Stephanie R. Morain

A New Era in Noninvasive Prenatal Testing

Cell-free fetal DNA testing permits earlier detection of common trisomies and generally provides earlier information about a fetuss sex. But with its clinical utility in the general population uncertain, such testing is drifting into routine practice ahead of the evidence.

Survey Finds Public Support For Legal Interventions Directed At Health Behavior To Fight Noncommunicable Disease

The high prevalence of chronic diseases in the United States with lifestyle-related risk factors, such as obesity and tobacco use, has sparked interest in legal strategies to influence health behavior. However, little is known about the publics willingness to accept these policies as legitimate, which in turn may affect compliance. We present results from a national survey of 1,817 US adults concerning the acceptability of different public health legal interventions that address noncommunicable, or chronic, diseases. We found that support for these new interventions is high overall; substantially greater among African Americans and Hispanics than among whites; and tied to perceptions of democratic representation in policy making. There was much support for strategies that enable people to exercise healthful choices--for example, menu labeling and improving access to nicotine patches--but considerably less for more coercive measures, such as insurance premium surcharges. These findings suggest that the least coercive path will be the smoothest and that support for interventions may be widespread among different social groups. In addition, the findings underscore the need for policy makers to involve the public in decision making, understand the publics values, and communicate how policy decisions reflect this understanding.

Parents’ Choices and Rationales for Alternative Vaccination Schedules A Qualitative Study

Background. A growing number of parents adopt alternative vaccination schedules for their children. A better understanding of parents’ rationales for these choices is needed to guide vaccine decision making. Methods. We conducted 24 semistructured telephone interviews with parents of 12- to 36-month-olds and analyzed data using an inductive approach. Results. We identified 5 alternative vaccination approaches: “Dr Sears” schedule, shot-limiting approach, selective delay or decline, visit-by-visit decisions, and refusal of all vaccines. Parents who adopted alternative approaches expressed a desire for more control of exposure to vaccine ingredients; vaccine safety, immune system burden, and perceived disease risk were articulated as concerns. Conclusions. Parents who adopt alternative vaccination schedules can be classified in defined subgroups based on their decision-making approaches, and many describe considered reasons to support their actions. Communications that acknowledge and address those reasons may be better able to engage parents and ultimately enhance the process of decision making about vaccines.

Have Tobacco 21 Laws Come of Age

Recent research has shown that laws raising the minimum age for purchase of tobacco products to 21 are effective, enjoy very high levels of public support, and have minimal economic impact in the short term. The time seems right for federal adoption of this approach.

What allows a health care system to become a learning health care system: Results from interviews with health system leaders

The US health care system faces pressure to improve quality while managing complexity, curbing costs, and reducing inefficiency. These shortcomings have sparked interest in the Learning Health Care System (LHCS) as an alternate approach to organizing research and clinical care. Although diverse stakeholders have expressed support for moving toward an LHCS model, limited guidance exists for institutions considering such a transition.

Ethics Issues Arising in the Transition to Learning Health Care Systems: Results from Interviews with Leaders from 25 Health Systems

Introduction: There is increased interest in transitioning to a “learning health care system” (LHCS). While this transition brings the potential for significant benefits, it also presents several ethical considerations. Identifying the ethical issues faced by institutions in this transition is critical for realizing the goals of learning health care so that these issues can be anticipated and, where possible, resolved. Methods: 29 semi-structured telephone interviews were conducted with leaders within 25 health care institutions. Respondents were recruiting using purposive sampling, targeting institutions considered as LHCS leaders. All interviews were audiorecorded and transcribed. NVIVO10 software was used to support qualitative analysis. Results: Respondents described seven ethical challenges: (1) ethical oversight of learning activities; (2) transparency of learning activities to patients; (3) potential tensions between improving quality and reducing costs; (4) data sharing and data management; (5) lag time between discovery and implementation; (6) transparency to patients about quality; and (7) randomization for quality improvement initiatives. Discussion: To move towards LHCS, several ethical considerations require further attention, including: the continued appropriateness of the research-treatment distinction; policy frameworks for privacy and data sharing; informing patients about learning activities; obligations to share data on quality; and the potential for trade-offs between quality improvement and cost control. Conclusion: To our knowledge, this is the first project to ask leaders from health care systems committed to ongoing learning about the ethical issues they have faced in this effort. Their experiences can provide guidance on relevant ethical issues, and what might be done to resolve them.

Deliberative Engagement Methods for Patient-Centered Outcomes Research

There is growing emphasis on eliciting and incorporating stakeholder perspectives into health research and public policy development. The deliberative engagement session (DES) method provides one approach to elicit informed preferences from patients and other stakeholders on policy issues. DES involves day-long interaction with participants, including short plenary presentations followed by small group discussion. While interest in DES methods is expanding, practical guidance for researchers on this method remains limited. In this paper, we describe the DES method and its contemporary relevance for health policy research, illustrate how to conduct a DES using an example of a recent patient-centered outcomes research (PCOR) study with which we were involved, and discuss strengths and challenges of using this approach. DES methods generate rich data, reduce the risk of eliciting uniformed preferences or non-attitudes, and increase the likelihood of eliciting informed, reflective preferences. However, they are resource-intensive, and thus generally require trading away a larger, more representative sample. Despite these limitations, the DES method, when carefully designed, is well-suited for engaging stakeholders in research on complex health policy issues.

Stakeholder perspectives regarding alternate approaches to informed consent for comparative effectiveness research

Traditional informed consent approaches, involving separate discussions and lengthy consent forms, may be an imperfect fit for comparative effectiveness research (CER) that is integrated into usual care and compares non‐investigational treatments. However, systematic efforts to collect broad stakeholder perspectives about alternative streamlined approaches to disclosure and consent in this context have been limited.

Learning Is Not Enough: Earning Institutional Trustworthiness Through Knowledge Translation

Prevention’s endorsement of using community engagement strategies for improved public health in general (Haldeman et al. 2014). Our recommendations for establishing systems for bidirectional, longitudinal community engagement are couched in the established value of involving patients and other stakeholders throughout the research process, from research prioritization, to implementation, interpretation of results, and dissemination of findings to broad audiences. Without broad community support for biobanks—including racial and ethnic diversity in biobanked materials—potential scientific advances and utility of precision medicine research in the fight against disease and health disparities will be thwarted.

Automated speed enforcement systems to reduce traffic-related injuries: closing the policy implementation gap

In the USA, traffic-related injuries are responsible for over 33 000 deaths each year1 and are the leading cause of death for individuals aged 1–24 years.2 Traffic-related injuries also take a substantial economic toll, accounting for over