Michele M. Easter

Clinical Trials and Medical Care: Defining the Therapeutic Misconception

A key component of informed consent to participate in medical research includes understanding that research is not the same as treatment.

Not all my fault: genetics, stigma, and personal responsibility for women with eating disorders.

Medical researchers and clinicians increasingly understand and present eating disorders (anorexia and bulimia nervosa) as biologically-based psychiatric disorders, with genetic risk factors established by high heritability estimates in twin studies. But there has been no research on interpretation of genetic involvement by people with eating disorders, who may hold other views. Their interpretations are particularly important given the frequent presumption that biogenetic framing will reduce stigma, and recent findings that it exacerbates stigma for other mental illnesses. To identify implications of genetic framing in eating disorders, I conducted semi-structured interviews with 50 US women with a history of eating disorders (half recovered, half in treatment; interviewed 2008-9 in the USA). Interviews introduced the topic of genetics, but not stigma per se. Analysis followed the general principles of grounded theory to identify perceived implications of genetic involvement; those relevant to stigma are reported here. Most anticipated that genetic reframing would help reduce stigma from personal responsibility (i.e., blame and guilt for eating disorder as ongoing choice). A third articulated ways it could add stigma, including novel forms of stigma related to genetic-essentialist effacing of social factors. Despite welcoming reductions in blame and guilt, half also worried genetic framing could hamper recovery, by encouraging fatalistic self-fulfilling prophecies and genetic excuses. This study is the first to elicit perceptions of genetic involvement by those with eating disorders, and contributes to an emerging literature on perceptions of psychiatric genetics by people with mental illness.

Confidentiality: more than a linkage file and a locked drawer.

S omewhere near the end of a consent form, script, recruitment letter, or brochure, researchers usually state that they will keep information “confidential.” But how is this promise evaluated by the Institutional Review Board (IRB) and kept by the researchers? Given the researchers’ confidentiality plan, the IRB must assess the risks related to participation, including risks created by disclosure of any information shared by subjects, and determine whether the study will be able to provide the level of confidentiality promised to subjects. In clinical research, confidentiality often concerns access to medical records or inadvertent revelation of patient status or of diagnosis. In comparison, survey research may raise fewer flags. When investigators offer confidentiality, it has frequently seemed sufficient to note that the study team will provide a locked cabinet, coded files, or confidentiality statements. In reality, these safeguards may be inadequate or difficult to implement. Indeed, unique and important confidentiality concerns arise during the different stages of a survey research project, but are often under-appreciated in comparison to those of clinical research. According to a recent National Research Council Panel on Institutional Review Boards, Surveys, and Social Science Research, “It is likely that those involved in the human participant protection system... are paying too little attention to the ways in which technological and other changes in the research environment are increasing the risk of disclosure of the identity of participants in research.”1 What attention there is, however, has focused on statistical and administrative techniques to protect confidentiality of largescale public-use micro data in secondary data analyses.2 This paper examines how researchers keep their promise of confidentiality and how that promise is sometimes challenged during primary data collection and analysis for an interview study.

“Una Mujer Trabaja Doble Aquí”: Vignette-Based Focus Groups on Stress and Work for Latina Blue-Collar Women in Eastern North Carolina

Latina women are a growing percentage of the working population, and very little is known about their health needs and interests. The purpose of this article is to share qualitative research results gathered from Latina women with a particular focus on exploring stress and health. This project was a substudy of Health Works in the Community, a 5-year CDC-funded multiple risk-factor reduction trial using participatory action research approaches to address smoking, healthy eating, stress, and physical activity among blue-collar women from 12 manufacturing work sites in rural, eastern North Carolina. Five focus groups were conducted with trained, bilingual facilitators using a vignettebased moderator guide that appeared particularly effective with this population. Results from the focus groups are used to make recommendations for future research with Latinas and for developing effective work-site-based interventions to address issues of stress and health within this population.

Informing Federal Policy on Firearm Restrictions for Veterans with Fiduciaries: Risk Indicators in the Post-Deployment Mental Health Study

This article examines the public safety rationale for a federal policy of prohibiting gun sales to veterans with psychiatric disabilities who are assigned a fiduciary to manage their benefits from the Department of Veterans Affairs. The policy was evaluated using data on 3200 post-deployment veterans from the Iraq and Afghanistan war era. Three proxy measures of fiduciary need—based on intellectual disability, drug abuse, or acute psychopathology—were associated in bivariate analysis with interpersonal violence and suicidality. In multivariate analysis, statistical significance remained only for the measure based on acute psychopathology. Implications for reforms to the fiduciary firearm restriction policy are discussed.

Influence of Criminal Justice Involvement and Psychiatric Diagnoses on Treatment Costs Among Adults With Serious Mental Illness

The impact of criminal justice involvement and clinical characteristics on the cost of public treatment services for adults with serious mental illnesses is unknown. The authors examined differential effects of justice involvement on behavioral health treatment costs by primary psychiatric diagnosis (schizophrenia or bipolar disorder) and also by substance use diagnosis among 25,133 adult clients of Connecticuts public behavioral health system in fiscal years 2006 and 2007. Justice-involved adults with schizophrenia had the highest costs, strongly driven by forensic hospitalizations. Addressing the cross-system burdens of forensic hospitalizations may be a sensible starting point in the effort to reduce costs in both the public behavioral health and justice systems.

