Randomised controlled trial and parallel economic evaluation of conventional ventilatory support versus extracorporeal membrane oxygenation for severe adult respiratory failure (CESAR)

Health Technology Assessment

Volumn 14, Issue 35, 2010, Pages 1-73

  Peek, G J ^a   Elbourne, D ^b   Mugford, M ^c   Tiruvoipati, R ^a   Wilson, A ^d   Allen, E ^b   Clemens, F ^b   Firmin, R ^a   Hardy, P ^b,e   Hibbert, C ^f   Jones, N ^a   Killer, H ^a   Thalanany, M ^c   Truesdale, A ^b  

^a GLENFIELD HOSPITAL   (United Kingdom)

^b LONDON SCHOOL OF HYGIENE AND TROPICAL MEDICINE   (United Kingdom)

^c UNIVERSITY OF EAST ANGLIA   (United Kingdom)

^d UNIVERSITY OF LEICESTER   (United Kingdom)

^e ROYAL CHILDREN'S HOSPITAL   (Australia)

^f UNIVERSITY OF SHEFFIELD   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

CORTICOSTEROID DERIVATIVE; NITRIC OXIDE;

ARTICLE; ASSISTED VENTILATION; CLINICAL EFFECTIVENESS; CLINICAL TRIAL; COST EFFECTIVENESS ANALYSIS; COST UTILITY ANALYSIS; DEATH; DISEASE SEVERITY; ECONOMIC EVALUATION; EXTRACORPOREAL OXYGENATION; FOLLOW UP; HEALTH CARE COST; HUMAN; LENGTH OF STAY; PHYSICAL DISABILITY; QUALITY ADJUSTED LIFE YEAR; RANDOMIZATION; RESOURCE ALLOCATION; RESPIRATORY FAILURE; SURVIVAL RATE; TREATMENT DURATION; TREATMENT OUTCOME; UNITED KINGDOM;

ADOLESCENT; ADULT; AGED; APACHE; CONFIDENCE INTERVALS; COST-BENEFIT ANALYSIS; ECONOMICS, HOSPITAL; EXTRACORPOREAL MEMBRANE OXYGENATION; FEMALE; GREAT BRITAIN; HEALTH STATUS INDICATORS; HUMANS; MALE; MIDDLE AGED; MODELS, ECONOMIC; NITRIC OXIDE; QUALITY-ADJUSTED LIFE YEARS; RESPIRATION, ARTIFICIAL; RESPIRATORY INSUFFICIENCY; RISK; TREATMENT OUTCOME; YOUNG ADULT;

EID: 77955129382     PISSN: 13665278     EISSN: None     Source Type: Journal    
DOI: 10.3310/hta14350     Document Type: Article

References (88)

