Impact of integrated upper limb spasticity management including botulinum toxin A on patient-centred goal attainment: rationale and protocol for an international prospective, longitudinal cohort study (ULIS-III)

Lynne Turner-Stokes, Stephen Ashford, Jorge Jacinto, Pascal Maisonobe, Jovita Balcaitiene, Klemens Fheodoroff, Lynne Turner-Stokes, Stephen Ashford, Jorge Jacinto, Pascal Maisonobe, Jovita Balcaitiene, Klemens Fheodoroff

Abstract

Objectives: Describe the rationale and protocol for the Upper Limb International Spasticity (ULIS)-III study, which aims to evaluate the impact of integrated spasticity management, involving multiple botulinum toxin A (BoNT-A) injection cycles and concomitant therapies, on patient-centred goal attainment. Outline novel outcome assessment methods for ULIS-III and report initial evaluation data from goal setting in early stages of the study.

Design: Large international longitudinal cohort study of integrated upper limb spasticity management, including BoNT-A.

Participants and setting: ULIS-III is a 2-year study expected to enrol >1000 participants at 58 study centres across 14 countries.

Interventions: The study design is non-interventional and intended to reflect real-life clinical practice. It will describe injection practices and additional treatment strategies, and record clinical decision-making in a serial approach to long-term spasticity management.

Outcome measures: ULIS-III will use a goal-directed approach to selection of targeted standardised measures to capture the diversity of presentation, goals and outcomes. ULIS-III will implement the Upper Limb Spasticity Index, a battery of assessments including a structured approach to goal attainment scaling (Goal Attainment Scaling-Evaluation of Outcomes for Upper Limb Spasticity tool), alongside a limited set of standardised measures, chosen according to patients' selected goal areas. Concomitant therapy inputs, patient satisfaction with engagement in goal setting, health economic end points and health-related quality of life data will also be captured.

Results of initial evaluation of goal quality: Recruitment started in January 2015. By June 2015, 58 sites had been identified and initial data collected for 79 patients across 13 sites in 3 countries. Goal setting data were quality-checked and centres rated on the basis of function-related and Specific, Measurable, Achievable, Realistic, Timed (SMART) characteristics of goal statements. Overall, 11/13 centres achieved the highest rating (A++).

Conclusions: ULIS-III will provide valuable information regarding treatment of and outcomes from real-life upper limb spasticity management worldwide.

Trial registration number: NCT02454803; Pre-results.

Keywords: REHABILITATION MEDICINE; botulinum toxin A; goal attainment scaling (GAS); rehabilitation; spasticity.

Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Figures

Figure 1
Figure 1
Process of application of measures in the ULIS-III study. BoNT-A, botulinum toxin A; GAS-eous, Goal Attainment Scaling—Evaluation of Outcome for Upper Limb Spasticity; ULIS-III, third study in the Upper Limb International Spasticity programme.

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