BMJ  2004;329:1381 (11 December), doi:10.1136/bmj.38282.607859.AE (published 19 November 2004)

Primary care

United Kingdom back pain exercise and manipulation (UK BEAM) randomised trial: cost effectiveness of physical treatments for back pain in primary care

Abstract

Objective To assess the cost effectiveness of adding spinal manipulation, exercise classes, or manipulation followed by exercise ("combined treatment") to "best care" in general practice for patients consulting with low back pain.

Design Stochastic cost utility analysis alongside pragmatic randomised trial with factorial design.

Setting 181 general practices and 63 community settings for physical treatments around 14 centres across the United Kingdom.

Participants 1287 (96%) of 1334 trial participants.

Main outcome measures Healthcare costs, quality adjusted life years (QALYs), and cost per QALY over 12 months.

Results Over one year, mean treatment costs relative to "best care" were £195 ($360; 279; 95% credibility interval £85 to £308) for manipulation, £140 (£3 to £278) for exercise, and £125 (£21 to £228) for combined treatment. All three active treatments increased participants' average QALYs compared with best care alone. Each extra QALY that combined treatment yielded relative to best care cost £3800; in economic terms it had an "incremental cost effectiveness ratio" of £3800. Manipulation alone had a ratio of £8700 relative to combined treatment. If the NHS was prepared to pay at least £10 000 for each extra QALY (lower than previous recommendations in the United Kingdom), manipulation alone would probably be the best strategy. If manipulation was not available, exercise would have an incremental cost effectiveness ratio of £8300 relative to best care.

Conclusions Spinal manipulation is a cost effective addition to "best care" for back pain in general practice. Manipulation alone probably gives better value for money than manipulation followed by exercise.

Introduction

An economic evaluation found that physiotherapy led exercise classes for back pain were less expensive and more effective than general practice care alone.¹ In contrast, a Finnish study found that patients randomised to exercise had higher costs and poorer outcomes.² A Swedish study found no differences in costs or outcomes between physiotherapy and chiropractic manipulation,³ whereas a UK trial comparing private chiropractic and NHS outpatient treatment found that reductions in time off work more than offset the net health service cost incurred by chiropractic treatment.⁴ To reduce the uncertainty surrounding the cost effectiveness of these physical treatments for back pain, we report the economic evaluation of the UK BEAM trial.⁵

Methods

Interventions
"Best care" in general practice (the "comparator" treatment)—We trained practice teams in "active management" and provided The Back Book for patients.

Exercise programme—This comprised an initial assessment and up to nine classes in community settings over 12 weeks.

Spinal manipulation package—The UK chiropractic, osteopathic, and physiotherapy professions agreed to use a package of techniques developed by a multidisciplinary group, during eight sessions over 12 weeks.

Combined treatment—Participants received six weeks of manipulation followed by six weeks of exercise. Treatments were otherwise those given to the manipulation only or exercise only groups.

Study design
We randomised participants between these four interventions. We also randomised participants receiving manipulation between private and NHS premises. As we did not find statistically significant differences in outcome between manipulation in NHS and private premises, this paper analyses the simpler two by two factorial trial.

Data collection
Participants completed questionnaires, including the EQ-5D health status instrument,^{6 7} at baseline, three months, and 12 months. Over the same period they recorded use of health care—including hospital stays, visits to secondary and primary care, and physical therapists, both private and within the NHS—whether related to back pain or not. Physical therapists completed record forms, including the number of treatments they delivered.

Unit costs
We conducted an economic analysis from the perspective of health care. Follow up was between August 1999 and April 2002. We used unit costs in pounds sterling at 2000-1 prices. We costed NHS care from national averages for England.^{8 9} We costed private care by using information from a major insurance provider.¹⁰

Health outcomes
The EQ-5D measures health on five three point scales. We estimated how many quality adjusted life years (QALYs) participants had experienced over their year in the UK BEAM trial by calculating "areas under (health utility) curves"¹¹ (see bmj.com).

