Clinical Trial of Diagnostic Tests and Clinical Algorithms for Dengue in Febrile Subjects in Endemic Areas in Colombia

Clinical Trial of Diagnostic Tests and Clinical Algorithms for Dengue in Febrile Subjects in Endemic Areas in Colombia

Multicenter Clinical Trial of the Validity and Impact of Diagnostic Tests and Clinical Algorithms for Dengue in Febrile Subjects in Endemic Areas in Colombia 2016

COMFANDI CAJA DE COMPENSACION DEL VALLE DEL CAUCA, SISTEMA GENERAL DE REGALIAS CASANARE, SANTANDER VALLE DEL CAUCA, RED AEDES

The present study aimed to develop a sensitive dengue diagnostic clinical algorithm using the resources that are available at the health care institutions, clinical expertise, and identification of signs and symptoms and variables of the hemogram associated with dengue. The performance of the potential algorithms were assessed under routine care. A single group cuasiexperimental study with a Bayesian adaptive design was conducted. Prior and cumulative information was used during intermediate analysis of clinical algorithms performance and according to these results algorithms were modified and then implemented in the subsequent study subjects. Men and women of all ages, seeking care due to fever of less than 15 days were recruited in 3 endemic areas in Colombia. The algorithms were applied by study physicians and blood samples taken for hemogram and dengue reference tests. It was planned that algorithms with high sensitivity (95%) and specificity (80%) were implemented in real life to assess their impact on patients outcomes alone and in combination with dengue rapid diagnostic tests but this was not feasible as not algorithms achieved the targetted performance. The experience of physicians using the algorithm in a mobile device was going to be explored with qualitative methods but this was explored with study physicians.

Algorithms were developed and validated in silico, those with the highest sensitivity were tested in consecutive eligible subjects and their performance compared to dengue reference tests (gold standard combination of tests). Algorithms were modified according to intermediate analysis of performance planned in advance

Samples were coded and laboratory personnel were unaware of algorithm results, the participant did not know what algorithm prototype was tested.

single arm of consecutive enrolled subjects with fever in whom the dengue diagnostic algorithms were applied by study physician and blood sample taken for hemogram and dengue reference tests (gold standard)

Clinical diagnostic algorithms of dengue generated by discrete and continuos Bayes formulas installed in a mobile device

Number of correctly identified dengue cases by intervention out of all laboratory confirmed dengue cases

Number of correctly identified non-dengue cases by intervention out of all laboratory confirmed non-dengue cases

Number of correctly identified dengue cases by intervention out of all laboratory confirmed plus probable dengue cases