The aim of the study was to report physician experience–based “real-world” treatment patterns with botulinum toxin type A in patients with stroke and traumatic brain injury.
A prospective, multicenter, international observational registry design was used.
Six hundred twenty-seven participants with stroke and 132 participants with traumatic brain injury were assessed and treated by 17 more experienced physicians and 12 less experienced physicians. Due to the limited usage of abobotulinumtoxinA Dysport and incobotulinumtoxinA Xeomin, data were reported on onabotulinumtoxinA BOTOX only. Based on physician experience, onabotulinumtoxinA doses were statistically different with larger mean doses injected by more experienced physicians in the upper limb (59.9 [39.0], P = 0.001) and in the lower limb (101.8 [69.2], P < 0.001). Treated deformities significantly differed for both upper limb and lower limb (P < 0.001). More experienced physicians showed a larger mean change in Ashworth Scale scores from baseline for the equinovarus/equinus foot and stiff knee (P = 0.001 and 0.03). Less experienced physicians showed a larger mean change in Ashworth Scale scores from baseline for the adducted thigh (P = 0.05). Less experienced physicians had statistically significant larger change in hand pain scores for clenched fist deformity treatment at follow-up compared with more experienced physicians (P = 0.01). Physician experience demonstrated a significant difference on patients reported satisfaction toward their secondary goal with higher scores for more experienced physician (P = 0.04).
This international registry provides clinical nuances of treatment based on physician clinical experience in a robust sample size.
Every year, 15 million people worldwide are adversely affected by a stroke, and according to the World Health Organization, traumatic brain injury (TBI) will surpass by 2020 many other diseases as the major cause of death and disability.1 Functional problems caused by stroke or a TBI may include paralysis, cognitive and speech changes, and impaired motor control and dexterity as well as abnormal muscle activity that include spasticity, clonus, dystonia, co-contraction, associated reactions, and flexor and extensor spasms as seen in the upper motor neuron syndrome.2Spasticity as a motor behavior is a specific physiologic sign that has classically been described by Lance et al.3 as one component of the upper motor neuron syndrome, distinguishable from other positive features of muscle overactivity (e.g., dystonia, co-contraction). For simplification, all of these abnormal muscle activation patterns are frequently referred to as “spasticity.”4 We have elected the term spastic muscle overactivity as a more encompassing and better suited term.5–7Muscle overactivity can result in multiple patterns of clinical motor dysfunction affecting the lower (e.g., equinovarus, stiff knee, striatal toe, adducted thighs, flexed hip) and/or upper limbs (flexed elbow, internally rotated shoulder, flexed wrist, clenched fist, thumb-in-palm, intrinsics).4
Botulinum toxin has become a widely used biological toxin for a growing number of clinical applications. Clinical trials provide evidence that botulinum toxin can improve symptoms of muscle overactivity when appropriate muscles, doses, and the number of injection sites are selected.4,7 The proper use of these treatments in a “real-world” setting is not restricted to a regimented dosing structure provided by a clinical trial requires appropriate training and education. As in other areas of medicine, physician experience may play a role in care delivery. Physician level of experience may serve as a surrogate in understanding physician practice patterns variation that can inform healthcare services use8 and reduce physician care variations.9 Given these information void, we proposed and conducted a global, multicenter, observational study of participants treated with botulinum toxins in patients with stroke- or TBI-related spastic muscle overactivity to generate real-world data. The use of botulinum toxin A varies internationally; onabotulinumtoxinA (onaBoNTA) BOTOX has been approved for use in the United States for many years, whereas abobotulinumtoxinA (aboBoNTA) Dysport and incobotulinumtoxinA (incoBoNTA) Xeomin were only recently approved (2016). The onaBoNTA and aboBoNTA have been in use in Europe for more than 20 yrs, and incoBoNTA was approved only 10 yrs ago. Published registries have presented real-life data on the treatment of spasticity with onaBonTA10–12; however, to our knowledge, this is the first international registry that includes real-world longitudinal data that include baseline, injection, and outcomes when using the various botulinum toxins available while considering physician experience for its stratification and analysis. Despite the available evidence of botulinum toxin use, it is unclear whether physician level of experience may play a role in the appropriate delivery of toxin-related care. We hypothesized that the physician experience level may impart differences in care patterns in the use of botulinum toxin for spasticity management. Specifically, we focus on analyses based on the physician experience related to the identification of the problem presentation, muscle selection for treatment, formulation selected, dosing, injection technique, dilution, and number of injection sites. We also recorded the primary and secondary goals for treatment as selected by the patient and agreed upon by the treating physician. The primary purpose for this registry was to describe treatment patterns and clinical presentation used in these populations from a global perspective on the basis of clinical experience. Ashworth Scale (AS), presence of pain, and patient-reported satisfaction after treatment were stratified on the basis of reported physicians’ clinical experiences to determine treatment effect.[…]
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