"Helping fill that gap:" a qualitative study of aging in place after disaster through the lens of home-based care providers.

BACKGROUND: During a disaster, home-based care fills the critical need for continuation of health care. Home-based care is intended to function using existing care delivery models, continuing to provide care for patients wherever they are located, including in shelters and hotels. Home-based care providers are often the closest in contact with their patients -seeing them in place, even throughout a disaster- through which they develop a unique insight into aging in place during a disaster. The purpose of this study was to identify individual and community-level support needs of older adults after a disaster through the lens of home-based care providers. METHODS: Using qualitative inquiry, five focus groups were conducted with home-based care providers (n = 25) who provided in-home care during Hurricane Irma and Hurricane Harvey. Participants were identified by contacting home health agencies listed in an open-source database of agencies participating in Centers for Medicare and Medicaid Services programs. Data were coded using an abductive analytic approach, and larger themes were generated in light of existing theory. RESULTS: The results were distilled into eight themes that related to the importance of community and family, informal and formal supports throughout the disaster management cycle, maintaining autonomy during a disaster, and institutional and systemic barriers to obtaining assistance. CONCLUSIONS: In this study, home-based care providers described the challenges aging adults face in the response and recovery period after a large-scale disaster including maintaining continuity of care, encouraging individual preparedness, and accessing complex governmental support. Listening to home-based care providers offers new and important insights for developing interventions to address social and health needs for older adults aging in place after a large-scale disaster.

Euthanasia and Assisted Suicide of Persons With Dementia in the Netherlands.

OBJECTIVE: To describe the characteristics of persons with dementia receiving euthanasia/assisted suicide (EAS) and how the practice is regulated in the Netherlands. DESIGNS: Qualitative directed content analysis of dementia EAS reports published by the Dutch euthanasia review committees between 2011 and October 5, 2018. RESULTS: Seventy-five cases were reviewed: 59 concurrent requests and 16 advance requests. Fifty-three percent (40/75) were women, and 48% (36/75) had Alzheimer disease. Advance request EAS patients were younger, had dementia longer, and more frequently had personal experience with dementia. Some concurrent request EAS patients were quite impaired: 15% (9/59) were deemed incompetent by at least one physician; in 24% (14/59), patients' previous statements or current body language were used to assess competence. In 39% (29/75), patients' own physicians declined to perform EAS; in 43% (32/75), the physician performing EAS was new to them. Physicians disagreed about patients' eligibility in 21% (16/75). All advance request and 14 (25%) concurrent request patients had an advance euthanasia directive but the conditions of applicability often lacked specificity. In 5 of 16 advance request EAS and 2 of 56 concurrent request EAS cases, EAS procedure was modified (e.g., premedication). Twenty-five percent (4/16) of advance request cases did not meet legal due care criteria, in particular the "unbearable suffering" criterion. CONCLUSIONS: Advance and concurrent request EAS cases differ in age, duration of illness, and past experience. Advance request EAS cases were complicated by ambiguous directives, patients being unaware of the EAS procedure, and physicians' difficulty assessing "unbearable suffering." Notably, some concurrent request patients were quite impaired yet deemed competent by appeals to previous statements.

Interpretations of the Term "Actionable" when Discussing Genetic Test Results: What you Mean Is Not What I Heard.

In genomic medicine, the familiarity and inexactness of the term "actionable" can lead to multiple interpretations and mistaken beliefs about realistic treatment options. As part of a larger study focusing on public attitudes toward policies for the return of secondary genomic results, we looked at how members of the lay public interpret the term "medically actionable" in the context of genetic testing. We also surveyed a convenience sample of oncologists as part of a separate study and asked them to define the term "medically actionable." After being provided with a definition of the term, 21 out of 60 (35%) layperson respondents wrote an additional action not specified in the provided definition (12 mentioned "cure" and 9 mentioned environment or behavioral change) and 17 (28%) indicated "something can be done" with no action specified. In contrast, 52 surveyed oncologists did not mention environment, behavioral change, or cure. Based on our findings, we propose that rather than using the term "actionable" alone, providers should also say "what they mean" to reduce miscommunication and confusion that could negatively impact medical decision-making. Lastly, to guide clinicians during patient- provider discussion about genetic test results, we provide examples of phrasing to facilitate clearer communication and understanding of the term "actionable."

Biobanks and the Moral Concerns of Donors: A Democratic Deliberation.

