Measurement of equivalence using a patient-reported daily pain diary across three smartphone devices
Keywords:Equivalence, Electronic data capture, Patient-reported outcomes, Clinical outcome assessments, Bring your own device
Background: Patient-reported outcomes play an essential role in evaluating the results of clinical trials. As technological advances are made throughout the industry, pharmaceutical sponsors’ ability to collect field-based patient data has greatly increased. Recently, many clinical trials are utilizing varying modes of data capture in order to enable maximum flexibility. Given the regulatory concern over the equivalence of mixed modes of administration, the need to research the use of varying devices is essential.
Methods: This study reviewed three handheld smartphone devices for conceptual equivalence and conducted usability for standard questions used in a daily pain diary. Ten participants, 7 females 3 males; ages 27-70 years, diagnosed with chronic pain or fibromyalgia, completed the same pain diary on three different smartphone devices.
Results: Overall, participants reported no differences between these three smartphone devices and found the presentation of the diary content to be similar, if not identical, on all three devices.
Conclusions: Device type had no impact on the presentation of the diary content or participants’ understanding of the diary questions.
Coons SJ, Gwaltney CJ, Hays RD, Lundy J, Sloan JA, Revicki DA, et al. Recommendations on evidence needed to support measurement equivalence between electronic and paper-based patient-reported outcome (PRO) measures: ISPOR ePRO Good Research Practices Task Force report. Value Health. 2009;12(4):419-29.
Eremenco S, Coons SJ, Paty J, Coyne K, Bennnet AV, McEntegart D. PRO data collection in clinical trials using mixed modes: Report of the ISPOR PRO mixed modes good research practices task force. Value Health. 2014;17:501-16.
US Food and Drug Administration. Guidance for Industry: Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims. Rockville, MD: U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research; 2009.
Yeomans A. The Future of ePRO Platforms. Applied Clin Trials. 2014;23(12):14-9.
Ring AE, Cheong KA, Watkins CL, Meddis D, Cella D, Harper PG. The Patient: Patient Centered Outcomes Res. 2008;1:105.
Perfetti C, TK Eight is not enough. Available at: https://articles.uie.com/eight_is_not_enough/. 2001. Accessed on 14 January 2019.
Coons SJ, Eremenco S, Lundy JJ, O’Donohoe P, O’Gorman H & Malizia W. Capturing Patient-Reported Outcome (PRO) Data Electronically: The Past, Present, and Promise of ePRO Measurement in Clinical Trials. Patient. 2015;8(30):1–9.
Gwaltney C, Coons SJ, O’Donohoe P, O’Gorman H, Denomey M, Howry C, et al. “Bring your own device” (BYOD): the future of field-based patient-reported outcome data collection in clinical trials? Therap Innovation Regulatory Sci. 2015;49:783-91.