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How to Improve Research Participants Understanding

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Understanding is a goal of the ... research tell us about how to improve research participants understanding? ... to confirm understanding and guide ... – PowerPoint PPT presentation

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Title: How to Improve Research Participants Understanding


1
How to Improve Research Participants
Understanding
  • James Flory, BA
  • Bioethics Fellow
  • Department of Clinical Bioethics
  • Warren G. Magnuson Clinical Center
  • National Institutes of Health

2
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

3
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.

4
Central question
  • What can empirical research tell us about how to
    improve research participants understanding?

5
Disclosure
6
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

7
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

8
Understanding
9
What is understanding?
  • Understanding is processing of disclosed
    information
  • Understanding is hard to measure
  • Understanding is not the same as memory

10
What should research participants understand?
  • Purpose of the research
  • Research methods (randomization, placebo)
  • Risks
  • Benefits
  • Requirementse.g. number of clinic visits
  • Right to withdraw
  • Alternatives

11
Empirical question
  • How well do research participants understand
    these key areas?

12
Purpose
13
Randomization
14
Risks
15
Right to Withdraw
16
Conclusions on understanding
  • Understanding varies a lot from setting to
    setting
  • Understanding of randomization is particularly
    poor
  • Can understanding be improved?

17
Improving understanding
18
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

19
Video or Computer-Based Presentation
  • Only 3 out of 12 trials showed an improvement in
    understanding due to video or computerized
    presentation (P
  • Although videos and computers may improve
    understanding sometimes, they usually have not
    worked

20
Recommendations Multimedia
  • Multimedia can be expensive, and high expense
    does not guarantee success
  • Investigators who invest in multimedia should
    consider research on its effectiveness

21
Shorter, More Readable Consent Forms
  • 6 out of 15 trials showed an improvement in
    understanding (P
  • But 5 of the 6 trials that showed improvement
    were simulated consent processes
  • Improved consent forms may be no better than
    multimedia

22
How were consent forms improved?
  • Lower reading levels
  • Better formatting
  • Graphics
  • Shorter length

23
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

24
Extended Discussion
  • 3 out of 5 trials showed an improvement in
    understanding (P
  • The other 2 trials showed trends toward
    improvement (P.054, P.08)

25
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

26
Using a Test to Confirm Understanding
  • 5 out of 5 studies showed an improvement in
    understanding (P
  • But these studies may have mistaken rote
    memorization for understanding

27
Recommendations Test to Confirm Understanding
  • Research that avoids flawed methodology needed
  • This approach often proposed but not yet
    convincingly evaluated

28
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

29
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

30
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
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