- Oliver Rivero-Arias, research officer1,
- Helen Campbell, research officer ()1,
- Alastair Gray, professor of health economics1,
- Jeremy Fairbank, consultant orthopaedic surgeon2,
- Helen Frost, research fellow3,
- James Wilson-MacDonald, consultant orthopaedic surgeon2
- for the Spine Stabilisation Trial Group
- 1Health Economics Research Centre, Department of Public Health, University of Oxford, Oxford OX3 7LF Oliver
- 2Nuffield Orthopaedic Centre, Oxford OX3 7LD
- 3Division of Health in the Community, University of Warwick, Warwick CV4 7AL
- Correspondence to: H Campbell
- Accepted 29 March 2005
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 £7830 (SD £5202) in the surgery group and £4526 (SD £4155) in the intensive rehabilitation arm, a significant difference of £3304 (95% confidence interval £2317 to £4291). 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 £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.
Additional details of the costing method, the participating units, and the members of the MRC steering committee are on bmj.com
Contributors OR-A collected unit cost data, analysed resource use data, produced cost effectiveness estimates, and revised the paper. HEC supervised the collection of unit costs, analysed HRQoL data, wrote and revised the paper. AG designed and supervised the economic evaluation and revised the paper, and is guarantor of the economic analysis. JF was responsible for the overall trial design, the organisation of the trial, recruitment, surgical intervention, provision of unit costs, and revision of the paper. HF was responsible for overall trial design, the organisation of the trial, the design and implementation of the rehabilitation programme, and revising the paper. JW-M was responsible for overall trial design, the organisation of the study, recruitment, operating on trial participants, and editingthe paper. Patricia Carver, Nuffield Orthopaedic Centre, was responsible for data collection, maintenance, and cleaning. Ly-Mee Yu, Centre for Statistics in Medicine, provided statistical advice and commented on the paper. Karen Barker, Nuffield Orthopaedic Centre NHS Trust, assisted with the collection of unit costs and provided valuable comments on the paper. Rory Collins, Clinical Trial Service Unit, Nuffield Department of Clinical Medicine, University of Oxford, was involved in the overall trial design and revising the manuscript. Douglas Altman, Centre for Statistics in Medicine, was responsible for statistical analysis and sat on the data monitoring committee. Nikolaos Maniadakis, Patras General University Hospital, assisted with the design of the economic evaluation. Katharine Johnston, Economics and Statistics Division, Scottish Executive, monitored progression of the study and produced power calculations. Lesley Morgan, Nuffield Department of Anaesthetics, John Radcliffe Hospital, was responsible for helping to set up the study, data collection, and database design. Kate Stevens, Victoria Erlanger, and Rebecca Bale (previous trial managers) collected and entered data. Peter Smith, X-I Interactive Database and Internet Solutions, developed and maintained the database.
Funding This study was supported by the UK Medical Research Council. The NHS (326) or private patient insurance (23) funded the treatment of patients. The Health Economics Research Centre is partly funded by the National Coordinating Centre for Research Capacity Development. JF and JW-M receive funding from Synthes for a spinal fellow.
Competing interests None declared.
Ethical approval Granted by 15 local research ethics committees and one multicentre research ethics committee.
- Accepted 29 March 2005