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26358063
10.1007/s11136-015-1133-1
PMC4786466
Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation
April 1, 2016
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.
Speech Recognition Software, Voice, Sexual Dysfunction, Physiological, Fatigue, Pilot Projects, Disability Evaluation, Quality of Life, Male, Surveys and Questionnaires, Reproducibility of Results, Humans, Aged, Aged, 80 and over
UL1 TR001427, DK079626, R01 AG037679, P60 DK079626, P30 DK079626, R01 AG007181, R01 DK031801, R37 AG007181, R01 AG028507, P30AG028740, U01 AG030644, AG07181, AG028507, P30 AG028740
Pahor M, Barrett-Connor E, Lewis CE, Snyder PJ, Cunningham GR, Farrar JT, Cella D, Rosen RC, Cifelli D, Stephens-Shields AJ, Hou X
Rosen RC, Stephens-Shields AJ, Cunningham GR, Cifelli D, Cella D, Farrar JT, Barrett-Connor E, Lewis CE, Pahor M, Hou X, Snyder PJ. Comparison of interactive voice response (IVR) with paper administration of instruments to assess functional status, sexual function, and quality of life in elderly men. Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation 2016 Apr.

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.