Methods
protocolFurther, post-stroke spasticity, post-stroke
WEST
This study reports on the cost-consequences of the early use of botulinum toxin in
post-stroke spasticity. The trial was approved by North West – Greater Manchester
South Ethics Committee Reference number 10/H1003/111. It was registered with EudraCT
(2010-021257-39) and at ClinicalTrials.gov-Identifier: NCT01882556.The protocolFurther, details regarding participants’ use of health services were documented at
two, four, six and 12 weeks following treatment and at six months post-stroke. These
included GP visits, hospital visits and admissions. Current medication use and any
changes from discharge were documented. Treatments to manage contractures were also
recorded. Patients were encouraged to document such activities in a diary and this
additional informal questioning was completed at each review to ensure all
information was provided.Resource use costs associated with the study were summarised into relevant categories
and valued in £ sterling using a price year of 2017/18. The costs were determined
from national published sources of unit costs British National Formulary,The Barthel Index and Action Research Arm Test were used to generate a cost per unit
of improvement in each of the measures. A one-way sensitivity analysis was
undertaken (using IBM SPSS 27) to assess the extent of potential changes in the main
cost parameters and outcomes of the treatment using the mean difference and lower
and upper bounds of the confidence intervals. The 95% confidence interval of net
cost and changes in outcomes were used to generate a series of potential scenarios
and explore the changes in the estimated cost per unit of improvement.