The required size of cluster randomized trials of nonpharmaceutical interventions in epidemic settings

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The required size of cluster randomized trials of nonpharmaceutical interventions in epidemic settings

Sheen, Justin K. (author)

Haushofer, Johannes (author): Stockholms universitet,Nationalekonomiska institutionen,Research Institute of Industrial Economics, Sweden; Max Planck Institute for Research on Collective Goods, Germany; Jain Family Institute, USA

Metcalf, C. Jessica E. (author)

Kennedy-Shaffer, Lee (author)

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(creator_code:org_t)

2022-03-07
2022
English.
In: Statistics in Medicine. - : Wiley. - 0277-6715 .- 1097-0258. ; 41:13, s. 2466-2482

Related links:: https://doi.org/10.1...; show more...; https://doi.org/10.1...; https://urn.kb.se/re...; https://doi.org/10.1...; show less...

Journal article (peer-reviewed)

Abstract Subject headings

To control the SARS-CoV-2 pandemic and future pathogen outbreaks requires an understanding of which nonpharmaceutical interventions are effective at reducing transmission. Observational studies, however, are subject to biases that could erroneously suggest an impact on transmission, even when there is no true effect. Cluster randomized trials permit valid hypothesis tests of the effect of interventions on community transmission. While such trials could be completed in a relatively short period of time, they might require large sample sizes to achieve adequate power. However, the sample sizes required for such tests in outbreak settings are largely undeveloped, leaving unanswered the question of whether these designs are practical. We develop approximate sample size formulae and simulation-based sample size methods for cluster randomized trials in infectious disease outbreaks. We highlight key relationships between characteristics of transmission and the enrolled communities and the required sample sizes, describe settings where trials powered to detect a meaningful true effect size may be feasible, and provide recommendations for investigators in planning such trials. The approximate formulae and simulation banks may be used by investigators to quickly assess the feasibility of a trial, followed by more detailed methods to more precisely size the trial. For example, we show that community-scale trials requiring 220 clusters with 100 tested individuals per cluster are powered to identify interventions that reduce transmission by 40% in one generation interval, using parameters identified for SARS-CoV-2 transmission. For more modest treatment effects, or when transmission is extremely overdispersed, however, much larger sample sizes are required.

Subject headings

MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Infektionsmedicin (hsv//swe)
MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Infectious Medicine (hsv//eng)

Keyword

nonpharmaceutical interventions
power
reproduction number
sample size
SARS-CoV-2

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ref (subject category)
art (subject category)

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MEDICAL AND HEALTH SCIENCES: MEDICAL AND HEAL ...; and Clinical Medicin ...; and Infectious Medic ...

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By the university: Stockholm University

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