The ASSESS Study
Research type
Research Study
Full title
ASSESSment of modified composite disease measures in recently diagnosed psoriatic arthritis
IRAS ID
200519
Contact name
W Tillett
Contact email
Sponsor organisation
Royal United Hospital NHS FT
Clinicaltrials.gov Identifier
RP-PG-1212-20007, NIHR Programme
Duration of Study in the UK
2 years, 9 months, 1 days
Research summary
Psoriatic arthritis is an inflammatory arthritis occurring in up to 30% of patients with skin psoriasis. Patients can develop swelling in joints, tendons, spine, skin, nails and eyes causing stiffness, pain and fatigue. Left untreated the inflammation results in damage causing further pain and restricted movement. Cohort studies have demonstrated progression of joint destruction, deteriorating functional status and a negative impact quality of life and ability to work.
Historically the primary outcome measure in psoriatic arthritis trials have been measures that focus solely on the articular manifestations of disease. It is now recognised that this approach is insufficient to truly capture the totality of disease burden. In response there has been an international effort to devise a composite measure that captures all domains of disease. Several candidate measures have now been developed however these existing measures lacked patient involvement during their development (thereby potentially not fully capturing domains of disease important to patients) and remain time consuming to undertake. This study forms part of a National Institute for Health Research funded study to investigate the effect of enhanced surveillance for the early detection of arthritis amongst patients with psoriasis. A major theme of this programme is to improve outcome measurement in psoriatic arthritis through the incorporation of the patient perspective in existing composite measures and development of shortened versions for use in routine clinical practice.
In order to modify the existing composite measures a staged qualitative study is already underway which will report a ranked list of outcomes important to patients mapped on to existing measures. In addition shorter versions of the measures will be developed from existing datasets. The purpose of this study is to compare the modified and shortened composite measures with the original versions and assess their validity (reliability, responsiveness and determining the minimally important difference).
REC name
North East - York Research Ethics Committee
REC reference
17/NE/0084
Date of REC Opinion
20 Mar 2017
REC opinion
Favourable Opinion