Economic evaluation alongside randomised controlled trials: Design, conduct, analysis, and reporting

BMJ

Volumn 342, Issue 7806, 2011, Pages

  Petrou, Stavros ^a   Gray, Alastair ^b  

^a UNIVERSITY OF WARWICK   (United Kingdom)

^b UNIVERSITY OF OXFORD   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; COST EFFECTIVENESS ANALYSIS; DECISION MAKING; ECONOMIC EVALUATION; HEALTH CARE COST; HEALTH CARE SYSTEM; HEALTH ECONOMICS; INFORMATION PROCESSING; METHODOLOGY; NATIONAL HEALTH SERVICE; PRIORITY JOURNAL; QUALITY ADJUSTED LIFE YEAR; RANDOMIZED CONTROLLED TRIAL (TOPIC); SOCIAL WORK; ECONOMICS; HEALTH CARE PLANNING; STANDARD; UNCERTAINTY; UTILIZATION REVIEW;

DATA COLLECTION; HEALTH RESOURCES; QUALITY-ADJUSTED LIFE YEARS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RESEARCH DESIGN; UNCERTAINTY;

EID: 79955963939     PISSN: None     EISSN: 17561833     Source Type: Journal    
DOI: 10.1136/bmj.d1548     Document Type: Article

References (53)

