Dataset Information

Clinical Significance, Species Distribution, and Temporal Trends of Nontuberculous Mycobacteria, Denmark, 1991-2022.

ABSTRACT: Nontuberculous mycobacteria (NTM) are emerging as notable causative agents of opportunistic infections. To examine clinical significance, species distribution, and temporal trends of NTM in Denmark, we performed a nationwide register-based study of all unique persons with NTM isolated in the country during 1991-2022. We categorized patients as having definite disease, possible disease, or isolation by using a previously validated method. The incidence of pulmonary NTM increased throughout the study period, in contrast to earlier findings. Mycobacterium malmoense, M. kansasii, M. szulgai, and M. avium complex were the most clinically significant species based on microbiologic findings; M. avium dominated in incidence. This study shows the need for surveillance for an emerging infection that is not notifiable in most countries, provides evidence to support clinical decision-making, and highlights the importance of not considering NTM as a single entity.

SUBMITTER: Dahl VN

PROVIDER: S-EPMC11346989 | biostudies-literature | 2024 Sep

REPOSITORIES: biostudies-literature

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Clinical Significance, Species Distribution, and Temporal Trends of Nontuberculous Mycobacteria, Denmark, 1991-2022.

Dahl Victor Naestholt VN Pedersen Andreas Arnholdt AA Norman Anders A Rasmussen E Michael EM van Ingen Jakko J Andersen Aase Bengaard AB Wejse Christian Morberg CM Lillebaek Troels T

Emerging infectious diseases 20240901 9

Nontuberculous mycobacteria (NTM) are emerging as notable causative agents of opportunistic infections. To examine clinical significance, species distribution, and temporal trends of NTM in Denmark, we performed a nationwide register-based study of all unique persons with NTM isolated in the country during 1991-2022. We categorized patients as having definite disease, possible disease, or isolation by using a previously validated method. The incidence of pulmonary NTM increased throughout the st ...[more]

PMID: 39173666

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Project description:Adverse event reporting for medical devices is critical for risk mitigation. The Food and Drug Administration's (FDA) Manufacturer and User Facility Device Experience (MAUDE) database serves as a key tool for post-market surveillance, receiving reports from various sources. Ensuring information integrity, especially across diverse reporting sources, is paramount. Periodic regulatory updates aim to enhance reporting.ObjectiveAnalyze reporting patterns, assess the potential contribution of 2015 and 2018 regulatory updates on reporting rates for varies reporters. Additionally, evaluating reporting schedule compliance by comparing average reporting times to regulatory requirements for these reporters.MethodsData from 1991-2022 was retrieved from the MAUDE database. Annual report counts were filtered by reporter and event type. Average reporting time was calculated as the difference between received and awareness dates.ResultsThe 2018 Voluntary Malfunction Summary Reporting (VMSR) program correlated with an increase in manufacturers' event reporting, peaking at 3,135,501 events in 2022. Distributors' reports surged post-2018, while voluntary reports steadily increased since 1997, spiking notably in 2015 with the Electronic Medical Device Reporting (eMDR) submission update. Reporting times for deaths averaged 80 days for manufacturers, far exceeding regulatory requirements, compared to 40 days for distributors and 46 days for user facilities. Malfunction events had longer average reporting times for manufacturers (89 days) compared to distributors (44 days).ConclusionsChanges in reporting trends around 2015 and 2018 may be linked to regulatory updates. Tailoring regulatory changes for each reporter type, like user-friendly electronic forms, new reporting programs, and exemptions cancelations, can improve reporting. Balancing the volume of reports among different reporters is crucial for enhancing database integrity, transparency, and overall health outcomes.

Dataset Information

Clinical Significance, Species Distribution, and Temporal Trends of Nontuberculous Mycobacteria, Denmark, 1991-2022.

Publications

Clinical Significance, Species Distribution, and Temporal Trends of Nontuberculous Mycobacteria, Denmark, 1991-2022.

Similar Datasets

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