Diagnostic Research


quality      Quality of TB Diagnostic Trials
ip  Guidance on Improving Reporting of Diagnostic Research                
Guidance     Guidance on Diagnostic Meta-analysis
Guidance     Guidance on Improving Quality of Laboratory and Research Practice
Guidance     Guidance on Improving Quality of Diagnostic Research
Guidance     Books on Diagnostic Research
tb Consensus Statements on TB Diagnostic Research in Children
tb     Models and Economic Evaluations of TB Diagnosis

   Quality of TB Diagnostic Trials

Small PM, Perkins MD. More rigour needed in trials of new diagnostic agents for tuberculosis.
Lancet. 2000 Sep 23;356(9235):1048-9 - Download [Link]
Pai M, O'Brien R. Tuberculosis diagnostics trials: do they lack methodological rigor?
Expert Rev Mol Diagn. 2006 Jul;6(4):509-14 - Download [Link]
Fontela PS, Pai NP, 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(11): e7753 - Download [Link]

   Guidance on Improving Quality of Diagnostic Research

Evaluation of diagnostic tests for infectious diseases: general principles
TDR Diagnostics Evaluation Expert Panel (DEEP) - Download [Link]
Guidance for Industry and FDA Staff; Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials
Center for Devices and Radiological Health (CDRH) - Download [Link]

   Guidance on Improving Reporting of Diagnostic Research

STARD Statement
Standards for the Reporting of Diagnostic Accuracy Studies - Download
The resource centre for good reporting of health research studies - Download [Link]

 Guidance on Improving Quality of Laboratory and Research Practice

Beyond accuracy: creating a comprehensive evidence base for tuberculosis diagnosis tools
INT J TUBERC LUNG DIS, 2010 - Download [Link]
Assessing the impact of new diagnostics on tuberculosis control
INT J TUBERC LUNG DIS, 2010 - Download [Link]
Good Clinical Laboratory Practice (GCLP)
TDR/WHO - Download [Link]
Handbook for Good Clinical Research Practice (GCP)
World Health Organization - Download [Link]
Good Laboratory Practice (GLP)
TDR/WHO - Download [Link]
Quality Practices in Basic Biomedical Research
TDR/WHO - Download [Link]

   Guidance on Diagnostic Meta-analysis

Systematic Reviews of Diagnostic Test Accuracy
Cochrane Diagnostic Accuracy Working Group - Download [Link]
Systematic Reviews of Diagnostic Test Evaluations: What's behind the scenes?
Evidence-Based Medicine - Download [Link]
QUADAS: A Tool for the Quality Assessment of Studies of Diagnostic Accuracy Included in Systematic Reviews
BMC Medical Research Methodology, 2003 - Download [Link]
Preferred Reporting Items for Systematic Reviews and Meta-Analyses
PRISMA - Download [Link]

   Books on Diagnostic Research

Evidence-Based Diagnosis
Thomas B. Newman & Michael A. Kohn, Cambridge University Press, 2009 - Download [Link]
The Evidence Base of Clinical Diagnosis: Theory and Methods of Diagnostic Research, 2nd Edition
Andre Knottnerus & Frank Buntinx, Wiley Blackwell & BMJ Books, 2008 - Download [Link]
The Rational Clinical Examination: Evidence-Based Clinical Diagnosis
David L. Simel & Drummond Rennie, McGraw Hill, 2008 - Download [Link]

Consensus Statements on TB Diagnostic Research in Children

Evaluation of Tuberculosis Diagnostics in Children: 1. Proposed Clinical Case Definitions for Classification of Intrathoracic Tuberculosis Disease. Consensus From an Expert Panel
Stephen M. Graham et al., Journal of Infectious Diseases, 2012 - Download [Link]
Evaluation of Tuberculosis Diagnostics in Children: 2. Methodological Issues for Conducting and Reporting Research Evaluations of Tuberculosis Diagnostics for Intrathoracic Tuberculosis in Children. Consensus From an Expert Panel
Luis E. Cuevas et al., Journal of Infectious Diseases, 2012 - Download [Link]

   Models and Economic Evaluations of TB Diagnosis

A Aspler, D Menzies, O Oxlade, J Banda, L Mwenge, P Godfrey-Faussett, H Ayles

Cost of tuberculosis diagnosis and treatment from the patient perspective in Lusaka, Zambia, Int J Tuberc Lung Dis 12(8):928-935. – Download [Link]

D Dowdy, M Lourenço, S Cavalcante, V Saraceni, B King, J Golub, D Bishai, B Durovni, R Chaisson, S Dorman

Impact and Cost-Effectiveness of Culture for Diagnosis of Tuberculosis in HIV-Infected Brazilian Adults, PLoS ONE 3(12): e4057. – Download [Link]

D Dowdy, R Chaisson

The persistence of tuberculosis in the age of DOTS: reassessing the effect of case detection, Bull World Health Organ 2009: 87:296-304. – Download [Link]

D Dowdy, R Chaisson, G Maartens, E Corbett, S Dorman

Impact of enhanced tuberculosis diagnosis in South Africa: A mathematical model of expanded culture and drug susceptibility testing, PNAS 12 August 2008: 105(32): 11293-11298. – Download [Link]

