Loren H. Roth

The therapeutic misconception: informed consent in psychiatric research

The process by which informed consent has become an accepted part of medical and psychiatric research is reflected in the evolution of the voluminous professional literature on the subject. Early papers, focusing on the existence of ethically improper research,’ soon gave way to discussions of informed consent as a tool for satisfying ethical imperatives and protecting research subjects.2 Researchers themselves weighed in next with concerns about the impact of informed consent on the conduct of research.3 At the same time, as federal regulations firmly established informed consent as an integral part of research with human subjects, a plethora of empirical studies began to appear. Some fought a rear guard action, challenging the applicability of the doctrine on the grounds that subjects could not comprehend or utilize the information researchers were now obliged to disclose;4 others investigated a variety of approaches for improving subject comprehension.5 Conspicuous by the relative inattention it received in this process was a detailed consideration of the actual material to be disclosed to prospective research subjects. Accepting the ethical and legal importance of informed consent, what information must be communicated to achieve the desired ends? Many writers on the subject cite the items enumerated in the regulations of the U.S. Department of Health and Human Services, which govern most research with human subjects in the United States, as if they provide a satisfactory answer to this question. Yet, the requirement that prospective subjects be pro-

A classification tree approach to the development of actuarial violence risk assessment tools

Since the 1970s, a wide body of research has suggested that the accuracy of clinical risk assessments of violence might be increased if clinicians used actuarial tools. Despite considerable progress in recent years in the development of such tools for violence risk assessment, they remain primarily research instruments, largely ignored in daily clinical practice. We argue that because most existing actuarial tools are based on a main effects regression approach, they do not adequately reflect the contingent nature of the clinical assessment processes. To enhance the use of actuarial violence risk assessment tools, we propose a classification tree rather than a main effects regression approach. In addition, we suggest that by employing two decision thresholds for identifying high- and low-risk cases--instead of the standard single threshold--the use of actuarial tools to make dichotomous risk classification decisions may be further enhanced. These claims are supported with empirical data from the MacArthur Violence Risk Assessment Study.

Insight and the clinical outcome of schizophrenic patients.

At the time of discharge from their index hospitalizations, 52 schizopheric patients initially admitted for acute psychotic episodes were assessed on an Insight and Treatment Attitudes Questionnaire. When these patients were followed up 2½ to 3½ years later, adequate information on their clinical courses and outcomes was available in 46 cases. A global assessment of aftercare environment was made in each case, reflecting the degree to which individuals other than the patient were helpfully invested in maintaining the patient in treatment, whether these individuals were in the patients living or treatment situations. Five factual outcome variables were also assessed: a) compliance with treatment 30 days after discharge; b) long-term compliance; c) whether or not patients were readmitted; d) readmissions per year; and e) percent of time spent in the hospital. As expected, aftercare environment was significantly related to outcome (p = .039). The overall relationship between insight and the outcome variables closely approached statistical significance (p = .053). Patients with more insight were significantly less likely to be readmitted over the course of follow-up. There was a trend for patients with more insight to be compliant with treatment 30 days after discharge. No significant interaction between aftercare environment and insight was found, suggesting that insight may influence outcome independently of aftercare environment.

A Multiple-Models Approach to Violence Risk Assessment Among People with Mental Disorder

Actuarial models for violencerisk assessment have proliferatedin recent years. In this article, we describe an approach that integrates the predictions of many actuarial risk-assessment models, each of which may capture a different but important facet of the interactive relationship between the measured risk factors and violence. Using this multiple-models approach, we ultimately combined the results of five prediction models generated by the iterative classification tree (ICT) methodology developed in the MacArthur Violence Risk Assessment Study. This combination of models produced results not only superior to those of any of its constituent models, but superior to any other actuarial violence risk-assessment procedure reported in the literature to date.

Life quality in the era of bridging to cardiac transplantation. Bridge patients in an outpatient setting.

