Table 2 Clinical data collection
From: The BSR-PsA: study protocol for the British Society for Rheumatology psoriatic arthritis register
Domain | Items |
|---|---|
General information | Date of birth; gender; ethnicity; family history of PsA, psoriasis, and other relevant conditions. |
Symptom onset and diagnosis | Age at onset for joint disease, and skin disease, separately. Year that patient was first seen in rheumatology. |
Joint disease | 66/68 joint count. |
Skin disease severity/phenotype | Personal history of psoriasis. Current psoriasis: (a) phenotype: plaque, pustular (sub classified as palmoplantar pustulosis or generalised pustular psoriasis); and (b) severity: body surface area affected, static physician global assessment. |
Nail disease | Presence of nail disease: nail matrix (e.g. pitting); nail bed (e.g. onycholysis); hyperkeratosis. |
Dactylitis | Current swelling of an entire digit; count of involved digits; history of dactylitis. |
Enthesopathy | Leeds Enthesitis Index [8]. |
Physical measurements | Height; weight; waist circumference; and blood pressure. |
Comorbidities | Diabetes; ischaemic heart disease; hypertension; hyperlipidaemia; statin use; fatty liver disease; history of malignancy; history of serious infection (infection resulting in hospitalisation, intravenous antibiotics); history of vasculitis; mental health. |
Novel therapy exposure | Past history of all bDMARDs and tsDMARDs, including start date, dose, stop date and reason for discontinuation. |
Other current and recent therapies | History of conventional synthetic DMARDs, steroids, NSAIDs, PUVA, and systemic therapies for psoriasis. Data recorded will comprise ever received therapy (yes/no); and, if applicable, calendar year. A recent history (past 6 months) will also be taken, comprising start date, dose, and if applicable, stop date and reason for discontinuation. Information will also be collected on any relevant concomitant therapies for comorbidities. |
Spinal involvement/imaging | Evidence of (a) juxta-articular new bone formation; (b) any erosion; and/or (c) sacroiliitis, by plain x-ray or MRI. (NB: No new images will be taken specifically for the BSR-PsA.) |
Laboratory markers | Recent measure of inflammation (C-reactive protein) from the date of clinic visit date ±4 weeks. Baseline only: rheumatoid factor and anti-citrullinated protein (anti-CCP) antibody, if available. |