Do members of the public believe that biobanks should accommodate the moral concerns of donors about the types of research done with their biospecimens? The answer to this question is critical to the future of genomic and precision medicine, endeavors that rely on a public willing to share their biospecimens and medical data. To explore public attitudes regarding the requirements of consent for biobank donations, we organized three democratic deliberations involving 180 participants. The deliberative sessions involved small group discussions informed by presentations given by experts in both biobank research and ethics. We found that participants had a sophisticated understanding of the ethical problems of biobank consent and the complexity of balancing donor concerns while promoting research important to the future of health care. Our research shows how deliberative methods can offer policy makers creative ideas for accommodating the moral concerns of donors in the biobank consent process.

Factors influencing the clinical decision-making of midwives: a qualitative study.

BACKGROUND: Although midwives make clinical decisions that have an impact on the health and well-being of mothers and babies, little is known about how they make those decisions. Wide variation in intrapartum decisions to refer women to obstetrician-led care suggests that midwives' decisions are based on more than the evidence based medicine (EBM) model - i.e. clinical evidence, midwife's expertise, and woman's values - alone. With this study we aimed to explore the factors that influence clinical decision-making of midwives who work independently. METHODS: We used a qualitative approach, conducting in-depth interviews with a purposive sample of 11 Dutch primary care midwives. Data collection took place between May and September 2015. The interviews were semi-structured, using written vignettes to solicit midwives' clinical decision-making processes (Think Aloud method). We performed thematic analysis on the transcripts. RESULTS: We identified five themes that influenced clinical decision-making: the pregnant woman as a whole person, sources of knowledge, the midwife as a whole person, the collaboration between maternity care professionals, and the organisation of care. Regarding the midwife, her decisions were shaped not only by her experience, intuition, and personal circumstances, but also by her attitudes about physiology, woman-centredness, shared decision-making, and collaboration with other professionals. The nature of the local collaboration between maternity care professionals and locally-developed protocols dominated midwives' clinical decision-making. When midwives and obstetricians had different philosophies of care and different practice styles, their collaborative efforts were challenged. CONCLUSION: Midwives' clinical decision-making is a more varied and complex process than the EBM framework suggests. If midwives are to succeed in their role as promoters and protectors of physiological pregnancy and birth, they need to understand how clinical decisions in a multidisciplinary context are actually made.

Developing quality indicators for assessing quality of birth centre care: a mixed- methods study.

BACKGROUND: Birth centres are described as settings where women with uncomplicated pregnancies can give birth in a home-like environment assisted by midwives and maternity care assistants. If complications arise or threaten, the woman is referred to a maternity unit of a hospital where an obstetrician will take over responsibility. In the last decade, a number of new birth centres have been established in the Netherlands, based on the assumption that birth centres provide better quality of care since they offer a better opportunity for more integrated care than the existing system with independent primary and secondary care providers. At present, there is no evidence for this assumption. The Dutch Birth Centre Study is designed to present evidence-based recommendations for organization and functioning of future birth centres in the Netherlands. A necessary first step in this evaluation is the development of indicators for measuring the quality of the care delivered in birth centres in the Netherlands. The aim of this study is to identify a comprehensive set of structure and process indicators to assess quality of birth centre care. METHODS: We used mixed methods to develop a set of structure and process quality indicators for evaluating birth centre care. Beginning with a literature review, we developed an exhaustive list of determinants. We then used a Delphi study to narrow this list, calling on experts to rate the determinants for relevance and feasibility. A multidisciplinary expert panel of 63 experts, directly or indirectly involved with birth centre care, was invited to participate. RESULTS: A panel of 42 experts completed two Delphi rounds rating determinants of the quality of birth centre care based on their relevance (to the setting) and feasibility (of use). A set of 30 determinants for structure and process quality indicators was identified to assess the quality of birth centre care in the Netherlands. CONCLUSIONS: We identified 30 determinants for structure and process quality indicators concerning birth centre care. This set will be validated during the evaluation of birth centres in the Dutch Birth Centre Study.

Typology of birth centres in the Netherlands using the Rainbow model of integrated care: results of the Dutch Birth Centre Study.

