Cost-effectiveness analysis of six strategies to treat recurrent clostridium difficile infection

PLoS ONE

Volumn 11, Issue 2, 2016, Pages

  Lapointe Shaw, Lauren ^a,b   Tran, Kim L ^b   Coyte, Peter C ^c   Hancock Howard, Rebecca L ^c   Powis, Jeff ^a,d   Poutanen, Susan M ^a,b,e   Hota, Susy ^a,b  

^a UNIVERSITY OF TORONTO   (Canada)

^b UNIVERSITY HEALTH NETWORK   (Canada)

^c UNIVERSITY OF TORONTO   (Canada)

^d TORONTO EAST GENERAL HOSPITAL   (Canada)

^e MOUNT SINAI HOSPITAL   (Canada)

Author keywords

[No Author keywords available]

Indexed keywords

ENEMA; FIDAXOMICIN; METRONIDAZOLE; VANCOMYCIN; ANTIINFECTIVE AGENT;

ARTICLE; CLOSTRIDIUM DIFFICILE INFECTION; COLONOSCOPY; COST BENEFIT ANALYSIS; COST EFFECTIVENESS ANALYSIS; DRUG EFFECT; FECAL MICROBIOTA TRANSPLANTATION; HUMAN; NASOGASTRIC TUBE; QUALITY OF LIFE; RECURRENT INFECTION; TREATMENT DURATION; TREATMENT PLANNING; CANADA; COST; ECONOMICS; ENTEROCOLITIS, PSEUDOMEMBRANOUS; FEMALE; MALE; PEPTOCLOSTRIDIUM DIFFICILE;

ANTI-BACTERIAL AGENTS; CANADA; CLOSTRIDIUM DIFFICILE; COSTS AND COST ANALYSIS; ENTEROCOLITIS, PSEUDOMEMBRANOUS; FECAL MICROBIOTA TRANSPLANTATION; FEMALE; HUMANS; MALE;

EID: 84960496951     PISSN: None     EISSN: 19326203     Source Type: Journal    
DOI: 10.1371/journal.pone.0149521     Document Type: Article

References (68)

