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Published on: February 14, 2014
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A pragmatic randomized trial comparing tablet computer informed consent to traditional paper-based methods for an
A H Warriner1, P J Foster2, A Mudano2
1Division of Endocrinology, Diabetes, and Metabolism, University of Alabama at Birmingham, United States.
Contemporary Clinical Trials Communications
|May 9, 2018
Summary
Tablet-based informed consent showed similar patient comprehension but improved staff preference over paper methods in pragmatic clinical trials. Further research is needed for electronic informed consent utility.
Area of Science:
- Clinical Trials
- Health Informatics
- Patient Education
Background:
- Improving the efficiency and effectiveness of informed consent is crucial for pragmatic clinical trials.
- Traditional paper-based informed consent methods may present limitations in clarity and engagement.
Purpose of the Study:
- To compare the efficiency and effectiveness of tablet-based informed consent versus traditional paper-based methods.
- To assess patient comprehension and satisfaction, and clinic staff satisfaction and perceived time demands for both methods in an osteoporosis clinical trial setting.
Main Methods:
- A mock osteoporosis clinical trial was conducted across nine community-based practices.
- Participants (women ≥55 years) underwent informed consent using either a tablet (including animation and comprehension checks) or paper format.
- Patient comprehension and satisfaction, and staff satisfaction and time perceptions were evaluated via surveys.
Main Results:
- No significant difference in patient comprehension was found between tablet and paper informed consent methods.
- Office staff showed a preference for the tablet method in identifying potential study participants (p=0.02).
- The tablet process was perceived to take longer (28.3 min vs. 19.0 min), though not statistically significant (p=0.08).
Conclusions:
- Tablet-based informed consent did not significantly differ in patient comprehension or satisfaction compared to paper methods.
- A trend towards greater satisfaction with tablet informed consent was observed in both patients and office staff.
- Larger studies are recommended to fully evaluate the utility of electronic informed consent in pragmatic clinical trials.
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