Evidence map›Paper›PMID 23667572›Full record

ArticlePloS one2013

Drug-associated adverse events and their relationship with outcomes in patients receiving treatment for extensively drug-resistant tuberculosis in South Africa.

Karen Shean, Elizabeth Streicher, Elize Pieterson, Greg Symons, Richard van Zyl Smit, Grant Theron, Rannakoe Lehloenya, Xavier Padanilam, Paul Wilcox, Tommie C Victor and 6 more

Erratum issuedOpen access · goldAbstract read
In one paragraph

Article in PloS one, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 57 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
57citing papers in PubMed, 7 pooled it
4.9field-weighted citation impact, top 4% 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

57 citing papers in PubMed, 7 syntheses or guidelines pooled it, 111 citations in OpenAlex.

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  10. Risk of hearing loss among multidrug-resistant tuberculosis patients according to cumulative aminoglycoside dose.The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease · 2020
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4 · The record

Corrections and comments

  • Erratum issued
    Groubusch, Martin [corrected to Grobusch, Martin P]
5 · Who and what money

Authors and funding

16 authors at 6 institutions in 4 countries.

Karen SheanLung Infection and Immunity Unit, Division of Pulmonology and UCT Lung Institute, Department of Medicine, University of Cape Town, Cape Town, South Africa.
Elizabeth Streicher
Elize Pieterson
Greg Symons
Richard van Zyl Smit
Grant Theron
Rannakoe Lehloenya
Xavier Padanilam
Paul Wilcox
Tommie C Victor
Paul van Helden
Martin P Grobusch
Martin Groubusch
Robin Warren
Motasim Badri
Keertan Dheda
University of Cape Town · ZAStellenbosch University · ZAAmsterdam University Medical Centers · NLKing Saud bin Abdulaziz University for Health Sciences · SAUniversity College London · GBUniversity of the Witwatersrand · ZA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTreatment-related outcomes in patients with extensively drug-resistant tuberculosis (XDR-TB) are poor. However, data about the type, frequency and severity of presumed drug-associated adverse events (AEs) and their association with treatment-related outcomes in patients with XDR-TB are scarce.

methodsCase records of 115 South-African XDR-TB patients were retrospectively reviewed by a trained researcher. AEs were estimated and graded according to severity [grade 0 = none; grade 1-2 = mild to moderate; and grade 3-5 = severe (drug stopped, life-threatening or death)].

findings161 AEs were experienced by 67/115(58%) patients: 23/67(34%) required modification of treatment, the offending drug was discontinued in 19/67(28%), reactions were life-threatening in 2/67(3.0%), and 6/67(9.0%) died. ∼50% of the patients were still on treatment at the time of data capture. Sputum culture-conversion was less likely in those with severe (grade 3-5) vs. grade 0-2 AEs [2/27(7%) vs. 24/88(27%); p = 0.02]. The type, frequency and severity of AEs was similar in HIV-infected and uninfected patients. Capreomycin, which was empirically administered in most cases, was withdrawn in 14/104(14%) patients, implicated in (14/34) 41% of the total drug withdrawals, and was associated with all 6 deaths in the severe AE group (renal failure in five patients and hypokalemia in one patient).

conclusionDrug-associated AEs occur commonly with XDR-TB treatment, are often severe, frequently interrupt therapy, and negatively impact on culture conversion outcomes. These preliminary data inform on the need for standardised strategies (including pre-treatment counselling, early detection, monitoring, and follow-up) and less toxic drugs to optimally manage patients with XDR-TB.

Indexed as

Antitubercular AgentsDemographyDose-Response Relationship, DrugExtensively Drug-Resistant TuberculosisFemaleHIV InfectionsHumansKaplan-Meier EstimateMaleMultivariate AnalysisMycobacterium tuberculosisSouth AfricaTreatment OutcomeAntitubercular Agents

Identifiers

PMID23667572
PMCPMC3646906
OpenAlexW2098771520

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.