Development of a Core Outcome Set for Chronic Venous Insufficiency
Research type
Research Study
Full title
Development of a Core Outcome Set for Chronic Venous Insufficiency
IRAS ID
312226
Contact name
Robert Hinchliffe
Contact email
Sponsor organisation
University of Bristol
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
Background
The prevalence of chronic venous insufficiency (CVI) is high and expected to increase secondary to increasing rates of venous thromboembolism, obesity, and the aging population. The term chronic venous insufficiency (CVI) is reserved for describing the most advanced stages of chronic venous disease, where symptoms secondary to functional changes, that may occur in the lower extremities due to persistently raised venous pressure, have a marked impact on quality of life. CVI significantly impacts patients’ health, quality of life and may even precipitate death. However, the most effective treatment is still debated. Trials into novel treatments (e.g. venous stents) have shown promising results. However, trials report a variety of outcomes that are not easily compared. One solution to this problem is to develop a core outcome set (COS) that standardises the results or outcomes that investigators should report when evaluating a treatment for a particular condition. This facilitates comparison of a range of treatments for one condition, permitting effective result pooling for large scale analysis.
Methods:
A COS is developed in three phases. Firstly, all the possible results or outcomes in the treatment of CVI are identified through interviewing patients, reviewing published literature and by consulting a panel of experts. A systematic review, registered on PROSPERO (CRD42021236795), has already been undertaken. Secondly, the long list of outcomes is then sent to healthcare professionals and patients and ranked most important to least important in multiple rounds in a Delphi Survey. The least important outcomes are then removed in an iterative process. Thirdly, the COS is created by anonymous voting amongst a consensus meetings of stakeholders including patients and healthcare professionals. By including patients and healthcare professionals in each stage of development, it ensures outcomes are relevant to both groups.
Due to the ongoing COVID-19 pandemic, vulnerability of patients with CVI and ongoing shielding policies, patient interviews will be conducted via Microsoft teams or over the telephone rather than face to face. The Delphi survey will be completed online using REDCAP and the consensus meeting will be held on Microsoft Teams with Vevox software used for live voting.
REC name
West of Scotland REC 3
REC reference
22/WS/0172
Date of REC Opinion
2 Dec 2022
REC opinion
Favourable Opinion