Observational studyPloS one2015
Doing no harm? Adverse events in a nation-wide cohort of patients with multidrug-resistant tuberculosis in Nigeria.
Observational study in PloS one, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 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.
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Who cites it
21 citing papers in PubMed, 1 synthesis or guideline pooled it, 50 citations in OpenAlex.
- Pooled it
- Article
- Safety Profile of Medicines Used for the Treatment of Drug-Resistant Tuberculosis: A Descriptive Study Based on the WHO Database (VigiBaseAntibiotics (Basel, Switzerland) · 2023Article
- Clinical standards for the dosing and management of TB drugs.The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease · 2022Article
- Frequency and Management of Adverse Drug Reactions Among Drug-Resistant Tuberculosis Patients: Analysis From a Prospective Study.Frontiers in pharmacology · 2022Article
- Baseline assessment of pharmacovigilance activities in four sub-Saharan African countries: a perspective on tuberculosis.BMC health services research · 2021Article
- Frequency and Factors Associated With Adverse Events Among Multi-Drug Resistant Tuberculosis Patients in Pakistan: A Retrospective Study.Frontiers in medicine · 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
- "Death is a better option than being treated like this": a prevalence survey and qualitative study of depression among multi-drug resistant tuberculosis in-patients.BMC public health · 2020Article
- Article
- Integration of drug safety monitoring in tuberculosis treatment programmes: country experiences.European respiratory review : an official journal of the European Respiratory Society · 2019Review
- Health-related quality of life of patients with multidrug-resistant tuberculosis in Yemen: prospective study.Health and quality of life outcomes · 2019Article
- Governance of tuberculosis control programme in Nigeria.Infectious diseases of poverty · 2019Review
- Incidence and predictors of major adverse drug events among drug-resistant tuberculosis patients on second-line anti-tuberculosis treatment in Amhara regional state public hospitals; Ethiopia: a retrospective cohort study.BMC infectious diseases · 2019Article
- Article
- Article
- Does the Structured Operational Research and Training Initiative (SORT IT) continue to influence health policy and/or practice?Global health action · 2018Article
- Cost-effectiveness of adding novel or group 5 interventions to a background regimen for the treatment of multidrug-resistant tuberculosis in Germany.BMC health services research · 2017Article
- Evaluation of community-based treatment for drug-resistant tuberculosis in Bangladesh.Tropical medicine & international health : TM & IH · 2016Article
- Effects of Multidrug Resistant Tuberculosis Treatment on Patients' Health Related Quality of Life: Results from a Follow Up Study.PloS one · 2016Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
19 authors at 6 institutions in 5 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundAdverse events (AEs) of second line anti-tuberculosis drugs (SLDs) are relatively well documented. However, the actual burden has rarely been described in detail in programmatic settings. We investigated the occurrence of these events in the national cohort of multidrug-resistant tuberculosis (MDR-TB) patients in Nigeria.
methodThis was a retrospective, observational cohort study, using pharmacovigilance data systematically collected at all MDR-TB treatment centers in Nigeria. Characteristics of AEs during the intensive phase treatment were documented, and risk factors for development of AEs were assessed.
resultsFour hundred and sixty patients were included in the analysis: 62% were male; median age was 33 years [Interquartile Range (IQR):28-42] and median weight was 51 kg (IQR: 45-59). Two hundred and three (44%) patients experienced AEs; four died of conditions associated with SLD AEs. Gastro-intestinal (n = 100), neurological (n = 75), ototoxic (n = 72) and psychiatric (n = 60) AEs were the most commonly reported, whereas ototoxic and psychiatric AEs were the most debilitating. Majority of AEs developed after 1-2 months of therapy, and resolved in less than a month after treatment. Some treatment centers were twice as likely to report AEs compared with others, highlighting significant inconsistencies in reporting at different treatment centers. Patients with a higher body weight had an increased risk of experiencing AEs. No differences were observed in risk of AEs between HIV-infected and uninfected patients. Similarly, age was not significantly associated with AEs.
conclusionPatients in the Nigerian MDR-TB cohort experienced a wide range of AEs, some of which were disabling and fatal. Early identification and prompt management as well as standardized reporting of AEs at all levels of healthcare, including the community is urgently needed. Safer regimens for drug-resistant TB with the shortest duration are advocated.
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