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; A. Nock; V. Slingsby; Angela Davies Smith; Roger Baker; Kathleen Galvin; Charles Hillier

doi:10.1136/jnnp-2012-303816

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, A. Nock, V. Slingsby, Angela Davies Smith, Roger Baker, Kathleen Galvin, Charles Hillier

University of Brighton

Research output: Contribution to journal › Article › peer-review

Abstract

Background symptom for people with multiple sclerosis (MS).Fatigue is a common and troubling Aim of a six-session group-based programme for managing MS-fatigue (Fatigue: Applying Cognitive behavioural and Energy effectiveness Techniques to lifeStyle (FACETS)).To evaluate the effectiveness and cost-effectiveness Methods controlled trial with economic evaluation. Patients with MS and signi plus current local practice (FACETS) or current local practice alone (CLP), using concealed computergenerated randomisation. Participant blinding was not possible. Primary outcomes were fatigue severity (Fatigue Assessment Instrument), self-ef Fatigue Self-Ef (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).Three-centre parallel arm randomisedficant fatigue were randomised to FACETSficacy (Multiple Sclerosis-ficacy) and disease-specific quality of life Results 164 patients were randomised; primary outcome data were available for 146 (89%). Statistically signi differences favour the intervention group on fatigue selfef 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 95% CI ( differences for MSIS-29 or QALYs. No adverse events reported. Estimated cost per person for FACETS is £453;Between May 2008 and November 2009,ficantficacy−0.36,−0.63 to −0.08), SES −0.35, p=0.01) but no fi of £2157 per additional person with a clinically signindings suggest an incremental cost-effectiveness ratioficant improvement in fatigue. Conclusions severity and increasing fatigue self-ef is dif (ie, cost per QALY) as improvements in fatigue are not re signi strengths of this trial are its pragmatic nature and high external validity.FACETS is effective in reducing fatigueficacy. However, itficult to assess the additional cost in terms of costeffectivenessflected in the QALY outcomes, with noficant differences between FACETS and CLP. The Trial registration: ISRCTN76517470Current Controlled Trials

Original language	English
Pages (from-to)	1-8
Number of pages	8
Journal	Journal of Neurology Neurosurgery and Psychiatry
Volume	84
Issue number	10
DOIs	https://doi.org/10.1136/jnnp-2012-303816
Publication status	Published - 31 Oct 2013

Bibliographical note

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/

Keywords

multiple sclerosis
randomised trials
quality of life
psychology
interventional

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Thomas, S., Thomas, P. W., Kersten, P., Jones, R., Green, C., Nock, A., Slingsby, V., Smith, A. D., Baker, R., Galvin, K., & Hillier, C. (2013). 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. Journal of Neurology Neurosurgery and Psychiatry, 84(10), 1-8. https://doi.org/10.1136/jnnp-2012-303816

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abstract = "Background symptom for people with multiple sclerosis (MS).Fatigue is a common and troubling Aim of a six-session group-based programme for managing MS-fatigue (Fatigue: Applying Cognitive behavioural and Energy effectiveness Techniques to lifeStyle (FACETS)).To evaluate the effectiveness and cost-effectiveness Methods controlled trial with economic evaluation. Patients with MS and signi plus current local practice (FACETS) or current local practice alone (CLP), using concealed computergenerated randomisation. Participant blinding was not possible. Primary outcomes were fatigue severity (Fatigue Assessment Instrument), self-ef Fatigue Self-Ef (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).Three-centre parallel arm randomisedficant fatigue were randomised to FACETSficacy (Multiple Sclerosis-ficacy) and disease-specific quality of life Results 164 patients were randomised; primary outcome data were available for 146 (89%). Statistically signi differences favour the intervention group on fatigue selfef 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 95% CI ( differences for MSIS-29 or QALYs. No adverse events reported. Estimated cost per person for FACETS is £453;Between May 2008 and November 2009,ficantficacy−0.36,−0.63 to −0.08), SES −0.35, p=0.01) but no fi of £2157 per additional person with a clinically signindings suggest an incremental cost-effectiveness ratioficant improvement in fatigue. Conclusions severity and increasing fatigue self-ef is dif (ie, cost per QALY) as improvements in fatigue are not re signi strengths of this trial are its pragmatic nature and high external validity.FACETS is effective in reducing fatigueficacy. However, itficult to assess the additional cost in terms of costeffectivenessflected in the QALY outcomes, with noficant differences between FACETS and CLP. The Trial registration: ISRCTN76517470Current Controlled Trials",

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author = "Sarah Thomas and Thomas, {Peter W.} and Paula Kersten and Rosemary Jones and Colin Green and A. Nock and V. Slingsby and Smith, {Angela Davies} and Roger Baker and Kathleen Galvin and Charles Hillier",

