Development of a national registry of congenital anomalies in Argentine: a pilot feasibility study

Abstract

NTRODUCTION: the Health Statistics System in Argentina does not record data on the occurrence of congenital anomalies (CA) in newborns. OBJECTIVE: to evaluate the reliability of a new methodology for the record of CA in live births by comparison with the Latin American Collaborative Study of Congenital Malformations (ECLAMC, according to its Spanish acronym). METHODS: we used data from two independent methodologies: the ECLAMC and a special form attached to the Hospitalization Statistical Report (F-IEH, according to its Spanish acronym). On the F-IEH, neonatologists registered those newborns with CA and described the anomalies. RESULTS: in a population of 18,491 live births, the ECLAMC reported 658 (3.56%) malformed infants, while the F-IEH registered 587 (3.17%). The prevalence of major malformations was 2.58% and 2.11 %, respectively. Most diagnostic categories were more frequent in the ECLAMC than in the F-IEH. The reliability measured by the Percentage of Positive Agreement was 62.2%, in all the CA cases; 42.4%, in minor CA; and ranged from 42.9% to 88.9% among different categories of major CA. CONCLUSIONS: the degree of agreement between the F-IEH and the ECLAMC in the detection of CA is greater for major AC. The diagnoses were the same in all the cases detected by both methodologies. Before using the register nationwide, neonatologist’s training is required to ensure adequate case detection.