Adult Spasticity International Registry Study: methodology and baseline patient, healthcare provider, and caregiver characteristics
Gerard E. Francisco, Daniel S. Bandari, Ganesh Bavikatte, Wolfgang H. Jost, Aubrey Manack Adams, Joan Largent, Alberto Esquenazi
Physical Medicine and Rehabilitation, University of Texas Health Science Center McGovern Medical School and TIRR Memorial Hermann, Houston, TX 77030, USA. E-mail: email@example.com
Objective: The main aim of this study was to determine the utilization patterns and effectiveness of onabotulinumtoxinA (Botox®) for treatment of spasticity in clinical practice.
Design: An international, multicentre, prospective, observational study at selected sites in North America, Europe, and Asia.
Patients: Adult patients with newly diagnosed or established focal spasticity, including those who had previously received treatment with onabotulinum-toxin A.
Methods: Patients were treated with onabotulinumtoxinA, approximately every 12 weeks, according to their physician’s usual clinical practice over a period of up to 96 weeks, with a final follow-up interview at 108 weeks. Patient, physician and caregiver data were collected.
Results: Baseline characteristics are reported. Of the 745 patients enrolled by 75 healthcare providers from 54 sites, 474 patients had previously received onabotulinumtoxinA treatment for spasticity. Lower limb spasticity was more common than upper limb spasticity, with stroke the most common underlying aetiology. The Short-Form 12 (SF-12) health survey scores showed that patients’ spasticity had a greater perceived impact on physical rather than mental aspects.
Conclusion: The data collected in this study will guide the development of administration strategies to optimize the effectiveness of onabotulinumtoxinA in the management of spasticity of various underlying aetiologies.
People with spasticity have stiff muscles. Spasticity can also cause muscles to move without control. OnabotulinumtoxinA, sold as BOTOX®, is a medicine used to treat spasticity. This study looks at how BOTOX is used in adults who have spasticity during real office visits to their doctor. We look at how much, in which muscles, and when BOTOX is given to treat spasticity. A total of 745 adults with spasticity joined the study. Seventy-five doctors in North America, Europe, and Asia treated the people in this study. A total of 474 people were treated before the study with BOTOX for spasticity. More people had spasticity in their leg muscles compared to their arm muscles. Most people were being treated for spasticity after having a stroke. Information from this study will help decide the best way for doctors to use BOTOX for people with spasticity.
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