Methodological issues in studies reporting the costs of sepsis patients

Care of the Critically Ill

Volumn 20, Issue 6, 2004, Pages 167-176

  Hibbert, Clare L ^a   Coates, Elizabeth J ^a  

^a UNIVERSITY OF SHEFFIELD   (United Kingdom)

Author keywords

Cost allocation; Costs and cost analysis; Intensive care units; Sepsis syndrome

Indexed keywords

ACTIVATED PROTEIN C; ANTIBIOTIC AGENT; DROTRECOGIN; MONOCLONAL ANTIBODY; VASOACTIVE AGENT;

ARTIFICIAL VENTILATION; CLINICAL STUDY; CLINICAL TRIAL; COST EFFECTIVENESS ANALYSIS; CRITICAL ILLNESS; EVALUATION; HEALTH CARE COST; HEMODIALYSIS; HOSPITAL CARE; HOSPITAL COST; HUMAN; INTENSIVE CARE; LANGUAGE; LENGTH OF STAY; META ANALYSIS; METHODOLOGY; RESOURCE MANAGEMENT; REVIEW; SEPSIS; SYSTEMATIC REVIEW;

EID: 11244278661     PISSN: 02660970     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (62)

1. NHS National Institute for Clinical Excellence. Drotrecogin alfa (activated) for severe sepsis. Technology Appraisal 84, September 2004.
2. Bernard GR, Vincent JL, Laterre PF, Larose SP, Dhainant JF, Lopez-Rodriguez A, et al. Efficacy and safety of recombinant human activated protein C for severe sepsis. New Engl J Med 2001; 344: 699-709.
3. Frampton JE, Foster RH. Drotrecogin Alfa (activated): A pharmacoeconomic review of its use in severe sepsis. Pharmacoeconomics 2004; 22: 445-76.
4. Levy MM, Fink MP, Marshall JC, Abraham E, Angus D, Cook D, Cohen J, Opal SM, Vincent J-L, Ramsay G, for the International Sepsis Definitions Conference. 2001 SCCM/ESICM/ACCP/ATS/SIS International Sepsis Definitions Conference. Intensive Care Med 2003; 29: 530-8.
5. Angus DC, Linde-Zwirble WT, Lidicker J, Clermont G, Carcillo J, Pinsky MR. Epidemiology of severe sepsis in the United States: analysis of incidence, outcome, and associated costs of care. Crit Care Med 2001; 29: 1303-10.
6. Linde-Zwirble WT, Rickert T, Cooper L, Clermont G, Watson RS, Hartman ME, Angus DC. The changing epidemiology of severe sepsis in the US. Crit Care Med 2003; 30: 12: Suppl 1: A29.99.
7. Angus DC, Linde-Zwirble WT, Clermont G, Ball DE, Basson BR, Ely EW, Laterre PF, Vincent JL, Bernard G, van Hout B; PROWESS Investigators. Cost-effectiveness of drotrecogin alfa (activated) in the treatment of severe sepsis. Crit Care Med 2003; 31: 1-11.
8. National Institute for Clinical Excellence. Guide to the methods of technology appraisal (2004). NICE, London.
9. Capri S, Ceci A, Terranova L, Merlo F, Mantovani L, The Members of the Italian Group for Pharmacoeconomic Studies. Guidelines for economic evaluations in Italy: Recommendations from the Italian Group of Pharmacoeconomic Studies. Drug Information Journal 2001; 35: 189-201.
10. Rovira J, Antoñanzas F. Economic analysis of health technologies and programmes. A Spanish proposal for methodological standardisation. Pharmacoeconomics 1995; 8: 245-52.
11. Bernard GR. Drotrecogin alfa (activated) (recombinant human activated protein C for severe sepsis. Crit Care Med 2003; 31 [suppl.]: S85-S93.
12. Zeni F, Freeman B, Natanson C. Antiinflammatory therapies to treat sepsis and septic shock: A reassessment. Crit Care Med 1997; 25: 1095-100.
13. Assman SF, Pocock SJ, Enos LE, Kasten LE. Sub-group analysis and other (mis)uses of base-line data in clinical trials. Lancet 2000; 355: 1064-69.
