MEAN-IT v.1.0
Research type
Research Study
Full title
Determination of minimal important difference and patient acceptable symptom state of patient reported outcome measures in immunologically mediated oral mucosal diseases
IRAS ID
222002
Contact name
Stefano Fedele
Contact email
Sponsor organisation
Joint Research Office
Clinicaltrials.gov Identifier
Z6364106/2017/08/83 , UCL Data Protection Registration
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
"Immunologically mediated oral mucosal diseases" are disorders of the lining of the mouth that are caused by an overactive dysfunctional immune system. They are typically long-lasting and cause painful symptoms to the mouth, leading to a reduction in quality of life due to the impairment of speech, eating and swallowing. Available treatment can reduce painful symptoms and improve quality of life of affected individuals.
The best mean to assess the efficacy of treatment in these conditions is through “patient reported outcome measures” (PROMs in short), which refers to "self-reporting" by the patient. PROMs consists of questionnaires, which the patients complete themselves, covering issues and concerns that are specific to patients, including painful symptoms and quality of life.
A number of PROMs are available for individuals with immunologically mediated oral mucosal diseases; however, interpretation of these questionnaires remains difficult.
The aim of this study is to improve the interpretability of some of the available PROMs so to allow easier and more effective use in clinical practice. In particular we wish to determine what changes in answering the questionnaire before and after treatment patients consider to be important to them. Similarly, we wish to understand the need for patients to receive treatment based on their response to the questionnaire.
We plan to recruit 250 participants with immunologically mediated oral mucosal diseases in the proposed study. Participants will be asked to complete a set of questionnaires assessing oral symptoms and quality of life at enrolment and after 4 months of therapy.
The results of the present study will provide a more meaningful way to interpret patients’ answers to the questions of available PROMs, which has the potential to inform clinicians’ decisions with respect to therapy and long-term disease management.REC name
London - Queen Square Research Ethics Committee
REC reference
17/LO/1825
Date of REC Opinion
3 Nov 2017
REC opinion
Further Information Favourable Opinion