This study provides an empirical evaluation of quality of life in the first two heart transplant candidates with mechanical circulatory support who were transferred (with support in place) to an outpatient setting to await transplantation. Their life quality in physical, emotional, and social domains following transfer was compared to 1) their previous life quality while hospitalized, 2) life quality among a case series of five other candidates awaiting transplantation during the same time period, and 3) life quality among recent samples of heart recipients from our center and elsewhere. The transferred patients improved markedly in physical and emotional well being, with smaller gains in social functioning after leaving the hospital. They not only improved over their own earlier status while hospitalized, but showed life quality advantages over other hospitalized transplant candidates. Overall, they came to more closely resemble transplant recipients, rather than candidates, of similar age and indication for transplant. Outpatient care for selected mechanically supported heart transplant candidates provides an important potential option for the increasing numbers of patients requiring such support for extended time periods. The study yields critical data as fully implantable mechanical circulatory support devices for permanent heart replacement become a possibility.

Reduction in the Incidence of Influenza A But Not Influenza B Associated With Use of Hand Sanitizer and Cough Hygiene in Schools A Randomized Controlled Trial

Background: Laboratory-based evidence is lacking regarding the efficacy of nonpharmaceutical interventions (NPIs) such as alcohol-based hand sanitizer and respiratory hygiene to reduce the spread of influenza. Methods: The Pittsburgh Influenza Prevention Project was a cluster-randomized trial conducted in 10 elementary schools in Pittsburgh, PA, during the 2007 to 2008 influenza season. Children in 5 intervention schools received training in hand and respiratory hygiene, and were provided and encouraged to use hand sanitizer regularly. Children in 5 schools acted as controls. Children with influenza-like illness were tested for influenza A and B by reverse-transcriptase polymerase chain reaction. Results: A total of 3360 children participated in this study. Using reverse-transcriptase polymerase chain reaction, 54 cases of influenza A and 50 cases of influenza B were detected. We found no significant effect of the intervention on the primary study outcome of all laboratory-confirmed influenza cases (incidence rate ratio [IRR]: 0.81; 95% confidence interval [CI]: 0.54, 1.23). However, we did find statistically significant differences in protocol-specified ancillary outcomes. Children in intervention schools had significantly fewer laboratory-confirmed influenza A infections than children in control schools, with an adjusted IRR of 0.48 (95% CI: 0.26, 0.87). Total absent episodes were also significantly lower among the intervention group than among the control group; adjusted IRR 0.74 (95% CI: 0.56, 0.97). Conclusions: NPIs (respiratory hygiene education and the regular use of hand sanitizer) did not reduce total laboratory-confirmed influenza. However, the interventions did reduce school total absence episodes by 26% and laboratory-confirmed influenza A infections by 52%. Our results suggest that NPIs can be an important adjunct to influenza vaccination programs to reduce the number of influenza A infections among children.

The Validity of Mental Patients' Accounts of Coercion-Related Behaviors in the Hospital Admission Process

Although the recent development of a measure for perceived coercion has led to great progress in research on coercion in psychiatric settings, there still exists no consensus on how to measure the existence of real coercive events or pressures. This article reports the development of a system for integrating chart review data and data from interviews with multiple participants in the decision for an individual to be admitted to a psychiatric hospital. The method generates a “most plausible factual account” (MPFA). We then compare this account with that of patients, admitting clinicians and other collateral informants in 171 cases. Patient accounts most closely approximate the MPFA on all but one of nine dimensions related to coercion. This may be due to wider knowledge of the events surrounding the admission.

Gender differences in patterns of emotional distress following heart transplantation