14. Hutton J, Maynard A. A NICE challenge for health economics. Health Economics 2000; 9: 89-93.
15. Glick HA, Polksy DP, Schulman KA. Trial-based economic evaluations: an overview of design and analysis. In: Economic evaluation in health care: merging theory with practice. Chapter 6. Edited by Drummond M & McGuire A. Oxford University Press, 2001.
16. Bowling A. Research Methods in Health. Investigating Health and Health Services (2nd Edition). Open University Press, Buckingham, Philadelphia, 2002.
17. Drummond M, O'Brien B, Stoddart G, Torrance G. Methods for the evaluation of health care programs (2nd Edition). Oxford University Press, Oxford, 1997.
18. Burchardi H, Schneider H. Economic aspects of severe sepsis: a review of intensive care unit costs, cost of illness and cost effectiveness of therapy. Pharmacoeconomics 2004; 22: 793-813.
19. Frampton JE, Foster RH. Drotrecogin alfa (activated): a pharmacoeconomic review of its use in severe sepsis. Pharmacoeconomics 2004; 22: 445-76.
20. Gyldmark M. A review of cost studies of intensive care units: Problems with the cost concept. Crit Care Med 1995; 23: 964-72.
21. Badia X, Segu L, Garcia Alonso F, Rovira J. A cost-efficacy analysis of treatment with antiendotoxin monoclonal antibodies in gram-negative sepsis. Med Clin (Barc) 1993; 100: 84-9.
22. Chalfin DB, Holbein ME, Fein AM, Carlon GC. Cost-effectiveness of monoclonal antibodies to gram-negative endotoxin in the treatment of gram-negative sepsis in ICU patients. JAMA 1993; 269: 249-54.
23. Edbrooke DL, Hibbert CL, Kingsley JM, Smith S, Bright NM, Quinn JM. The patient-related costs of care for sepsis patients in a United Kingdom adult general intensive care unit. Crit Care Med 1999; 27: 1760-7.
24. Wang EC, Grasela TH, Walawander CA. Applying epidemiology-based outcomes research to clinical decision-making. A hypothetical model of biotechnology therapy in gram-negative sepsis. Pharmacoeconomics 1999; 15: 385-93.
25. Moerer O, Schmid A, Hofmann M, Herklotz A, Reinhart K, Werdan K, Schneider H, Burchardi H. Direct costs of severe sepsis in three German intensive care units based on retrospective electronic patient record analysis of resource use. Intensive Care Med 2002; 28: 1440-6.
26. Schmid A, Schneider H, Adlof A, Smolle KH, Edelmann G, Sporn P, Frass M, Sumann G, Koller W, Schobersberger W. Economic burden of illness imposed by severe sepsis in Austria. Wien Klin Wochenschr 2002; 114: 697-701.
27. Teres D, Rapoport J, Lemeshow S, Kim S, Akhras K. Effects of severity of illness on resource use by survivors and nonsurvivors of severe sepsis at intensive care unit admission. Crit Care Med 2002; 30: 2413-9.
28. Brun-Buisson C, Roudot-Thoraval F, Girou E, Greiner-Sennelier C, Durand-Zaleski I. The costs of septic syndromes in the intensive care unit and influence of hospital-acquired sepsis. Intensive Care Med 2003; 29: 1464-71.
29. Yu DT, Black E, Sands KE, Schwartz JS, Hibberd PL, Graman PS, Lanken PN, Kahn KL, Snydman DR, Parsonnet J, Moore R, Platt R, Bates DW for the Academic Medical Center Consortium Sepsis Working Group. Severe sepsis: variation in resource and therapeutic modality use among academic centres. Crit Care 2003; 7: R24-R34.