Cost utility analysis
We estimated the mean costs of, and mean QALYs gained by, each of four distinct treatments. Firstly, we ranked treatments by mean cost, starting from the least costly. Secondly, we calculated incremental cost effectiveness ratios for all treatments by dividing incremental costs by incremental QALYs. Finally, we excluded from the comparison "dominated" treatments and treatments subject to "extended dominance,"¹² and we recalculated ratios if necessary. See bmj.com for details.

We used Bayesian multilevel analysis.¹³ We made no assumptions about the probabilities before UK BEAM that one treatment was more effective or cost more than another.

To report the uncertainty due to sampling variation, we calculated Bayesian credibility intervals (Bayesian analogue of 95% confidence intervals) and plotted multi-treatment cost effectiveness acceptability curves.^{14 15} These curves show the posterior (after UK BEAM) probability that each strategy is better than the other three across the range of values that decision makers may pay to achieve an additional QALY. This assumes that these people have maximum values that they are willing to pay for an additional QALY. It is this "ceiling" against which they should compare estimated incremental cost effectiveness ratios and read the probability that the corresponding treatment is "best." This decision oriented formulation selects as "best" or "cost effective" that treatment, with an incremental cost effectiveness ratio below the ceiling, likely to be more effective than competing treatments. This is not necessarily the strategy with the lowest ratio, as that may generate fewer QALYs.¹⁴ We also plotted two-treatment cost effectiveness acceptability curves to compare best care with manipulation alone or exercise alone.

Finally, we did three sensitivity analyses to explore how dependent the results were on participants' estimates of total costs and our estimates of unit costs. The first analysis examined the influence of cost "outliers," very large healthcare costs reported by a few participants. The other two sensitivity analyses assessed the influence of the unit costs of manipulation: by costing the scenario in which the NHS buys all manipulation from the private sector using private manipulation costs; and by costing the scenario in which the NHS buys half its manipulation from the private sector, using private costs when trial manipulation took place in private premises and NHS costs when in NHS premises.

Results

Recruitment
We recruited 1334 participants from 181 practices around 14 centres. Of these, 1287 (96.5%) yielded enough data for inclusion in the economic analysis; 326 received best care in general practice, 297 received best care plus exercise, 342 received best care plus manipulation, and 322 received best care plus combined treatment.

Clinical outcomes
Exercise achieved a small functional benefit at three months but not at one year; manipulation achieved a small to moderate benefit at three months and a small benefit at one year; and combined treatment achieved a moderate benefit at three months and a small benefit at one year.⁵ These benefits were specific to back pain, in contrast to the general health benefits determined in this paper.

Costs
Combined treatment had the highest therapy costs but the lowest subsequent hospital costs. So it cost only £125 ($231; 179; 95% credibility interval £21 to £228) more than best care, whereas exercise cost £140 (£3 to £278) more than best care, and manipulation cost £195 (£85 to £308) more.

Health outcomes
Relative to best care, manipulation generated a mean of 0.041 (95% credibility interval 0.016 to 0.066) QALYs per participant, combined treatment generated 0.033 (-0.001 to 0.067), and exercise generated 0.017 (-0.017 to 0.051).

Cost utility analysis
When manipulation and exercise are both available, combined treatment generates 0.033 more QALYs than does best care at an additional cost of £125, yielding an incremental cost effectiveness ratio of £3800 (table 1). This achievement dominates that of exercise alone, which costs more and achieves less over 12 months. Manipulation alone, however, can generate 0.008 more QALYs than combined treatment for an extra £70, yielding a ratio of £8700 relative to combined treatment. If exercise is not available, however, manipulation generates 0.041 more QALYs than best care, yielding an incremental cost effectiveness ratio of £4800. If manipulation is not available, exercise generates 0.017 more QALYs than best care, yielding a ratio of £8300.

View this table: [in this window] [in a new window]   Table 1 Cost utility analysis by scenario and treatment group*

 

The cost effectiveness acceptability curves in the top panel of the figure show the probability that each of the four treatments is better than the other three when all are available. If the ceiling was only £2000 per QALY, the top panel shows a 74% probability that best care would be the best strategy. If the ceiling was £5000 per QALY, combined treatment has a lower incremental cost effectiveness ratio than this; the top panel of the figure shows a 46% chance that it would be best. If the ceiling was £15 000 per QALY (lower than implied by previous recommendations by the National Institute for Clinical Excellence¹⁶), manipulation alone has a lower incremental cost effectiveness ratio than this; the top panel shows a 50% probability that it would be best. The cost effectiveness acceptability curve in the middle panel of the figure shows the probability that manipulation is better than best care when exercise is not available; and vice versa for the curve in the bottom panel.

