Interrogating the Value of Return of Results for Diverse Populations: Perspectives from Precision Medicine Researchers.

BACKGROUND: Over the last decade, the return of results (ROR) in precision medicine research (PMR) has become increasingly routine. Calls for individual rights to research results have extended the "duty to report" from clinically useful genetic information to traits and ancestry results. ROR has thus been reframed as inherently beneficial to research participants, without a needed focus on who benefits and how. This paper addresses this gap, particularly in the context of PMR aimed at increasing participant diversity, by providing investigator and researcher perspectives on and questions about the assumed value of ROR in PMR. METHODS: Semi-structured interviews with a purposive sample of investigators and researchers across federally funded PMR studies in three national consortia, as well as observations of study activities, focused on how PM researchers conceptualize diversity and implement inclusive practices across research stages, including navigating ROR. RESULTS: Interviewees (1) validated the value of ROR as a benefit of PMR, while others (2) questioned the benefit of clinically actionable results to individuals in the absence of sufficient resources for translating findings into health care for diverse and disadvantaged populations; (3) expressed uncertainties in applying the presumed value of ROR as a benefit for non-clinical results; and (4) and debated when the promise of the value of ROR may undermine trust in PMR, and divert efforts to return value beyond ROR. CONCLUSIONS: Conceptualizations of diversity and inclusion among PM researchers and investigators raise unique ethical questions where unexamined assumptions of the value of ROR inform study recruitment efforts to enroll minoritized and under-represented populations. A lack of consideration for resources and infrastructure necessary to translate ROR into actionable information may hinder trustworthy community-research relationships. Thus, we argue for a more intentional interrogation of ROR practices as an offer of benefit and for whom.

Community Engagement in Precision Medicine Research: Organizational Practices and Their Impacts for Equity.

BACKGROUND: In the wake of mandates for biomedical research to increase participation by members of historically underrepresented populations, community engagement (CE) has emerged as a key intervention to help achieve this goal. METHODS: Using interviews, observations, and document analysis, we examine how stakeholders in precision medicine research understand and seek to put into practice ideas about who to engage, how engagement should be conducted, and what engagement is for. RESULTS: We find that ad hoc, opportunistic, and instrumental approaches to CE exacted significant consequences for the time and resources devoted to engagement and the ultimate impacts it has on research. Critical differences emerged when engagement and research decisionmaking were integrated with each other versus occurring in parallel, separate parts of the study organization, and whether community members had the ability to determine which issues would be brought to them for consideration or to revise or even veto proposals made upstream based on criteria that mattered to them. CE was understood to have a range of purposes, from instrumentally facilitating recruitment and data collection, to advancing community priorities and concerns, to furthering long-term investments in relationships with and changes in communities. These choices about who to engage, what engagement activities to support, how to solicit and integrate community input into the workflow of the study, and what CE was for were often conditioned upon preexisting perceptions and upstream decisions about study goals, competing priorities, and resource availability. CONCLUSIONS: Upstream choices about CE and constraints of time and resources cascade into tradeoffs that often culminated in "pantomime community engagement." This approach can create downstream costs when engagement is experienced as improvised and sporadic. Transformations are needed for CE to be seen as a necessary scientific investment and part of the scientific process.

Targeting Representation: Interpreting Calls for Diversity in Precision Medicine Research.

Scientists have identified a "diversity gap" in genetic samples and health data, which have been drawn predominantly from individuals of European ancestry, as posing an existential threat to the promise of precision medicine. Inadequate inclusion as articulated by scientists, policymakers, and ethicists has prompted large-scale initiatives aimed at recruiting populations historically underrepresented in biomedical research. Despite explicit calls to increase diversity, the meaning of diversity - which dimensions matter for what outcomes and why - remain strikingly imprecise. Drawing on our document review and qualitative data from observations and interviews of funders and research teams involved in five precision medicine research (PMR) projects, we note that calls for increasing diversity often focus on "representation" as the goal of recruitment. The language of representation is used flexibly to refer to two objectives: achieving sufficient genetic variation across populations and including historically disenfranchised groups in research. We argue that these dual understandings of representation are more than rhetorical slippage, but rather allow for the contemporary collection of samples and data from marginalized populations to stand in as correcting historical exclusion of social groups towards addressing health inequity. We trace the unresolved historical debates over how and to what extent researchers should procure diversity in PMR and how they contributed to ongoing uncertainty about what axes of diversity matter and why. We argue that ambiguity in the meaning of representation at the outset of a study contributes to a lack of clear conceptualization of diversity downstream throughout subsequent phases of the study.

