Intra- and Inter-Individual Variations In Disease Activity
Research type
Research Study
Full title
Intra- and Inter-Individual Variations In Disease Activity and Disability in Inflammatory Arthritis Patients Attending Routine NHS Clinics
IRAS ID
239636
Contact name
James Galloway
Contact email
Sponsor organisation
King's College Hospital
Duration of Study in the UK
0 years, 6 months, 1 days
Research summary
The current paradigm of managing patients with inflammatory arthritis involves using intensive treatment with disease-modifying anti-rheumatic drugs (DMARDs) and biologics to reduce inflammation and disease activity. The main goal of doing this is to indirectly reduce disability and optimise health-related quality of life (HRQoL).
The commonest way that disease activity is captured in clinical practice is using the Disease Activity Score for 28 joints (DAS28). Whilst this is only validated in patients with rheumatoid arthritis (RA), it is often used in other types of inflammatory arthritis, such as psoriatic arthritis (PsA). Disability is often captured using the health assessment questionnaire (HAQ), which are patient completed questionnaires.
Within the NHS Rheumatology department in KCH all patients with inflammatory arthritis attending clinical appointments have their consultations recorded using electronic healthcare records. Their DAS28 scores is captured as part of their routine care, guiding decisions on treatment intensities and modalities. Information on their medication use, demographics, and comorbidities is also routinely captured.
These electronic healthcare records represent a crucial resource to address clinically important questions that can improve patient care. One such question is the extent to which using intensive treatment to reduce a patient’s disease activity improves their function and if variability in disease activity score plays any part of the improvement. There is strong evidence that intensive treatment improves disease activity score in clinical trials. However, there is uncertainty as to whether this short-term trial data is generalisable to patients seen in routine clinical practice, as many patients seen in rheumatology clinics would fail to satisfy trial inclusion criteria. Consequently, it is vital to have real-life routine care data to supplement clinical trial findings.
We wish to use the anonymised, routinely collected, electronic healthcare record clinical data from inflammatory arthritis patients attending Kings College Hospital NHS Foundation Trust rheumatology clinics to address two inter-related questions. These comprise: (1) to what extent does disease activity vary within and between patients; and (2) what is the relationship between disease activity and disability. An associated issue is whether there are patients that fail to respond to current drug management approaches that might benefit from alternative strategies like physiotherapy to improve functional status.
Using routinely collected clinical data to answer these questions will have several patient benefits. At a local level it will enable rheumatologists at KCH to optimise the care they provide to patients currently attending rheumatology clinics. On a national level it will enable general themes in patient care to be identified that could be applicable across England.
REC name
East of England - Cambridge South Research Ethics Committee
REC reference
18/EE/0088
Date of REC Opinion
19 Apr 2018
REC opinion
Further Information Favourable Opinion