title: Understanding the relationships between health outcomes in generalized anxiety disorder clinical trials.
abstract: OBJECTIVE
  The Wilson-Cleary health outcomes model is a hypothesized pathway linking traditional clinical variables to health-related quality of life (HRQL). This study tested the application of the Wilson-Cleary model to a patient population with generalized anxiety disorder (GAD) using longitudinal clinical trial data.
  
  
  METHODS
  These secondary analyses pooled data from three similar 8-week, placebo-controlled, double-blind, randomized, multicenter trials of quetiapine XR therapy in GAD. Relevant health assessments for the model concepts included the Clinical Global Impression-Severity of Illness, Hamilton Rating Scale for Anxiety, the Pittsburgh Sleep Quality Index and Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form. A lagged path model tested whether the hypothesized relationships at baseline and week 8 between the concepts of the adapted Wilson-Cleary model were consistent with the observed data.
  
  
  RESULTS
  The resulting model fit the data (RMSEA = 0.077; CFI = 0.98; NFI = 0.96) and explained 56% of the variance in overall quality of life assessment at baseline and 69% of the variance in this assessment at week 8. Moderate to strong relationships between the adjacent hypothesized concepts support the specified model.
  
  
  CONCLUSIONS
  This adapted Wilson-Cleary model for health outcomes validated in GAD should improve the understanding and usefulness of health status measurements in this condition and increase the applications of this model to other clinical trial data.
authors.affiliation: United BioSource Corporation, 7101 Wisconsin Ave. Suite 600, Bethesda, MD 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: Julie C
authors.initials: JC
authors.lastname: Locklear
authors.forename: Henrik
authors.initials: H
authors.lastname: Svedsäter
authors.forename: Dennis A
authors.initials: DA
authors.lastname: Revicki
mesh_terms: D000293:Adolescent; D000328:Adult; D001008:Anxiety Disorders / Q000188:drug therapy*; D003692:Delayed-Action Preparations; D005260:Female; D006304:Health Status; D006801:Humans; D008297:Male; D008875:Middle Aged; D008960:Models, Psychological; D015337:Multicenter Studies as Topic; D017063:Outcome Assessment, Health Care; D011788:Quality of Life / Q000523:psychology*; D016032:Randomized Controlled Trials as Topic; D013223:Statistics as Topic; D011795:Surveys and Questionnaires; D055815:Young Adult
chemical_list: D003692:Delayed-Action Preparations
references.citation: Qual Life Res. 2004 Oct;13(8):1369-79
references.pmid: 15503832
references.citation: Int Clin Psychopharmacol. 2008 Sep;23(5):276-86
references.pmid: 18703937
references.citation: BMC Psychiatry. 2005 Dec 14;5:46
references.pmid: 16351733
references.citation: Acta Psychiatr Scand. 1989 Apr;79(4):308-12
references.pmid: 2786666
references.citation: Int Clin Psychopharmacol. 2007 Jan;22(1):29-37
references.pmid: 17159457
references.citation: J Acquir Immune Defic Syndr Hum Retrovirol. 1997 Dec 15;16(5):343-9
references.pmid: 9420312
references.citation: Depress Anxiety. 2007;24(5):342-9
references.pmid: 17091478
references.citation: J Adv Nurs. 1999 Jan;29(1):178-87
references.pmid: 10064297
references.citation: J Gen Intern Med. 2005 Jan;20(1):21-7
references.pmid: 15693923
references.citation: Br J Med Psychol. 1959;32(1):50-5
references.pmid: 13638508
references.citation: Parkinsonism Relat Disord. 2002 Jan;8(3):199-209
references.pmid: 12039432
references.citation: Psychiatry Res. 1989 May;28(2):193-213
references.pmid: 2748771
references.citation: JAMA. 1995 Jan 4;273(1):59-65
references.pmid: 7996652
references.citation: Qual Life Res. 2005 Sep;14(7):1693-703
references.pmid: 16119181
references.citation: J Affect Disord. 2005 Sep;88(1):87-91
references.pmid: 16009431
references.citation: Acta Psychiatr Scand Suppl. 2004;(420):21-7
references.pmid: 15128384
references.citation: BMC Oral Health. 2007 Jul 11;7:9
references.pmid: 17625014
references.citation: J Clin Psychiatry. 2002;63 Suppl 8:4-10
references.pmid: 12044107
references.citation: Am J Med. 2000 Jun 15;108(9):714-22
references.pmid: 10924648
references.citation: J Card Fail. 2005 Jun;11(5):372-9
references.pmid: 15948088
references.citation: Int J Neuropsychopharmacol. 2010 Apr;13(3):305-20
references.pmid: 19691907
references.citation: Med Care. 1996 Jun;34(6):610-23
references.pmid: 8656726
references.citation: J Atten Disord. 2008 Jan;11(4):504-9
references.pmid: 17934183
references.citation: Curr Med Res Opin. 2008 Sep;24(9):2457-66
references.pmid: 18662492
references.citation: Health Qual Life Outcomes. 2007 May 24;5:27
references.pmid: 17524152
references.citation: Psychopharmacol Bull. 1993;29(2):321-6
references.pmid: 8290681
references.citation: Qual Life Res. 2006 May;15(4):725-37
references.pmid: 16688505
references.citation: J Card Fail. 2004 Oct;10(5):368-73
references.pmid: 15470645
references.citation: Int Clin Psychopharmacol. 2009 Nov;24(6):289-95
references.pmid: 19707153
references.citation: Qual Life Res. 2001;10(8):671-82
references.pmid: 11871588
references.citation: Eur J Heart Fail. 2005 Mar 16;7(3):419-22
references.pmid: 15718183
references.citation: Psychol Med. 2005 Dec;35(12):1747-59
references.pmid: 16202187
references.citation: Depress Anxiety. 2002;16(4):162-71
references.pmid: 12497648
references.citation: Soc Sci Med. 2005 Nov;61(10):2144-54
references.pmid: 15927333
references.citation: Psychol Med. 2002 Oct;32(7):1227-37
references.pmid: 12420892
references.citation: Qual Life Res. 2008 Dec;17(10):1285-94
references.pmid: 18949580
references.citation: J Clin Psychiatry. 2007 Apr;68(4):518-24
references.pmid: 17474806
references.citation: Am J Psychiatry. 1993 Apr;150(4):600-7
references.pmid: 8465877
references.citation: J Nurs Scholarsh. 2005;37(2):120-6
references.pmid: 15960055
references.citation: Brain Cogn. 2000 Apr;42(3):399-416
references.pmid: 10753487
references.citation: AIDS Patient Care STDS. 2000 May;14(5):269-79
references.pmid: 10833814
references.citation: Am J Psychiatry. 1999 Dec;156(12):1915-23
references.pmid: 10588405
references.citation: Soc Sci Med. 2006 Nov;63(9):2367-80
references.pmid: 16884840
references.citation: Int Clin Psychopharmacol. 2000 Nov;15(6):319-28
references.pmid: 11110007