Cost effectiveness analysis of laparoscopic hysterectomy compared with standard hysterectomy: results from a randomised trial
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《英国医生杂志》
1 Centre for Health Economics, University of York, Heslington, York YO10 5DD, 2 Department of Endo-Gynaecology, University of New South Wales, Royal Hospital for Women, Barker Street, Randwick, NSW 2031, Australia, 3 Clinical Trials and Research Unit, University of Leeds, Leeds LS2 9NG, 4 School of Women's and Infants' Health, University of Western Australia, King Edward Memorial Hospital, Perth 6008, Australia
Correspondence to: M Sculpher mjs23@york.ac.uk
Abstract
Hysterectomy is a common operation, with up to 100 0001 and 550 0002 procedures undertaken annually in the United Kingdom and the United States, respectively. Traditionally, most hysterectomies have been undertaken through the abdomen, but there have been no randomised comparisons of abdominal and vaginal hysterectomy. The advent of laparoscopic approaches to hysterectomy offers the prospect of improved outcomes and gains in cost effectiveness through reduced severity of convalescence and shorter length of inpatient stay. With the exception of some observational studies3-5 and small randomised trials,6 7 however, little is known about the costs and cost effectiveness of laparoscopic forms of hysterectomy relative to conventional (abdominal and vaginal) approaches.
The eVALuate trial is the largest trial of laparoscopic hysterectomy compared with standard methods yet undertaken.8 This report describes a cost effectiveness analysis undertaken with eVALuate data.
Methods
Resource use
Table 2 provides a summary of the key measures of resource use in the trial; results are presented separately for the two comparisons in the study. For the comparison of laparoscopic and vaginal hysterectomy, the main differences related to time in theatre (mean 98 v 65 minutes, respectively) and the use of disposable equipment in many laparoscopic hysterectomies—for example, a disposable linear stapler was used to achieve haemostasis in 36% of ovarian pedicles and 19% of uterine pedicles, and disposable scissors were used in 37% of laparoscopic hysterectomies (more details are available elsewhere22). No marked differences emerged between the procedures in length of stay or use of resources after the initial admission.
Table 2 Key resource use measured in two parts of trial comparing different methods of hysterectomy. Figures are numbers (percentages) of patients unless stated otherwise
The second comparison, between laparoscopic and abdominal hysterectomy, showed rather more differences in terms of use of resources (table 2). Again, time in theatre was longer with laparoscopic hysterectomy (mean 108 v 74 minutes). Also, a high proportion of laparoscopic procedures used disposable equipment. Compared with abdominal hysterectomy, however, laparoscopic hysterectomy had a lower mean length of hospital stay (3.95 v 5.11 days). During follow up, there were no differences in use of resources that would be expected to have a large effect on differential cost.
Costs
Table 3 shows mean and median costs per patient. For the comparison of laparoscopic and vaginal hysterectomy, the only marked difference related to theatre cost, which reflects differences in theatre times and the use of disposable equipment in a large proportion of laparoscopic procedures. None of the other cost components showed marked differences between the groups. Overall, laparoscopic hysterectomy cost a mean of ￡401 (95% confidence interval ￡271 to ￡542) more per patient.
Table 3 Comparison of costs between laparoscopic and standard hysterectomy (1999-2000 prices)
The comparison of laparoscopic with abdominal hysterectomy showed that costs for laparoscopy were closer to, but still higher than for, conventional hysterectomy. A mean difference of ￡335 in theatre costs again reflects longer theatre times and the use of disposable equipment with laparoscopy. However, the shorter length of admission with laparoscopic hysterectomy offset some of that additional cost, with a mean saving in hotel costs of ￡144. Overall, laparoscopic hysterectomy cost a mean of ￡186 more per patient, with 95% confidence intervals crossing zero (-￡26 to ￡375).
Health outcomes
There were no deaths during follow up. In terms of both mean and median EQ-5D values, and for both comparisons, women showed improvements between baseline and six weeks and between six weeks and four months; and little change between four months and a year (table 4). The utilities were used to calculate QALYs for each woman over a one year period (table 4). These differences were small and 95% confidence intervals crossed zero. Mean QALYs per patient were higher with laparoscopic hysterectomy, both compared with vaginal hysterectomy (0.0015, -0.015 to 0.018) and the abdominal procedure (0.007, -0.008 to 0.023).