1. Poutanen SM, Simor AE. Clostridium difficile-associated diarrhea in adults. CMAJ. 2004; 171(1):51-8. Epub 2004/07/09. PMID: 15238498; PubMed Central PMCID: PMCPMC437686.
2. McFarland LV. Epidemiology of infectious and iatrogenic nosocomial diarrhea in a cohort of general medicine patients. Am J Infect Control. 1995; 23(5):295-305. PMID: 8585641
3. Kelly CP, Pothoulakis C, LaMont JT. Clostridium difficile colitis. N Engl J Med. 1994; 330(4):257-62. Epub 1994/01/27. doi: 10.1056/nejm199401273300406 PMID: 8043060.
4. Cohen SH, Gerding DN, Johnson S, Kelly CP, Loo VG, McDonald LC, et al. Clinical practice guidelines for Clostridium difficile infection in adults: 2010 update by the society for healthcare epidemiology of America (SHEA) and the infectious diseases society of America (IDSA). Infect Control Hosp Epidemiol. 2010; 31(5):431-55. Epub 2010/03/24. doi: 10.1086/651706 PMID: 20307191.
5. McFarland LV, Surawicz CM, Greenberg RN, Fekety R, Elmer GW, Moyer KA, et al. A randomized placebo-controlled trial of Saccharomyces boulardii in combination with standard antibiotics for Clostridium difficile disease. JAMA. 1994; 271(24):1913-8. Epub 1994/06/22. PMID: 8201735.
6. Bartlett JG, Tedesco FJ, Shull S, Lowe B, Chang T. Symptomatic relapse after oral vancomycin therapy of antibiotic-associated pseudomembranous colitis. Gastroenterology. 1980; 78(3):431-4. Epub 1980/03/01. PMID: 7053190.
7. Wenisch C, Parschalk B, Hasenhundl M, Hirschl AM, Graninger W. Comparison of vancomycin, teicoplanin, metronidazole, and fusidic acid for the treatment of Clostridium difficile-associated diarrhea. Clin Infect Dis. 1996; 22(5):813-8. Epub 1996/05/01. PMID: 8722937.
8. McFarland LV, Surawicz CM, Rubin M, Fekety R, Elmer GW, Greenberg RN. Recurrent Clostridium difficile disease: epidemiology and clinical characteristics. Infect Control Hosp Epidemiol. 1999; 20(1):43-50. Epub 1999/02/02. doi: 10.1086/501553 PMID: 9927265.
9. van Nood E, Vrieze A, Nieuwdorp M, Fuentes S, Zoetendal EG, de Vos WM, et al. Duodenal infusion of donor feces for recurrent Clostridium difficile. N Engl J Med. 2013; 368(5):407-15. Epub 2013/01/18. doi: 10.1056/NEJMoa1205037 PMID: 23323867.
10. McFarland LV, Elmer GW, Surawicz CM. Breaking the cycle: treatment strategies for 163 cases of recurrent Clostridium difficile disease. Am J Gastroenterol. 2002; 97(7):1769-75. Epub 2002/07/24. doi: 10.1111/j.1572-0241.2002.05839.x PMID: 12135033.
11. Crook DW, Walker AS, Kean Y, Weiss K, Cornely OA, Miller MA, et al. Fidaxomicin versus vancomycin for Clostridium difficile infection: meta-analysis of pivotal randomized controlled trials. Clin Infect Dis. 2012; 55 Suppl 2:S93-103. Epub 2012/09/05. doi: 10.1093/cid/cis499 PMID: 22752871; PubMed Central PMCID: PMCPMC3388031.
12. Cornely OA, Crook DW, Esposito R, Poirier A, Somero MS, Weiss K, et al. Fidaxomicin versus vancomycin for infection with Clostridium difficile in Europe, Canada, and the USA: a double-blind, non-inferiority, randomised controlled trial. Lancet Infect Dis. 2012; 12(4):281-9. Epub 2012/02/11. doi: 10.1016/s1473-3099(11)70374-7 PMID: 22321770.
13. Louie TJ, Miller MA, Mullane KM, Weiss K, Lentnek A, Golan Y, et al. Fidaxomicin versus vancomycin for Clostridium difficile infection. N Engl J Med. 2011; 364(5):422-31. Epub 2011/02/04. doi: 10.1056/NEJMoa0910812 PMID: 21288078.
