Assessment of US Food and Drug Administration-Approved Digital Medical Devices for Just-in-Time Interventions: A Systematic Review.

Importance: Just-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. Objective: To 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 Review: Two 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. Findings: In 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 Relevance: The 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.

Foodborne zoonotic trematode infections in Yen Bai, Vietnam: a situational analysis on knowledge, attitude, and practice (KAP) and risk behaviors.

Introduction: Foodborne Zoonotic Trematode Infections (FZTi) are neglected tropical diseases of public health concern in Vietnam. The transmission of FZTi is linked to human behavior patterns. The aims to investigate the knowledge, attitude, and practices regarding FZTi among local people. Methods: A cross-sectional study was conducted using a mixed method, which included a baseline survey and in-depth interviews. 375 participants were interviewed face-to-face in the survey, and 27 participants had the in-depth interviews. Results: The results showed that 36.3% passed the knowledge assessment, 86.7% passed the attitude assessment, and 24% passed the practical assessment. There were differences in average knowledge scores among gender (men higher than women, p = 0.006), ethnicities (Kinh higher than Dao and Tay, p < 0.001), and educational level (higher education, higher knowledge score, p < 0.001). There were differences in the frequency of eating raw fish between men and women (men higher than women, p < 0.001), and in the average practice score between men and women (women higher than men, p = 0.028). Eating raw fish and/or undercooked fish, raw vegetables, and drinking untreated water from Thac Ba lake in Yen Bai province were identified as FZTi risk behaviors. The occurrence of these risky habits can be explained by the lack of knowledge on FZTi, poor economic conditions and typical social features of local people. Conclusion: The current knowledge of local people in regard to safe eating practices is poor. They keep performing unsafe practices, which lead to infection with FZTi; therefore, an integrated control of FZTi is essential.