Table 4 Health outcomes measured in trial comparing different methods of hysterectomy: responses to EQ-5D and quality adjusted life years (QALYs)
Cost effectiveness
For the comparison of laparoscopic and vaginal hysterectomy, mean costs were ￡401 higher and mean QALYs 0.0015 higher with laparoscopy. In this circumstance, the issue is whether decision makers are willing to pay the implied ICER—that is, the mean difference in cost divided by the mean difference in QALYs—here ￡267 333 (￡401/0.0015). However, we estimated mean differences in costs and QALYs with sampling uncertainty, which is represented in the figure in the form of cost effectiveness acceptability curves. This shows the probability that laparoscopic hysterectomy is more cost effective than vaginal hysterectomy for a range of maximum values that decision makers may place on an additional QALY. The probability that laparoscopic hysterectomy is the more cost effective is never above 50%.
Cost effectiveness acceptability curves for laparoscopic hysterectomy v conventional hysterectomy (abdominal or vaginal). ICER (incremental cost effectiveness ratio) for laparoscopic hysterectomy is not shown as it exceeds ￡200 000
For the comparison of laparoscopic hysterectomy and abdominal hysterectomy, tables 3 and 4 show that laparoscopy had higher mean costs (￡186) and higher mean QALYs (0.007) per patient. This generates an ICER of ￡26 571. The figure shows the cost effectiveness acceptability curve for this comparison, reflecting the imprecision with which these mean differences are estimated. This indicates that the higher the value decision makers place on an additional QALY, the higher the probability that laparoscopic hysterectomy will be more cost effective than abdominal hysterectomy. For example, at a maximum value of ￡30 000 the probability reaches 56%.
Sensitivity analysis
We conducted a sensitivity analysis to assess how differential costs would have changed if all laparoscopic procedures had been undertaken with reusable equipment (reusable scissors, sutures rather than staples, and reusable trocars). We assumed that there would be no impact on health outcomes from this change in policy. The mean difference in cost between laparoscopic and vaginal hysterectomy was reduced to ￡260 and the incremental cost effectiveness ratio for laparoscopy fell to ￡173 334. For the comparison with abdominal hysterectomy, the equivalent figures were ￡74 and ￡10 571. If most of the surgical equipment was disposable the incremental cost effectiveness ratios were ￡1 320 667 for laparoscopic versus vaginal hysterectomy and ￡259 428 for laparoscopic versus abdominal hysterectomy. Details of further sensitivity analysis are available elsewhere.22
Discussion
Vessey MP, Villard-Mackintosh L, McPherson K, Coulter A, Yeates D. The epidemiology of hysterectomy: findings in a large cohort study. Br J Obstet Gynaecol 1992;99: 402-7.
Lepine LA, Hillis SD, Marchbanks PA, Koonin LM, Morrow B, Kieke BA, et al. Hysterectomy surveillance—United States 1980-1993. MMWR Surveill Summ 1997;46: 1-15.
Lowell L, Kessler AA. Laparoscopically assisted vaginal hysterectomy—a suitable substitute for abdominal hysterectomy? J Reprod Med 2000;45: 738-42.
Schneider A, Merker A, Martin C, Michels W, Krause N. Laparoscopically assisted vaginal hysterectomy as an alternative to abdominal hysterectomy in patients with fibroids. Arch Gynecol Obstet 1997;259: 79-85.
Chapron C, Fernandez B, Dubuisson JB. Total hysterectomy for benign pathologies: direct costs comparison between laparoscopic and abdominal hysterectomy. Eur J Obstet Gynecol Reprod Biol 2000;89: 141-7.
Lumsden MA, Twaddle S, Hawthorn R, Traynor I, Gilmore D, Davis J, et al. A randomised comparison and economic evaluation of laparoscopic-assisted hysterectomy and abdominal hysterectomy. Br J Obstet Gynaecol 2000;107: 1386-91.
Ellstrom M, Ferraz-Nunes J, Hahlin M, Olsson JH. A randomized trial with a cost-consequence analysis after laparoscopic and abdominal hysterectomy. Obstet Gynecol 1998;91: 30-4.
Garry R, Fountain J, Mason S, Hawe J, Napp V, Abbott J, et al. The eVALuate study: two parallel randomised trials, one comparing laparoscopic with abdominal hysterectomy, the second comparing laparoscopic with vaginal hysterectomy. BMJ 2004 doi = 10.1136/bmj.37958.696840.5A
Sculpher MJ, Smith DH, Clayton T, Henderson RA, Buxton MJ, Pocock SJ, et al. Coronary angioplasty versus medical therapy for angina: health service costs based on the second randomised intervention treatment of angina (RITA-2) trial. Eur Heart J 2002;23: 1291-300.
