Protocol for the economic evaluation of the InTENSE program for rehabilitation of chronic upper limb spasticity.
Botulinum toxin
Cost effectiveness analysis
Costs
Motor training
Quality of life
Rehabilitation
Therapy
Journal
BMC health services research
ISSN: 1472-6963
Titre abrégé: BMC Health Serv Res
Pays: England
ID NLM: 101088677
Informations de publication
Date de publication:
27 May 2020
27 May 2020
Historique:
received:
08
03
2019
accepted:
18
05
2020
entrez:
29
5
2020
pubmed:
29
5
2020
medline:
21
11
2020
Statut:
epublish
Résumé
Assessment of the costs of care associated with chronic upper-limb spasticity following stroke in Australia and the potential benefits of adding intensive upper limb rehabilitation to botulinum toxin-A are key objectives of the InTENSE randomised controlled trial. Recruitment for the trial has been completed. A total of 139 participants from 6 stroke units across 3 Australian states are participating in the trial. A cost utility analysis will be undertaken to compare resource use and costs over 12 months with health-related quality of life outcomes associated with the intervention relative to a usual care comparator. A cost effectiveness analysis with the main clinical measure of outcome, Goal Attainment Scaling, will also be undertaken. The primary outcome measure for the cost utility analysis will be the incremental cost effectiveness ratio (ICER) generated from the incremental cost of the intervention as compared to the incremental benefit, as measured in quality adjusted life years (QALYs) gained. The utility scores generated from the EQ-5D three level instrument (EQ-5D-3 L) measured at baseline, 3 months and 12 months will be utilised to calculate the incremental Quality Adjusted Life Year (QALY) gains for the intervention relative to usual care using area-under the curve methods. The results of the economic evaluation will provide evidence of the total costs of care for patients with chronic upper limb spasticity following stroke. It will also provide evidence for the cost-effectiveness of adding evidence-based movement therapy to botulinum toxin-A as a treatment, providing important information for health system decision makers tasked with the planning and provision of services.
Sections du résumé
BACKGROUND
BACKGROUND
Assessment of the costs of care associated with chronic upper-limb spasticity following stroke in Australia and the potential benefits of adding intensive upper limb rehabilitation to botulinum toxin-A are key objectives of the InTENSE randomised controlled trial.
METHODS
METHODS
Recruitment for the trial has been completed. A total of 139 participants from 6 stroke units across 3 Australian states are participating in the trial. A cost utility analysis will be undertaken to compare resource use and costs over 12 months with health-related quality of life outcomes associated with the intervention relative to a usual care comparator. A cost effectiveness analysis with the main clinical measure of outcome, Goal Attainment Scaling, will also be undertaken. The primary outcome measure for the cost utility analysis will be the incremental cost effectiveness ratio (ICER) generated from the incremental cost of the intervention as compared to the incremental benefit, as measured in quality adjusted life years (QALYs) gained. The utility scores generated from the EQ-5D three level instrument (EQ-5D-3 L) measured at baseline, 3 months and 12 months will be utilised to calculate the incremental Quality Adjusted Life Year (QALY) gains for the intervention relative to usual care using area-under the curve methods.
DISCUSSION
CONCLUSIONS
The results of the economic evaluation will provide evidence of the total costs of care for patients with chronic upper limb spasticity following stroke. It will also provide evidence for the cost-effectiveness of adding evidence-based movement therapy to botulinum toxin-A as a treatment, providing important information for health system decision makers tasked with the planning and provision of services.
Identifiants
pubmed: 32460773
doi: 10.1186/s12913-020-05333-z
pii: 10.1186/s12913-020-05333-z
pmc: PMC7254740
doi:
Substances chimiques
Botulinum Toxins, Type A
EC 3.4.24.69
Types de publication
Clinical Trial, Phase III
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
478Subventions
Organisme : National Health and Medical Research Council
ID : GNT1079542
Organisme : National Health and Medical Research Council
ID : GNT1112158
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