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Comparison of interactive voice response (IVR) with paper administration of instruments to assess functional status, sexual function, and quality of life in elderly men

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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.

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Acknowledgments

The Testosterone Trials are supported by a grant from the National Institute on Aging, National Institutes of Health [U01 AG030644, R01 AG037679 (Bone Trial)]. AbbVie (formerly Solvay and Abbott Laboratories) generously provided additional funding, AndroGel and placebo gel. UAB Diabetes Research and Training Center (DRCT), Grant No. DK079626 from the National Institute for Diabetes, Digestive and Kidney Diseases, National Institutes of Health. The University of Florida site is supported by the Claude D. Pepper Older Americans Independence Center [NIH/NIA P30AG028740]. Funding for Rancho Bernardo Study has been supported by National Institutes of Health/National Institute on Aging grants AG07181 and AG028507 and the National Institute of Diabetes and Digestive and Kidney Diseases, Grant No. DK31801.

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Authors and Affiliations

  1. New England Research Institutes, Inc., Watertown, MA, USA

    Raymond C. Rosen

  2. Department of Biostatistics and Epidemiology, Perelman School of Medicine at The University of Pennsylvania, Philadelphia, PA, USA

    Alisa J. Stephens-Shields, Denise Cifelli, John T. Farrar & Xiaoling Hou

  3. Division of Diabetes, Endocrinology and Metabolism, Baylor College of Medicine, St. Luke’s Episcopal Hospital, Houston, TX, USA

    Glenn R. Cunningham

  4. Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, IL, USA

    David Cella

  5. Department of Family and Preventative Medicine, University of California San Diego School of Medicine, La Jolla, CA, USA

    Elizabeth Barrett-Connor

  6. Division of Preventive Medicine, University of Alabama at Birmingham, Birmingham, AL, USA

    Cora E. Lewis

  7. Department of Aging and Geriatric Research, University of Florida, Gainesville, FL, USA

    Marco Pahor

  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

    Peter J. Snyder

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  1. Raymond C. Rosen
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  2. Alisa J. Stephens-Shields
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  3. Glenn R. Cunningham
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  4. Denise Cifelli
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  8. Cora E. Lewis
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  10. Xiaoling Hou
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  11. Peter J. Snyder
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Corresponding author

Correspondence to Peter J. Snyder.

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Conflict of interest

GRC has served as a consultant to AbbVie, Clarus Therapeutics, Endo Pharma, Ferring, Lilly, Repros Therapeutics, and he has served as an expert witness for Repros Therapeutics and Solvay. He has received research support from Ardana, Unimed and Abbvie; CEL was supported by the National Institute for Diabetes, Digestive and Kidney Diseases, National Institutes of Health (DK079626) to the UAB Diabetes Research and Training Center; PJS reports grants from NIH and AbbVie for the conduct of this study; remaining authors report no conflict of interest.

Ethical approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

Informed consent

Informed consent was obtained from all individual participants included in the study.

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Rosen, R.C., Stephens-Shields, A.J., Cunningham, G.R. et al. Comparison of interactive voice response (IVR) with paper administration of instruments to assess functional status, sexual function, and quality of life in elderly men. Qual Life Res 25, 811–821 (2016). https://doi.org/10.1007/s11136-015-1133-1

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  • DOI: https://doi.org/10.1007/s11136-015-1133-1

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