Background Clonorchiasis, caused by the fish-borne trematode Clonorchis sinensis, is a neglected tropical disease and a public health issue in endemic countries. In Vietnam, an in-depth analysis of risk factors for the condition is missing up to now. This study aimed to determine the prevalence of C. sinensis infection and associated risk factors in rural communities in northern Vietnam. Methodology/Principal findings A cross-sectional survey was conducted in 4 communes in Yen Bai and Thanh Hoa provinces where clonorchiasis is known to be present and raw fish consumption is a common. Using a simple random sampling approach, stool was collected from 841 cparticipants over 6 years old for coprological examination, and a questionnaire measured knowledge, attitudes, and practices with regard to clonorchiasis in 757 participants over 15 years old. Univariable and multivariable logistic regression models were run to identify risk factors for infection with C. sinensis. The overall prevalence of C. sinensis infection was 40.4%, with commune prevalences ranging between 26.5% and 53.3%. In the final model, males were significantly more likely to be infected with C. sinensis (OR 2.00; 95% CI 1.31-3.05). Recent PLOS NEGLECTED TROPICAL DISEASES

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ImportanceJust-in-time interventions (JITIs) are a type of digital therapeutic intervention that combines remote monitoring tools and algorithms to personalize the delivery of specific interventions at the right time. The US Food and Drug Administration (FDA) regulatory approval documents are often the only available source of information on the effectiveness of therapeutic interventions based on these devices.ObjectiveTo systematically review the publicly available information from the FDA on all recently approved medical devices used in JITIs to (1) assess how they operate to deliver JITIs and (2) appraise the evidence supporting their performance and clinical effectiveness.Evidence ReviewTwo reviewers systematically searched the Premarket Notifications (510(k)), Premarket Approvals, De Novo, and Humanitarian Device Exemption databases from January 2019 to December 2021 for all entries associated with devices that monitored patients’ data over time to personalize the delivery of interventions to treat, prevent, or mitigate health conditions or events. They assessed whether the product summaries (1) enabled an understanding of how the device operated to deliver a JITI (eg, the nature, type, and frequency of the monitoring, the nature of the decision algorithm, and the nature and intended receiver of the intervention); (2) informed about the performance and effectiveness of the JITI; and (3) included information on data security and ownership.FindingsIn total, 38 devices were included in this review. These were mainly intended for cardiac conditions (12 [31.6%]), diabetes (10 [26.3%]), and neurological diseases (4 [10.5%]). Monitoring devices ranged from wearable (18 of 28 [64.4%]; eg, smartwatches) to implanted sensors (6 of 28 [21.4%]; eg, inserted electrocardiographic sensors). Only 10 of 38 product summaries (26.3%) allowed a full understanding of how the device operated to deliver a JITI. Similarly, only 12 of 28 (42.9%), 12 of 36 (33.3%), and 5 of 38 (13.2%) reported the assessment of the performance of the monitoring device, assessment of the decision algorithm, and results of clinical studies assessing the effectiveness of the JITI, respectively. Finally, 14 of 36 product summaries (38.9%) included some information on data security, but none included information on data ownership.Conclusion and RelevanceThe results of this systematic review suggest that the information publicly available in the FDA databases on the performance and effectiveness of digital medical devices used in JITIs is heterogeneous.