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Research paper
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
  1. Sarah Thomas1,
  2. Peter W Thomas1,
  3. Paula Kersten2,
  4. Rosemary Jones3,
  5. Colin Green4,
  6. Alison Nock5,
  7. Vicky Slingsby5,
  8. Angela Davies Smith3,
  9. Roger Baker1,
  10. Kathleen T Galvin6,
  11. Charles Hillier5
  1. 1Clinical Research Unit, School of Health and Social Care, Bournemouth University, Bournemouth, Dorset, UK
  2. 2Person Centred Research Centre, School of Rehabilitation and Occupation Studies, AUT University, Auckland, New Zealand
  3. 3MS Research Unit, Bristol and Avon MS Clinical Centre, Frenchay Hospital, Bristol UK
  4. 4Health Economics Group, University of Exeter Medical School, University of Exeter, Exeter, UK
  5. 5Dorset MS Service, Poole Hospital NHS Foundation Trust, Poole, UK
  6. 6Faculty of Health and Social Care, Hull University, Hull, UK
  1. Correspondence to Dr Sarah Thomas, Clinical Research Unit, School of Health and Social Care, Bournemouth University, Bournemouth, Dorset BH1 3LT, UK; saraht{at}bournemouth.ac.uk

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 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.

  • MULTIPLE SCLEROSIS
  • RANDOMISED TRIALS
  • QUALITY OF LIFE
  • PSYCHOLOGY
  • INTERVENTIONAL

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 3.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/3.0/

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