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Results of the Economic Evaluation of the FIRST Study: A Multinational Prospective Economic Evaluation

Published online by Cambridge University Press:  10 March 2009

Kevin A. Schulman ,
Martin Buxton ,
Henry Glick ,
Mark Sculpher ,
Gladys Guzman ,
Janet Kong ,
Martin Backhouse ,
Jo Mauskopf ,
Larry Bell  and
John M. Eisenberg
Kevin A. Schulman
Affiliation:
Georgetown University Medical Center
Martin Buxton
Affiliation:
Brunel University
Henry Glick
Affiliation:
University of Pennsylvania Medical Center
Mark Sculpher
Affiliation:
Brunel University
Gladys Guzman
Affiliation:
Georgetown University Medical Center
Janet Kong
Affiliation:
Georgetown University Medical Center
Martin Backhouse
Affiliation:
SmithKline Beecham Pharmaceutical Corporation
Jo Mauskopf
Affiliation:
Burroughs Wellcome Co.
Larry Bell
Affiliation:
Burroughs Wellcome Co.
John M. Eisenberg
Affiliation:
Georgetown University Medical Center
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Abstract

We present the prospective economic evaluation that served as a secondary endpoint for the FIRST study, a randomized international multicenter trial of patients with severe congestive heart failure. Although the clinical results of this study were disappointing, we demonstrated the feasibility of incorporating prospective economic evaluation in phase III clinical trials.

Type
General Essays
Information
International Journal of Technology Assessment in Health Care , Volume 12 , Issue 4 , Fall 1996 , pp. 698 - 713
Copyright
Copyright © Cambridge University Press 1996

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References

REFERENCES

1.Backhouse, M. B., Mauskopf, J. A., Jones, D., et al. Economic outcomes of colfosceril palmitate rescue theapy in infants weighing 1250g or more with respiratory distress syndrome: Results from a randomized trial. Pharmacoeconomics, 1994, 4, 358–69.CrossRefGoogle Scholar
2.Cohn, J. N., Archibald, D. G., Ziesche, S., et al. Effect of vasodilator therapy on mortality in chronic congestive heart failure: Results of a Veterans Administration Cooperative Study. New England Journal of Medicine, 1986, 314, 1547–52.CrossRefGoogle Scholar
3.Drummond, M. F., Stoddart, G. L., & Torrance, G. W.Methods for the Evaluation of Health Care Programs. New York: Oxford Medical Publications, 1987.Google Scholar
4.Dudley, R. A., Harrell, F. E., Smith, L. R., et al. Comparison of analytic models for estimating the effects of clinical factors on the cost of coronary artery bypass graft surgery. Journal of Clinical Epidemiology, 1993, 329, 546–51.Google Scholar
5.Efron, B.Better bootstrap confidence intervals. Journal of the American Statistical Association, 1987, 82, 171–200.CrossRefGoogle Scholar
6.Efron, B., & Gong, G.A leisurely look at the bootstrap, jackknife and cross-validation. American Statistician, 1983, 37, 36–48.Google Scholar
7.Eisenberg, J. M., Schulman, K. A., Glick, H., & Koffer, H. Pharmacoeconomics: Economic evaluation of Pharmaceuticals. In Strom, B. L. (ed.), Pharmacoepidemiology. New York: Churchill Livingstone, 1989, 469–93.Google Scholar
8.Fenn, P., McGuire, A., Phillips, V., et al. The analysis of censored treatment cost data in economic evaluation. Medical Care, 1995, 33, 851–61.CrossRefGoogle ScholarPubMed
9.Fryback, D. G. QALYs, HYEs, and the loss of innocence (editorial). Medical Decision Making, 1993, 271–72.CrossRefGoogle Scholar
10.Guidelines for Economic Evaluation of Pharmaceuticals. Ottawa, Ontario: Canadian Coordinating Office for Health Technology Assessment, 1994, 17.Google Scholar
11.Guidelines for the Pharmaceutical Industry on Preparation of Submissions to the Pharmaceutical Benefits Advisory Committee. Australia: Commonwealth Department of Health, Housing, and Community Services, 1992.Google Scholar
12.Harrell, F. E., Lee, K. L., & Mark, D. B. Multivariable prognostic models: Issues in developing models, evaluating assumptions and adequacy, and measuring and reducing errors. Statistics in Medicine, In press.Google Scholar
13.Health Care Financing Administration. Revisions to payment policies and adjustments to the relative value units under the physician fee schedule for calendar year 1994: Final rule. Federal Register, 12 2, 1993, 58, 63689–839.Google Scholar
14.Kalbfleish, J. D., & Prentice, R. L.The statistical analysis of failure time data. New York: John Wiley & Sons, Inc., 1980.Google Scholar
15.Lancaster, T., & Intrator, O.Panel data with survival: Hospitalization of HIV patients. Department of Economics Working Paper No 95–36. Providence, RI: Brown University, 1995.Google Scholar
16.Laupacis, A., Feeney, D., Detsky, A. S., & Tugwell, R. X.How attractive does a new technology have to be to warrant adoption and utilization? Tentative guidelines for using clinical and economic evaluations. Canadian Medical Association Journal, 1992, 146, 473–81.Google ScholarPubMed
17.Mauskopf, J. A., Backhouse, M. E., Jones, D., et al. Synthetic surfactant for rescue treatment of respiratory distress syndrome in premature infants weighing from 700 to 1350 grams: Impact on hospital resource use and charges. Journal of Pediatrics, 1995, 126, 94–100.CrossRefGoogle ScholarPubMed
18.McKenna, W. J., Swedberg, K., Zannad, F., et al. Experience of chronic intravenous epoprostenol infusion in end-stage cardiac failure: Results of FIRST. European Heart Journal, 1994, 15, 36A.Google Scholar
19.Proposal for standardization of some methodological aspects of cost-effectiveness analysis: Cost utility analyses, and cost-minimization analyses in the evaluation of health technologies and programs for the purpose of decision making in resource allocation. General Directorate of Services and Evaluation of Health Technologies and General Directorate of Insurance and Health Planning of the Ministry of Health and Consumption, Spain, 1994.Google Scholar
20.Schulman, K. A., Glick, H. A., Buxton, M., et al. The economic evaluation of the FIRST study: Design of a prospective analysis alongside a multinational phase III clinical trial. Controlled Clinical Trials, in press.Google Scholar
21.The SOLVD Investigators. Effect of enalapril on mortality and the development of heart failure in asymptomatic patients with reduced left ventricular ejection fractions. New England Journal of Medicine, 1992, 327, 685–91.CrossRefGoogle Scholar
22.Torrance, G. W.Measurement of health state utilities for economic appraisal. Journal of Health Economics, 1986, 5, 1–30.CrossRefGoogle ScholarPubMed
23.Rutten-Van Mölken, M. P. M. H., Van Doorslaer, E. K. A., & Van Vliet, R. C. J. A.Statistical analysis of cost outcomes in a randomized controlled clinical trial. Health Economics, 1994, 3, 333–45.CrossRefGoogle Scholar