Beyond inclusion: Enacting team equity in precision medicine research.

PURPOSE: To identify meanings of and challenges to enacting equitable diversification of genomics research, and specifically precision medicine research (PMR), teams. METHODS: We conducted in-depth interviews with 102 individuals involved in three U.S.-based precision medicine research consortia and conducted over 400 observation hours of their working group meetings, consortium-wide meetings, and conference presentations. We also reviewed published reports on genomic workforce diversity (WFD), particularly those relevant to the PMR community. RESULTS: Our study finds that many PMR teams encounter challenges as they strive to achieve equitable diversification on scientific teams. Interviewees articulated that underrepresented team members were often hired to increase the study's capacity to recruit diverse research participants, but are limited to on-the-ground staff positions with little influence over study design. We find existing hierarchies and power structures in the academic research ecosystem compound challenges for equitable diversification. CONCLUSION: Our results suggest that meaningful diversification of PMR teams will only be possible when team equity is prioritized as a core value in academic research communities.

Social Literacy: Nurses' Contribution Toward the Co-Production of Self-Management.

We share findings from a larger ethnographic study of two urban complex care management programs in the Western United States. The data presented stem from in-depth interviews conducted with 17 complex care management RNs and participant observations of home visits. We advance the concept of social literacy as a nursing attribute that comprises an RN's recognition and responses to the varied types of hinderances to self-management with which patients must contend in their lived environment. It is through social literacy that complex care management RNs reconceptualize and understand health literacy to be a product born out of the social circumstances in which patients live and the stratified nature of the health care systems that provide them care. Social literacy provides a broader framework for health literacy-one that is situated within the patient's social context through which complex care management RNs must navigate for self-management goals to be achieved.

Patient Engagement, Chronic Illness, and the Subject of Health Care Reform.

In the United States, in the wake of health care reform, health care systems have been subject to intensifying demands to increase patient engagement, a term that refers broadly to participation in care. We draw from ethnographic research in urban health care safety-net settings in California to examine efforts to increase patient engagement among chronically ill, marginalized patients who have long been disconnected from outpatient care. We suggest that the work of engagement in this context involved getting people to accept the norms of biomedicine while also reworking these norms to account for the complex circumstances of their lives.

Caring for "Super-utilizers": Neoliberal Social Assistance in the Safety-net.

Hospitals throughout the United States are implementing new forms of care delivery meant to address social needs for structurally vulnerable patients as a strategy to prevent emergency department visits and hospitalizations and to thereby reduce costs. This article examines how the deployment of social assistance within a neoliberal institutional logic involves the negotiation and alignment of economistic values with ethics of care. We focus on care practices meant to stabilize the socioeconomic conditions of the most expensive patients in the health care system-the "super-utilizers"-through the provisioning of basic resources such as housing, food, transportation, and social support. These patients typically suffer from multiple chronic illnesses accompanied by conditions of poverty, housing and food insecurity, exposure to violence and trauma, and associated substance use and mental health problems. We offer an account of how practices of social assistance are being forged within contexts defined by neoliberal governance.

Stratified citizenship, stratified health: Examining latinx legal status in the U.S. healthcare safety net.

Our paper explores how legal status stratification shapes the health and health care of low-income patients with chronic illnesses in the U.S. healthcare safety net. Drawing on data from over two years of ethnographic fieldwork at urban safety-net clinics, we examine efforts by Complex Care Management (CCM) teams to stabilize patients with uncontrolled chronic illnesses through primary care-integrated support. We show that stratified citizenship and geographic variability correspond to different possibilities for health care. We suggest an approach to immigration as a structural determinant of health that accounts for the complex, stratified, and changing nature of citizenship status. We also highlight how geographical differences and interactions among local, state, and federal policies support the notion that citizenship is stratified across multiple tiers with distinctive possibilities and constraints for health. While county-based health plans at each of the study sites include residents with varying legal status, lack of formal legal status remains a substantial obstacle to care. Many immigrants are unable to take full advantage of primary and specialty care, resulting in unnecessary morbidity and mortality. In some cases, patients have returned to their country of origin to die. While CCM teams provide an impressive level of support to assist immigrant patients in navigating healthcare and immigration bureaucracies, legal and geographic stratification limit their ability to address broader aspects of these patients' social context.

Complex care and contradictions of choice in the safety net.

