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
MRC Clinical Trials Unit at UCL, London WC1V 6LJ, UK
Nottingham Clinical Trials Unit, School of Medicine, University of Nottingham, Nottingham, UK.
BMJ. 2025 Feb 4;388:e080785. doi: 10.1136/bmj-2024-080785.
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.
本报告介绍了2010年CONSORT（试验报告统一标准）和2013年SPIRIT（干预性试验标准方案条目：建议）针对析因试验的扩展说明及阐述文件。析因试验涉及将参与者随机分配至一种以上干预措施，其目的通常是在一项研究中评估多种干预措施，或评估治疗方法之间是否存在相互作用。CONSORT和SPIRIT声明已进行扩展，以适应析因设计的独特特征。报告项目以及详细解释和良好实践示例均已提供，同时还提供了关键术语词汇表以及析因试验方法学特征概述。
