Journal Article

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

Jones, Rosemary, Galvin, Kathleen T, Thomas, Peter W, Nock, Alison, Green, Colin, Thomas, Sarah, Baker, Roger, Smith, Angela Davies, Hillier, Charles, Kersten, Paula, Slingsby, Vicky

2013

Overview

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 computer-generated 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 self-efficacy 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 cost-effectiveness (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. Trial registration: Current Controlled Trials ISRCTN76517470.

• Publisher: BMJ Publishing Group Ltd,BMJ Publishing Group LTD,BMJ Publishing Group
• Subject: Adult / Aged / Antidepressants / Autoimmune diseases / Cognitive Therapy - economics / Cognitive Therapy - methods / Combined Modality Therapy / Cost analysis / Cost-Benefit Analysis / Disability Evaluation / Fatigue / Fatigue - diagnosis / Fatigue - economics / Fatigue - rehabilitation / Female / Follow-Up Studies / Humans / INTERVENTIONAL / Life Style / Male / Medical personnel / Middle Aged / MULTIPLE SCLEROSIS / Multiple Sclerosis, Chronic Progressive - diagnosis / Multiple Sclerosis, Chronic Progressive - economics / Multiple Sclerosis, Chronic Progressive - rehabilitation / Multiple Sclerosis, Relapsing-Remitting - diagnosis / Multiple Sclerosis, Relapsing-Remitting - economics / Multiple Sclerosis, Relapsing-Remitting - rehabilitation / Professional ethics / Professionals / Psychologists / PSYCHOLOGY / Psychotherapy, Group - economics / Psychotherapy, Group - methods / QUALITY OF LIFE / Quality-Adjusted Life Years / RANDOMISED TRIALS / Self Efficacy / State Medicine - economics / Surveys and Questionnaires