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Healthcare systems are using big data-driven methods to realize the vision of learning health systems and improve care quality. In so doing, many are partnering with third-party commercial companies to provide novel data processing and analysis capabilities, while also providing personal health information to a for-profit industry that may store and sell data. In this research we describe the public’s comfort with sharing health data with third-party commercial companies for patient and business purposes and how this comfort is associated with demographic factors (sex, age, race/ethnicity, education, employment, income, insurance status, and self-reported health status), perceived healthcare access, and concerns about privacy. We surveyed the US public (n = 1841) to assess comfort with sharing health data with third-party commercial companies for patient or business purposes and examined whether there was a difference between comfort with data sharing for patient or business purposes. Univariate and stepwise regression modeling is used here to estimate the relationship between comfort with third-party commercial companies for patient and business purposes (outcomes) and demographic factors, self-reported health status, perceived healthcare access, and privacy concerns. The public is more comfortable sharing health data with third party commercial companies for patient purposes as compared to business purposes (paired t = 39.84, p β = 0.205, p β = −0.145, p = 0.079). An inverse relationship exists between privacy concerns and comfort with sharing health data for both patient (β = −0.223, p β = −0.246, p β = −0.154, p = 0.0012) than participants aged 18–29. Proactive acknowledgment of privacy concerns and better communication of the steps being taken to protect the privacy of health data can increase patient comfort. Healthcare systems may be able to increase public and patient comfort with sharing health data with third-party commercial companies by emphasizing the patient-centered benefits of these partnerships.

Physicians are expected and incentivized to coordinate patient care with other providers, including nonphysician clinician (NPC) members of care teams, requiring trust. Trust in the context of care teams has not been well-studied; even less is known about how health information technologies (HIT) may modify trust in these relationships. We conducted semistructured interviews with 30 physicians at a Midwestern academic center to examine how physicians determine they can trust NPCs, and how technology modifies these relationships. A majority of physicians base trust in NPCs on cognitive factors such as competence and reliability. Technology enhances trust between physicians and NPCs by supporting evidence-based decision making; it can also erode trust by limiting opportunities for developing familiarity and comfort with fellow providers. Our work has implications for enhancing HIT to promote trust between providers, and for developing more robust measures of trust that can be used in evaluating and improving teamwork within practices.

Purpose Nations such as the USA are investing in technologies such as electronic health records in order to collect, store and transfer information across boundaries of health care, public health and research. Health information brokers such as health care providers, public health departments and university researchers function as “access points” to manage relationships between the public and the health system. The relationship between the public and health information brokers is influenced by trust; and this relationship may predict the trust that the public has in the health system as a whole, which has implications for public trust in the system, and consequently, legitimacy of involved institutions, under circumstances of health information data sharing in the future. This paper aims to discuss these issues. Design/methodology/approach In this study, the authors aimed to examine characteristics of trustors (i.e. the public) that predict trust in health information brokers; and further, to identify the factors that influence trust in brokers that also predict system trust. The authors developed a survey that was administered to US respondents in 2014 using GfK’s nationally representative sample, with a final sample of 1,011 participants and conducted ordinary least squares regression for data analyses. Findings Results suggest that health care providers are the most trusted information brokers of those examined. Beliefs about medical deceptive behavior were negatively associated with trust in each of the information brokers examined; however, psychosocial factors were significantly associated with trust in brokers, suggesting that individual attitudes and beliefs are influential on trust in brokers. Positive views of information sharing and the expectation of benefits of information sharing for health outcomes and health care quality are associated with system trust. Originality/value This study suggests that demonstrating the benefits and value of information sharing could be beneficial for building public trust in the health system; however, trust in brokers of information are variable across the public; that is, knowledge, attitudes and beliefs are associated with the level of trust different individuals have in various health information brokers – suggesting that the need for a personalized approach to building trust.

This study aimed to (1) examine what patient-centeredness means for older adults and family caregivers, and (2) assess circumstances underlying their preference for geriatric care. We conducted separate focus groups with older adults and family caregivers of older adults about health care experiences and expectations and conducted a vignette-based experiment to assess preference for geriatric care. Participants expressed a need for greater skill and empathy and integration of caregivers. They preferred geriatric care to usual primary care with increasing social, health, and healthcare complexity. Distinct needs of older adults should be considered in referral practices to geriatric medicine.