30. Lee H, Doig CJ, Ghali WA, Donaldson C, Johnson D, Manns B. Detailed cost analysis of care for survivors of severe sepsis. Crit Care Med 2004; 32: 981-85.
31. Sacristan JA, Prieto L, Huete T, Artigas A, Badia X, Chinn C, Hudson P. Cost-effectiveness of drotrecogin alpha (activated) in the treatment of severe sepsis in Spain. Gac Sanit 2004; 18: 50-7.
32. Schmid A, Pugin J, Chevrolet JC, Marsch S, Ludwig S, Stocker R, Finnern H. Burden of illness imposed by severe sepsis in Switzerland. Swiss Med Wkly 2004; 134: 97-102.
33. Letarte J, Longo CJ, Pelletier J, Nabonne B, Fisher HN. Patient characteristics and costs of severe sepsis and septic shock in Quebec. J Crit Care 2002; 17: 39-49.
34. Manns BJ, Lee H, Doig CJ, Johnson D, Donaldson C. An economic evaluation of activated protein C treatment for severe sepsis. New Eng J Med 2002; 347: 993-1000.
35. Schmid A, Burchardi H, Clouth J, Schneider H. Burden of illness imposed by severe sepsis in Germany. European Journal of Health Economics 2002; 3: 77-82.
36. Betancourt M, McKinnon PS, Massanari RM, Kanji S, Bach D, Devlin JW. An evaluation of the cost effectiveness of drotrecogin alfa (activated) relative to the number of organ system failures. Pharmacoeconomics 2003; 21: 1331-40.
37. Fowler RA, Hill-Popper M, Stasinos J, Petrou C, Sanders GD, Garber AM. Cost-effectiveness of recombinant human activated protein C and the influence of severity of illness in the treatment of patients with severe sepsis. J Crit Care 2003; 18: 181-91.
38. Neilson AR, Burchardi H, Chinn C, Clouth J, Schneider H, Angus D. Cost-effectiveness of drotrecogin alfa (activated) for the treatment of severe sepsis in Germany. J Crit Care 2003; 18: 217-27.
39. Weycker D, Akhras KS, Edelsberg J, Angus DC, Oster G. Long-term mortality and medical care charges in patients with severe sepsis. Crit Care Med 2003; 31: 2316-23.
40. Bone RC, Balk RA, Cerra FB, Dellinger EP, Fein AM, Knaus WA, Schein RM, Sibbald WJ, The ACCP/SCCM Consensus Conference Committee. Definitions for sepsis and organ failure and guidelines for the use of innovative therapies in sepsis. Chest 1992; 101: 1644-55.
41. American College of Chest Physicians/Society of Critical Care Medicine Consensus Conference. Definitions for sepsis and organ failure and guidelines for the use of innovative therapies in sepsis. Crit Care Med 1992; 20: 864-74.
42. World Health Organization: International Classification of Diseases, 9th Revision. Albany, NY, World Health Organization, 1978.
43. Marshall JC, Cook DJ, Christou NV, Bernard GR, Sprung CL, Sibbald WJ. Multiple organ dysfunction score. A reliable descriptor of a complex clinical outcome. Crit Care Med 1995; 23: 1638-52.
44. Sands KE, Bates DW, Lanken PN, Graman PS, Hibberd PL, Kahn KL, Parsonnet J, Panzer R, Orav EJ, Snydman DR, Black E, Schwartz JS, Moore R, Johnson BL, Platt R. Epidemiology of sepsis syndrome in 8 academic medical centers. Academic Medical Center Consortium Sepsis Project Working Group. JAMA 1997; 278: 234-40.
45. Chaix C, Durand-Zaleski I, Alberti C, Brun-Buisson C. A model to compute the medical cost of patients in intensive care. Pharmacoeconomics 1999; 15: 573-82.
46. Weinstein MC, Siegel JE, Gold MR, Kamlet MS, Russell LB. Recommendations of the Panel on Cost-Effectiveness in Health and Medicine. JAMA 1996; 276: 1253-8.
