Optimising measurement of patient reported outcomes in PsA
Research type
Research Study
Full title
Optimising measurement of patient reported outcomes in psoriatic arthritis
IRAS ID
251578
Contact name
Laura Coates
Contact email
Sponsor organisation
University of Oxford, Clinical Trials and Research Governance
Duration of Study in the UK
0 years, 6 months, 31 days
Research summary
Psoriatic arthritis (PsA) is a chronic disease with a significant patient-perceived impact. Currently, the definitive goal of treatment is to prevent flares and induce remission.
Both the Multidimensional Health Assessment Questionnaire (MDHAQ) and the Health Assessment Questionnaire Disability Index (HAQDI) are validated questionnaires developed to assess patients’ perspective of disease activity in rheumatic diseases. However, the MDHAQ is quicker to score and postulated to be more sensitive to ‘floor effects’ compared to the HAQDI. This is when patients report normal scores despite experiencing functional impairment with more challenging tasks.
To date, no fully powered study has been conducted to directly compare the MDHAQ and the HAQDI in patients with PsA. Our pilot study of 51 patients with PsA found similar scores in the MDHAQ and HAQDI questionnaires and suggest that a sample size of 210 patients is required to detect non-inferiority between the two questionnaires.
The aim of this study is to conduct a fully powered study to compare the MDHAQ and the HAQDI in patients with PsA. Both questionnaires will be compared with the PsAID, a validated questionnaire to assess the impact of disease in patients with PsA. We also aim to compare the visual analogue scale (VAS), a 100 mm horizontal line, to the numerical rating scale (NRS), a 21-point horizontal scale, for patient global disease activity, psoriasis activity, arthritis activity and pain. The NRS is simple to complete, faster to score and less prone to measurement error compared to the VAS however to date, they have not been directly compared in PsA.
Our results will help to inform clinicians in their choice of patient questionnaire in routine clinical settings, enabling a more holistic assessment of disease activity. This information can also guide future clinical trial development using optimized outcome measures to reflect the patient experience.
REC name
London - Surrey Research Ethics Committee
REC reference
18/LO/2057
Date of REC Opinion
7 Dec 2018
REC opinion
Further Information Favourable Opinion