The volume of biomedical knowledge is growing exponentially and much of this knowledge is represented in computer executable formats, such as models, algorithms, and programmatic code. There is a growing need to apply this knowledge to improve health in Learning Health Systems, health delivery organizations, and other settings. However, most organizations do not yet have the infrastructure required to consume and apply computable knowledge, and national policies and standards adoption are not sufficient to ensure that it is discoverable and used safely and fairly, nor is there widespread experience in the process of knowledge implementation as clinical decision support. The Mobilizing Computable Biomedical Knowledge (MCBK) community was formed in 2016 to address these needs. This report summarizes the main outputs of the third annual MCBK public meeting, which was held virtually from June 30 to July 1, 2020 and brought together over 200 participants from various domains to frame and address important dimensions for mobilizing CBK.

Key Points Question What are the national prevalence, frequency, and main types of discrimination that adult patients report experiencing in the US health care system? Findings In this nationally representative cross-sectional survey study, 21% of 2137 US adult survey respondents indicated that they had experienced discrimination in the health care system, and 72% of those who had experienced discrimination reported experiencing it more than once. Racial/ethnic discrimination was the most frequently reported type of discrimination respondents experienced. Meaning Experiences of discrimination in the health care system appear to be more common than previously recognized and deserve considerable attention., Importance Although considerable evidence exists on the association between negative health outcomes and daily experiences of discrimination, less is known about such experiences in the health care system at the national level. It is critically necessary to measure and address discrimination in the health care system to mitigate harm to patients and as part of the larger ongoing project of responding to health inequities. Objectives To (1) identify the national prevalence of patient-reported experiences of discrimination in the health care system, the frequency with which they occur, and the main types of discrimination experienced and (2) examine differences in the prevalence of discrimination across demographic groups. Design, Setting, and Participants This cross-sectional national survey fielded online in May 2019 used a general population sample from the National Opinion Research Center’s AmeriSpeak Panel. Surveys were sent to 3253 US adults aged 21 years or older, including oversamples of African American respondents, Hispanic respondents, and respondents with annual household incomes below 200% of the federal poverty level. Main Outcomes and Measures Analyses drew on 3 survey items measuring patient-reported experiences of discrimination, the primary types of discrimination experienced, the frequency with which they occurred, and the demographic and health-related characteristics of the respondents. Weighted bivariable and multivariable logistic regressions were conducted to assess associations between experiences of discrimination and several demographic and health-related characteristics. Results Of 2137 US adult respondents who completed the survey (66.3% response rate; unweighted 51.0% female; mean [SD] age, 49.6 [16.3] years), 458 (21.4%) reported that they had experienced discrimination in the health care system. After applying weights to generate population-level estimates, most of those who had experienced discrimination (330 [72.0%]) reported experiencing it more than once. Of 458 reporting experiences of discrimination, racial/ethnic discrimination was the most common type (79 [17.3%]), followed by discrimination based on educational or income level (59 [12.9%]), weight (53 [11.6%]), sex (52 [11.4%]), and age (44 [9.6%]). In multivariable analysis, the odds of experiencing discrimination were higher for respondents who identified as female (odds ratio [OR], 1.88; 95% CI, 1.50-2.36) and lower for older respondents (OR, 0.98; 95% CI, 0.98-0.99), respondents earning at least $50 000 in annual household income (OR, 0.76; 95% CI, 0.60-0.95), and those reporting good (OR, 0.59; 95% CI, 0.46-0.75) or excellent (OR, 0.41; 95% CI, 0.31-0.56) health compared with poor or fair health. Conclusions and Relevance The results of this study suggest that experiences of discrimination in the health care system appear more common than previously recognized and deserve considerable attention. These findings contribute to understanding of the scale at which interpersonal discrimination occurs in the US health care system and provide crucial evidence for next steps in assessing the risks and consequences of such discrimination. The findings also point to a need for further analysis of how interpersonal discrimination interacts with structural inequities and social determinants of health to build effective responses., This cross-sectional study examines the responses to a recent National Opinion Research Center survey to assess the prevalence, frequency, and main types of discrimination experienced by adult patients in the US health care system.