1. Zapol WM, Snider MT, Hill JD, Fallat RJ, Bartlett RH, Edmunds LH, et al. Extracorporeal membrane oxygenation in severe acute respiratory failure. A randomized prospective study. JAMA 1979;242:2193-6.
2. Vasilyev S, Schaap RN, Mortensen JD. Hospital survival rates of patients with acute respiratory failure in modern respiratory intensive care units. An international, multicenter, prospective survey. Chest 1995;107:1083-8.
3. The Acute Respiratory Distress Syndrome Network. Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. N Engl J Med 2000;342:1301-8.
4. Gerlach H, Pappert D, Lewandowski K, Rossaint R, Falke KJ. Long-term inhalation with evaluated low doses of nitric oxide for selective improvement of oxygenation in patients with adult respiratory distress syndrome. Intensive Care Med 1993;19:443-9.
5. Rossaint R, Gerlach H, Schmidt-Ruhnke H, Pappert D, Lewandowski K, Steudel W, Falke K. Efficacy of inhaled nitric oxide in patients with severe ARDS. Chest 1995;107:1107-15.
6. Pappert D, Rossaint R, Slama K, Gruning T, Falke KJ. Influence of positioning on ventilationperfusion relationships in severe adult respiratory distress syndrome. Chest 1994;106:1511-6.
7. Derdak S. High-frequency oscillatory ventilation for acute respiratory distress syndrome in adult patients. Crit Care Med 2003;31(Suppl. 4):S317-23.
8. Anonymous. UK collaborative randomised trial of neonatal extracorporeal membrane oxygenation. UK Collaborative ECMO Trial Group. Lancet 1996;348:75-82.
9. Anonymous. The collaborative UK ECMO (Extracorporeal Membrane Oxygenation) trial: follow-up to 1 year of age. Pediatrics 1998;101:E1.
10. Green TP, Timmons OD, Fackler JC, Moler FW, Thompson AE, Sweeney MF. The impact of extracorporeal membrane oxygenation on survival in pediatric patients with acute respiratory failure. Pediatric Critical Care Study Group. Crit Care Med 1996;24:323-9.
11. Peek GJ, Moore HM, Moore N, Sosnowski AW, Firmin RK. Extracorporeal membrane oxygenation for adult respiratory failure. Chest 1997;112:759-64.
12. Morris AH, Wallace CJ, Menlove RL, Clemmer TP, Orme JF Jr, Weaver LK, et al. Randomized clinical trial of pressure-controlled inverse ratio ventilation and extracorporeal CO2 removal for adult respiratory distress syndrome [published erratum appears in Am J Respir Crit Care Med 1994;149:838]. Am J Respir Crit Care Med 1994;149:295-305.
13. Peevy KJ, Hernandez LA, Moise AA, Parker JC. Barotrauma and microvascular injury in lungs of nonadult rabbits: effect of ventilation pattern. Crit Care Med 1990;18:634-7.
14. Parker JC, Hernandez LA, Peevy KJ. Mechanisms of ventilator-induced lung injury. Crit Care Med 1993;21:131-43.
15. Kolla S, Awad SS, Rich PB, Schreiner RJ, Hirschl RB, Bartlett RH. Extracorporeal life support for 100 adult patients with severe respiratory failure. Ann Surg 1997;226:544-64; discussion 565-6.
16. Anonymous. ECMO, Extracorporeal cardiopulmonary support in critical care. Ann Arbor, MI: Extracorporeal Life Support Organization; 1995.
17. Van Meurs K, Lally KP, Peek GJ, Zwischenberger JB (editors). ECMO, Extracorporeal cardiopulmonary support in critical care. 3rd edition. Ann Arbor, MI: Extracorporeal Life Support Organization; 2005.
18. Abel SJ, Finney SJ, Brett SJ, Keogh BF, Morgan CJ, Evans TW. Reduced mortality in association with the acute respiratory distress syndrome (ARDS). Thorax 1998;53:292-4.
19. Mehta S, Lapinsky SE, Hallett DC, Merker D, Groll RJ, Cooper AB, et al. Prospective trial of highfrequency oscillation in adults with acute respiratory distress syndrome. Crit Care Med 2001;29:1360-9.
20. Mancebo J, Fernandez R, Blanch, L, Railp G, Gordo F, Ferrer M, et al. A multicenter trial of prolonged prone ventilation in severe acute respiratory distress syndrome. Am J Respir Crit Care Med 2006;173:1233-9.
21. American Thoracic Society. Understanding costs and cost-effectiveness in critical care. Am J Respir Crit Care Med 2002;164:540-50.
