Development and validation of a clinical instrument to predict risk of an adverse drug reactions in hospitalized patients

Development and internal validation of a clinical tool for assessment of the risk of adverse drug reactions (ADR) in hospitalized patients. Nested case-control study in an open cohort of all patients admitted to a general hospital. Cases of ADR were matched to two controls. Eighty four patient varia...

Full description

Saved in:
Bibliographic Details
Published in:PloS one 2020-12, Vol.15 (12), p.e0243714
Main Authors: Lima, Sara Iasmin Vieira Cunha, Martins, Rand Randall, Saldanha, Valdjane, Silbiger, Vivian Nogueira, Dos Santos, Isabelle Cristina Clemente, Araújo, Ivonete Batista de, Oliveira, Antonio Gouveia
Format: Article
Language:English
Subjects:
Adult
Adverse drug reactions
Aged
Blood pressure
Case studies
Case-Control Studies
Causality
Chemotherapy
Clustering
Cohort Studies
Diabetes mellitus
Disease
Drug Prescriptions - statistics & numerical data
Drug stores
Drug-Related Side Effects and Adverse Reactions - epidemiology
Drugs
Evaluation
Female
Health risks
Health sciences
Heart rate
Hospital patients
Hospitalization
Hospitalization - statistics & numerical data
Hospitals
Humans
Incidence
Independent variables
Intravenous administration
Logistic Models
Male
Medicine and Health Sciences
Middle Aged
Odds Ratio
Oral administration
Patients
Patients' Rooms - statistics & numerical data
Pharmaceutical sciences
Physical Sciences
Potassium
Prescription Drugs - adverse effects
Questionnaires
Regression analysis
Regression coefficients
Research ethics
Risk analysis
Risk Assessment - methods
Risk Factors
ROC Curve
Side effects
Urea
Citations: Items that this one cites
Items that cite this one
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary:Development and internal validation of a clinical tool for assessment of the risk of adverse drug reactions (ADR) in hospitalized patients. Nested case-control study in an open cohort of all patients admitted to a general hospital. Cases of ADR were matched to two controls. Eighty four patient variables collected at the time of the ADR were analyzed by conditional logistic regression. Multivariate logistic regression with clustering of cases in a random sample of 2/3 of the cases and respective controls, with baseline odds-ratio corrected with an estimate of ADR incidence, was used to obtain regression coefficients for each risk factor and to develop a risk score. The clinical tool was validated in the remaining 1/3 observations. The study was approved by the institution's research ethics committee. In the 8060 hospitalized patients, ADR occurred in 343 (5.31%), who were matched to 686 controls. Fourteen variables were identified as independent risk factors of ADR: female, past history of ADR, heart rate ≥72 bpm, systolic blood pressure≥148 mmHg, diastolic blood pressure
ISSN:1932-6203
1932-6203
DOI:10.1371/journal.pone.0243714