Perspectives of Pregnant and Breastfeeding Women on Participating in Longitudinal Mother-Baby Studies Involving Electronic Health Records: Qualitative Study

Abstract

Background Electronic health records (EHRs) hold great potential for longitudinal mother-baby studies, ranging from assessing study feasibility to facilitating patient recruitment to streamlining study visits and data collection. Existing studies on the perspectives of pregnant and breastfeeding women on EHR use have been limited to the use of EHRs to engage in health care rather than to participate in research. Objective The aim of this study is to explore the perspectives of pregnant and breastfeeding women on releasing their own and their infants’ EHR data for longitudinal research to identify factors affecting their willingness to participate in research. Methods We conducted semistructured interviews with pregnant or breastfeeding women from Alachua County, Florida. Participants were asked about their familiarity with EHRs and EHR patient portals, their comfort with releasing maternal and infant EHR data to researchers, the length of time of the data release, and whether individual research test results should be included in the EHR. The interviews were transcribed verbatim. Transcripts were organized and coded using the NVivo 12 software (QSR International), and coded data were thematically analyzed using constant comparison. Results Participants included 29 pregnant or breastfeeding women aged between 22 and 39 years. More than half of the sample had at least an associate degree or higher. Nearly all participants (27/29, 93%) were familiar with EHRs and had experience accessing an EHR patient portal. Less than half of the participants (12/29, 41%) were willing to make EHR data available to researchers for the duration of a study or longer. Participants’ concerns about sharing EHRs for research purposes emerged in 3 thematic domains: privacy and confidentiality, transparency by the research team, and surrogate decision-making on behalf of infants. The potential release of sensitive or stigmatizing information, such as mental or sexual health history, was considered in the decisions to release EHRs. Some participants viewed the simultaneous use of their EHRs for both health care and research as potentially beneficial, whereas others expressed concerns about mixing their health care with research. Conclusions This exploratory study indicates that pregnant and breastfeeding women may be willing to release EHR data to researchers if researchers adequately address their concerns regarding the study design, communication, and data management. Pregnant and breastfeeding women should be included in EHR-based research as long as researchers are prepared to address their concerns.

Developing a digital informed consent app: opportunities and challenges of a new format to inform and obtain consent in public health research

“…These trust issues relate to ndings of Simon et al who reported on the trust barriers of minorities in the US towards using electronic informed consents and privacy and con dentiality concerns of rural participants [19]. Concerns about privacy and con dentiality were also reported by Hentschel and colleagues to be one of the dominant factors in pregnant women's willingness to share electronic health records of themselves and their infant [21]. In order to create more trust among parents in the digital informed consent procedure, it might be helpful to invest in personal face to face contact.…”

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

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“…Barriers to research participation at individual-level included concerns about privacy and confidentiality as well as time commitment. 11,12,14 Community-level barriers included inadequate clinical support 15 , study risks 16 , and the uncertainty around characterizing the research or intervention 12 . However, these observations were all conducted before the COVID-19 pandemic and there is a critical need to understand the perspectives of these populations during the COVID-19 pandemic.…”

“…Facilitators at the community level included lactation support [10], healthcare provider influences [12], and the trust between participants and providers [12]. Barriers to research participation at individual level included concerns about privacy and confidentiality as well as time commitment [11,12,14]. Community-level barriers included inadequate clinical support [15], study risks [16], and the uncertainty around characterizing the research or intervention [12].…”

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