Jonathan R. Treadwell, PhD, ECRI Co-Director of the Evidence-based Practice Center

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Controversial New Study on Medical Masks versus N95 Respirators for COVID Prevention in Healthcare Workers

We noted with great interest the study by Loeb et al., published in the December 2022 issue of Annals of Internal Medicine, as well as a helpful commentary and various reactions to the findings. In this commentary, we discuss the notion of a “non-inferiority” trial and address several concerns.

What are non-inferiority trials?

When an effective treatment is expensive or inconvenient, we might consider a reasonable alternative that is cheaper and/or more convenient. How much reduction in effectiveness is acceptable? Research studies can be designed as “non-inferiority” trials that, critically, set a numerical threshold for how much reduced effectiveness one is willing to tolerate in exchange for the known benefits of reduced cost and/or convenience. If the study can rule out the possibility of an effectiveness reduction as large as the numerical threshold, then the cheaper treatment can be deemed “non-inferior.” Ideally, the threshold is not based on one research team’s opinion, but rather on empirical data from those who would experience both the reduced benefits and better cost/harm profile. Even if data-based, the answer is a middle-of-the-road judgment with no objectively correct answer, as different people would set higher or lower thresholds.

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Topics: Patient Safety

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