VOUCHER version 1
Research type
Research Study
Full title
Development and validation of a specific patient-reported outcome measure for osteoradionecrosis of the jaws in head and neck cancer survivors (VOUCHER)
IRAS ID
302538
Contact name
Stefano Fedele
Contact email
Sponsor organisation
University College London
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
Background:
Osteoradionecrosis (ORN) is a severe side effect of head and neck cancer and is provoked by failure of bone healing. The affecting area is usually mandible and it often starts from few months to several years after radiotherapy.
The prevalence of ORN is under debate. However, it has shown a decrease in recent years due to advances in radiotherapy techniques and different protocols for dental care.
Health Related Quality of Life (HRQoL) is affected by ORN in many areas and has a poor outcome. According to the WHO, patient experience and quality of life in patients with long-term conditions has been the main focus. As a result, selecting the right outcome measure is a necessary component to evaluate a procedure or treatment. Questionnaires can be classified into subjective questionnaires (reported by patient), objectives questionnaires (evaluated by clinician) or mixed. Patient-reported outcome measures (PROMs) has the benefit of not being biased by examiner. Furthermore, a disease specific questionnaire has the benefit of reporting a minimum clinically important difference (MCID), which is vital to assess the effectiveness of a treatment and/or for clinicians to design trials in patients with ORN.Aims:
1. To develop a new tool for assessment of ORN specific patient related outcome measures.
2. To evaluate psychometric properties of VOUCHER.Methods:
The initial stages of questionnaire development will involve both clinical experts' and patient input, via qualitative
interviews. Experts and patient's views will be used to develop a draft questionnaire. The newly developed draft
ORN-specific instrument will then be tested and modified as needed in patients diagnosed with ORN in order to
ensure that it does reflect aspects of the disease and related patient experience (a research methodology called
psychometric testing).REC name
London - South East Research Ethics Committee
REC reference
22/PR/0761
Date of REC Opinion
12 Jul 2022
REC opinion
Further Information Favourable Opinion