Peripartum women's perspectives on research study participation in the OneFlorida Clinical Research Consortium during COVID-19 pandemic.

Introduction: The COVID-19 pandemic created an unprecedented need for population-level clinical trials focused on the discovery of life-saving therapies and treatments. However, there is limited information on perception of research participation among perinatal populations, a population of particular interest during the pandemic. Methods: Eligible respondents were 18 years or older, were currently pregnant or had an infant (≤12 months old), and lived in Florida within 50 miles of sites participating in the OneFlorida Clinical Research Consortium. Respondents were recruited via Qualtrics panels between April and September 2020. Respondents completed survey items about barriers and facilitators to participation and answered sociodemographic questions. Results: Of 533 respondents, most were between 25 and 34 years of age (n = 259, 49%) and identified as White (n = 303, 47%) and non-Hispanic (n = 344, 65%). Facebook was the most popular social media platform among our respondents. The most common barriers to research participation included poor explanation of study goals, discomforts to the infant, and time commitment. Recruitment through healthcare providers was perceived as the best way to learn about clinical research studies. When considering research participation, "myself" had the greatest influence, followed by familial ties. Noninvasive biological samples were highly acceptable. Hispanics had higher positive perspectives on willingness to participate in a randomized study (p = 0.009). Education (p = 0.007) had significant effects on willingness to release personal health information. Conclusion: When recruiting women during the pregnancy and postpartum periods for perinatal studies, investigators should consider protocols that account for common barriers and preferred study information sources. Social media-based recruitment is worthy of adoption.

A Checklist for Reproducible Computational Analysis in Clinical Metabolomics Research.

Clinical metabolomics emerged as a novel approach for biomarker discovery with the translational potential to guide next-generation therapeutics and precision health interventions. However, reproducibility in clinical research employing metabolomics data is challenging. Checklists are a helpful tool for promoting reproducible research. Existing checklists that promote reproducible metabolomics research primarily focused on metadata and may not be sufficient to ensure reproducible metabolomics data processing. This paper provides a checklist including actions that need to be taken by researchers to make computational steps reproducible for clinical metabolomics studies. We developed an eight-item checklist that includes criteria related to reusable data sharing and reproducible computational workflow development. We also provided recommended tools and resources to complete each item, as well as a GitHub project template to guide the process. The checklist is concise and easy to follow. Studies that follow this checklist and use recommended resources may facilitate other researchers to reproduce metabolomics results easily and efficiently.

Acceptability of Research and Health Care Visits During the COVID-19 Pandemic: Cross-sectional Survey Study.

BACKGROUND: The COVID-19 pandemic has had a widespread impact on attendance in biomedical research and health care visits. OBJECTIVE: This study aimed to identify when and how American adults might feel comfortable about resuming in-person research and health care visits. METHODS: Cross-sectional questionnaire data were collected from 135 adults (age: median 48 years; women: n=113, 83.7%; White participants: n=92, 68.2%) who were engaged in health-related research. RESULTS: More than half of the respondents (65/122, 53.3%) felt that the COVID-19 pandemic positively affected their desire to participate in research. Although 73.6% (95/129) of respondents also indicated a willingness to attend in-person health care visits while Centers for Disease Control and Prevention (CDC) guidelines are implemented, 85.8% (109/127) indicated a willingness to attend in-person, outdoor visits, and 92.2% (118/128) reported a willingness to attend drive-through visits (with CDC guidelines implemented during both visit types). Videoconferencing was the most preferred format for intervention visits; however, adults over the age of 65 years preferred this format less than younger adults (P=.001). CONCLUSIONS: Researchers and clinicians should continue to provide opportunities for continuing the conduction of remote-based interventions while enforcing CDC guidelines during in-person visits.

COVID-19 Impacts Mental Health Outcomes and Ability/Desire to Participate in Research Among Current Research Participants.

OBJECTIVE: This study aimed to examine the impact of coronavirus disease 2019 (COVID-19) on current research participants' mental health outcomes, ability to adhere to behavioral intervention recommendations, and desire to participate in research. METHODS: A quantitative/qualitative cross-sectional survey was used among adults currently enrolled in health-related research (N = 250; 85% women; > 50% currently enrolled in behavioral weight loss intervention). RESULTS: COVID-19 was perceived as a severe threat by most (62.3%). Related to COVID-19, 29.6% of participants reported moderate/severe symptoms of anxiety/depression, and 68.4% reported moderate/severe posttraumatic stress disorder (PTSD) symptomatology, with women more likely to demonstrate moderate/severe anxiety/depression (P = 0.047) and PTSD symptomatology (P = 0.028) relative to men. Those with moderate/severe levels of anxiety/depression (P = 0.0154) and distress (P = 0.0330) were more likely to report a decreased desire to participate in research. Among those in behavioral interventions, individuals perceiving COVID-19 as a moderate/severe threat or experiencing moderate/severe depression or PTSD symptomatology were 4 to 19 times more likely to report that COVID-19 affected their ability to adhere to behavioral recommendations. Qualitative analysis identified four themes describing COVID-19's impact on research experiences: transition, remote intervention delivery, ability to adhere to program goals, and research participation interest. CONCLUSIONS: These data suggest that participants engaged in health-related research perceive COVID-19 as a significant threat, affecting mental health, desire to participate in research, and ability to adhere to intervention recommendations.