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| Preoperative cognitive-behavioural patient education versus standard care for lumbar spinal fusion patients: economic evaluation alongside a randomized controlled trial [with consumer summary] |
| Rolving N, Sogaard R, Nielsen CV, Christensen FB, Bunger C, Oestergaard LG |
| Spine 2016 Jan;41(1):18-25 |
| clinical trial |
| 5/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: Yes; 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* |
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STUDY DESIGN: A cost-effectiveness analysis conducted alongside a randomized clinical trial. OBJECTIVE: To assess the cost-effectiveness of a preoperative cognitive-behavioural therapy (CBT) intervention compared to usual care for patients undergoing lumbar spinal fusion surgery (LSF). SUMMARY OF BACKGROUND DATA: The clinical effectiveness of a preoperative CBT intervention for patients undergoing LSF has been investigated in a randomized clinical trial. Economic evaluation is however essential for decision makers to make informed choices regarding allocation of scarce resources. METHODS: 90 patients undergoing LSF were randomly allocated to usual care (control group) or usual care plus a preoperative CBT intervention (CBT group). Outcome parameters included quality-adjusted life years (QALY), based on the EQ-5D, and pain-related disability, based on the Oswestry Disability Index (ODI). Health care use and productivity loss were estimated from national registers. RESULTS: One year after LSF the estimated QALY was significantly better for the CBT group with 0.710 (95% CI 0.670 to 0.749) versus 0.636 (95% CI 0.5573 to 0.687). For the ODI, the CBT group reported significantly larger disability reductions at 3 months (p = 0.003) and 6 months (p = 0.047), but not at 1 year (p = 0.082). There was no difference in the overall costs of the two groups (-89 Euro (95% CI -12,080 to 11,902)), leading to a 70% probability of the CBT intervention being cost-effective at a willingness-to-pay of Euro 40,000 for 1 additional QALY. For an additional gain of 15 ODI points the probability was 90% at a threshold of Euro 10,000. These results remained largely unaffected by relevant sensitivity analyses, confirming the robustness of findings. CONCLUSIONS: Preoperative CBT appears to be more effective and cost neutral when considering the overall health care sector and labour market perspective, supporting the implementation of preoperative CBT in the course of treatment for LSF surgery in a Danish context. LEVEL OF EVIDENCE: 2.
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