Steven D Targum1,2,3,4,5,6, Christopher Murphy1,2,3,4,5,6, Jibran Khan1,2,3,4,5,6, Laura Zumpano1,2,3,4,5,6, Mark Whitlock1,2,3,4,5,6, Arthur A Simen1,2,3,4,5,6, Brendon Binneman1,2,3,4,5,6. 1. Drs. Targum and Murphy are with Bracket Global LLC in Boston, Massachusetts. 2. Dr. Khan was with Bracket Global LLC in Boston, Massachusetts, at the time of this study. 3. Ms. Zumpano is with Pfizer Inc. in New York, United States. 4. Dr. Whitlock is with Pfizer Inc. in Cambridge, United Kingdom. 5. Dr. Simen was with Pfizer Inc. at the time of the study but is now with Takeda Pharmaceuticals in Cambridge, Massachusetts. 6. Dr. Binneman was with Pfizer Inc. in Cambridge, Massachusetts, at the time of this study (†deceased).
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.
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 anxiouspatients. 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.
Authors: Gavin Andrews; Megan J Hobbs; Thomas D Borkovec; Katja Beesdo; Michelle G Craske; Richard G Heimberg; Ronald M Rapee; Ayelet Meron Ruscio; Melinda A Stanley Journal: Depress Anxiety Date: 2010-02 Impact factor: 6.505
Authors: D V Sheehan; Y Lecrubier; K H Sheehan; P Amorim; J Janavs; E Weiller; T Hergueta; R Baker; G C Dunbar Journal: J Clin Psychiatry Date: 1998 Impact factor: 4.384
Authors: Steven D Targum; Celine Houser; Joanne Northcutt; Jessica A Little; Andrew J Cutler; David P Walling Journal: Ann Gen Psychiatry Date: 2013-01-31 Impact factor: 3.455