Background In the past decade, Lynn Etheredge presented a vision for the Learning Health System (LHS) as an opportunity for increasing the value of health care via rapid learning from data and immediate translation to practice and policy. An LHS is defined in the literature as a system that seeks to continuously generate and apply evidence, innovation, quality, and value in health care. Objective This review aimed to examine themes in the literature and rhetoric on the LHS in the past decade to understand efforts to realize the LHS in practice and to identify gaps and opportunities to continue to take the LHS forward. Methods We conducted a thematic analysis in 2018 to analyze progress and opportunities over time as compared with the initial Knowledge Gaps and Uncertainties proposed in 2007. Results We found that the literature on the LHS has increased over the past decade, with most articles focused on theory and implementation; articles have been increasingly concerned with policy. Conclusions There is a need for attention to understanding the ethical and social implications of the LHS and for exploring opportunities to ensure that these implications are salient in implementation, practice, and policy efforts.

Medical biobanks often struggle to obtain sustainable funding. Commercialization of specimens is one solution, but disclosure of commercial interests to potential contributors can be dissuasive. Recent revisions to the federal human subjects research regulations will soon mandate such commercialization disclosure in some circumstances, which raises questions about implications for practice. In this nationally representative, probability-based survey sample of the US adult population, we found that 67 percent of participants agreed that clear notification of potential commercialization of biospecimens is warranted, but only 23 percent were comfortable with such use. Sixty-two percent believed that profits should be used only to support future research, and 41 percent supported sharing profits with the public. We also considered other factors related to disclosure in our analysis and argue for a "disclosure plus" standard: informing potential contributors that their biospecimens might be accessed by commercial organizations and explaining how profits would be used to both enhance transparency and facilitate contributors' altruistic motivations.

One of the significant modifications to the Common Rule is the requirement that prospective participants are given information sufficient for a “reasonable person”. However, there is limited research on what types of information patients, caregivers, and providers consider “key information”. Although certain aspects of informed consent (IC) may be considered standard, considering individualized needs and preferences of patients is necessary for patient-centered consent. In the current study, we qualitatively examined the specific types of information that patients and caregivers involved in hematopoietic cell transplantation (HCT), as well as their providers, believe are important and necessary as part of the IC process in order to make a decision about participating in clinical research; and further, how these perspectives are aligned. Our findings suggest opportunities for improving the IC document and process by emphasizing information of importance to patients such as the benefits to others and contributions to science that are associated with participation in clinical research. Further, increasing patient engagement during the IC process may enable providers to streamline information that is aligned with patient information needs and preferences.

Scholarship on newborn screening, dried bloodspot retention, and large population biobanking call consistently for improved public engagement. Communication with participants likely occurs only in the context of collection, consent, or notification, if at all. We ran an 11-week advertising campaign to inform Michigan Facebook users unlikely to know that their or their children's dried bloodspots (DBSs) were stored in a state biobank. We investigated the pattern and content of comments posted during the campaign, focusing on users' questions, attitudes and concerns, and the role the moderator played in addressing them. We used Facebook data to quantitatively assess engagement and employed conventional content analysis to investigate themes, attitudes, and social dynamics among user and moderator comments. Five ad sets elicited comments during campaign weeks 4-8, reaching ∼800,000 Facebook users ($6000). Gravitating around broad, underlying ethical, legal, and social issues, 180 posts from 129 unique users related to newborn screening or biobanking. Thirty six conveyed negative attitudes and 33 conveyed positive attitudes; 53 posed questions. The most prevalent themes identified were consent, privacy, bloodspot use, identifiability, inclusion criteria, research benefits, (mis)trust, genetics, DBS destruction, awareness, and the role of government. The moderator's 81 posts were responsive-answering questions, correcting or clarifying information, or providing information about opting out. Facebook ad campaigns can improve engagement by pushing out relevant content and creating dynamic, responsive, visible forums for discussion. Reduced control over messaging may be worth the trade-off for creating accessible, transparent, people-centered engagement on public health issues that are sensitive and complex.

The volume of biomedical knowledge is growing exponentially and much of this knowledge is represented in computer executable formats, such as models, algorithms and programmatic code. There is a growing need to apply this knowledge to improve health in Learning Health Systems, health delivery organizations, and other settings. However, most organizations do not yet have the infrastructure required to consume and apply computable knowledge, and national policies and standards adoption are not sufficient to ensure that it is discoverable and used safely and fairly, nor is there widespread experience in the process of knowledge implementation as clinical decision support. The Mobilizing Computable Biomedical Knowledge (MCBK) community formed in 2016 to address these needs. This report summarizes the main outputs of the Second Annual MCBK public meeting, which was held at the National Institutes of Health on July 18‐19, 2019 and brought together over 150 participants from various domains to frame and address important dimensions for mobilizing CBK.

