Innovations In Clinical Neuroscience

MAR-APR 2018

A peer-reviewed, evidence-based journal for clinicians in the field of neuroscience

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37 ICNS INNOVATIONS IN CLINICAL NEUROSCIENCE March-April 2018 • Volume 15 • Number 3–4 O R I G I N A L R E S E A R C H A Anxiety symptoms are prevalent in most populations where people experience the stress of modern life. A cluster of anxiety symptoms becomes an anxiety disorder when the symptoms are difficult to control, cause significant distress for the person, and impact the ability to function. 1,2 It has been reported that patients who meet diagnostic criteria for generalized anxiety disorder (GAD) might also have substantial economic and social burden as a consequence of the disorder. 3–7 There are several effective treatments for GAD, including psychotropic medications, complementary and alternative medicines, psychotherapy, cognitive-behavioral therapy, and/ or other nonpharmacological strategies that can be given to address troubling and/or disruptive anxiety symptoms. 6–10 The use of psychotropic medications for treating anxiety symptoms, including approved antidepressants, is sometimes challenged because other treatment alternatives might be effective and do not convey the same potential adverse effects. Furthermore, the clinical decision about whether to prescribe a medication intervention is not always clear in some patients and might rely more on personal bias than the clinical evidence. As a result, some clinicians might withhold anxiolytic medications from some patients who really need them, whereas others might prescribe medications indiscriminately to patients who do not. A confirmatory assessment of treatment needs (a "second" opinion) is always a useful clinical tool, but the reality is that a second independent clinical assessment is rarely feasible in most busy clinical settings. A second opinion would be particularly helpful to assess the need for medications and/ or to change treatments after an intervention has been initiated. The digital revolution has abetted the introduction of innovative tools to facilitate site- ABSTRACT Objective: The assessment of patients with generalized anxiety disorder (GAD) to deteremine whether a medication intervention is necessary is not always clear and might benefit from a second opinion. However, second opinions are time consuming, expensive, and not practical in most settings. We obtained independent, second opinion reviews of the primary clinician's assessment via audio-digital recording. Design: An audio-digital recording of key site-based assessments was used to generate site-independent "dual" reviews of the clinical presentation, symptom severity, and medication requirements of patients with GAD as part of the screening procedures for a clinical trial ( NCT02310568). Results: Site-independent reviewers affirmed the diagnosis, symptom severity metrics, and treatment requirements of 90 moderately ill patients with GAD. The patients endorsed excessive worry that was hard to control and essentially all six of the associated DSM-IV-TR anxiety symptoms. The Hamilton Rating Scale for Anxiety scores revealed moderately severe anxiety with a high Pearson's correlation (r=0.852) between site-based and independent raters and minimal scoring discordance on each scale item. Based upon their independent reviews, these "second" opinions confirmed that these GAD patients warranted a new medication intervention. Thirty patients (33.3%) reported a previous history of a major depressive episode (MDE) and had significantly more depressive symptoms than patients without a history of MDE. Conclusion: The audio-digital recording method provides a useful second opinion that can affirm the need for a different treatment intervention in these anxious patients. A second live assessment would have required additional clinic time and added patient burden. The audio-digital recording method is less burdensome than live second opinion assessments and might have utility in both research and clinical practice settings. Keywords: Generalized anxiety disorder (GAD), anxiolytic medications, anxious symptoms, audio- digital recording, dual review, second opinions Audio Recording for Independent Confirmation of Clinical Assessments in Generalized Anxiety Disorder by STEVEN D. TARGUM, MD; CHRISTOPHER MURPHY, PhD; JIBRAN KHAN, BA; LAURA ZUMPANO, BA; MARK WHITLOCK, PhD; ARTHUR A. SIMEN, MD, PhD; and BRENDON BINNEMAN, MD † Drs. Targum and Murphy are with Bracket Global LLC in Boston, Massachusetts. Dr. Khan was with Bracket Global LLC in Boston, Massachusetts, at the time of this study. Ms. Zumpano is with Pfizer Inc. in New York, United States, and Dr. Whitlock is with Pfizer Inc. in Cambridge, United Kingdom. Dr. Simen was with Pfizer Inc. at the time of the study but is now with Takeda Pharmaceuticals in Cambridge, Massachusetts. Dr. Binneman was with Pfizer Inc. in Cambridge, Massachusetts, at the time of this study (†deceased). Innov Clin Neurosci. 2018;15(3–4):37–42 FUNDING: Pfizer sponsored this study. Support for this study came from the sponsor Pfizer (Cambridge, Massachusetts) to conduct quality assurance in a clinical trial with additional support for the data analysis from Bracket Global LLC and Clintara LLC (Boston, Massachusetts). DISCLOSURES: Dr. Targum is an employee of Bracket LLC and has received vendor grants, retainers, or honoraria from Acadia Pharmaceuticals, Alkermes Inc., Functional Neuromodulation Inc., Intracellular Therapeutics, Janssen Research & Development, LLC, Karuna, Methylation Sciences Inc., Navitor Pharmaceuticals, Neurim Pharmaceuticals, Pfizer Inc., Prana Biotechnology Ltd., Resilience Therapeutics, and Sunovion. Dr. Murphy is an employee and Mr. Khan was an employee of Bracket Global LLC at the time of this study and have no other disclosures. Drs. Binneman and Simen, Mr. Whitlock, and Ms. Zumpano are employees of Pfizer Inc. and have no other disclosures relevant to the content of this article. CORRESPONDENCE: Steven D. Targum, MD; Email:

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