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Assessment of Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form responder thresholds in generalized anxiety disorder and bipolar disorder studies

Wyrwich, Kathleen W.a; Harnam, Neeshaa; Revicki, Dennis A.a; Locklear, Julie C.b; Svedsater, Henrikd; Endicott, Jeanc

International Clinical Psychopharmacology: May 2011 - Volume 26 - Issue 3 - p 121–129
doi: 10.1097/YIC.0b013e3283427cd7
Reviews

Interpretation of change over time in patient-reported outcomes requires appropriate responder definitions. This study compares responder definitions for the short-form version of the Quality of Life Enjoyment and Satisfaction Questionnaire [Q-LES-Q(SF)] in populations with generalized anxiety disorder (GAD) and bipolar disorder. A review of the Q-LES-Q(SF) literature published in English from 1993 through May 2009 identified publications using the Q-LES-Q(SF) in GAD or bipolar disorder clinical trials. In six relevant articles reporting Q-LES-Q(SF) responder definitions in GAD or bipolar disorder, two methods for defining responders emerged: (i) return to a score within 10% of community norms for the Q-LES-Q(SF); and (ii) a change score at or greater than the condition-specific mean change achieved by patients with minimal improvement on the Clinical Global Impression–Improvement (CGI-I) at study endpoint or a 1-point decrease on the CGI–Severity scale between baseline and study endpoint. The magnitude of the CGI-I based responder thresholds differed across mental health conditions. Use of the Q-LES-Q(SF) community norms as a responder definition is discouraged. A responder definition needs to be investigated within each condition or disease using appropriate anchors, and may not be generalizable from one condition or disease to another.

aUnited BioSource Corporation, Bethesda, Maryland

bAstraZeneca Pharmaceuticals LP, Wilmington, Delaware

cNew York State Psychiatric Institute, New York City, New York, USA

dAstraZeneca R&D, Mölndal, Sweden

Correspondence to Kathleen W. Wyrwich, PhD, United BioSource Corporation, 7101 Wisconsin Avenue, Suite 600, Bethesda, MD 20814, USA Tel/fax: +1 314 773 8000; e-mail: kathy.wyrwich@unitedbiosource.com

Received September 8, 2010

Accepted November 10, 2010

© 2011 Lippincott Williams & Wilkins, Inc.