Healthcare providers' use of a concise summary to prescribe for lactating patients.

BACKGROUND: Most breastfeeding individuals take at least one prescription drug, yet limited data from lactation studies are available to inform the safety of these drugs during breastfeeding. As a result, healthcare providers (HCPs) rely on available information about safety of drugs used during pregnancy or on personal experiences to inform prescribing/counseling decisions for breastfeeding individuals. To improve risk communication regarding drugs used during lactation, the U.S. Food and Drug Administration published the Pregnancy and Lactation Labeling Rule (PLLR) in 2015, which added a narrative summary of available risk information to the lactation section of Prescribing Information (PI). Prior studies on labeling in PLLR format revealed that although HCPs found these details valuable, they regarded the narrative as too long to support decision-making during patient encounters. OBJECTIVE: This qualitative study's objective was to assess the utility of adding a concise summary to the Lactation subsection of PI to complement the narrative and succinctly communicate to busy HCPs a drug's risks when used during lactation. The concise summary consisted of a bolded headline, bulleted descriptions of available study findings and potential adverse reactions, and recommendations for risk mitigation. METHODS: Twenty-five online focus groups were conducted with five segments of HCPs to obtain their feedback on the concise summary and discuss their prescribing/counseling decisions for four fictitious prescription drugs including one vaccine. RESULTS: HCPs utilized the concise summary to make initial prescribing/counseling decisions. Many also used the labeling narrative for a comprehensive benefit-risk assessment. CONCLUSION: The findings indicate a need to continue to improve communication about safety of drugs used during lactation, and that the concise summary may help facilitate this communication. The study also highlights the need to educate HCPs about PI limitations when clinical data are lacking and the need to encourage clinical studies to be conducted to support actionable recommendations about use of prescription drugs during lactation.

Dialogues on mixed-methods and mental health services research: anticipating challenges, building solutions.

Increasingly, contemporary mental health services research projects aim to combine qualitative and quantitative components. Yet researchers often lack theoretical and practical guidance for undertaking such studies. In September 2006 the authors convened under the auspices of the National Institute of Mental Health at a working conference, "Mixed Methods in Community-Based Mental Health Services Research." This meeting provided the opportunity for participants to share their experiences in conducting mixed-methods research, to critically consider problems they had encountered and their solutions, and to develop guiding principles for others conducting similar research. The authors' discussions, which are described in this article, emphasize that the problems encountered by mixed-methods research teams are rarely simple misunderstandings but often reflect epistemological differences that are overlooked in the study planning phases. Failure to acknowledge these different worldviews may result in significant tensions between members of the study team, use of qualitative methods that are insufficient or inappropriate for a particular research question, or serious conflicts when team members belatedly discover they are interpreting key concepts -- or each other's research techniques -- differently. The authors conclude that ongoing communication is the organizing principle for robust and effective mixed-methods research. Among the recommendations for preventing problems are collaboration between quantitative and qualitative researchers during the study design phase; open acknowledgement of the philosophical approaches brought to the study by various team members; and because not all challenges can be anticipated, a shared willingness to negotiate emerging problems.

Why lower income mothers do not engage with the formal mental health care system: perceived barriers to care.

Lower income mothers who bring their children for mental health services also have high rates of depression and anxiety, yet few seek help. Maternal and child mental health are intimately intertwined; thus, the distress of both is likely to continue if the mother's needs are unaddressed. Because mothers overcome numerous instrumental challenges to help their children, the authors identify potential perceptual barriers to mothers' help seeking. An ethnographic analysis of in-depth qualitative interviews with 127 distressed mothers suggests several critical perceptual factors. For example, mothers attributed their distress to external causes (e.g., poverty, negative life stressors), which they believed individually focused mental health services could not affect. Interviewees also anticipated negative ramifications for seeking care, including being labeled unfit mothers, and thus potentially losing custody of their children. The authors discuss the implications of these and other key themes for engaging lower income mothers and their children.

Financial vulnerability among Medicare managed care enrollees.

