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How to Improve Research Participants’ Understanding
James Flory, BA
Bioethics FellowDepartment of Clinical Bioethics
Warren G. Magnuson Clinical CenterNational Institutes of Health
Background
• Understanding is a goal of the informed consent process
• Empirical research can provide information about how well research participants understand
• And how research participants can understand better
Disclaimer
The views expressed in this presentation do not represent the views of the NIH, the United
States DHHS, or any other government agency or official.
Central question
What can empirical research tell us about how to improve research participants understanding?
Disclosure
Typical disclosure requirements
• Purpose of research
• Risks
• Benefits
• Alternatives
• Voluntariness and right to withdraw
• Confidentiality of records
• Compensation for injuries
• Who to contact with questions
How is disclosure usually done?
• A written version of the required information is almost always used: the consent form
• Usually there is also discussion
• In spite of emphasis on consent form, it is only one element in an interpersonal process of communication
Understanding
What is understanding?
• Understanding is processing of disclosed information
• Understanding is hard to measure
• Understanding is not the same as memory
What should research participants understand?
• Purpose of the research
• Research methods (randomization, placebo)
• Risks
• Benefits
• Requirements—e.g. number of clinic visits
• Right to withdraw
• Alternatives
Empirical question
• How well do research participants understand these key areas?
Purpose
Study Participants Understanding
Lynoe
1991
Swedish women in gynec. study
98% research study
Joffe
2001
US oncology studies
30% drugs unproven
Pitisuttithum
1997
Thai HIV vaccine study
80% vaccine might not work
Ciriscione
2003
US rheumatoid arthritis drug study
100% research experiment
Randomization
Study Participants Understanding
Hietanen
2000
Finnish women breast cancer
23% randomization
Harrison
1995
US HIV vaccine 21% everyone get vaccine
Howard
1981
US men cardiac
Beta blocker
42% randomization
Pace
2003
Thai HIV
IL-2 treatment
42% randomization
Risks
Study Participants Understanding
Bergler
1980
U.S. Hypertension
28% not recall 2 risks 2 hours after consent
Miller
1994
Analgesia 52% not recall even one risk 60 days later
Dougherty
2000
US oncology 100% recall at least 1 side effect
Leach
1999
Gambian mothers vaccine
56% recall 1 or more risks
Right to Withdraw
Study and Year
Country Subjects Knew they could
Withdraw
Pitisuttithum
1997
Thailand 33 HIV vaccine
88%
Karim
1998
South Africa
56 perinatal HIV prevent
93%(freedom to quit)
Lynoe
2000
Bang-
ladesh
105 iron for pregnancy
48%
Conclusions on understanding
• Understanding varies a lot from setting to setting
• Understanding of randomization is particularly poor
• Can understanding be improved?
Improving understanding
Improving understanding
• Comprehensive review identifies 42 trials of ways to improve understanding
• Four main approaches:– Video or computer-based disclosure– Shorter, more readable forms– More time spent on discussion– Using short tests to confirm understanding and
guide discussion
Video or Computer-Based Presentation
• Only 3 out of 12 trials showed an improvement in understanding due to video or computerized presentation (P<.05)
• Although videos and computers may improve understanding sometimes, they usually have not worked
Recommendations: Multimedia
• Multimedia can be expensive, and high expense does not guarantee success
• Investigators who invest in multimedia should consider research on its effectiveness
Shorter, More Readable Consent Forms
• 6 out of 15 trials showed an improvement in understanding (P<.05)
• But 5 of the 6 trials that showed improvement were simulated consent processes
• Improved consent forms may be no better than multimedia
How were consent forms improved?
• Lower reading levels
• Better formatting
• Graphics
• Shorter length
Recommendations: Consent Forms
• Better consent forms are not a magic bullet
• The one realistic trial that showed effectiveness used a form with less boilerplate
• Removing unnecessary material may be effective
Extended Discussion
• 3 out of 5 trials showed an improvement in understanding (P<.001)
• The other 2 trials showed trends toward improvement (P=.054, P=.08)
Recommendations: Extended Discussion
• Limited, but encouraging, evidence
• One effective implementation was a 30 minute phone conversation with a trained research nurse
• Stronger case can be made for extended discussion than for other interventions
Using a Test to Confirm Understanding
• 5 out of 5 studies showed an improvement in understanding (P<.05)
• But these studies may have mistaken rote memorization for understanding
Recommendations: Test to Confirm Understanding
• Research that avoids flawed methodology needed
• This approach often proposed but not yet convincingly evaluated
Effect of Education
• In most studies, even effective interventions did not make as large a difference as education
• In one study, the gap between the most and least educated participants was 51 points out of 100
Conclusions on Improving Understanding
• Improving understanding is difficult
• The most effective kind of intervention appears to be extended discussion
• Less educated research participants may need help the most
• Further research important
Practical Recommendations
• Recognize limitations of all approaches
• One-on-one interactions may be better than forms or multimedia
• Less educated research participants may need help most