View larger version (29K): [in this window] [in a new window]   Cost effectiveness acceptability curves. Top: manipulation and exercise available; middle: exercise not available; bottom: manipulation not available. ICER=incremental cost effectiveness ratio

 

Sensitivity analyses
To assess the robustness of these results to the presence of "outliers," we excluded the 51 participants whose healthcare costs exceeded £2000. Manipulation achieves extended dominance over both exercise and combined treatment (table 2). The second sensitivity analysis used private costs for manipulation that took place in private premises, and the third sensitivity analysis used private unit costs for all manipulation within the trial (table 2).

View this table: [in this window] [in a new window]   Table 2 Sensitivity analyses by treatment group*

 

Discussion

Principal findings
This economic evaluation supports and extends the findings of the clinical evaluation of the UK BEAM trial reported in the accompanying paper.⁵ If decision makers value additional quality adjusted life years (QALYs) at much less than £3800, "best care" in general practice is probably the best strategy. If their valuation lies between £3800 and £8700, spinal manipulation followed by exercise classes ("combined treatment") is likely to be the best treatment. If their valuation is well above £8700, manipulation alone is probably the best treatment.

Strengths and weaknesses of the study
The sensitivity analysis that removed 51 "outliers" from the UK BEAM dataset, was more favourable to manipulation than was the primary analysis. Under this scenario manipulation cost only £3000 per QALY relative to best care in general practice.

We believe that this is the first study of physical therapy for low back pain to show convincingly that both manipulation alone and manipulation followed by exercise provide cost effective additions to care in general practice. As we trained practice teams in the best care of back pain, we may have underestimated the benefit of physical therapy when compared with "usual care" in general practice.

What is already known on this topic Back pain is a major economic problem Little evidence exists for the effectiveness and cost effectiveness of two commonly used treatments—exercise classes and spinal manipulation What this study adds Spinal manipulation, exercise classes, and manipulation followed by exercise all increased participants' quality of life over 12 months by more than did "best care" in general practice Adding spinal manipulation to best care in general practice is effective and cost effective for patients in the United Kingdom If the NHS can afford at least £10 000 for each quality adjusted life year yielded by physical treatments, manipulation alone probably gives better value for money than manipulation followed by exercise

Unanswered questions
Funding constraints prevented us from following up participants for more than 12 months. Combined therapy depends on an ample supply of both trained manipulators prepared to work for the NHS and exercise physiotherapists with access to suitable premises. As back pain is a common problem, making manipulation generally available will require many therapists. Therapists can achieve higher incomes in private practice than in the NHS. In the short term it may be difficult to make manipulative or combined treatment generally available within the NHS.

Whereas physiotherapists can rapidly train to deliver the exercise package, insufficient trained manipulators are available to meet potential demand, and it may be decades before the NHS can implement these findings. Fortunately, using private costs for manipulation had little effect on the choice of best treatment. Purchasing manipulation from the private sector to provide treatment within the NHS would still represent good value for money if decision makers were willing to pay £10 000 per additional QALY.

Meaning of the study
Adding spinal manipulation to best care in general practice is effective and cost effective for patients with back pain in the United Kingdom. If the NHS can afford more than £10 000 for an extra QALY, manipulation alone probably gives better value for money than manipulation followed by exercise. These conclusions hold even if the NHS has to buy spinal manipulation from the private sector.

