Scoping and targeted reviews to support development of SPIRIT and CONSORT extensions for randomised controlled trials with surrogate primary endpoints: protocol.
Scoping and targeted reviews to support development of SPIRIT and CONSORT extensions for randomised controlled trials with surrogate primary endpoints: protocol.
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DOI：
10.1136/bmjopen-2022-062798
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发表时间：
2022-10-13
期刊：
影响因子：
2.9
通讯作者：
中科院分区：
文献类型：
--
作者：
使用替代终点作为主要患者相关结局的替代品，可以更有效地进行随机对照试验（RCT），即，时间更短，样本量更小，成本更低。然而，目前尚无关于使用替代终点作为主要结局的RCT报告的共识驱动指南;因此，我们寻求开发SPIRIT（标准方案项目：干预性试验建议）和CONSORT（报告试验的统一标准）扩展，以改进这些试验的设计和报告。作为第一步，范围界定和有针对性的审查将确定潜在的项目，以纳入扩展和参与者，以促进德尔菲共识进程。范围审查将检索并纳入关于在试验中使用替代终点的当前理解、局限性和指南的文献报告。相关文献将通过以下方式确定：（1）书目数据库;（2）灰色文献;（3）手工检索参考文献清单;（4）征求专家意见。将对合格记录中的数据进行专题分析，以确定是否有可能列入扩展部分。本次有针对性的综述将检索2017年至2021年在6种高影响力的普通医学期刊上发表的RCT报告和方案。试验通讯作者联系人将被列为德尔菲练习的潜在参与者。不需要伦理批准。这些审查将支持SPIRIT和CONSORT扩展的开发，用于报告替代主要终点（替代终点作为主要结局）。调查结果将在开放获取的出版物上发表。本综述已在OSF注册DOI：10.17605/OSF.IO/WP 3QH中进行前瞻性注册。
Using a surrogate endpoint as a substitute for a primary patient-relevant outcome enables randomised controlled trials (RCTs) to be conducted more efficiently, that is, with shorter time, smaller sample size and lower cost. However, there is currently no consensus-driven guideline for the reporting of RCTs using a surrogate endpoint as a primary outcome; therefore, we seek to develop SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) and CONSORT (Consolidated Standards of Reporting Trials) extensions to improve the design and reporting of these trials. As an initial step, scoping and targeted reviews will identify potential items for inclusion in the extensions and participants to contribute to a Delphi consensus process. The scoping review will search and include literature reporting on the current understanding, limitations and guidance on using surrogate endpoints in trials. Relevant literature will be identified through: (1) bibliographic databases; (2) grey literature; (3) handsearching of reference lists and (4) solicitation from experts. Data from eligible records will be thematically analysed into potential items for inclusion in extensions. The targeted review will search for RCT reports and protocols published from 2017 to 2021 in six high impact general medical journals. Trial corresponding author contacts will be listed as potential participants for the Delphi exercise. Ethical approval is not required. The reviews will support the development of SPIRIT and CONSORT extensions for reporting surrogate primary endpoints (surrogate endpoint as the primary outcome). The findings will be published in open-access publications. This review has been prospectively registered in the OSF Registration DOI: 10.17605/OSF.IO/WP3QH.
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DOI：
10.1136/bmj.f457
发表时间：
2013-01-29
期刊：
BMJ (Clinical research ed.)
影响因子：
--
作者：
Ciani O;Buyse M;Garside R;Pavey T;Stein K;Sterne JA;Taylor RS
通讯作者：
Taylor RS
影响因子：
1.9
作者：
Alonso, Ariel;Van der Elst, Wim;Burzykowski, Tomasz
通讯作者：
Burzykowski, Tomasz
影响因子：
2.3
作者：
Green, E. M.;Yothers, G.;Sargent, Daniel J.
通讯作者：
Sargent, Daniel J.
影响因子：
1.9
作者：
Alonso, Ariel;Van der Elst, Wim;Burzykowski, Tomasz
通讯作者：
Burzykowski, Tomasz
影响因子：
120.7
作者：
Casarett, D;Karlawish, J;Asch, DA
通讯作者：
Asch, DA