Results Summary
What was the research about?
Before people can join a research study, they need to provide informed consent. Informed consent is a process that helps people know
- What a study is about
- What will happen in the study
- The benefits and risks people may experience
- That they have a choice whether to join the study
Getting informed consent can take a long time, and people may not understand all the details. Researchers want to know what patients think about having short or longer discussions with doctors for studies with low risk. Low risk means the study’s risks are no greater than those in daily life or from usual health care.
In this study, the research team compared people’s views about a shorter consent discussion for a study on blood pressure with the usual, longer discussion.
What were the results?
People had high ratings for the way the doctor talked to the patient in all versions of a video showing different ways of doing informed consent. Differences across groups who watched different versions were small.
Across the videos,
- 87 percent of people said the amount of information was “just right”
- 90 percent said they would take part in the study
- 88 percent answered five out of six questions about the study correctly
- 85 percent said the consent process was very respectful
Who was in the study?
The study included 2,600 people who were receiving care from two health systems or recruited by a national online survey company. Of these, 70% were white, 15% were black, and 6% were other races; also, 9% were Hispanic. In addition, 52% were men, and 56% were age 45 or older.
What did the research team do?
The research team assigned people by chance to one of seven groups. In one group, people watched an animated video with a standard informed consent process about a hypothetical study. This video showed a doctor and a nurse explaining the study and asking a patient to read and sign a consent form if the patient wanted to join the study. In the other groups, people watched videos with a shorter consent discussion. In these videos, a doctor explained the study and told the patient they would be in the study unless they didn’t want to join. These videos also differed in how much information they had on topics like
- Why the research mattered
- Patients having a choice to be in the study
- Whether the doctors talked about other ways the researchers doing a study were working to involve and share information with patients
People then filled out a survey asking if they would be willing to join the study and how respectful they thought the consent process was. The survey also asked people questions to see if they understood the study and whether there was enough information about the study given during the consent process.
A group of 21 people receiving care from the health systems gave feedback on the videos and survey.
What were the limits of the study?
The videos showed animations of the informed consent process between doctors and patients about a hypothetical study. Results may differ for people taking part in informed consent in real life. Because people gave high ratings for each video, it may have been difficult to find differences among them.
Future research could see how people rate videos of live actors doing informed consent.
How can people use the results?
Researchers can use these results when deciding how to ask patients for their consent to join studies that compare medicines and are of low risk to patients.
Professional Abstract
Objective
To determine whether viewing animated videos of streamlined informed consent discussions for low-risk comparative effectiveness studies, compared with viewing animated videos of traditional informed consent interactions, affects people’s perceptions of the consent process
Study Design
| Design Elements | Description |
|---|---|
| Design | Randomized controlled trial |
| Population | 2,600 people recruited from two health systems and from an online nationally representative survey panel maintained by Growth from Knowledge (GfK) |
| Interventions/ Comparators |
7 animated videos, each showing a different type of informed consent interaction:
|
| Outcomes | Respondents’ perception of appropriateness and adequacy of information, respondents’ willingness to participate in hypothetical study, their understanding of study, and perceived respectfulness of consent process |
| Timeframe | Immediate follow-up after viewing video for study outcomes |
This randomized controlled trial compared respondents’ views after watching one of seven animated videos showing a doctor and patient engage in either a streamlined or traditional informed consent discussion about a low-risk comparative research study. Researchers wanted to determine whether the streamlined videos affected respondents’ willingness to join a study and their perceptions of the informed consent process viewed. Low-risk comparative studies compare treatments that are widely used, similar in patient experience and burden, and pose no greater risks than those typically encountered in daily life.
