Evidence map›Paper›PMID 27821893›Full record

ArticleColombia medica (Cali, Colombia)2016

Adverse drug reactions in hospitalized Colombian children.

Roxana de Las Salas, Daniela Díaz-Agudelo, Francisco Javier Burgos-Flórez, Claudia Vaca, Dolores Vanessa Serrano-Meriño

Abstract read
In one paragraph

Article in Colombia medica (Cali, Colombia), 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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  4. Article
  5. Outcome measures in pediatric polypharmacy research: a scoping review.Drugs & therapy perspectives : for rational drug selection and use · 2019
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Roxana de Las SalasGrupo de Investigación en Enfermería, Departamento de Enfermería, Universidad del Norte, Barranquilla, Colombia.
Daniela Díaz-AgudeloGrupo de Investigación en Enfermería, Departamento de Enfermería, Universidad del Norte, Barranquilla, Colombia.
Francisco Javier Burgos-FlórezDepartamento de Farmacia, Universidad Nacional de Colombia, Bogotá, Colombia.
Claudia VacaDepartamento de Farmacia, Universidad Nacional de Colombia, Bogotá, Colombia.
Dolores Vanessa Serrano-MeriñoGrupo de Investigación en Enfermería, Departamento de Enfermería, Universidad del Norte, Barranquilla, Colombia.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThe occurrence of adverse drug reactions is an important issue due to the lack of drug safety data in children.

objectiveTo describe the Adverse Drug Reactions in inpatient children under 6 years of age in two general pediatrics wards located in Barranquilla, Colombia.

methodsA prospective cohort study based on intensive pharmacovigilance was conducted during six months in order to monitor the emergence of Adverse Drug Reactions in inpatients children under 6 years of age with at least one medication prescribed. The study was conducted in two pediatric wards of two hospitals located in Barranquilla, Colombia. Naranjo´s Algorithm was used to evaluate imputability, the modified Hartwig and Siegel assessment scale to establish severity and the Schumock and Thornton criteria to determine preventability.

resultsOf a total of 772 monitored patients, 156 Adverse Drug Reactions were detected on 147 children. The cumulative incidence of Adverse Drug Reactions was 19.0% (147/772); the incidence density was 37.6 Adverse Drug Reactions per 1,000 patients-days (147/3,913). The frequency was higher in children under 2 years of age (12.7%). Emergence of Adverse Drug Reactions was higher in male patients (RR= 1.66; 95% CI= 1.22-2.22,

conclusionsAdverse Drug Reactions are common among hospitalized children and represent an additional burden of morbidity and risk, particularly in those who used several medicines, including antibiotics. INTRODUCCIÓN: La aparición de reacciones adversas a medicamentos es un tópico importante debido a la escasa información sobre seguridad de medicamentos en niños. OBJETIVO: Describir las reacciones adversas a medicamentos en niños menores de 6 años de edad hospitalizados en dos servicios de pediatría general en Barranquilla, Colombia. MÉTODOS: Estudio prospectivo de una cohorte de pacientes basado en farmacovigilancia intensiva, realizado durante seis meses para monitorizar la aparición de reacciones adversas a medicamentos en niños menores de 6 años de edad hospitalizados y con indicación de al menos un medicamento. El estudio fue conducido en dos servicios de pediatría general de dos hospitales en Barranquilla, Colombia. El algoritmo de Naranjo fue usado para evaluar imputabilidad, la escala modificada de Hartwig y Siegel para establecer severidad y los criterios de Schumock y Thornton para determinar evitabilidad. RESULTADOS: En total se monitorizaron 772 pacientes. Se detectaron 156 reacciones adversas a medicamentos en 147 niños. La incidencia acumulada de las reacciones adversas a medicamentos fue 19.0% (147/772); la densidad de incidencia fue de 37.6 reacciones adversas a medicamentos por 1,000 pacientes-día (147/3,913). La frecuencia de reacciones adversas fue mayor en niños <2 años de edad (12.7%). La ocurrencia de reacciones adversas a medicamentos fue mayor en pacientes masculinos (RR= 1.66; IC 95% =1.22-2.22, CONCLUSIONES: Las reacciones adversas a medicamentos son comunes en niños hospitalizados y representan una morbilidad adicional y mayor riesgo, particularmente en aquellos que usaron varios medicamentos, incluyendo antibióticos.

Indexed as

Age DistributionChild, HospitalizedChild, PreschoolDrug-Related Side Effects and Adverse ReactionsFemaleHumansIncidenceInfantMalePharmacovigilanceProspective StudiesSex Distributionadverse reactionschildColombiadrug monitoringDrug-related side effectsPediatricspharmacovigilanceRisk

Identifiers

PMID27821893
PMCPMC5091272

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.