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Journal of General Internal Medicine

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01-04-2020 | Vancomycin | Original Research

Cost-Effectiveness Analysis of Four Common Diagnostic Methods for Clostridioides difficile Infection

Authors: Si Xuan, MPH, Kenneth M. Zangwill, MD, Weiyi Ni, PhD, Junjie Ma, PhD, Joel W. Hay, PhD

Published in: Journal of General Internal Medicine | Issue 4/2020

Abstract

Background

No studies have evaluated the cost-effectiveness of single and two-step different diagnostic test strategies for Clostridioides difficile infection (CDI), including direct and indirect costs.

Objective

To evaluate the cost-effectiveness of commonly available diagnostic tests for CDI including nucleic acid amplification testing (NAAT) alone, glutamate dehydrogenase followed by enzyme immunoassay for toxin (GDH/EIA), GDH then NAAT (GDH/NAAT), and NAAT then EIA (NAAT/EIA).

Design

Decision tree model from the US societal perspective with inputs derived from the literature. Willingness-to-pay threshold was set at $150,000 per quality-adjusted life year (QALY) gained. To assess the impact of uncertainty in model inputs on the findings, we performed one-way and probabilistic sensitivity analyses.

Participants

We conducted the analysis to represent a population aged 65 years old with diarrhea who received a CDI diagnostic test.

Main Measures

Incremental cost-effectiveness ratios (ICER) and incremental net monetary benefits (INMB).

Key Results

NAAT alone was the most cost-effective approach overall; GDH/NAAT was the most cost-effective two-step option. NAAT alone led to the highest QALYs gained, at an incremental cost of $54,547 (vs. GDH/NAAT), $55,410 (vs. GDH/EIA), and $50,231 (vs. NAAT/EIA) per QALY gained. NAAT/EIA was not cost-effective compared to any other strategy. GDH/NAAT resulted in a higher QALY compared to GDH/EIA, at an incremental cost of $96,841 per QALY gained. Variability in the likelihood of comorbidities, CDI probability, and age at disease onset did not substantially change the results. One-way sensitivity analyses showed that results were most sensitive to likelihood of recurrence, followed by CDI mortality rate and probability of severe CDI. Probabilistic sensitivity analyses explored known uncertainties in the base case and confirmed the robustness of the results.

Conclusions

NAAT alone and GDH/NAAT (among the two-step options) were the most cost-effective diagnostic test approaches for CDI.

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Lessa FC, Mu Y, Bamberg WM, Beldavs ZG, Dumyati GK, Dunn JR, et al. Burden of Clostridium difficile infection in the United States. N Engl J Med 2015;372(9):825-34. https://doi.org/10.1056/NEJMoa1408913 CrossRefPubMed

Evans CT, Safdar N. Current trends in the epidemiology and outcomes of Clostridium difficile infection. Clin Infect Dis 2015;60 Suppl 2:S66-71. https://doi.org/10.1093/cid/civ140 CrossRefPubMed

Lucado J, Gould C, Elixhauser A. Clostridium difficile infections (CDI) in hospital stays, 2009. HCUP Statistical Brief #124. Agency for Healthcare Research and Quality, Rockville, MD. 2012. https://www.hcup-us.ahrq.gov/reports/statbriefs/sb124.pdf. Accessed 16 August 2019.

Centers for Disease Control and Prevention. Antibiotic resistance threats in the United States, 2013. http://www.cdc.gov/drugresistance/threat-report-2013/. Accessed 16 August 2019.

McDonald LC, Gerding DN, Johnson S, Bakken JS, Carroll KC, Coffin SE, et al. Clinical practice guidelines for Clostridium difficile infection in adults and children: 2017 update by the Infectious Diseases Society of America (IDSA) and Society for Healthcare Epidemiology of America (SHEA). Clin Infect Dis 2018;66(7):e1-e48.CrossRef

Schroeder LF, Robilotti E, Peterson LR, Banaei N, DW D. Economic evaluation of laboratory testing strategies for hospital-associated Clostridium difficile infection. J Clin Microbiol 2014;52(2):489-96.CrossRef

Verhoye E, Vandecandelaere P, De Beenhouwer H, Coppens G, Cartuyvels R, Van den Abeele A, et al. A hospital-level cost-effectiveness analysis model for toxigenic Clostridium difficile detection algorithms. J Hosp Infect 2015;91(2):123-8. https://doi.org/10.1016/j.jhin.2015.06.001 CrossRefPubMed

Vasoo S, Stevens J, Portillo L, Barza R, Schejbal D, Wu MM, et al. Cost-effectiveness of a modified two-step algorithm using a combined glutamate dehydrogenase/toxin enzyme immunoassay and real-time PCR for the diagnosis of Clostridium difficile infection. J Microbiol Immunol Infect 2014;47(1):75-8. https://doi.org/10.1016/j.jmii.2012.07.008 CrossRefPubMed

Bartsch SM, Umscheid CA, Nachamkin I, Hamilton K, Lee BY. Comparing the economic and health benefits of different approaches to diagnosing Clostridium difficile infection. Clin Microbiol Infect. 2015;21(1):77 e1-9. https://doi.org/10.1016/j.cmi.2014.07.002 CrossRef

10.

