BMJ Open. 2016 Jun 17;6(6):e011157. doi: 10.1136/bmjopen-2016-011157.

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).

Turner-Stokes L¹, Ashford S¹, Jacinto J², Maisonobe P³, Balcaitiene J³, Fheodoroff K⁴.

Author information

1: Department of Palliative Care, Policy and Rehabilitation and Regional Rehabilitation Unit, King's College London School of Medicine, Northwick Park Hospital, London, UK.
2: Centro de Medicina de Reabilitaçãode Alcoitão, Serviço de Reabilitação de Adultos, Estoril, Portugal.
3: Medical Affairs, Ipsen Pharma, Boulogne-Billancourt, France.
4: Department of Neurorehabilitation, Gailtal-Klinik, Hermagor, Austria.

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.

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