14. Kassam Z, Lee CH, Yuan Y, Hunt RH. Fecal microbiota transplantation for Clostridium difficile infection: systematic review and meta-analysis. Am J Gastroenterol. 2013; 108(4):500-8. Epub 2013/03/21. doi: 10.1038/ajg.2013.59 PMID: 23511459.
15. Ministry of Health and Long-term Care. Exeptional Acces Program Reimbursement Criteria for Frequently Requested Drugs. Available from: http://www.health.gov.on.ca/en/pro/programs/drugs/pdf/frequently-requested-drugs.pdf.
16. Ahmad A, Hugtenburg J, Welschen LM, Dekker JM, Nijpels G. Effect of medication review and cognitive behaviour treatment by community pharmacists of patients discharged from the hospital on drug related problems and compliance: design of a randomized controlled trial. BMC Public Health. 2010; 10:133. PMID: 20230611; PubMed Central PMCID: PMCPMC2850341. doi: 10.1186/1471-2458-10-133
17. Bartsch SM, Umscheid CA, Fishman N, Lee BY. Is fidaxomicin worth the cost? An economic analysis. Clin Infect Dis. 2013; 57(4):555-61. Epub 2013/05/25. doi: 10.1093/cid/cit346 PMID: 23704121; PubMed Central PMCID: PMCPmc3719891.
18. Wagner M, Lavoie L, Goetghebeur M. Clinical and economic consequences of vancomycin and fidaxomicin for the treatment of Clostridium difficile infection in Canada. Can J Infect Dis Med Microbiol. 2014; 25(2):87-94. Epub 2014/05/24. PMID: 24855476; PubMed Central PMCID: PMCPmc4028674.
19. Allen-Vercoe E, Reid G, Viner N, Gloor GB, Hota S, Kim P, et al. A Canadian Working Group report on fecal microbial therapy: microbial ecosystems therapeutics. Can J Gastroenterol. 2012; 26(7):457-62. Epub 2012/07/18. PMID: 22803022; PubMed Central PMCID: PMCPmc3395448.
20. Health Canada. Fecal Microbiota Therapy Used in the Treatment of Clostridium difficile Infection Not Responsive to Conventional Therapies Ottawa, Canada2015.
21. Zipursky JS, Sidorsky TI, Freedman CA, Sidorsky MN, Kirkland KB. Physician attitudes toward the use of fecal microbiota transplantation for the treatment of recurrent Clostridium difficile infection. Canadian Journal of Gastroenterology & Hepatology. 2014; 28(6):319-24. PMID: 24719899; PubMed Central PMCID: PMCPMC4072236.
22. Konijeti GG, Sauk J, Shrime MG, Gupta M, Ananthakrishnan AN. Cost-effectiveness of Competing Strategies for Management of Recurrent Clostridium difficile Infection: A Decision Analysis. Clin Infect Dis. 2014; 58(11):1507-14. Epub 2014/04/03. doi: 10.1093/cid/ciu128 PMID: 24692533; PubMed Central PMCID: PMCPmc4017891.
23. Gravel D, Miller M. Clostridium difficile Associated Diarrhea in Acute-Care Hospitals Participating in CNISP: November 1, 2004 to April 30, 2005. 2007.
24. Belmares J, Gerding DN, Parada JP, Miskevics S, Weaver F, Johnson S. Outcome of metronidazole therapy for Clostridium difficile disease and correlation with a scoring system. J Infect. 2007; 55 (6):495-501. Epub 2007/11/07. doi: 10.1016/j.jinf.2007.09.015 PMID: 17983659.
25. Cornely OA, Miller MA, Louie TJ, Crook DW, Gorbach SL. Treatment of first recurrence of Clostridium difficile infection: fidaxomicin versus vancomycin. Clin Infect Dis. 2012; 55 Suppl 2:S154-61. Epub 2012/07/07. doi: 10.1093/cid/cis462 PMID: 22752865; PubMed Central PMCID: PMCPmc3388030.
26. Naimark DM, Kabboul NN, Krahn MD. The half-cycle correction revisited: redemption of a kludge. Med Decis Making. 2013; 33(7):961-70. Epub 2013/09/21. doi: 10.1177/0272989x13501558 PMID: 24048350.
