Introduction Stakeholders continue to discuss the appropriateness of antiretroviral‐based pre‐exposure prophylaxis (PrEP) for HIV prevention among sub‐Saharan African and other women. In particular, women need formulations they can adhere given that effectiveness has been found correlate with adherence. Evidence from family planning shows contraceptive use, continuation adherence may be increased by expanding choices. To explore potential role choice in women's use methods, we conducted a...

The Sacred Mountain Youth Project was conducted to investigate risk and protective factors related alcohol drug use among American Indian youth. Findings indicated that stressful life events were positively associated with depressed mood, substance use, risky behavior; cultural identity had no direct effects, but a secondary model showed social support family peer influences identity. These findings suggest the relationships between stressors their negative sequelae are complex. Emphasis on...

<h3>Importance</h3> Parents who receive a prenatal diagnosis of congenital heart disease may experience more short- and long-term stress than those postnatal diagnosis. To identify potential interventions to ameliorate that stress, the longitudinal emotional parents must first be understood. <h3>Objective</h3> better understand parents' accounts their own experience, particularly aspects they found stressful or challenging, strategies improve support. <h3>Design, Setting, Participants</h3>...

Mobile devices with health apps, direct-to-consumer genetic testing, crowd-sourced information, and other data sources have enabled research by new classes of researchers. Independent researchers, citizen scientists, patient-directed self-experimenters, others are not covered federal regulations because they recipients financial assistance or conducting in anticipation a submission to the FDA for approval drug medical device. This article addresses difficult policy challenge promoting...

Background: The increased use of electronic health records (EHRs) has resulted in new opportunities for research, but also raises concerns regarding privacy, confidentiality, and patient awareness. Because public trust is essential to the success research enterprise, perspectives are development implementation ethical approaches EHRs. Yet, little known about patients' views expectations various seeking permission their EHR data. Methods: We conducted semi-structured interviews with 120...

Neither the range of potential results from genomic research that might be returned to participants nor future uses stored data and biospecimens can fully predicted at outset a study. Informed consent procedures require clear explanations about how by whom decisions are made what principles criteria apply. To ensure trustworthy governance, there is also need for empirical studies incorporating public input evaluate strengthen these processes.

Background: Comparative effectiveness research (CER) and pragmatic clinical trials commonly test interventions that are in routine use pose minimal incremental risk or burdens to patients who participate this research. The objective of study was elicit the range patients' views opinions regarding a variety different types on usual medical practices, especially notification authorization for them. Methods: We conducted 12 focus groups with adults five U.S. cities—six addressing CER ("CER...

Background/Aims: An increasing body of research is being conducted with non-English-speaking subjects. Study-related materials, including those essential for obtaining informed consent, must often be translated from English into other languages. In this study, we sought to examine the types issues that may arise when consent materials are Spanish. Methods: Drawing on expertise five individuals associated our team, four whom native Spanish speakers different dialects Spanish, crafted...

Precision medicine research is underway to identify targeted approaches improving health and preventing disease. However, such endeavors raise significant privacy confidentiality concerns. The objective of this study was elucidate the potential benefits harms associated with precision through in-depth interviews a diverse group thought leaders, including primarily U.S.-based experts scholars in areas ethics, genome research, law, historically-disadvantaged populations, informatics,...

EHR phenotyping offers the ability to rapidly assemble a precisely defined cohort of patients prescreened for eligibility participate in health-related research. Even so, stakeholders process must still contend with practical and ethical challenges associated research recruitment. Patient perspectives on these matters are particularly important given that success recruitment depends patients' willingness participate.

Objective: The goal of this study was to determine surgical patients’ perceptions hypothetical continuous audio-video OR recording (ORR). Summary Background Data: Continuous the operating room (OR), akin aviation industry's black box, has been proposed as a means enhance training, supplement medical record, and allow large-scale analysis performance safety. These recordings would include patients' bodies; yet, understanding patient regarding such technology is limited. Methods:...

Precision medicine research is rapidly taking a lead role in the pursuit of new ways to improve health and prevent disease, but also presents challenges for protecting human subjects. The extent which current "web" legal protections, including technical data security measures, as well measures restrict access or misuse data, will protect participants this context remains largely unknown. Understanding strength, usefulness, limitations constellation laws, regulations, procedures critical...