This article explores the complicated and often-contradictory notions of choice at play in complex care management (CCM) programmes in the US healthcare safety net. Drawing from longitudinal data collected over two years of ethnographic fieldwork at urban safety-net clinics, our study examines the CCM goal of transforming frequent emergency department (ED) utilisers into 'active' patients who will reduce their service utilisation and thereby contribute to a more rational, cost-effective healthcare system. By considering our data alongside philosopher Annemarie Mol's (2008) conceptualisation of the competing logics of choice and care, we argue that these premises often undermine CCM teams' efforts to support patients and provide the care they need - not only to prevent medical crises, but to overcome socio-economic barriers as well. We assert that while safety-net CCM programmes are held accountable for the degree to which their patients successfully transform into self-managing, cost-effective actors, much of the care CCM staff provide in fact involves attempts to intervene on structural obstacles that impinge on patient choice. CCM programmes thus struggle between an economic imperative to get patients to make better health choices and a moral imperative to provide care in the face of systemic societal neglect. (A virtual abstract of this paper can be viewed at: https://www.youtube.com/channel/UC_979cmCmR9rLrKuD7z0ycA).

Defining trauma in complex care management: Safety-net providers' perspectives on structural vulnerability and time.

In this paper, we delineate how staff of two complex care management (CCM) programs in urban safety net hospitals in the United States understand trauma. We seek to (1) describe how staff in CCM programs talk about trauma in their patients' lives; (2) discuss how trauma concepts allow staff to understand patients' symptoms, health-related behaviors, and responses to care as results of structural conditions; and (3) delineate the mismatch between long-term needs of patients with histories of trauma and the short-term interventions that CCM programs provide. Observation and interview data gathered between February 2015 and August 2016 indicate that CCM providers define trauma expansively to include individual experiences of violence such as childhood abuse and neglect or recent assault, traumatization in the course of accessing health care and structural violence. Though CCM staff implement elements of trauma-informed care, the short-term design of CCM programs puts pressure on the staff to titrate their efforts, moving patients towards graduation or discharge. Trauma concepts enable clinicians to name structural violence in clinically legitimate language. As such, trauma-informed care and structural competency approaches can complement each other.

Assessing Patient Activation among High-Need, High-Cost Patients in Urban Safety Net Care Settings.

We sought to examine the literature using the Patient Activation Measure (PAM) or the Patient Enablement Instrument (PEI) with high-need, high-cost (HNHC) patients receiving care in urban safety net settings. Urban safety net care management programs serve low-income, racially/ethnically diverse patients living with multiple chronic conditions. Although many care management programs track patient progress with the PAM or the PEI, it is not clear whether the PAM or the PEI is an effective and appropriate tool for HNHC patients receiving care in urban safety net settings in the United States. We searched PubMed, EMBASE, Web of Science, and PsycINFO for articles published between 2004 and 2015 that used the PAM and between 1998 and 2015 that used the PEI. The search was limited to English-language articles conducted in the United States and published in peer-reviewed journals. To assess the utility of the PAM and the PEI in urban safety net care settings, we defined a HNHC patient sample as racially/ethnically diverse, low socioeconomic status (SES), and multimorbid. One hundred fourteen articles used the PAM. All articles using the PEI were conducted outside the U.S. and therefore were excluded. Nine PAM studies (8%) included participants similar to those receiving care in urban safety net settings, three of which were longitudinal. Two of the three longitudinal studies reported positive changes following interventions. Our results indicate that research on patient activation is not commonly conducted on racially and ethnically diverse, low SES, and multimorbid patients; therefore, there are few opportunities to assess the appropriateness of the PAM in such populations. Investigators expressed concerns with the potential unreliability and inappropriate nature of the PAM on multimorbid, older, and low-literacy patients. Thus, the PAM may not be able to accurately assess patient progress among HNHC patients receiving care in urban safety net settings. Assessing progress in the urban safety net care setting requires measures that account for the social and structural challenges and competing demands of HNHC patients.

Patient engagement at the margins: Health care providers' assessments of engagement and the structural determinants of health in the safety-net.

