A new patient-reported outcome measure for acute otitis externa
Research type
Research Study
Full title
Assessment and validation of a patient-reported outcome measure for acute otitis externa in adults
IRAS ID
284602
Contact name
James Tysome
Contact email
Sponsor organisation
Cambridge University Hospitals NHS Foundation Trust
Duration of Study in the UK
0 years, 5 months, 1 days
Research summary
Acute otitis externa is a common condition that causes inflammation of the external ear canal. This can present in a variety of ways in different patients which include ear pain, itchiness and ear discharge. AOE can affect quality of life, sleep and daily activities.
Despite AOE affecting around 1 in 100 adults each year, there is no standardised method of assessment to record patient symptoms or how the condition affects quality of life. As a result, doctors and researchers can struggle to reliably measure a patient's response to treatment, both in clinical practice and trials. In research, the lack of standardised assessment also means that clinicians are unable to compare the effectiveness of treatment across different studies.
Our own work has identified the treatment outcomes considered most important for AOE by patients and clinicians, leading to a list of key measures (a consensus core outcome set). This new study will develop a patient-reported outcome measure (PROM), and assess its ability to reliably measure patient symptoms and the other effects of AOE. A candidate PROM has been created, with each question in the PROM derived from one of the AOE core outcome set list of measures.
This study will refine and then validate the new PROM, using established methods recommended by the COSMIN initiative (COnsensus-based Standards for the selection of health Measurement Instruments).
Following a 10-patient pilot, a total of 55 patients receiving standard care at four UK hospitals will be asked to complete online forms that include the PROM, on 3 separate occasions.
The results will then be analysed using standard methods to determine the reliability and characteristics of the PROM, and further changes may be made based on this analysis. The final PROM will be published for use in both clinical practice and future trials, and results given to participants.
REC name
London - City & East Research Ethics Committee
REC reference
21/PR/1198
Date of REC Opinion
11 Apr 2022
REC opinion
Further Information Favourable Opinion