Economic evaluation of multidisciplinary rehabilitation treatment versus cognitive behavioural therapy for patients with chronic fatigue syndrome: A randomized controlled trial

Vos-Vromans, D.C.W.M.; Evers, Silvia M. A. A.; Huijnen, Ivan P.J.; Köke, Albère; Hitters, Minou W M G C; Rijnders, Nieke; Pont, Menno; Knottnerus, André; Smeets, Rob

doi:10.1371/journal.pone.0177260

Cited by 10 publications

(29 citation statements)

References 36 publications

(54 reference statements)

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“…99 A cost-effectiveness study comparing a rehabilitation programme with a CBT intervention for patients with CFS over 12 months also found no statistical differences in EQ-5D-3L-derived QALYs, despite a significant difference between the intervention arms for fatigue severity. 108 These studies support the view that the EQ-5D may not be responsive to changes in fatigue in long-term conditions. Work productivity was improved for patients in the RAFT programme intervention arm at 26 weeks and 2 years, although the difference between intervention arms was not statistically significant.…”

Section: Discussionsupporting

confidence: 68%

Group cognitive–behavioural programme to reduce the impact of rheumatoid arthritis fatigue: the RAFT RCT with economic and qualitative evaluations

Hewlett

Almeida

Ambler

et al. 2019

Health Technol Assess

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Background Fatigue is a major problem in rheumatoid arthritis (RA). There is evidence for the clinical effectiveness of cognitive–behavioural therapy (CBT) delivered by clinical psychologists, but few rheumatology units have psychologists. Objectives To compare the clinical effectiveness and cost-effectiveness of a group CBT programme for RA fatigue [named RAFT, i.e. Reducing Arthritis Fatigue by clinical Teams using cognitive–behavioural (CB) approaches], delivered by the rheumatology team in addition to usual care (intervention), with usual care alone (control); and to evaluate tutors’ experiences of the RAFT programme. Design A randomised controlled trial. Central trials unit computerised randomisation in four consecutive cohorts within each of the seven centres. A nested qualitative evaluation was undertaken. Setting Seven hospital rheumatology units in England and Wales. Participants Adults with RA and fatigue severity of ≥ 6 [out of 10, as measured by the Bristol Rheumatoid Arthritis Fatigue Numerical Rating Scale (BRAF-NRS)] who had no recent changes in major RA medication/glucocorticoids. Interventions RAFT – group CBT programme delivered by rheumatology tutor pairs (nurses/occupational therapists). Usual care – brief discussion of a RA fatigue self-management booklet with the research nurse. Main outcome measures Primary – fatigue impact (as measured by the BRAF-NRS) at 26 weeks. Secondary – fatigue severity/coping (as measured by the BRAF-NRS); broader fatigue impact [as measured by the Bristol Rheumatoid Arthritis Fatigue Multidimensional Questionnaire (BRAF-MDQ)]; self-reported clinical status; quality of life; mood; self-efficacy; and satisfaction. All data were collected at weeks 0, 6, 26, 52, 78 and 104. In addition, fatigue data were collected at weeks 10 and 18. The intention-to-treat analysis conducted was blind to treatment allocation, and adjusted for baseline scores and centre. Cost-effectiveness was explored through the intervention and RA-related health and social care costs, allowing the calculation of quality-adjusted life-years (QALYs) with the EuroQol-5 Dimensions, five-level version (EQ-5D-5L). Tutor and focus group interviews were analysed using inductive thematic analysis. Results A total of 308 out of 333 patients completed 26 weeks (RAFT, n/N = 156/175; control, n/N = 152/158). At 26 weeks, the mean BRAF-NRS impact was reduced for the RAFT programme (–1.36 units; p < 0.001) and the control interventions (–0.88 units; p < 0.004). Regression analysis showed a difference between treatment arms in favour of the RAFT programme [adjusted mean difference –0.59 units, 95% confidence interval (CI) –1.11 to –0.06 units; p = 0.03, effect size 0.36], and this was sustained over 2 years (–0.49 units, 95% CI –0.83 to –0.14 units; p = 0.01). At 26 weeks, further fatigue differences favoured the RAFT programme (BRAF-MDQ fatigue impact: adjusted mean difference –3.42 units, 95% CI –6.44 to – 0.39 units, p = 0.03; living with fatigue: adjusted mean difference –1.19 units, 95% CI –2.17 to –0.21 units, p = 0.02; and emotional fatigue: adjusted mean difference –0.91 units, 95% CI –1.58 to –0.23 units, p = 0.01), and these fatigue differences were sustained over 2 years. Self-efficacy favoured the RAFT programme at 26 weeks (Rheumatoid Arthritis Self-Efficacy Scale: adjusted mean difference 3.05 units, 95% CI 0.43 to 5.6 units; p = 0.02), as did BRAF-NRS coping over 2 years (adjusted mean difference 0.42 units, 95% CI 0.08 to 0.77 units; p = 0.02). Fatigue severity and other clinical outcomes were not different between trial arms and no harms were reported. Satisfaction with the RAFT programme was high, with 89% of patients scoring ≥ 8 out of 10, compared with 54% of patients in the control arm rating the booklet (p < 0.0001); and 96% of patients and 68% of patients recommending the RAFT programme and the booklet, respectively, to others (p < 0.001). There was no significant difference between arms for total societal costs including the RAFT programme training and delivery (mean difference £434, 95% CI –£389 to £1258), nor QALYs gained (mean difference 0.008, 95% CI –0.008 to 0.023). The probability of the RAFT programme being cost-effective was 28–35% at the National Institute for Health and Care Excellence’s thresholds of £20,000–30,000 per QALY. Tutors felt that the RAFT programme’s CB approaches challenged their usual problem-solving style, helped patients make life changes and improved tutors’ wider clinical practice. Limitations Primary outcome data were missing for 25 patients; the EQ-5D-5L might not capture fatigue change; and 30% of the 2-year economic data were missing. Conclusions The RAFT programme improves RA fatigue impact beyond usual care alone; this was sustained for 2 years with high patient satisfaction, enhanced team skills and no harms. The RAFT programme is < 50% likely to be cost-effective; however, NHS costs were similar between treatment arms. Future work Given the paucity of RA fatigue interventions, rheumatology teams might investigate the pragmatic implementation of the RAFT programme, which is low cost. Trial registration Current Controlled Trials ISRCTN52709998. Funding This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 57. See the NIHR Journals Library website for further project information.