Booth C. Review body for nursing staff, midwives, health visitors and professions allied to medicine. 17th report. London: Stationery Office, 2000. (Cm 4563.)
Gough CB. Review body on doctors' and dentists' remuneration. 29th report. London: Stationery Office, 2000. (Cm 4562.)
Netten A, Dennett J, Knight J. Unit costs of health and social care. Canterbury: PSSRU, University of Kent, 2000.
Chartered Institute of Public Finance and Accountancy (CIPFA). The health service database 2000. Croydon: CIPFA, 2000.
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. 2nd ed. Philadelphia: Lippincott-Raven, 1996.
Dolan P, Gudex C, Kind P, Williams A. A social tariff for EuroQol: results from a UK general population survey. Centre for Health Economics, University of York: Centre for Health Economics, 1995. (Discussion paper 138.)
Matthews JNS, Altman D, Campbell MJ. Analysis of serial measurements in medical research. BMJ 1990;300: 230-5.
Lin DY, Feuer EJ, Etzioni R, Wax Y. Estimating medical costs from incomplete follow-up data. Biometrics 1997;53: 419-34.
Willan AR, Lin DY. Incremental net benefit in randomised clinical trials. Stat Med 2001;20: 1563-74.
Efron B, Tibshirani R. An introduction to the bootstrap. New York: Chapman and Hall, 1993.
Barber JA, Thompson SG. Analysis of cost data in randomised controlled trials: an application of the non-parametric bootstrap. Stat Med 2000;19: 3219-36.
Van Hout BA, Al MJ, Gordon GS, Rutten FFH. Costs, effects and c/e-ratios alongside a clinical trial. Health Econ 1994;3: 309-19.
Garry R, Fountain J, Braunholtz D, Bridgman S, Brown J, Lilford R, et al. EVALUATE hysterectomy trial. A multicentre randomised trial comparing abdominal, vaginal and laparoscopic methods of hysterectomy. Health Technol Assess (in press).
Raftery J. NICE: faster access to modern treatments? Analysis of guidance on health technologies. BMJ 2001;323: 1300-3.
Sculpher MJ. The role and estimation of productivity costs in economic evaluation. In: Drummond MF, McGuire AE, eds. Theory and practice of economic evaluation in health. Oxford: Oxford University Press, 2001.
((Mark Sculpher, professor1)
Correspondence to: M Sculpher mjs23@york.ac.uk
Abstract
Hysterectomy is a common operation, with up to 100 0001 and 550 0002 procedures undertaken annually in the United Kingdom and the United States, respectively. Traditionally, most hysterectomies have been undertaken through the abdomen, but there have been no randomised comparisons of abdominal and vaginal hysterectomy. The advent of laparoscopic approaches to hysterectomy offers the prospect of improved outcomes and gains in cost effectiveness through reduced severity of convalescence and shorter length of inpatient stay. With the exception of some observational studies3-5 and small randomised trials,6 7 however, little is known about the costs and cost effectiveness of laparoscopic forms of hysterectomy relative to conventional (abdominal and vaginal) approaches.
The eVALuate trial is the largest trial of laparoscopic hysterectomy compared with standard methods yet undertaken.8 This report describes a cost effectiveness analysis undertaken with eVALuate data.
Methods
Resource use
Table 2 provides a summary of the key measures of resource use in the trial; results are presented separately for the two comparisons in the study. For the comparison of laparoscopic and vaginal hysterectomy, the main differences related to time in theatre (mean 98 v 65 minutes, respectively) and the use of disposable equipment in many laparoscopic hysterectomies—for example, a disposable linear stapler was used to achieve haemostasis in 36% of ovarian pedicles and 19% of uterine pedicles, and disposable scissors were used in 37% of laparoscopic hysterectomies (more details are available elsewhere22). No marked differences emerged between the procedures in length of stay or use of resources after the initial admission.
Table 2 Key resource use measured in two parts of trial comparing different methods of hysterectomy. Figures are numbers (percentages) of patients unless stated otherwise
The second comparison, between laparoscopic and abdominal hysterectomy, showed rather more differences in terms of use of resources (table 2). Again, time in theatre was longer with laparoscopic hysterectomy (mean 108 v 74 minutes). Also, a high proportion of laparoscopic procedures used disposable equipment. Compared with abdominal hysterectomy, however, laparoscopic hysterectomy had a lower mean length of hospital stay (3.95 v 5.11 days). During follow up, there were no differences in use of resources that would be expected to have a large effect on differential cost.
