Diagnostic Research
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] |
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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] |
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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] |
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Guidance on Improving Quality of Diagnostic Research |
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Evaluation of diagnostic tests for infectious diseases: general principlesTDR Diagnostics Evaluation Expert Panel (DEEP) - Download [Link] |
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Guidance for Industry and FDA Staff; Guidance for the Use of Bayesian Statistics in Medical Device Clinical TrialsCenter for Devices and Radiological Health (CDRH) - Download [Link] |
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Guidance on Improving Reporting of Diagnostic Research |
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STARD StatementStandards for the Reporting of Diagnostic Accuracy Studies - Download [Link]Website |
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EQUATOR NetworkThe resource centre for good reporting of health research studies - Download [Link] |
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Guidance on Improving Quality of Laboratory and Research Practice |
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Good Clinical Laboratory Practice (GCLP)TDR/WHO - Download [Link] |
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Handbook for Good Clinical Research Practice (GCP)World Health Organization - Download [Link] |
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Good Laboratory Practice (GLP)TDR/WHO - Download [Link] |
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Quality Practices in Basic Biomedical ResearchTDR/WHO - Download [Link] |
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Guidance on Diagnostic Meta-analysis |
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Systematic Reviews of Diagnostic Test AccuracyCochrane Diagnostic Accuracy Working Group - Download [Link] |
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Systematic Reviews of Diagnostic Test Evaluations: What's behind the scenes?Evidence-Based Medicine - Download [Link] |
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QUADAS: A Tool for the Quality Assessment of Studies of Diagnostic Accuracy Included in Systematic ReviewsBMC Medical Research Methodology, 2003 - Download [Link] |
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Preferred Reporting Items for Systematic Reviews and Meta-AnalysesPRISMA - Download [Link] |
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Books on Diagnostic Research |
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Evidence-Based DiagnosisThomas B. Newman & Michael A. Kohn, Cambridge University Press, 2009 - Download [Link] |
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The Evidence Base of Clinical Diagnosis: Theory and Methods of Diagnostic Research, 2nd EditionAndre Knottnerus & Frank Buntinx, Wiley Blackwell & BMJ Books, 2008 - Download [Link] |
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The Rational Clinical Examination: Evidence-Based Clinical DiagnosisDavid L. Simel & Drummond Rennie, McGraw Hill, 2008 - Download [Link] |







