Core Outcomes for early PHasE Surgical Innovation and deViceEs (COHESIVE) Study

Our study aims to develop a core outcome set and reporting guidelines for new surgical devices and procedures.

The aim of COHESIVE (Core Outcomes for early pHasE Surgical Innovation and deVicEs) is to develop reporting guidelines and a core outcome set (COS) for new surgical procedures and devices. A COS is an agreed minimum set of outcomes that are measured and reported in all new surgeries. Before new medicines can be introduced into clinical practice, they undergo rigorous testing and this process is highly regulated. New medical devices are also regulated before they can be widely used, though ways of assessing their safety and performance vary, and standardisation of what is reported is also lacking. New surgical procedures are, however, even less regulated. There is uncertainty and inconsistency around what outcomes should be monitored and reported to evaluate them, which can compromise patient safety and lead to inefficiencies.

A vital part of this project is a multi-stakeholder Delphi survey, consisting of two rounds of online questionnaires. Healthcare professionals and patients internationally have already completed Round 1 of the survey. A summary of Round 1 results can be downloaded below. The second round is now live, and we are inviting participants to complete the final questionnaire. E-mail invitations were sent to Round 1 participants with a personalised link.  

A consensus meeting will take place 24th February 2020 in Bristol at which invitees will discuss, vote and decide on which items will be included in the final COS. Participation can be either in person or via teleconference. Respondents will be asked for their availability and preference at the end of Round 2 survey.

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Summary of Round 1 survey results

Patient and Public Leaflet

Further information regarding the study can be found in our Patient and Public Information Leaflet (PDF, 316kB).


Healthcare, research and industry professionals have participated in the study. Download the summary report for healthcare professionals. (PDF, 755kB)

Patients and public

Individuals with experience of surgery have contributed their views.  Download the summary report for patient and public participants. (PDF, 911kB) 

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