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Section: Discussionsupporting

confidence: 68%

Group cognitive–behavioural programme to reduce the impact of rheumatoid arthritis fatigue: the RAFT RCT with economic and qualitative evaluations

Hewlett

Almeida

Ambler

et al. 2019

Health Technol Assess

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“…Of the 22 eligible trials, 18 studies contributed usable data for meta-analysis of healthcare use outcomes; contact with six of these studies 26,30,31,40,42,46 provided data for two. 26,46 All assessed healthcare use at follow-up (8 weeks to 3 years); the latest complete measurement was used where there was more than one. Most trials (n = 16) collected data through self-report, five directly from medical records, 26,30,32,41,44 and one from insurance company records.…”

Section: Discussionmentioning

confidence: 99%

“…Nine trials contributed data to the meta-analysis of healthcare costs. 6,26,27,32,36,37,38,41,46 One study 46 included the cost of the intervention in the total healthcare costs, so it was subtracted for consistency with other trials in this analysis. The overall effect showed no difference in healthcare costs between groups: SMD = 0.17 (95% CI = -0.15 to 0.49); z = 1.04, P = 0.3.…”

Section: Discussionmentioning

confidence: 99%

“…29 The expanded and updated search produced 22 eligible trials. [24][25][26][27][29][30][31][32][33][34][35][36][37][38][39][40][41][42][43][44][45][46] Full details of the trials are available from the authors on request.…”

Section: Searchmentioning

confidence: 99%

“…Several studies focused on specific disorders classified as medically unexplained: four treated chronic fatigue (n = 1026), 38,39,41,46 one treated IBS (n = 149), 37 and one treated tinnitus (n = 304). 40 Finally, two studies 32,42 recruited patients who met criteria for a newly proposed diagnosis of bodily distress syndrome (n = 119), covering chronic fatigue, fibromyalgia, non-cardiac chest pain, IBS, hyperventilation syndrome, and tension headache.…”

Section: Diagnosesmentioning

confidence: 99%

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CBT to reduce healthcare use for medically unexplained symptoms: systematic review and meta-analysis

