Children’s Nutrition Research Center Staff Publications

Language

English

Publication Date

12-1-2022

Journal

Nature Aging

DOI

10.1038/s43587-022-00333-6

PMID

37063472

PMCID

PMC10099485

PubMedCentral® Posted Date

4-13-2023

PubMedCentral® Full Text Version

Author MSS

Abstract

Investigators traditionally use randomized designs and corresponding analysis procedures to make causal inferences about the effects of interventions, assuming independence between an individual's outcome and treatment assignment and the outcomes of other individuals in the study. Often, such independence may not hold. We provide examples of interdependency in model organism studies and human trials and group effects in aging research and then discuss methodologic issues and solutions. We group methodologic issues as they pertain to (1) single-stage individually randomized trials; (2) cluster-randomized controlled trials; (3) pseudo-cluster-randomized trials; (4) individually randomized group treatment; and (5) two-stage randomized designs. Although we present possible strategies for design and analysis to improve the rigor, accuracy and reproducibility of the science, we also acknowledge real-world constraints. Consequences of nonadherence, differential attrition or missing data, unintended exposure to multiple treatments and other practical realities can be reduced with careful planning, proper study designs and best practices.

Keywords

Humans, Animals, Mice, Geroscience, Reproducibility of Results, Random Allocation, Causality

Published Open-Access

yes

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