Skip to main content

A pragmatic parallel arm multi-centre randomised controlled trial to assess the effectiveness and cost-effectiveness of a group-based fatigue management programme (FACETS) for people with multiple sclerosis.

Thomas, S., Thomas, P., Kersten, P., Jones, R, Green, C., Nock, A., Slingsby, V, Smith, A.D., Baker, R., Galvin, K. T. and Hillier, C, 2013. A pragmatic parallel arm multi-centre randomised controlled trial to assess the effectiveness and cost-effectiveness of a group-based fatigue management programme (FACETS) for people with multiple sclerosis. Journal of Neurology, Neurosurgery and Psychiatry, 84 (10), 1092 - 1099 .

Full text available as:

[img]
Preview
PDF
JNNP final.pdf - Published Version
Available under License Creative Commons Attribution.

588kB
[img]
Preview
PDF
jnnp final suppl.pdf - Published Version
Available under License Creative Commons Attribution.

269kB

DOI: 10.1136/jnnp-2012-303816

Abstract

Background Fatigue is a common and troubling symptom for people with multiple sclerosis (MS). Aim To evaluate the effectiveness and cost-effectiveness of a six-session group-based programme for managing MS-fatigue (Fatigue: Applying Cognitive behavioural and Energy effectiveness Techniques to lifeStyle (FACETS)). Methods Three-centre parallel arm randomised controlled trial with economic evaluation. Patients with MS and significant fatigue were randomised to FACETS plus current local practice (FACETS) or current local practice alone (CLP), using concealed computergenerated randomisation. Participant blinding was not possible. Primary outcomes were fatigue severity (Fatigue Assessment Instrument), self-efficacy (Multiple Sclerosis- Fatigue Self-Efficacy) and disease-specific quality of life (Multiple Sclerosis Impact Scale (MSIS-29)) at 1 and 4 months postintervention (follow-up 1 and 2). Quality adjusted life years (QALYs) were calculated (EuroQoL 5- Dimensions questionnaire and the Short-form 6- Dimensions questionnaire). Results Between May 2008 and November 2009, 164 patients were randomised; primary outcome data were available for 146 (89%). Statistically significant differences favour the intervention group on fatigue selfefficacy at follow-up 1 (mean difference (MD) 9, 95% CI (4 to 14), standardised effect size (SES) 0.54, p=0.001) and follow-up 2 (MD 6, 95% CI (0 to 12), SES 0.36, p=0.05) and fatigue severity at follow-up 2 (MD -0.36, 95% CI (-0.63 to -0.08), SES -0.35, p=0.01) but no differences for MSIS-29 or QALYs. No adverse events reported. Estimated cost per person for FACETS is £453; findings suggest an incremental cost-effectiveness ratio of £2157 per additional person with a clinically significant improvement in fatigue. Conclusions FACETS is effective in reducing fatigue severity and increasing fatigue self-efficacy. However, it is difficult to assess the additional cost in terms of costeffectiveness (ie, cost per QALY) as improvements in fatigue are not reflected in the QALY outcomes, with no significant differences between FACETS and CLP. The strengths of this trial are its pragmatic nature and high external validity.

Item Type:Article
ISSN:0022-3050
Group:Faculty of Health & Social Sciences
ID Code:22499
Deposited By: Symplectic RT2
Deposited On:25 Sep 2015 13:24
Last Modified:14 Mar 2022 13:53

Downloads

Downloads per month over past year

More statistics for this item...
Repository Staff Only -