22. Roberts T. Economic evaluation and randomised controlled trial of extracorporeal membrane oxygenation: UK collaborative trial. BMJ 1998;317:911-16.
23. Petrou S and Edwards L. Cost effectiveness analysis of neonatal extracorporeal membrane oxygenation based on four year results from the UK Collaborative ECMO Trial. Arch Dis Child Fetal Neonatal Ed 2004;89:F263-8.
24. Petrou S, Bischof M, Bennett C, Elbourne D, Field D, McNally H. Cost-effectiveness of neonatal extracorporeal membrane oxygenation based on 7-year results from the United Kingdom Collaborative ECMO Trial. Pediatrics 2006;117:1640-9.
25. Mahle WT, Forbess JM, Kirshbom PM, Cuadrado AR, Simsic JM, Kanter KR. Cost-utility analysis of salvage cardiac extracorporeal membrane oxygenation in children. J Thorac Cardiovasc Surg 2005;129:1084-90.
26. Murray JF, Matthay MA, Luce JM, Flick MR. An expanded definition of the adult respiratory distress syndrome [published erratum appears in Am Rev Respir Dis 1989;139:1065]. Am Rev Respir Dis 1988;138:720-3.
27. Peek GJ, Tirouvopaiti R, Firmin RK. In: Extracorporeal life support in cardio-pulmonary critical care. 3rd edition. Ann Arbor, MI: Extracorporeal Life Support Organization; 2005.
28. Moreno R, Vincent JL, Matos R, Mendonca A, Cantraine F, Thijs L, et al. The use of maximum SOFA score to quantify organ dysfunction/failure in intensive care. Results of a prospective, multicentre study. Working Group on Sepsis related Problems of the ESICM. Intensive Care Med 1999;25:686-96.
29. Vincent JL, de Mendonca A, Cantraine F, Moreno R, Thakala J, Suter PM, et al. Use of the SOFA score to assess the incidence of organ dysfunction/failure in intensive care units: results of a multicenter, prospective study. Working group on 'sepsis-related problems' of the European Society of Intensive Care Medicine. Crit Care Med 1998;26:1793-800.
30. Annane D, Bellissant E, Bollaert PE, Briegel J, Keh D, Kupfer Y. Corticosteroids for severe sepsis and septic shock: a systematic review and metaanalysis. BMJ 2004;329:480.
31. Peek GJ, Killer HM, Sosnowski MA, Firmin RK. Modular Extra-corporeal Life Support for Multi- Organ Failure Patients. Liver 2002;22(Suppl. 2): 69-71.
32. Ware JE. SF-36 health survey-manual and interpretation guide. Boston, MA: Nimrod Press; 1993.
33. Williams A. EuroQol - A new facility for the measurement of health-related quality of life. Health Policy 1990;16:199-208.
34. Jones PW, Quirk FH, Bevestock CH, Littlejohns P. A self-complete measure of health status for chronic airflow limitation. Am Rev Respir Dis 2006;145:1321-7.
35. Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand 2006;67:361-70.
36. Folstein MF, Folstein SE. 'Mini-mental state' A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res 1975;12:189-98.
37. Williams, SJ. Measuring health status? A review of the sickness impact and functional limitations profile. Health Care Anal 2006;4:273-83.
38. Robinson BC. Validation of a caregiver strain index. J Gerontol 1983;38:344-8.
39. Peek GJ, Clemens F, Elbourne D, Firmin R, Hardy P, Hibbert C, et al. CESAR: conventional ventilatory support vs extracorporeal membrane oxygenation for severe adults respiratory failure. BMC Health Serv Res 2006;6:163.
40. Haybittle JL. Repeated assessment of results in clinical trials of cancer treatment. Br J Radiol 1971;44:793-7.
41. Peto R, Pike MC, Armitage P, Breslow NE, Cox DR, Howard SV, et al. Design and analysis of randomised clinical trials requiring prolonged observation of each patient. Introduction and design. Br J Cancer 1976;34:585-612.
42. Drummond MF, O'Brien B, Stoddart GL, Torrance GW. Methods for the economic evaluation of health care programmes. Oxford: Oxford University Press; 1997.
43. National Institute of Clinical Excellence (NICE). Guide to the Methods of Technology Appraisal. 2004. URL: www.nice.org.uk/page.aspx?o=201973.
