PATIENT-CENTERED OUTCOMES IN UPPER LIMB SPASTICITY - RESULTS FROM A LARGE INTERNATIONAL COHORT STUDY (ULIS-2)
Author(s)
Balcaitiene J1;Kurth H*2;Fheodoroff K3;Jacinto J4, Turner-Stokes L5 1IPSEN Pharma, Boulogne-Billancourt, France, 2IPSEN Pharma, Boulogne Billancourt, France, 3Gailtal-Klinik, Hermagor, Austria, 4Serviço de Reabilitação de adultos 3, Alcoitão, Portugal, 5King’s College London, London, United Kingdom
BACKGROUND : Muscle spasticity following stroke may interfere with motor and activity performance, cause pain, and lead to secondary complications. Goals of spasticity management include improving function (active and passive) and body image, and facilitating concomitant treatments. The efficacy of BoNT-A in upper limb spasticity (ULS) patients focusing on reduction of muscle tone and pain is well established. However, there are no specific ULS patient-reported outcome measures (PROs) available. As patients with ULS are highly heterogeneous, there is a need to develop measures to capture realistic, patient-specific treatment goals. OBJECTIVES: To assess effectiveness of BoNTA on ULS considering patient-specific experience. METHODS: A prospective multinational, multicenter (84 centers in 22 countries), observational, post-marketing, longitudinal study (ULIS-2), investigating routine use of BoNT-A for treating post-stroke ULS. Primary outcome: achievement of the patient’s primary goal for treatment using Goal Attainment Scaling (GAS). Goals were set together by physicians and patients/caregivers. Patients were able to rate goals for importance. Secondary outcome: global assessment of benefits by both physician and patients/caregiver. RESULTS: Among the 456 adults with post-stroke ULS presenting for treatment with BoNT-A, the most commonly selected primary treatment goals were passive function (132 (28.9%)), active function (104 (22.8%)), pain (61 (13.4%), and impairment (105 (23%)). Patients rated 404/456 primary goals (88.6 %) as “important” (395/456 (86.6%) as “very” or “moderately” important), indicating high patient involvement in goal-setting. Overall, 363 (79.6%) (95% CI 75.6% to 83.2%) patients achieved (or overachieved) their primary goal. GAS T-scores were strongly correlated with rating of global benefit and other standard measures (correlations of 0.38 and 0.63, respectively; p<0.001). CONCLUSIONS: Patient-centered goal setting and evaluation using GAS to calculate changes of health-related status is a feasible way to capture changes in ULS patient experience. GAS as primary outcome measure in ULIS-2 is a step closer to a PRO in ULS patients.
Conference/Value in Health Info
2013-11, ISPOR Europe 2013, The Convention Centre Dublin
Value in Health, Vol. 16, No. 7 (November 2013)
Code
PND46
Topic
Patient-Centered Research
Topic Subcategory
Patient-reported Outcomes & Quality of Life Outcomes
Disease
Neurological Disorders, Respiratory-Related Disorders