Recently the National Institutes of Health has been emphasizing research that takes findings generated by clinical research and translates them into treatments for patients who are seen in day-to-day nonresearch settings. This translational process requires a series of steps in which elements of both efficacy and effectiveness research are combined into successively more complex designs. However, there has been little discussion of exactly how to develop and operationalize these designs. This article describes an approach to the development of these hybrid designs. Their operationalization is illustrated by using the design of an ongoing effectiveness treatment study of panic disorder in primary care. Experts in both efficacy and effectiveness research collaborated to address the methodologic and data collection issues that need to be considered in designing a first-generation effectiveness study. Elements of the overall study design, setting or service delivery context, inclusion and exclusion criteria, recruitment and screening, assessment tools, and intervention modification are discussed to illustrate the thinking behind and rationale for decisions about these different design components. Although the series of decisions for this study were partly influenced by considerations specific to the diagnosis of panic disorder and the context of the primary care setting, the general stepwise approach to designing treatment interventions using an effectiveness model is relevant for the development of similar designs for other mental disorders and other settings.
Objective. The purpose of this study was to compare the sensitivity of four generic effectiveness measures with clinically meaningful symptom improvement in persons with schizophrenia. Method. Baseline and 6-month interviews were conducted with 134 subjects diagnosed with schizophrenia or schizoaffective disorder. The design was observational. The four generic effectiveness measures included the Quality of Well-Being scale (QWB), a quality-adjusted index score based on the SF-36 VAS, Veterans SF-36 mental health component summary score (MCS), and the World Health Organization Disablement Assessment Schedule (WHO-DAS). Symptom measures included the Positive and Negative Syndrome Scale (PANSS) and Calgary Depression Scale (CDS). The side effect measure was the Extrapyramidal Symptom Rating Scale (ESRS). Data analysis included correlations between symptom, side effect, and generic effectiveness change scores; and an effect size calculation to detect a clinically significant improvement in the total PANSS. Results. All four effectiveness measures were correlated with changes in side effects. All but the SG-36 VAS were correlated with changes in depression. Only the QWB was correlated with changes in PANSS scores. The QWB required at least three times fewer subjects (n = 61) to detect a clinically significant improvement in total PANSS compared with the other effectiveness measures (n = 201–324). Conclusions. It is recommended that clinicians and researchers use the QWB to demonstrate the effectiveness and cost-effectiveness of schizophrenia interventions. The QWB allows for direct comparison of the effectiveness and cost-effectiveness of schizophrenia interventions with other mental and physical health interventions and may contribute to a greater recognition of the value of mental health interventions.
Objectives: The objective of this study was to examine age differences in the likelihood of endorsing of death and suicidal ideation in primary care patients with anxiety disorders.Method: Participants were drawn from the Coordinated Anxiety Learning and Management (CALM) Study, an effectiveness trial for primary care patients with panic disorder (PD), generalized anxiety disorder (GAD), post-traumatic stress disorder (PTSD), and/or social anxiety disorder (SAD).Results: Approximately one third of older adults with anxiety disorders reported feeling like they were better off dead. Older adults with PD and SAD were more likely to endorse suicidal ideation lasting at least more than half the prior week compared with younger adults with these disorders. Older adults with SAD endorsed higher rates of suicidal ideation compared with older adults with other anxiety disorders. Multivariate analyses revealed the importance of physical health, social support, and comorbid MDD in this association.Conclusions: Suicidal ideation is common in anxious, older, primary care patients and is particularly prevalent in socially anxious older adults. Findings speak to the importance of physical health, social functioning, and MDD in this association.Clinical Implications: When working with anxious older adults it is important to conduct a thorough suicide risk assessment and teach skills to cope with death and suicidal ideation-related thoughts.
Article AbstractBackground: Interventions to improve adherence to antipsychotic medication are needed. The aims of the current study were to identify the most common barriers to medication adherence in a cohort of patients receiving outpatient and inpatient treatment for an acute exacerbation of schizophrenia, compare clinical and demographic characteristics of patients with lower versus higher numbers of barriers, and characterize patients most likely to be nonadherent to antipsychotic medication. Method: The present study analyzed data collected during the Schizophrenia Guidelines Project (SGP), a multisite study of strategies to implement practice guidelines that was funded by the U.S. Department of Veterans Affairs and conducted from March 1999 to October 2000. Nurse coordinators had conducted clinical assessments and performed an intervention designed to improve medication adherence by addressing barriers to adherence. Data on patient symptoms, functioning, and side effects had been obtained using the Positive and Negative Syndrome Scale (PANSS), the Schizophrenia Outcomes Module, the Medical Outcomes Study 36-item Short-Form Health Survey, and the Barnes Akathisia Scale (BAS). Administrative data were used to identify patients with an ICD-9 code for schizophrenia. A total of 153 patients who met this criterion and participated in the intervention arm of the SGP had complete data available for analysis in the current study. Results: The most common patient-reported barriers were related to the stigma of taking medications, adverse drug reactions, forgetfulness, and lack of social support. Bivariate analysis showed that patients with high barriers were significantly more likely to be nonadherent (p <= .02), to have problems with alcohol or drug use (p = .02), to have higher PANSS total scores (p = .03), and to have higher mean BAS scores (p = .02). Logistic regression showed that lower patient education level (odds ratio = 3.95, p = .02), substance abuse (OR = 3.24, p = .01), high PANSS total scores (OR = 1.02, p = .05), and high barriers (OR = 2.3, p = .05) were significantly associated with the probability of nonadherence. Conclusions: It may be possible to identify patients most likely to benefit from adherence intervention. The data presented here will help to inform future research of clinical interventions to improve medication adherence in schizophrenia and help to stimulate further work in this area.