27. Roberts M, Russell LB, Paltiel AD, Chambers M, McEwan P, Krahn M. Conceptualizing a model: a report of the ISPOR-SMDM Modeling Good Research Practices Task Force-2. Value Health. 2012; 15(6):804-11. Epub 2012/09/25. doi: 10.1016/j.jval.2012.06.016 PMID: 22999129.
28. Pepin J, Routhier S, Gagnon S, Brazeau I. Management and outcomes of a first recurrence of Clostridium difficile-associated disease in Quebec, Canada. Clin Infect Dis. 2006; 42(6):758-64. Epub 2006/02/16. doi: 10.1086/501126 PMID: 16477549.
29. O'Brien JA, Lahue BJ, Caro JJ, Davidson DM. The emerging infectious challenge of clostridium difficile-associated disease in Massachusetts hospitals: clinical and economic consequences. Infect Control Hosp Epidemiol. 2007; 28(11):1219-27. Epub 2007/10/11. doi: 10.1086/522676 PMID: 17926270.
30. Debast SB, Bauer MP, Kuijper EJ, on behalf of the C. European Society of Clinical Microbiology and Infectious Diseases: update of the treatment guidance document for Clostridium difficile infection. Clin Microbiol Infect. 2014; 20:1-26. doi: 10.1111/1469-0691.12418
31. Vardakas KZ, Polyzos KA, Patouni K, Rafailidis PI, Samonis G, Falagas ME. Treatment failure and recurrence of Clostridium difficile infection following treatment with vancomycin or metronidazole: a systematic review of the evidence. Int J Antimicrob Agents. 2012; 40(1):1-8. Epub 2012/03/09. doi: 10.1016/j.ijantimicag.2012.01.004 PMID: 22398198.
32. Kassam Z, Hundal R, Marshall JK, Lee CH. Fecal transplant via retention enema for refractory or recurrent Clostridium difficile infection. Arch Intern Med. 2012; 172(2):191-3. Epub 2012/01/25. doi: 10.1001/archinte.172.2.191 PMID: 22271132.
33. MacConnachie AA, Fox R, Kennedy DR, Seaton RA. Faecal transplant for recurrent Clostridium difficile-associated diarrhoea: a UK case series. QJM. 2009; 102(11):781-4. Epub 2009/09/04. doi: 10.1093/qjmed/hcp118 PMID: 19726581.
34. Garborg K, Waagsbo B, Stallemo A, Matre J, Sundoy A. Results of faecal donor instillation therapy for recurrent Clostridium difficile-associated diarrhoea. Scand J Infect Dis. 2010; 42(11-12):857-61. Epub 2010/07/29. doi: 10.3109/00365548.2010.499541 PMID: 20662620.
35. Aas J, Gessert CE, Bakken JS. Recurrent Clostridium difficile colitis: case series involving 18 patients treated with donor stool administered via a nasogastric tube. Clin Infect Dis. 2003; 36(5):580-5. Epub 2003/02/21. doi: 10.1086/367657 PMID: 12594638.
36. Mattila E, Uusitalo-Seppala R, Wuorela M, Lehtola L, Nurmi H, Ristikankare M, et al. Fecal transplantation, through colonoscopy, is effective therapy for recurrent Clostridium difficile infection. Gastroenterology. 2012; 142(3):490-6. Epub 2011/12/14. doi: 10.1053/j.gastro.2011.11.037 PMID: 22155369.
37. Rohlke F, Surawicz CM, Stollman N. Fecal flora reconstitution for recurrent Clostridium difficile infection: results and methodology. J Clin Gastroenterol. 2010; 44(8):567-70. Epub 2010/05/21. doi: 10.1097/MCG.0b013e3181dadb10 PMID: 20485184.
38. Yoon SS, Brandt LJ. Treatment of refractory/recurrent C. difficile-associated disease by donated stool transplanted via colonoscopy: a case series of 12 patients. J Clin Gastroenterol. 2010; 44(8):562-6. Epub 2010/05/14. doi: 10.1097/MCG.0b013e3181dac035 PMID: 20463588.
39. Kelly CR, de Leon L, Jasutkar N. Fecal microbiota transplantation for relapsing Clostridium difficile infection in 26 patients: methodology and results. J Clin Gastroenterol. 2012; 46(2):145-9. Epub 2011/12/14. doi: 10.1097/MCG.0b013e318234570b PMID: 22157239.
