Challenges in evaluating the cost-effectiveness of new diagnostic tests for HIV-associated tuberculosis

Clinical Infectious Diseases

Volumn 57, Issue 7, 2013, Pages 1021-1026

  Andrews, Jason R ^a   Lawn, Stephen D ^b,c   Dowdy, David W ^d,e   Walensky, Rochelle P ^a  

^a MASSACHUSETTS GENERAL HOSPITAL   (United States)

^b UNIVERSITY OF CAPE TOWN   (South Africa)

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

^d JOHNS HOPKINS BLOOMBERG SCHOOL OF PUBLIC HEALTH   (United States)

^e JOHNS HOPKINS UNIVERSITY   (United States)

Author keywords

Cost effectiveness; Diagnostics; Health policy; HIV; Tuberculosis

Indexed keywords

ANTI HUMAN IMMUNODEFICIENCY VIRUS AGENT; LIPOARABINOMANNAN; RIFAMPICIN;

ARTICLE; CD4 LYMPHOCYTE COUNT; CLINICAL DECISION MAKING; COST EFFECTIVENESS ANALYSIS; DIAGNOSTIC ACCURACY; DIAGNOSTIC TEST; DISABILITY; DISABILITY ADJUSTED LIFE YEAR; EARLY DIAGNOSIS; HEALTH CARE POLICY; HEALTH CARE QUALITY; HIV ASSOCIATED TUBERCULOSIS; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTED PATIENT; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; MEDICAL ETHICS; OUTCOME ASSESSMENT; PATIENT CARE; PRIORITY JOURNAL; QUALITY ADJUSTED LIFE YEAR; RESOURCE ALLOCATION; SENSITIVITY AND SPECIFICITY; SPUTUM SMEAR; THORAX RADIOGRAPHY; TUBERCULOSIS; TUBERCULOSIS RAPID TEST; URINALYSIS;

COST-EFFECTIVENESS; DIAGNOSTICS; HEALTH POLICY; HIV; TUBERCULOSIS;

BACTERIOLOGICAL TECHNIQUES; COST-BENEFIT ANALYSIS; HIV INFECTIONS; HUMANS; REAGENT KITS, DIAGNOSTIC; TUBERCULOSIS; UNITED STATES;

EID: 84884410489     PISSN: 10584838     EISSN: 15376591     Source Type: Journal    
DOI: 10.1093/cid/cit412     Document Type: Article

References (46)