Gold MR, Siegel JE, Russell LB, Weinstein MC, eds. Cost-effectiveness in health and medicine. New York: Oxford University Press; 1996.

11.

Neumann PJ, Sanders GD, Russell LB, Siegel JE, Ganiats TG, eds. Cost-effectiveness in health and medicine. 2nd ed. New York: Oxford University Press; 2016.

12.

CDC Life Table 2015. https://www.cdc.gov/nchs/data/hus/hus16.pdf#015. Accessed 16 August 2019.

13.

Briggs A, Schulper MJ, Claxton K. Decision modelling for health economic evaluation. 2006.

14.

Neumann PJ, Cohen JT, Weinstein MC. Updating cost-effectiveness—the curious resilience of the $50,000-per-QALY threshold. N Engl J Med 2014;371(9):796-7. https://doi.org/10.1056/NEJMp1405158 CrossRefPubMed

15.

Loraine AW, Samantha C, Daniel G, He W. 65+ in the United States: 2010. Special Studies. Current Population Reports. U.S. Department of Health and Human Services. 2014. https://www.census.gov/content/dam/Census/library/publications/2014/demo/p23-212.pdf. Accessed 16 August 2019.

16.

Jones T, McMillian M, Scallan E, Frenzen P, Cronquist A, Thomas S, et al. A population-based estimate of the substantial burden of diarrhoeal disease in the United States; FoodNet, 1996–2003. Epidemiol Infect 2007;135(2):293-301.CrossRef

17.

Abrahamian FM, Talan DA, Krishnadasan A, Citron DM, Paulick AL, Anderson LJ, et al. Clostridium difficile infection among US emergency department patients with diarrhea and no vomiting. Ann Emerg Med. 2017;70(1):19-27. e4.CrossRef

18.

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. https://doi.org/10.1016/s1473-3099(11)70374-7 CrossRefPubMed

19.

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.CrossRef

20.

Appaneal HJ, Caffrey AR, Beganovic M, Avramovic S, LaPlante KL, editors. Predictors of Mortality Among a National Cohort of Veterans with Recurrent Clostridium difficile Infection. Open forum infectious diseases. 2018: Oxford University Press US.

21.

Dallas KB, Condren A, Divino CM. Life after colectomy for fulminant Clostridium difficile colitis: a 7-year follow up study. Am J Surg 2014;207(4):533-9. https://doi.org/10.1016/j.amjsurg.2013.04.008 CrossRefPubMed

22.

Seder CW, Villalba MR, Jr., Robbins J, Ivascu FA, Carpenter CF, Dietrich M, et al. Early colectomy may be associated with improved survival in fulminant Clostridium difficile colitis: an 8-year experience. Am J Surg 2009;197(3):302-7. https://doi.org/10.1016/j.amjsurg.2008.11.001 CrossRefPubMed

23.

Kasper AM, Nyazee HA, Yokoe DS, Mayer J, Mangino JE, Khan YM, et al. A multicenter study of Clostridium difficile infection-related colectomy, 2000-2006. Infect Control Hosp Epidemiol 2012;33(5):470-6. https://doi.org/10.1086/665318 CrossRefPubMedPubMedCentral

24.

Johnson S, Louie TJ, Gerding DN, Cornely OA, Chasan-Taber S, Fitts D, et al. Vancomycin, metronidazole, or tolevamer for Clostridium difficile infection: results from two multinational, randomized, controlled trials. Clin Infect Dis 2014;59(3):345-54. https://doi.org/10.1093/cid/ciu313 CrossRefPubMed

25.

Thomas J. Louie, Mark A. Miller, Kathleen M. Mullane, Karl Weiss, Arnold Lentnek, Yoav Golan, et al. Fidaxomicin versus vancomycin for Clostridium difficile infection. N Engl J Med 2011;364.

26.

Lynne V. McFarland, Gary W. Elmer, Surawicz CM. Breaking the cycle: treatment strategies for 163 cases of recurrent Clostridium difficile disease. Am J Gastroenterol. 2002;97(7).

27.

Mattila E, Arkkila P, Mattila PS, Tarkka E, Tissari P, Anttila VJ. Rifaximin in the treatment of recurrent Clostridium difficile infection. Aliment Pharmacol Ther 2013;37(1):122-8. https://doi.org/10.1111/apt.12111 CrossRefPubMed

28.

Rokas KE, Johnson JW, Beardsley JR, Ohl CA, Luther VP, Williamson JC. The addition of intravenous metronidazole to oral vancomycin is associated with improved mortality in critically ill patients with Clostridium difficile infection. Clin Infect Dis 2015;61(6):934-41. https://doi.org/10.1093/cid/civ409 CrossRefPubMed

29.

Crobach MJ, Planche T, Eckert C, Barbut F, Terveer EM, Dekkers OM, et al. European Society of Clinical Microbiology and Infectious Diseases: update of the diagnostic guidance document for Clostridium difficile infection. Clin Microbiol Infect 2016;22 Suppl 4:S63-81. https://doi.org/10.1016/j.cmi.2016.03.010 CrossRefPubMed

30.

