Consensus Statement for Protocols of Factorial Randomized Trials: Extension of the SPIRIT 2013 Statement

Brennan C. Kahan; Sophie S. Hall; Elaine M. Beller; Megan Birchenall; Diana Elbourne; Edmund Juszczak; Paul Little; John Fletcher; Robert M. Golub; Beatriz Goulao; Sally Hopewell; Nazrul Islam; Merrick Zwarenstein; An-Wen Chan; Alan A. Montgomery

doi:10.1001/jamanetworkopen.2023.46121

Consensus Statement for Protocols of Factorial Randomized Trials: Extension of the SPIRIT 2013 Statement

Brennan C. Kahan^* (Corresponding Author), Sophie S. Hall, Elaine M. Beller, Megan Birchenall, Diana Elbourne, Edmund Juszczak, Paul Little, John Fletcher, Robert M. Golub, Beatriz Goulao, Sally Hopewell, Nazrul Islam, Merrick Zwarenstein, An-Wen Chan, Alan A. Montgomery

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

3 Citations (Scopus)

Abstract

Trial protocols outline a trial’s objectives as well as the methods (design, conduct, and analysis) that will be used to meet those objectives, and transparent reporting of trial protocols ensures objectives are clear and facilitates appraisal regarding the suitability of study methods. Factorial trials, in which 2 or more interventions are assessed in the same set of participants, have unique methodological considerations. However, no extension of the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2013 Statement, which provides guidance on reporting of trial protocols, for factorial trials is available.To develop a consensus-based extension to the SPIRIT 2013 Statement for factorial trials.The SPIRIT extension for factorial trials was developed using the Enhancing the Quality and Transparency of Health Research (EQUATOR) methodological framework. First, a list of reporting recommendations was generated using a scoping review of methodological articles identified using a MEDLINE search (inception to May 2019), which was supplemented with relevant articles from the personal collections of the authors. Second, a 3-round Delphi survey (January to June 2022, completed by 104 panelists from 14 countries) was conducted to assess the importance of items and identify additional recommendations. Third, a hybrid consensus meeting was held, attended by 15 panelists to finalize selection and wording of the checklist.This SPIRIT extension for factorial trials modified 9 of the 33 items in the SPIRIT 2013 checklist. Key reporting recommendations were that the rationale for using a factorial design should be provided, including whether an interaction is hypothesized; the treatment groups that will form the main comparisons should be identified; and statistical methods for each main comparison should be provided, including how interactions will be assessed.In this consensus statement, 9 factorial-specific items were provided that should be addressed in all protocols of factorial trials to increase the trial’s utility and transparency.

Original language	English
Article number	e2346121
Number of pages	12
Journal	JAMA Network Open
Volume	6
Issue number	12
DOIs	https://doi.org/10.1001/jamanetworkopen.2023.46121
Publication status	Published - 5 Dec 2023

Bibliographical note

Funding/Support: This work was supported by the Medical Research Council [grant number MR/V020803/1].

Data Availability Statement

Data available: No Additional Information
Explanation for why data not available: Data can be requested by contacting the corresponding author

Access to Document

10.1001/jamanetworkopen.2023.46121Licence: CC BY

Kahan_etal_JAMAOp_Consensus_Statement_Protocol_VOR
Open Access: This is an open access article distributed under the terms of the CC-BY License. © 2023 Kahan BC et al. JAMA Network Open. https://creativecommons.org/licenses/by/4.0/
Final published version, 831 KBLicence: CC BY

Cite this

Kahan, B. C., Hall, S. S., Beller, E. M., Birchenall, M., Elbourne, D., Juszczak, E., Little, P., Fletcher, J., Golub, R. M., Goulao, B., Hopewell, S., Islam, N., Zwarenstein, M., Chan, A.-W., & Montgomery, A. A. (2023). Consensus Statement for Protocols of Factorial Randomized Trials: Extension of the SPIRIT 2013 Statement. JAMA Network Open, 6(12), Article e2346121. https://doi.org/10.1001/jamanetworkopen.2023.46121

Kahan, BC, Hall, SS, Beller, EM, Birchenall, M, Elbourne, D, Juszczak, E, Little, P, Fletcher, J, Golub, RM, Goulao, B, Hopewell, S, Islam, N, Zwarenstein, M, Chan, A-W & Montgomery, AA 2023, 'Consensus Statement for Protocols of Factorial Randomized Trials: Extension of the SPIRIT 2013 Statement', JAMA Network Open, vol. 6, no. 12, e2346121. https://doi.org/10.1001/jamanetworkopen.2023.46121

@article{1752b54e5d364fbc905001ffcc4d437b,

title = "Consensus Statement for Protocols of Factorial Randomized Trials: Extension of the SPIRIT 2013 Statement",

abstract = "Trial protocols outline a trial{\textquoteright}s objectives as well as the methods (design, conduct, and analysis) that will be used to meet those objectives, and transparent reporting of trial protocols ensures objectives are clear and facilitates appraisal regarding the suitability of study methods. Factorial trials, in which 2 or more interventions are assessed in the same set of participants, have unique methodological considerations. However, no extension of the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2013 Statement, which provides guidance on reporting of trial protocols, for factorial trials is available.To develop a consensus-based extension to the SPIRIT 2013 Statement for factorial trials.The SPIRIT extension for factorial trials was developed using the Enhancing the Quality and Transparency of Health Research (EQUATOR) methodological framework. First, a list of reporting recommendations was generated using a scoping review of methodological articles identified using a MEDLINE search (inception to May 2019), which was supplemented with relevant articles from the personal collections of the authors. Second, a 3-round Delphi survey (January to June 2022, completed by 104 panelists from 14 countries) was conducted to assess the importance of items and identify additional recommendations. Third, a hybrid consensus meeting was held, attended by 15 panelists to finalize selection and wording of the checklist.This SPIRIT extension for factorial trials modified 9 of the 33 items in the SPIRIT 2013 checklist. Key reporting recommendations were that the rationale for using a factorial design should be provided, including whether an interaction is hypothesized; the treatment groups that will form the main comparisons should be identified; and statistical methods for each main comparison should be provided, including how interactions will be assessed.In this consensus statement, 9 factorial-specific items were provided that should be addressed in all protocols of factorial trials to increase the trial{\textquoteright}s utility and transparency.",