BACKGROUND: The goal of integrated care is to offer a continuum of care that crosses the boundaries of public health, primary, secondary, and tertiary care. Integrated care is increasingly promoted for people with complex needs and has also recently been promoted in maternity care systems to improve the quality of care. Especially when located near an obstetric unit, birth centres are considered to be ideal settings for the realization of integrated care. At present, however, we know very little about the degree of integration in these centres and we do not know if increased levels of integration improve the quality of the care delivered. The Dutch Birth Centre Study is designed to evaluate birth centres and their contribution to the Dutch maternity care system. The aim of this particular sub-study is to classify birth centres in clusters with similar characteristics based on integration profiles, to support the evaluation of birth centre care. METHODS: This study is based on the Rainbow Model of Integrated Care. We used a survey followed by qualitative interviews in 23 birth centres in the Netherlands to determine which integration profiles can be distinguished and to describe their discriminating characteristics. Cluster analysis was used to classify the birth centres. RESULTS: Birth centres were classified into three clusters: 1)"Mono-disciplinary-oriented birth centres" (n = 10): which are mainly owned by primary care organizations and established as physical facilities to provide an alternative birthplace for low risk births; 2) "Multi-disciplinary-oriented birth centres" (n = 6): which are mainly multi-disciplinary oriented and can be regarded as facilities to give birth, with a focus on integrated birth care; 3) "Mixed Cluster of birth centres" (n = 7): which have a range of organizational forms that differentiate them from centres in the other clusters. CONCLUSION: We identified a recognizable classification, with similar characteristics between birth centres in the clusters. The results of this study can be used to relate integration profiles of birth centres to quality of care, costs, and perinatal outcomes. This assessment makes it possible to develop recommendations with regard to the type and degree of integration of Dutch birth centres in the future.

Public's Views toward Return of Secondary Results in Genomic Sequencing: It's (Almost) All about the Choice.

The therapeutic use of genomic sequencing creates novel and unresolved questions about cost, clinical efficacy, access, and the disclosure of sequencing results. The disclosure of the secondary results of sequencing poses a particularly challenging ethical problem. Experts disagree about which results should be shared and public input - especially important for the creation of disclosure policies - is complicated by the complex nature of genetics. Recognizing the value of deliberative democratic methods for soliciting informed public opinion on matters like these, we recruited participants from a clinical research site for an all-day deliberative democracy (DD) session. Participants were introduced to the clinical and ethical issues associated with genomic sequencing, after which they discussed the tradeoffs and offered their opinions about policies for the return of secondary results. Participants (n = 66; mean age = 57 (SD = 15); 70% female; 76% white) were divided into 10 small groups (5 to 8 participants each) allowing interactive deliberation on policy options for the return of three categories of secondary results: 1) medically actionable results; 2) risks for adult-onset disorders identified in children; and 3) carrier status for autosomal recessive disorders. In our qualitative analysis of the session transcripts, we found that while participants favored choice and had a preference for making information available, they also acknowledged the risks (and benefits) of learning such information. Our research reveals the nuanced reasoning used by members of the public when weighing the pros and cons of receiving genomic information, enriching our understanding of the findings of surveys of attitudes regarding access to secondary results.

Effect of Public Deliberation on Attitudes toward Return of Secondary Results in Genomic Sequencing.

The increased use of genomic sequencing in clinical diagnostics and therapeutics makes imperative the development of guidelines and policies about how to handle secondary findings. For reasons both practical and ethical, the creation of these guidelines must take into consideration the informed opinions of the lay public. As part of a larger Clinical Sequencing Exploratory Research (CSER) consortium project, we organized a deliberative democracy (DD) session that engaged 66 participants in dialogue about the benefits and risks associated with the return of secondary findings from clinical genomic sequencing. Participants were educated about the scientific and ethical aspects of the disclosure of secondary findings by experts in medical genetics and bioethics, and then engaged in facilitated discussion of policy options for the disclosure of three types of secondary findings: 1) medically actionable results; 2) adult onset disorders found in children; and 3) carrier status. Participants' opinions were collected via surveys administered one month before, immediately following, and one month after the DD session. Post DD session, participants were significantly more willing to support policies that do not allow access to secondary findings related to adult onset conditions in children (Χ 2 (2, N = 62) = 13.300, p = 0.001) or carrier status (Χ 2 (2, N = 60) = 11.375, p = 0.003). After one month, the level of support for the policy denying access to secondary findings regarding adult-onset conditions remained significantly higher than the pre-DD level, although less than immediately post-DD (Χ 2 (1, N = 60) = 2.465, p = 0.041). Our findings suggest that education and deliberation enhance public appreciation of the scientific and ethical complexities of genome sequencing.

The influence of preferred place of birth on the course of pregnancy and labor among healthy nulliparous women: a prospective cohort study.

