Goal Attainment Scaling in the evaluation of treatment of Upper Limb Spasticity with Botulinum Toxin:A secondary analysis from double-blind-placebo-controlled randomized clinical trial.

摘要

OBJECTIVE: To examine goal attainment scaling for evaluation of treatment for upper limb post-stroke spasticity with botulinum toxin-A.DESIGN: Secondary analysis of a multi-centre double-blind, placebo-controlled randomized clinical trial.Setting: Six outpatient clinics in Australia.Participants: Patients (n = 90) completing per protocol 2 cycles of treatment/placebo. Mean age 54.5 (standard deviation 13.2) years. Mean time since stroke 5.9 (standard deviation 10.5) years.Interventions: Intramuscular botulinum toxin-A (Dysport ® 500–1000U) or placebo given at 0 and 12 weeks. Measurement points were baseline, 8 and 20 weeks.Main outcome measures: Individualized goal attainment and its relationship with spasticity and other person-centred measures – pain, mood, quality of life and global benefit. RESULTS: A significant treatment effect was observed with respect to goal attainment (Mann-Whitney z = –2.33, p ≤ 0.02). Goal-attainment scaling outcome T-scores were highly correlated with reduction in spasticity (rho = 0.36, p = 0.001) and global benefit (rho = 0.45, p < 0.001), but not with other outcome measures. Goal-attainment scaling T-scores were lower than expected (median 32.4, interquartile range 29.6–40.6). Goals related to passive tasks were more often achieved than those reflecting active function. Qualitative analysis of goals nevertheless demonstrated change over a wide area of patient experience.CONCLUSION: Goal-attainment scaling provided a responsive measure for evaluating focal intervention for upper limb spasticity, identifying outcomes of importance to the individual/carers, not otherwise identifiable using standardized measures.