Evidence map›Paper›PMID 24587066›Full record

ArticlePloS one2014

Adverse drug reactions of spontaneous reports in Shanghai pediatric population.

Hui Li, Xiao-Jing Guo, Xiao-Fei Ye, Hong Jiang, Wen-Min Du, Jin-Fang Xu, Xin-Ji Zhang, Jia He

Open access · goldAbstract read
In one paragraph

Article in PloS one, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 1 pooled it
8.1field-weighted citation impact, top 3% 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

16 citing papers in PubMed, 1 synthesis or guideline pooled it, 55 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Jordanians' knowledge, attitude and practice regarding adverse drug reactions reporting.Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society · 2023
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  15. Adverse drug reactions in hospitalized Colombian children.Colombia medica (Cali, Colombia) · 2016
    Article
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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

8 authors at 2 institutions in 1 country.

Hui LiDepartment of Health Statistics, Second Military Medical University, Shanghai, China.
Xiao-Jing GuoDepartment of Health Statistics, Second Military Medical University, Shanghai, China.
Xiao-Fei YeDepartment of Health Statistics, Second Military Medical University, Shanghai, China.
Hong JiangDepartment of Health Statistics, Second Military Medical University, Shanghai, China ; Department of politics, Second Military Medical University, Shanghai, China.
Wen-Min DuAdverse Drug Reaction Monitoring Center of Shanghai, Shanghai, China.
Jin-Fang XuDepartment of Health Statistics, Second Military Medical University, Shanghai, China.
Xin-Ji ZhangDepartment of Health Statistics, Second Military Medical University, Shanghai, China.
Jia HeDepartment of Health Statistics, Second Military Medical University, Shanghai, China.
Second Military Medical University · CNShanghai Drug Administration · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundKnowledge of drug safety in the pediatric population of China is limited. This study was designed to evaluate ADRs in children reported to the spontaneous reporting system (SRS) of Shanghai in 2009. METHODOLOGY AND PRINCIPAL

findingsCrude ADR reports submitted to Shanghai SRS in 2009 for individuals aged from birth to 17 years (including 17 years) were included. Data were analyzed with respect to age, gender, category of ADR (System Organ Class [SOC]), the severity of reports and type of reporter.

resultsA male overrepresentation was observed regarding the total number of reports. The most frequently reported group of drugs were vaccines (42.15%). Skin rash and fever were the commonest symptoms reported in the total pediatric dataset. The proportion of children that suffered from a serious ADR was 2.16% and that for drug related deaths was 0.34%. And we found that the multiple drug exposure experienced a high proportion of serious ADRs compared with the single drug use (χ² = 15.99, P<0.0001). Sixty-five percent of ADRs were for children less than 6 years of age. And more than half of reports were from doctors.

conclusionsIn our study, consumers were more likely to report new ADRs though they appear to contribute a relatively small percentage of total reports. We propose that patients would take an active role in reporting ADRs. More researches are needed in order to achieve better understanding the characteristics of ADRs in pediatric population of China.

Indexed as

AdolescentAge FactorsChildChild, PreschoolChinaCommunity ParticipationDrug-Related Side Effects and Adverse ReactionsFemaleHumansInfantInfant, NewbornLogistic ModelsMaleSex FactorsVaccinesVaccines

Identifiers

PMID24587066
PMCPMC3933652
OpenAlexW1987434192

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.