Evaluation of tuberculosis diagnostics: Establishing an evidence base around the public health impact

Journal of Infectious Diseases

Volumn 204, Issue SUPPL. 4, 2011, Pages

  Lessells, Richard J ^a,b   Cooke, Graham S ^b,c   Newell, Marie Louise ^c,d   Godfrey Faussett, Peter ^a  

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

^b UNIVERSITY OF KWAZULU NATAL   (South Africa)

^c UNIVERSITY COLLEGE LONDON   (United Kingdom)

^d IMPERIAL COLLEGE LONDON   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

RIFAMPICIN; TUBERCULOSTATIC AGENT;

ANTIBIOTIC RESISTANCE; ANTIBIOTIC SENSITIVITY; ARTICLE; BACTERIUM CULTURE; BACTERIUM IDENTIFICATION; DIAGNOSTIC ACCURACY; DIAGNOSTIC PROCEDURE; EVIDENCE BASED MEDICINE; HEALTH CARE POLICY; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; INFORMATION PROCESSING; MEDICAL RESEARCH; METHODOLOGY; MYCOBACTERIUM TUBERCULOSIS; POINT OF CARE TESTING; PREVALENCE; PRIORITY JOURNAL; PUBLIC HEALTH SERVICE; RANDOMIZED CONTROLLED TRIAL (TOPIC); RESEARCH ETHICS; RETROSPECTIVE STUDY; SENSITIVITY AND SPECIFICITY; SPUTUM SMEAR; TUBERCULOSIS; TUBERCULOSIS CONTROL;

BACTERIOLOGICAL TECHNIQUES; CLINICAL TRIALS AS TOPIC; COST-BENEFIT ANALYSIS; HEALTH POLICY; HUMANS; MYCOBACTERIUM TUBERCULOSIS; PUBLIC HEALTH; TUBERCULOSIS;

EID: 80054746237     PISSN: 00221899     EISSN: None     Source Type: Journal    
DOI: 10.1093/infdis/jir412     Document Type: Article

References (76)