Increasing "patient engagement" has become a priority for health care organizations and policy-makers seeking to reduce cost and improve the quality of care. While concepts of patient engagement have proliferated rapidly across health care settings, little is known about how health care providers make use of these concepts in clinical practice. This paper uses 20 months of ethnographic and interview research carried out from 2015 to 2016 to explore how health care providers working at two public, urban, safety-net hospitals in the United States define, discuss, and assess patient engagement. We investigate how health care providers describe engagement for high cost patients-the "super-utilizers" of the health care system-who often face complex challenges related to socioeconomic marginalization including poverty, housing insecurity, exposure to violence and trauma, cognitive and mental health issues, and substance use. The health care providers in our study faced institutional pressure to assess patient engagement and to direct care towards engaged patients. However, providers considered such assessments to be highly challenging and oftentimes inaccurate, particularly because they understood low patient engagement to be the result of difficult socioeconomic conditions. Providers tried to navigate the demand to assess patient engagement in care by looking for explicit positive and negative indicators of engagement, while also being sensitive to more subtle and intuitive signs of engagement for marginalized patients.

How Neighborhoods Influence Health: Lessons to be learned from the application of political ecology.

AIM: This paper articulates how political ecology can be a useful tool for asking fundamental questions and applying relevant methods to investigate structures that impact relationship between neighborhood and health. Through a narrative analysis, we identify how political ecology can develop our future agendas for neighborhood-health research as it relates to social, political, environmental, and economic structures. Political ecology makes clear the connection between political economy and neighborhood by highlighting the historical and structural processes that produce and maintain social inequality, which affect health and well-being. These concepts encourage researchers to examine how people construct neighborhood and health in different ways that, in turn, can influence different health outcomes and, thus, efforts to address solutions.

Illness Narratives of African Americans Living With Coronary Heart Disease: A Critical Interactionist Analysis.

How African American men and women respond to and manage living with coronary heart disease (CHD) is not well understood despite the well-documented disproportionate burden of CHD and its complications among African Americans in the United States. Through a critical interactionist perspective, we explore illness experiences of African Americans living with CHD and describe a broad range of micro-, meso-, and macro-contextual factors that influence their illness experiences. For participants in this study, CHD has become a "Black disease" wherein certain bodies have become historically and racially marked; a conceptualization maintained and passed on by African Americans themselves. Such findings highlight that CHD is more than a "lifestyle disease" where high-risk behaviors and lack of healthy choices are ultimate culprits. Rather, CHD is perceived by African Americans who have it as yet another product of ongoing racial and socio-structural dynamics through which their health burdens are created, sustained, and reproduced.

Enacting the molecular imperative: How gene-environment interaction research links bodies and environments in the post-genomic age.

Despite a proclaimed shift from 'nature versus nurture' to 'genes and environment' paradigms within biomedical and genomic science, capturing the environment and identifying gene-environment interactions (GEIs) has remained a challenge. What does 'the environment' mean in the post-genomic age? In this paper, we present qualitative data from a study of 33 principal investigators funded by the U.S. National Institutes of Health to conduct etiological research on three complex diseases (cancer, cardiovascular disease and diabetes). We examine their research practices and perspectives on the environment through the concept of molecularization: the social processes and transformations through which phenomena (diseases, identities, pollution, food, racial/ethnic classifications) are re-defined in terms of their molecular components and described in the language of molecular biology. We show how GEI researchers' expansive conceptualizations of the environment ultimately yield to the imperative to molecularize and personalize the environment. They seek to 'go into the body' and re-work the boundaries between bodies and environments. In the process, they create epistemic hinges to facilitate a turn from efforts to understand social and environmental exposures outside the body, to quantifying their effects inside the body. GEI researchers respond to these emergent imperatives with a mixture of excitement, ambivalence and frustration. We reflect on how GEI researchers struggle to make meaning of molecules in their work, and how they grapple with molecularization as a methodological and rhetorical imperative as well as a process transforming biomedical research practices.

Accounting for Complexity: Gene-environment Interaction Research and the Moral Economy of Quantification.

Scientists now agree that common diseases arise through interactions of genetic and environmental factors, but there is less agreement about how scientific research should account for these interactions. This paper examines the politics of quantification in gene-environment interaction (GEI) research. Drawing on interviews and observations with GEI researchers who study common, complex diseases, we describe quantification as an unfolding moral economy of science, in which researchers collectively enact competing ''virtues.'' Dominant virtues include molecular precision, in which behavioral and social risk factors are moved into the body, and ''harmonization,'' in which scientists create large data sets and common interests in multisited consortia. We describe the negotiations and trade-offs scientists enact in order to produce credible knowledge and the forms of (self-)discipline that shape researchers, their practices, and objects of study. We describe how prevailing techniques of quantification are premised on the shrinking of the environment in the interest of producing harmonized data and harmonious scientists, leading some scientists to argue that social, economic, and political influences on disease patterns are sidelined in postgenomic research. We consider how a variety of GEI researchers navigate quantification's productive and limiting effects on the science of etiological complexity.

