Stephen Inrig

Can medicalization be good? Situating medicalization within bioethics

Medicalization has been a process articulated primarily by social scientists, historians, and cultural critics. Comparatively little is written about the role of bioethics in appraising medicalization as a social process. The authors consider what medicalization means, its definition, functions, and criteria for assessment. A series of brief case sketches illustrate how bioethics can contribute to the analysis and public policy discussion of medicalization.

Residential racial segregation and mortality among black, white, and Hispanic urban breast cancer patients in Texas, 1995 to 2009.

The authors investigated whether residential segregation (the degree to which racial/ethnic groups live separately from one another in a geographic area) 1) was associated with mortality among urban women with breast cancer, 2) explained racial/ethnic disparities in mortality, and 3) whether its association with mortality varied by race/ethnicity.

Ethical Issues in Perinatal Mental Health Research

Purpose of review To review the background of current ethical standards for the conduct of perinatal mental health research and describe the ethical challenges in this research domain. Recent findings Current literature reflects a growing sentiment in the scientific community that having no information regarding the impact of psychiatric treatment on the mother and developing fetus/infant poses dangers that may exceed the risks involved in research. However, without sufficient consensus across the scientific community, both regulatory bodies and perinatal researchers find themselves without a framework for decision making that satisfactorily limits the risks and facilitates the benefits of participation of pregnant and lactating women in clinical research. Summary Psychiatric research in perinatal mental health is critically important as it enables clinicians and patients to participate in informed decision-making concerning treatment for psychiatric disorders. Specific areas of concern include fetal safety, maternal risk, the therapeutic misconception, commercial interests, forensic/legal issues, the informed consent process, and study design. Developing guidelines that address ethical challenges and include the views and concerns of multiple stakeholders could improve the access of perinatal women to the benefits of participation in mental health research in addition to providing evidence-based mental healthcare for this subpopulation.

Ethical challenges in designing, conducting, and reporting research to improve the mental health of pregnant women: The voices of investigators and IRB members

Background: Legitimate concern for fetal safety often precludes women who are pregnant or planning to become pregnant from participating in randomized controlled trials (RCTs), preventing the development of an empirically-derived evidence base for the safety and efficacy of treatments. Perinatal science can only move forward when the research community understands and addresses the practical and ethical roadblocks impeding this research. Methods: To understand these challenges better, our study team interviewed 15 perinatal mental health investigators from 12 leading academic institutions in the United States and 6 members of the respective institutional review boards (IRBs). Results: Respondents confirmed seven broad ethical challenges. Through analyzing interview transcripts, we identified four themes: research design/methodology, safety, participant selection/recruitment, and autonomy. Fifteen subthemes further delineate the complexities of the issues revealed in narratives describing specific experiences related to these themes. Conclusions: The lack of reasonable solutions to these ethical challenges is a barrier to rigorous clinical research in this population, preventing the collection of empirical evidence for psychiatric care in the perinatal setting. Our study population confirms that the current federal human subjects protections guidelines (i.e., 45 CFR 46 Subpart B) do not fully address the themes of concern that emerged in the interviews. There is a need for greater flexibility in accepting womens competence to balance the risks and benefits of research participation for themselves and their fetuses.

County-level outcomes of a rural breast cancer screening outreach strategy: a decentralized hub-and-spoke model (BSPAN2)

Rural mammography screening remains suboptimal despite reimbursement programs for uninsured women. Networks linking non-clinical community organizations and clinical providers may overcome limited delivery infrastructure in rural areas. Little is known about how networks expand their service area. To evaluate a hub-and-spoke model to expand mammography services to 17 rural counties by assessing county-level delivery and local stakeholder conduct of outreach activities. We conducted a mixed-method evaluation using EMR data, systematic site visits (73 interviews, 51 organizations), 92 patient surveys, and 30 patient interviews. A two-sample t test compared the weighted monthly average of women served between hub- and spoke-led counties; nonparametric trend test evaluated time trend over the study period; Pearson chi-square compared sociodemographic data between hub- and spoke-led counties. From 2013 to 2014, the program screened 4603 underinsured women. Counties where local “spoke” organizations led outreach activities achieved comparable screening rates to hub-led counties (9.2 and 8.7, respectively, p = 0.984) and did not vary over time (p = 0.866). Qualitative analyses revealed influence of program champions, participant language preference, and stakeholders’ concerns about uncompensated care. A program that leverages local organizations’ ability to identify and reach rural underserved populations is a feasible approach for expanding preventive services delivery.

