Evidence-based biostatistics and value-based biostatistics practices in biomedical research: Application to evaluating the association between phthalate metabolites and sex hormones in US male adults.

The robustness of biostatistical approaches varies according to study design features in prognostic research. Multiple approaches are available for analyzing a specific type of research data. The evidence-based biostatistics (EBB) practice suggests selecting and applying the best statistical approaches and preferred methods aligned with the study objective, study design, and data generation process. The value-based biostatistics (VBB) practice suggests the selection and application of statistical approaches to address multiple questions simultaneously to improve the interpretation of findings. This report highlights the classification of statistical analysis approaches and reporting according to EBB and VBB practices. We explored the relationship between phthalate metabolites and sex hormones in US male adults using the NHANES database. Using statistical approaches, ignoring study design features in data analysis, phthalate metabolites were not consistently associated with sex hormone-binding globulin (SHBG) and testosterone (TT) concentrations. However, most phthalate metabolites were found to be strongly and inversely associated with SHBG and TT concentrations, particularly in younger adults, as per the EBB analyses. In addition, the VBB approaches suggest that the associations between phthalate metabolites and sex hormones varied according to the distribution of SHBG and TT and sociodemographic characteristics. While EBB practice may minimize the statistical controversies and heterogeneity in statistical analysis practices and improve the quality of the research findings, the VBB practice may provide better insights and useful information for the implications of study findings in future studies. As per EBB and VBB approaches, the considered phthalate metabolites were inversely associated with SHBG and TT, particularly among younger males, suggesting prevention and control strategies to avoid exposure to phthalate metabolites.