United Kingdom back pain exercise and manipulation (UK BEAM) randomised trial: cost effectiveness of physical treatments for back pain in pr
http://www.100md.com
《英国医生杂志》
Abstract
Back pain is a major economic problem. Before the accompanying clinical paper,1 little evidence existed for the effectiveness of two commonly used treatments—exercise classes and spinal manipulation. Until the UK BEAM trial, little evidence existed for the cost effectiveness of those treatments.2 3
An economic evaluation in British primary care found that physiotherapy led exercise classes were less expensive and more effective than general practice care alone.4 In contrast, a Finnish study found that patients randomised to exercise, different from that investigated by the British study, had higher costs and poorer outcomes than those randomised to the control group and encouraged to keep active.5 A Swedish study found no differences in costs or outcomes between physiotherapy and chiropractic manipulation.6 In contrast, 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.7 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.
Methods
Recruitment
We recruited 1334 participants from 181 practices around 14 centres across the United Kingdom. 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
The accompanying clinical paper reports that 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 (all statistically significant).1 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 (table 2). So it cost only ￡125 (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.
Table 2 Reported mean (SD) cost (￡) of health care over 12 months by treatment group
Health outcomes
Physical interventions improved EQ-5D scores more than did best care (table 3). 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).
Table 3 Utilities and QALYs over 12 months by treatment group
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 4). 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.
Table 4 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 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 Excellence25), 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.
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 (9, 16, 16, and 10 from best care, exercise alone, manipulation alone, and combined treatment respectively) whose healthcare costs exceeded ￡2000. Manipulation achieves extended dominance over both exercise and combined treatment (table 5). It is thus the only alternative to best care, with an incremental cost effectiveness ratio of ￡3000 per additional QALY. At a ceiling of ￡10 000 per QALY, manipulation has a 73% chance of being best. If manipulation alone were not available, exercise would have a ratio of ￡4100.
Table 5 Sensitivity analyses by treatment group*
The second sensitivity analysis used private costs for manipulation that took place in private premises. Combined treatment now achieves extended dominance over exercise, with an incremental cost effectiveness ratio of ￡6600 compared with best care (table 5). Manipulation alone then has a ratio of ￡8700 relative to combined treatment
The third sensitivity analysis used private unit costs for all manipulation within the trial. The findings are analogous to those in the second scenario. Exercise is subject to extended dominance, and combined treatment has an incremental cost effectiveness ratio of ￡8600 compared with best care (table 5). Manipulation alone then has a ratio of ￡10 600 relative to combined treatment.
Discussion
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:doi:10.1136/bmj.38282.669225.AE.
Baldwin ML, C?té P, Frank JW, Johnson WG. Cost-effectiveness studies of medical and chiropractic care for occupational low back pain: a critical review of the literature. Spine J 2001;1: 138-47.
Maetzel A, Li L. The economic burden of low back pain: a review of studies published between 1996 and 2001. Best Pract Res Clin Rheumatol 2002;16: 23-30.
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.
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.
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.
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.
Underwood M, O'Meara S, Harvey E, UK BEAM Trial Team. The acceptability to primary care staff of a multidisciplinary training package on acute back pain guidelines. Fam Pract 2002;19: 511-5.
Roland M, Waddell G, Klaber Moffett J, Burton AK, Main CJ, Cantrell T. The back book. Norwich: Stationery Office, 1996.
Klaber Moffett J, Frost H, UK BEAM Trial Team. Back to fitness programme: the manual for physiotherapists to set up the classes. Physiotherapy 2000;85: 295-305.
Harvey E, Burton AK, Moffett JK, Breen A, UK BEAM Trial Team. Spinal manipulation for low-back pain: a treatment package agreed to by the UK chiropractic, osteopathy and physiotherapy professional associations. Man Ther 2003;8: 46-51.
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.
Kind P, Hardman G, Macran S. UK population norms for EQ-5D. York: Centre for Health Economics, University of York, 1999. (Discussion paper 172.)
Chartered Institute of Public Finance and Accountancy. The health service database 2002. Croydon: CIPFA, 2002.
Netten A, Dennett J, Knight J. Unit costs of health and social care. Canterbury: Personal Social Services Research Unit, University of Kent, 2002.
BUPA Hospitals UK. How much will it cost? www.bupahospitals.co.uk/asp/paying/priceguides.asp (accessed 17 Nov 2004).
Matthews JNS, Altman DG, Campbell MJ, Royston P. Analysis of serial measurements in medical research. BMJ 1990;300: 230-5.
Manca A, Hawkins N, Sculpher MJ. Estimating mean QALYs in trial-based cost-effectiveness analysis: the importance of controlling for baseline utility. Health Econ 2004 Oct 20 .
McAlister FA, Straus SE, Sackett DL, Altman DG. Analysis and reporting of factorial trials: a systematic review. JAMA 2003;289: 2545-53.
Gold MR, Siegel JE, Russell LB, Weinstein MC. Cost-effectiveness in health and medicine. New York: Oxford University Press, 1996.
Manca A, Rice N, Sculpher MJ, Briggs AH. Assessing generalisability by location in trial-based cost-effectiveness analysis: the use of multilevel models. Health Econ 2004 Jun 14 .
Rasbash J, Browne W, Goldstein H. A user's guide to MLwiN Version 2.1. London: Institute of Education, University of London, 2000.
Fenwick E, Claxton K, Sculpher M. Representing uncertainty: the role of cost-effectiveness acceptability curves. Health Econ 2001;10: 779-87.
Fenwick E, O'Brien BJ, Briggs AH. Cost-effectiveness acceptability curves—facts, fallacies and frequently asked questions. Health Econ 2004;13: 405-15.
Raftery J. NICE: faster access to modern treatments? Analysis of guidance on health technologies. BMJ 2001;323: 1300-3.