Cultural health capital and the interactional dynamics of patient-centered care.

As intuitive and inviting as it may appear, the concept of patient-centered care has been difficult to conceptualize, institutionalize and operationalize. Informed by Bourdieu's concepts of cultural capital and habitus, we employ the framework of cultural health capital to uncover the ways in which both patients' and providers' cultural resources, assets, and interactional styles influence their abilities to mutually achieve patient-centered care. Cultural health capital is defined as a specialized collection of cultural skills, attitudes, behaviors and interactional styles that are valued, leveraged, and exchanged by both patients and providers during clinical interactions. In this paper, we report the findings of a qualitative study conducted from 2010 to 2011 in the Western United States. We investigated the various elements of cultural health capital, how patients and providers used cultural health capital to engage with each other, and how this process shaped the patient-centeredness of interactions. We find that the accomplishment of patient-centered care is highly dependent upon habitus and the cultural health capital that both patients and providers bring to health care interactions. Not only are some cultural resources more highly valued than others, their differential mobilization can facilitate or impede engagement and communication between patients and their providers. The focus of cultural health capital on the ways fundamental social inequalities are manifest in clinical interactions enables providers, patients, and health care organizations to consider how such inequalities can confound patient-centered care.

Cultural health capital: A theoretical approach to understanding health care interactions and the dynamics of unequal treatment.

In this article, I propose and define the new concept of cultural health capital, based on cultural capital theories,to help account for how patient-provider interactions unfold in ways that may generate disparities in health care. I define cultural health capital as the repertoire of cultural skills, verbal and nonverbal competencies, attitudes and behaviors, and interactional styles, cultivated by patients and clinicians alike, that, when deployed, may result in more optimal health care relationships. I consider cultural health capital alongside existing frameworks for understanding clinical interactions, and I argue that the concept of cultural health capital offers theoretical traction to help account for several dynamics of unequal treatment. These dynamics include the often nonpurposeful, habitual nature of culturally-mediated interactional styles; their growing importance amidst sociocultural changes in U.S. health care; their direct and indirect effects as instrumental as well as symbolic forms of capital; and their ability to account for the systematic yet variable relationship between social status and health care interactions.

The value of "life at any cost": talk about stopping kidney dialysis.

With the trend toward an older, sicker dialysis population in the USA, discussions of ethical issues surrounding dialysis have shifted from concerns about access to and availability of the therapy, to growing unease about non-initiation and treatment discontinuation. Recent studies report treatment withdrawal as the leading cause of death among elderly dialysis patients. Yet, the actual activities that move patients toward stopping treatment often remain obscure, even to clinicians and patients themselves. This paper explores that paradox, drawing on anthropological research among patients over age 70, their families, and clinicians in two California renal dialysis units. It concludes that many older patients sacrifice a sense of choice about dialysis in the present to maintain "choice" as both value and possibility for the future. Even so, patients desire more information and communication, provided earlier in their illness, about prognosis, how long they can expect to be on dialysis, and what the impact of the treatment will be on their daily lives. That, with time, there is a transition to be made from dialysis as "treatment" to end of life care could be better explained and managed to alleviate patients' confusion and unneeded isolation.

Clinical life: expectation and the double edge of medical promise.

This article introduces the concept of clinical life to capture a form of life produced in the pursuit and wake of medically achieved longevity. Relying on the retrospective accounts of 28 individuals over age 70 who have undergone cardiac bypass surgery, angioplasty or a stent procedure, as well as interviews with their families and with clinicians, we examine three features of clinical life. First, patients do not distinguish between clinical possibility and clinical promise, and thus assume that life can and will be improved by medical intervention in late life. Rather than anticipating a range of potential treatment outcomes, patients therefore expect the best-case scenario: that medical procedures will reverse aging, disease and the march of time. Second, patients then assess the value of their post-procedure lives in accordance with that expectation. Norms regarding what life 'should be like' at particular ages are continually recalibrated to the horizon of what is clinically possible. And third, the price of living longer entails a double-edged relationship with the clinic--it generates opportunities for bodily restoration and increased self-worth but also creates ambivalence about the value of life. This latter feature of clinical life is rarely publicly acknowledged in an environment that emphasizes medical promise.