BACKGROUND: Most studies on birth settings investigate the association between planned place of birth at the start of labor and birth outcomes and intervention rates. To optimize maternity care it also is important to pay attention to the entire process of pregnancy and childbirth. This study explores the association between the initial preferred place of birth and model of care, and the course of pregnancy and labor in low-risk nulliparous women in the Netherlands. METHODS: As part of a Dutch prospective cohort study (2007-2011), we compared medical indications during pregnancy and birth outcomes of 576 women who initially preferred a home birth (n = 226), a midwife-led hospital birth (n = 168) or an obstetrician-led hospital birth (n = 182). Data were obtained by a questionnaire before 20 weeks of gestation and by medical records. Analyses were performed according to the initial preferred place of birth. RESULTS: Low-risk nulliparous women who preferred a home birth with midwife-led care were less likely to be diagnosed with a medical indication during pregnancy compared to women who preferred a birth with obstetrician-led care (OR 0.41 95% CI 0.25-0.66). Preferring a birth with midwife-led care - both at home and in hospital - was associated with lower odds of induced labor (OR 0.51 95% CI 0.28-0.95 respectively OR 0.42 95% CI 0.21-0.85) and epidural analgesia (OR 0.32 95% CI 0.18-0.56 respectively OR 0.34 95% CI 0.19-0.62) compared to preferring a birth with obstetrician-led care. In addition, women who preferred a home birth were less likely to experience augmentation of labor (OR 0.54 95% CI 0.32-0.93) and narcotic analgesia (OR 0.41 95% CI 0.21-0.79) compared to women who preferred a birth with obstetrician-led care. We observed no significant association between preferred place of birth and mode of birth. CONCLUSIONS: Nulliparous women who initially preferred a home birth were less likely to be diagnosed with a medical indication during pregnancy. Women who initially preferred a birth with midwife-led care - both at home and in hospital - experienced lower rates of interventions during labor. Although some differences can be attributed to the model of care, we suggest that characteristics and attitudes of women themselves also play an important role.

Ethics and the architecture of choice for home and hospital birth.

In this issue of The Journal of Clinical Ethics, we offer a variety of perspectives on the moral and medical responsibilities of professionals with regard to a woman's choice of where she will birth her baby. The articles in this special issue focus on place of birth, but they have larger resonance for clinicians whose decisions about providing the best possible care require them to sort through evidence, consider their own possible biases and the limitations of their training, and balance the wishes of their patients with the demands of colleagues, hospitals, and insurers. The articles published in this special issue of The Journal of Clinical Ethics will help those who wrestle with such dilemmas in everyday clinical decision making.

Moral science: ethical argument and the production of knowledge about place of birth.

Ethical arguments about caregiver responsibility and the limits of client autonomy rely on best evidence about the risks and benefits of medical interventions. But when the evidence is unclear, or when the peer-reviewed literature presents conflicting accounts of the evidence, how are clinicians and their clients to recommend or decide the best course of action? Conflicting evidence about the outcomes of home and hospital birth in the peer-reviewed literature offers an opportunity to explore this question. We present the contrary evidence and describe the social and cultural elements that influence the production of the science of birth, including professional, publication, and critical bias. We then consider how the science of birth has been used an misused in making ethical arguments about preferred place of birth. We conclude with a number of recommendations about the responsible use of the evidence, arguing for an "ethics of information" that can be drawn on to guide caregivers and clients in the use of evidence for clinical decision making.

Comparison of enrollees and decliners of Parkinson disease sham surgery trials.

Concerns have been raised that persons with serious illnesses participating in high-risk research, such as PD patients in sham surgery trials, have unrealistic expectations and are vulnerable to exploitation. A comparison of enrollees and decliners of such research may provide insights about the adequacy of decision making by potential subjects. We compared 61 enrollees and 10 decliners of two phase II neurosurgical intervention (i.e., cellular and gene transfer) trials for PD regarding their demographic and clinical status, perceptions and attitudes regarding research risks, potential direct benefit, and societal benefit, and perspectives on the various potential reasons for and against participation. In addition to bivariate analyses, a logistic regression model examined variables regarding risks and benefits as predictors of participation status. Enrollees perceived lower risk of harm while tolerating higher risk of harm and were more action oriented, but did not have more advanced disease. Both groups rated hope for benefit as a strong reason to participate, whereas the fact that the study's purpose was not solely to benefit them was rated as "not a reason" against participation. Hope for benefit and altruism were rated higher than expectation of benefit as reasons in favor of participation for both groups. Enrollees and decliners are different in their views and attitudes toward risk. Although both are attracted to research because of hopes of personal benefit, this hope is clearly distinguishable from an expectation of benefit and does not imply a failure to understand the main purpose of research.

