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, 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 25-34 years of age (n=259, 49%) and identified as White (n=303, 47%) 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. Non-invasive 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.
BackgroundPreeclampsia (PE) is one of the leading factors in maternal and perinatal mortality and morbidity worldwide. The only cure for PE to date is to deliver the placenta and stop gestation. However, the timing of delivery among PE patients is essential to minimize the risk of severe maternal morbidities, and at the same time ensure the survival of the baby.MethodsIn this study, we constructed a series of deep learning-based models to predict the prognosis, or the time to delivery, since the initial diagnosis of PE using electronic health record (EHR) data. We extracted and processed 1578 pregnancies in Michigan Medicine at the University of Michigan in 2015-2021 as the discovery cohort. Using the Cox-nnet v2 algorithm, we built the baseline model with EHR information prior to diagnosis, as well as the full model including baseline information and lab testing results and vital signs at the time of diagnosis. We evaluated the models using the C-index and log-rank p-values in KM survival curves, using both 20% testing data of the Michigan cohort, as well as 1177 PE pregnancy EHR data from the Medical Center of the University of Florida.ResultsThe baseline prognosis model for time to delivery since PE diagnosis achieved C-index values of 0.75 and 0.72 on the training and testing set respectively. While the full model reached C-indices of 0.77 and 0.74 in the same training and testing sets. Both models performed better than their Cox-PH model counterparts. The seven most important features in the baseline model in descending order were diagnosis gestational age, severe PE, past PE, age, parity, gravidity, and uncomplicated diabetes. Meanwhile, 14 most important features were selected and interpreted in the full model, including diagnosis gestational age, parity, severe PE, past PE, features in lab tests (white blood cell, platelet, and red blood cell counts, AST value), min respiratory rate, and features measuring blood pressure (minimum, mean and standard deviation of systolic blood pressure, and maximum and standard deviation of diastolic blood pressure).ConclusionThe time to delivery predicting models provide clinicians valuable tools and options to quantify the delivery risks and make better decisions on the optimal delivery time of PE patients at the time of diagnosis. Implementation of these actionable models into PE clinical care practice is expected to significantly improve the management of PE patients.
Background Preeclampsia is a potentially fatal complication during pregnancy, characterized by high blood pressure and presence of proteins in the urine. Due to its complexity, prediction of preeclampsia onset is often difficult and inaccurate. Methods This study aims to create quantitative models to predict the onset gestational age of preeclampsia using electronic health records. We retrospectively collected 1178 preeclamptic pregnancy records from the University of Michigan Health System(UM) as the discovery cohort, and 881 records from the University of Florida Health System(UF) as the validation cohort. We constructed two Cox-proportional hazards models with Lasso regularization: one baseline model utilizing maternal and pregnancy characteristics, and the other full model with additional lab results, vital signs, and medications in the first 20 weeks of pregnancy. We built the models using 80% of the UM data and subsequently tested them on the remaining 20% UM data and validated with UF data. We further stratified the patients into high and low risk groups for preeclampsia onset risk assessment. Findings The baseline model reached C-indices of 0.64 and 0.61 in the 20% UM testing data and the UF validation data, respectively, while the full model increased these C-indices to 0.69 and 0.61 respectively. Both the baseline and full models contain five selective features, among which number of fetuses in the pregnancy, hypertension and parity are shared between the two models with similar hazard ratios. In the baseline model, history of complicated type II diabetes and a mood/anxiety disorder during the first 20 weeks of pregnancy were important. In the full model, maximum diastolic blood pressure in early pregnancy was the predominant feature. Interpretation Electronic health record data provide useful information to predict gestational age of preeclampsia onset. Stratification of the cohorts using five-predictor Cox-PH models provide clinicians with convenient tools to assess the patient onset time of preeclampsia. Funding This study was supported by grants through the NIEHS, NICHD, NIDDK, and NCATS.
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