# Presentation: 337918

## How to Improve Research Participants’ Understanding

- James Flory, BA
- Bioethics Fellow
- Department of Clinical Bioethics
- Warren G. Magnuson Clinical Center
- National 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