Miscarriage: The Pain of Unacknowledged Loss.

These stories of fetal death make us aware of the several losses that attend a miscarriage and-equally important-they highlight the personal, cultural, and organizational constraints that make difficult the kind of caring responses needed to address these losses. In reading these narratives, we feel the grief and frustration caused by the inappropriate, or absent, reactions of caregivers. The seeming meaninglessness of the event led some to look for meaning in religion, while for others, the loss challenged their understandings of God. These stories also point to the importance of rituals-religious or otherwise-for helping the bereaved "carry their sorrow." Careful listening to the experiences of these women can help us make the changes-organizational and personal-that are necessary to provide the care and comfort those living through a miscarriage need.

The failure of success: four lessons learned in five years of research on research integrity and research assessments.

In the past 5 years, we captured the perspectives from a broad array of research stakeholders to better understand the impact that current approaches to success and research assessment may have on the integrity and the quality of research. Here, we translate our findings in four actions that are urgently needed to foster better research. First, we need to address core research structures to overcome systemic problems of the research enterprise; second, we must realign research assessments to value elements that advance and strengthen science; third, we need to remodel, diversify, and secure research careers; and finally, we need to unite and coordinate efforts for change.

Perinatal factors related to pregnancy and childbirth satisfaction: a prospective cohort study.

BACKGROUND: Satisfaction of pregnancy and childbirth is an important quality measure of maternity care. Satisfaction questionnaires generally result in high scores. However, it has been argued that dissatisfaction relies on a different construct. In response to a worldwide call for obstetric care that is more woman-centered, we identified and described the contributors to suboptimal satisfaction with pregnancy and childbirth. METHODS: A prospective subcohort of 739 women from a larger cohort (Expect Study I, n = 2614) received a pregnancy and childbirth satisfaction questionnaire. Scores were transformed to a binary outcome whereby a score <100 points corresponded with less satisfied women. We performed a multiple logistic regression analysis to define independent perinatal factors related to suboptimal satisfaction. RESULTS: Decreased perceived personal well-being, antenatal anxiety, and obstetrician-led care during labor were all independently associated with suboptimal pregnancy and childbirth satisfaction. No difference in satisfaction was found between antenatal care led by a midwife or an obstetrician, but midwife-led antenatal care reduced the odds of suboptimal satisfaction compared to women who were transferred to an obstetrician in the antenatal period. Antenatal anxiety was experienced by 25% of all women and is associated with decreased satisfaction scores. DISCUSSION: Screening and treatment of women suffering from anxiety might improve pregnancy and childbirth satisfaction, but further research is necessary. Women's birthing experience may improve by reducing unnecessary secondary obstetric care.

Human Biospecimens Come from People.

Contrary to the revised Common Rule, and contrary to the views of many bioethicists and researchers, we argue that broad consent should be sought for anticipated later research uses of deidentified biospecimens and health information collected during medical care. Individuals differ in the kinds of risk they find concerning and in their willingness to permit use of their biospecimens for future research. For this reason, asking their permission for unspecified research uses is a fundamental expression of respect for them as persons and should be done absent some compelling moral consideration to the contrary. We examine three moral considerations and argue that each of them fails: that there is a duty of easy rescue binding on all, that seeking consent creates a selection bias that undermines the validity of biospecimen research, and that seeking and documenting consent will be prohibitively expensive.

Conscience reconsidered: The moral work of navigating participation in abortion care on labor and delivery.

How do caregivers make decisions about participating in morally contested care, such as abortion? Debates about conscience in the delivery of health care generally assume that participation decisions stem from religious beliefs and moral values. Few studies have examined this question in the context of everyday practice. Drawing on 50 interviews with the staff of a labor and delivery unit offering abortion care-including nurses, maternal-fetal medicine specialists, obstetrics and gynecology residents, and anesthesiologists-we show that respondents have varied definitions of "participation" in abortion care and that participation decisions are driven by an array of factors beyond personal beliefs. We present a conceptual model of "moral work" that shows conscience to be an emerging, iterative process influenced not only by beliefs-religious and non-religious-but also by personal and work experiences and social and institutional contexts. Our study brings new insights into understanding conscience and participation in contested care.