Protocol for the development of SPIRIT and CONSORT extensions for randomised controlled trials with surrogate primary endpoints: SPIRIT-SURROGATE and CONSORT-SURROGATE.
Protocol for the development of SPIRIT and CONSORT extensions for randomised controlled trials with surrogate primary endpoints: SPIRIT-SURROGATE and CONSORT-SURROGATE.
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DOI：
10.1136/bmjopen-2022-064304
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发表时间：
2022-10-11
期刊：
影响因子：
2.9
通讯作者：
中科院分区：
文献类型：
--
作者：
随机对照试验（RCT）可能使用替代终点作为患者相关/参与者相关最终结局（如生存期、健康相关生活质量）的替代和预测因素。将替代终点测量的效应转化为患者/受试者的健康获益取决于替代终点的有效性;因此，需要更准确和透明的替代终点报告，以限制对试验结果的误导性解释。然而，目前没有关于报告此类审判的明确指导。因此，我们的目标是扩展SPIRIT（标准方案项目：干预性试验的建议）和CONSORT（报告试验的统一标准）报告指南，以改进RCT及其方案报告的设计和完整性，使用替代终点作为主要结局。该项目将分为四个阶段：第一阶段（文献综述）以确定在德尔菲研究中待评级的候选报告项目;第2阶段（德尔菲研究）对第1阶段确定的项目的重要性进行评级，并接受关于增加项目的建议; 3期（协商一致会议）商定列入延期和第4阶段的最后一套项目（知识转化）使利益攸关方参与进来，并通过包括同行评审出版物在内的各种战略传播项目产出。患者和公众的参与将嵌入到项目的所有阶段。本研究已获得格拉斯哥大学医学、兽医和生命科学伦理委员会的伦理批准（项目编号：200210051）。调查结果将发表在开放获取的同行评审出版物上，并在各种会议和相关论坛上介绍。
Randomised controlled trials (RCTs) may use surrogate endpoints as substitutes and predictors of patient-relevant/participant-relevant final outcomes (eg, survival, health-related quality of life). Translation of effects measured on a surrogate endpoint into health benefits for patients/participants is dependent on the validity of the surrogate; hence, more accurate and transparent reporting on surrogate endpoints is needed to limit misleading interpretation of trial findings. However, there is currently no explicit guidance for the reporting of such trials. Therefore, we aim to develop extensions to the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) and CONSORT (Consolidated Standards of Reporting Trials) reporting guidelines to improve the design and completeness of reporting of RCTs and their protocols using a surrogate endpoint as a primary outcome. The project will have four phases: phase 1 (literature reviews) to identify candidate reporting items to be rated in a Delphi study; phase 2 (Delphi study) to rate the importance of items identified in phase 1 and receive suggestions for additional items; phase 3 (consensus meeting) to agree on final set of items for inclusion in the extensions and phase 4 (knowledge translation) to engage stakeholders and disseminate the project outputs through various strategies including peer-reviewed publications. Patient and public involvement will be embedded into all project phases. The study has received ethical approval from the University of Glasgow College of Medical, Veterinary and Life Sciences Ethics Committee (project no: 200210051). The findings will be published in open-access peer-reviewed publications and presented in conferences, meetings and relevant forums.
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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：
9.3
作者：
Dimairo M;Coates E;Pallmann P;Todd S;Julious SA;Jaki T;Wason J;Mander AP;Weir CJ;Koenig F;Walton MK;Biggs K;Nicholl J;Hamasaki T;Proschan MA;Scott JA;Ando Y;Hind D;Altman DG
通讯作者：
Altman DG
影响因子：
2.9
作者：
Calvert M;King M;Mercieca-Bebber R;Aiyegbusi O;Kyte D;Slade A;Chan AW;Basch E;Bell J;Bennett A;Bhatnagar V;Blazeby J;Bottomley A;Brown J;Brundage M;Campbell L;Cappelleri JC;Draper H;Dueck AC;Ells C;Frank L;Golub RM;Griebsch I;Haywood K;Hunn A;King-Kallimanis B;Martin L;Mitchell S;Morel T;Nelson L;Norquist J;O'Connor D;Palmer M;Patrick D;Price G;Regnault A;Retzer A;Revicki D;Scott J;Stephens R;Turner G;Valakas A;Velikova G;von Hildebrand M;Walker A;Wenzel L
通讯作者：
Wenzel L
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：
1.9
作者：
Alonso, Ariel;Van der Elst, Wim;Burzykowski, Tomasz
通讯作者：
Burzykowski, Tomasz