, and across both rounds, respectively. Twenty-seven delegates from Europe, the USA, and Asia attended the consensus meeting. The main checklist has seven new and nine modified items and six unchanged items with expanded E&E text to clarify further considerations for ADs. The abstract checklist has one new and one modified item together with an unchanged item with expanded E&E text. The E&E document will describe the scope of the guideline, the definition of an AD, and some types of ADs and trial adaptations and explain each reporting item in detail including case studies. Conclusions: We hope that making the development processes, methods, and all supporting information that aided decision-making transparent will enhance the acceptability and quick uptake of the guideline. This will also help other groups when developing similar CONSORT extensions. The guideline is applicable to all randomised trials with an AD and contains minimum reporting requirements. © 2018 The Author(s).

KW - Adaptive design

KW - CONSORT extension

KW - Flexible design

KW - Randomised controlled trial

KW - Reporting guidance

KW - Reporting guideline

KW - article

KW - Asia

KW - checklist

KW - controlled study

KW - decision making

KW - Delphi study

KW - Europe

KW - human

KW - human experiment

KW - randomized controlled trial

KW - writing

U2 - 10.1186/s12916-018-1196-2

DO - 10.1186/s12916-018-1196-2

M3 - Journal article

VL - 16

JO - BMC Medicine

JF - BMC Medicine

SN - 1741-7015

IS - 1

ER -