Audio Recording for Independent Confirmation of Clinical Assessments in Generalized Anxiety Disorder

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 (ClinicalTrials.gov: 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.

Conflict of interest statement

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.

Figures

FIGURE 1.

Comparison of individual Hamilton Rating Scale for Anxiety (HAM-A) items: site-based and site-independent “dual” scores