Consumer Assessment of Health Plans Survey (CAHPS) data show that Medicare managed care plans often receive low satisfaction scores from certain vulnerable populations. This article describes findings from a qualitative study with beneficiaries about their Medicare managed care experiences. Focus groups were stratified by participant race/ethnicity and self-described health status. Yet participants did not describe their concerns in terms of their race, ethnicity, or health condition, but rather their access to financial resources. Our findings suggest that researchers consider how socioeconomics creates health care vulnerability for racial and ethnic minorities, females, people with disabilities, and other economically marginalized persons.

Consumers' perceptions of negative experiences and "sanctuary harm" in psychiatric settings.

OBJECTIVE: Recent studies show a high prevalence of trauma symptoms among people with serious mental illness who are treated in public-sector mental health systems. Unfortunately, growing evidence suggests that many consumers have had traumatic or harmful experiences while being treated in various psychiatric settings. This study explores consumers' perceptions of such harmful inpatient experiences, events that the authors place under the rubric of "sanctuary harm." METHODS: The authors conducted semistructured qualitative interviews with 27 randomly selected mental health consumers to hear their descriptions of adverse events that they experienced while receiving psychiatric care. Our analysis of interview transcriptions focused on understanding consumers' narratives of harmful experiences-events that would not meet DSM-IV criteria for trauma but that nevertheless resulted in significant distress. RESULTS: Eighteen of 27 interviewees described harmful incidents that they had witnessed or experienced directly, many of which evoked strong emotional responses by consumers during their narration. Nearly all incidents described were hospital based and were clustered around two sets of themes. The first set related to the hospital setting, including the fear of physical violence and the arbitrary nature of the rules. The second set related to the narrators' interactions with clinical staff, including depersonalization, lack of fairness, and disrespect. CONCLUSIONS: The findings suggest that many mental health consumers have had a lifetime sanctuary experience that they perceived as harmful. They also offered suggestions for how the mental health service delivery system might reduce the potential for sanctuary harm experiences.

Patients' reports of traumatic or harmful experiences within the psychiatric setting.

OBJECTIVE: This study examined the frequency and associated distress of potentially traumatic or harmful experiences occurring within psychiatric settings among persons with severe mental illness who were served by a public-sector mental health system. METHODS: Participants were 142 randomly selected adult psychiatric patients who were recruited through a day hospital program. Participants completed a battery of self-report measures to assess traumatic and harmful events that occurred during the course of their mental health care, lifetime trauma exposure, and symptoms of posttraumatic stress disorder. RESULTS: Data revealed high rates of reported lifetime trauma that occurred within psychiatric settings, including physical assault (31 percent), sexual assault (8 percent), and witnessing traumatic events (63 percent). The reported rates of potentially harmful experiences, such as being around frightening or violent patients (54 percent), were also high. Finally, reported rates of institutional measures of last resort, such as seclusion (59 percent), restraint (34 percent), takedowns (29 percent), and handcuffed transport (65 percent), were also high. Having medications used as a threat or punishment, unwanted sexual advances in a psychiatric setting, inadequate privacy, and sexual assault by a staff member were associated with a history of exposure to sexual assault as an adult. CONCLUSIONS: Findings suggest that traumatic and harmful experiences within psychiatric settings warrant increased attention.

Are there racial differences in the experience of harmful or traumatic events within psychiatric settings?

The current study examined racial differences in the reported frequency and distress associated with potentially harmful or traumatic experiences occurring within psychiatric settings. One hundred and forty-two (109 African-American; 32 Caucasian) randomly selected adult consumers recruited from a community psychosocial day program completed a battery of self-report measures to assess experiences in the psychiatric setting, lifetime trauma exposure, PTSD severity, and were the subject of a chart review. A subset of participants (20%) also completed a qualitative interview exploring their perceptions of events occurring in psychiatric settings. Few racial differences were noted in the reported frequency or distress associated with particular events in the psychiatric setting. However, we found differential patterns of association between adverse psychiatric events and lifetime trauma history, and racial differences in diagnosis and medications prescribed by the mental health center. These racial differences merit further attention to better understand their meaning and to improve mental health services provided to both African-Americans and Caucasian public-sector psychiatric patients.