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Thomas, S, Thomas, PW, Kersten, P, Jones, R, Green, C, Nock, A, Slingsby, V, Smith, AD, Baker, R, Galvin, K & Hillier, C 2013, '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', Journal of Neurology Neurosurgery and Psychiatry, vol. 84, no. 10, pp. 1-8. https://doi.org/10.1136/jnnp-2012-303816

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. / Thomas, Sarah; Thomas, Peter W.; Kersten, Paula et al.
In: Journal of Neurology Neurosurgery and Psychiatry, Vol. 84, No. 10, 31.10.2013, p. 1-8.

Research output: Contribution to journal › Article › peer-review

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T1 - 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

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AU - Kersten, Paula

AU - Jones, Rosemary

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AU - Smith, Angela Davies

AU - Baker, Roger

AU - Galvin, Kathleen

AU - Hillier, Charles

N1 - 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/

PY - 2013/10/31

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N2 - Background symptom for people with multiple sclerosis (MS).Fatigue is a common and troubling Aim of a six-session group-based programme for managing MS-fatigue (Fatigue: Applying Cognitive behavioural and Energy effectiveness Techniques to lifeStyle (FACETS)).To evaluate the effectiveness and cost-effectiveness Methods controlled trial with economic evaluation. Patients with MS and signi plus current local practice (FACETS) or current local practice alone (CLP), using concealed computergenerated randomisation. Participant blinding was not possible. Primary outcomes were fatigue severity (Fatigue Assessment Instrument), self-ef Fatigue Self-Ef (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).Three-centre parallel arm randomisedficant fatigue were randomised to FACETSficacy (Multiple Sclerosis-ficacy) and disease-specific quality of life Results 164 patients were randomised; primary outcome data were available for 146 (89%). Statistically signi differences favour the intervention group on fatigue selfef 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 95% CI ( differences for MSIS-29 or QALYs. No adverse events reported. Estimated cost per person for FACETS is £453;Between May 2008 and November 2009,ficantficacy−0.36,−0.63 to −0.08), SES −0.35, p=0.01) but no fi of £2157 per additional person with a clinically signindings suggest an incremental cost-effectiveness ratioficant improvement in fatigue. Conclusions severity and increasing fatigue self-ef is dif (ie, cost per QALY) as improvements in fatigue are not re signi strengths of this trial are its pragmatic nature and high external validity.FACETS is effective in reducing fatigueficacy. However, itficult to assess the additional cost in terms of costeffectivenessflected in the QALY outcomes, with noficant differences between FACETS and CLP. The Trial registration: ISRCTN76517470Current Controlled Trials

AB - Background symptom for people with multiple sclerosis (MS).Fatigue is a common and troubling Aim of a six-session group-based programme for managing MS-fatigue (Fatigue: Applying Cognitive behavioural and Energy effectiveness Techniques to lifeStyle (FACETS)).To evaluate the effectiveness and cost-effectiveness Methods controlled trial with economic evaluation. Patients with MS and signi plus current local practice (FACETS) or current local practice alone (CLP), using concealed computergenerated randomisation. Participant blinding was not possible. Primary outcomes were fatigue severity (Fatigue Assessment Instrument), self-ef Fatigue Self-Ef (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).Three-centre parallel arm randomisedficant fatigue were randomised to FACETSficacy (Multiple Sclerosis-ficacy) and disease-specific quality of life Results 164 patients were randomised; primary outcome data were available for 146 (89%). Statistically signi differences favour the intervention group on fatigue selfef 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 95% CI ( differences for MSIS-29 or QALYs. No adverse events reported. Estimated cost per person for FACETS is £453;Between May 2008 and November 2009,ficantficacy−0.36,−0.63 to −0.08), SES −0.35, p=0.01) but no fi of £2157 per additional person with a clinically signindings suggest an incremental cost-effectiveness ratioficant improvement in fatigue. Conclusions severity and increasing fatigue self-ef is dif (ie, cost per QALY) as improvements in fatigue are not re signi strengths of this trial are its pragmatic nature and high external validity.FACETS is effective in reducing fatigueficacy. However, itficult to assess the additional cost in terms of costeffectivenessflected in the QALY outcomes, with noficant differences between FACETS and CLP. The Trial registration: ISRCTN76517470Current Controlled Trials

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Thomas S, Thomas PW, Kersten P, Jones R, Green C, Nock A et al. 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. Journal of Neurology Neurosurgery and Psychiatry. 2013 Oct 31;84(10):1-8. doi: 10.1136/jnnp-2012-303816