Errors in the implementation, analysis, and reporting of randomization within obesity and nutrition research: a guide to their avoidance.
Colby J VorlandAndrew W BrownJohn A DawsonStephanie L DickinsonLilian Golzarri-ArroyoBridget A HannonMoonseong HeoSteven B HeymsfieldWasantha P JayawardeneChanaka N KahathuduwaScott W KeithJ Michael OakesCarmen D TekweLehana ThabaneDavid B AllisonPublished in: International journal of obesity (2005) (2021)
Randomization is an important tool used to establish causal inferences in studies designed to further our understanding of questions related to obesity and nutrition. To take advantage of the inferences afforded by randomization, scientific standards must be upheld during the planning, execution, analysis, and reporting of such studies. We discuss ten errors in randomized experiments from real-world examples from the literature and outline best practices for their avoidance. These ten errors include: representing nonrandom allocation as random, failing to adequately conceal allocation, not accounting for changing allocation ratios, replacing subjects in nonrandom ways, failing to account for non-independence, drawing inferences by comparing statistical significance from within-group comparisons instead of between-groups, pooling data and breaking the randomized design, failing to account for missing data, failing to report sufficient information to understand study methods, and failing to frame the causal question as testing the randomized assignment per se. We hope that these examples will aid researchers, reviewers, journal editors, and other readers to endeavor to a high standard of scientific rigor in randomized experiments within obesity and nutrition research.
Keyphrases
- double blind
- open label
- placebo controlled
- phase iii
- adverse drug
- insulin resistance
- metabolic syndrome
- phase ii
- weight loss
- type diabetes
- physical activity
- electronic health record
- high fat diet induced
- primary care
- clinical trial
- weight gain
- healthcare
- patient safety
- systematic review
- big data
- randomized controlled trial
- emergency department
- skeletal muscle
- machine learning
- adipose tissue
- social media