Introduction to tropical infectious diseases：热带传染病的介绍.ppt

STUDY DESIGN FOR DIAGNOSTIC STUDY FOR MELIOIDOSIS Dr Direk Limmathurotsakul, MD MSc PhD Introduction: 3 phases of study design Laboratory phase - develop test - test with few cases and healthy controls - prove of concept Case-control phase - test with definite cases and definite controls - calculate Se Sp Prospective phase - test with disease-suspected patients - calculate Se, Sp, PPV NPV Introduction: 3 phases of study design Laboratory phase - develop test - test with few cases and healthy controls - prove of concept Case-control phase - test with definite cases and definite controls - calculate Se Sp Prospective phase - test with disease-suspected patients - calculate Se, Sp, PPV NPV Look promising Introduction: 3 phases of study design Laboratory phase - develop test - test with few cases and healthy controls - prove of concept Case-control phase - test with definite cases and definite controls - calculate Se Sp Prospective phase - test with disease-suspected patients - calculate Se, Sp, PPV NPV Look promising Look good Introduction: 3 phases of study design Laboratory phase - develop test - test with few cases and healthy controls - prove of concept Case-control phase - test with definite cases and definite controls - calculate Se Sp Prospective phase - test with disease-suspected patients - calculate Se, Sp, PPV NPV Look promising Look good Look rubbish (GS problem) Good guideline Good guideline Recommendation 1: Access index test’s ability to predict patient-relevant outcomes instead of test accuracy Recommendation 2: Access the concordance of difference tests instead of test accuracy Recommendation 3: Qualify the interpretation of “na?ve” estimates of the index test’s performance Recommendation 4: Imperfect gold standard model Recommended design for melioidosis Define need For example, estimate Se, Sp, PPV and NPV in a prospective design (to represent the real clinical situation) Define study population (that we w