47. Angus DC, Rubenfeld GD, Roberts MS, Curtis JR, Connors AF, Cook DJ, Lave JR, Pinsky MR, Cohen IL, Edbrooke DL, Jacobs P, Lambrinos J, Miranda D, Hibbert C, Cook DJ, Linde-Zwirble WT, Moreno R, Tsevat J, Chalfin DB, Hlatky M, Kamlet MS, Roberts MS, Sonnenburg FA, Asch D, Morreim EH, Lave JR, Rie M, Rubenfeld GD. Understanding costs and cost-effectiveness in critical care. Report from the Second American Thoracic Society Workshop on Outcomes Research. Am J Respir Crit Care Med 2002; 165: 540-50.
48. Jegers M, Edbrooke DL, Hibbert CL, Chalfin DB, Burchardi H. Definitions of cost assessment: an intensivist's guide. Intensive Care Med 2002; 28: 1279-5.
49. Angus DC, Carlet J. On behalf of the 2002 Brussels Roundtable Participants. Surviving Intensive Care: A report from the 2002 Brussels Roundtable. Intensive Care Med 2003; 29: 368-77.
50. Keenan SP, Dodek P. Survival as an outcome for ICU patients. In: Angus DC, Carlet J (eds) Surviving Intensive Care. Update in intensive care and emergency medicine, no 39. Springer, Berlin Heidelberg New York, 2003.
51. Johnston K, Buxton MJ, Jones DR, Fitzpatrick R. Assessing the costs of healthcare technologies in clinical trials. Health Technol Assess 1999; 3: ???.
52. Conboy K, Welage LS, Walawander CA, Duffy LC, Welliver RC, Xielezny MA, Dipiro JT, Rachel MA, Grasela TH. Sepsis syndrome and associated sequelae in patients at high risk for gram-negative sepsis. Pharmacotherapy 1995; 15: 66-77.
53. Bone RC. Sepsis, the sepsis syndrome, multi-organ failure: a plea for comparable definitions. Ann Intern Med 1991; 114: 332-3.
54. Fryback DG, Dashbach EJ, Klein R, Klein BEK, Dorn N, Peterson K, Martin PA. The Beaver Dam Health Outcomes Study: Initial catalog of health-care quality factors. Med Decis Making 1993; 13: 89-102.
55. Alberti C, Brun-Buisson C, Burchardi H, Martin C, Goodman S, Artigas A, Sicignano A, Palazzo M, Moreno R, Boulmé R, Lepage E, Le Gall JR, The European Sepsis Group. Epidemiology of sepsis and infection in ICU patients from an international multicenter cohort study. Intensive Care Med 2002; 28: 108-21 (erratum p526).
56. Greenman RL, Schein RMH, Martin MA, Wenzel RP, MacIntyre NR, Emmanuel G, Chmel H, Kohler RB, McCarthy M, Plouffe J, et al. A controlled clinical trial of E5 murine monoclonal IgM antibody to endotoxin in the treatment of gram-negative sepsis. JAMA 1991; 266: 1097-102.
57. Ziegler EJ, Fischer CJ, Sprung CL, Straube RC, Sadoff JC, Foulke GE, Wortel CH, Fink MP, Dellinger RP, Teng NNH, Allen IE, Berger HJ, Knatterud GL, Lobulglio AJ, Smith CR. Treatment of gram-negative bacteremia and septic shock with HA-1A human monoclonal antibody against endoxin. N Engl J Med 1991; 324: 429-36.
58. Eidgenössiches Department des Innern (EDI). Analysenliste. Edition October 1999.
59. Santéssuise. Tagestaxen in Heilanstalten. Edition September 2002.
60. Bundesamt für Statistik. Statistisches Jahrbuch der Schweiz 2002. Verlag Neue Zürcher Zeitung, Zürich 2002.
61. Bundesamt für Statistik. Medizinische Statistik der Krankenhäuser 1998. http://www.statistik.admin.ch/stat_ch/ber14/gewe/drfr14a.htm
62. Bureau of Labor Statistics. Consumer Price Index (CPI), Medical Care Services. Available at: http://146.142.4.24/cgi-bin/surveymost