Chronisch Vermoeidheidssyndroom: diagnose, behandeling en ...

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58 Chronic Fatigue Syndrome KCE reports 88 Table 5. General characteristics of the economic evaluations Author Publication Country Analysis Time Discount Costing perspective: year CUA CEA horizon rate cost items included Severens et al. 2004 Netherlands X X 14 months na Direct medical costs Direct non-medical costs Indirect costs McCrone et al. 2004 UK - X 8 months na Direct medical costs Direct non-medical costs Chisholm et al. 2001 UK - X 6 months na Direct medical costs Direct non-medical costs Indirect costs CUA: cost-utility analysis; CEA: cost-effectiveness analysis; na: not applicable 3.2.1 Analytical technique and outcome measures Severens et al. 142 report their results in terms of cost-effectiveness ratios (Table 5). As CFS treatments are not expected to impact much on survival, the number of life-years gained (LYG) was not used as a measure of outcome, but rather surrogate measures of the improvements of the main CFS symptoms, i.e. number of patients with a clinically significant improvement in fatigue score. The change in fatigue was measured by the Checklist Individual Strength (CIS) Questionnaire. 69 Further, Severens et al. 142 also report their results in terms of cost-utility ratios, with outcomes expressed as qualityadjusted life-years (Table 5). The EQ-5D questionnaire 147 was used to collect patients’ preferences on their health state but the valuation set used to derive utilities is not explicitly stated by the authors. McCrone et al. 141 and Chisholm et al. 143 only report their results in terms of costeffectiveness ratios. The measures of outcome in those studies were the mean improvement in fatigue score 141, 143 and the number of patients with a clinically significant improvement in fatigue score. 141 In both studies, the change in fatigue was assessed by the Chalder Fatigue Questionnaire. 68 3.2.2 Perspective The costs categories considered by Severens et al. 142 are direct medical costs (i.e. the costs of the intervention and other direct medical costs such as outpatient visits, medications…), direct non-medical costs (i.e. the costs of travelling to seek care, informal home care support e , visits to practitioners for alternative medicine…) and indirect (or productivity) costs (i.e. the cost related to the absence of the patient from work due to the condition) (Table 5). In this study, 142 those three cost categories were combined to present the results under a “Societal” perspective. The results were also presented under a “Payers” perspective by ignoring the indirect costs category and by combining only the direct medical cost with the direct non-medical cost categories. The cost categories considered in McCrone et al. 141 and in Chisholm et al. 143 consisted also in direct medical and direct non-medical costs. Indirect (productivity) costs were further considered in Chisholm et al. 143 only. The combination of these cost categories for the computation of the cost-effectiveness was however different between both studies, so that their results cannot be compared on the basis of a unique costing perspective. In Chisholm et al., 143 results are presented including direct medical costs alone (“Health Care Payers” perspective) and in combination with direct non-medical costs and indirect costs (“Societal” perspective). In McCrone et al., 141 results are only presented by combining direct medical costs with direct non-medical costs (“Payers” perspective). 3.2.3 Time horizon and discount rate The time horizon of the economic evaluations was limited by the duration of the followup period of the trials they rest on. This follow-up period was 14 months in Severens et e Informal home care is defined as the time spent by friends or relatives for personal support, child care, help in or around the house, help outside the home or other tasks.
KCE Reports 88 Chronic Fatigue Syndrome 59 al. 142 based on the Prins et al. 88 trial (Table 5). The time horizon in Severens et al. 142 is certainly long enough to capture important clinical changes such as improvements in fatigue. However, due to the chronic nature of CFS and since CFS may require maintenance treatment later in time, costs and outcomes should be tracked for a longer timeframe, ideally over a patient’s lifetime. Severens et al. 142 did not use modelling to extrapolate their results to longer timeframes. The follow-up period was limited to 6 months in Chisholm et al. 143 (based on the Ridsdale et al. 148 trial) and to 8 months in McCrone et al. 141 (based on an other Ridsdale et al. 149 trial). Given their short timeframe, none of the studies applied discounting (Table 5). 3.2.4 Population In Severens et al. 142 and its underlying trial, 88 the target population consisted in patients with CFS. Patients were included if they were aged 18 to 60 years, if they had a score of 40 or more on the subscale fatigue severity of the Checklist Individual Strength (criteria for CFS according to Fukuda et al. 12 ) and if they had a score of 800 or more on the Sickness Impact Profile. In Chisholm et al. 143 and in McCrone et al., 141 the target population was more broadly defined and included patients with chronic fatigue. Only a subset of those patients was thus classified as having CFS (about 30% of the trial population in McCrone et al. 141 ) In those studies and in their underlying trials, 148,149 patients were included if they were aged 16 to 75 years, if they had complaints of fatigue as a main or important problem and if their fatigue symptoms lasted for more than 3 months. In those studies, sub-group analyses pertaining only to the subset of CFS patients were not performed. 3.2.5 Intervention / comparators As explained in a previous chapter (section 2.5.3.1.), cognitive behaviour therapy (CBT) is a combination of cognitive and behaviour therapy. CBT is delivered by trained therapists and includes energy/activity management, the establishment of a sleep routine, goal setting and psychological support. In Severens et al., 142 the alternative therapeutic strategies compared to CBT were guided support group (SG) and a do nothing (DN) strategy (Table 6). SG consisted in meetings between groups of CFS patients and open discussions about their own condition, under the supervision of a single therapist. The DN strategy represented the medical seeking behaviour of CFS patients as in current practice. In McCrone et al. 141 and in Chisholm et al., 143 the therapeutic strategies compared to CBT were graded exercise therapy (GET) 141 and counselling therapy (CT) 143 (Table 6). GET consisted in structured and progressively increasing activities or exercises under the supervision of a therapist, with the aim to improve the patient's physical condition. CT consisted in discussions among CFS patients and a trained counsellor, allowing the patient to share his concerns and difficulties in a supportive environment. Table 6. Comparators to CBT Author Publication Cognitive Behaviour Therapy compared with Therapy intensity year Intervention Trial source CBT Comparator Severens et al. 2004 Guided Support Group (SG) Do Nothing (DN) Prins et al., 2001 16 x 60 min SG: 11 x 90 min McCrone et al. 2004 Graded Exercise Therapy (GET) Ridsdale et al., 2004 6 x 45 min GET: 6 x 45 min Chisholm et al. 2001 Counselling Therapy (CT) Ridsdale et al., 2001 6 x 50 min CT: 6 x 50 min CBT: cognitive behaviour therapy; SG: guided support group; GET: graded exercise therapy; CT: counselling therapy In Severens et al., 142 the various therapeutic strategies administered to CFS patients consisted in 16 sessions of 60 minutes each for CBT and 11 sessions of 90 minutes each for SG (Table 6).
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