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Guidance for protocol content and reporting of factorial randomised trials: explanation and elaboration of the CONSORT 2010 and SPIRIT 2013 extensions.

作者信息

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

机构信息

MRC Clinical Trials Unit at UCL, London WC1V 6LJ, UK

Nottingham Clinical Trials Unit, School of Medicine, University of Nottingham, Nottingham, UK.

出版信息

BMJ. 2025 Feb 4;388:e080785. doi: 10.1136/bmj-2024-080785.

DOI:10.1136/bmj-2024-080785
PMID:39904527
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11791685/
Abstract

This report presents the explanation and elaboration paper for the CONSORT (Consolidated Standards of Reporting Trials) 2010 and SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013 extensions for factorial trials. Factorial trials involve randomising participants to more than one intervention, often with the aim of evaluating multiple interventions in one study or assessing whether treatments interact. The CONSORT and SPIRIT statements have been extended to allow for the unique features of the factorial design. Reporting items along with detailed explanations and examples of good practice are provided, as well as a glossary of key terms and an overview of the methodological features of factorial trials.

摘要
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/253c/11791685/acadba824768/kahb080785.f2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/253c/11791685/2420e130cc35/kahb080785.f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/253c/11791685/acadba824768/kahb080785.f2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/253c/11791685/2420e130cc35/kahb080785.f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/253c/11791685/acadba824768/kahb080785.f2.jpg

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Guidance for protocol content and reporting of factorial randomised trials: explanation and elaboration of the CONSORT 2010 and SPIRIT 2013 extensions.

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引用本文的文献

[1]
Realizing the benefits of the estimand framework when reporting and communicating clinical trial results-some recommendations.

Trials. 2025-7-11

[2]
Development of a consensus extension of the estimands framework for cluster randomised trials (CRT-estimands): results from an international Delphi study.

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本文引用的文献

[1]
The estimands framework: a primer on the ICH E9(R1) addendum.

BMJ. 2024-1-23

[2]
Consensus Statement for Protocols of Factorial Randomized Trials: Extension of the SPIRIT 2013 Statement.

JAMA Netw Open. 2023-12-1

[3]
Reporting of Factorial Randomized Trials: Extension of the CONSORT 2010 Statement.

JAMA. 2023-12-5

[4]
When should factorial designs be used for late-phase randomised controlled trials?

Clin Trials. 2024-4

[5]
Enhancing reporting quality and impact of early phase dose-finding clinical trials: CONSORT Dose-finding Extension (CONSORT-DEFINE) guidance.

BMJ. 2023-10-20

[6]
Design and analysis of factorial clinical trials: The impact of one treatment's effectiveness on the statistical power and required sample size of the other.

Stat Methods Med Res. 2023-6

[7]
Eliminating Ambiguous Treatment Effects Using Estimands.

Am J Epidemiol. 2023-6-2

[8]
Assessment of infant position and timing of stylet removal to improve lumbar puncture success in neonates (NeoCLEAR): an open-label, 2 × 2 factorial, randomised, controlled trial.

Lancet Child Adolesc Health. 2023-2

[9]
Evaluating how clear the questions being investigated in randomised trials are: systematic review of estimands.

BMJ. 2022-8-23

[10]
EvaLuation of early CRRT and beta-blocker InTervention in patients with ECMO (ELITE) trial: study protocol for a 2 × 2 partial factorial randomized controlled trial.

Trials. 2022-8-19

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