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. 2022;4(SI3):10.1162/99608f92.116c43fe.
doi: 10.1162/99608f92.116c43fe. Epub 2022 Sep 8.

Introducing Data Sciences to N-of-1 Designs, Statistics, Use-Cases, the Future, and the Moniker 'N-of-1' Trial

Karina W Davidson  1 , Ying Kuen Cheung  2 , Ciarán P Friel  1 , Jerry Suls  1
Affiliations

Introducing Data Sciences to N-of-1 Designs, Statistics, Use-Cases, the Future, and the Moniker 'N-of-1' Trial

Karina W Davidson et al. Harv Data Sci Rev. 2022.

Abstract

This article, an introduction to HDSR's "Personalized (N-of-1) Trials: Methods, Applications, and Impact" special issue, describes the rationale for a primer of the methods, data types and management, designs, and use cases for personalized (N-of-1) trials. It explains that the design and implementation of personalized (N-of-1) trials is only useful if patients volunteer for research involving them and actively participate in clinical services that use them. However, 'N-of-1 trials' may be an inadequate name to enact such patient engagement. The authors briefly review what patients have reported about the 'N-of-1' label and propose a more consumer-friendly moniker for this type of research and clinical approach to improve evidence-based science.

Keywords: N-of-1 trials; between-subject designs; personalized trials; single-patient trials; within-subject trials.

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Figures

Figure 1.
Figure 1.
Word cloud of disciplines represented by contributing authors.
See this image and copyright information in PMC

References

    1. Altman DG, & Bland JM (2003). Interaction revisited: The difference between two estimates. BMJ, 326(7382), 219. 10.1136/bmj.326.7382.219 - DOI - PMC - PubMed
    1. Butler M, D’Angelo S, Kaplan M, Tashnim Z, Miller D, Ahn H, Falzon L, Dominello AJ, Foroughi C, Chandereng T, Cheung K, & Davidson K (2022). A series of virtual interventions for chronic lower back pain: A feasibility pilot study for a series of personalized (N-of-1) trials. Harvard Data Science Review, (Special Issue 3). 10.1162/99608f92.72cd8432 - DOI - PMC - PubMed
    1. Chandereng T (2022). An R Shiny app for a chronic lower back pain study, personalized N-of-1 trial. Harvard Data Science Review, (Special Issue 3). 10.1162/99608f92.6c21dab7 - DOI - PMC - PubMed
    1. Cheung K, & Mitsumoto H (2022). Evaluating personalized (N-of-1) trials in rare diseases: How much experimentation is enough? Harvard Data Science Review, (Special Issue 3). 10.1162/99608f92.e11adff0 - DOI - PMC - PubMed
    1. Clinical and Translational Science Awards Consortium, Community Engagement Key Function Committee Task Force on the Principles of Community Engagement. (2011). The principles of community engagement (2nd ed.). Centers for Disease Control and Prevention.

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