Researchers randomly assigned respondents to one of seven groups. Each group viewed one of the animated videos of a doctor-patient discussion about a hypothetical study comparing two widely used blood pressure medications. One showed a traditional informed consent process involving a doctor briefly introducing the study to a patient and then the patient reviewing the study and consent form with a research nurse. The other six showed a streamlined process, in which a doctor verbally explained the study to a patient and indicated that the patient would be enrolled in the study unless the patient opted out. Doctors did not ask patients in these videos to sign a consent form. These videos also varied by the amount of other information included, such as
- Additional background information on the need for research that compares widely used treatments
- Emphasis on the patient having a choice to participate in the study
- Descriptions of ways patients are engaged and of transparency and accountability processes in the research and in place at the provider’s location
The study included 2,600 adult respondents recruited from two health systems and an online survey panel. Of these, 70% were white, 15% were black, and 6% were other races; also, 9% were Hispanic. In addition, 52% were male, and 56% were age 45 or older.
Respondents viewed their randomly assigned videos and answered a survey immediately after.
A group of 21 people receiving care from the two health systems provided feedback on the videos and study outcomes.
Results
Respondents’ ratings of the streamlined and long consent processes were relatively high overall, although ratings differed slightly across groups (p<0.05). Across processes,
- 87% of respondents said the information provided was “just right”
- 90% said they would be willing to participate in the hypothetical study
- 88% correctly answered five out of six questions assessing study understanding
- 85% reported high satisfaction scores for perceived respectfulness of the consent interaction
Limitations
In this study, respondents watched animated videos. People may respond differently during real-life informed consent discussions. Respondents’ high ratings of the videos may have limited researchers’ ability to detect differences between groups.
Conclusions and Relevance
Streamlined consent processes for low-risk comparative effectiveness research were generally perceived to be as acceptable to respondents as traditional consent processes in this study.
Future Research Needs
Future research could explore streamlined versus longer consent in the context of ongoing real comparative studies. Researchers could also use videos of live actors performing consent interactions.
Final Research Report
View this project's final research report.
Journal Citations
Related Journal Citations
Peer-Review Summary
Peer review of PCORI-funded research helps make sure the report presents complete, balanced, and useful information about the research. It also assesses how the project addressed PCORI’s Methodology Standards. During peer review, experts read a draft report of the research and provide comments about the report. These experts may include a scientist focused on the research topic, a specialist in research methods, a patient or caregiver, and a healthcare professional. These reviewers cannot have conflicts of interest with the study.
The peer reviewers point out where the draft report may need revision. For example, they may suggest ways to improve descriptions of the conduct of the study or to clarify the connection between results and conclusions. Sometimes, awardees revise their draft reports twice or more to address all of the reviewers’ comments.
Peer reviewers commented, and the researchers made changes or provided responses. The comments and responses included the following:
- Reviewers asked for more information about any power calculations the researchers performed to determine the study’s sample size. The researchers responded that their initial power calculations showed that they would have the power to detect a 10-percent difference between study arms. However, they stated that greater than expected sample sizes at the two hospitals increased their power to detect clinically meaningful differences in participants’ responses to different models of informed consent procedures.
- Reviewers expressed concern about the researchers’ decision to collapse the Likert-scale values on two of the outcome measures and about how that affected the measures’ validity. The researchers acknowledged that they did not conduct additional psychometric evaluations to determine the overall validity of the outcome measures when used this way, but they believed that the measures maintained face validity based on their cognitive interviews and feedback from their patient advisory groups. The researchers also did revise their results by reporting all categories on the Likert scale rather than collapsing categories.
- Reviewers asked about subgroup analyses and the completeness of reporting. The researchers added analyses of primary outcomes by study arm as well as summary statistics for basic demographic data by study arm and site. The researchers said they plan to conduct further subgroup analyses in the future.
- Reviewers wondered about the likelihood of substantial selection bias, noting that participants were almost certainly predisposed to have favorable attitudes about participating in research because they had to indicate willingness to participate in this study. Reviewers suggested the report discuss this limitation at length. The researchers added text about limitations. They noted that they believe this limitation applies more to the online sample than for participants recruited at medical clinics who were coming in for routine care.
Conflict of Interest Disclosures
Project Information
Key Dates
Study Registration Information
^Ruth Faden, PhD, MPH was the original principal investigator for this project.