title: Assessment of quality of life enjoyment and satisfaction questionnaire-short form responder thresholds in generalized anxiety disorder and bipolar disorder studies.
abstract: 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.
authors.affiliation: United BioSource Corporation, Bethesda, Maryland 20814, USA. kathy.wyrwich@unitedbiosource.com
authors.forename: Kathleen W
authors.initials: KW
authors.lastname: Wyrwich
authors.forename: Neesha
authors.initials: N
authors.lastname: Harnam
authors.forename: Dennis A
authors.initials: DA
authors.lastname: Revicki
authors.forename: Julie C
authors.initials: JC
authors.lastname: Locklear
authors.forename: Henrik
authors.initials: H
authors.lastname: Svedsater
authors.forename: Jean
authors.initials: J
authors.lastname: Endicott
mesh_terms: D001008:Anxiety Disorders / Q000188:drug therapy / Q000523:psychology*; D001714:Bipolar Disorder / Q000188:drug therapy / Q000523:psychology*; D005260:Female; D006801:Humans; D008297:Male; D010549:Personal Satisfaction; D011569:Psychiatric Status Rating Scales; D011788:Quality of Life; D011795:Surveys and Questionnaires; D016896:Treatment Outcome