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Cognitive-educational treatment of fibromyalgia: a randomized clinical trial. II. economic evaluation
Goossens ME, Rutten-van Molken MP, Leidl RM, Bos SG, Vlaeyen JW, Teeken-Gruben NJ
The Journal of Rheumatology 1996 Jul;23(7):1246-1254
clinical trial
3/10 [Eligibility criteria: No; Random allocation: Yes; Concealed allocation: No; Baseline comparability: No; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: No; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

OBJECTIVE: In this 3 year randomized clinical trial the cost effectiveness of a 6 week educational/cognitive intervention (ECO) is compared with an educational discussion intervention (EDI) and a waiting list condition (WLC). METHODS: A total of 131 patients with fibromyalgia were randomly allocated to the ECO, EDI, or WLC intervention. The ECO and EDI groups were followed for 12 months, whereas the WLC group was followed for 6 weeks. Direct health care and nonhealth care costs, and the indirect costs associated with lost production due to illness, were calculated. The effects were measured in terms of utilities, using rating scale and standard gamble methods. RESULTS: Treatment costs were estimated to be US $980 per patient for both ECO and EDI. The total direct health care costs of ECO treatment were US $1623 higher than those for EDI. This difference was significant. Indirect costs for the 2 groups were not significantly different. At 6 weeks there was a significant difference in rating scale utilities between the 3 groups, caused by a significantly greater improvement in the EDI group compared to the WLC group. However, no significant differences in either rating scale or standard gamble utilities were found between the ECO and EDI groups immediately after treatment, or at the 6 or 12 month followups. CONCLUSION: The economic evaluation showed that the addition of a cognitive component to the educational intervention led to significantly higher health care costs and no additional improvement in quality of life compared to the educational intervention alone. This conclusion is robust through a range of plausible values used in a sensitivity analysis.

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