Introduction: Health information generated by health care encounters, research enterprises, and public health is increasingly interoperable and shareable across uses and users. This paper examines the US public’s willingness to be a part of multi-user health information networks and identifies factors associated with that willingness.Methods: Using a probability-based sample (n = 890), we examined the univariable and multivariable relationships between willingness to participate in health information networks and demographic factors, trust, altruism, beliefs about the public’s ethical obligation to participate in research, privacy, medical deception, and policy and governance using linear regression modeling.Results: Willingness to be a part of a multi-user network that includes health care providers, mental health, social services, research, or quality improvement is low (26 percent–7.4 percent, depending on the user). Using stepwise regression, we identified a model that explained 42.6 percent of the variability in willingness to participate and included nine statistically significant factors associated with the outcome: Trust in the health system, confidence in policy, the belief that people have an obligation to participate in research, the belief that health researchers are accountable for conducting ethical research, the desire to give permission, education, concerns about insurance, privacy, and preference for notification.Discussion: Our results suggest willingness to be a part of multi-user data networks is low, but that attention to governance may increase willingness. Building trust to enable acceptance of multi-use data networks will require a commitment to aligning data access practices with the expectations of the people whose data is being used.

Background: Rapid treatment is critical to improve survival from out-of-hospital cardiac arrest (OHCA) and is directly affected by bystanders’ abilities to immediately recognize cardiac arrest, call 911, and provide early CPR and/or Automated External Defibrillation (AED). Given the critical element of early bystander interventions, we chose to use a learning health system (LHS) approach to reduce time-to-first-treatment for OHCA. In a LHS, a community of diverse stakeholders embark on continuous, data-driven learning to improve best practices and health outcomes. Methods: We established an OHCA learning community (LC) comprised of multidisciplinary representatives of the chain of survival in Michigan’s Washtenaw-Livingston county medical control authority region (a two-county entity, population 555,278, that coordinates emergency medical services). The LC aimed to accelerate the shared identification of priority areas for investigation and to facilitate more rapid implementation of innovative interventions to reduce OHCA response time. Results: We held two LC meetings. Using an approach that included facilitated discussion, 65 diverse stakeholders (OHCA survivors, 911 dispatchers, first responders, physicians) identified the following 4 themes as critical to improving time-to-first-treatment: 1) Improve bystander response; 2) Increase OHCA public awareness; 3) Reduce time-to-treatment and improve data collection for key process measures (time of cardiac arrest, time to first chest compression, time to AED); and 4) Improve post-cardiac arrest systems of care. The LC was supported by examination of standardized processes and infrastructure in a learning cycle (see graphic). These LC findings are being deployed in the Washtenaw-Livingston region to enhance OHCA data collection and increase bystander engagement; e.g. by establishing a system to review 911 calls to accurately assess times and identify systematic barriers to rapid treatment. Conclusions: The LHS approach and multi-stakeholder LC has led to the identification of community-owned key priority areas within a local context for OHCA. We believe this approach will accelerate the implementation and adoption of new data collection methods and innovative practices that will facilitate continuous learning and improvement.

Knowledge artifacts in digital repositories for clinical decision support (CDS) can promote the use of CDS in clinical practice. However, stakeholders will benefit from knowing which they can trust before adopting artifacts from knowledge repositories. We discuss our investigation into trust for knowledge artifacts and repositories by the Patient‐Centered CDS Learning Network's Trust Framework Working Group (TFWG). The TFWG identified 12 actors (eg, vendors, clinicians, and policy makers) within a CDS ecosystem who each may play a meaningful role in prioritizing, authoring, implementing, or evaluating CDS and developed 33 recommendations distributed across nine “trust attributes.” The trust attributes and recommendations represent a range of considerations such as the “Competency” of knowledge artifact engineers and the “Organizational Capacity” of institutions that develop and implement CDS. The TFWG findings highlight an initial effort to make trust explicit and embedded within CDS knowledge artifacts and repositories and thus more broadly accepted and used.

