Individualized OnabotulinumtoxinA Treatment for Upper Limb Spasticity Resulted in High Clinician- and Patient-Reported Satisfaction: Long-Term Observational Results from the ASPIRE Study.

This was an observational registry, not a randomised controlled trial, so it cannot show that onabotulinumtoxinA alone caused the reported improvements. There was no control group or comparison treatment. Of 484 upper limb patients, 199 discontinued and only 285 completed, so later satisfaction and function results may represent people who tolerated or benefited from treatment. No formal sample size or power calculations were performed, and missing values were not imputed. Most patients had stroke (358 of 484), so results may not apply equally to cerebral palsy, multiple sclerosis, spinal cord injury or traumatic brain injury. Patients could also have received lower limb treatment, so overall functional or pain improvements may not be exclusive to the upper limb. Non-naive patients may have been selected because they had tolerated or responded to botulinum toxin before. Patient-reported outcomes were collected by phone or web and sample size diminished over time. Satisfaction outcomes are subjective and can be influenced by expectations, clinician relationship, or other concurrent care. The paper does not report all concurrent treatments for each patient, so the contribution of any single component cannot be separated.

The study was funded by Allergan plc, the company that makes onabotulinumtoxinA. The paper states that financial support was not provided by the sponsor for treatment or treatment-related costs.

Do not conclude that onabotulinumtoxinA alone improves upper limb function or pain. It was an uncontrolled observational study, many patients stopped treatment, and other spasticity treatments or therapy may have been given at the same time, so the contribution of any single component cannot be separated.