1. World Health Organization. Global tuberculosis control: epidemiology, strategy, financing: WHO report 2009. Geneva, Switzerland: World Health Organization, 2009.
2. Marais BJ, Raviglione MC, Donald PR, et al. Scale-up of services and research priorities for diagnosis, management, and control of tuberculosis: a call to action. Lancet 2010; 375:2179-91.
3. United Nations General Assembly. Road map toward the implementation of the United Nations Millennium Declaration. New York: United Nations, 2002.
4. Stop TB Partnership/World Health Organization. The global plan to stop TB, 2006-2015. Geneva, Switzerland: World Health Organization, 2006.
5. Abdool Karim SS, Churchyard GJ, Abdool Karim Q, Lawn SD. HIV infection and tuberculosis in South Africa: an urgent need to escalate the public health response. Lancet 2009; 374:921-33.
6. Perkins MD, Cunningham J. Facing the crisis: improving the diagnosis of tuberculosis in the HIV era. J Infect Dis 2007; 196(Suppl 1):S15-27. (Pubitemid 47206081)
7. Steingart KR, Ramsay A, Pai M. Optimizing sputum smear microscopy for the diagnosis of pulmonary tuberculosis. Expert Rev Anti Infect Ther 2007; 5:327-31. (Pubitemid 47050155)
8. Urbanczik R, Rieder HL. Scaling up tuberculosis culture services: a precautionary note. Int J Tuberc Lung Dis 2009; 13:799-800.
9. World Health Organization. Improving the diagnosis and treatment of smear-negative pulmonary and extrapulmonary tuberculosis among adults and adolescents. Recommendations for HIV-prevalent and resource-constrained settings. Geneva, Switzerland: World Health Organization, 2007.
10. Shingadia D, Novelli V. Diagnosis and treatment of tuberculosis in children. Lancet Infect Dis 2003; 3:624-32. (Pubitemid 37210226)
11. Menzies D, Pai M, Comstock G. Meta-analysis: new tests for the diagnosis of latent tuberculosis infection: areas of uncertainty and recommendations for research. Ann Intern Med 2007; 146:340-54. (Pubitemid 351650594)
12. Pai M, Kalantri S, Dheda K. New tools and emerging technologies for the diagnosis of tuberculosis: part II. Active tuberculosis and drug resistance. Expert Rev Mol Diagn 2006; 6:423-32. (Pubitemid 44174346)
13. Pai M, Minion J, Steingart K, Ramsay A. New and improved tuberculosis diagnostics: evidence, policy, practice, and impact. Curr Opin Pulm Med 2010; 16:271-84.
14. Grandjean L, Moore DA. Tuberculosis in the developing world: recent advances in diagnosis with special consideration of extensively drugresistant tuberculosis. Curr Opin Infect Dis 2008; 21:454-61.
15. World Health Organization/Stop TB Partnership. The global plan to stop TB 2011-2015: transforming the fight towards elimination of tuberculosis. Geneva, Switzerland: World Health Organization, 2010.
16. Boehme CC, Nabeta P, Hillemann D, et al. Rapid molecular detection of tuberculosis and rifampin resistance. N Engl J Med 2010; 363:1005-15.
17. Helb D, Jones M, Story E, et al. Rapid detection of Mycobacterium tuberculosis and rifampin resistance by use of on-demand, near-patient technology. J Clin Microbiol 2010; 48:229-37.
18. Chaisson RE, Harrington M. How research can help control tuberculosis. Int J Tuberc Lung Dis 2009; 13:558-68.
19. Cobelens FG, Heldal E, Kimerling ME, et al. Scaling up programmatic management of drug-resistant tuberculosis: a prioritized research agenda. PLoS Med 2008; 5:e150.
20. Fauci AS. Multidrug-resistant and extensively drug-resistant tuberculosis: the National Institute of Allergy and Infectious Diseases Research agenda and recommendations for priority research. J Infect Dis 2008; 197:1493-8. (Pubitemid 351706477)
21. Wallis RS, Pai M, Menzies D, et al. Biomarkers and diagnostics for tuberculosis: progress, needs, and translation into practice. Lancet 2010; 375:1920-37.
22. Young DB, Perkins MD, Duncan K, Barry CE 3rd. Confronting the scientific obstacles to global control of tuberculosis. J Clin Invest 2008; 118:1255-65. (Pubitemid 351500418)
23. Treatment Action Group. 2009 report on tuberculosis research funding trends, 2005-2008. 2nd ed. New York: Treatment Action Group, 2010.
24. Mabey D, Peeling RW, Ustianowski A, Perkins MD. Diagnostics for the developing world. Nat Rev Microbiol 2004; 2:231-40. (Pubitemid 39490084)
25. 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.
26. Abu-Raddad LJ, Sabatelli L, Achterberg JT, et al. Epidemiological benefits of more-effective tuberculosis vaccines, drugs, and diagnostics. Proc Natl Acad Sci U S A 2009; 106:13980-5.
27. 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.