The VIVID (Videos for Addressing Racial Disparities in Implantable Cardioverter Defibrillator Therapy via Innovative Designs) study was a multicenter, randomized controlled trial aimed at evaluating the effectiveness of video-based decision support tool enhancing informed consent implantable cardioverter defibrillator (ICD) implantation among Black patients who met guideline criteria primary prevention ICDs. Within broader trial, qualitative investigation conducted to elucidate decisional...

Direct-to-consumer genetic testing is marketed as a tool to uncover ancestry and kin. Recent studies of actual potential users have demonstrated that individuals' responses the use these tests for purposes are complex, with privacy, disruptive consequences, misuse, secondary by law enforcement cited concerns. We conducted six focus groups diverse sample participants (n = 62) who were aware but had not used direct-to-consumer tests, in an effort understand more about what people considering...

Background: For pragmatic clinical research comparing commonly used treatments, questions exist about if and how to notify participants it secure their authorization for participation. Objective: To determine patients react when they seek care encounter one of several different studies. Research Design: In an online survey using a between-subjects experimental design, respondents read responded 1 24 hypothetical scenarios reflecting types studies approaches notification (eg, general...

Aim: Practicing physicians inevitably become involved in pragmatic clinical trials (PCTs), including comparative effectiveness research. We sought to identify physicians’ perspectives related PCTs. Methods: In-depth semistructured interviews with 20 the USA. Results: Although are generally willing participate PCTs, their support is predicated on several factors expected benefits, minimization of time and workflow burdens physician engagement. Physicians communicated a desire respect...

The use of electronic health records (EHRs) for research has the potential to improve diagnosis and treatment disease, yet contact with patients based on results EHR phenotyping received little attention. Researchers will almost certainly discover discrepancies in EHRs that call resolution and, some cases, raise ethical dilemma whether about a potentially undiagnosed or untreated concern. objective this study was explore patients' attitudes opinions by researchers who have had access their...

Abstract Objective: To better understand parents’ accounts of their prenatal and postnatal experience after diagnosis CHD – particularly emotional processing coping mechanisms to identify strategies improve support. Methods: This single-centre, longitudinal qualitative study included pregnant mothers support persons seen in Fetal Cardiology Clinic at Vanderbilt Children’s Hospital from May through August 2019 for probable complex CHD. Twenty-seven individuals 17 families participated 62...

Researchers now commonly collect biospecimens for genomic analysis together with information from mobile devices and electronic health records. This rich combination of data creates new opportunities understanding addressing important issues, but also intensifies challenges to privacy confidentiality. Here, we elucidate the “web” legal protections precision medicine research by integrating findings qualitative interviews structured applying them realistic scenarios involving various threats.

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To assist in resolving ethical questions surrounding unregulated mHealth research, we conducted in-depth qualitative interviews with experts from four key stakeholder groups: patient/research advocates, researchers, regulatory professionals, and mobile app/device developers. They discussed challenges potential solutions the context of two hypothetical scenarios involving including notifications/permissions for research use data, data access procedures, new primary collection, offering...

ABSTRACT Biomedical research is increasingly capitalizing on an array of data to illuminate the interplay between “omics,” lifestyle, and health. Leveraging this information presents opportunities advance knowledge but also poses risks participants. In interviews with thought leaders, we asked which type associated a hypothetical precision medicine endeavor was riskiest: 42% chose ongoing access electronic health records, 17% genomic analyses biospecimens, 15% streaming from mobile devices....

Abstract Background Efforts to improve informed consent have led calls for providing information a reasonable person would want have, in way that facilitates understanding of the reasons why one might or not participate. At same time, advances large-scale genomic research expanded both opportunities and risks participants, families, communities. To advance use effective materials reflect this landscape, we used empirical data develop model language, as well brief questions assist people...

Objective: Identify the considerations academic surgeons use when determining which portions of a procedure are “critical” and necessitate their presence. Background: Teaching physicians required to be present for “critical portion” surgical procedures, but definition what constitutes critical portion remains elusive. Current guidelines defer surgeons' expert judgment in identifying portion(s) procedure; little is known about concepts apply deciding parts critical. Methods: Qualitative...

To examine opinions on trainee independence and attending presence among a cross-section of the general population explore how perceptions trust, past experiences, demographics interacted with comfort consenting to these surgical scenarios.Mixed-methods METHODS: Based prior qualitative analysis, we designed survey patient preferences values that focused trust in healthcare practitioners processes, which also included ratings three scenarios (including overlapping surgery). The was...