Methods for prospectively incorporating gender into health sciences research

Abstract

©. This manuscript version is made available under the CC BY-NC-ND 4.0 license http://creativecommons.org/licenses/by-nc-nd/4.0/ This document is the Submitted, Accepted, Published, version of a Published Work that appeared in final form in Journal of Clinical Epidemiology. To access the final edited and published work see https://doi.org/10.1016/j.jclinepi.2020.08.018Numerous studies have demonstrated that sex (a biological variable) and gender (a psychosocial construct) impact health and have dis-cussed the mechanisms that may explain these relationships. Funding agencies have called for all health researchers to incorporate sex andgender into their studies; however, the way forward has been unclear to many, particularly due to the varied definition of gender. We arguethat just as there is no standardized definition of gender, there can be no standardized measurement thereof. However, numerous measurablegender-related variables may influence individual or population-level health through various pathways. The initial question should guide theselection of specific gender-related variables based on their relevance to the study, to prospectively incorporate gender into research. Weoutline various methods to provide clarification on how to incorporate gender into the design of prospective clinical and epidemiologicalstudies as well as methods for statistical analysi