44. Government Actuary's Department. Life tables for the UK. 2007. URL: www.gad.gov.uk/Life_Tables/Interim_life_tables.htm (cited 29 August 2007).
45. Angus DC, Musthafa AA, Clermont G, Griffin MF, Linde-Zwirble WT, Dremsizov TT, et al. Qualityadjusted survival in the first year after the acute respiratory distress syndrome. Am J Respir Crit Care Med 2001;163:1389-94.
46. Herridge MS, Cheung AM, Tansey CM, Matte-Martyn A, Diaz-Granados N, Al-Saidi F, et al. Oneyear outcomes in survivors of the acute respiratory distress syndrome. N Engl J Med 2003;348:683-93.
47. Graf J, Wagner J, Graf C, Koch KC, Janssens U. Five-year survival, quality of life, and individual costs of 303 consecutive medical intensive care patients-a cost-utility analysis. Crit Care Med 2005;33:547-55.
48. Rimachi R, Vincent JL, Brimioulle S. Survival and quality of life after prolonged intensive care unit stay. Anaesth Intensive Care 2007;35:62-7.
49. Sznajder M, Aegerter P, Launois R, Merliere Y, Guidet B, CubRea. A cost-effectiveness analysis of stays in intensive care units. Intensive Care Med 2001;27:146-53.
50. Department of Health. Health Survey for England 1996. URL: www.dh.gov.uk/en/Publicationsandstatistics/PublishedSurvey/HealthSurveyForEngland/Healthsurveyresults/DH_4001554 (cited 29 August 2007).
51. Curtis L, Netten A. Unit costs of health and social care 2005. Canterbury: Personal Social Services Research Unit, University of Kent. URL: www.pssru.ac.uk/uc/uc2005contents.htm.
52. NHS Reference costs. 2007. URL: www.dh.gov.uk/PolicyAndGuidance/OrganisationPolicy/FinanceAndPlanning/NHSReferenceCosts/fs/en.
53. British Medical Association and Royal Pharmaceutical Society of Great Britain British National Formulary. No. 53, March 2007. London: BMA and RPS; 2007.
54. Posnett J, Jan S. Indirect cost in economic evaluation: The opportunity cost of unpaid inputs. Health Econ 1996;5:13-23.
55. Automobile Association (AA). Motoring costs. 2007. URL: www.theaa.com/allaboutcars/advice/advice_rcosts_home.html.
56. Office of National Statistics. 2003. URL: www.statistics.gov.uk
57. HM Government. Commons Hansard. Parliamentary proceedings. 2004. URL: www.publications.parliament.uk/pa/cm200405/cmhansrd/vo041214/text/41214w25.htm (cited 22 August 2007)
58. HM Treasury. The green book: appraisal and evaluation in central government. London: The Stationery Office; 2007.
59. Hibbert CL, Coates EJ, Brazier JE, Morris J. A cost survey of 70 adult critical care units - results from volunteer sample in England, Scotland and Northern Ireland in 2003. Care Crit Ill 2005;21:8-17.
60. Dean JE, Edbrooke DL, Corcoran M. The Critical Care National Cost Block Programme: implementing a standard costing methodology on a national scale. Care Crit Ill 2002;18:3.
61. Sutton AJ, Abrams KR, Jones DR, Sheldon TA, Song F. Methods for meta-analysis in medical research. Chichester: John Wiley & Sons; 2000.
62. Hibbert CL, Coates E, Brazier J, Morris J. Development of Healthcare Resource Groups for adult critical care. Report for the NHS Information Authority. London: Department of Health; 2004.
63. Hibbert C. Development and application of a method for estimating case-mix adjusted costs of adult critical care units. PhD Thesis. Sheffield: University of Sheffield; 2007.
64. Thalanany MM, Mugford M, Mitchell-Inwang C. Visiting adult patients in intensive care: the importance of relatives' travel and time costs. Intensive Crit Care Nurs 2006;22:40-8.
65. Briggs AH. Statistical methods for cost-effectiveness research: a guide to current issues and future developments. London: Office of Health Economics; 2003.
66. Karlsson G, Johannesson M. The decision rules of cost-effectiveness analysis. PharmacoEconomics 1996;9:113-20.
67. Glick HA, Briggs AH, Polsky D. Quantifying stochastic uncertainty and presenting results of cost-effectiveness analyses. Expert Rev Pharmacoecon Outcomes Res 2001;1:25-36.
