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

Core Outcomes for early pHasE Surgical Innovation and deVicEs (COHESIVE) study steering group: Mr. Alberto Casonato, TOKA HEALTHCARE, UK; Mr. Thomas A Drake, University of Edinburgh, UK; Dr. Camilla Fleetcroft, The Medicines and Healthcare Products Regulatory Agency, UK; Mr. Matthew Gardiner, Kennedy Institute of Rheumatology, UK; Mr. Henk Giele, University of Oxford, UK; Dr. James Glasbey, University of Birmingham, UK; Mr. Robert Hinchliffe, University of Bristol, UK; Ms. Allison Hirst, University of Oxford, UK; Mr. Stephen Johnston, Johnson & Johnson, USA; Mr Angelos Kolias, University of Cambridge, UK; Ms. Vee Mapunde, National Institute for Health Research Surgical MedTech Co-operative, UK; Mr Hani Marcus, National Hospital for Neurology and Neurosurgery, UK; Dr Bethany Shinkins, University of Leeds, UK; Mr. Neil Smart, Royal Devon & Exeter Hospital, UK; Dr Amie Smirthwaite, Medical Devices Group, British Standards Institution, UK; Mrs. Sarah Squire, Patient representative, UK; Mr. Alan Thomas, Patient...

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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
JournalAnnals of Surgery
Early online date7 Jun 2021
Publication statusE-pub ahead of print - 7 Jun 2021
Externally publishedYes


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