Quality of Life Assessment Using the Leg Activity Measure in Ambulatory Individuals With Leg Spasticity: Findings From a Longitudinal, Observational Study Evaluating the Effectiveness of AbobotulinumtoxinA in Routine Practice.

There was no control group and no randomisation, so the improvements over time cannot be attributed to abobotulinumtoxinA or separated from the rest of the rehabilitation people were receiving. Missing data were extensive and no attempt was made to account for them. The number of patients contributing quality of life scores fell from 249 at Cycle 1 to 194 by Cycle 4, and the people who dropped out may have been doing worse. The LegA was only completed by patients who set an active or passive function goal in that cycle, so it is not available for the whole group. About two-thirds of the participants also received treatment for upper limb spasticity at least once during the study, which may have changed their EQ-5D-5L scores. Assessments were done at the start and end of each injection cycle rather than at the time of peak effect, which is what controlled trials of botulinum toxin normally do. The correlation analyses were done after the fact rather than planned in advance. The authors themselves note that how much change on the EQ-5D-5L actually matters clinically varies widely between populations and treatments, so it is unclear how much of the improvement patients would notice. The study did not examine other factors that might explain who improved, so it cannot say which patients are most likely to benefit.

The article text supplied contains no funding statement and no conflict of interest declaration, so who paid for the work and what the authors declared is not reported here.

Do not read the steady rise in quality of life scores as proof that the injections caused it. Everyone in this study was treated with abobotulinumtoxinA, there was no control group, and two-thirds of patients were also having upper limb injections during the same period, so the improvement could reflect the wider rehabilitation they received or the passage of time rather than the leg injections themselves.