Raymond C Rosen1, Alisa J Stephens-Shields2, Glenn R Cunningham3, Denise Cifelli2, David Cella4, John T Farrar2, Elizabeth Barrett-Connor5, Cora E Lewis6, Marco Pahor7, Xiaoling Hou2, Peter J Snyder8. 1. New England Research Institutes, Inc., Watertown, MA, USA. 2. Department of Biostatistics and Epidemiology, Perelman School of Medicine at The University of Pennsylvania, Philadelphia, PA, USA. 3. Division of Diabetes, Endocrinology and Metabolism, Baylor College of Medicine, St. Luke's Episcopal Hospital, Houston, TX, USA. 4. Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, IL, USA. 5. Department of Family and Preventative Medicine, University of California San Diego School of Medicine, La Jolla, CA, USA. 6. Division of Preventive Medicine, University of Alabama at Birmingham, Birmingham, AL, USA. 7. Department of Aging and Geriatric Research, University of Florida, Gainesville, FL, USA. 8. 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.
Abstract
PURPOSE: 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.
PURPOSE: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.
Entities:
Keywords:
Fatigue; Interactive voice response; Quality of life; Sexual function; Vitality
Authors: Peter J Snyder; Susan S Ellenberg; Glenn R Cunningham; Alvin M Matsumoto; Shalender Bhasin; Elizabeth Barrett-Connor; Thomas M Gill; John T Farrar; David Cella; Raymond C Rosen; Susan M Resnick; Ronald S Swerdloff; Jane A Cauley; Denise Cifelli; Laura Fluharty; Marco Pahor; Kristine E Ensrud; Cora E Lewis; Mark E Molitch; Jill P Crandall; Christina Wang; Matthew J Budoff; Nanette K Wenger; Emile R Mohler; Diane E Bild; Nakela L Cook; Tony M Keaveny; David L Kopperdahl; David Lee; Ann V Schwartz; Thomas W Storer; William B Ershler; Cindy N Roy; Leslie J Raffel; Sergei Romashkan; Evan Hadley Journal: Clin Trials Date: 2014-06 Impact factor: 2.486
Authors: Glenn R Cunningham; Alisa J Stephens-Shields; Raymond C Rosen; Christina Wang; Shalender Bhasin; Alvin M Matsumoto; J Kellogg Parsons; Thomas M Gill; Mark E Molitch; John T Farrar; David Cella; Elizabeth Barrett-Connor; Jane A Cauley; Denise Cifelli; Jill P Crandall; Kristine E Ensrud; Laura Gallagher; Bret Zeldow; Cora E Lewis; Marco Pahor; Ronald S Swerdloff; Xiaoling Hou; Stephen Anton; Shehzad Basaria; Susan J Diem; Vafa Tabatabaie; Susan S Ellenberg; Peter J Snyder Journal: J Clin Endocrinol Metab Date: 2016-06-29 Impact factor: 5.958