Costs
Table 3 shows mean and median costs per patient. For the comparison of laparoscopic and vaginal hysterectomy, the only marked difference related to theatre cost, which reflects differences in theatre times and the use of disposable equipment in a large proportion of laparoscopic procedures. None of the other cost components showed marked differences between the groups. Overall, laparoscopic hysterectomy cost a mean of ￡401 (95% confidence interval ￡271 to ￡542) more per patient.
Table 3 Comparison of costs between laparoscopic and standard hysterectomy (1999-2000 prices)
The comparison of laparoscopic with abdominal hysterectomy showed that costs for laparoscopy were closer to, but still higher than for, conventional hysterectomy. A mean difference of ￡335 in theatre costs again reflects longer theatre times and the use of disposable equipment with laparoscopy. However, the shorter length of admission with laparoscopic hysterectomy offset some of that additional cost, with a mean saving in hotel costs of ￡144. Overall, laparoscopic hysterectomy cost a mean of ￡186 more per patient, with 95% confidence intervals crossing zero (-￡26 to ￡375).
Health outcomes
There were no deaths during follow up. In terms of both mean and median EQ-5D values, and for both comparisons, women showed improvements between baseline and six weeks and between six weeks and four months; and little change between four months and a year (table 4). The utilities were used to calculate QALYs for each woman over a one year period (table 4). These differences were small and 95% confidence intervals crossed zero. Mean QALYs per patient were higher with laparoscopic hysterectomy, both compared with vaginal hysterectomy (0.0015, -0.015 to 0.018) and the abdominal procedure (0.007, -0.008 to 0.023).
Table 4 Health outcomes measured in trial comparing different methods of hysterectomy: responses to EQ-5D and quality adjusted life years (QALYs)
Cost effectiveness
For the comparison of laparoscopic and vaginal hysterectomy, mean costs were ￡401 higher and mean QALYs 0.0015 higher with laparoscopy. In this circumstance, the issue is whether decision makers are willing to pay the implied ICER—that is, the mean difference in cost divided by the mean difference in QALYs—here ￡267 333 (￡401/0.0015). However, we estimated mean differences in costs and QALYs with sampling uncertainty, which is represented in the figure in the form of cost effectiveness acceptability curves. This shows the probability that laparoscopic hysterectomy is more cost effective than vaginal hysterectomy for a range of maximum values that decision makers may place on an additional QALY. The probability that laparoscopic hysterectomy is the more cost effective is never above 50%.
Cost effectiveness acceptability curves for laparoscopic hysterectomy v conventional hysterectomy (abdominal or vaginal). ICER (incremental cost effectiveness ratio) for laparoscopic hysterectomy is not shown as it exceeds ￡200 000
For the comparison of laparoscopic hysterectomy and abdominal hysterectomy, tables 3 and 4 show that laparoscopy had higher mean costs (￡186) and higher mean QALYs (0.007) per patient. This generates an ICER of ￡26 571. The figure shows the cost effectiveness acceptability curve for this comparison, reflecting the imprecision with which these mean differences are estimated. This indicates that the higher the value decision makers place on an additional QALY, the higher the probability that laparoscopic hysterectomy will be more cost effective than abdominal hysterectomy. For example, at a maximum value of ￡30 000 the probability reaches 56%.
Sensitivity analysis
We conducted a sensitivity analysis to assess how differential costs would have changed if all laparoscopic procedures had been undertaken with reusable equipment (reusable scissors, sutures rather than staples, and reusable trocars). We assumed that there would be no impact on health outcomes from this change in policy. The mean difference in cost between laparoscopic and vaginal hysterectomy was reduced to ￡260 and the incremental cost effectiveness ratio for laparoscopy fell to ￡173 334. For the comparison with abdominal hysterectomy, the equivalent figures were ￡74 and ￡10 571. If most of the surgical equipment was disposable the incremental cost effectiveness ratios were ￡1 320 667 for laparoscopic versus vaginal hysterectomy and ￡259 428 for laparoscopic versus abdominal hysterectomy. Details of further sensitivity analysis are available elsewhere.22
Discussion
Vessey MP, Villard-Mackintosh L, McPherson K, Coulter A, Yeates D. The epidemiology of hysterectomy: findings in a large cohort study. Br J Obstet Gynaecol 1992;99: 402-7.
