title: Psychometric evaluation of a patient-rated troubling symptom scale for generalized anxiety disorder clinical trials.
abstract: BACKGROUND
  The majority of clinical outcome assessments developed for generalized anxiety disorder (GAD) may not efficiently and sensitively reflect heterogeneous symptom clusters from a patient perspective. The Patient-Rated Troubling Symptoms Scale for Anxiety (PaRTS-A) instrument was developed to provide an individualized assessment of patient relevant GAD symptoms.
  
  
  OBJECTIVE
  The objective of this analysis was to evaluate the psychometric characteristics of the PaRTS-A.
  
  
  METHODS
  Data were taken from a 6-week clinical trial evaluating the efficacy of adjunctive risperidone therapy in GAD patients undergoing standard treatment. Patients completed the PaRTS-A, the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q), and the Sheehan Disability Scale (SDS) as well as impressions of improvement. Physicians completed the Hamilton Anxiety Rating Scale (HAM-A). A instrument characteristics were assessed through statistical tests of reliability, reproducibility, construct and discriminant validity, and responsiveness.
  
  
  RESULTS
  In the item response theory (IRT) analysis, the PaRTS-A items fit into a single construct of anxiety. Internal consistency reliability exceeded 0.70. The PaRTS-A total score was moderately correlated with the Q-LES-Q and the SDS. The PaRTS-A distinguished between patients with high and low HAM-A scores (p<0.001). The PaRTS-A was responsive to changes in clinical status and the minimal important difference was identified.
  
  
  CONCLUSIONS
  The PaRTS-A provides a unique patient-rated assessment of anxiety symptoms. The instrument may provide clinicians with useful information regarding patient's self-rated anxiety disorder symptoms and the hierarchy of symptoms that they considered most troubling. Our analysis suggests that the PaRTS-A is an internally consistent, valid, and responsive instrument that may be a beneficial adjunct to other instruments in clinical trials.
authors.affiliation: Johnson & Johnson Pharmaceutical Research & Development, Titusville, NJ, USA. gpandina@prdus.jnj.com
authors.forename: Gahan J
authors.initials: GJ
authors.lastname: Pandina
authors.forename: Dennis A
authors.initials: DA
authors.lastname: Revicki
authors.forename: Leah
authors.initials: L
authors.lastname: Kleinman
authors.forename: Ibrahim
authors.initials: I
authors.lastname: Turkoz
authors.forename: Jasmanda
authors.initials: J
authors.lastname: Wu
authors.forename: Ramy
authors.initials: R
authors.lastname: Mahmoud
authors.forename: Georges M
authors.initials: GM
authors.lastname: Gharabawi
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D001008:Anxiety Disorders / Q000188:drug therapy / Q000523:psychology*; D002986:Clinical Trials as Topic; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011569:Psychiatric Status Rating Scales; D011594:Psychometrics / Q000379:methods*; D011788:Quality of Life; D018967:Risperidone / Q000627:therapeutic use
chemical_list: D018967:Risperidone