28. Dowdy DW, Chaisson RE, Moulton LH, Dorman SE. The potential impact of enhanced diagnostic techniques for tuberculosis driven by HIV: a mathematical model. AIDS 2006; 20:751-62. (Pubitemid 43884303)
29. Guyatt GH, Tugwell PX, Feeny DH, Haynes RB, Drummond M. A framework for clinical evaluation of diagnostic technologies. CMAJ 1986; 134:587-94. (Pubitemid 16099651)
30. Medicins sans Frontieres/Treatment Action Group/ Partners in Health. Specifications for point-of-care TB tests: expert opinion check from TB field practitioners. http://www.msfaccess.org/TB-POC-Parismeeting/ fileadmin/user-upload/diseases/tuberculosis/TB%20POC%20Full%20- Survey%20Analysis%20report.pdf. Accessed 13 October 2010.
31. Small PM, Perkins MD. More rigour needed in trials of new diagnostic agents for tuberculosis. Lancet 2000; 356:1048-9.
32. Pai M, O'Brien R. Tuberculosis diagnostics trials: do they lack methodological rigor? Expert Rev Mol Diagn 2006; 6:509-14.
33. Ransohoff DF, Feinstein AR. Problems of spectrum and bias in evaluating the efficacy of diagnostic tests. N Engl J Med 1978; 299: 926-30. (Pubitemid 9050459)
34. Lijmer JG, Mol BW, Heisterkamp S, et al. Empirical evidence of design-related bias in studies of diagnostic tests. JAMA 1999; 282:1061-6. (Pubitemid 29436454)
35. Rutjes AW, Reitsma JB, Di Nisio M, Smidt N, van Rijn JC, Bossuyt PM. Evidence of bias and variation in diagnostic accuracy studies. CMAJ 2006; 174:469-76.
36. Whiting P, Rutjes AW, Reitsma JB, Glas AS, Bossuyt PM, Kleijnen J. Sources of variation and bias in studies of diagnostic accuracy: a systematic review. Ann Intern Med 2004; 140:189-202. (Pubitemid 38155650)
37. The TDR Diagnostics Evaluation Expert Panel. Evaluation of diagnostic tests for infectious diseases: general principles. Nat Rev Microbiol 2008; 6:S16-S28.
38. Whiting P, Rutjes AW, Reitsma JB, Bossuyt PM, Kleijnen J. The development of QUADAS: a tool for the quality assessment of studies of diagnostic accuracy included in systematic reviews. BMC Med Res Methodol 2003; 3:25.
39. Bossuyt PM, Reitsma JB, Bruns DE, et al. Towards complete and accurate reporting of studies of diagnostic accuracy: the STARD initiative. Ann Intern Med 2003; 138:40-4. (Pubitemid 36232093)
40. Bossuyt PM, Reitsma JB, Bruns DE, et al. The STARD statement for reporting studies of diagnostic accuracy: explanation and elaboration. Ann Intern Med 2003; 138:W1-12.
41. Fontela PS, Pant Pai N, Schiller I, Dendukuri N, Ramsay A, Pai M. Quality and reporting of diagnostic accuracy studies in TB, HIV and malaria: evaluation using QUADAS and STARD standards. PLoS One 2009; 4:e7753.
42. Albert H, Bwanga F, Mukkada S, et al. Rapid screening of MDR-TB using molecular Line Probe Assay is feasible in Uganda. BMC Infect Dis 2010; 10:41.
43. Anek-Vorapong R, Sinthuwattanawibool C, Podewils LJ, et al. Validation of the GenoType MTBDRplus assay for detection of MDR-TB in a public health laboratory in Thailand. BMC Infect Dis 2010; 10:123.
44. Barnard M, Albert H, Coetzee G, O'Brien R, Bosman ME. Rapid molecular screening for multidrug-resistant tuberculosis in a highvolume public health laboratory in South Africa. Am J Respir Crit Care Med 2008; 177:787-92. (Pubitemid 351490566)
45. Bazira J, Asiimwe BB, Joloba ML, Bwanga F, Matee MI. Use of the GenoType(R) MTBDRplus assay to assess drug resistance of Mycobacterium tuberculosis isolates from patients in rural Uganda. BMC Clin Pathol 2010; 10:5.
46. Evans J, Stead MC, Nicol MP, Segal H. Rapid genotypic assays to identify drug-resistant Mycobacterium tuberculosis in South Africa. J Antimicrob Chemother 2009; 63:11-6.
47. Hillemann D, Rusch-Gerdes S, Richter E. Evaluation of the GenoType MTBDRplus assay for rifampin and isoniazid susceptibility testing of Mycobacterium tuberculosis strains and clinical specimens. J Clin Microbiol 2007; 45:2635-40. (Pubitemid 47295497)
48. Huang WL, Chen HY, Kuo YM, Jou R. Performance assessment of the GenoType MTBDRplus test and DNA sequencing in detection of multidrug-resistant Mycobacterium tuberculosis. J Clin Microbiol 2009; 47:2520-4.
49. Huyen MN, Tiemersma EW, Lan NT, et al. Validation of the GenoType MTBDRplus assay for diagnosis of multidrug resistant tuberculosis in South Vietnam. BMC Infect Dis 2010; 10:149.
50. Matsoso LG, Veriava Y, Poswa X, et al. Validation of a rapid tuberculosis PCR assay for detection of MDR-TB patients in Gauteng, South Africa. South Afr J Epidemiol Infect 2010; 25:12-5.
51. Nikolayevskyy V, Balabanova Y, Simak T, Malomanova N, Fedorin I, Drobniewski F. Performance of the Genotype MTBDRplus assay in the diagnosis of tuberculosis and drug resistance in Samara, Russian Federation. BMC Clin Pathol 2009; 9:2.
