An “opt-out” approach may encourage more patient participation in research

Shivan Mehta
Shivan Mehta

Shivan J Mehta (Department of Medicine, Perelman School of Medicine,  University of Pennsylvania, Philadelphia, USA) and others report in JAMA Cardiology that an “opt out” framing approach rather than a traditional “opt it” approach resulted in significantly greater participation of patients enrolled in a study evaluating a remote monitoring intervention for patients with myocardial infarction. Mehta talks to Cardiovascular News about the research.

Why do you think so many studies are limited by a low participation rates?

Low participation is an issue for just about every research study—particularly those that require informed consent. Obviously, consent is really important as participants need to understand the risks and benefits of the intervention that is being evaluated. However, obtaining consent can be difficult.

With a traditional “opt in” approach, a research coordinator has to provide detailed information to prospective participants about the intervention being evaluated and about the planned study in a standard format. Much like legal disclaimers, this can cause cognitive overload for the prospective patient and the default human response in these situations is to say no. That is one of the reasons why participation rates can be low so in opt in studies.

Another potential limitation of opt in studies is that you can have a “healthy user” effect. In our study, we were evaluating an intervention that monitors adherence to medication regimens. Many of the patients in the “opt in” group were already engaged in the process of taking medication and may not need any help to take their medication. Therefore, you may not really know if the intervention improves adherence rate because the participants may not represent those that need the intervention. The external validity of research can often be called into question because it is done on such a narrow scale. We need to know if an intervention works in a real-world population.

What was the “opt-out” framing approach used in your study?

In the opt in group, we sent participants a letter about the study and subsequently called them to ask if they wanted to participate. But in the opt out group, we sent them remote monitoring devices with the exact same letter and then called them to ask if they wanted to participate. The rationale was that the opt out participants would be able to see the intervention and, therefore, better understand how it works. Having the devices made the study more tangible for the participants.

The opt out participants still had the ability to decline; additionally, with the remote monitoring systems in the study, you have to actively use them. If they did not want to take part in the study, they would not use the system.

What were the key findings of your study?

The main finding was that there was a significantly higher participation rate in the opt out group—38.5% vs. 15.7% for the opt in group (p<0.001). Another finding that with the opt out group, because they had already been sent the devices, it was easier to show them how to use them; we could start the study  right away. With the opt in group, after they agreed to participate, we had to send them the devices and then explain how to use them.

Also when we looked at adherence, it was similar between groups. Therefore once they had agreed to the study, participants had a very similar level of engagement whether they were in the opt in or opt out group.

With an opt out approach, do think prospective participants would be under pressure to say yes because they already have the intervention?

That is an always a consideration. We need to balance the potential risks of a new approach against its benefits. However, in this study, the opt out approach had definite benefits and participants have plenty of opportunities not to give consent—for example, they did not have to use the intervention.

We feel that the opt out approach made it easier for participants to say yes and to better understand what we were asking them to do. Actually, the feedback we received from participants was overwhelmingly positive.

Going forward, an opt out framing approach would have to be used on a case-by-case basis to ensure participants were not being pressured into consenting. Also, such an approach would not be suitable for higher-risk studies—ie, those comparing drug to placebo etc.