Evidence map›Paper›PMID 34466629›Full record

ArticleOpen forum infectious diseases2021

QT Interval Prolongation in People Treated With Bedaquiline for Drug-Resistant Tuberculosis Under Programmatic Conditions: A Retrospective Cohort Study.

Sharon Isralls, Kathy Baisley, Eric Ngam, Alison D Grant, James Millard

Open access · goldAbstract read
In one paragraph

Article in Open forum infectious diseases, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 1 pooled it
4.4field-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

24 citing papers in PubMed, 1 synthesis or guideline pooled it, 33 citations in OpenAlex.

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  15. Efficacy and safety profile of 2Pakistan journal of medical sciences · 2024
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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 at 4 institutions in 2 countries.

Sharon IsrallsLondon School of Hygiene and Tropical Medicine, London, United Kingdom.ORCID https://orcid.org/0000-0003-4206-8022
Kathy BaisleyLondon School of Hygiene and Tropical Medicine, London, United Kingdom.ORCID https://orcid.org/0000-0003-1849-6625
Eric NgamUniversity of KwaZulu-Natal, Durban, South Africa.
Alison D GrantAfrica Health Research Institute, Durban, South Africa.ORCID https://orcid.org/0000-0002-2437-5195
James MillardAfrica Health Research Institute, Durban, South Africa.ORCID https://orcid.org/0000-0001-6427-552X
London School of Hygiene & Tropical Medicine · GBUniversity of KwaZulu-Natal · ZAUniversity of Liverpool · GBUniversity of the Witwatersrand · ZA

Funding

Medical Research Council MR/R010161/1Wellcome Trust
6 · The paper itself

Abstract

backgroundBedaquiline has a black-box warning of the risk of arrhythmias and sudden death. This study aimed to determine the incidence of QTc prolongation and cardiac events in patients receiving bedaquiline for drug-resistant tuberculosis (DR-TB) under programmatic conditions.

methodsRetrospective cohort study of patients receiving bedaquiline at a DR-TB hospital in KwaZulu Natal, South Africa from September 2017 to February 2019. The primary outcome, a prolonged QT interval corrected using the Fridericia formula (QTcF), was defined as QTcF >500 ms, QTcF change >60 ms from baseline, or both.

resultsAmong 420 patients (66.2% male, median age 36 years), the median QTcF was 406.4 (interquartile range [IQR], 389.1-421.3) ms at baseline, increasing to 430.5 (IQR, 414.4-445.1) ms by 3 months and 434.0 (IQR, 419.0-447.9) ms at 6 months. Eighteen of 420 patients (4.3%) had a QTcF >500 ms and 110 of 420 patients (26.2%) had a QTcF change >60 ms. There were no recorded arrhythmias or cardiac deaths. Odds of prolonged QTcF were increased with concomitant azoles (adjusted odds ratio [aOR], 5.61 [95% confidence interval (CI), 2.26-13.91];

conclusionsWe observed a modest prolongation of QTcF, maximal at week 15; there were no recorded arrhythmias or related deaths.

Indexed as

bedaquilineQT interval prolongationtuberculosis

Identifiers

PMID34466629
PMCPMC8403230
OpenAlexW3191327872

What OpenQuestion holds

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Registered trials

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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.