author = "Kahan, {Brennan C.} and Hall, {Sophie S.} and Beller, {Elaine M.} and Megan Birchenall and Diana Elbourne and Edmund Juszczak and Paul Little and John Fletcher and Golub, {Robert M.} and Beatriz Goulao and Sally Hopewell and Nazrul Islam and Merrick Zwarenstein and An-Wen Chan and Montgomery, {Alan A.}",

note = "Funding/Support: This work was supported by the Medical Research Council [grant number MR/V020803/1].",

year = "2023",

month = dec,

day = "5",

doi = "10.1001/jamanetworkopen.2023.46121",

language = "English",

volume = "6",

journal = "JAMA Network Open",

issn = "2574-3805",

publisher = "American Medical Association",

number = "12",

}

TY - JOUR

T1 - Consensus Statement for Protocols of Factorial Randomized Trials

T2 - Extension of the SPIRIT 2013 Statement

AU - Kahan, Brennan C.

AU - Hall, Sophie S.

AU - Beller, Elaine M.

AU - Birchenall, Megan

AU - Elbourne, Diana

AU - Juszczak, Edmund

AU - Little, Paul

AU - Fletcher, John

AU - Golub, Robert M.

AU - Goulao, Beatriz

AU - Hopewell, Sally

AU - Islam, Nazrul

AU - Zwarenstein, Merrick

AU - Chan, An-Wen

AU - Montgomery, Alan A.

N1 - Funding/Support: This work was supported by the Medical Research Council [grant number MR/V020803/1].

PY - 2023/12/5

Y1 - 2023/12/5

N2 - Trial protocols outline a trial’s objectives as well as the methods (design, conduct, and analysis) that will be used to meet those objectives, and transparent reporting of trial protocols ensures objectives are clear and facilitates appraisal regarding the suitability of study methods. Factorial trials, in which 2 or more interventions are assessed in the same set of participants, have unique methodological considerations. However, no extension of the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2013 Statement, which provides guidance on reporting of trial protocols, for factorial trials is available.To develop a consensus-based extension to the SPIRIT 2013 Statement for factorial trials.The SPIRIT extension for factorial trials was developed using the Enhancing the Quality and Transparency of Health Research (EQUATOR) methodological framework. First, a list of reporting recommendations was generated using a scoping review of methodological articles identified using a MEDLINE search (inception to May 2019), which was supplemented with relevant articles from the personal collections of the authors. Second, a 3-round Delphi survey (January to June 2022, completed by 104 panelists from 14 countries) was conducted to assess the importance of items and identify additional recommendations. Third, a hybrid consensus meeting was held, attended by 15 panelists to finalize selection and wording of the checklist.This SPIRIT extension for factorial trials modified 9 of the 33 items in the SPIRIT 2013 checklist. Key reporting recommendations were that the rationale for using a factorial design should be provided, including whether an interaction is hypothesized; the treatment groups that will form the main comparisons should be identified; and statistical methods for each main comparison should be provided, including how interactions will be assessed.In this consensus statement, 9 factorial-specific items were provided that should be addressed in all protocols of factorial trials to increase the trial’s utility and transparency.

AB - Trial protocols outline a trial’s objectives as well as the methods (design, conduct, and analysis) that will be used to meet those objectives, and transparent reporting of trial protocols ensures objectives are clear and facilitates appraisal regarding the suitability of study methods. Factorial trials, in which 2 or more interventions are assessed in the same set of participants, have unique methodological considerations. However, no extension of the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2013 Statement, which provides guidance on reporting of trial protocols, for factorial trials is available.To develop a consensus-based extension to the SPIRIT 2013 Statement for factorial trials.The SPIRIT extension for factorial trials was developed using the Enhancing the Quality and Transparency of Health Research (EQUATOR) methodological framework. First, a list of reporting recommendations was generated using a scoping review of methodological articles identified using a MEDLINE search (inception to May 2019), which was supplemented with relevant articles from the personal collections of the authors. Second, a 3-round Delphi survey (January to June 2022, completed by 104 panelists from 14 countries) was conducted to assess the importance of items and identify additional recommendations. Third, a hybrid consensus meeting was held, attended by 15 panelists to finalize selection and wording of the checklist.This SPIRIT extension for factorial trials modified 9 of the 33 items in the SPIRIT 2013 checklist. Key reporting recommendations were that the rationale for using a factorial design should be provided, including whether an interaction is hypothesized; the treatment groups that will form the main comparisons should be identified; and statistical methods for each main comparison should be provided, including how interactions will be assessed.In this consensus statement, 9 factorial-specific items were provided that should be addressed in all protocols of factorial trials to increase the trial’s utility and transparency.

U2 - 10.1001/jamanetworkopen.2023.46121

DO - 10.1001/jamanetworkopen.2023.46121

M3 - Article

C2 - 38051535

SN - 2574-3805

VL - 6

JO - JAMA Network Open

JF - JAMA Network Open

IS - 12

M1 - e2346121

ER -

Consensus Statement for Protocols of Factorial Randomized Trials: Extension of the SPIRIT 2013 Statement

Abstract

Bibliographical note

Data Availability Statement

Access to Document

Fingerprint

Cite this