TY - JOUR
T1 - Guided graded exercise self-help for chronic fatigue syndrome
T2 - Long term follow up and cost-effectiveness following the GETSET trial
AU - Clark, Lucy V.
AU - McCrone, Paul
AU - Pesola, Francesca
AU - Vergara-Williamson, Mario
AU - White, Peter D.
N1 - Funding Information:
PDW reports grants from the National Institute of Health Research and the Sue Estermann Charity during the conduct of the study; personal fees from Swiss Re-insurance company, outside the submitted work; and PDW is an appointed member of the Independent Medical Experts' Group, a non-department public body, which advises the UK Ministry of Defence about its Armed Forces Compensation Scheme.
Funding Information:
This paper presents independent research funded by the National Institute for Health Research (NIHR) under its Research for Patient Benefit (RfPB) Programme (Grant Reference Number PB-PG-0610-22060 ). The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care. This study was also supported by funding through the Sue Estermann Fund . We thank Michelle Beynon for facilitating the long-term follow-up data collection and entry.
Publisher Copyright:
© 2021 Elsevier Inc.
Copyright:
Copyright 2021 Elsevier B.V., All rights reserved.
PY - 2021/7
Y1 - 2021/7
N2 - Objective: The GETSET trial found that guided graded exercise self-help (GES) improved fatigue and physical functioning more than specialist medical care (SMC) alone in adults with chronic fatigue syndrome (CFS) 12 weeks after randomisation. In this paper, we assess the longer-term clinical and health economic outcomes. Methods: GETSET was a randomised controlled trial of 211 UK secondary care patients with CFS. Primary outcomes were the Chalder fatigue questionnaire and the physical functioning subscale of the short-form-36 survey. Postal questionnaires assessed the primary outcomes and cost-effectiveness of the intervention 12 months after randomisation. Service costs and quality-adjusted life years (QALYs) were combined in a cost-effectiveness analysis. Results: Between January 2014 and March 2016, 164 (78%) participants returned questionnaires 15 months after randomisation. Results showed no main effect of intervention arm on fatigue (chi2(1) = 4.8, p = 0.03) or physical functioning (chi2(1) = 1.3, p = 0.25), adjusting for multiplicity. No other intervention arm or time*arm effect was significant. The short-term fatigue reduction was maintained at long-term follow-up for participants assigned to GES, with improved fatigue from short- to long-term follow up after SMC, such that the groups no longer differed. Healthcare costs were £85 higher for GES and produced more QALYs. The incremental cost-effectiveness ratio was £4802 per QALY. Conclusions: The short-term improvements after GES were maintained at long-term follow-up, with further improvement in the SMC group such that the groups no longer differed at long-term follow-up. The cost per QALY for GES compared to SMC alone was below the usual threshold indicating cost-effectiveness, but with uncertainty around the result.
AB - Objective: The GETSET trial found that guided graded exercise self-help (GES) improved fatigue and physical functioning more than specialist medical care (SMC) alone in adults with chronic fatigue syndrome (CFS) 12 weeks after randomisation. In this paper, we assess the longer-term clinical and health economic outcomes. Methods: GETSET was a randomised controlled trial of 211 UK secondary care patients with CFS. Primary outcomes were the Chalder fatigue questionnaire and the physical functioning subscale of the short-form-36 survey. Postal questionnaires assessed the primary outcomes and cost-effectiveness of the intervention 12 months after randomisation. Service costs and quality-adjusted life years (QALYs) were combined in a cost-effectiveness analysis. Results: Between January 2014 and March 2016, 164 (78%) participants returned questionnaires 15 months after randomisation. Results showed no main effect of intervention arm on fatigue (chi2(1) = 4.8, p = 0.03) or physical functioning (chi2(1) = 1.3, p = 0.25), adjusting for multiplicity. No other intervention arm or time*arm effect was significant. The short-term fatigue reduction was maintained at long-term follow-up for participants assigned to GES, with improved fatigue from short- to long-term follow up after SMC, such that the groups no longer differed. Healthcare costs were £85 higher for GES and produced more QALYs. The incremental cost-effectiveness ratio was £4802 per QALY. Conclusions: The short-term improvements after GES were maintained at long-term follow-up, with further improvement in the SMC group such that the groups no longer differed at long-term follow-up. The cost per QALY for GES compared to SMC alone was below the usual threshold indicating cost-effectiveness, but with uncertainty around the result.
KW - Chronic fatigue syndrome
KW - Cost-effectiveness
KW - Follow up
KW - Graded exercise therapy
KW - Guided self-help
KW - Myalgic encephalomyelitis
UR - http://www.scopus.com/inward/record.url?scp=85104787332&partnerID=8YFLogxK
U2 - 10.1016/j.jpsychores.2021.110484
DO - 10.1016/j.jpsychores.2021.110484
M3 - Article
AN - SCOPUS:85104787332
SN - 0022-3999
VL - 146
JO - Journal of Psychosomatic Research
JF - Journal of Psychosomatic Research
M1 - 110484
ER -
