Background: Gender refers to the socially constructed roles, behaviors, expressions, and identities of girls, women, boys, men, and gender diverse people. It influences self-perception, individual’s actions and interactions, as well as the distribution of power and resources in society. Gender-related factors are seldom assessed as determinants of health outcomes, despite their powerful contribution.
Methods: Investigators of the GOING-FWD project developed a standard methodology applicable for observational studies to retrospectively identify gender-related factors to assess their relationship to outcomes and applied this method to selected cohorts of non-communicable chronic diseases from Austria, Canada, Spain, Sweden.
Results: The following multistep process was applied. Step 1 (Identification of Gender-related Variables): Based on the gender framework of the Women Health Research Network (i.e. gender identity, role, relations, and institutionalized gender), and available literature for a certain disease, an optimal “wish-list” of gender-related variables/factors was created and discussed by experts. Step 2 (Definition of Outcomes): each of the cohort data dictionaries were screened for clinical and patient relevant outcomes, using the ICHOM framework. Step 3 (Building of Feasible Final List): A cross-validation between gender-related and outcome variables available per database and the “wish-list” was performed. Step 4 (Retrospective Data Harmonization): The harmonization potential of variables was evaluated. Step 5 (Definition of Data Structure and Analysis): Depending on the database data structure, the following analytic strategies were identified: (1) local analysis of data not transferable followed by a meta-analysis combining study-level estimates; (2) centrally performed federated analysis of anonymized data, with the individual-level participant data remaining on local servers; (3) synthesizing the data locally and performing a pooled analysis on the synthetic data; and (4) central analysis of pooled transferable data.
Conclusion: The application of the GOING-FWD systematic multistep approach can help guide investigators to analyze gender and its impact on outcomes in previously collected data.