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This is the abridged version of an article that was posted on bmj.com on 19 November 2004: http://bmj.com/cgi/doi/10.1136/bmj.38282.607859.AE; revised 29 November 2004

Full authorship details are given in the accompanying paper on page 1380

We thank all participants—patients, primary care staff, and collaborators listed in the accompanying clinical paper—for their contributions. We thank Mark Sculpher and Daphne Russell for advice on analysis. Members of the UK BEAM Trial Team: Ian Russell, Martin Underwood, Stephen Brealey, Kim Burton, Simon Coulton, Amanda Farrin, Andrew Garratt, Emma Harvey, Louise Letley, Andrea Manca, Jeannett Martin, Jennifer Klaber Moffett, Veronica Morton, David Torgerson, Madge Vickers, Ken Whyte, Melanie Williams. The trial ISRCTN is 32683578.

Contributors: See

Funding: Medical Research Council (research costs); NHS in England, Northern Ireland, Scotland, and Wales (excess treatment and service support costs).

Competing interests: LL, JM, MU, MV, and KW have received salaries from the MRC. MU has received fees for speaking from Menarini Pharmaceuticals, the manufacturers of dexketoprofen and ketoprofen, and Pfizer, the manufacturers of celecoxib and valdecoxib. The other 12 authors have nothing to declare.

Ethical approval: The Northern and Yorkshire multicentre research ethics committee and 41 local research ethics committees approved the trial protocol.

References

1. Klaber Moffett J, Torgerson D, Bell-Syer S, Jackson D, Llewlyn-Phillips H, Farrin A, et al. Randomised controlled trial of exercise for low back pain: clinical outcomes, costs, and preferences. BMJ 1999;319: 279-83.[Abstract/Free Full Text]
2. Malmivaara A, Hakkinen U, Heinrichs M, Koskenniemi L, Kuosma E, Lappi S, et al. The treatment of acute low back pain—bed rest, exercises, or ordinary activity? N Engl J Med 1995;332: 351-5.[Abstract/Free Full Text]
3. Skargren EI, Carlsson PG, Oberg BE. One-year follow-up comparison of the cost and effectiveness of chiropractic and physiotherapy as primary management for back pain. Spine 1998;23: 1875-84.[CrossRef][ISI][Medline]
4. Meade TW, Dyer S, Browne W, Townsend J, Frank AO. Low back pain of mechanical origin: randomised comparison of chiropractic and hospital outpatient treatment. BMJ 1990;300: 1431-7.
5. UK BEAM Trial Team. United Kingdom back pain exercise and manipulation (UK BEAM) randomised trial: effectiveness of physical treatments for back pain in primary care. BMJ 2004;329: 1377-81.
6. Kind P. The EuroQoL instrument: an index of health-related quality of life. In: Spilker B, ed. Quality of life and pharmacoeconomics in clinical trials. Philadelphia: Lippincott-Raven, 1996.
7. Kind P, Hardman G, Macran S. UK population norms for EQ-5D. York: Centre for Health Economics, University of York, 1999. (Discussion paper 172.)
8. Chartered Institute of Public Finance and Accountancy. The health service database 2002. Croydon: CIPFA, 2002.
9. Netten A, Dennett J, Knight J. Unit costs of health and social care. Canterbury: Personal Social Services Research Unit, University of Kent, 2002.
10. BUPA Hospitals UK. How much will it cost? www.bupahospitals.co.uk/asp/paying/priceguides.asp (accessed 17 Nov 2004).
11. Matthews JNS, Altman DG, Campbell MJ, Royston P. Analysis of serial measurements in medical research. BMJ 1990;300: 230-5.
12. Gold MR, Siegel JE, Russell LB, Weinstein MC. Cost-effectiveness in health and medicine. New York: Oxford University Press, 1996.
13. Rasbash J, Browne W, Goldstein H. A user's guide to MLwiN Version 2.1. London: Institute of Education, University of London, 2000.
14. Fenwick E, Claxton K, Sculpher M. Representing uncertainty: the role of cost-effectiveness acceptability curves. Health Econ 2001;10: 779-87.[CrossRef][ISI][Medline]
15. Fenwick E, O'Brien BJ, Briggs AH. Cost-effectiveness acceptability curves—facts, fallacies and frequently asked questions. Health Econ 2004;13: 405-15.[CrossRef][ISI][Medline]
16. Raftery J. NICE: faster access to modern treatments? Analysis of guidance on health technologies. BMJ 2001;323: 1300-3.[Free Full Text]

(Accepted 14 October 2004)

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