The study provides the first empirical evaluation of gender differences in psychological symptomatology and DSM-III-R major depressive disorder (MDD) across the first year following heart transplantation. An important goal was to identify physical health-related and psychosocial factors that could account for, or mediate, any association between gender and psychological distress. The sample for the present analyses was drawn from a larger cohort of 172 heart recipients and included all 28 women in the cohort plus 118 men who were matched demographically with the group of women. Detailed patient assessments were completed at 2, 7, and 12 months posttransplant. As expected, womens symptom levels were consistently higher than mens. However, while mens symptom levels in all areas declined with time posttransplant, womens distress in the area of depression initially improved but then worsened by the 12-month assessment. The distribution of episodes of MDD showed a temporal pattern of gender differences similar to that of depressive symptoms. The most important mediators of the gender-depression relationship were factors related to early posttransplant daily functional limitations: women reported more impairments in daily activities. Higher levels of such impairments, in turn, predicted subsequently higher depression levels by 12 months posttransplant. Several additional variables pertaining to transplant-related concerns and a low sense of personal mastery—while not serving as mediators—exerted their own independent effects on 12-month depression levels. The findings are relevant to the tailoring of educational and clinical interventions to the individual needs of women and men who receive heart transplants.

Coercion to Inpatient Treatment

Debate over the role of coercion in mental hospital admission frequently invokes the prospective patient’s moral right to decision-making autonomy and individual dignity (e.g., Blanch & Parrish, 1993; Wertheimer, 1993). But empirical arguments for or against coercion are often pressed as well. The empirical issue most often raised is whether coerced treatment “works.” On one side, some patient advocates argue that the alleged benefits of treatment to the patient or others can be negated by patients’ feelings of alienation and dissatisfaction, as a result of which patients become unlikely to comply with treatment as soon as the coercion is lifted (cf. National Center for State Courts, 1986). Even if coerced treatment benefits those on whom it is imposed, other prospective patients may be deterred from seeking treatment voluntarily for fear that they too will be committed (Campbell & Schraiber, 1989). On the other side, a recent report by the Group for the Advancement of Psychiatry (1994), though it grants that “there seems to be a kind of embarrassment about situations in which the patient did not enter treatment entirely on his or her own initiative” (p. x), concludes that “sometimes involuntary psychiatric treatment is necessary, can be effective, and can lead to freedom from the constraints of illness. Conversely, tight restrictions against coercive treatment can have disastrous consequences” (p. 43).

Preparing the Next Generation of Leaders in Clinician-Education and Academic Administration

Interest has been increasing in supporting the career advancement of faculty clinician-educators in psychiatry. This is best evidenced by the development of the Clinician-Educator Section of the Association for Academic Psychiatry in 2003. Over the past few decades, the role of the clinician-educator has grown, as have the responsibilities. Not only are clinician-educators teachers in the classical sense, but they are often called to serve as leaders in multiple realms: clinical program chiefs, residency training directors and innovators, hospital administrators, advisers to managed care organizations, consultants for legislative policy change, physician educators, and disseminators of information to the community at large (1, 2). Despite expectations for academic career advancement being relatively clear cut for faculty dedicated to research, promotion criteria for clinician-educators are widely ill defined (3). As a result, clinician-educators often have difficulty advancing in academic rank, even though their impact on a system may be remarkable. Levinson and Rubenstein (4) highlight the problems with “the present system of recognition for clinician-educators—i.e., the requirement for regional and national reputation, the lack of reliable measures of clinical and teaching excellence, and the lack of training opportunities for young clinician-educators.” To address such issues, some major academic centers have developed clinician-educator faculty tracks that more clearly define career paths (3, 5). Historically, psychiatric residents have not been explicitly targeted for nonresearch career paths during residency. As a result, many graduating psychiatrists are behind in developing the formal skills necessary to take on leadership roles within the academic and clinical infrastructure. This contrasts with efforts to create research training opportunities from medical school onward (6). In recent years, several U.S. psychiatric residency training programs have attempted to address this shortcoming by creating specialized residency training tracks for clinician-educators. The first of these appears to be the University of Michigan’s Clinical Scholars Track, established in 1998 (7). Likewise, Baylor’s Menninger Department of Psychiatry developed a Clinician-Educator Track, and the University of California Davis created a specialized Teaching Track. This trend is encouraging, but in general, specialized residency training tracks geared toward clinicianeducators are still in the early stages of development, and it is unclear how successful these tracks have been in promoting their aims into long-term faculty careers. Furthermore, none of the existing tracks explicitly focus on developing the administrative skills crucial to the promotion of young physicians into subsequent leadership roles in academic or other care delivery settings.