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Assessing How Consumers Interpret and Act on Results From At-Home COVID-19 Self-test KitsA Randomized Clinical Trial

Educational Objective
To identify the key insights or developments described in this article
1 Credit CME
Key Points

Question  How do people interpret results of at-home COVID-19 self-test kits when they use instructions authorized by the US Food and Drug Administration or instructions developed with decision science principles, or no instructions, and do they choose to self-quarantine per federal recommendations or quarantine unnecessarily?

Findings  This randomized clinical trial of 360 adults in the US found that a substantial proportion misinterpreted the negative results of at-home self-tests by failing to consider the implications of a high pretest probability of infection and ignoring the federal self-quarantine recommendations. Decision science−based instructions may increase the contribution of at-home self-test kits to public health.

Meaning  The findings of this randomized clinical trial indicate that people who use at-home COVID-19 self-test kits may fail to self-quarantine or may quarantine unnecessarily because they misinterpret the implications of test results. Redesigned instructions may increase the benefits and reduce the harms from at-home self-test kits.

Abstract

Importance  The US Food and Drug Administration (FDA) authorized SARS-CoV-2 rapid at-home self-test kits for individuals with and without symptoms. How appropriately users interpret and act on the results of at-home COVID-19 self-tests is unknown.

Objective  To assess how users of at-home COVID-19 self-test kits interpret and act on results when given instructions authorized by the FDA, instructions based on decision science principles, or no instructions.

Design, Setting, and Participants  A randomized clinical trial was conducted of 360 adults in the US who were recruited in April 2021 to complete an online survey on their interpretation of at-home COVID-19 self-test results. Participants were given 1 of 3 instruction types and were presented with 1 of 4 risk scenarios. Participants were paid $5 and had a median survey completion time of 8.7 minutes. Data analyses were performed from June to July 2021.

Intervention  Participants were randomized to receiving either the FDA-authorized instructions (authorized), the intervention instructions (intervention), or no instructions (control), and to 1 of 4 scenarios: 3 with a high pretest probability of infection (COVID-19 symptoms and/or a close contact with COVID-19) and 1 with low pretest probability (no symptoms and no contact). The intervention instructions were designed using decision science principles.

Main Outcomes and Measures  Proportion of participants in the high pretest probability scenarios choosing to quarantine per federal recommendations and perceived probabilities of infection given a negative or positive COVID-19 test result. A Bonferroni correction accounted for multiple comparisons (3 instruction types × 4 scenarios; α = 0.004).

Results  After excluding 22 individuals who completed the survey too quickly, the responses of 338 participants (median [IQR] age, 38 [31 to 48] years; 154 (46%) women; 215 (64%) with a college degree or higher) were included in the study analysis. Given a positive test result, 95% (322 of 338; 95% CI, 0.92 to 0.97) of the total participants appropriately chose to quarantine regardless of which instructions they had received. Given a negative test result, participants in the high pretest probability scenarios were more likely to fail to quarantine appropriately with the authorized instructions (33%) than with the intervention (14%; 95% CI for the 19% difference, 6% to 31%; P = .004) or control (24%; 95% CI for the 9% difference, −4% to 23%; P = .02). In the low pretest probability scenario, the proportion choosing unnecessary quarantine was higher with the authorized instructions (31%) than with the intervention (22%; 95% CI for the 9% difference, −14% to 31%) or control (10%; 95% CI for the 21% difference, 0.5% to 41%)—neither comparison was statistically significant (P = .05 and P = .20 respectively).

Conclusions and Relevance  The findings of this randomized clinical trial indicate that at-home COVID-19 self-test kit users relying on the authorized instructions may not follow the Centers for Disease Control and Prevention’s quarantine recommendations, producing unintended risks and unnecessary disruptions. Redesigned instructions that follow decision science principles may improve compliance.

Trial Registration  ClinicalTrials.gov Identifier: NCT04758299

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Article Information

Accepted for Publication: November 4, 2021.

Published Online: January 31, 2022. doi:10.1001/jamainternmed.2021.8075

Corresponding Author: Steven Woloshin, MD, MS, Dartmouth Institute for Health Policy and Clinical Practice, Level 5, WTRB, 1 Medical Center Dr, Lebanon, NH 03756 (steven.woloshin@dartmouth.edu).

Author Contributions: Dr Woloshin had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.

Concept and design: All authors.

Acquisition, analysis, or interpretation of data: All authors.

Drafting of the manuscript: Woloshin, Dewitt, Krishnamurti.

Critical revision of the manuscript for important intellectual content: All authors.

Statistical analysis: Woloshin, Dewitt.

Administrative, technical, or material support: Woloshin, Dewitt, Krishnamurti.

Supervision: Krishnamurti.

Conflict of Interest Disclosures: Dr Woloshin serving on the Cochrane Collaboration and the JAMA Internal Medicine editorial boards; personal fees from the US National Cancer Institute and the State of New Mexico as an expert witness in litigation against testosterone manufacturer for deceptive marketing, all outside the submitted work. No other disclosures were reported.

Funding/Support: The research was funded by the Swedish Foundation for Social Sciences and Humanities and the Agency for Healthcare Research and Quality Comparative Health System Performance Initiative (grant No. 1U19HS024075) and the S&R Foundation's Kuno Award for Applied Science for the Social Good.

Role of the Funder/Sponsor: The funders had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

Disclaimer: Dr Woloshin serves on the editorial board of JAMA Internal Medicine but was not involved in any of the decisions regarding review of the manuscript or its acceptance.

Additional Contributions: The authors gratefully acknowledge Ayça Akin, MDes (independent consultant) for the graphic design work on the intervention instructions and Miriam Bernard, BA (University of Pittsburg) for research assistance. Both were compensated for their work.

Data Sharing Statement: See Supplement 3.

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