Effect of angiotensin-converting enzyme inhibitor and angiotensin receptor blocker initiation on organ support-free days in patients hospitalized with COVID-19

IMPORTANCE Overactivation of the renin-angiotensin system (RAS) may contribute to poor clinical outcomes in patients with COVID-19. Objective To determine whether angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) initiation improves outcomes in patients hospitalized for COVID-19. DESIGN, SETTING, AND PARTICIPANTS In an ongoing, adaptive platform randomized clinical trial, 721 critically ill and 58 non–critically ill hospitalized adults were randomized to receive an RAS inhibitor or control between March 16, 2021, and February 25, 2022, at 69 sites in 7 countries (final follow-up on June 1, 2022). INTERVENTIONS Patients were randomized to receive open-label initiation of an ACE inhibitor (n = 257), ARB (n = 248), ARB in combination with DMX-200 (a chemokine receptor-2 inhibitor; n = 10), or no RAS inhibitor (control; n = 264) for up to 10 days. MAIN OUTCOMES AND MEASURES The primary outcome was organ support–free days, a composite of hospital survival and days alive without cardiovascular or respiratory organ support through 21 days. The primary analysis was a bayesian cumulative logistic model. Odds ratios (ORs) greater than 1 represent improved outcomes. RESULTS On February 25, 2022, enrollment was discontinued due to safety concerns. Among 679 critically ill patients with available primary outcome data, the median age was 56 years and 239 participants (35.2%) were women. Median (IQR) organ support–free days among critically ill patients was 10 (–1 to 16) in the ACE inhibitor group (n = 231), 8 (–1 to 17) in the ARB group (n = 217), and 12 (0 to 17) in the control group (n = 231) (median adjusted odds ratios of 0.77 [95% bayesian credible interval, 0.58-1.06] for improvement for ACE inhibitor and 0.76 [95% credible interval, 0.56-1.05] for ARB compared with control). The posterior probabilities that ACE inhibitors and ARBs worsened organ support–free days compared with control were 94.9% and 95.4%, respectively. Hospital survival occurred in 166 of 231 critically ill participants (71.9%) in the ACE inhibitor group, 152 of 217 (70.0%) in the ARB group, and 182 of 231 (78.8%) in the control group (posterior probabilities that ACE inhibitor and ARB worsened hospital survival compared with control were 95.3% and 98.1%, respectively). CONCLUSIONS AND RELEVANCE In this trial, among critically ill adults with COVID-19, initiation of an ACE inhibitor or ARB did not improve, and likely worsened, clinical outcomes. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT0273570

Screening for Intimate Partner Violence

Intimate partner violence (IPV) is a serious concern for women that is associated with significant adverse health effects. Routine screening for IPV is recommended, but there are many barriers to screening that have been identified by providers, including discomfort, lack of training, and not knowing how to respond to a positive screen. This article reviews IPV screening and appropriate techniques for responding to a positive screen. IPV screening best practices include using a systematic protocol, developing a screening script, using a validated screening tool, and considerations for privacy and mandatory reporting. Responding to a positive screen should include acknowledging the experience, asking if the woman desires help, offering support and referrals, encouraging safety planning, and completing additional assessments to determine level of danger and to identify any comorbidities. Using these techniques along with therapeutic communication may increase IPV identification and create an environment in which women feel empowered to get help

Feasibility of a pilot, randomized controlled trial using a personalized health monitoring device with pregnant women for behavioral sleep research

Sleep disruptions are common in pregnancy and can have significant maternal and infant health consequences. Management of sleep using a personal health monitoring (PHM) device may be effective in promoting behavior change and contribute to improved pregnancy-related sleep. The purpose of this pilot, randomized controlled trial was to determine the feasibility of recruitment (i.e., recruiting a 20% minority sample, most successful recruitment methods), retention, adherence, and data collection methods with a sample of pregnant women (n = 24) at 24 weeks gestation for a 12-week intervention using a PHM device. Of 24 enrolled participants, 20 (83%) were retained through the 12-week intervention and the follow-up at 2-4 weeks postpartum. The majority of participants had a four-year education and identified as White. Ninety-one percent (n = 11) wore the device for at least ten weeks. Pregnant women may be willing engage in sleep intervention research and wear a PHM to self-monitor sleep during pregnancy. Future research should consider recruitment methods tailored to recruit diverse populations of pregnant women

The Preliminary Efficacy of a Sleep Self-management Intervention Using a Personalized Health Monitoring Device during Pregnancy

Background: Sleep disturbances are common during pregnancy and are associated with the development of adverse pregnancy outcomes. Personal health monitors (PHM) can facilitate change in health behaviors, though few studies have examined their use in improving sleep during pregnancy. This pilot study aimed to characterize sleep changes during pregnancy in women participating in a self-management intervention using a PHM. Participants/Methods: Participants with low risk, singleton pregnancies from Western Massachusetts were randomized at 24 weeks gestation to receive sleep education only (n = 12) or sleep education, and PHM intervention (n = 12). The single-session sleep education was given at baseline by a registered nurse. Sleep quality, duration, efficiency, disturbances, daytime sleepiness, and fatigue were assessed at baseline and 12 weeks follow-up using questionnaires. We described mean +/- standard deviation within and between-group changes in each sleep outcome from baseline to 12 weeks follow-up. Results: The PHM arm experienced larger sleep quality improvements and daytime sleepiness than the sleep-education only arm, but the differences were not statistically significant. In the PHM arm, the Pittsburgh Sleep Quality Index (PSQI) score decreased (i.e., sleep quality increased) 1.22 +/- 2.39 (p = .16), and the Epworth Sleepiness Scale (ESS) score decreased (i.e., daytime sleepiness decreased) 1.11 +/- 2.08 (p = .15). In the sleep-education arm PSQI decreased 0.57 +/- 2.37 (p = .55) and ESS decreased 1.29 +/- 2.93 (p = .29). Neither group experienced statistically significant changes in sleep duration, efficiency, disturbances, or fatigue. Conclusion: Sleep education with PHM may improve or prevent decreases in sleep outcomes during pregnancy. Further investigation in larger trials is warranted

Impact of Intimate Partner Forced Sex on HIV Risk Factors in Physically Abused African American and African Caribbean Women.

We examined associations between intimate partner forced sex (IPFS) and HIV sexual risk behaviors among physically abused Black women. Women aged 18-55 in intimate relationships were interviewed in health clinics in Baltimore, MD and St. Thomas and St. Croix, US Virgin Islands (USVI). Of 426 physically abused women, 38% experienced IPFS; (Baltimore = 44 and USVI = 116). USVI women experiencing IPFS were more likely to have 3+ past-year sex partners (AOR 2.06, 95% CI 1.03-4.14), casual sex partners (AOR 2.71, 95% CI 1.42-5.17), and concurrent sex partners (AOR 1.94, 95% CI 1.01-3.73) compared to their counterparts. Baltimore women reporting IPFS were more likely to have exchanged sex (AOR 3.57, 95% CI 1.19-10.75). Women experiencing IPFS were more likely to report their abuser having other sexual partners in Baltimore (AOR 3.30, 95% CI 1.22-8.88) and USVI (AOR 2.03, 95% CI 1.20-3.44). Clinicians should consider the influence of IPFS on individual and partnership HIV sexual risk behaviors