D Dowdy, A Maters, N Parrish, C Beyrer, S Dorman

Cost-Effectiveness Analysis of the Gen-Probe Amplified Mycobacterium Tuberculosis Direct Test as Used Routinely on Smear-Positive Respiratory Specimens, J Clin Microb March 2003: 41(3): 948-953. – Download[Link]

D Dowdy, R Chaisson, L Moulton, S Dorman

The potential impact of enhanced diagnostic techniques for tuberculosis driven by HIV: a mathematical model, AIDS 2006: 20: 751-762. – Download [Link]

D Dowdy, A Cattamanchi, K Steingart, M Pai

Is Scale-Up Worth It? Challenges in Economic Analysis of Diagnostic Tests for Tuberculosis, PLoS Med 8(7): e1001063. – Download [Link]

D Dowdy, K Steingart, M Pai

Serological Testing Versus Other Strategies for Diagnosis of Active Tuberculosis in India: A Cost-Effectiveness Analysis, PLoS Med 8(8): e1001074. – Download [Link]

V Jacquet, W Morose, K Schwartzman, O Oxlade, G Barr, F Grimard, D Menzies

Impact of DOTS expansion on tuberculosis related outcomes and costs in Haiti, BMC Pub Health 2006: 6: 209.– Download [Link]

K John, P Daley, N Kincler, O Oxlade, D Menzies

Costs incurred by patients with pulmonary tuberculosis in rural India, INT J TUBERC DIS 2009: 13(10):1281-1287. – Download [Link]

D Menzies, M Lewis, O Oxlade

Costs for Tuberculosis Care in Canada, Can J of Pub Health 2008: 99(5): 391-396. – Download [Link]

K Ngmalert, C Sinthuwattanawibool, K McCarthy, H SOhn, A Starks, P Kanjamongkolsiri, R Anek-vorpaong, T Tasaneeyapan, P Monkongdee, L Diem, Jay Varma

Diagnostic performance and costs of Capilia TB for Mycobacterium tuberculosis complex identification from broth-based culture in Bangkok, Thailand, Trop Med & Int Health 2009: 14(7): 1-6. – Download [Link]

O Oxlade, K Schwartzman, D Menzies

Interferon-gamma release assays and TB screening in high-income countries: a cost-effectiveness analysis,Int J Tuberc Lung Dis 2007: 11(1):16-26. – Download [Link]

O Oxlade, D Falzon, D Menzies

The Impact and Cost-effectiveness of Strategies to Detect Drug Resistant Tuberculosis, ERJ Express 2011. DOI: 10.1183/09031936.00065311. – Download [Link]

Y Balabanova, F Drobniewski, V Nikolayevskyy, A Kruuner, N Malomanova, T Simak, N Ilyina, S Zakharova, N Lebedeva, H Alexander, R O’Brien, H Sohn, A Shakhmistova, I Fedorin

An Integrated Approach to Rapid Diagnosis of Tuberculosis and Multidrug Resistance Using Liquid Culture and Molecular Methods in Russia, PLoS ONE 2009 4(9): e7129. – Download [Link]

V Rouzier, O Oxlade, R Verduga, L Gresely, D Menzies

Patient and family costs associated with tuberculosis, including multidrug-resistant tuberculosis, in Ecuador, Int J Tuberc Lung Dis 2010 14(10): 1316-1322. – Download [Link]

H Sohn, J Minion, H Albert, K Dheda, M Pai

TB diagnostic tests: how do we figure out their costs?, Expert Rev Anti Infect Ther 2009 7(6): 723-733. – Download [Link]

D Dowdy, M O’Brien, D Bishai

Cost-effectiveness of novel diagnostic tools for the diagnosis of tuberculosis, Int J Tuberc Lung Dis 2008 12(9): 1021-1029. – Download [Link]

Vassall A, van Kampen S, Sohn H, Michael JS, John KR, den Boon S, Davis JL, Whitelaw A, Nicol MP, Gler MT, Khaliqov A, Zamudio C, Perkins MD, Boehme CC, Cobelens F.

Rapid Diagnosis of Tuberculosis with the Xpert MTB/RIF Assay in High Burden Countries: A Cost-Effectiveness Analysis. PLoS Med. 2011 Nov;8(11):e1001120. Epub 2011 Nov 8. – Download

Dye C.

The potential impact of new diagnostic tests on tuberculosis epidemics. Indian J Med Res 135, May 2012, pp. 737-744. – Download

World Health Organization

Guidelines for cost and cost-effectivness of tuberculosis control. Document 1: INTRODUCTION, IMPORTANT ECONOMIC CONCEPTS, PROTOCOLS, AND USEFUL REFERENCES – Download [Link]

World Health Organization

Guidelines for cost and cost-effectiveness of tuberculosis control. Document 2: DATA ENTRY SHEETS FOR EXERCISES AND PROTOCOLS – Download [Link]

ESSENCE Good practice document series

Five keys to improving research costing in low- and middle- income countries – Download [Link]