Informed consent (IC) struggles to meet the ethical principles it strives to embody in the context of hematopoietic cell transplantation (HCT). Patients often participate in multiple clinical trials making it difficult to effectively inform the participants and fulfill complex regulations. The recent Notice of Proposed Rule Making would make major changes to federal requirements, providing a timely opportunity to evaluate existing practice. Twenty health care professionals within a Midwest Academic Medical Center involved in obtaining IC in the HCT clinic or involved in patient care during or after the IC process were interviewed to understand: (1) how they approached the IC process; (2) how they described a 'successful' IC process; and (3) opportunities for innovation. Narrative and discourse analyses of interviews indicate that providers understand IC to be a collaborative process requiring engagement and participation of providers, patients and caregivers. 'Markers of success' were identified including cognitive, affective and procedural markers focusing on patient understanding and comfort with the decision to participate. Opportunities for innovating the process included use of decision aids and tablet-based technology, and better use of patient portals. Our findings suggest specific interventions for the IC process that could support the process of consent for providers, patients and caregivers.

BackgroundWith the emergence of new health information technologies, health information can be shared across networks, with or without patients’ awareness and/or their consent. It is often argued that there can be an ethical obligation to participate in biomedical research, motivated by altruism, particularly when risks are low. In this study, we explore whether altruism contributes to the belief that there is an ethical obligation to share information about one’s health as well as how other health care experiences, perceptions, and concerns might be related to belief in such an obligation.MethodsWe conducted an online survey using the National Opinion Research Center’s (NORC) probability-based, nationally representative sample of U.S. adults. Our final analytic sample included complete responses from 2069 participants. We used multivariable logistic regression to examine how altruism, together with other knowledge, attitudes, and experiences contribute to the belief in an ethical obligation to allow health information to be used for research.ResultsWe find in multivariable regression that general altruism is associated with a higher likelihood of belief in an ethical obligation to allow one’s health information to be used for research (OR = 1.22, SE = 0.14, p = 0.078). Trust in the health system and in care providers are both associated with a significantly higher likelihood of believing there is an ethical obligation to allow health information to be used (OR = 1.48, SE = 0.76, pConclusionsBelief that there is an ethical obligation to allow one’s health information to be used for research is shaped by altruism and by one’s experience with, and perceptions of, health care and by general concerns about the use of personal information. Altruism cannot be assumed and researchers must recognize the ways encounters with the health care system influence (un)willingness to share one’s health information.

Opportunities to advance science increasingly arise through investigations embedded within routine clinical practice in the form of learning health systems. Such activities challenge conventional approaches to research regulation that have not caught up with those opportunities, often imposing burdens generalized from riskier research. We analyze the rules and conventions in the US, demonstrating how even those rules are compatible with a much more flexible approach to participant risk, institutional oversight, participant consent, and disclosure for low-risk learning activities in all jurisdictions.

Biobanks are made all the more valuable when the biological samples they hold can be linked to health information collected in research, electronic health records, or public health practice. Public trust in such systems that share health information for research and health care practice is understudied. Our research examines characteristics of the general public that predict trust in a health system that includes researchers, health care providers, insurance companies and public health departments. We created a 119-item survey of predictors and attributes of system trust and fielded it using Amazon’s MTurk system (n = 447). We found that seeing one’s primary care provider, having a favorable view of data sharing and believing that data sharing will improve the quality of health care, as well as psychosocial factors (altruism and generalized trust) were positively and significantly associated with system trust. As expected, privacy concern, but counterintuitively, knowledge about health information sharing were negatively associated with system trust. We conclude that, in order to assure the public’s trust, policy makers charged with setting best practices for governance of biobanks and access to electronic health records should leverage critical access points to engage a diverse public in joint decision making.