52. Atkins D, Best D, Briss PA, et al. Grading quality of evidence and strength of recommendations. BMJ 2004; 328:1490.
53. Guyatt GH, Oxman AD, Vist GE, et al. GRADE: an emerging consensus on rating quality of evidence and strength of recommendations. BMJ 2008; 336:924-6. (Pubitemid 351632017)
54. Schunemann HJ, Oxman AD, Brozek J, et al. Grading quality of evidence and strength of recommendations for diagnostic tests and strategies. BMJ 2008; 336:1106-0. (Pubitemid 351731739)
55. STOP TB Partnership's New Diagnostics Working Group and World Health Organization. Pathways to better diagnostics for tuberculosis: a blueprint for the development of TB diagnostics. Geneva: World Health Organization, 2009.
56. Pocock SJ. Justification for randomized controlled trials. In: Clinical trials: a practical approach. Chichester, UK: John Wiley & Sons Ltd., 1983:50-65.
57. World Health Organization. Molecular line proble assays for rapid screening of patients at risk of multi-drug resistant tuberculosis (MDRTB). Expert Group Report. Geneva, Switzerland: World Health Organization, 2008.
58. World Health Organization and UNITAID. Expanding and accelerating access to diagnostics for patients at risk of multidrug-resistant tuberculosis. http://www.who.int/tb/publications/factsheet-expand-tb.pdf. Accessed 13 October 2010.
59. Knottnerus JA, van Weel C, Muris JW. Evaluation of diagnostic procedures. BMJ 2002; 324:477-80.
60. Bossuyt PM, Lijmer JG, Mol BW. Randomised comparisons of medical tests: sometimes invalid, not always efficient. Lancet 2000; 356:1844-7.
61. Lijmer JG, Bossuyt PM. Various randomized designs can be used to evaluate medical tests. J Clin Epidemiol 2009; 62:364-73.
62. World Health Organization. Malaria rapid diagnostic test performance: results of WHO product testing of malaria RDTs: round 1 (2008). Geneva, Switzerland: World Health Organization, 2009.
63. Rafael ME, Taylor T, Magill A, Lim YW, Girosi F, Allan R. Reducing the burden of childhood malaria in Africa: the role of improved diagnostics. Nature 2006; 444(Suppl 1):39-48.
64. Reyburn H, Mbakilwa H, Mwangi R, et al. Rapid diagnostic tests compared with malaria microscopy for guiding outpatient treatment of febrile illness in Tanzania: randomised trial. BMJ 2007; 334:403.
65. Bisoffi Z, Sirima BS, Angheben A, et al. Rapid malaria diagnostic tests vs. clinical management of malaria in rural Burkina Faso: safety and effect on clinical decisions. A randomized trial. Trop Med Int Health 2009; 14:491-8.
66. Skarbinski J, Ouma PO, Causer LM, et al. Effect of malaria rapid diagnostic tests on the management of uncomplicated malaria with artemether-lumefantrine in Kenya: a cluster randomized trial. Am J Trop Med Hyg 2009; 80:919-26.
67. Ansah EK, Narh-Bana S, Epokor M, et al. Rapid testing for malaria in settings where microscopy is available and peripheral clinics where only presumptive treatment is available: a randomised controlled trial in Ghana. BMJ 2010; 340:c930.
68. Rutjes AW, Reitsma JB, Coomarasamy A, Khan KS, Bossuyt PM. Evaluation of diagnostic tests when there is no gold standard. A review of methods. Health Technol Assess 2007; 11:iii-ix-51.
69. Van Deun A, Barrera L, Bastian I, et al. Mycobacterium tuberculosis strains with highly discordant rifampin susceptibility test results. J Clin Microbiol 2009; 47:3501-6.
70. Hayes RJ, Moulton LH. Cluster randomised trials. Interdisciplinary Statistics Series. Boca Raton, FL: CRC Press, 2009.
71. Edwards SJ, Braunholtz DA, Lilford RJ, Stevens AJ. Ethical issues in the design and conduct of cluster randomised controlled trials. BMJ 1999; 318:1407-9. (Pubitemid 29237838)
72. Osrin D, Azad K, Fernandez A, et al. Ethical challenges in cluster randomized controlled trials: experiences from public health interventions in Africa and Asia. Bull World Health Organ 2009; 87:772-9.
73. Brown CA, Lilford RJ. The stepped wedge trial design: a systematic review. BMC Med Res Methodol 2006; 6:54.
74. Shadish WR, Cook TD, Campbell DT. Experimental and quasiexperimental designs for generalized causal inference. Boston: Houghton Mifflin Company, 2002.
75. Banerjee R, Allen J, Lin SY, et al. Rapid drug susceptibility testing with a molecular beacon assay is associated with earlier diagnosis and treatment of multidrug-resistant tuberculosis in California. J Clin Microbiol 2010; 48:3779-81.
76. O'Riordan P, Schwab U, Logan S, et al. Rapid molecular detection of rifampicin resistance facilitates early diagnosis and treatment of multi-drug resistant tuberculosis: case control study. PLoS One 2008; 3:e3173.