DOI: 10.3886/icpsr39575.v1
title: Demonstrating Respect and Acceptable Consent Strategies: What Matters to Patients in Patient-Centered Outcomes Research (PCOR)? [Methods Study], United States, 2017
title: Version 1

description: 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.
description: 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
description: 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.
description: Datasets: 
DS1: Demonstrating Respect and Acceptable Consent Strategies: What Matters to Patients in Patient-Centered Outcomes Research (PCOR)? [Methods Study], United States, 2017
description: 2,600 people recruited from two health systems and from an online nationally representative survey panel maintained by Growth from Knowledge (GfK).