Diagnostic Research


Quality of TB Diagnostic Trials Guidance on Improving Quality of Diagnostic Research
Guidance on Improving Reporting of Diagnostic Research Guidance on Improving Quality of Laboratory and Research Practice
Guidance on Diagnostic Meta-analysis Books on 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]

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 [Link]
Website

EQUATOR Network

The resource centre for good reporting of health research studies - Download [Link]

Guidance on Improving Quality of Laboratory and Research Practice

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]