Health information was once generally collected and reserved either to inform clinical care, conduct research, or survey the public's health. Today, with digital data infrastructure, health information can technically flow between all of these purposes simultaneously, enabling learning health systems (LHSs) and related enterprises. LHSs are emerging through infrastructural innovation that allows for connectedness in data collection, analytics to transform data to knowledge, and application of that knowledge in practice and in ways that generate new data through evaluation of outcomes (Figure 1).1 LHSs create cycles of continuous improvement that will allow health systems to address well‐known, chronic maladies—e.g., high rates of medical error, spiraling costs, the slow rate of translational science, and failure to implement agreed‐upon best practices.2, 3 LHSs represent an innovation in health infrastructure such that learning occurs at multiple levels of scale, ranging from individuals, single practices, and systems to systems of systems spanning organizational and geopolitical boundaries. LHSs are successful when platforms and culture support efficient organization of technology, people, processes, and policy.4 Open in a separate window Figure 1 Learning health systems are infrastructural innovations

Large population biobanks, important resources for genomic research, also present ethical challenges. The Michigan BioTrust for Health makes dried bloodspots (DBS) leftover from newborn screening, including ~4.5 million collected before 2010 without written consent, available for health research. Absent prospectively gathered consent and/or current engagement with 18- to 29-year olds, little is known about opinions and beliefs from this age group about use of the bloodspots for research. We engaged 2,101 students—BioTrust participants and their peers—at information booths at 20 college campuses across the state to educate youth about the BioTrust and gather information about consent preferences and about hopes and concerns about this public health program. We surveyed student stakeholder DBS research consent preferences and fielded a “postengagement” survey to gauge the attitudes of participants and to evaluate the campus engagement. The most prevalent themes in open-ended comments were support for biobank research and concern that Michiganders are not aware of their participation. While 78 % of students said they would, if asked, opt in to the BioTrust, half of these preferred to be contacted each time a researcher sought to use their DBS. Students reported great interest in the topic and strong likelihood to share what they had learned. BioTrust participants are interested in learning about their role in an initiative whose goals they widely support. Public engagement is particularly important to biobank participants who, absent traditional consent practices, are unaware of their participation. Health-fair style engagements were effective for targeting college-aged stakeholders, communicating complex messages, and likely increasing knowledge. Retrospective biobanks and biobanks that collect proxy consent need policies to respect those who would opt out and will need resources to educate participants and conduct community outreach that is a safeguard to public trust.

Improving health care and quality of life for older adults in the U.S. requires increased attention to the informal caregivers supporting aging relatives. Studies estimate that over 40 million unpaid caregivers provide more than $400 billion of unpaid care; however, there is little research examining the scope and variety of support caregivers provide. Less research has examined how caregivers conceptualize their experience beyond “caregiver burden”. A more comprehensive understanding of the types of support caregivers provide and caregiver perceptions of their role and purpose are critical to enhancing policies, e.g., the Family and Medical Leave Act, to be more responsive to caregiver needs. This study seeks to (a) identify the ways informal caregivers provide support and (b) describe what it means to be a caregiver from the perspective of informal caregivers. We conducted four focus groups with informal caregivers (relatives or partners) in Southeastern Michigan (n=18) and conducted qualitative thematic analyses. Support that caregivers provide ranges from financial planning to medical decision-making to social engagement. While caregivers face frustration and isolation consistent with “caregiver burden,” they also recognize positive attributes of being a caregiver such as overcoming adversity and helping elderly relatives maintain dignity. These attributes contribute to their identity of what it means to be a caregiver and perceived capacity to improve their relative’s health. Our findings suggest that we are underestimating the scope of work involved in care-giving and that a wider range of activities should be considered when developing workplace policies and resources to promote caregiver wellness.

Objective To measure public trust in a health information sharing in a broadly defined health system (system trust), inclusive of health care, public health, and research; to identify individual characteristics that predict system trust; and to consider these findings in the context of national health initiatives (e.g., learning health systems and precision medicine) that will expand the scope of data sharing. Data Sources Survey data (n = 1,011) were collected in February 2014. Study Design We constructed a composite index of four dimensions of system trust—competency, fidelity, integrity, and trustworthiness. The index was used in linear regression evaluating demographic and psychosocial predictors of system trust. Data Collection Data were collected by GfK Custom using a nationally representative sample and analyzed in Stata 13.0. Principal Findings Our findings suggest the public's trust may not meet the needs of health systems as they enter an era of expanded data sharing. We found that a majority of the U.S. public does not trust the organizations that have health information and share it (i.e., the health system) in one or more dimensions. Together, demographic and psychosocial factors accounted for ~18 percent of the observed variability in system trust. Future research should consider additional predictors of system trust such as knowledge, attitudes, and beliefs to inform policies and practices for health data sharing.

