Banca de DEFESA: RAMON WEYLER DUARTE LEOPOLDINO

Uma banca de DEFESA de DOUTORADO foi cadastrada pelo programa.
STUDENT : RAMON WEYLER DUARTE LEOPOLDINO
DATE: 12/07/2023
TIME: 16:00
LOCAL: Sessão de videoconferência: https://meet.google.com/njq-kxry-evm
TITLE:

DEVELOPMENT AND VALIDATION OF AN INSTRUMENT FOR PREDICTION OF ADVERSE DRUG REACTION IN NEONATES IN THE INTENSIVE CARE UNIT

KEY WORDS:

Neonates; Intensive Care, Neonatal; Patient safety; Pharmacovigilance

PAGES: 153
BIG AREA: Ciências da Saúde
AREA: Farmácia
SUMMARY:

Introduction: The Adverse Drug Reactions (ADR) are common in hospitalized neonates, but their detection is made more difficult in these individuals by the severe health status and rapid physiological changes related to organ maturation. The ADR predictive tools are the best care strategies. However, these instruments are not yet available to the neonatal population. Objectives: To develop and validate an instrument for predicting ADR in neonates admitted to a Neonatal Intensive Care Unit (NICU). Methods: This is a nested case-control study in an open cohort conducted from January 2019 to January 2022 with neonates admitted to the NICU of a public maternity hospital in Natal/Brazil. All neonates admitted to the NICU for more than 24 hours were included in the study. ADR were detected by actively searching electronic medical records and analyzing spontaneous notification. For the cohort, ADR were characterized for incidence, prevalence, and risk factors via a multivariate model. Subsequently, patients with ADR were randomly matched with two controls in a 1:2 ratio, allowing the development of a predictive model of ADR by multivariate logistic regression. The discriminative ability of the model was assessed by the area under the ROC curve by bootstrap adjusted c-statistic. From a sample of ADR cases, the performance of the Du and Naranjo algorithms was analyzed by three independent assessors. For these tools, inter-rater, inter-rater and inter-tool agreement (kappa coefficient) were calculated. Results: With a cohort of 600 neonates, the prevalence of ADR was 19.7% (95% CI 16.7 - 23.0%) and incidence of 310 cases per 1,000 neonates (95% CI 267.8 - 357.0). The most frequent reactions were tachycardia (30.6%), polyuria (9.1%) and hypokalemia (8.6%). The long hospital stay (OR 1.025 95%CI 1.011 - 1.038; p < 0.01) and polypharmacy (OR 1.121 95%CI 1.057 - 1.189; p < 0.01) were factors associated with ADR. For the development of the predictive instrument, 450 neonates (150 cases and 300 controls) were included in the analysis. The instrument entered four conditions from the neonate (mechanical ventilation, heart rate ≥ 178 bpm, intravenous medications, 5 or more medications) and one from the mother (gestational hypertension) for ADR prediction and obtained an area under the ROC curve of 0.74 (95% CI 0.68 - 0.80). In the performance of the Du and Naranjo algorithms, the former showed good ability to identify defined ADR (≈60%), but had low reproducibility (overall k = -0.031; 95%CI -0.049 - 0.065). The results of the algorithms were not equivalent (overall k = -0.031; 95% CI -0.049 - 0.065). Conclusion: The ADR frequently observed in the NICU were tachycardia, hyperthermia, polyuria, and hypokalemia. Based on five variables commonly monitored in the NICU, a simple, well-calibrated predictive instrument with adequate discriminative capacity was constructed. Regarding the performance of the causality algorithms, Du's algorithm showed promise for identifying ADR in NICU due to its good ability to classify reactions as defined.

COMMITTEE MEMBERS:
Interno - 1178187 - ERYVALDO SOCRATES TABOSA DO EGITO
Externo à Instituição - HILRIS ROCHA E SILVA - UFPI
Externo à Instituição - PABLO DE MOURA SANTOS - UFBA
Presidente - 2432313 - RAND RANDALL MARTINS
Externo ao Programa - ***.283.220-** - RICARDO NEY OLIVEIRA COBUCCI - UFRN