ArticleThe international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease2016
Discordance between patient and clinician reports of adverse reactions to MDR-TB treatment.
Article in The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04298905 (Leveraging mHealth to Enable and Adapt Community Health Worker Strategies to Improve TB/HIV Patient Outcomes in South Africa), which is not on this map. Cited by 12 papers, 1 of them a synthesis that pooled it.
What it found
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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.
Leveraging mHealth to Enable and Adapt Community Health Worker Strategies to Improve TB/HIV Patient Outcomes in South Africa (LEAP-TB-SA) Trial
Who cites it
12 citing papers in PubMed, 1 synthesis or guideline pooled it, 19 citations in OpenAlex.
- Increased risk of aminoglycoside-induced hearing loss in MDR-TB patients with HIV coinfection.The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease · 2018Pooled it
- Adverse drug reactions to first-line anti-tuberculosis treatments, associated factors, and treatment outcomes: a retrospective study from Southern Morocco.Naunyn-Schmiedeberg's archives of pharmacology · 2026Article
- Symptom network analysis of insomnia-depression-anxiety-stigma in tuberculosis patients.Frontiers in psychiatry · 2024Article
- Frequency and Management of Adverse Drug Reactions Among Drug-Resistant Tuberculosis Patients: Analysis From a Prospective Study.Frontiers in pharmacology · 2022Article
- Risk factors for poor engagement in drug-resistant TB care in South Africa: a systematic review.Public health action · 2021Article
- Quality of sleep among patients diagnosed with tuberculosis-a cross-sectional study.Sleep & breathing = Schlaf & Atmung · 2021Article
- "Side effects--part of the package": a mixed methods approach to study adverse events among patients being programmatically treated for DR-TB in Gujarat, India.BMC infectious diseases · 2020Article
- Retrospective record review of pregnant women treated for rifampicin-resistant tuberculosis in South Africa.PloS one · 2020Article
- Integration of drug safety monitoring in tuberculosis treatment programmes: country experiences.European respiratory review : an official journal of the European Respiratory Society · 2019Review
- The impact of adverse events on health-related quality of life among patients receiving treatment for drug-resistant tuberculosis in Johannesburg, South Africa.Health and quality of life outcomes · 2019Article
- Adverse Events Associated with Treatment of Multidrug-Resistant Tuberculosis in China: An Ambispective Cohort Study.Medical science monitor : international medical journal of experimental and clinical research · 2017Article
- Article
Corrections and comments
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Authors and funding
7 authors at 3 institutions in 1 country.
Funding
Abstract
settingAn urban out-patient clinic in Durban, South Africa, providing community-based treatment for drug-resistant tuberculosis (TB).
objectiveTo describe concordance between patient report and clinician documentation of adverse drug reactions (ADRs) to treatment for multidrug-resistant TB (MDR-TB).
designADRs were documented by interview using an 18-item symptom checklist and medical record data abstraction during a cross-sectional parent study with 121 MDR-TB patients, 75% of whom were co-infected with the human immunodeficiency virus. Concordance was analyzed using Cohen's κ statistic, Gwet's agreement coefficient (AC) 1, and McNemar's test.
resultsADRs were reported much more frequently in patient interviews (μ = 8.6) than in medical records (μ = 1.4). Insomnia was most common (67% vs. 2%), followed by peripheral neuropathy (65% vs. 18%), and confusion (61 vs. 4%). κ scores were very low, with the highest degree of concordance found in hearing loss (κ = 0.23), which was the only ADR not found to be significantly different between the two data sources (P = 0.34).
conclusionsOur study showed a lack of concordance between patient report and clinician documentation of ADRs. These findings indicate the need for improved documentation of ADRs to better reflect patients' experiences during MDR-TB treatment. These data have important implications for country-level pharmacovigilance programs that rely on clinician documentation of ADRs for MDR-TB policy formation.
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Registered trials
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.