Home Blood Pressure Monitoring in Women of Child-Bearing Age With Hypertension From 2009 to 2014.

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/m2, 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.

Pivotal clinical trials with patient-reported outcome measures in premarket approval applications for high-risk medical devices from 2005 to 2018: Review, examples, and regulatory considerations.

BACKGROUND: Patient-reported outcome (PRO) measures are key to reflecting the patient experience and patient perspective when developing new medical devices. The PRO measures used in pivotal clinical trials for investigational medical devices are miscellaneous and diversified. METHODS: This article analyzes and presents the trend and distribution of the use of PRO measures in the pivotal clinical trials for high-risk medical devices regulated and approved by the United States Food and Drug Administration (FDA) from 2005 to 2018 through Premarket Approval (PMA). RESULTS: As clinical endpoints in pivotal clinical trials, the use of PRO measures in FDA-approved PMA applications for high-risk Class III medical devices significantly increased from September 2005 to December 2018. The percentage of PRO use peaked at the years 2014 and 2015 and remains high till 2018. The most used PRO measure among these PMAs was the 36-Item Short Form Survey quality-of-life questionnaire. Three examples are further elaborated in this article to show how the pivotal clinical trials are designed and analyzed with PRO measures as their clinical endpoints for FDA-regulated high-risk medical devices. The article also reiterates regulatory perspectives and considerations from the FDA. CONCLUSION: The regulatory perspectives and considerations provided by the FDA on evaluating PRO instruments and design and analysis of pivotal clinical trials with PRO measures should be closely followed in the development process of new medical devices.

Identifying barriers, facilitators, and interventions to support healthy eating in pregnant women with or at risk for hypertensive disorders of pregnancy.

Background: Heart-healthy diets are important in the prevention and treatment of hypertension (HTN), including among pregnant women. Yet, the barriers, facilitators, and beliefs/preferences regarding healthy eating are not well described in this population. Objective: To identify barriers and facilitators to healthy diet, examine the prevalence of food insecurity, and determine interest in specific healthy diet interventions. Methods: Pregnant women, aged 18-50 years (N = 38), diagnosed with HTN, hypertensive disorders in pregnancy (HDP), or risk factors for HDP, were recruited from a large academic medical center in central Massachusetts between June 2020 and June 2022. Participants completed an electronic survey using a 5-point Likert scale (strongly disagree to strongly agree). Results: The mean age of participants was 31.6 years (SD 5.5) and 35.1% identified as Hispanic. Finances and time were major barriers to a healthy diet, reported by 42.1% and 28.9% of participants, respectively. Participants reported that their partners and families were supportive of healthy eating and preparing meals at home, though 30.0% of those with children considered their children's diet a barrier to preparing healthy meals. Additionally, 40.5% of the sample were considered food insecure. Everyone agreed that healthy diet was important for maternal and fetal health, and the most popular interventions were healthy ingredient grocery deliveries (89.4%) and meal deliveries (84.2%). Conclusion: Time and cost emerged as major challenges to healthy eating in these pregnant women. Such barriers, facilitators, and preferences can aid in intervention development and policy-level changes to mitigate obstacles to healthy eating in this vulnerable patient population.

Study Design and Data Analysis of Artificial Pancreas Device Systems with Closed-Loop Glucose-Sensing Insulin Delivery.

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.

Exploring the Dynamics of Hemorrhagic Fever with Renal Syndrome Incidence in East China Through Seasonal Autoregressive Integrated Moving Average Models.

OBJECTIVE: 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.

Neutral diagnosis: An innovative concept for medical device clinical trials.

Study design and statistical analysis are crucial in pivotal clinical trials to evaluate the effectiveness and safety of new medical devices under investigation. In recent years, innovative intraoperative in vivo breast tumor diagnostic devices have been proposed to improve the accuracy and surgical outcomes of breast tumor patients undergoing resection. Although such technologies are promising, investigators need to obtain statistical evidence for the effectiveness and safety of these devices by conducting valid clinical trials. However, the study design and statistical analysis for these clinical trials are complicated. While these trials are designed to provide real-time intraoperative diagnosis of cancerous tissue, they also have clear therapeutic objectives to lower the reoperation rate of breast cancer surgery. This research article introduces the new concept of neutral diagnosis (ND), and the ND clinical trial design as an innovative study design to evaluate the effectiveness and safety of diagnostic devices with direct therapeutic purposes. A joint modeling approach is adopted to make inferences on the effectiveness and safety of these devices for non-neutral diagnosis (non-ND) clinical trials. Simulation studies were conducted to show the efficiency of the ND trials and strength of the joint modeling approach in the non-ND clinical trials. An example on a diagnostic medical device that provides real-time, intraoperative diagnosis of breast cancer tumor tissues during breast cancer surgeries is comprehensively discussed and analyzed.