Timothy D Planche, Kerrie A Davies, Pietro G Coen, John M Finney, Irene M Monahan, Kirsti A Morris, et al. Differences in outcome according to Clostridium difficile testing method: a prospective multicentre diagnostic validation study of C difficile infection. Lancet Infect Dis 2013(13):936-45. https://doi.org/10.1016/S1473-3099(13)70200-7 CrossRefPubMedPubMedCentral

31.

Rice JA. Mathematical statistics and data analysis. 2003.

32.

Kanchanaraksa S. Evaluation of diagnostic and screening tests: validity and reliability. http://ocw.jhsph.edu/courses/fundepi/pdfs/lecture11.pdf. Accessed 16 August 2019.

33.

Jia H, Lubetkin EI. Impact of nine chronic conditions for US adults aged 65 years and older: an application of a hybrid estimator of quality-adjusted life years throughout remainder of lifetime. Qual Life Res Int J Qual Life Asp Treat Care Rehab. 2016;25(8):1921-9. https://doi.org/10.1007/s11136-016-1226-5 CrossRef

34.

Gibson PR, Vaizey C, Black CM, Nicholls R, Weston AR, Bampton P, et al. Relationship between disease severity and quality of life and assessment of health care utilization and cost for ulcerative colitis in Australia: a cross-sectional, observational study. J Crohns Colitis 2014;8(7):598-606. https://doi.org/10.1016/j.crohns.2013.11.017 CrossRefPubMed

35.

Gani F, Makary MA, Wick EC, Efron JE, Fang SH, Safar B, et al. Bundled payments for surgical colectomy among Medicare enrollees: potential savings vs the need for further reform. JAMA Surg 2016;151(5):e160202. https://doi.org/10.1001/jamasurg.2016.0202 CrossRefPubMed

36.

U.S. Department of Veterans Affairs. Drug pharmaceutical prices. https://www.fss.va.gov/. Accessed 16 August 2019.

37.

Schneider KM, O’Donnell BE, Dean D. Prevalence of multiple chronic conditions in the United States’ Medicare population. Health Qual Life Outcomes 2009;7:82. https://doi.org/10.1186/1477-7525-7-82 CrossRefPubMedPubMedCentral

38.

Li R, Lu L, Lin Y, Wang M, Liu X. Efficacy and safety of metronidazole monotherapy versus vancomycin monotherapy or combination therapy in patients with Clostridium difficile infection: a systematic review and meta-analysis. PLoS One 2015;10(10):e0137252. https://doi.org/10.1371/journal.pone.0137252 CrossRefPubMedPubMedCentral

39.

Bureau of Labor Statistics, United States Department of Labor. www.bls.gov/data/. Accessed 16 August 2019.

40.

World Health Organization. Cost-effectiveness thresholds. http://www.who.int/bulletin/volumes/94/12/15-164418/en/. Accessed 16 August 2019.

41.

Burnham CA, Carroll KC. Diagnosis of Clostridium difficile infection: an ongoing conundrum for clinicians and for clinical laboratories. Clin Microbiol Rev 2013;26(3):604-30. https://doi.org/10.1128/CMR.00016-13 CrossRefPubMedPubMedCentral

42.

Smits WK, Lyras D, Lacy DB, Wilcox MH, Kuijper EJ. Clostridium difficile infection. Nat Rev Dis Primers 2016;2:16020. https://doi.org/10.1038/nrdp.2016.20 CrossRefPubMedPubMedCentral

43.

Sheitoyan-Pesant C, Abou Chakra CN, Pepin J, Marcil-Heguy A, Nault V, Valiquette L. Clinical and Healthcare burden of multiple recurrences of Clostridium difficile infection. Clin Infect Dis 2016;62(5):574-80. https://doi.org/10.1093/cid/civ958 CrossRefPubMed

44.

Lapointe-Shaw L, Tran KL, Coyte PC, Hancock-Howard RL, Powis J, Poutanen SM, et al. Cost-effectiveness analysis of six strategies to treat recurrent Clostridium difficile infection. PLoS One 2016;11(2):e0149521. https://doi.org/10.1371/journal.pone.0149521 CrossRefPubMedPubMedCentral

45.

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. https://doi.org/10.1093/cid/ciu128 CrossRefPubMedPubMedCentral

Title: Cost-Effectiveness Analysis of Four Common Diagnostic Methods for Clostridioides difficile Infection
Authors: Si Xuan, MPH
Kenneth M. Zangwill, MD
Weiyi Ni, PhD
Junjie Ma, PhD
Joel W. Hay, PhD
Publication date: 01-04-2020
Publisher: Springer International Publishing
Keywords: Vancomycin
Clostridioides Difficile
Published in: Journal of General Internal Medicine / Issue 4/2020
Print ISSN: 0884-8734
Electronic ISSN: 1525-1497
DOI: https://doi.org/10.1007/s11606-019-05487-5

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Abstract

Background

Objective

Design

Participants

Main Measures

Key Results

Conclusions

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