Community, Constituency, and Morbidity: Applying Chervenak and McCullough's Criteria

the pregnant research participant and her fetus(es) as patients, as do Chervenak and McCullough. As presented, Chervenak and McCullough seem to base the move from research subject to patient on their reading of Emanuel and colleagues (2000) and the Belmont Report (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research 1979) as espousing determination of the “risk–benefit ratio [of clinical research as] clinical judgments about health-related benefits and risks . . . as if [subjects] were patients” (Chervenak and McCullough 2011, 39). They then assert that clinical investigators have a “fiduciary responsibility to protect research subjects from . . . net clinical harm.” While health-related outcomes often drive risk–benefit assessments in research design, these assessments are not based on clinical judgments. Specifically, they are not made with any individual participant’s best interest in mind. Risk–benefit calculations are made—from the investigator’s standpoint—by considering the range of probable outcomes likely to accrue to potential participants and balancing these against the benefit expected from the knowledge to be generated. Furthermore, investigators cannot be said to have a responsibility to protect research participants from net clinical harm—even a relatively harmless blood draw or biopsy, when done exclusively for research purposes, has zero clinical value and may have some risk. Again, the risks associated with clinical research are properly counterbalanced against the social value (to quote Emanuel et al. 2000) of the research, and should be considered in the context of the investigator–participant relationship rather than the physician–patient relationship. Researchers therefore should seek to minimize risk to study participants as a group while creating the generalizable knowledge society values. Our arguments and objections beg the question of how to address situations when physicians do conduct clinical research with their pregnant patients. Without question, the ethical landscape is difficult to navigate in these cases. However, clinicians who conduct research should be aware of and clear about the conflicting obligations brought by their roles as care provider and investigator, and move forward carefully. They should not blur boundaries further by adopting a patient-centric view of clinical research.

Identifying quality improvement targets to facilitate colorectal cancer screening completion

The colorectal cancer (CRC) screening process involves multiple interfaces (communication exchanges and transfers of responsibility for specific actions) among primary care and gastroenterology providers, laboratory, and administrative staff. After a retrospective electronic health record (EHR) analysis discovered substantial clinic variation and low CRC screening prevalence overall in an urban, integrated safety-net system, we launched a qualitative analysis to identify potential quality improvement targets to enhance fecal immunochemical test (FIT) completion, the systems preferred screening modality. Here, we report examination of organization-, clinic-, and provider-level interfaces over a three-year period (December 2011–October 2014). We deployed in parallel 3 qualitative data collection methods: (1) structured observation (90+ hours, 10 sites); (2) document analysis (n > 100); and (3) semi-structured interviews (n = 41) and conducted iterative thematic analysis in which findings from each method cross-informed subsequent data collection. Thematic analysis was guided by a conceptual model and applied deductive and inductive codes. There was substantial variation in protocols for distributing and returning FIT kits both within and across clinics. Providers, clinic and laboratory staff had differing access to important data about FIT results based on clinical information system used and this affected results reporting. Communication and coordination during electronic referrals for diagnostic colonoscopy was suboptimal particularly for co-morbid patients needing anesthesia clearance. Our multi-level approach elucidated organizational deficiencies not evident by quantitative analysis alone. Findings indicate potential quality improvement intervention targets including: (1) best-practices implementation across clinics; (2) detailed communication to providers about FIT results; and (3) creation of EHR alerts to resolve pending colonoscopy referrals before they expire.

