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

BACKGROUND: A 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. AIM: To compare the cost-effectiveness of MRT versus CBT for patients with CFS from a societal perspective. METHODS: A 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. RESULTS: The 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. CONCLUSIONS: The 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 REGISTRATION: ISRCTN77567702.

Improving the Multidisciplinary Treatment of Chronic Pain by Stimulating Body Awareness: A Cluster-randomized Trial.

BACKGROUND: Because of methodological flaws and a lack of theoretical foundation of body awareness (BA) in previous effect studies of interventions directed to stimulate BA, it is impossible to attribute treatment effects to this specific component of a multidisciplinary treatment. Therefore, this study evaluated short-term and long-term effects of a multidisciplinary pain rehabilitation program with and without psychomotor therapy (PMT), which focused on BA (measured by the scale of body connection) as a primary target of intervention. METHODS: Ninety-four patients clustered in 20 treatment groups were cluster randomized, using a biased-coin design, to multidisciplinary treatment as usual with or without PMT. Outcome variables were health-related quality of life, disability, and depression. BA, catastrophizing, and self-efficacy were measured as potential process variables. Assessments were performed at baseline, directly after treatment, and at 3, 6, and 12 month follow-ups. The data were analyzed by linear mixed-model analysis according to the intention-to-treat principle. RESULTS: Data of all 94 patients were used for analyses. After treatment, significant differences favoring PMT were found between conditions on depression (regression coefficient [RC]=-5.01; 95% confidence interval [CI], -8.81 to -1.21), BA (RC=0.23; 95% CI, 0.04 to 0.42) and catastrophizing (RC=-4.76; 95% CI, -8.03 to -1.48). These differences were no longer significant for depression at the 3-month follow-up and for catastrophizing at the 6-month follow-up. CONCLUSIONS: No clinical meaningful differences were found between treatment conditions in the primary outcome measures health-related quality of life and disability. However, this is the first long-term RCT that has shown that PMT improves BA in patients with chronic pain and shows good effect size and a significant decrease for catastrophizing.

Cognitive behavioural therapy versus multidisciplinary rehabilitation treatment for patients with chronic fatigue syndrome: study protocol for a randomised controlled trial (FatiGo).

BACKGROUND: Patients with chronic fatigue syndrome experience extreme fatigue, which often leads to substantial limitations of occupational, educational, social and personal activities. Currently, there is no consensus regarding the treatment. Patients try many different therapies to overcome their fatigue. Although there is no consensus, cognitive behavioural therapy is seen as one of the most effective treatments. Little is known about multidisciplinary rehabilitation treatment, a combination of cognitive behavioural therapy with principles of mindfulness, gradual increase of activities, body awareness therapy and pacing. The difference in effectiveness and cost-effectiveness between multidisciplinary rehabilitation treatment and cognitive behavioural therapy is as yet unknown. The FatiGo (Fatigue-Go) trial aims to compare the effects of both treatment approaches in outpatient rehabilitation on fatigue severity and quality of life in patients with chronic fatigue syndrome. METHODS: One hundred twenty patients who meet the criteria of chronic fatigue syndrome, fulfil the inclusion criteria and sign the informed consent form will be recruited. Both treatments take 6 months to complete. The outcome will be assessed at 6 and 12 months after the start of treatment. Two weeks after the start of treatment, expectancy and credibility will be measured, and patients will be asked to write down their personal goals and score their current performance on these goals on a visual analogue scale. At 6 and 14 weeks after the start of treatment, the primary outcome and three potential mediators-self-efficacy, causal attributions and present-centred attention-awareness-will be measured. Primary outcomes are fatigue severity and quality of life. Secondary outcomes are physical activity, psychological symptoms, self-efficacy, causal attributions, impact of disease on emotional and physical functioning, present-centred attention-awareness, life satisfaction, patient personal goals, self-rated improvement and economic costs. The primary analysis will be based on intention to treat, and longitudinal analysis of covariance will be used to compare treatments. DISCUSSION: The results of the trial will provide information on the effects of cognitive behavioural therapy and multidisciplinary rehabilitation treatment at 6 and 12 months follow-up, mediators of the outcome, cost-effectiveness, cost-utility, and the influence of treatment expectancy and credibility on the effectiveness of both treatments in patients with chronic fatigue syndrome. TRIAL REGISTRATION: Current Controlled Trials ISRCTN77567702.

Reasons of drop-out from rehabilitation in patients of Turkish and Moroccan origin with chronic low back pain in The Netherlands: a qualitative study.

OBJECTIVE: To explore which factors led to drop-out in patients of Turkish and Moroccan origin with chronic non-specific low back pain who participated in a rehabilitation programme. SUBJECTS: Patients of Turkish or Moroccan origin with chronic non-specific low back pain (n = 23) from 2 rehabilitation centres and 4 rehabilitation departments of general hospitals in the Netherlands. METHODS: In-depth semi-structured interviews were conducted with patients of Turkish and Moroccan origin (n = 23), rehabilitation physicians (n = 8) and rehabilitation therapists (n = 2). Interviews were transcribed or summarized and subsequently coded and analysed according to themes. RESULTS: Most patients dropped out due to expectations of a specific medical diagnosis and pain relief as the main aims of rehabilitation treatment. Other reasons for drop-out detected in the interviews were: lack of acknowledgement of the patient's complaints, lack of trust in the rehabilitation physician, contradicting views to those of the physician from the patients' country of origin with regard to the cause and treatment of pain, and communication problems. CONCLUSION: The major reason for drop-out was patients having different expectations, from those of their health providers, of the aim of treatment, as a result of a different view of the origin and treatment of low back pain.

Effects of attention on the control of locomotion in individuals with chronic low back pain.

BACKGROUND: People who suffer from low back pain (LBP) exhibit an abnormal gait pattern, characterized by shorter stride length, greater step width, and an impaired thorax-pelvis coordination which may undermine functional walking. As a result, gait in LBP may require stronger cognitive regulation compared to pain free subjects thereby affecting the degree of automaticity of gait control. Conversely, because chronic pain has a strong attentional component, diverting attention away from the pain might facilitate a more efficient walking pattern. METHODS: Twelve individuals with LBP and fourteen controls participated. Subjects walked on a treadmill at comfortable speed, under varying conditions of attentional load: (a) no secondary task, (b) naming the colors of squares on a screen, (c) naming the colors of color words ("color Stroop task"), and (d) naming the colors of words depicting motor activities. Markers were attached to the thorax, pelvis and feet. Motion was recorded using a three-camera SIMI system with a sample frequency of 100 Hz. To examine the effects of health status and attention on gait, mean and variability of stride parameters were calculated. The coordination between thoracic and pelvic rotations was quantified through the mean and variability of the relative phase between those oscillations. RESULTS: LBP sufferers had a lower walking speed, and consequently a smaller stride length and lower mean thorax-pelvis relative phase. Stride length variability was significantly lower in the LBP group but no significant effect of attention was observed. In both groups gait adaptations were found under performance of an attention demanding task, but significantly more so in individuals with LBP as indicated by an interaction effect on relative phase variability. CONCLUSION: Gait in LBP sufferers was characterized by less variable upper body movements. The diminished flexibility in trunk coordination was aggravated under the influence of an attention demanding task. This provides further evidence that individuals with LBP tighten their gait control, and this suggests a stronger cognitive regulation of gait coordination in LBP. These changes in gait coordination reduce the capability to deal with unexpected perturbations, and are therefore maladaptive.