The purpose of this study was to explore the dynamics of incidence of hemorrhagic fever with renal syndrome (HFRS) from 2000 to 2017 in Anqiu City, a city located in East China, and find the potential factors leading to the incidence of HFRS. Methods: Monthly reported cases of HFRS and climatic data from 2000 to 2017 in the city were obtained. Seasonal autoregressive integrated moving average (SARIMA) models were used to fit the HFRS incidence and predict the epidemic trend in Anqiu City. Univariate and multivariate generalized additive models were fit to identify and characterize the association between the HFRS incidence and meteorological factors during the study period. Results: Statistical analysis results indicate that the annualized average incidence at the town level ranged from 1.68 to 6.31 per 100,000 population among 14 towns in the city, and the western towns exhibit high endemic levels during the study periods. With high validity, the optimal SARIMA(0,1,1,)(0,1,1) 12 model may be used to predict the HFRS incidence. Multivariate generalized additive model (GAM) results show that the HFRS incidence increases as sunshine time and humidity increases and decreases as precipitation increases. In addition, the HFRS incidence is associated with temperature, precipitation, atmospheric pressure, and wind speed. Those are identified as the key climatic factors contributing to the transmission of HFRS. Conclusion: This study provides evidence that the SARIMA models can be used to characterize the fluctuations in HFRS incidence. Our findings add to the knowledge of the role played by climate factors in HFRS transmission and can assist local health authorities in the development and refinement of a better strategy to prevent HFRS transmission.

Objective. The objective of this article is to provide a high-profile review and discussion on the study design and statistical analysis of pivotal clinical trials conducted to demonstrate the safety and effectiveness of closed-loop investigational artificial pancreas device systems (APDSs) in premarket approval applications. Methods. The United States Food and Drug Administration (FDA) guidance on the content of investigational device exemption and premarket approval applications for APDSs is reviewed with special emphasis on study design and statistical analysis of the pivotal clinical trials. The two pivotal studies for the MiniMed 670G hybrid closed-loop system by Medtronic in their premarket approval application are summarized and discussed. Results. The United States FDA established detailed recommendations on the study design and statistical analysis of pivotal clinical trials for the industry that seek market investigational APDSs and for FDA scientific reviewers that regulate the device applications. The recommendations cover specifics regarding patient population, clinical endpoints, and strategies for data analysis. However, the two pivotal studies that demonstrated the effectiveness of the FDA-approved MiniMed 670G hybrid closed-loop system were not typical randomized controlled trials as per FDA recommendations. Conclusion. The development and regulation of investigational APDSs require careful and sophisticated clinical study designs and data analysis in premarket approval applications. The regulatory evaluation process of the APDSs is rather complicated since the devices consist of multiple components that collaboratively function to mimic human pancreases.

Background Hypertension (HTN) is a leading cause of maternal mortality, and HTN guidelines recommend home blood pressure monitoring (HBPM) to help achieve blood pressure (BP) control. Evidence suggests that HBPM be coupled with a care team to maximize its effectiveness. HBPM use and the prevalence of provider counseling in child-bearing age women with HTN are unknown. Methods We used data from 3,614 women in the cross-sectional National Health and Nutrition Examination Surveys 2009-2014 to determine HBPM use and provider counseling for women of child-bearing age (20-50 years) with and without HTN. HBPM use and provider counseling were self-reported. We examined rates of HBPM use by race/ethnicity, poverty-income ratio (PIR), education, and insurance. Results Among women of child-bearing age with HTN, the mean (SE) age was 37.0 (0.3) years, the mean (SE) BMI was 35.5 (0.6) kg/m 2, and 73% were on BP medication. Of these women with HTN, 49.6% reported HBPM use in the past year and 40.4% received provider counseling. There was no significant difference in HBPM use by race/ethnicity, PIR, or insurance, though higher education was associated with HBPM use. Women with HTN who received provider counseling were more likely to use HBPM (odds ratio = 15.7, 95% confidence interval 9.1-26.9). Conclusions Nearly half of child-bearing age women with HTN have adopted HBPM, and provider counseling was strongly associated with HBPM use. This highlights a need and opportunity for providers to improve BP management by supporting a popular and valuable monitoring approach among women of child-bearing age with HTN.

Introduction: Heart-healthy diets are important in preventing hypertension (HTN) and hypertensive disorders of pregnancy (HDP), leading causes of preventable maternal mortality. However, perspectives of pregnant people with these conditions on barriers and facilitators of healthy eating are not well established. This study explored these experiences through qualitative feedback. Hypothesis: There are pregnancy-specific barriers and facilitators impacting healthy eating in people with HTN or at risk for HDP. Methods: Pregnant people with HTN or at risk for HDP were recruited from a large academic medical center for an electronic survey assessing barriers and facilitators to healthy eating. Participants answered open-ended questions about barriers to healthy diets and agents for change. Qualitative responses were analyzed using thematic analysis. Results: Of 46 participants (mean age 31.6 (SD 5.5) years, 35.1% Hispanic), 71.7% (33) responded to the question about barriers to healthy eating, with 56.5% (26) reporting specific barriers and 15.2% (7) reporting no barriers. Major themes for barriers included: (1) lack of education on what is “healthy;” (2) intrinsic factors (i.e., motivation, portion control, food cravings, and food aversions); (3) lack of access due to social determinants (i.e., time, finance, housing, culture and social factors); and (4) current health problems. Furthermore, 67.4% described facilitators to support healthy eating ( Table ), with themes of (1) external support, (2) discipline/routine; (3) increased affordability; and (4) menu/grocery guidance. Conclusion: Given lack of access and food preferences were common barriers to healthy eating, pregnant people with HTN or those at risk for HDP may benefit from food insecurity screening and individualized guidance from healthcare professionals. With personalized meal plans, specific recipes, and ingredient lists attainable in terms of cost, time, and social/cultural factors, these patients may be better supported for healthy eating.

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