68. Fenwick E, O'Brien B, Briggs A. Cost-effectiveness acceptability curves: facts, fallacies and frequently asked questions. Health Econ 2004;13:405-15.
69. Rubin DB. Multiple imputation for nonresponse in surveys. New York: John Wiley & Sons, Inc; 1987.
70. Bernard GR, Artigas A, Brigham KL, Carlet J, Falke K, Hudson L, et al. The American-European Consensus Conference on ARDS. Definitions, mechanisms, relevant outcomes, and clinical trial coordination. Am J Respir Crit Care Med 1994;149:818-24.
71. Derdak S, Mehta S, Stewart TE, Smith T, Rogers M, Buchman TG, et al. High-frequency oscillatory ventilation for acute respiratory distress syndrome in adults: a randomised, controlled trial. Am J Respir Crit Care Med 2002;166:801-8.
72. Luecke T, Muench E, Roth H, Friess U, Paul T, Kleinhuber K, et al. Predictors of mortality in ARDS patients referred to a tertiary care centre: a pilot study. Eur J Anaesthesiol 2006;23:403-10.
73. Suntharalingam G, Regan K, Keogh BF, Morgan CJ, Evans TW. Influence of direct and indirect etiology on acute outcome and 6-month functional recovery in acute respiratory distress syndrome. Crit Care Med 2001;29:562-6.
74. Claridge JA, Hostetter RG, Lowson SM, Young JS. High-frequency oscillatory ventilation can be effective as rescue therapy for refractory acute lung dysfunction. Am Surg 1999;65:1092-6.
75. Bernard GR, Vincent JL, Laterre PF, LaRosa SP, Dhainaut JF, Lopez-Rodriguez A, et al. Efficacy and safety of recombinant human activated protein C for severe sepsis. N Engl J Med 2001;344:699-709.
76. Dellinger RP, Carlet JM, Masur H, Gerlach H, Calandra T, Cohen J, et al. Surviving Sepsis Campaign guidelines for management of severe sepsis and septic shock. Crit Care Med 2004;32:858-73.
77. Gao F, Melody T, Daniels DF, Giles S, Fox S. The impact of compliance with 6-hour and 24-hour sepsis bundles on hospital mortality in patients with severe sepsis: a prospective observational study. Crit Care 2005;9:R764-70.
78. Wiedemann HP, Wheeler AP, Bernard GR, Thompson BT, Hayden D, deBoisblanc B, et al. Comparison of two fluid-management strategies in acute lung injury. N Engl J Med 2006;354:2564-75.
79. Badin S, Gress TW, Munn N, Zeid FM. Mechanical ventilation management by pulmonologists and surgeons in patients with adult respiratory distress syndrome. Am J Med Sci 2007;334:155-9.
80. Thorburn W. 'The Myth of Ockham'. Mind 1918;27:345-53.
81. Beed M, Jayamaha J, Sherman R, Mahajan R. Successful use of portable extracorporeal carbondioxide removal in a patient with incontrollable hypercapnoea. Br J Intensive Care 2006;16:24-6.
82. Tiruvoipati R, Truesdale A, Elbourne D, Peek GJ. Letters to the editor. Br J Intensive Care 2007;17:33.
83. Foley DS, Pranikoff T, Younger JG, Swaniker F, Hemmila MR, Remenapp RA, et al. A review of 100 patients transported on extracorporeal life support. ASAIO J 2002;48:612-19.
84. Linden V, Palmer K, Reinhard J, Westman R, Ehren H, Granholm T, Frenckner B. Inter-hospital transportation of patients with severe acute respiratory failure on extracorporeal membrane oxygenation - national and international experience. Intensive Care Med 2001;27:1643-8.
85. CEVR. CEA registry. Boston, MA: Center for the Evaluation of Value and Risk in Health (CEVR), Tufts-New England Medical Center; 2007.
86. Desbiens NA. Deciding on anticoagulating the oldest old with atrial fibrillation: insights from costeffectiveness analysis. J Am Geriatr Soc 2002;50:863-9.
87. Gaspoz JM, Coxson PG, Goldman PA, Williams LW, Kuntz KM, Hunink MG, et al. Cost effectiveness of aspirin, clopidogrel, or both for secondary prevention of coronary heart disease. N Engl J Med 2002;346:1800-6.
88. Anyanwu AC, McGuire A, Rogers CA, Murday AJ. An economic evaluation of lung transplantation. J Thorac Cardiovasc Surg 2002;123:411-8; discussion 8-20.