Objectives. The aim of this trial was to evaluate the difference in treatment effect, at 26 and 52 weeks after the start of treatment, between cognitive behavioural therapy (CBT) and multidisciplinary rehabilitation treatment (MRT) for patients with chronic fatigue syndrome (CFS).Design. Multicentre, randomized controlled trial of patients with CFS. Participants were randomly assigned to MRT or CBT.Setting. Four rehabilitation centres in the Netherlands.
Subjects. A total of 122 patients participated in the trial.Main outcome measures. Primary outcomes were fatigue measured by the fatigue subscale of the Checklist Individual Strength and health-related quality of life measured by the Short-Form 36. Outcomes were assessed prior to treatment and at 26 and 52 weeks after treatment initiation.Results. A total of 114 participants completed the assessment at 26 weeks, and 112 completed the assessment at 52 weeks. MRT was significantly more effective than CBT in reducing fatigue at 52 weeks. The estimated difference in fatigue between the two treatments was À3.02 [95% confidence interval (CI) À8.07 to 2.03; P = 0.24] at 26 weeks and À5.69 (95% CI À10.62 to À0.76; P = 0.02) at 52 weeks. Patients showed an improvement in quality of life over time, but between-group differences were not significant.
Conclusion.This study provides evidence that MRT is more effective in reducing long-term fatigue severity than CBT in patients with CFS. Although implementation in comparable populations can be recommended based on clinical effectiveness, it is advisable to analyse the cost-effectiveness and replicate these findings in another multicentre trial.
BackgroundA multi-centre RCT has shown that multidisciplinary rehabilitation treatment (MRT) is more effective in reducing fatigue over the long-term in comparison with cognitive behavioural therapy (CBT) for patients with chronic fatigue syndrome (CFS), but evidence on its cost-effectiveness is lacking.AimTo compare the cost-effectiveness of MRT versus CBT for patients with CFS from a societal perspective.MethodsA multi-centre randomized controlled trial comparing MRT with CBT was conducted among 122 patients with CFS diagnosed using the 1994 criteria of the Centers for Disease Control and Prevention and aged between 18 and 60 years. The societal costs (healthcare costs, patient and family costs, and costs for loss of productivity), fatigue severity, quality of life, quality-adjusted life-year (QALY), and cost-effectiveness ratios (ICERs) were measured over a follow-up period of one year. The main outcome of the cost-effectiveness analysis was fatigue measured by the Checklist Individual Strength (CIS). The main outcome of the cost-utility analysis was the QALY based on the EuroQol-5D-3L utilities. Sensitivity analyses were performed, and uncertainty was calculated using the cost-effectiveness acceptability curves and cost-effectiveness planes.ResultsThe data of 109 patients (57 MRT and 52 CBT) were analyzed. MRT was significantly more effective in reducing fatigue at 52 weeks. The mean difference in QALY between the treatments was not significant (0.09, 95% CI: -0.02 to 0.19). The total societal costs were significantly higher for patients allocated to MRT (a difference of €5,389, 95% CI: 2,488 to 8,091). MRT has a high probability of being the most cost effective, using fatigue as the primary outcome. The ICER is €856 per unit of the CIS fatigue subscale. The results of the cost-utility analysis, using the QALY, indicate that the CBT had a higher likelihood of being more cost-effective.ConclusionsThe probability of being more cost-effective is higher for MRT when using fatigue as primary outcome variable. Using QALY as the primary outcome, CBT has the highest probability of being more cost-effective.Trial registrationISRCTN77567702.
The responsiveness of the Ten-Meter Walking Test (10 MWT) for assessing the walking ability of patients with hemiparesis in the acute phase was evaluated. To put this into perspective, the responsiveness of two other measures, the Berg Balance Scale (BBS) and the Motricity Index (MI) were evaluated as well. Nineteen patients with hemiparesis due to stroke or cerebral tumour in the acute phase were recruited to this study. To measure its responsiveness, the 10 MWT was performed three times a week, and the BBS and the MI performed twice a week. The responsiveness of all tests was computed using the Effect Sizes (ES) and Standardized Response Means (SRM). The ES for the 10 MWT was 1.17 and the SRM was 1.68. The ES and SRM of the BBS were 0.59 and 0.99. The ES and SRM of the MI were 0.27 and 0.96. The results of this study indicate that the 10 MWT is a responsive assessment tool, and appears to be more responsive than other commonly used tests.
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