title: Validity of the patient-reported Clinical Global Impression of Change as a measure of treatment response in men with premature ejaculation.
abstract: BACKGROUND
  The Clinical Global Impression of Change (CGIC) measures have high utility in clinical practice. However, it is unknown whether the CGIC is valued for assessing premature ejaculation (PE) symptoms and/or the relationship between CGIC and other validated PE patient-reported measures.
  
  
  OBJECTIVE
  The study aims to assess the validity of the patient-reported CGIC measure in men with PE and to examine the relationship between CGIC ratings and assessments of control, satisfaction, personal distress, and interpersonal difficulty.
  
  
  METHODS
  Data from a randomized, double-blind, 24-week phase 3 trial in 1,162 men with PE who received dapoxetine (30 mg or 60 mg) or placebo on demand provided the basis for the analysis. Patients were ≥18 years, in a stable monogamous relationship for ≥6 months, met the Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition-Text Revision criteria for PE for ≥6 months, and had an intravaginal ejaculatory latency time (IELT) ≤2 minutes in ≥75% of intercourse episodes.
  
  
  METHODS
  The CGIC asked patients to rate improvement or worsening of their PE compared with the start of the study using a 7-point response scale; other patient-reported measures were control over ejaculation, satisfaction with sexual intercourse, interpersonal difficulty, and personal distress related to ejaculation. Stopwatch-measured IELT was recorded. Associations between CGIC and change in other measures at study end point were assessed.
  
  
  RESULTS
  The magnitude of IELT increased for each category of improvement on the CGIC: 1.63, 4.03, and 7.15 minutes for slightly better, better, and much better, respectively. Higher CGIC ratings were correlated with greater improvement in control (r = 0.73), satisfaction (r = 0.62), greater reduction in distress (r = -0.52), and interpersonal difficulty (r = -0.39). Total variance accounted for was 57.4%: control (48.7%), satisfaction (4.5%), IELT (2.8%), and distress (1.15%).
  
  
  CONCLUSIONS
  The analyses support the validity of the CGIC measure in men with PE. The CGIC can provide clinicians in practice with a valid and brief outcome assessment of their patient's condition.
authors.affiliation: Case Western Reserve University School of Medicine, Center for Marital and Sexual Health of South Florida, West Palm Beach, FL, USA. Electronic address: Stanley.Althof@case.edu.
authors.forename: Stanley E
authors.initials: SE
authors.lastname: Althof
authors.affiliation: Department of Surgery, Division of Urology, St. Joseph's Health Center, London, ON, Canada.
authors.forename: Gerald B
authors.initials: GB
authors.lastname: Brock
authors.affiliation: New England Research Institutes, Watertown, MA, USA.
authors.forename: Raymond C
authors.initials: RC
authors.lastname: Rosen
authors.affiliation: Graduate and Continuing Education, Valparaiso University, Valparaiso, IN, USA.
authors.forename: David L
authors.initials: DL
authors.lastname: Rowland
authors.affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Raritan, NJ, USA.
authors.forename: Joseph W
authors.initials: JW
authors.lastname: Aquilina
authors.affiliation: Johnson & Johnson Pharmaceutical Services, L.L.C., Raritan, NJ, USA.
authors.forename: Margaret
authors.initials: M
authors.lastname: Rothman
authors.affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Raritan, NJ, USA.
authors.forename: Fisseha
authors.initials: F
authors.lastname: Tesfaye
authors.affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Raritan, NJ, USA.
authors.forename: Scott
authors.initials: S
authors.lastname: Bull
mesh_terms: D000328:Adult; D001596:Benzylamines / Q000009:adverse effects / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004542:Ejaculation / Q000187:drug effects*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009281:Naphthalenes / Q000009:adverse effects / Q000627:therapeutic use*; D017060:Patient Satisfaction; D011594:Psychometrics / Q000706:statistics & numerical data; D011788:Quality of Life / Q000523:psychology; D015203:Reproducibility of Results; D017367:Selective Serotonin Reuptake Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D012735:Sexual Dysfunction, Physiological / Q000188:drug therapy* / Q000523:psychology; D011795:Surveys and Questionnaires
chemical_list: D001596:Benzylamines; D009281:Naphthalenes; D017367:Selective Serotonin Reuptake Inhibitors; C080598:dapoxetine