The COHESIVE Study
Research type
Research Study
Full title
Core Outcomes for early pHasE Surgical Innovation and deVicEs (COHESIVE) study
IRAS ID
253034
Contact name
Kerry Avery
Contact email
Sponsor organisation
University of Bristol
Duration of Study in the UK
1 years, 11 months, 30 days
Research summary
Before new medicines or drugs can be introduced into clinical practice, they undergo rigorous, highly-regulated testing. In contrast, the way in which new invasive procedures (eg surgery) and medical devices (eg implantable surgical devices) are introduced into clinical practice is not nearly as formalised or regulated. New surgeries and surgical devices maybe introduced without firm evidence that they are safe and effective. This can compromise patient safety and health outcomes. A major contributing factor to this is uncertainty and inconsistency around the selection, measurement and reporting of health-related outcomes, including benefits and harms, of new surgeries and surgical devices.
A series of ongoing reviews has shown that reporting of outcomes of new surgeries and surgical devices is inconsistent. This means that it is difficult to determine if a new type of surgery or device is safe and effective to be used. A solution to this problem is to develop a core outcome set, which is an agreed minimum set of outcomes that should be measured and reported in all uses of a new surgical device in clinical practice, research studies or audits. It is anticipated that a core outcome set would have a impact on improving the quality of information available to patients and health professionals for decision-making and for monitoring the safety and effectiveness of new surgeries and surgical devices.
The aim of this study is to develop a core outcome and reporting guidelines set for new surgeries and new surgical devices. The methods include inviting patients and professionals (e.g. surgeons, device manufacturers, journal editors) to complete a series of survey questionnaires in which they are asked to prioritise outcomes for inclusion in the core outcome set. Participants will be invited to participate in a consensus meeting to agree on the final set of outcomes in the core outcome set.REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
18/NE/0378
Date of REC Opinion
10 Dec 2018
REC opinion
Favourable Opinion