title: Comparison of interactive voice response (IVR) with paper administration of instruments to assess functional status, sexual function, and quality of life in elderly men.
abstract: OBJECTIVE
  Patient-reported outcome (PRO) measures are essential for assessing subjective patient experiences. Interactive voice response (IVR) data collection provides advantages for clinical trial design by standardizing and centralizing the assessment. Prior to adoption of IVR as a mode of PRO administration in the Testosterone Trials (TTrials), we compared IVR to paper versions of the instruments to be used.
  
  
  METHODS
  IVR versions of the FACIT-Fatigue scale and Psychosexual Daily Questionnaire, Question 4, were developed. In one pilot study, IVR versions of these scales were compared to paper versions in 25 men ≥ 65 years at each of two clinical sites. In another study, IVR versions of the SF-36 Vitality Scale (SF-36), Positive and Negative Affect Scale, and Patient Health Questionnaire were evaluated in comparison with previously validated paper versions in 25 men at two clinical sites. Both paper and IVR versions of each instrument were administered in counterbalanced order, and test-retest reliability was evaluated by repeated administration of the test. Bland-Altman plots were used to assess the degree of agreement. Test-retest correlations for each measure were also determined.
  
  
  RESULTS
  Satisfactory agreement was observed between IVR and paper versions of each study measure. Specifically, linear and highly positive associations were observed consistently across the study for IVR and paper versions of all study measures. These ranged from r = 0.91-0.99. Test-retest reliability for all measures was acceptable or better (r = 0.70-0.90).
  
  
  CONCLUSIONS
  The IVR versions of TTrials endpoints in these two studies performed consistently well in comparison with paper versions.
authors.affiliation: New England Research Institutes, Inc., Watertown, MA, USA.
authors.forename: Raymond C
authors.initials: RC
authors.lastname: Rosen
authors.affiliation: Department of Biostatistics and Epidemiology, Perelman School of Medicine at The University of Pennsylvania, Philadelphia, PA, USA.
authors.forename: Alisa J
authors.initials: AJ
authors.lastname: Stephens-Shields
authors.affiliation: Division of Diabetes, Endocrinology and Metabolism, Baylor College of Medicine, St. Luke's Episcopal Hospital, Houston, TX, USA.
authors.forename: Glenn R
authors.initials: GR
authors.lastname: Cunningham
authors.affiliation: Department of Biostatistics and Epidemiology, Perelman School of Medicine at The University of Pennsylvania, Philadelphia, PA, USA.
authors.forename: Denise
authors.initials: D
authors.lastname: Cifelli
authors.affiliation: Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.
authors.forename: David
authors.initials: D
authors.lastname: Cella
authors.affiliation: Department of Biostatistics and Epidemiology, Perelman School of Medicine at The University of Pennsylvania, Philadelphia, PA, USA.
authors.forename: John T
authors.initials: JT
authors.lastname: Farrar
authors.affiliation: Department of Family and Preventative Medicine, University of California San Diego School of Medicine, La Jolla, CA, USA.
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Barrett-Connor
authors.affiliation: Division of Preventive Medicine, University of Alabama at Birmingham, Birmingham, AL, USA.
authors.forename: Cora E
authors.initials: CE
authors.lastname: Lewis
authors.affiliation: Department of Aging and Geriatric Research, University of Florida, Gainesville, FL, USA.
authors.forename: Marco
authors.initials: M
authors.lastname: Pahor
authors.affiliation: Department of Biostatistics and Epidemiology, Perelman School of Medicine at The University of Pennsylvania, Philadelphia, PA, USA.
authors.forename: Xiaoling
authors.initials: X
authors.lastname: Hou
authors.affiliation: Division of Endocrinology, Diabetes, and Metabolism, Perelman School of Medicine at the University of Pennsylvania, Room 12-135, Translational Research Building (Building 421), 3400 Civic Center Boulevard, Philadelphia, PA, 19104-5160, USA. pjs@mail.med.upenn.edu.
authors.forename: Peter J
authors.initials: PJ
authors.lastname: Snyder
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D004185:Disability Evaluation; D005221:Fatigue; D006801:Humans; D008297:Male; D010865:Pilot Projects; D011788:Quality of Life; D015203:Reproducibility of Results; D012735:Sexual Dysfunction, Physiological / Q000175:diagnosis*; D049250:Speech Recognition Software; D011795:Surveys and Questionnaires; D014831:Voice
keywords: Fatigue; Interactive voice response; Quality of life; Sexual function; Vitality