[Gender: new methodological approaches in guideline development].

Gender and diversity have a strong impact on health and illness as evidenced by sex and gender differences in the onset and progression of diseases as well as in diagnosis, therapy, and therapeutic outcome. The number of sex/gender-specific studies in medicine has increased steadily in recent years, indicating sex (biological) and gender (social) differences in numerous diseases. Despite this evidence, however, sex/gender differences are rarely considered in medical practice or in health systems, suggesting a delay in transferring such research into evidence-based medical treatment. Similarly, quality improvement guidelines in medical care do not systematically integrate the sex/gender perspective. Against this backdrop, this paper seeks to enumerate the necessary components of a guideline development and evaluation process that systematically integrates sex/gender differences in addition to providing a sex/gender-based methodological approach. The latter is illustrated by a pilot study in which four international guidelines on depression were selected. The sex/gender appropriateness of these guidelines was analysed using two methods: first, sex/gender-relevant words were counted; and second, relevant sex/gender differences were summarised based on a systematic literature review and then compared with the information given in the guidelines. The findings of the pilot study revealed that although strong evidence exists on sex/gender differences in depression, such research was rarely implemented in the guidelines. Given the scope and potential of guidelines to improve the quality of health care, it is essential that they consider the crucial role of sex/gender differences. To date, sex/gender differences have been insufficiently addressed in guideline development and evaluation when they should be an integral component of the process.