Validation of a scoring system for oral mucosal disease
Research type
Research Study
Full title
Validation of a scoring system for oral involvement in pemphigus vulgaris, mucous membrane pemphigoid and lichen planus.
IRAS ID
144160
Contact name
Jane Setterfield
Contact email
Duration of Study in the UK
1 years, 8 months, 11 days
Research summary
Pemphigus vulgaris (PV) and mucous membrane pemphigoid (MMP) are rare autoimmune bullous diseases often presenting with severe oral lesions. There are several scoring methodologies proposed in the literature but the sensitivity in oral disease severity is unproven. The oral medicine department at Guy’s Hospital have devised a comprehensive disease scoring methodology for PV, MMP and lichen planus (LP). Its value in LP has been shown (Escudier 2007) but it needs to be formally validated for all three diseases to facilitate multicentre studies.
We will compare the inter- and intra-observer variability and ease of use of our method with the oral part of two validated systems for PV, Autoimmune Bullous Skin Disorder Intensity Score (ABSIS) and the Pemphigus Disease Activity Index (PDAI). For MMP we will use ABSIS and a proposed but unvalidated scoring system, the Mucous Membrane Pemphigoid Disease Activity Score (MMPDAI). We will also undertake a Physician’s Global Assessment (PGA).
Additionally patients will complete a Treatment of Autoimmune Bullous Disease Quality of Life Questionnaire (TABQOL).
The study will involve 10 oral medicine specialists from 4 UK centres. All clinicians participating in the study will be familiar with all of the scoring systems. Only to oral components of each scoring system will be used.
15 patients with a confirmed diagnosis of PV, MMP or LP will be invited and consented to participate. Each patient will attend for a total of one day as part of their routine follow up appointment.
Each patient will be scored by each clinician using the appropriate scoring systems. After a two hour break all patients will be re-scored by 2 clinicians for intra-observer reproducibility.
We will compare the scoring methodologies in a longitudinal study over the following 12 months in order to assess the relative sensitivity of each system for changes in disease severity.
REC name
East of Scotland Research Ethics Service REC 1
REC reference
15/ES/0038
Date of REC Opinion
18 Mar 2015
REC opinion
Further Information Favourable Opinion