DOMINO version 1
Research type
Research Study
Full title
The development and validation of a medication-related osteonecrosis of the jaws-specific patient reported outcome measures (DOMINO)
IRAS ID
280416
Contact name
Fedele Stefano
Contact email
Sponsor organisation
University College London
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
BACKGROUND
Medication-related osteonecrosis of the jaws (MRONJ) is an adverse reaction of a group of medications commonly used for the treatment of osteoporosis and bone cancer: bisphosphonates, denosumab and antiangiogenics. Affected individuals can develop area of irreversible bone necrosis ("dead bone") to the jaw bones, with consequent chronic pain, infection, tooth loss, bone fracture, dysfunction and disfigurement. Treatment options include long-term antibiotics and surgery. As MRONJ can cause significant morbidity, it is crucial to understand and measure the symptoms and experiences (quality of life) of affected individuals in order to assess the severity of the disease and related changes after treatment. A number of generic quality of life questionnaires have been used to assess patients' perception of MRONJ, however these generic instruments are not specific to the disease and unlikely to capture in detail the impact of the disease as perceived by patients. Therefore there is a need to develop a disease-specific quality of life questionnaire which includes aspects of health that are considered by patients or clinicians to be of greatest importance.
AIMS
The aim of DOMINO is to develop and test a patient-reported outcome measure (quality of life questionnaire) relevant to MRONJ, to be used in daily clinical practice and future research.
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 MRONJ-specific instrument will then be tested and modified as needed in patients diagnosed with MRONJ in order to ensure that it does reflect aspects of the disease and related patient experience (a research methodology called psychometric testing).REC name
South Central - Hampshire B Research Ethics Committee
REC reference
21/SC/0209
Date of REC Opinion
17 Aug 2021
REC opinion
Further Information Favourable Opinion