Understanding willingness and barriers to participate in clinical trials during pregnancy and lactation: findings from a US study.

BACKGROUND: Due to the exclusion of pregnant and lactating people from most clinical trials, there is an incomplete understanding of the risks and benefits of medication use in these populations and therapeutic decision-making is often conducted without adequate evidence. To change this paradigm, it is imperative to understand the perspectives of pregnant and lactating individuals concerning their participation in clinical trials. OBJECTIVES: To describe attitudes, perceptions, barriers, and preferences of pregnant and postpartum people in the United States (US) regarding participation in clinical trials and to identify factors influencing participation. METHODS: In November 2022, individuals aged ≥ 18 residing in the US who self-identified as pregnant or pregnant within the last 12 months were invited to complete an online survey about their perspectives regarding clinical trial participation. The survey included questions about demographic characteristics, health history, behaviors, and willingness to participate in clinical trials while pregnant and/or lactating. Multivariable logistic regression models were fit to identify predictors of clinical trial participation. RESULTS: Among the 654 respondents, 34.8% and 40.9% reported being likely or extremely likely to participate in a clinical trial for a new medication while pregnant or lactating, respectively; and 24.5% and 41.7% for a new vaccine while pregnant or lactating, respectively. Higher educational attainment (≥ Bachelor's degree) was associated with greater likelihood of clinical trial participation in pregnancy (odds ratio (OR) = 1.50, 95% Confidence Interval (CI): 1.01, 2.25 for medications; OR = 2.00, 95% CI: 1.28, 3.12 for vaccines). Chronic medical conditions were associated with a greater likelihood of participation in clinical trials for vaccines during lactation (OR = 1.59, 95% CI: 1.07, 2.36). The most cited motivator for participation in a clinical trial while pregnant or lactating was anticipated personal medical benefit (85.8% and 75.6%, respectively), while the primary deterrent was possible risk to the fetus or baby (97.9% and 97.2%, respectively). CONCLUSIONS: Willingness of a US sample to participate in clinical trials while pregnant or lactating varied by demographics and health status, with safety to the fetus being a nearly universal concern. These findings have implications for enhancing inclusion of pregnant and lactating people in clinical research and developing effective and equitable recruitment strategies.

Maternal health expert feedback on the attributes of a predictive analytics tool to improve pregnancy-related cardiovascular and mental health outcomes in the United States.

Identify pregnancy-related challenges and opportunities to improve maternal health care in the United States and understand the potential role of predictive analytics tool(s) in bridging the existing gaps, specifically, in CVD (cardiovascular disease) and depression. Experts in maternal health care, research, patient advocacy, CVD, psychiatry, and technology were interviewed during February and March of 2020. Additionally, published literature was reviewed to assess existing data, insights, and best practices that might help develop effective predictive analytics tool(s). The majority (78%) of the 18 experts interviewed were women. The feedback revealed several insights, including multiple barriers to diagnosis and treatment of pregnancy-related CVD and depression. In experts' collective opinion, predictive analytics could play an important role in maternal health care and in limiting pregnancy-related CVD and depression, but it must be grounded in quality data and integrate with existing health management systems. A holistic approach to maternal health that factors in racial-ethnic, regional, and socioeconomic disparities is needed that starts with preconception counseling and continues through 1 year postpartum. Predictive analytics tool(s) that are based on diverse and high-quality data could bridge some of the existing gaps in maternal health care and potentially help limit pregnancy-related CVD and depression.

Sex differences in sequelae from COVID-19 infection and in long COVID syndrome: a review.

OBJECTIVE: We conducted literature reviews to uncover differential effects of sex on sequelae from coronavirus disease 2019 (COVID-19) and on long COVID syndrome. METHODS: Two authors independently searched OvidSP in Embase, Medline, Biosis, and Derwent Drug File. Publications reporting original, sex-disaggregated data for sequelae of COVID-19 (published before August 2020) and long COVID syndrome (published before June 2021) were included in the reviews. The association between COVID-19 sequelae (i.e. lasting <4 weeks after symptom onset) and sex, and between long COVID syndrome (i.e. lasting >4 weeks after symptom onset) and sex, was determined by odds ratio (OR) and 95% confidence interval (CI) (statistical significance defined by 95% CI not including 1). RESULTS: Of 4346 publications identified, 23 and 12 met eligibility criteria for COVID-19 sequelae and long COVID syndrome, respectively. COVID-19 sequelae in the categories of psychiatric/mood (OR = 1.80; 95% CI: 1.35-2.41), ENT (OR = 1.42; 95% CI: 1.39-1.46), musculoskeletal (OR = 1.15; 95% CI: 1.14-1.16), and respiratory (OR = 1.09; 95% CI: 1.08-1.11) were significantly more likely among females (vs. males), whereas renal sequelae (OR = 0.83; 95% CI: 0.75-0.93) were significantly more likely among males. The likelihood of having long COVID syndrome was significantly greater among females (OR = 1.22; 95% CI: 1.13-1.32), with the odds of ENT (OR = 2.28; 95% CI: 1.94-2.67), GI (OR = 1.60; 95% CI: 1.04-2.44), psychiatric/mood (OR = 1.58; 95% CI: 1.37-1.82), neurological (OR = 1.30; 95% CI: 1.03-1.63), dermatological (OR = 1.29; 95% CI: 1.05-1.58), and other (OR = 1.36; 95% CI: 1.25-1.49) disorders significantly higher among females and the odds of endocrine (OR = 0.75; 95% CI: 0.69-0.81) and renal disorders (OR = 0.74; 95% CI: 0.64-0.86) significantly higher among males. CONCLUSIONS: Sex-disaggregated differences for COVID-19 sequelae and long COVID syndrome were observed. Few COVID-19 studies report sex-disaggregated data, underscoring the need for further sex-based research/reporting of COVID-19 disease.

Preferences of Patients with Chronic Hepatitis B - A Discrete Choice Experiment on the Acceptability of Functional Cure.

BACKGROUND: Current antiviral therapies for chronic hepatitis B (CHB) rarely achieve functional cure, thus often requiring lifelong therapy. A therapy achieving functional cure in a significant percentage of patients could change the treatment landscape substantially. However, the acceptability of functional cure by patients is unknown, especially if associated with additional treatment burden. METHODS: A Discrete Choice Experiment (DCE) including patients with CHB was performed between 2018 and 2019 in Germany. Patient inclusion criteria were confirmed CHB; age of at least 18 years; no history of hepatocellular carcinoma; no HIV or HCV/HDV co-infection. The final DCE included the following attributes: route of administration (oral administration by tablets; subcutaneous injection + tablets; intramuscular electroporation + tablets), side effect frequency (0/1/3 days per month), functional cure (1%/30%/50% of patients), frequency of physician visits (monthly, half-yearly) and travel time to treating physician (15/45 min). RESULTS: The main analysis sample consisted of 108 patients with CHB (mean age: 49.1 years, female: 37.0%, average time since CHB diagnosis: 14.0 years, 52.8% with Hepatitis B surface antigen (HBsAg) chronic HBV infection). High efficacy was found to be the main driver of decisions for/against the presented treatment options (impacted 57% of patients' decisions), followed by therapy regimen (17%), safety profile (12%) and number of physician visits (11%). Latent class analysis revealed first insights into different decision patterns, with age, gender and previous side-effect experience affecting patients' decisions. CONCLUSION: In comparison to all other treatment-related attributes such as therapy regimen or safety profile, patients with CHB showed a strong preference towards a scenario where a substantial number of patients benefit from sustained disease remission, which mimics functional cure.