Lepine LA, Hillis SD, Marchbanks PA, Koonin LM, Morrow B, Kieke BA, et al. Hysterectomy surveillance—United States 1980-1993. MMWR Surveill Summ 1997;46: 1-15.
Lowell L, Kessler AA. Laparoscopically assisted vaginal hysterectomy—a suitable substitute for abdominal hysterectomy? J Reprod Med 2000;45: 738-42.
Schneider A, Merker A, Martin C, Michels W, Krause N. Laparoscopically assisted vaginal hysterectomy as an alternative to abdominal hysterectomy in patients with fibroids. Arch Gynecol Obstet 1997;259: 79-85.
Chapron C, Fernandez B, Dubuisson JB. Total hysterectomy for benign pathologies: direct costs comparison between laparoscopic and abdominal hysterectomy. Eur J Obstet Gynecol Reprod Biol 2000;89: 141-7.
Lumsden MA, Twaddle S, Hawthorn R, Traynor I, Gilmore D, Davis J, et al. A randomised comparison and economic evaluation of laparoscopic-assisted hysterectomy and abdominal hysterectomy. Br J Obstet Gynaecol 2000;107: 1386-91.
Ellstrom M, Ferraz-Nunes J, Hahlin M, Olsson JH. A randomized trial with a cost-consequence analysis after laparoscopic and abdominal hysterectomy. Obstet Gynecol 1998;91: 30-4.
Garry R, Fountain J, Mason S, Hawe J, Napp V, Abbott J, et al. The eVALuate study: two parallel randomised trials, one comparing laparoscopic with abdominal hysterectomy, the second comparing laparoscopic with vaginal hysterectomy. BMJ 2004 doi = 10.1136/bmj.37958.696840.5A
Sculpher MJ, Smith DH, Clayton T, Henderson RA, Buxton MJ, Pocock SJ, et al. Coronary angioplasty versus medical therapy for angina: health service costs based on the second randomised intervention treatment of angina (RITA-2) trial. Eur Heart J 2002;23: 1291-300.
Booth C. Review body for nursing staff, midwives, health visitors and professions allied to medicine. 17th report. London: Stationery Office, 2000. (Cm 4563.)
Gough CB. Review body on doctors' and dentists' remuneration. 29th report. London: Stationery Office, 2000. (Cm 4562.)
Netten A, Dennett J, Knight J. Unit costs of health and social care. Canterbury: PSSRU, University of Kent, 2000.
Chartered Institute of Public Finance and Accountancy (CIPFA). The health service database 2000. Croydon: CIPFA, 2000.
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. 2nd ed. Philadelphia: Lippincott-Raven, 1996.
Dolan P, Gudex C, Kind P, Williams A. A social tariff for EuroQol: results from a UK general population survey. Centre for Health Economics, University of York: Centre for Health Economics, 1995. (Discussion paper 138.)
Matthews JNS, Altman D, Campbell MJ. Analysis of serial measurements in medical research. BMJ 1990;300: 230-5.
Lin DY, Feuer EJ, Etzioni R, Wax Y. Estimating medical costs from incomplete follow-up data. Biometrics 1997;53: 419-34.
Willan AR, Lin DY. Incremental net benefit in randomised clinical trials. Stat Med 2001;20: 1563-74.
Efron B, Tibshirani R. An introduction to the bootstrap. New York: Chapman and Hall, 1993.
Barber JA, Thompson SG. Analysis of cost data in randomised controlled trials: an application of the non-parametric bootstrap. Stat Med 2000;19: 3219-36.
Van Hout BA, Al MJ, Gordon GS, Rutten FFH. Costs, effects and c/e-ratios alongside a clinical trial. Health Econ 1994;3: 309-19.
Garry R, Fountain J, Braunholtz D, Bridgman S, Brown J, Lilford R, et al. EVALUATE hysterectomy trial. A multicentre randomised trial comparing abdominal, vaginal and laparoscopic methods of hysterectomy. Health Technol Assess (in press).
Raftery J. NICE: faster access to modern treatments? Analysis of guidance on health technologies. BMJ 2001;323: 1300-3.
Sculpher MJ. The role and estimation of productivity costs in economic evaluation. In: Drummond MF, McGuire AE, eds. Theory and practice of economic evaluation in health. Oxford: Oxford University Press, 2001.
((Mark Sculpher, professor1)