1. World Health Organization. Roadmap for rolling out Xpert MTB/RIF for rapid diagnosis of TB and MDR-TB. Geneva, Switzerland: WHO, 2010. Available at: www.who.int/tb/laboratory/roadmap-xpert-mtbrif. pdf. Accessed 27 September 2011.
2. Lawn SD, Mwaba P, Bates M, et al. Advances in tuberculosis diagnostics: the Xpert MTB/RIF assay and future prospects for a point-of-care test. Lancet Infect Dis. 2013; 13:349-61.
3. World Health Organization. Update: implementation and roll-out of Xpert MTB/RIF. Geneva, Switzerland: WHO, 2012. Available at: http://www.stoptb.org/wg/ gli/assets/documents/Xpert%20MTB-RIF%20 UPDATE%20February%202012.pdf. Accessed 29 October 2012.
4. UNITAID. Tuberculosis diagnostic technology landscape. Geneva, Switzerland: UNITAID Secretariat, 2012.
5. Lawn SD. Point-of-care detection of lipoarabinomannan (LAM) in urine for diagnosis of HIV-associated tuberculosis: a state of the art review. BMC Infect Dis 2012; 12:103.
6. World Health Organization. Global tuberculosis report 2012. Geneva, Switzerland: WHO, 2012.
7. Dowdy DW, Lourenço MC, Cavalcante SC, et al. Impact and cost-effectiveness of culture for diagnosis of tuberculosis in HIV-infected Brazilian adults. PLoS One 2008; 3:e4057.
8. Bonnet M, Tajahmady A, Hepple P, et al. Added value of bleach sedimentation microscopy for diagnosis of tuberculosis: a cost-effectiveness study. Int J Tuberc Lung Dis 2010; 14:571-7.
9. Scherer LC, Sperhacke RD, Ruffino-Netto A, et al. Cost-effectiveness analysis of PCR for the rapid diagnosis of pulmonary tuberculosis. BMC Infect Dis 2009; 9:216.
10. Vassall A, van Kampen S, Sohn H, et al. Rapid diagnosis of tuberculosis with the Xpert MTB/RIF assay in high burden countries: a costeffectiveness analysis. PLoS Med 2011; 8:e1001120.
11. Andrews JR, Lawn SD, Rusu C, et al. The cost-effectiveness of routine tuberculosis screening with Xpert MTB/RIF prior to initiation of antiretroviral therapy in South Africa: a model-based analysis. AIDS 2012; 26:987-95.
12. Abimbola TO, Marston BJ, Date AA, Blandford JM, Sangrujee N,Wiktor SZ. Cost-effectiveness of tuberculosis diagnostic strategies to reduce early mortality among persons with advanced HIV infection initiating antiretroviral therapy. J Acquir Immune Defic Syndr 2012; 60:e1-7.
13. Menzies NA, Cohen T, Lin H-H, Murray M, Salomon JA. Population health impact and cost-effectiveness of tuberculosis diagnosis with Xpert MTB/RIF: a dynamic simulation and economic evaluation. PLoS Med 2012; 9:e1001347.
14. Sun D, Dorman S, Shah M, et al. Cost-utility of lateral-flow urine lipoarabinomannan for tuberculosis diagnosis in HIV-infected African adults. Int J Tuberc Lung Dis. 2013; 17:552-8.
15. 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.
16. Hunink M, Glasziou P, Siegel J, et al. Decision making in health and medicine: integrating evidence and values. Cambridge: Cambridge UP, 2001.
17. Dowdy DW, Chaisson RE, Maartens G, Corbett EL, Dorman SE. Impact of enhanced tuberculosis diagnosis in South Africa: a mathematical model of expanded culture and drug susceptibility testing. Proc Natl Acad Sci U S A 2008; 105:11293-8.
18. Basu S, Friedland GH, Medlock J, et al. Averting epidemics of extensively drug-resistant tuberculosis. Proc Natl Acad Sci U S A 2009; 106:7672-7.
19. Dowdy DW, Gounder CR, Corbett EL, Ngwira LG, Chaisson RE, Merritt MW. The ethics of testing a test: randomized trials of the health impact of diagnostic tests for infectious diseases. Clin Infect Dis 2012; 55:1522-6.
20. Yoon C, Cattamanchi A, Davis JL, et al. Impact of Xpert MTB/RIF testing on tuberculosis management and outcomes in hospitalized patients in Uganda. PLoS One 2012; 7:e48599.
21. Peter J. A trial of the urine LAM strip test for TB diagnosis amongst hospitalized HIV-infected patients (LAMRCT). Available at: http:// clinicaltrials.gov/ct2/show/NCT01770730. Accessed 17 May 2013.
22. Churchyard G. Xpert for tuberculosis: evaluating a new diagnostic (XTEND). Available at: http://www.controlled-trials.com/ISRCTN68905568. Accessed 17 May 2013.
23. Lessells RJ, Cooke GS, Newell M-L, Godfrey-Faussett P. Evaluation of tuberculosis diagnostics: establishing an evidence base around the public health impact. J Infect Dis 2011; 204(suppl 4):S1187-95.