Informed consent is fundamental to ethical clinical practice and research. In the context of hematopoietic cell transplantation (HCT), informed consent struggles to meet its ideals of beneficence, justice, and respect for persons(1) given the severity of the disease and complexity of the treatment. As argued by D'Souza and colleagues in Bone Marrow Transplantation,(2) and as shown in other studies, including our own in the setting of pediatric HCT,(3) patient and caregiver expectations of consent are often left unmet in both adult and pediatric contexts. For example, participants enroll in studies with limited knowledge about what they are undertaking and find themselves involved in a rote, passive process that fails to inform and gets bogged down by legalistic language.(4) Consent is often requested under conditions characterized by duress. The medical urgency of HCT or associated treatments that are experimental often blurs the line between treatment and research, even from the clinicians’ perspective. Furthermore, miscommunication or misunderstanding is almost inevitable because the paper forms are overwhelmingly lengthy and complex.(5) Greater simplicity in terms of readability and length is a major goal of recent and forthcoming policy regarding informed consent. For example, the NCI’s Office of Human Research Protection and FDA developed a joint consensus in the “Development of Informed Consent Documents for Cancer Clinical Trials” for less complicated informed consent documents,(6) and the BMT CTN recently published new recommended guidelines for consent forms.(7) The Notice of Proposed Rule Making (NPRM) that would update the Common Rule calls for greater standardization, simplicity, and readability of forms.(8) However, improving patients’ comprehension of what they are consenting to will not be achieved without equal attention to the process of obtaining consent. Universal consent forms will always fall short of meeting the goals of being patient-centered, complete, and fulfilling institutional and regulatory requirements because of the diversity of individual patient needs.(9) Pediatric HCT provides an excellent case example of the need for a more personalized, two-way approach that promotes patient and caregiver activation and utilizes principles of shared decision-making.

Increasingly, physicians are expected to work in productive, trusting relationships with other health system stakeholders to improve patient and system outcomes. A better understanding of physicians' trust is greatly needed. This study assesses the state of the literature on physicians' trust in patients, other health care providers, institutions, and data systems or technology, and identifies key themes, dimensions of trust considered, quantitative measures used, and opportunities for further development via a scoping review. Peer-reviewed, English-language research articles were identified for inclusion in this study based on systematic searches of the Ovid/Medline, Pubmed, Proquest, Scopus, Elsevier, and Web of Science databases. Search terms included "trust" along with "physician," "doctor," "primary care provider," "family practitioner," "family practice," "generalist," "general practitioner," "general practice," "internist," "internal medicine," or "health professional," and plausible variants. Among the relevant articles identified (n = 446), the vast majority focused on patient trust in physicians (81.2%). Among articles examining physicians' trust, rigorous investigations of trust are rare, narrowly focused, and imprecise in their discussion of trust. Robust investigations of the effects of trust or distrust-as opposed to trust's determinants-and studies using validated quantitative trust measures are particularly rare. Studies typically measured trust using the language of confidence, effective communication, or cooperation, rarely or never capturing other important dimensions of trust, such as fidelity, the trustee's reputation, social capital, vulnerability, and acceptance. Research employing new, validated measures of physicians' trust, especially trust in institutions, may be highly informative to health system leaders and policymakers seeking to hone and enhance tools for improving the effectiveness and efficiency of the health care system.

This paper provides a review of some previously identified requirements of a learning health system, a post hoc analysis of narrative artifacts describing a learning health system, and some new potential requirements of a learning health system. Engaging a transdisciplinary group of researchers and health care practitioners, we used a method of group conceptualization to elicit potential requirements of a learning health system. Several unresolved challenges of creating and using narrative stories, diagrams and storyboards to elicit and share the potential requirements of a learning health system amongst a diverse group of researchers are discussed.

Background: Michigan's BioTrust for Health, a public health research biobank comprised of residual dried bloodspot (DBS) cards from newborn screening contains over 4 million samples collected without written consent. Participant-centric initiatives are IT tools that hold great promise to address the consent challenges in biobank research. Methods: Working with Private Access™ Inc., a pioneer in patient-centric web solutions, we created and pilot tested a dynamic informed consent simulation, paired with an educational website, focusing on consent for research utilizing DBSs in Michigan's BioTrust for Health. Results: Out of 187 pilot testers recruited in 2 groups, 137 completed the consent simulation and exit survey. Over 50% indicated their willingness to set up an account if the simulation went live and to recommend it to others. Participants raised concerns about the process of identity verification and appeared to have little experience with sharing health information online. Conclusions: Applying online, dynamic approaches to address the consent challenges raised by biobanks with legacy sample collections should be explored, given the positive reaction to our pilot test and the strong preference for active consent. Balancing security and privacy with accessibility and ease of use will continue to be a challenge.