1. Drummond MF, Sculpher MJ, Torrance GW, O'Brien BJ, Stoddart G. Methods for the economic evaluation of health care programmes , 3rd ed. Oxford University Press, 2005.
2. National Institute for Health and Clinical Excellence. NICE guide to the methods of technology appraisal . NICE, 2008.
3. Scottish Medicines Consortium. Guidance to manufacturers for completion of new product assessment form (NPAF) . SMC, 2007.
4. Pharmaceutical Benefits Advisory Committee. Guidelines for the pharmaceutical industry on preparation of submissions to the Pharmaceutical Benefits Advisory Committee . PBAC, 2002.
5. CDR Directorate at Canadian Coordinating Office for Health Technology Assessment. Canada common drug review submission guidelines for manufacturers . CCOHTA, 2003.
6. Petrou S, Gray A. Economic evaluation using decision analytical modelling: design, conduct, analysis and reporting. BMJ 2011;342:d1766.
7. Black WC. The CE plane: a graphic representation of cost-effectiveness. Med Decis Making 1990;10:212-4. (Pubitemid 20311440)
8. Gray A, Clarke P, Wolstenholme J, Wordsworth S. Applied methods of cost-effectiveness analysis in health care . Oxford University Press, 2010.
9. Devlin N, Parkin D. Does NICE have a cost-effectiveness threshold and what other factors influence its decisions? A binary choice analysis. Health Econ 2004;13:437-52. (Pubitemid 38660393)
10. Grosse S. Assessing cost-effectiveness in healthcare: history of the $50,000 per QALY threshold. Expert Rev Pharmacoeconomics Outcomes Res 2008;8:165-78. (Pubitemid 351959547)
11. Edwards RT, Hounsome B, Linck P, Russell IT. Economic evaluation alongside pragmatic randomised trials: developing a standard operating procedure for clinical trials units. Trials 2008;9:64.
12. Glick HA, Joshi JA, Sonnad SS, Polsky D. Economic evaluation in clinical trials . Oxford University Press, 2007.
13. O'Sullivan AK, Thompson D, Drummond MF. Collection of health-economic data alongside clinical trials: iIs there a future for piggyback evaluations? Value Health 2005;8:67-79. (Pubitemid 40293643)
14. Coyle D, Lee LM. The problem of protocol driven costs in pharmacoeconomic analysis. Pharmacoeconomics 1998;14:357-63. (Pubitemid 28455684)
15. Briggs AH, Gray AM. Power and sample size calculations for stochastic cost-effectiveness analysis. Med Decis Making 1998;18:S81-92.
16. Gardiner JC, Sirbu CM, Rahbar MH. Updated on statistical power and sample size assessments for cost-effectiveness studies. Expert Rev Pharmacoeconomics Outcomes Res 2004;4:89-98. (Pubitemid 38213097)
17. Gafni A, Walter SD, Birch S, Sendi P. An opportunity cost approach to sample size calculation in cost-effectiveness analysis. Health Econ 2008;17:99-107. (Pubitemid 351227529)
18. Briggs A. Economic evaluation and clinical trials: size matters. BMJ 2000;321:1362.
19. Claxton K. The irrelevance of inference: a decision-making approach to the stochastic evaluation of health care technologies. J Health Econ 1999;18:341-64. (Pubitemid 29242816)
20. Simon J, Gray A, Duley L, Magpie Trial Collaborative Group. Cost-effectiveness of prophylactic magnesium sulphate for 9996 women with pre-eclampsia from 33 countries: economic evaluation of the Magpie Trial. BJOG 2006;113:144-51.
21. Drummond M, Manca A, Sculpher M. Increasing the generalizability of economic evaluations: recommendations for the design, analysis, and reporting of studies. Int J Technol Assess 2005;21:165-71. (Pubitemid 40656544)
22. Petrou S, Bischof M, Bennett C, Elbourne D, Field D, McNally H. Cost-effectiveness of neonatal ECMO based on seven year results from the UK Collaborative ECMO Trial. Pediatrics 2006;117:1640-9. (Pubitemid 46071391)
23. Ridyard CH, Hughes DA. Methods for the collection of resource use data within clinical trials: a systematic review of studies funded by the UK Health Technology Assessment program. Value Health 2010;13:867-72.
24. Clarke PM, Fiebig DG, Gerdtham UG. Optimal recall length in survey design. J Health Econ 2008;27:1275-84.
25. Department of Health, England. Payment by results. Department of Health, 2010. www.dh.gov.uk/en/Managingyourorganisation/Financeandplanning/ NHSFinancialReforms/DH-900.
26. Centers for Medicare and Medicaid Services. Acute inpatient PPS. www.cms.gov/InpatientPPS/.
27. Raikou M, Briggs A, Gray A, McGuire A. Centre-specific or average unit costs in multi-centre studies? Some theory and simulation. Health Econ 2000;9:191-8. (Pubitemid 30248636)
28. Torti FM, Reed SD, Schulman KA. Analytic considerations in economic evaluations of multinational cardiovascular clinical trials. Value Health 2006;9:281-91. (Pubitemid 44337781)
29. Curtis L. Unit costs of health and social care 2009. Personal Social Services Research Unit, University of Kent, 2009. www.pssru.ac.uk.
30. World Bank. Global purchasing power parities and real expenditures 2005. World Bank International Comparison Program, 2009. http://siteresources. worldbank.org/ICPINT/Resources/icp-final.pdf.
31. Torrance GW, Feeny D. Utilities and quality-adjusted life years. Int J Technol Assess Health Care 1989;5:559-75. (Pubitemid 20153102)
32. Brooks R. EQ-5D, the current state of play. Health Pol 1996;37:53-72.
33. Torrance GW, Furlong W, Feeny D, Boyle M. Multi-attribute preference functions: Health Utilities Index. PharmacoEcon 1995;7:503-20.
34. Brazier J, Roberts J, Deverill M. The estimation of a preference-based measure of health from the SF-36. J Health Econ 2002;21:271-92. (Pubitemid 34143147)
35. Dolan P, Gudex C, Kind P, Williams A. Valuing health states: a comparison of methods. J Health Econ 1996;15:209-31. (Pubitemid 26290919)
36. Ramsey S, Willke R, Briggs A, Brown R, Buxton M, Chawla A, et al. Good research practices for cost-effectiveness analysis alongside clinical trials: the ISPOR RCT-CEA Task Force report. Value Health 2005;8:521-33. (Pubitemid 41727304)
37. Brazier J, Ratcliffe J, Salomon JA, Tsuchiya A. Measuring and valuing health benefits for economic evaluation . Oxford University Press, 2007.
38. Brazier J, Yang Y, Tsuchiya A, Rowen DL. A review of studies mapping (or cross walking) non-preference based measures of health to generic preference-based measures. Eur J Health Econ 2010;11:215-25.
39. Dakin H, Petrou S, Haggard M, Benge S, Williamson I. Mapping analyses to estimate health utilities based on responses to the OM8-30 otitis media questionnaire. Qual Life Res 2010:19:65-80.
40. Williamson I, Benge S, Barton S, Petrou S, Letley L, Fasey N, et al. A double-blind randomised placebo controlled trial of topical intra-nasal corticosteroids in 4-11 year old children with persistent bilateral otitis media with effusion in primary care. Health Technol Assess 2009;13:1-274.
41. Coast J, Flynn TN, Natarajan L, Sproston K, Lewis J, Louviere JJ, et al. Valuing the ICECAP capability index for older people. Soc Sci Med 2008;67:874-82.
42. Brouwer WBF, van Exel NJA. Discounting in decision making: the consistency argument revisited empirically. Health Policy 2004;67:187-94. (Pubitemid 38068216)
43. Thompson SG, Barber JA. How should cost data in pragmatic randomised trials be analysed? BMJ 2000;320:1197-200. (Pubitemid 30224273)
44. Mihaylova B, Briggs A, O'Hagan A, Thompson S. Review of statistical methods for analysing healthcare resources and costs. Health Econ 2010, doi:10.1002/hec.1653.
45. Manca A, Hawkins N, Sculpher MJ. Estimating mean QALYs in trial-based cost-effectiveness analysis: the importance of controlling for baseline utility. Health Econ 2005;14:487-96. (Pubitemid 40723857)
46. Sterne JAC, White IR, Carlin JB, Spratt M, Royston P, Kenward MG, et al. Multiple imputation for missing data in epidemiological and clinical research: potential and pitfalls. BMJ 2009;338:b2393.
47. Zethraeus N, Johannesson M, Jonsson B, Lothgren M, Tambour M. Advantages of using the net-benefit approach for analysing uncertainty in economic evaluation studies. Pharmacoeconomics 2003;21:39-48. (Pubitemid 36078491)
48. Fenwick E, O'Brien BJ, Briggs A. Cost-effectiveness acceptability curves: facts, fallacies and frequently asked questions. Health Econ 2004;13:405-15. (Pubitemid 38660390)
49. Hlatky MA, Owens DK, Sanders GD. Cost-effectiveness as an outcome in randomized clinical trials. Clin Trials 2006;3:543-51.
50. Mark DB, Hlatky MA, Califf RM, Naylor CD, Lee KL, Armstrong PW, et al. Cost-effectiveness of thrombolytic therapy with tissue plasminogen activator as compared with streptokinase for acute myocardial infarction. N Engl J Med 1995;332:1418-24.
51. UKPDS Group. Cost effectiveness analysis of improved blood pressure control in hypertensive patients with type 2 diabetes: UKPDS 40. BMJ 1998;317:720-6.
52. Clarke PM, Gray AM, Briggs A, Stevens R, Matthews DR, Holman RR. Cost-utility analyses of intensive blood glucose and tight blood pressure control in type 2 diabetes (UKPDS 72). Diabetologia 2005;48:868-77. (Pubitemid 40767979)
53. Sculpher MJ, Claxton K, Drummond M, McCabe C. Whither trial-based economic evaluation for health care decision making? Health Econ 2006;15:677-87. (Pubitemid 44057239)