title: 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.
abstract: BACKGROUND
  Fatigue is a common and troubling symptom for people with multiple sclerosis (MS).
  
  
  OBJECTIVE
  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.
  
  
  BACKGROUND
  Current Controlled Trials ISRCTN76517470.
authors.affiliation: Clinical Research Unit, School of Health and Social Care, Bournemouth University, Bournemouth, Dorset, UK. saraht@bournemouth.ac.uk
authors.forename: Sarah
authors.initials: S
authors.lastname: Thomas
authors.forename: Peter W
authors.initials: PW
authors.lastname: Thomas
authors.forename: Paula
authors.initials: P
authors.lastname: Kersten
authors.forename: Rosemary
authors.initials: R
authors.lastname: Jones
authors.forename: Colin
authors.initials: C
authors.lastname: Green
authors.forename: Alison
authors.initials: A
authors.lastname: Nock
authors.forename: Vicky
authors.initials: V
authors.lastname: Slingsby
authors.forename: Angela Davies
authors.initials: AD
authors.lastname: Smith
authors.forename: Roger
authors.initials: R
authors.lastname: Baker
authors.forename: Kathleen T
authors.initials: KT
authors.lastname: Galvin
authors.forename: Charles
authors.initials: C
authors.lastname: Hillier
mesh_terms: D000328:Adult; D000368:Aged; D015928:Cognitive Behavioral Therapy / Q000191:economics* / Q000379:methods*; D003131:Combined Modality Therapy; D003362:Cost-Benefit Analysis; D004185:Disability Evaluation; D005221:Fatigue / Q000175:diagnosis / Q000191:economics* / Q000534:rehabilitation*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008019:Life Style; D008297:Male; D008875:Middle Aged; D020528:Multiple Sclerosis, Chronic Progressive / Q000175:diagnosis / Q000191:economics* / Q000534:rehabilitation*; D020529:Multiple Sclerosis, Relapsing-Remitting / Q000175:diagnosis / Q000191:economics* / Q000534:rehabilitation*; D011615:Psychotherapy, Group / Q000191:economics* / Q000379:methods*; D011788:Quality of Life; D019057:Quality-Adjusted Life Years; D020377:Self Efficacy; D013222:State Medicine / Q000191:economics; D011795:Surveys and Questionnaires
keywords: INTERVENTIONAL; MULTIPLE SCLEROSIS; PSYCHOLOGY; QUALITY OF LIFE; RANDOMISED TRIALS