A Core Outcome Set for Seamless, Standardized Evaluation of Innovative Surgical Procedures and Devices (COHESIVE): A Patient and Professional Stakeholder Consensus Study

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Abstract

Objective:
To develop a core outcome set (COS), an agreed minimum set of outcomes to measure and report in all studies evaluating the introduction and evaluation of novel surgical techniques.

Summary Background Data:
Agreement on the key outcomes to measure and report for safe and efficient surgical innovation is lacking, hindering transparency and risking patient harm.

Methods:
(I) Generation of a list of outcome domains from published innovation-specific literature, policy/regulatory body documents, and surgeon interviews; (II) Prioritization of identified outcome domains using an international, multi-stakeholder Delphi survey; (III) Consensus meeting to agree the final COS. Participants were international stakeholders, including patients/public, surgeons, device manufacturers, regulators, trialists, methodologists and journal editors.

Results:
7,972 verbatim outcomes were identified, categorized into 32 domains, and formatted into survey items/questions. 410 international participants (220 professionals, 190 patients/public) completed at least one round 1 survey item, of which 153 (69.5%) professionals and 116 (61.1%) patients completed at least one round 2 item. 12 outcomes were scored ‘consensus in’ (‘very important’ by ≥70% of patients and professionals) and 20 ‘no consensus’. A consensus meeting, involving 19 professionals and 10 patient/public representatives, led to agreement on a final 8-domain COS. Six domains are specific to a surgical innovation context: modifications, unexpected disadvantages, device problems, technical procedure success, whether the overall desired effect was achieved, surgeons’/operators’ experience. Two domains relate to intended benefits and expected disadvantages.

Conclusions:
The COS is recommended for use in all studies prior to definitive RCT evaluation to promote safe, transparent, and efficient surgical innovation.
Original languageEnglish
Pages (from-to)238-245
Number of pages8
JournalAnnals of Surgery
Volume277
Issue number2
Early online date7 Jun 2021
DOIs
Publication statusPublished - 1 Feb 2023

Bibliographical note

Funding Information:
This study was funded by the National Institute for Health Research (NIHR) Biomedical Research Centre (BRC) at University Hospitals Bristol NHS Foundation Trust and the University of Bristol (BRC-1215-20011). This work was supported by the Royal College of Surgeons of England Bristol Surgical Trials Centre and the MRC ConDuCT-II (Collaboration and innovation for Difficult and Complex randomized controlled Trials In Invasive procedures) Hub for Trials Methodology Research (MR/K025643/1) (www.bristol.ac.uk/social-community-medicine/centres/conduct2).

Publisher Copyright:
© 2022 Wolters Kluwer Health, Inc. All rights reserved.

Keywords

  • core outcome set
  • Delphi technique
  • device approval
  • operative
  • outcome assessment
  • surgical procedures

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