A study protocol for the development of a SPIRIT extension for trials conducted using cohorts and routinely collected data (SPIRIT-ROUTINE)

Megan McCarthy*, Linda O'Keeffe, Paula Williamson, Matthew Sydes, Amanda Farrin, Fiona Lugg-Widger, Gwyneth Davies, Kerry N L Avery, An-Wen Chen, Linda Kwakkenbos, Brett Thombs, Alan Watkins, Lars Hemkens, Chris Gale, Merrick Zwarenstein, Sinead Langan, Lehana Thabane, Edmund Juszczak, David Moher, Patricia Kearney

*Corresponding author for this work

Research output: Contribution to journalArticle (Academic Journal)peer-review

2 Citations (Scopus)
54 Downloads (Pure)

Abstract

Background: Protocols are an essential document for conducting randomised controlled trials (RCTs) However, the completeness of the information provided is often inadequate. To help improve the content of trial protocols, an international group of stakeholders published the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) Initiative in 2013. Presently, there is increasing use of cohorts and routinely collected data (RCD) for RCTs because these data have the potential to improve efficiencies by facilitating recruitment, simplifying and reducing the cost of data collection. Reporting guidelines have been shown to improve the quality of reportings but there is currently no specific SPIRIT guidance on protocols for trials conducted using cohorts and RCD. This protocol outlines steps for the development of SPIRIT-ROUTINE which aims to address this gap by extending the SPIRIT guidance to protocols for trials conducted using cohorts and RCD.
Methods: The development of the SPIRIT-ROUTINE extension comprises five stages. Stage 1 consists of a project launch and a meeting to finalise the membership of the steering group and scope of the extension. In Stage 2, a rapid review will be performed to identify possible modifications to the original SPIRIT 2013 checklist. Other key reporting guidelines will be reviewed to identify areas where additional items may be needed such as the CONSORT Extension for Trials Conducted Using Cohorts and Routinely Collected Data (CONSORT-ROUTINE) statement. Stage 3 will involve an online Delphi exercise, consisting of two rounds and involving key international stakeholders to gather feedback on the preliminary checklist items. In Stage 4, a consensus meeting of the SPIRIT-ROUTINE steering group will finalise the items to include in the extension. Stage 5 will involve the publication preparation and dissemination of the final checklist.
Conclusion: The SPIRIT-ROUTINE extension will contribute to improving design of trials using cohorts and RCD and transparency of reporting.
Original languageEnglish
Number of pages10
JournalHRB Open Research
Volume4
Issue number82
DOIs
Publication statusPublished - 29 Jul 2021

Keywords

  • SPIRIT
  • routinely collected data
  • reporting guideline
  • cohort
  • electronic health records
  • electronic patient records
  • registries
  • registry-based randomised controlled trial

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