Perspective: Planning and Conducting Statistical Analyses for Human Nutrition Randomized Controlled Trials: Ensuring Data Quality and Integrity

Author:

Petersen Kristina S1,Kris-Etherton Penny M2,McCabe George P3,Raman Gowri4,Miller Joshua W5ORCID,Maki Kevin C6ORCID

Affiliation:

1. Department of Nutritional Sciences, Texas Tech University, Lubbock, TX, USA

2. Department of Nutritional Sciences, The Pennsylvania State University, University Park, PA, USA

3. Department of Statistics, Purdue University, West Lafayette, IN, USA

4. Institute for Clinical Research and Health Policy Studies, Center for Clinical Evidence Synthesis (CCES),Tufts Medical Center, Boston, MA, USA

5. Department of Nutritional Sciences, Rutgers University, New Brunswick, NJ, USA

6. Department of Applied Health Science, Indiana University School of Public Health, Bloomington, IN, USA

Abstract

Abstract Appropriate planning, execution, and reporting of statistical methods and results is critical for research transparency, validity, and reproducibility. This paper provides an overview of best practices for developing a statistical analysis plan a priori, conducting statistical analyses, and reporting statistical methods and results for human nutrition randomized controlled trials (RCTs). Readers are referred to the other NURISH (NUtrition inteRventIon reSearcH) publications for detailed information about the preparation and conduct of human nutrition RCTs. Collectively, the NURISH series outlines best practices for conducting human nutrition research.

Funder

National Institutes of Health Clinical and Translational Science

Tufts Clinical and Translational Science Institute

Publisher

Oxford University Press (OUP)

Subject

Nutrition and Dietetics,Medicine (miscellaneous),Food Science

Reference58 articles.

1. Perspective: Design and conduct of human nutrition randomized controlled trials;Lichtenstein;Adv Nutr,2021

2. Perspective: US documentation and regulation of human nutrition randomized controlled trials;Weaver;Adv Nutr,2021

3. Perspective: Laboratory considerations and clinical data management for human nutrition randomized controlled trials: guidance for ensuring quality and integrity;Maki;Adv Nutr,2021

4. Perspective: Guidelines needed for the conduct of human nutrition randomized controlled trials;Weaver;Adv Nutr,2021

5. American Statistical Association releases statement on statistical significance and P-values: provides principles to improve the conduct and interpretation of quantitative science;American Statistical Association

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