Validation of Diagnostic Tests 2012-2013

Pre-requisite

A minimum of 3 years of study in a biomedical field. Knowledge of biostatistics (level equivalent to CESAM (Centre d’Enseignement de la Statistique Appliquée à la Médecine) or a five-day introduction to biostatistics from Institut Pasteur)

Goals of the course

The main objective of this course is to teach students in sciences, medicine and public health how to evaluate diagnostic tests;

The course will cover: the different steps for the validation of a diagnostic test: from laboratory validation to field use – elaboration of a protocol and the identification and discussion of biases – the main measures to evaluate accuracy and reproducibility (Sensitivity, Specificity, ROC curve, kappa, Bland-Altman method…) – models used in case of imperfect or non-existent gold standard – quality criteria for a diagnostic study - comparison in terms of cost-effectiveness. All theoretical dimensions will be supported with practical examples by using appropriate software.

.The final evaluation is based on an exam

Detailed program

1 – Introduction to diagnostic test evaluation

2 – The different protocols: phase 1 (proof of concept), phase 2 (case-control), phase 3 (prospective study) 

3 – Bias

4 – Quality of diagnostic studies: STARD and QUADAS statements

5 – The main criteria for evaluation

- Qualitative methods: sensitivity, specificity, PPV, NPV, Kappa coefficient

- Quantitative methods: ROC curve, Bland and Altman plot, Intraclass correlation coefficient (ICC), coefficient of variation

6 – Problems with the gold standard. Modeling the gold standard (latent class analysis)

7 – Cost-Effectiveness analyses of diagnostic algorithms

• Full-time, from March 04, to 08, 2013

• Number of students: 20
• Closing-date for applications: November 15, 2012

- The Institut Pasteur Diploma will be awarded to students having successfully completed the final examination;

- 2 credits (ECTS) exclusively for students registered in Master’s training in Public Health - Pasteur/ CNAM of Public Health (Pasteur-Cnam),