Associations between pharmacotherapy for opioid dependence and clinical and criminal justice outcomes among adults with co-occurring serious mental illness ☆

Adults suffering from a serious mental illness (SMI) and a substance use disorder are at especially high risk for poor clinical outcomes and also arrest and incarceration. Pharmacotherapies for treating opioid dependence could be a particularly important mode of treatment for opioid-dependent adults with SMI to lower their risk for overdose, high-cost hospitalizations, repeated emergency department visits, and incarceration, given relapse rates are very high following detoxification in the absence of one of the three FDA-approved pharmacotherapies. This study estimates the effects of methadone, buprenorphine, and oral naltrexone on clinical and justice-related outcomes in a sample of justice-involved adults with SMI, opioid dependence, and criminal justice involvement. Administrative data were merged from several public agencies in Connecticut for 8736 adults 18years of age or older with schizophrenia spectrum disorder, bipolar disorder, or major depression; co-occurring moderate to severe opioid dependence; and who also had at least one night in jail during 2002-2009. Longitudinal multivariable regression models estimated the effect of opioid-dependence pharmacotherapy as compared to outpatient substance abuse treatment without opioid-dependence pharmacotherapy on inpatient substance abuse or mental health treatment, emergency department visits, criminal convictions, and incarcerations, analyzing instances of each outcome 12months before and after an index treatment episode. Several baseline differences between the study groups (opioid-dependence pharmacotherapy group versus outpatient treatment without opioid-dependence pharmacotherapy) were adjusted for in the regression models. All three opioid-dependence pharmacotherapies were associated with reductions in inpatient substance abuse treatment, and among the oral naltrexone subgroup, also reductions in inpatient mental health treatment, as well as improved adherence to SMI medications. Overall, the opioid-dependence pharmacotherapy group had higher rates of arrest and incarceration in the follow-up period than the comparison group; but those using oral naltrexone had lower rates of arrest (including felonies). The analysis of observational administrative data provides useful population-level estimates but also has important limitations that preclude conclusive causal inferences. Large reductions in crisis-driven service utilization associated with opioid-dependence pharmacotherapy in this study suggest that evidence-based medications for treating opioid dependence can be used successfully in adults with SMI and should be considered more systematically during assessments of treatment needs for this population.

Medication-Assisted Treatment for Alcohol-Dependent Adults With Serious Mental Illness and Criminal Justice Involvement: Effects on Treatment Utilization and Outcomes

OBJECTIVE Adults with serious mental illness and comorbid alcohol dependence are at high risk for both high utilization of crisis-driven health care services and criminal justice involvement. Evidence-based medication-assisted treatment (MAT) for alcohol dependence may reduce both crisis service utilization and criminal recidivism. The authors estimated the effect of MAT on behavioral health treatment utilization and criminal justice outcomes for this population. METHOD Relevant administrative data were merged from several public agencies in Connecticut for 5,743 adults ≥18 years old who had schizophrenia spectrum disorder, bipolar disorder, or major depressive disorder comorbid with moderate to severe alcohol dependence and who were incarcerated for at least one night during the study window (2002-2009). Longitudinal multivariable regression models were used to estimate the effect of MAT compared with other outpatient substance abuse treatments on inpatient mental health and substance abuse hospitalizations, emergency department visits, criminal convictions, and incarcerations. RESULTS MAT was associated with significant improvements in clinical outcomes in the 12 months following initiation compared with non-MAT comparison treatment, including greater reductions in mental health hospitalization and emergency department visits and greater improvements in psychotropic medication adherence. No benefits of MAT were found for most criminal justice outcomes, except for significant reductions in felony convictions among adults with bipolar disorder. CONCLUSIONS MAT is underused for treating alcohol dependence, especially among adults with serious mental illness. These results suggest that MAT can have important benefits for clinical outcomes in this population. More research is needed to improve its use in this patient population as well as to address barriers to its availability.

Facilitation of Psychiatric Advance Directives by Peers and Clinicians on Assertive Community Treatment Teams

OBJECTIVE Psychiatric advance directives (PADs) provide a legal mechanism for competent adults to document care preferences and authorize a surrogate to make treatment decisions. In a controlled research setting, an evidence-based intervention, the facilitated psychiatric advance directive (FPAD), was previously shown to overcome most barriers to PAD completion. This study examined implementation of the FPAD intervention in usual care settings as delivered by peer support specialists and nonpeer clinicians on assertive community treatment (ACT) teams. METHODS A total of 145 ACT consumers were randomly assigned, within teams, to FPAD with facilitation by either a peer (N=71) or a clinician (N=74). Completion rates and PAD quality were compared with the previous studys standard and across facilitator type. Logistic regression was used to estimate effects on the likelihood of PAD completion. RESULTS The completion rate of 50% in the intent-to-treat sample (N=145) was somewhat inferior to the prior standard (61%), but the rate of 58% for the retained sample (those who completed a follow-up interview, N=116) was not significantly different from the standard. Rates for peers and clinicians did not differ significantly from each other for either sample. PAD quality was similar to that achieved in the prior study. Four consumer variables predicted completion: independent living status, problematic substance use, length of time served by the ACT team, and no perceived unmet need for hospitalization in crisis. CONCLUSIONS Peers and clinicians can play a crucial role in increasing the number of consumers with PADs, an important step toward improving implementation of PADs in mental health care.