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Surgical stabilisation of the spine compared with a programme of intensive rehabilitation for the management of patients with chronic low back pain: cost utility analysis based on a randomised controlled trial [with consumer summary]
Rivero-Arias O, Campbell H, Gray A, Fairbank J, Frost H, J Wilson-MacDonald J, for the Spine Stabilisation Trial Group
BMJ 2005 May 28;330(7502):1239-1244
clinical trial
5/10 [Eligibility criteria: No; 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*

OBJECTIVE: To determine whether, from a health provider and patient perspective, surgical stabilisation of the spine is cost effective when compared with an intensive programme of rehabilitation in patients with chronic low back pain. DESIGN: Economic evaluation alongside a pragmatic randomised controlled trial. SETTING: Secondary care. PARTICIPANTS: 349 patients randomised to surgery (n = 176) or to an intensive rehabilitation programme (n = 173) from 15 centres across the United Kingdom between June 1996 and February 2002. MAIN OUTCOME MEASURES: Costs related to back pain and incurred by the NHS and patients up to 24 months after randomisation. Return to paid employment and total hours worked. Patient utility as estimated by using the EuroQol EQ-5D questionnaire at several time points and used to calculate quality adjusted life years (QALYs). Cost effectiveness was expressed as an incremental cost per QALY. RESULTS: At two years, 38 patients randomised to rehabilitation had received rehabilitation and surgery whereas just seven surgery patients had received both treatments. The mean total cost per patient was estimated to be Great British Pounds 7,830 (SD 5,202) in the surgery group and Great British Pounds 4,526 (SD 4,155) in the intensive rehabilitation arm, a significant difference of Great British Pounds 3,304 (95% confidence interval 2,317 to 4,291). Mean QALYs over the trial period were 1.004 (SD 0.405) in the surgery group and 0.936 (SD 0.431) in the intensive rehabilitation group, giving a non-significant difference of 0.068 (-0.020 to 0.156). The incremental cost effectiveness ratio was estimated to be Great British Pounds 48,588 per QALY gained (-279,883 to 372,406). CONCLUSION: Two year follow-up data show that surgical stabilisation of the spine may not be a cost effective use of scarce healthcare resources. However, sensitivity analyses show that this could change -- for example, if the proportion of rehabilitation patients requiring subsequent surgery continues to increase.
Reproduced with permission from the BMJ Publishing Group.

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