Biobanks raise challenges for developing ethically sound and practicable consent policies. Biobanks comprised of dried bloodspots (DBS) left over from newborn screening, maintained for long-term storage, and potential secondary research applications are no exception. Michigan has been a leader in transforming its DBS collection, marketing its biobank of de-identified samples for health research use. The Michigan BioTrust for Health includes approximately 4 million unconsented retrospective samples collected as early as 1984 and prospective samples added since the fall of 2010 with blanket parental consent. We engaged Michigan citizens to ascertain public attitudes, knowledge, and beliefs about the BioTrust and informed consent. A convenience sampling of 393 participants from communities around the state of Michigan (oversampling for minority populations) participated in meetings addressing newborn screening, the BioTrust and informed consent, yielding quantitative and qualitative survey and discussion data. Participants affirmed the principle of voluntary informed participation in research and advocated for greater public awareness of the existence of the BioTrust. Most expressed support for the use of DBS for research and a desire for greater involvement in granting permission for research use. Opinions varied as to which specific research uses were acceptable. Participants indicated a desire for greater engagement, public awareness, and more active decision making on the part of biobank participants and parents. Diversity of opinion over which research areas were deemed acceptable problematizes the blanket consent model that currently applies to the BioTrust’s prospective DBS collection and that could become the new norm for research using de-identified data under proposed changes to the Common Rule.

Some large population biobanks that house biospecimens and health information for research seek broad consent from participants, whereas others reconsent for specific new studies. Understanding research participants’ attitudes and preferences about broad and narrow consent may improve recruitment, retention, and public support. An online survey was conducted among a representative sample of 4,659 US adults to examine relationships between consent preferences and demographic factors, beliefs about privacy and the value of research, and the perceived trustworthiness of researchers. Participants preferred broad consent (52%) over study-by-study consent models (48%). Higher preferences for study-by-study consent observed among black non-Hispanic respondents and respondents with lower income and education were explained by differences in the prevalence of one or more beliefs about the study. Respondents with fears about research and those who would feel respected if asked for permission for each research use preferred study-by-study consent. Preference for broad consent was related to the desire not to be bothered with multiple requests and the belief that the study could lead to improved treatments, cures, and lives saved. These data suggest that support for broad consent is contingent on sufficient information about data use. Work with research participants and community leaders to understand, respond to, and influence opinions about a given, ongoing study may improve uptake of broad consent. Genet Med 16 1, 11–18.

Background: The interpersonal, dialogic features of social networking sites have untapped potential for public health communication. We ran a Facebook advertising campaign to raise statewide awareness of Michigan’s newborn screening and biobanking programs. Objective: We ran a Facebook advertising campaign to stimulate public engagement on the complex and sensitive issue of Michigan’s newborn screening and biobank programs. Methods: We ran an 11-week, US $15,000 Facebook advertising campaign engaging Michigan Facebook users aged 18-64 years about the state’s newborn screening and population biobank programs, and we used a novel “engagement spectrum” framework to contextualize and evaluate engagement outcomes ranging from observation to multi-way conversation. Results: The campaign reached 1.88 million Facebook users, yielding a range of engagement outcomes across ad sets that varied by objective, content, budget, duration, and bid type. Ad sets yielded 9009 page likes (US $4125), 15,958 website clicks (US $5578), and 12,909 complete video views to 100% (US $3750). “Boosted posts” yielded 528 comments and 35,966 page post engagements (US $1500). Overall, the campaign led to 452 shares and 642 comments, including 176 discussing newborn screening and biobanking. Conclusions: Facebook advertising campaigns can efficiently reach large populations and achieve a range of engagement outcomes by diversifying ad types, bid types, and content. This campaign provided a population-based approach to communication that also increased transparency on a sensitive and complex topic by creating a forum for multi-way interaction. [JMIR Public Health Surveill 2016;2(1):e27]