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Researchers often perform data-driven variable selection when modeling the associations between an outcome and multiple independent variables in regression analysis. Variable selection may improve the interpretability, parsimony and/or predictive accuracy of a model. Yet variable selection can also have negative consequences, such as false exclusion of important variables or inclusion of noise variables, biased estimation of regression coefficients, underestimated standard errors and invalid confidence intervals, as well as model instability. While the potential advantages and disadvantages of variable selection have been discussed in the literature for decades, few large-scale simulation studies have neutrally compared data-driven variable selection methods with respect to their consequences for the resulting models. We present the protocol for a simulation study that will evaluate different variable selection methods: forward selection, stepwise forward selection, backward elimination, augmented backward elimination, univariable selection, univariable selection followed by backward elimination, and penalized likelihood approaches (Lasso, relaxed Lasso, adaptive Lasso). These methods will be compared with respect to false inclusion and/or exclusion of variables, consequences on bias and variance of the estimated regression coefficients, the validity of the confidence intervals for the coefficients, the accuracy of the estimated variable importance ranking, and the predictive performance of the selected models. We consider both linear and logistic regression in a low-dimensional setting (20 independent variables with 10 true predictors and 10 noise variables). The simulation will be based on real-world data from the National Health and Nutrition Examination Survey (NHANES). Publishing this study protocol ahead of performing the simulation increases transparency and allows integrating the perspective of other experts into the study design., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2024 Ullmann et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

In the last decades, statistical methodology has developed rapidly, in particular in the field of regression modeling. Multivariable regression models are applied in almost all medical research projects. Therefore, the potential impact of statistical misconceptions within this field can be enormous Indeed, the current theoretical statistical knowledge is not always adequately transferred to the current practice in medical statistics. Some medical journals have identified this problem and published isolated statistical articles and even whole series thereof. In this systematic review, we aim to assess the current level of education on regression modeling that is provided to medical researchers via series of statistical articles published in medical journals. The present manuscript is a protocol for a systematic review that aims to assess which aspects of regression modeling are covered by statistical series published in medical journals that intend to train and guide applied medical researchers with limited statistical knowledge. Statistical paper series cannot easily be summarized and identified by common keywords in an electronic search engine like Scopus. We therefore identified series by a systematic request to statistical experts who are part or related to the STRATOS Initiative (STRengthening Analytical Thinking for Observational Studies). Within each identified article, two raters will independently check the content of the articles with respect to a predefined list of key aspects related to regression modeling. The content analysis of the topic-relevant articles will be performed using a predefined report form to assess the content as objectively as possible. Any disputes will be resolved by a third reviewer. Summary analyses will identify potential methodological gaps and misconceptions that may have an important impact on the quality of analyses in medical research. This review will thus provide a basis for future guidance papers and tutorials in the field of regression modeling which will enable medical researchers 1) to interpret publications in a correct way, 2) to perform basic statistical analyses in a correct way and 3) to identify situations when the help of a statistical expert is required., Competing Interests: The authors have declared that no competing interests exist.