Protocol for the development of SPIRIT and CONSORT extensions for randomised controlled trials with surrogate primary endpoints: SPIRIT-SURROGATE and CONSORT-SURROGATE

Manyara, A. M. et al. (2022) Protocol for the development of SPIRIT and CONSORT extensions for randomised controlled trials with surrogate primary endpoints: SPIRIT-SURROGATE and CONSORT-SURROGATE. BMJ Open, 12(10), e064304. (doi: 10.1136/bmjopen-2022-064304) (PMID:36220321) (PMCID:PMC9557267)

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Introduction: 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. Methods and analysis: 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. Ethics and dissemination: 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.

Item Type:Articles
Additional Information:The development of SPIRIT and CONSORT extensions has been funded by the UK Medical Research Council (grant number MR/V038400/1). GSC was supported by the NIHR Biomedical Research Centre, Oxford, and Cancer Research UK (programme grant: C49297/A27294).
Glasgow Author(s) Enlighten ID:Ciani, Professor Oriana and Manyara, Dr Anthony and Taylor, Professor Rod
Authors: Manyara, A. M., Davies, P., Stewart, D., Weir, C. J., Young, A., Butcher, N. J., Bujkiewicz, S., Chan, A.-W., Collins, G. S., Dawoud, D., Offringa, M., Ouwens, M., Ross, J. S., Taylor, R. S., and Ciani, O.
College/School:College of Medical Veterinary and Life Sciences > School of Health & Wellbeing > MRC/CSO SPHSU
Journal Name:BMJ Open
Publisher:BMJ Publishing Group
ISSN (Online):2044-6055
Published Online:11 October 2022
Copyright Holders:Copyright © 2022 The Authors
First Published:First published in BMJ Open 12(10): e064304
Publisher Policy:Reproduced under a Creative Commons License

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Project CodeAward NoProject NamePrincipal InvestigatorFunder's NameFunder RefLead Dept
313399Reporting of randomised trials using surrogate outcomes: development of extensions to the CONSORT 2010 and SPIRIT 2013 guidance statementsRodney Stephen TaylorMedical Research Council (MRC)MR/V038400/1HW - MRC/CSO Social and Public Health Sciences Unit