Development of a Core Outcome Set for Incisional Hernia
Research type
Research Study
Full title
The Development of a Core Outcome Set for Incisional Hernia
IRAS ID
246345
Contact name
Deena Harji
Contact email
Sponsor organisation
University of Exeter
Duration of Study in the UK
0 years, 9 months, 30 days
Research summary
The aim of this study is to develop a core outcome set (COS) of clinical and patient-reported outcomes for incisional hernia repair. This study has designed in keeping with guidance from the Comet (Core Outcome Measures in Effectiveness Trials) guidelines and consists of four consecutive phases.
Phase I aims to identify current outcomes reported in published research studies reporting outcomes for incisional hernia. A systematic review will be performed and reported outcomes will be extracted and synthesised into categories.
Phase II aims to undertake a series of qualitative interviews with all key stakeholders involved in the management of incisional hernia; this includes patients, surgeons, radiologists, specialist nurses, hernia society representatives and industry representatives. The aim is to identify broad outcomes of interest and importance in incisional hernia surgery.
Phase III will map key outcomes identified from Phase I and II and will inform the Delphi study. The aim of the Delphi study is to achieve consensus amongst all key stakeholders on the minimum outcomes which should be reported for incisional hernia. Two sequential rounds of Delphi voting will be held with a feedback round in between.
Phase IV will be a consensus meeting of all key stakeholders to discuss the results of the Delphi study, with an aim to agree on the final COS.REC name
Wales REC 7
REC reference
21/WA/0278
Date of REC Opinion
10 Sep 2021
REC opinion
Further Information Favourable Opinion