Capacity to provide informed consent among adults with bipolar disorder.

BACKGROUND: Identifying correlates of capacity to provide informed consent among individuals with bipolar disorder is essential for patient protection. As part of a clinical trial involving approved, standard treatments, we investigated relationships between clinical characteristics and capacity to provide informed consent in adults with bipolar disorder using the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR). After administering the MacCAT-CR, continuing participants in the trial were capable of and provided informed consent. METHODS: Trained, board-certified psychiatrists administered the MacCAT-CR to potential study participants (N = 50) after they provided informed consent, but prior to initiation of study procedures. RESULTS: Higher Schedule for Assessment of Positive Symptoms (SAPS) scores were significantly correlated with worse MacCAT-CR Understanding and Appreciation (p < 0.04) subscale scores; lower Hamilton Depression Rating Scale (HDRS) scores and higher Clinical Global Impression-Severity (CGI-S) scores were significantly correlated with worse Reasoning and Understanding subscale scores (p < 0.03); and patients with comorbid substance use disorders (SUD) had better Appreciation and Reasoning subscale scores (p < 0.05). LIMITATIONS: The MacCAT-CR identifies areas where participants need explanation. However, there is not a predetermined score to indicate understanding of study procedures and therefore input from a trained clinician is needed to determine capacity to provide informed consent. CONCLUSIONS: Our findings suggest that certain measures of illness severity are associated with lower levels of capacity to provide informed consent among adults with bipolar disorder. This study provides important information for clinicians and researchers to consider when obtaining informed consent in this population.

Impulsive aggression with irritability and responsive to divalproex: a pediatric bipolar spectrum disorder phenotype?

BACKGROUND: The objective of this retrospective chart review was to evaluate the phenomenology and response to divalproex in a sub-population of children admitted to an inpatient setting with severe impairing symptoms of irritability and aggression. In addition, we examined whether the symptomatology of this group was consistent with a pediatric divalproex-responsive bipolar spectrum disorder. METHODS: The charts of 46 child and adolescent patients with prominent impulsive aggression with irritability admitted to a crisis stabilization center were assessed retrospectively. Impulsive aggressive symptoms were assessed for admission and discharge severity by two clinicians using the Overt Aggression Scale (OAS) and the Anger-Hostility Subscale of the SCL-90 (SCL-A), with overall functioning changes assessed using the Children's Global Assessment Scale (C-GAS). RESULTS: Statistically significant improvements were obtained for the group in the C-GAS, with significant decreases in the OAS and the SCL-A scores at discharge, following a maximal 14-day stay. No severe side effects were reported. All patients met the criteria for a potential pediatric bipolar phenotype. LIMITATIONS: This was a retrospective study without randomization or a control group. Additionally, the non-blinded design may have biased the raters concerning the effectiveness of divalproex for impulsive aggression. CONCLUSIONS: Our data are in line with divalproex response in children and adolescents with target symptoms of explosive temper and mood instability. Our data further suggest that such symptoms, coupled with impulsive aggression and irritability, as well as related manic symptoms, constitute a pediatric divalproex-responsive bipolar spectrum disorder.

Using models and data to support optimization of the Military Health System: a case study in an intensive care unit.

Optimizing healthcare delivery--improving processes to reduce impediments to care--is an important goal of the Military Health System. Models and data can be effective tools to assist managers in achieving this goal. This paper illustrates this utility with a case study of the intensive care unit (ICU) at the US Air Force's Wilford Hall Medical Center. A discrete-event simulation demonstrates how the integration of corporate data and ICU data through a model can help identify changes intended to improve ICU performance. Results of the analysis describe impacts of ICU size and bed mix, operating policies, and the deployment of ICU staff on measures of occupancy, congestion, and physician training needs.