Evidence map›Paper›PMID 23695501›Full record

Trial reportJournal of neurology, neurosurgery, and psychiatry2013

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.

Sarah Thomas, Peter W Thomas, Paula Kersten, Rosemary Jones, Colin Green, Alison Nock, Vicky Slingsby, Angela Davies Smith, Roger Baker, Kathleen T Galvin and 1 more

2 registry-linked trialsAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of neurology, neurosurgery, and psychiatry, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 56 papers, 10 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
56citing papers in PubMed, 10 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03758820 nacompletednot on this mapstarted 2017, after this paper: background citation

Multicenter Study, Randomized, Parallel Group Controlled, Testing the Effectiveness of a Behavioral Cognitive Therapy (BCT) vs Usual Local Practice on the Fatigue of Patients With Relapsing Remittent Multiple Sclerosis (RRMS)

TypeinterventionalSponsorRéseau Sep Idf OuestRan2017 to 2020Enrolled105ConditionsRelapsing Remitting Multiple Sclerosis, Fatigue, Cognitive TherapyArmsBehavorial Cognitive Therapy (BCT)
NCT07094269 narecruitingnot on this mapstarted 2025, after this paper: background citation

Protocol for a Superiority Randomized Controlled Trial of a Group-Based Fatigue Management Program Versus Standard Information to Improve Self-Efficacy in Energy Conservation in Parkinson's Disease

TypeinterventionalSponsorUniversita degli Studi di GenovaRan2025 to 2026Enrolled80ConditionsPARKINSON DISEASE (Disorder)ArmsOccupational Therapy Intervention, Fact-sheets
3 · Its place in the literature

Who cites it

56 citing papers in PubMed, 10 syntheses or guidelines pooled it.

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  4. Use of pragmatic randomized trials in multiple sclerosis: A systematic overview.Multiple sclerosis (Houndmills, Basingstoke, England) · 2024
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Sarah ThomasClinical Research Unit, School of Health and Social Care, Bournemouth University, Bournemouth, Dorset, UK. saraht@bournemouth.ac.uk
Peter W Thomas
Paula Kersten
Rosemary Jones
Colin Green
Alison Nock
Vicky Slingsby
Angela Davies Smith
Roger Baker
Kathleen T Galvin
Charles Hillier

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundFatigue is a common and troubling symptom for people with multiple sclerosis (MS).

aimTo 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)).

methodsThree-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).

resultsBetween 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.

conclusionsFACETS 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 registrationCurrent Controlled Trials ISRCTN76517470.

Indexed as

Life StyleAdultAgedCognitive Behavioral TherapyCombined Modality TherapyCost-Benefit AnalysisDisability EvaluationFatigueFemaleFollow-Up StudiesHumansMaleMiddle AgedMultiple Sclerosis, Chronic ProgressiveMultiple Sclerosis, Relapsing-RemittingPsychotherapy, GroupINTERVENTIONALMULTIPLE SCLEROSISPSYCHOLOGYQUALITY OF LIFERANDOMISED TRIALS

Identifiers

PMID23695501
PMCPMC3786656

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.