Evidence map›Paper›PMID 31901244›Full record

ArticleBMC pediatrics2020

Serious adverse drug reactions at two children's hospitals in South Africa.

Johannes P Mouton, Melony C Fortuin-de Smidt, Nicole Jobanputra, Ushma Mehta, Annemie Stewart, Reneé de Waal, Karl-Günter Technau, Andrew Argent, Max Kroon, Christiaan Scott and 1 more

Open access · goldAbstract read
In one paragraph

Article in BMC pediatrics, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 3 pooled it
3.6field-weighted citation impact, top 8% of its field
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

12 citing papers in PubMed, 3 syntheses or guidelines pooled it, 41 citations in OpenAlex.

  1. Pooled it
  2. The epidemiology of drug-related hospital admissions in paediatrics - a systematic review.Archives of public health = Archives belges de sante publique · 2024
    Pooled it
  3. Pooled it
  4. Article
  5. Article
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  7. Article
  8. Adverse Drug Reactions to Antiretroviral Therapy: Frequency, Type, and Risk Factors in Children in Mali.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2023
    Article
  9. Article
  10. Article
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  12. Systems Biology Approaches for Therapeutics Development Against COVID-19.Frontiers in cellular and infection microbiology · 2020
    Review
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

11 authors at 1 institution in 1 country.

Johannes P MoutonDepartment of Medicine, Division of Clinical Pharmacology, University of Cape Town, Cape Town, South Africa.
Melony C Fortuin-de SmidtDepartment of Medicine, Division of Clinical Pharmacology, University of Cape Town, Cape Town, South Africa.
Nicole JobanputraDepartment of Medicine, Division of Clinical Pharmacology, University of Cape Town, Cape Town, South Africa.
Ushma MehtaCentre for Infectious Disease Epidemiology and Research, School of Public Health and Family Medicine, University of Cape Town, Cape Town, South Africa.
Annemie StewartDepartment of Medicine, Division of Clinical Pharmacology, University of Cape Town, Cape Town, South Africa.
Reneé de WaalCentre for Infectious Disease Epidemiology and Research, School of Public Health and Family Medicine, University of Cape Town, Cape Town, South Africa.
Karl-Günter TechnauDepartment of Paediatrics and Child Health, Empilweni Services and Research Unit, Rahima Moosa Mother and Child Hospital, School of Clinical Medicine, Faculty of Health Sciences, University of Witwatersrand, Johannesburg, South Africa.
Andrew ArgentDepartment of Paediatrics and Child Health, University of Cape Town, Cape Town, South Africa.
Max KroonDepartment of Paediatrics and Child Health, Division of Neonatology, University of Cape Town, Cape Town, South Africa.
Christiaan ScottDepartment of Paediatrics and Child Health, University of Cape Town, Cape Town, South Africa.
Karen CohenDepartment of Medicine, Division of Clinical Pharmacology, University of Cape Town, Cape Town, South Africa. karen.cohen@uct.ac.za.ORCID 0000-0002-1892-4207
University of Cape Town · ZA

Funding

PEPFAR
6 · The paper itself

Abstract

backgroundThe high HIV prevalence in South Africa may potentially be shaping the local adverse drug reaction (ADR) burden. We aimed to describe the prevalence and characteristics of serious ADRs at admission, and during admission, to two South African children's hospitals.

methodsWe reviewed the folders of children admitted over sequential 30-day periods in 2015 to the medical wards and intensive care units of each hospital. We identified potential ADRs using a trigger tool developed for this study. A multidisciplinary team assessed ADR causality, type, seriousness, and preventability through consensus discussion. We used multivariate logistic regression to explore associations with serious ADRs.

resultsAmong 1050 patients (median age 11 months, 56% male, 2.8% HIV-infected) with 1106 admissions we found 40 serious ADRs (3.8 per 100 drug-exposed admissions), including 9/40 (23%) preventable serious ADRs, and 8/40 (20%) fatal or near-fatal serious ADRs. Antibacterials, corticosteroids, psycholeptics, immunosuppressants, and antivirals were the most commonly implicated drug classes. Preterm neonates and children in middle childhood (6 to 11 years) were at increased risk of serious ADRs compared to infants (under 1 year) and term neonates: adjusted odds ratio (aOR) 5.97 (95% confidence interval 1.30 to 27.3) and aOR 3.63 (1.24 to 10.6) respectively. Other risk factors for serious ADRs were HIV infection (aOR 3.87 (1.14 to 13.2) versus HIV-negative) and increasing drug count (aOR 1.08 (1.04 to 1.12) per additional drug).

conclusionsSerious ADR prevalence in our survey was similar to the prevalence found elsewhere. In our setting, serious ADRs were associated with HIV-infection and the antiviral drug class was one of the most commonly implicated. Similar to other sub-Saharan African studies, a large proportion of serious ADRs were fatal or near-fatal. Many serious ADRs were preventable.

Indexed as

Drug-Related Side Effects and Adverse ReactionsHIV InfectionsChildFemaleHospitalizationHumansInfantInfant, NewbornMaleProspective StudiesSouth AfricaAdverse drug reactionHIVPharmacoepidemiologyPrevalenceTrigger tool

Identifiers

PMID31901244
PMCPMC6942333
OpenAlexW2998538261

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.