Jeffrey M. Pyne

Effectiveness-implementation Hybrid Designs: Combining Elements of Clinical Effectiveness and Implementation Research to Enhance Public Health Impact

Objectives:This study proposes methods for blending design components of clinical effectiveness and implementation research. Such blending can provide benefits over pursuing these lines of research independently; for example, more rapid translational gains, more effective implementation strategies, and more useful information for decision makers. This study proposes a “hybrid effectiveness-implementation” typology, describes a rationale for their use, outlines the design decisions that must be faced, and provides several real-world examples. Results:An effectiveness-implementation hybrid design is one that takes a dual focus a priori in assessing clinical effectiveness and implementation. We propose 3 hybrid types: (1) testing effects of a clinical intervention on relevant outcomes while observing and gathering information on implementation; (2) dual testing of clinical and implementation interventions/strategies; and (3) testing of an implementation strategy while observing and gathering information on the clinical intervention’s impact on relevant outcomes. Conclusions:The hybrid typology proposed herein must be considered a construct still in evolution. Although traditional clinical effectiveness and implementation trials are likely to remain the most common approach to moving a clinical intervention through from efficacy research to public health impact, judicious use of the proposed hybrid designs could speed the translation of research findings into routine practice.

Functional impact and health utility of anxiety disorders in primary care outpatients.

Objective:The objective of this study was to examine the relative impact of anxiety disorders and major depression on functional status and health-related quality of life of primary care outpatients. Method:Four hundred eighty adult outpatients at an index visit to their primary care provider were classified by structured diagnostic interview as having anxiety disorders (panic disorder with or without agoraphobia, social phobia, and posttraumatic stress disorder; generalized anxiety disorder was also assessed in a subset) with or without major depression. Functional status, sick days from work, and health-related quality of life (including a preference-based measure) were assessed using standardized measures adjusting for the impact of comorbid medical illnesses. Relative impact of the various anxiety disorders and major depression on these indices was evaluated. Results:In multivariate regression analyses simultaneously adjusting for age, sex, number of chronic medical conditions, education, and/or poverty status, each of major depression, panic disorder, posttraumatic stress disorder, and social phobia contributed independently and relatively equally to the prediction of disability and functional outcomes. Generalized anxiety disorder had relatively little impact on these indices when the effects of comorbid major depression were considered. Overall, anxiety disorders were associated with substantial decrements in preference-based health states. Conclusions:These observations demonstrate that the presence of each of 3 common anxiety disorders (ie, panic disorder, posttraumatic stress disorder, and social phobia)—over and above the impact of chronic physical illness, major depression, and other socioeconomic factors—contributes in an approximately additive fashion to the prediction of poor functioning, reduced health-related quality of life, and more sick days from work. Greater awareness of the deleterious impact of anxiety disorders in primary care is warranted.

Practice Based Versus Telemedicine Based Collaborative Care for Depression in Rural Federally Qualified Health Centers: A Pragmatic Randomized Comparative Effectiveness Trial

OBJECTIVE Practice-based collaborative care is a complex evidence-based practice that is difficult to implement in smaller primary care practices that lack on-site mental health staff. Telemedicine-based collaborative care virtually co-locates and integrates mental health providers into primary care settings. The objective of this multisite randomized pragmatic comparative effectiveness trial was to compare the outcomes of patients assigned to practice-based and telemedicine-based collaborative care. METHOD From 2007 to 2009, patients at federally qualified health centers serving medically underserved populations were screened for depression, and 364 patients who screened positive were enrolled and followed for 18 months. Those assigned to practice-based collaborative care received evidence-based care from an on-site primary care provider and a nurse care manager. Those assigned to telemedicine-based collaborative care received evidence-based care from an on-site primary care provider and an off-site team: a nurse care manager and a pharmacist by telephone, and a psychologist and a psychiatrist via videoconferencing. The primary clinical outcome measures were treatment response, remission, and change in depression severity. RESULTS Significant group main effects were observed for both response (odds ratio=7.74, 95% CI=3.94-15.20) and remission (odds ratio=12.69, 95% CI=4.81-33.46), and a significant overall group-by-time interaction effect was observed for depression severity on the Hopkins Symptom Checklist, with greater reductions in severity over time for patients in the telemedicine-based group. Improvements in outcomes appeared to be attributable to higher fidelity to the collaborative care evidence base in the telemedicine-based group. CONCLUSIONS Contracting with an off-site telemedicine-based collaborative care team can yield better outcomes than implementing practice-based collaborative care with locally available staff.