40. Lund-Tonnesen S, Berstad A, Schreiner A, Midtvedt T. [Clostridium difficile-associated diarrhea treated with homologous feces]. Tidsskr Nor Laegeforen. 1998; 118(7):1027-30. Epub 1998/04/09. PMID: 9531822.
41. Patel NC, Griesbach CL, DiBaise JK, Orenstein R. Fecal microbiota transplant for recurrent Clostridium difficile infection: Mayo Clinic in Arizona experience. Mayo Clin Proc. 2013; 88(8):799-805. PMID: 23910407. doi: 10.1016/j.mayocp.2013.04.022
42. Brandt LJ, Aroniadis OC, Mellow M, Kanatzar A, Kelly C, Park T, et al. Long-term follow-up of colonoscopic fecal microbiota transplant for recurrent Clostridium difficile infection. Am J Gastroenterol. 2012; 107(7):1079-87. Epub 2012/03/28. doi: 10.1038/ajg.2012.60 PMID: 22450732.
43. Mellow MH, Kanatzar A. Colonoscopic fecal bacteriotherapy in the treatment of recurrent Clostridium difficile infection-results and follow-up. J Okla State Med Assoc. 2011; 104(3):89-91. Epub 2011/05/26. PMID: 21608450.
44. Eyre DW, Walker AS, Wyllie D, Dingle KE, Griffiths D, Finney J, et al. Predictors of first recurrence of Clostridium difficile infection: implications for initial management. Clin Infect Dis. 2012; 55 Suppl 2: S77-87. Epub 2012/09/05. doi: 10.1093/cid/cis356 PMID: 22752869; PubMed Central PMCID: PMCPmc3388024.
45. Statistics Canada. Table 7a Complete life table, males, Canada, 2009 to 2011: Minister of Industry, 2015 [cited 2015 October 22]. Available from: http://www.statcan.gc.ca/pub/84-537-x/2013005/tbl-eng.htm.
46. Statistics Canada. Table 7a Complete life table, females, Canada, 2009 to 2011 http://www.statcan.gc. ca/pub/84-537-x/2013005/tbl-eng.htm: Ministry of Industry, 2015 [cited 2015 October 22].
47. Levin TR, Zhao W, Conell C, Seeff LC, Manninen DL, Shapiro JA, et al. Complications of Colonoscopy in an Integrated Health Care Delivery System. Ann Intern Med. 2006; 145(12):880-6. doi: 10.7326/0003-4819-145-12-200612190-00004 PMID: 17179057
48. Rassias AJ, Ball PA, Corwin HL. A prospective study of tracheopulmonary complications associated with the placement of narrow-bore enteral feeding tubes. Crit Care. 1998; 2(1):25-8. Epub 2000/11/01. doi: 10.1186/cc120 PMID: 11056706; PubMed Central PMCID: PMCPmc28998.
49. Walker AS, Eyre DW, Wyllie DH, Dingle KE, Griffiths D, Shine B, et al. Relationship Between Bacterial Strain Type, Host Biomarkers, and Mortality in Clostridium difficile Infection. Clinical Infectious Diseases: An Official Publication of the Infectious Diseases Society of America. 2013; 56(11):1589-600. doi: 10.1093/cid/cit127 PMID: PMC3641870.
50. Sharara N, Adam V, Crott R, Barkun AN. The costs of colonoscopy in a Canadian hospital using a microcosting approach. Can J Gastroenterol. 2008; 22(6):565-70. PMID: PMC2660815.
51. Ontario Ministry of Health and Long-Term Care. Ontario Case Costing Initiative 2013 [December 15, 2013]. Available from: http://www.occp.com/mainPage.htm.
52. Gold MR, Franks P, McCoy KI, Fryback DG. Toward consistency in cost-utility analyses: using national measures to create condition-specific values. Med Care. 1998; 36(6):778-92. Epub 1998/06/18. PMID: 9630120.
53. Mittmann N, Trakas K, Risebrough N, Liu BA. Utility scores for chronic conditions in a community-dwelling population. Pharmacoeconomics. 1999; 15(4):369-76. PMID: 10537955.
54. Kassam Z, Lee CH, Yuan Y, Hunt RH. Fecal microbiota transplantation for Clostridium difficile infection: systematic review and meta-analysis. Am J Gastroenterol. 2013; 108(4):500-8. PMID: 23511459. doi: 10.1038/ajg.2013.59
