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《SPIRIT 2025解释与阐述：随机试验方案更新指南》

SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials.

作者信息

Hróbjartsson Asbjørn, Boutron Isabelle, Hopewell Sally, Moher David, Schulz Kenneth F, Collins Gary S, Tunn Ruth, Aggarwal Rakesh, Berkwits Michael, Berlin Jesse A, Bhandari Nita, Butcher Nancy J, Campbell Marion K, Chidebe Runcie C W, Elbourne Diana R, Farmer Andrew J, Fergusson Dean A, Golub Robert M, Goodman Steven N, Hoffmann Tammy C, Ioannidis John P A, Kahan Brennan C, Knowles Rachel L, Lamb Sarah E, Lewis Steff, Loder Elizabeth, Offringa Martin, Ravaud Philippe, Richards Dawn P, Rockhold Frank W, Schriger David L, Siegfried Nandi L, Staniszewska Sophie, Taylor Rod S, Thabane Lehana, Torgerson David J, Vohra Sunita, White Ian R, Chan An-Wen

机构信息

Centre for Evidence-Based Medicine Odense and Cochrane Denmark, Department of Clinical Research, University of Southern Denmark, Odense, Denmark

Open Patient data Explorative Network, Odense University Hospital, Odense, Denmark.

出版信息

BMJ. 2025 Apr 28;389:e081660. doi: 10.1136/bmj-2024-081660.

DOI:10.1136/bmj-2024-081660
PMID:40294956
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12128891/
Abstract

High quality protocols facilitate proper planning, conduct, reporting, and external review of randomised trials, yet their completeness varies and key elements are often not considered. To strengthen good reporting of trial protocols, the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013 statement has been updated to incorporate new evidence and emerging perspectives. This SPIRIT 2025 explanation and elaboration document provides users with exemplars of reporting in contemporary trial protocols, contextual elaboration, more detailed guidance on reporting, references to key empirical studies, an expanded checklist, and a link to a website for further information. The document is intended to be used in conjunction with the SPIRIT 2025 statement and serves as a resource for researchers planning a trial and for others interested in trial protocols.

摘要

高质量的方案有助于随机试验的合理规划、实施、报告及外部评审，但其完整性各异，关键要素常未被纳入考量。为强化试验方案的良好报告，《标准方案条目：干预性试验建议》（SPIRIT）2013声明已更新，以纳入新证据和新观点。这份《SPIRIT 2025解释与阐述文件》为用户提供了当代试验方案报告的范例、背景阐述、更详细的报告指南、关键实证研究的参考文献、扩展清单，以及一个可获取更多信息的网站链接。该文件旨在与《SPIRIT 2025声明》一并使用，为正在规划试验的研究人员及其他对试验方案感兴趣的人提供参考资源。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8b33/12128891/9a993c5cbdda/hroa081660.f2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8b33/12128891/f7a1d47af288/hroa081660.f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8b33/12128891/9a993c5cbdda/hroa081660.f2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8b33/12128891/f7a1d47af288/hroa081660.f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8b33/12128891/9a993c5cbdda/hroa081660.f2.jpg

相似文献

[1]
SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials.

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[3]
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[6]
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本文引用的文献

[1]
SPIRIT 2025 statement: updated guideline for protocols of randomised trials.

BMJ. 2025-4-28

[2]
CONSORT 2025 statement: updated guideline for reporting randomised trials.

BMJ. 2025-4-14

[3]
Reporting summary results in clinical trial registries: updated guidance from WHO.

Lancet Glob Health. 2025-4

[4]
Reporting of surrogate endpoints in randomised controlled trial protocols (SPIRIT-Surrogate): extension checklist with explanation and elaboration.

BMJ. 2024-7-9

[5]
Enhancing reporting through structure: a before and after study on the effectiveness of SPIRIT-based templates to improve the completeness of reporting of randomized controlled trial protocols.

Res Integr Peer Rev. 2024-5-31

[6]
Remote Monitoring and Data Collection for Decentralized Clinical Trials.

JAMA Netw Open. 2024-4-1

[7]
The ARIA trial protocol: a randomised controlled trial to assess the clinical, technical, and cost-effectiveness of a cloud-based, ARtificially Intelligent image fusion system in comparison to standard treatment to guide endovascular Aortic aneurysm repair.

Trials. 2024-3-25

[8]
Peers plus mobile app for treatment in HIV (PATH): protocol for a randomized controlled trial to test a community-based integrated peer support and mHealth intervention to improve viral suppression among Hispanic and Black people living with HIV.

Trials. 2024-3-22

[9]
Categorisation of continuous covariates for stratified randomisation: How should we adjust?

Stat Med. 2024-5-20

[10]
The efficacy and safety of deucravacitinib compared to methotrexate, in patients with vulvar lichen planus who have failed topical therapy with potent corticosteroids: a study protocol for a single-centre double-blinded randomised controlled trial.

Trials. 2024-3-12

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