Direct-to-participant recruitment of mothers and infants: A strategic approach during challenging pandemic times.

Under traditional circumstances, most clinical trials rely on in-person operations to identify, recruit, and enroll study participants and to complete study-related visits. During unusual circumstances, such as the COVID-19 pandemic, the typical clinical trial model is challenged and forced to explore alternative approaches to implementing study recruitment, participant enrollment, and data collection strategies. One such alternative is a direct-to-participant approach which leverages electronic resources and relevant technological devices (e.g., smart phones) available to researchers and patients. This approach functions under the assumption that a participant has access to a device that connects to the internet such as a smart phone, tablet, or computer. Researchers are then able to transition a typical paper-based, in-person model to an electronic-based, siteless, remote study. This article describes the challenges clinicians and researchers faced when implementing a direct-to-participant study approach during the COVID-19 pandemic. The lessons learned during this study of infant populations could help increase efficiency of future trials, specifically, by lessening the burden on participants and clinicians as well as streamlining the process for enrollment and data collection. While direct-to-adult participant recruitment is not a novel approach, our findings suggest that studies attempting to recruit the infant population may benefit from such a direct-to-participant approach.

Cardiovascular Disease-Related Pregnancy Complications Are Associated with Increased Maternal Levels and Trajectories of Cardiovascular Disease Biomarkers During and After Pregnancy.

Background: Having a pregnancy complicated by hypertensive disorders of pregnancy (HDP) and/or having a small or preterm baby put a woman at risk for later cardiovascular disease (CVD). It is uncertain if higher maternal CVD risk factors (reflected by increased peripartum CVD biomarker levels) account for this risk, or if experiencing a complicated pregnancy itself increases a woman's CVD risk (reflected by an increase in biomarker trajectories from early pregnancy to postpartum). Methods: We conducted a secondary analysis of an 8-week mindful eating and stress reduction intervention in 110 pregnant women. We used mixed linear regression analysis to compare CVD biomarker levels and trajectories, between women with and without a CVD-related pregnancy complication (including HDP [gestational hypertension or preeclampsia] or having a small for gestational age [<10th percentile] or preterm [<37 weeks] baby), at three times: (1) 12-20 weeks of gestation, (2) 3 months postpartum, and (3) 9 months postpartum. CVD biomarkers studied included serum glucose, insulin, homeostasis model assessment of insulin resistance (HOMA-IR), body mass index (BMI), blood pressure (BP), interleukin-6 (IL-6), tumor necrosis factor, and lipids. We adjusted for age, maternal smoking, prepregnancy BMI, BP, age × time, and BMI × time. Results: Women had a mean age of 28 years (standard deviation [SD] 6), mean prior pregnancies of 0.8 (SD 1.0), and 22 women had one or more CVD-related pregnancy complications. HOMA-IR, diastolic BP, triglyceride, high-density lipoprotein cholesterol, and IL-6 average levels, but not trajectories, differed among women with complicated versus normal pregnancy (all p values were ≤0.04). Peripartum glucose and systolic BP trajectories were statistically greater in complicated versus normal pregnancies (p values were 0.008 and 0.01, respectively). Conclusion: We conclude that the experience of a complicated pregnancy in addition to elevated CVD risk factor levels may both increase a woman's risk of future CVD. ClinicalTrials.gov Identifier: NCT01307683.

Brain metastases from renal cell carcinoma in the era of tyrosine kinase inhibitors.

BACKGROUND: The effectiveness of tyrosine kinase inhibitors (TKI) in preventing brain metastases in patients with renal cell carcinoma is unclear. METHODS: Preclinical studies were conducted to determine the steady-state brain and plasma concentrations of sorafenib and sunitinib in mice deficient in the drug efflux transporters; p-glycoprotein, and breast cancer resistance protein. A single-institution retrospective analysis of patients treated from 2008 to 2010 was conducted to assess the incidence of brain metastases before and during TKI treatment. RESULTS: Transport of sorafenib and sunitinib across the blood-brain barrier was restricted. Retrospective analysis revealed that the median time to develop metastatic brain disease was 28 months (range, 1-108 months) while on TKI therapy and 11.5 months (range, 0-64 months) in patients who did not receive TKI therapy. The incidence of brain metastases per month in patients not treated with TKI therapy was 1.6 higher than the incidence in patients treated with TKI therapy. CONCLUSIONS: Penetration of sorafenib or sunitinib through an intact blood-brain barrier to brain tissue is limited; however, the incidence of brain metastases per unit time is decreased in patients on TKI therapy in comparison with the "cytokine" era.