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Researchers say COVID test instructions need to be better than what the FDA is offering

COVID at-home test, state of N.H.
Dan Tuohy
/
NHPR
A COVID-19 at-home test from the state of New Hampshire in December 2021.

COVID-19 rapid tests are now widely available in New Hampshire, but some of these test kits warn that a negative result may not mean a test-taker doesn’t have COVID. How should someone taking a test interpret their results, and what factors contribute to a correct, or incorrect interpretation of them?

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A recent study found that some people, after taking a rapid COVID-19 test, unnecessarily quarantined or skipped quarantine altogether. The study’s lead author is Dr. Steven Woloshin, co-director of the Center for Medicine and Media at the Dartmouth Institute.

Takeaways from Dr. Woloshin’s study:

How was the study conducted?

The study had 360 participants who were broken into three groups. One group received the FDA-authorized instructions for their hypothetical test, one group received modified instructions put together by the researchers, and the last group received no instructions at all.

The groups were then divided into four made-up scenarios: a known exposure to the virus with no symptoms, a known exposure and symptoms, no exposure and symptoms and no exposure and no symptoms. They were all asked to imagine themselves as “Jamie,” a 45-year-old unvaccinated man living with two other people.

The first three would be considered “high-risk” by the Centers for Disease Control and Prevention, but the study showed the decisions to quarantine varied based on the set of instructions the participants were given.

What did the participants decide to do when they got their results?

The overwhelming majority of participants who got positive results elected to quarantine, but a significant number of those who tested negative decided against quarantining, even if they were in high-risk situations. In fact, a higher percentage of people decided to quarantine themselves when they had no instructions at all as opposed to those who had the FDA-authorized instructions. Almost all those who received the instructions written by the researchers decided to quarantine.

What does Dr. Woloshin say about why the FDA instructions can be misinterpreted?

Dr. Woloshin says the instructions don’t elaborate on how the context in which someone is taking a test could have an impact on whether or not they should quarantine. If someone is sick and has symptoms, a negative test doesn't mean the same thing as a negative test when someone is well.

How do Dr. Woloshin’s instructions differ?

They are more detailed and contain a section that allows the test-taker to assess their risk based on their exposure situation. Dr. Woloshin says he hopes the FDA can adopt more detailed and well-researched instructions so that the tests people are using, and not just COVID tests, can not only be taken properly but interpreted properly.


Transcript

Peter Biello: Dr. Woloshin, thank you very much for speaking with me.

Dr. Steven Woloshin: Oh, thank you. Thanks for inviting me to speak with you.

Peter Biello: So, Dr. Woloshin, for your study, you surveyed 360 adults who were asked to give their reaction to hypothetical COVID-19 test result scenarios. Tell us a little bit about this. What were the four scenarios that you gave them?

Dr. Steven Woloshin: We divided the people up randomly into three groups. One group got the authorized FDA instructions that come with these home test kits and one group got instructions that we carefully developed and tested using the best decision science principles. And then because some people don't even read instructions, they don't bother to read them, we also had a third group where we gave them no instructions. Then what we did was we randomized again and people were given one of four different scenarios. And all the scenarios were about this person named Jamie, who is a healthy 45-year-old who lives with two other people and works from home. And Jamie had not been vaccinated against COVID 19. And then the four scenarios were Jamie had typical COVID symptoms and had a known exposure to someone with COVID or no symptoms and exposed, symptoms and not exposed, or neither symptoms nor exposure. In the first three, he would be considered a high risk for COVID, and CDC and FDA and others would recommend that he quarantine. In the last scenario, quarantine wouldn't be recommended.

Peter Biello: So for those three scenarios with the different instructions or no instructions, how did the test takers perform?

Dr. Steven Woloshin: So we gave them a negative test result and also a positive test result. On the positive side, people did really well. Almost everybody said that they would quarantine, but on the negative side, they didn't do so well, particularly with the [FDA] authorized instructions. People in the high probability of infection group, like symptoms and exposed, often failed to quarantine with the [FDA] authorized instructions. More than a third, 36%, failed to quarantine. Now, with our intervention instructions, we got that down to only 4%, which we were very pleased about that. And then it was disturbing, we found that with no instructions at all, 21% of people failed to quarantine. That's worse than our instructions, but it's better than the FDA authorized instructions. So that suggests that maybe the authorized instructions confuse people.

Peter Biello: So what was it about the authorized instructions that might have been confusing?

Dr. Steven Woloshin: Largely, the information in the authorized instructions, I think was very weak on helping people understand that in order to interpret the test, you have to take into account the context in which you're being tested. In other words, if you're sick and you have symptoms, a negative test doesn't mean the same thing as a negative test if you're well, and that doesn't appear in the instructions at all, our instructions made that really clear.

Peter Biello: Do you have plans to advocate that the FDA change their instructions to bring them in line with what you found to be most effective?

Dr. Steven Woloshin: Yes, I really hope that that we can convince the FDA to do that and not just for COVID testing, but any scenario where there's a test or information that's being given to the public, it's really important to vet the communication to make sure that it's effective. Otherwise it undermines the whole purpose. One of the co-authors on the paper, Baruch Fischhoff, once said that in these high-risk public health communication situations, the public shouldn't be exposed to an untested message any more than to an untested drug, and I think that's a really important concept. We shouldn't have had to do this study. This is something that should routinely be done by FDA and that we showed that better instructions based on these behavioral decision research principles, pretested it in the target audience, perform substantially better. So, this is a problem that's fixable.

Peter Biello: Dr. Steven Woloshin is co-director of the Center for Medicine and Media at the Dartmouth Institute and lead author of a study about the interpretation of COVID-19 test results. Dr. Woloshin, thank you again for your time.

Dr. Steven Woloshin: Sure, thank you.

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