((Correspondence to: Andrea)
Back pain is a major economic problem. Before the accompanying clinical paper,1 little evidence existed for the effectiveness of two commonly used treatments—exercise classes and spinal manipulation. Until the UK BEAM trial, little evidence existed for the cost effectiveness of those treatments.2 3
An economic evaluation in British primary care found that physiotherapy led exercise classes were less expensive and more effective than general practice care alone.4 In contrast, a Finnish study found that patients randomised to exercise, different from that investigated by the British study, had higher costs and poorer outcomes than those randomised to the control group and encouraged to keep active.5 A Swedish study found no differences in costs or outcomes between physiotherapy and chiropractic manipulation.6 In contrast, 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.7 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.
Methods
Recruitment
We recruited 1334 participants from 181 practices around 14 centres across the United Kingdom. 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
The accompanying clinical paper reports that 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 (all statistically significant).1 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 (table 2). So it cost only ￡125 (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.
Table 2 Reported mean (SD) cost (￡) of health care over 12 months by treatment group
Health outcomes
Physical interventions improved EQ-5D scores more than did best care (table 3). 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).
Table 3 Utilities and QALYs over 12 months by treatment group
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 4). 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.
Table 4 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 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 Excellence25), 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.
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 (9, 16, 16, and 10 from best care, exercise alone, manipulation alone, and combined treatment respectively) whose healthcare costs exceeded ￡2000. Manipulation achieves extended dominance over both exercise and combined treatment (table 5). It is thus the only alternative to best care, with an incremental cost effectiveness ratio of ￡3000 per additional QALY. At a ceiling of ￡10 000 per QALY, manipulation has a 73% chance of being best. If manipulation alone were not available, exercise would have a ratio of ￡4100.
Table 5 Sensitivity analyses by treatment group*
The second sensitivity analysis used private costs for manipulation that took place in private premises. Combined treatment now achieves extended dominance over exercise, with an incremental cost effectiveness ratio of ￡6600 compared with best care (table 5). Manipulation alone then has a ratio of ￡8700 relative to combined treatment
The third sensitivity analysis used private unit costs for all manipulation within the trial. The findings are analogous to those in the second scenario. Exercise is subject to extended dominance, and combined treatment has an incremental cost effectiveness ratio of ￡8600 compared with best care (table 5). Manipulation alone then has a ratio of ￡10 600 relative to combined treatment.
Discussion
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:doi:10.1136/bmj.38282.669225.AE.
Baldwin ML, C?té P, Frank JW, Johnson WG. Cost-effectiveness studies of medical and chiropractic care for occupational low back pain: a critical review of the literature. Spine J 2001;1: 138-47.
Maetzel A, Li L. The economic burden of low back pain: a review of studies published between 1996 and 2001. Best Pract Res Clin Rheumatol 2002;16: 23-30.
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.
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.
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.
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.
Underwood M, O'Meara S, Harvey E, UK BEAM Trial Team. The acceptability to primary care staff of a multidisciplinary training package on acute back pain guidelines. Fam Pract 2002;19: 511-5.
Roland M, Waddell G, Klaber Moffett J, Burton AK, Main CJ, Cantrell T. The back book. Norwich: Stationery Office, 1996.
Klaber Moffett J, Frost H, UK BEAM Trial Team. Back to fitness programme: the manual for physiotherapists to set up the classes. Physiotherapy 2000;85: 295-305.
Harvey E, Burton AK, Moffett JK, Breen A, UK BEAM Trial Team. Spinal manipulation for low-back pain: a treatment package agreed to by the UK chiropractic, osteopathy and physiotherapy professional associations. Man Ther 2003;8: 46-51.
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.
Kind P, Hardman G, Macran S. UK population norms for EQ-5D. York: Centre for Health Economics, University of York, 1999. (Discussion paper 172.)
Chartered Institute of Public Finance and Accountancy. The health service database 2002. Croydon: CIPFA, 2002.
Netten A, Dennett J, Knight J. Unit costs of health and social care. Canterbury: Personal Social Services Research Unit, University of Kent, 2002.
BUPA Hospitals UK. How much will it cost? www.bupahospitals.co.uk/asp/paying/priceguides.asp (accessed 17 Nov 2004).
Matthews JNS, Altman DG, Campbell MJ, Royston P. Analysis of serial measurements in medical research. BMJ 1990;300: 230-5.
Manca A, Hawkins N, Sculpher MJ. Estimating mean QALYs in trial-based cost-effectiveness analysis: the importance of controlling for baseline utility. Health Econ 2004 Oct 20 .
McAlister FA, Straus SE, Sackett DL, Altman DG. Analysis and reporting of factorial trials: a systematic review. JAMA 2003;289: 2545-53.
Gold MR, Siegel JE, Russell LB, Weinstein MC. Cost-effectiveness in health and medicine. New York: Oxford University Press, 1996.
Manca A, Rice N, Sculpher MJ, Briggs AH. Assessing generalisability by location in trial-based cost-effectiveness analysis: the use of multilevel models. Health Econ 2004 Jun 14 .
Rasbash J, Browne W, Goldstein H. A user's guide to MLwiN Version 2.1. London: Institute of Education, University of London, 2000.
Fenwick E, Claxton K, Sculpher M. Representing uncertainty: the role of cost-effectiveness acceptability curves. Health Econ 2001;10: 779-87.
Fenwick E, O'Brien BJ, Briggs AH. Cost-effectiveness acceptability curves—facts, fallacies and frequently asked questions. Health Econ 2004;13: 405-15.
Raftery J. NICE: faster access to modern treatments? Analysis of guidance on health technologies. BMJ 2001;323: 1300-3.
((Correspondence to: Andrea)