We carried out a pragmatic multi-centre randomised controlled trial following the published protocol  in which the full study design, inclusion and exclusion criteria, trial arms, and plan of analysis are described in detail. The main results are reported elsewhere . Here we report the results from the 1 year self-reported follow-up data.
Participants were recruited in three UK centres (Poole, Bristol, Southampton/Portsmouth) from primary or secondary care, or via MS Society newsletters/websites. Recruitment took place from May 2008 to November 2009. Ethical approval was obtained from the South West-Central Bristol Research Ethics Committee (ref: 08/H0106/2). All participants provided written informed consent before taking part.
The main inclusion criteria were: (1) clinically definite MS diagnosis, (2) fatigue impacting on daily life (Fatigue Severity Scale total score >4)  and (3) ambulatory. The main exclusion criteria were: (1) having taken part in a fatigue programme in the last year, (2) cognitive impairments (3) a relapse in the previous 3 months or (4) having started treatment with disease modifying or antidepressant drugs within the previous 3 months. The full eligibility criteria are described in the protocol .
Intervention (FACETS programme)
The manualised group-based FACETS programme is described elsewhere  and is based upon a conceptual framework integrating elements from cognitive behavioural, social-cognitive, energy effectiveness, self-management and self-efficacy theories. The aim of the intervention is to help people with MS normalise their fatigue experiences, learn helpful ways of thinking about fatigue and use available energy more effectively. The intervention consists of six sessions (∼90 min duration) held weekly and facilitated in groups of 6–12 by two health professionals with experience of working with people with MS and group-work (such as occupational therapists, nurses or physiotherapists). Each session follows the same general format, namely, facilitator-delivered presentations, flipchart discussions, group activities and homework. The facilitator manual provides guidance on preparation and delivery, detailed session content, notes and suggested timings, and a checklist of facilitator objectives as well as signposts to additional resources. Sessions are delivered via PowerPoint; hence can be easily replicated. A companion participant handbook, along with existing information booklets, reinforces programme content.
FACETS was delivered in hotel meeting-room facilities, with the exception of one centre, where it was held in a rehabilitation hospital. Apart from one MS specialist nurse, facilitators were either occupational therapists or physiotherapists. Facilitators were trained to deliver the intervention at 1-day workshops and psychological advice and debriefing were available for facilitators throughout the trial.
To increase external validity, no attempt was made in the FACETS arm to restrict or control participants’ access to current local practice or to standardise it across healthcare settings or treatment arms. When we refer to the FACETS arm, participants in this arm also received current local practice.
Control group (Current Local Practice (CLP))
Participants randomised to this arm of the trial received current local practice.
This could have ranged from general advice and information provision about MS-fatigue to more detailed individualised management advice from a variety of health professionals. Inevitably, there will have been variations in the exact composition of what was usually provided, within and between centres, depending on local resources and patient need. Collecting detailed information at an individual level on the type and quantity of advice received as part of current local practice was not deemed feasible. However, this real world variation increases applicability to a wider range of centres.
For those allocated to the FACETS arm outcomes were measured 1 week (baseline) before the start of the FACETS programme and 1 month (follow-up 1), 4 months (follow-up 2) and 12 months (follow-up 3) after the final session. Participants in the current local practice arm completed outcome measures within an identical time frame. Data from follow-up 1 and 2 have previously been reported . In this paper we focus on reporting follow-up 3.
Primary outcomes were fatigue severity (Global Fatigue Severity (GFS) subscale of the Fatigue Assessment Instrument (FAI)), disease specific quality of life (Multiple Sclerosis Impact Scale (MSIS-29, V.1)) and self-efficacy for managing fatigue (Multiple Sclerosis - Fatigue Self-Efficacy scale (MS-FSE)) [7,8].
Secondary outcomes included the Fatigue Symptom Inventory (FSI), the Hospital Anxiety and Depression Scale (HADS), the Medical Outcomes Short-Form Survey (SF-36, V. 2), and subscales of the MSIS-29 (V.1) and the FAI [7, 8]. All outcomes collected at 12 months were self-reported questionnaires and administered postally.
Sample size considerations
The sample size requirement was 146 participants with follow-up data based on having 85% power to detect a medium standardised effect size of 0.5 for the primary outcome measures, using a two-sided 5% significance level (see protocol for justification for this medium effect size) . As a variety of fatigue measures have been used in other trials, we used standardised effect sizes to enable comparisons between them.
The main analysis was intention-to-treat but we also conducted a per protocol analysis (excluding participants who attended fewer than four FACETS sessions). Data were analysed using IBM SPSS, V.18 and MLwiN 2.17. Outcome measures were assumed to be interval-scaled and the main analysis focused on absolute change in outcomes at 1 year follow-up relative to baseline. Change scores were compared between the groups using the independent samples t-test with a two sided 5% significance level, and summarised using mean differences (95% confidence intervals (CIs)) and standardised effect sizes (SES). As detailed in the protocol, additional pre-specified supplementary analyses were undertaken. Here we report results from a mixed model approach that includes 1 year and baseline measurements as repeated measures, incorporates clustering effects, and includes pre-specified covariates (baseline for other primary outcomes, age, gender, marital status, education level, type of MS, time since diagnosis, level of disability, and centre).