Alyssa J Mansfield

Identifying Priorities for Patient-Centered Outcomes Research for Serious Mental Illness

OBJECTIVE The purpose of this project was to engage a diverse group of stakeholders (N=38) to help establish priorities to guide patient-centered outcomes research (PCOR) in serious mental illness. METHODS Three meetings, two Web-based and one on site, were held to generate and prioritize an initial list of topics. Topics were then sorted and organized into common themes. RESULTS About 140 topics were identified and sorted into 21 main themes, ranked by priority. Three of the top four themes focused on how research was conducted, particularly the need to develop consensus measurement and outcomes definitions; improving infrastructure for research, longitudinal studies, and new data sets and investigators; and developing PCOR methodology. Stakeholders also identified a need to focus on service delivery, treatment settings, and structure of the delivery of care. CONCLUSIONS Engagement by a broad group of stakeholders in a transparent process resulted in the identification of priority areas for PCOR. Stakeholders clearly indicated a need to fundamentally change how research on serious mental illness is conducted and a critical need for the development of methodology and infrastructure. Most current PCOR has been focused on relatively short-term outcomes, but real world, long-term studies providing guidance for treatment over the lifetime of a serious mental illness are needed.

CLINICAL HETEROGENEITY IN SYSTEMATIC REVIEWS AND HEALTH TECHNOLOGY ASSESSMENTS: SYNTHESIS OF GUIDANCE DOCUMENTS AND THE LITERATURE

OBJECTIVES The aim of this study was to synthesize best practices for addressing clinical heterogeneity in systematic reviews and health technology assessments (HTAs). METHODS We abstracted information from guidance documents and methods manuals made available by international organizations that develop systematic reviews and HTAs. We searched PubMed® to identify studies on clinical heterogeneity and subgroup analysis. Two authors independently abstracted and assessed relevant information. RESULTS Methods manuals offer various definitions of clinical heterogeneity. In essence, clinical heterogeneity is considered variability in study population characteristics, interventions, and outcomes across studies. It can lead to effect-measure modification or statistical heterogeneity, which is defined as variability in estimated treatment effects beyond what would be expected by random error alone. Clinical and statistical heterogeneity are closely intertwined but they do not have a one-to-one relationship. The presence of statistical heterogeneity does not necessarily indicate that clinical heterogeneity is the causal factor. Methodological heterogeneity, biases, and random error can also cause statistical heterogeneity, alone or in combination with clinical heterogeneity. CONCLUSIONS Identifying potential modifiers of treatment effects (i.e., effect-measure modifiers) is important for researchers conducting systematic reviews and HTAs. Recognizing clinical heterogeneity and clarifying its implications helps decision makers to identify patients and patient populations who benefit the most, who benefit the least, and who are at greatest risk of experiencing adverse outcomes from a particular intervention.

PTSD Care Among Veterans With and Without Co-Occurring Substance Use Disorders

OBJECTIVE This study examined whether a co-occurring substance use disorder contributed to disparities in receipt of Veterans Health Administration (VHA) posttraumatic stress disorder (PTSD) specialty care or psychotherapy. METHODS Logistic regression, controlling for sociodemographic characteristics, was used to examine predictors of PTSD care among 424,211 veterans with confirmed PTSD (two or more PTSD diagnosis encounters) who accessed care in a VHA facility between fiscal years 2009 and 2010. RESULTS Overall, 16% of veterans had PTSD and a co-occurring substance use disorder diagnosis. In adjusted analyses, veterans with a co-occurring substance use disorder were more likely than veterans with PTSD alone to receive any outpatient PTSD specialty care and complete eight or more sessions of outpatient psychotherapy within 14 weeks, but they were less likely to be treated in inpatient PTSD specialty units. CONCLUSIONS Co-occurring substance use disorders did not appear to hinder receipt of outpatient specialty PTSD treatment or of sufficient psychotherapy among VHA-enrolled veterans.