55. Statistics Canada. Consumer Price Index, health and personal care, by province (Canada) 2015 [12 November, 2015]. Available from: http://www.statcan.gc.ca/tables-tableaux/sum-som/l01/cst01/econ161a-eng.htm.
56. Monthly Average Exchange Rates: 10-Year Lookup [Internet]. 2013 [cited 12 November, 2015]. Available from: http://www.bankofcanada.ca/rates/exchange/monthly-average-lookup/.
57. Ministry of Health and Long Term Care. Schedule of Benefits. Toronto, Ontario: Province of Ontario; 2013.
58. U.S. National Institutes of Health. Oral Vancomycin Followed by Fecal Transplant Versus Tapering Oral Vancomycin NCT01226992: ClinicalTrials.gov; 2013 [cited 2014 June 16]. Available from: http://clinicaltrials.gov/ct2/show/NCT01226992.
59. Ontario Nurses' Association. Unions and the Ontario Nurses' Association 2014 [cited 2014 March 30]. Available from: http://www.ona.org/faqs.html#f15.
60. Government of Canada. Explore Careers-Wage Report http://www.workingincanada.gc.ca/: Government of Canada; 2013 [updated 2013; cited 2014 February 4]. Available from: http://www.workingincanada.gc.ca/LMI-report-area.do?reportOption=wage&PROVINCE-ID=35&GEOAREA-CD=9219&selectLocation=Continue.
61. Stranges PM, Hutton DW, Collins CD. Cost-effectiveness analysis evaluating fidaxomicin versus oral vancomycin for the treatment of Clostridium difficile infection in the United States. Value Health. 2013; 16(2):297-304. Epub 2013/03/30. doi: 10.1016/j.jval.2012.11.004 PMID: 23538181.
62. Mohseninejad L, Feenstra T, van der Horst HE, Woutersen-Koch H, Buskens E. Targeted screening for Coeliac Disease among irritable bowel syndrome patients: analysis of cost-effectiveness and value of information. The European journal of health economics: HEPAC: health economics in prevention and care. 2013; 14(6):947-57. Epub 2012/11/28. doi: 10.1007/s10198-012-0441-4 PMID: 23179163.
63. Canadian Agency for Drugs and Technologies in Health. Guidelines for the Economic Evaluation of Health Technologies: Canada. Ottawa: 2006.
64. Law MR. Money Left on the Table: Generic Drug Prices in Canada. Healthcare Policy. 2013; 8(3):17-25. PMID: 23968624
65. Lynne V. McFarland P, Surawicz CMMD, Rubin MMD, Fekety RMD, Elmer GWP, Greenberg RNMD. Recurrent Clostridium difficile Disease: Epidemiology and Clinical Characteristics o Infect Control Hosp Epidemiol. 1999; 20(1):43-50. doi: 10.1086/501553 PMID: 9927265
66. Halabi WJ, Nguyen VQ, Carmichael JC, Pigazzi A, Stamos MJ, Mills S. Clostridium difficile colitis in the United States: a decade of trends, outcomes, risk factors for colectomy, and mortality after colectomy. J Am Coll Surg. 2013; 217(5):802-12. Epub 2013/09/10. doi: 10.1016/j.jamcollsurg.2013.05.028 PMID: 24011436.
67. Gravel D, Miller M, Simor A, Taylor G, Gardam M, McGeer A, et al. Health care-associated Clostridium difficile infection in adults admitted to acute care hospitals in Canada: a Canadian Nosocomial Infection Surveillance Program Study. Clin Infect Dis. 2009; 48(5):568-76. Epub 2009/02/05. doi: 10.1086/596703 PMID: 19191641.
68. Collins CE, Ayturk MD, Flahive JM, Emhoff TA, Anderson FA Jr, Santry HP. Epidemiology and Outcomes of Community-Acquired Clostridium difficile Infections in Medicare Beneficiaries. J Am Coll Surg. 2014; 218(6):1141-7.e1. Epub 2014/04/24. doi: 10.1016/j.jamcollsurg.2014.01.053 PMID: 24755188.