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).
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.



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



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



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.



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.



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++).



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



NCT02454803; Pre-results.
Department of Palliative Care, Policy and Rehabilitation and Regional Rehabilitation Unit, King's College London School of Medicine, Northwick Park Hospital, London, UK.
Lynne
L
Turner-Stokes
Department of Palliative Care, Policy and Rehabilitation and Regional Rehabilitation Unit, King's College London School of Medicine, Northwick Park Hospital, London, UK.
Stephen
S
Ashford
Centro de Medicina de Reabilitaçãode Alcoitão, Serviço de Reabilitação de Adultos, Estoril, Portugal.
Jorge
J
Jacinto
Medical Affairs, Ipsen Pharma, Boulogne-Billancourt, France.
Pascal
P
Maisonobe
Medical Affairs, Ipsen Pharma, Boulogne-Billancourt, France.
Jovita
J
Balcaitiene
Department of Neurorehabilitation, Gailtal-Klinik, Hermagor, Austria.
Klemens
K
Fheodoroff
D000328:Adult; D019274:Botulinum Toxins, Type A / Q000627:therapeutic use*; D000066491:Clinical Decision-Making; D006040:Goals; D006801:Humans; D008137:Longitudinal Studies; D009128:Muscle Spasticity / Q000188:drug therapy* / Q000503:physiopathology; D009465:Neuromuscular Agents / Q000627:therapeutic use*; D018802:Patient-Centered Care; D011446:Prospective Studies; D011788:Quality of Life; D034941:Upper Extremity / Q000503:physiopathology*; D055815:Young Adult
D009465:Neuromuscular Agents; D019274:Botulinum Toxins, Type A
REHABILITATION MEDICINE; botulinum toxin A; goal attainment scaling (GAS); rehabilitation; spasticity