24. Dowdy DW. Economic analyses of diagnostics for tuberculosis: what's the point? Expert Rev Pharmacoecon Outcomes Res 2012; 12:137-9.
25. Dowdy DW, Cattamanchi A, Steingart KR, Pai M. Is scale-up worth it? Challenges in economic analysis of diagnostic tests for tuberculosis. PLoS Med 2011; 8:e1001063.
26. New Diagnostics Working Group of the STOP TB Partnership and the World Health Organization. Pathways to better diagnostics for tuberculosis: a blueprint for the development of TB diagnostics. Geneva, Switzerland: WHO, 2009.
27. Schunemann HJ, Oxman AD, Brozek J, et al. Grading quality of evidence and strength of recommendations for diagnostic tests and strategies. BMJ 2008; 336:1106-10.
28. Keeler E, Perkins MD, Small P, et al. Reducing the global burden of tuberculosis: the contribution of improved diagnostics. Nature 2006; 444 (suppl 1):49-57.
29. Albert H. Economic analysis of the diagnosis of smear-negative pulmonary tuberculosis in South Africa: incorporation of a new rapid test, FASTPlaqueTB, into the diagnostic algorithm. Int J Tuberc Lung Dis 2004; 8:240-7.
30. Meyer-Rath G, Schnippel K, Long L, et al. The impact and cost of scaling up GeneXpert MTB/RIF in South Africa. PLoS One 2012; 7: e36966.
31. Lawn SD, Kerkhoff AD, Wood R. Progression of subclinical culturepositive tuberculosis to symptomatic disease in HIV-infected individuals. AIDS 2011; 25:2190-1.
32. Tiemersma EW, van derWerf MJ, BorgdorffMW,Williams BG, Nagelkerke NJD. Natural history of tuberculosis: duration and fatality of untreated pulmonary tuberculosis in HIV negative patients: a systematic review. PLoS One 2011; 6:e17601.
33. Lawn SD, Kerkhoff AD, Vogt M,Wood R. Clinical significance of lipoarabinomannan detection in urine using a low-cost point-of-care diagnostic assay for HIV-associated tuberculosis. AIDS 2012; 26:1635-43.
34. Lawn SD, Kerkhoff AD, Vogt M, Ghebrekristos Y, Whitelaw A, Wood R. Characteristics and early outcomes of patients with Xpert MTB/RIFnegative pulmonary tuberculosis diagnosed during screening before antiretroviral therapy. Clin Infect Dis 2012; 54:1071-9.
35. World Health Organization. Antiretroviral therapy for HIV infection in adults and adolescents: recommendations for a public health approach, 2010 revision. Geneva, Switzerland: WHO, 2010.
36. Sax PE, Islam R, Walensky RP, et al. Should resistance testing be performed for treatment-naive HIV-infected patients? A cost-effectiveness analysis. Clin Infect Dis 2005; 41:1316-23.
37. Badri M, Maartens G, Mandalia S, et al. Cost-effectiveness of highly active antiretroviral therapy in South Africa. PLoS Med 2006; 3:e4.
38. Martinson N, Mohapi L, Bakos D, Gray GE, McIntyre JA, Holmes CB. Costs of providing care for HIV-infected adults in an urban HIV clinic in Soweto, South Africa. J Acquir Immune Defic Syndr 2009; 50: 327-30.
39. Leisegang R, Cleary S, Hislop M, et al. Early and late direct costs in a Southern African antiretroviral treatment programme: a retrospective cohort analysis. PLoS Med 2009; 6:e1000189.
40. Nachega JB, Leisegang R, Bishai D, et al. Association of antiretroviral therapy adherence and health care costs. Ann Intern Med 2010; 152: 18-25.
41. Long L, Brennan A, Fox MP, et al. Treatment outcomes and cost-effectiveness of shifting management of stable ART patients to nurses in South Africa: an observational cohort. PLoS Med 2011; 8:e1001055.
42. Bongaarts J, Over M. Public health. Global HIV/AIDS policy in transition. Science 2010; 328:1359-60.
43. Walensky RP, Wood R, Ciaranello AL, et al. Scaling up the 2010 World Health Organization HIV treatment guidelines in resource-limited settings: a model-based analysis. PLoS Med 2010; 7:e1000382.
44. World Health Organization. Macroeconomics and health: investing in health for economic development. Report of the Commission on Macroeconomics and Health. Geneva, Switzerland: WHO, 2001.
45. World Health Organization. Making choices in health: WHO guide to cost-effectiveness analysis. Geneva, Switzerland: WHO, 2003.
46. Dowdy DW, Basu S, Andrews JR. Is passive diagnosis enough? The impact of subclinical disease on diagnostic strategies for tuberculosis. Am J Respir Crit Care Med 2013; 187:543-51.