Jones

Williams

2019

Br J Gen Pract

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BackgroundStudies have reported that medically unexplained symptoms (MUS) tend to be associated with increased healthcare use, which is demanding of resources and potentially harmful to patients. This association is often used to justify the funding and study of psychological interventions for MUS, yet no systematic review has specifically examined the efficacy of psychological interventions in reducing healthcare use.AimTo conduct a systematic review and meta-analysis to evaluate the effectiveness of cognitive behavioural therapies (CBT) for MUS in reducing healthcare use.Design and settingSystematic review and meta-analysis.MethodThe search from a previous systematic review was updated and expanded. Twenty-two randomised controlled trials reported healthcare use, of which 18 provided data for meta-analysis. Outcomes were healthcare contacts, healthcare costs, medication, and medical investigations.ResultsSmall reductions in healthcare contacts and medication use were found for CBT compared with active controls, treatment as usual, and waiting list controls, but not for medical investigations or healthcare costs.ConclusionCognitive behavioural interventions show weak benefits in reducing healthcare use in people with MUS. The imprecise use of MUS as a diagnostic label may impact on the effectiveness of interventions, and it is likely that the diversity and complexity of these difficulties may necessitate a more targeted approach.

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Cost-effectiveness of Interventions for Chronic Fatigue Syndrome or Myalgic Encephalomyelitis: A Systematic Review of Economic Evaluations

Cochrane

Mitchell

Hollingworth

et al. 2021

Appl Health Econ Health Policy

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Introduction Chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME) has profound quality of life and economic consequences for individuals, their family, formal services and wider society. Little is known about which therapeutic interventions are more cost-effective. Objective A systematic review was carried out to identify and critically appraise the evidence on the cost-effectiveness of CFS/ME interventions. Methods The review protocol was prespecified (PROSPERO: CRD42018118731). Searches were carried out across two databases—MEDLINE (1946–2020) and EMBASE (1974–2020). Additional studies were identified by searching reference lists. Only peer-reviewed journal articles of full economic evaluations examining CFS/ME interventions were included. Trial- and/or model-based economic evaluations were eligible. Data extraction and screening were carried out independently by two reviewers. The methodological quality of the economic evaluation and trial were assessed using the Consensus Health Economic Criteria checklist (CHEC-list) and Risk of Bias-2 (RoB-2) tool, respectively. A narrative synthesis was used to summarise the economic evidence for interventions for adults and children in primary and secondary care settings. Results Ten economic evaluations, all based on data derived from randomised controlled trials, met our eligibility criteria. Cognitive behavioural therapy (CBT) was evaluated across five studies, making it the most commonly evaluated intervention. There was evidence from three trials to support CBT as a cost-effective treatment option for adults; however, findings on CBT were not uniform, suggesting that cost-effectiveness may be context-specific. A wide array of other interventions were evaluated in adults, including limited evidence from two trials supporting the cost effectiveness of graded exercise therapy (GET). Just one study assessed intervention options for children. Our review highlighted the importance of informal care costs and productivity losses in the evaluation of CFS/ME interventions. Conclusions We identified a limited patchwork of evidence on the cost-effectiveness of interventions for CFS/ME. Evidence supports CBT as a cost-effective treatment option for adults; however, cost-effectiveness may depend on the duration and frequency of sessions. Limited evidence supports the cost effectiveness of GET. Key weaknesses in the literature included small sample sizes and short duration of follow-up. Further research is needed on pharmacological interventions and therapies for children. Supplementary Information The online version contains supplementary material available at 10.1007/s40258-021-00635-7.

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Economic evaluation of multidisciplinary rehabilitation treatment versus cognitive behavioural therapy for patients with chronic fatigue syndrome: A randomized controlled trial

Cited by 10 publications

References 36 publications

Group cognitive–behavioural programme to reduce the impact of rheumatoid arthritis fatigue: the RAFT RCT with economic and qualitative evaluations

Group cognitive–behavioural programme to reduce the impact of rheumatoid arthritis fatigue: the RAFT RCT with economic and qualitative evaluations

CBT to reduce healthcare use for medically unexplained symptoms: systematic review and meta-analysis

Cost-effectiveness of Interventions for Chronic Fatigue Syndrome or Myalgic Encephalomyelitis: A Systematic Review of Economic Evaluations

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