Core Outcome Measures in Effectiveness Trials

The development of a Core Outcome Set in Incisional Hernia Repair

General Information

Summary:
Incisional hernia following laparotomy has an incidence of up to 20% and is associated with significant morbidity and impairment of quality of life.The management of incisional hernia has significantly evolved over recent years, with a variety of available techniques, meshes and operative strategies available to manage this potentially complex cohort of patients. Given the range of options available there is significant complexity involved in the management of patients with incisional hernia, and alongside this there is considerable variation in management and outcome reporting. Despite an exponential increase in the number of peer-reviewed publications on the management of incisional hernia over the last decade, the methodological quality of the majority of these studies is poor, with the majority of studies reporting outcomes on incisional hernia being of Level 4 quality. A recent systematic review reported over 75% of randomised controlled trials and meta-analyses reporting outcomes on ventral hernias were methodologically flawed, with variable adherence to standardised reporting frameworks such as Consolidated Standards of Reporting Trials (CONSORT) checklist or Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) Checklist PRISMA.

The aim of this project is develop a COS of clinically important, patient-oriented outcomes to be used to guide reporting of future research in incisional hernia.

Methods

An international, mixed-methods study will be conducted in accordance with Core Outcome Measures in Effectiveness Trials (COMET) guidelines to develop a COS for use in complex incisional hernia. Phase I will be a systematic review of the current literature to identify current clinical and patient-reported outcomes reported. Phase II will involve in-depth qualitative interviews with patients and other key stakeholders not adequately represented within the literature to identify outcomes of importance. Phase III will involve an online international Delphi study. Forward-backward translations of the Delphi questions will be conducted for all participating European countries. Phase III will identify outcomes of importance that should be included in a COS. Phase IV will be a consensus meeting to agree on the final COS for incisional hernia repair.

Contributors:
Miss Deena Harji - Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle and Northern Surgical Trainees Research Association, Newcastle (PI)
Mr Christophe Thomas - Northern Surgical Trainees Research Association, Newcastle
Mr Liam Horgan - Consultant Colorectal Surgeon Northumbria Healthcare NHS Foundation Trust, North Tyneside, UK
Professor Manual López Cano, Vall d'Hebrón Universitary Hospital, Barcelona, Spain
Dr Frederik Helgstrand, Center for Surgical Science, Zealand University Hospital, Denmark
Dr Filip Muysoms , Head of Department Abdominal Surgery, Gent, Belgium
Dr Stavros Antoniou, Clinical Fellow, Royal Devon & Exeter NHS Foundation Trust, UK
Mr Ben Griffiths Consultant Colorectal Surgeon, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle, UK
Mr Neil Smart Consultant Colorectal Surgeon, Royal Devon & Exeter NHS Foundation Trust, UK (Supervisor)

Further Study Information

Current Stage:
Ongoing
Date:
January 2018 - July 2019
Funding source(s):
British Hernia Society - grant awarded; European Hernia Society - grant application submitted

Health Area

Disease Category
Other

Disease Name
Hernia

Target Population

Age Range
18 - 100

Sex
Either


Nature / type of Intervention
Surgery

Method(s)

Consensus conference
Delphi process
Interview
Literature review
Systematic review

Phase I: Systematic review of clinical and patient-reported outcomes for incisional hernia.
Phase II: In-depth qualitative interviews with patients and stakeholders to identify outcomes of interest.
Phase III: Delphi Meeting - The outcomes identified in Phase I and II will be combined, developed into a long-list of items and categorised into broad domains. Appropriate questions will be mapped to these domains and will form the basis of the Delphi study. Given the pan-European nature of this study we will translate the Delphi questions using forward-backward translation for all participating countries. Two sequential rounds of Delphi voting will be held with a feedback round in between. Pre=specified inclusion and exclusion criteria will be applied.
Phase IV: Consensus meeting will be held in conjunction with the May 2019 European Hernia Society meeting to discuss the results of the Delphi study. The aim of this consensus meeting will be to agree on the final COS for complex incisional hernia.


Stakeholders Involved

Clinical experts
Conference participants
Consumers (caregivers)
Consumers (patients)
Patient/ support group representatives
Service providers

Study Type

COS for clinical trials or clinical research
COS for practice

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