A pragmatic randomized trial comparing tablet computer informed consent to traditional paper-based methods for an osteoporosis study

A. H. Warriner, P. J. Foster, A. Mudano, N. C. Wright, M. E. Melton, S. E. Sattui, Walter L Calmbach, J. R. Curtis, M. Kilgore, C. E. Lewis, W. Pace, K. G. Saag

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7 Scopus citations

Abstract

Objective Methods to improve informed consent efficiency and effectiveness are needed for pragmatic clinical trials. We compared informed consent using a tablet computer to a paper approach to assess comprehension and satisfaction of patients and clinic staff for a future osteoporosis clinical trial. Methods Nine community-based practices identified and recruited patients to compare the informed consent processes (tablet vs. paper) in a mock osteoporosis clinical trial. The tablet informed consent included an animation summarizing the trial, complete informed consent document, and questions to assess and reinforce comprehension of the study. Participants were women age ≥55 years with ≥1 year of alendronate use. We surveyed participants to assess comprehension and satisfaction and office staff for satisfaction and perceived time demands. Results The nine practices enrolled 33 participants. There was not a significant difference in comprehension between the tablet vs. paper informed consent [mean (SD) tablet: 12.2 (1.0) vs. paper: 11.4 (1.7)]. Office staff preferred the tablet to the paper informed consent for identifying potential study participants (two-sided t-test p = 0.02) despite an increased perceived time spent to complete the tablet process [tablet: 28.3 min (SD 16.3) vs. paper: 19.0 min (SD 6.9); p = 0.08]. Conclusions Although, there were no significant differences in participant satisfaction and comprehension with the tablet informed consent compared to a paper informed consent, patients and office staff trended towards greater satisfaction with the tablet informed consent. Larger studies are needed to further evaluate the utility of electronic informed consent in pragmatic clinical trials.

Original languageEnglish (US)
Pages (from-to)32-38
Number of pages7
JournalContemporary Clinical Trials Communications
Volume3
DOIs
Publication statusPublished - Aug 15 2016

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Keywords

  • Informed consent
  • Osteoporosis
  • Pragmatic clinical trials

ASJC Scopus subject areas

  • Medicine(all)
  • Pharmacology

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