Assessing local capacity to expand rural breast cancer screening and patient navigation: An iterative mixed-method tool.

BACKGROUND Despite federal funding for breast cancer screening, fragmented infrastructure and limited organizational capacity hinder access to the full continuum of breast cancer screening and clinical follow-up procedures among rural-residing women. We proposed a regional hub-and-spoke model, partnering with local providers to expand access across North Texas. We describe development and application of an iterative, mixed-method tool to assess county capacity to conduct community outreach and/or patient navigation in a partnership model. METHODS Our tool combined publicly-available quantitative data with qualitative assessments during site visits and semi-structured interviews. RESULTS Application of our tool resulted in shifts in capacity designation in 10 of 17 county partners: 8 implemented local outreach with hub navigation; 9 relied on the hub for both outreach and navigation. Key factors influencing capacity: (1) formal linkages between partner organizations; (2) inter-organizational relationships; (3) existing clinical service protocols; (4) underserved populations. Qualitative data elucidate how our tool captured these capacity changes. CONCLUSIONS Our capacity assessment tool enabled the hub to establish partnerships with county organizations by tailoring support to local capacity and needs. Absent a vertically integrated provider network for preventive services in these rural counties, our tool facilitated a virtually integrated regional network to extend access to breast cancer screening to underserved women.

The cost of restricting knowledge.

Although clinicians lack evidence-based treatments for mental illness in perinatal women, this does not constitute “operating in a vast sea of ignorance.”1 In the relative absence of clinical studies, clinicians rely upon community-based standards of care that emerge from clinical experience, descriptive/observational studies, guidelines of professional associations, and the adaptation of scientific evidence from other populations. While these sources are less robust than the gold standard of research, randomized placebo-controlled trials (RCT), findings from these sources still provide credible treatment rationales. This state of affairs prompts a more substantive question: What prevents randomized, placebo-controlled trials in perinatal women? Like perinatal women, children constitute a vulnerable population requiring special protections, yet placebo-controlled trials of antidepressants among children appear in the literature today.2 We acknowledge the dual requirement to protect the fetus and the mother, and recognize that the ethical considerations complicating perinatal research are inescapable. However, the lack of robust research with perinatal women blinds us to the unknown risks or benefits of treatment and the lack of treatment to both mother and child over time. Nevertheless, funding agencies and regulatory boards continue to disqualify research with perinatal women that incorporates a placebo arm. Might we be, as Alta Charo provocatively asks, “Protecting [Women] to Death?”3 Ethicists, investigators, and clinicians have suggested that a framework for ethical decision-making in perinatal research would give all stakeholders an important tool to address this inequity in research.4 Such a framework has already been suggested for decision-making in the clinical setting.5 In this risk-benefit model for the treatment of schizophrenia in perinatal women, clinician and patient together carefully consider interventions by incorporating the values of both parties about treatment alternatives and possible outcomes. Collaboratively, those involved decide upon an integrative choice of treatment that is open to revision as necessary. However, this promising clinical model does not address the additional ethical considerations of perinatal research; therefore, we propose an equally collaborative development of a set of guidelines to aid all stakeholders in optimizing the risk-benefit ratio in the design and ethical conduct of RCTs. One approach towards the development of such guidelines is to invite investigators, decision-makers in regulatory and funding agencies, legal experts, community health providers, research participants, patients and their partners to describe their experiences, values, and beliefs regarding perinatal mental health research. A preliminary investigation of the concerns of prominent perinatal mental health investigators has already identified issues related to informed consent, inclusion/exclusion criteria, randomization, and the therapeutic misconception as important targets to address in a more inclusive group of stakeholders. Subsequently, a bioethical analysis of the issues and prospective solutions would generate guidelines and, in turn, an algorithm useful for weighing the risks and benefits as they are understood by all of the stakeholders. We recognize that excluding perinatal women and their unborn children from research disadvantages them across all medical treatments, so mental health guidelines for this population could stimulate the development of similar decision-making frameworks for other populations and conditions. We invite your comments.