You are here

  • Home
  • Archive
  • Volume 12, Issue 10
  • Scoping and targeted reviews to support development of SPIRIT and CONSORT extensions for randomised controlled trials with surrogate primary endpoints: protocol

Article Text

Article menu
Research methods
Protocol
Scoping and targeted reviews to support development of SPIRIT and CONSORT extensions for randomised controlled trials with surrogate primary endpoints: protocol
  1. Anthony Muchai Manyara1,
  2. Philippa Davies2,
  3. Derek Stewart3,
  4. Valerie Wells1,
  5. Christopher Weir4,
  6. Amber Young2,
  7. Rod Taylor1,5,
  8. Oriana Ciani6
  1. 1MRC/CSO Social and Public Health Sciences Unit, Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK
  2. 2Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK
  3. 3Patient and Public Involvement Lead, Nottingham, UK
  4. 4Edinburgh Clinical Trials Unit, Usher Institute, University of Edinburgh, Edinburgh, UK
  5. 5Robertson Centre for Biostatistics, Institute of Health and Well Being, University of Glasgow, Glasgow, UK
  6. 6SDA Bocconi School of Management, Milan, Italy
  1. Correspondence to Anthony Muchai Manyara; anthony.manyara{at}glasgow.ac.uk

Abstract

Introduction 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.

Methods and analysis 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.

Ethics and dissemination 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.

  • protocols & guidelines
  • epidemiology
  • public health
https://creativecommons.org/licenses/by/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.

https://doi.org/10.1136/bmjopen-2022-062798

Statistics from Altmetric.com

    Request Permissions

    If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.

    View Full Text

    Supplementary materials

    • Supplementary Data

      This web only file has been produced by the BMJ Publishing Group from an electronic file supplied by the author(s) and has not been edited for content.

    Footnotes

    • Twitter @Muchai_AM

    • Deceased We wish to acknowledge our dear colleague Professor Amber Young who lost her brave battle with cancer and passed away on 17th September 2022.

    • Contributors PD, CW, AY, RT and OC were involved in funding acquisition. AMM, PD, DS, CW, AY, RT and OC were involved in the initial phases of study conception and design. AMM, VW, RT and OC were involved in design of the search strategy and responsible for the first draft of the manuscript. PD, DS, CW and AY reviewed the first draft, and all authors approved the final version.

    • Funding The development of SPIRIT and CONSORT extensions has been funded by the Medical Research Council (PD, CJW, AY, RT, OC, grant number MR/V038400/1).

    • Competing interests None declared.

    • Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting or dissemination plans of this research. Refer to the Methods section for further details.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.