A randomized, controlled trial of virtual reality-graded exposure therapy for post-traumatic stress disorder in active duty service members with combat-related post-traumatic stress disorder.

Abstract Virtual reality (VR)-based therapy has emerged as a potentially useful means to treat post-traumatic stress disorder (PTSD), but randomized studies have been lacking for Service Members from Iraq or Afghanistan. This study documents a small, randomized, controlled trial of VR-graded exposure therapy (VR-GET) versus treatment as usual (TAU) for PTSD in Active Duty military personnel with combat-related PTSD. Success was gauged according to whether treatment resulted in a 30 percent or greater improvement in the PTSD symptom severity as assessed by the Clinician Administered PTSD Scale (CAPS) after 10 weeks of treatment. Seven of 10 participants improved by 30 percent or greater while in VR-GET, whereas only 1 of the 9 returning participants in TAU showed similar improvement. This is a clinically and statistically significant result (χ(2) = 6.74, p < 0.01, relative risk 3.2). Participants in VR-GET improved an average of 35 points on the CAPS, whereas those in TAU averaged a 9-point improvement (p < 0.05). The results are limited by small size, lack of blinding, a single therapist, and comparison to a relatively uncontrolled usual care condition, but did show VR-GET to be a safe and effective treatment for combat-related PTSD.

The economic burden of schizophrenia in Canada in 2004.

ABSTRACT Objective: To estimate the financial burden of schizophrenia in Canada in 2004. Methods: A prevalence-based cost-of-illness (COI) approach was used. The primary sources of information for the study included a review of the published literature, a review of published reports and documents, secondary analysis of administrative datasets, and information collected directly from various federal and provincial government programs and services. The literature review included publications up to April 2005 reported in MedLine, EMBASE and PsychINFO. Where specific information from a province was not available, the method of mean substitution from other provinces was used. Costs incurred by various levels/departments of government were separated into healthcare and non-healthcare costs. Also included in the analysis was the value of lost productivity for premature mortality and morbidity associated with schizophrenia. Sensitivity analysis was used to test major cost assumptions used in the analysis. Where possible, all resource utilization estimates for the financial burden of schizophrenia were obtained for 2004 and are expressed in 2004 Canadian dollars (CAN

Relationship between perceived stigma and depression severity.

). Results: The estimated number of persons with schizophrenia in Canada in 2004 was 234 305 (95% CI, 136 201–333 402). The direct healthcare and non-healthcare costs were estimated to be CAN

The Link Between Post-traumatic Stress Disorder and Physical Comorbidities: A Systematic Review

2.02 billion in 2004. There were 374 deaths attributed to schizophrenia. This combined with the high unemployment rate due to schizophrenia resulted in an additional productivity morbidity and mortality loss estimate of CAN

Cost-effectiveness of enhancing primary care depression management on an ongoing basis.

4.83 billion, for a total cost estimate in 2004 of CAN

Greater Prevalence and Incidence of Dementia in Older Veterans with Posttraumatic Stress Disorder

6.85 billion. By far the largest component of the total cost estimate was for productivity losses associated with morbidity in schizophrenia (70% of total costs) and the results showed that total cost estimates were most sensitive to alternative assumptions regarding the additional unemployment due to schizophrenia in Canada. Conclusions: Despite significant improvements in the past decade in pharmacotherapy, programs and services available for patients with schizophrenia, the economic burden of schizophrenia in Canada remains high. The most significant factor affecting the cost of schizophrenia in Canada is lost productivity due to morbidity. Programs targeted at improving patient symptoms and functioning to increase workforce participation has the potential to make a significant contribution in reducing the cost of this severe mental illness in Canada.

Does PTSD impair Cognition beyond the effect of Trauma

The purpose of this study was to explore the relationship between perceived stigma and being in treatment for depression and current depression severity. Face-to-face interviews were conducted with a convenience sample of depressed subjects from a Veterans Administration outpatient mental health clinic (N = 54) and never-depressed subjects from a Veterans Administration primary care clinic (N = 50). Depression severity was measured using the 9-item Primary Care Evaluation of Mental Disorders depression measure. Stigma was measured using the 5-item Stigma Scale for Receiving Psychological Help modified for depression treatment. Statistical analyses included Spearman correlation and multivariate regression. In the correlation analysis, being in treatment for depression compared with never experiencing depression was associated with significantly higher levels of perceived stigma (p < .001). In separate multivariate models controlling for significant univariate correlates, greater depression severity (p < .001) and meeting criteria for current major depression (p < .001) were significant predictors of perceived stigma. Greater depression severity appears to be a strong predictor of perceived stigma.