Geschlechtergerechte Gesundheitsversorgung: Betrachtung, Herausforderungen und Empfehlungen für einen geschlechtersensiblen Ansatz in der Leitlinienentwicklung - am Beispiel der deutschen Nationalen VersorgungsLeitlinien

Background: Clinical practice guidelines are a common and efficient approach to facilitate the transfer and use of scientific evidence into clinical practice. However, despite the increasing body of evidence about relevant differences between women and men for healthcare, differences are only rarely explicitly and systematically addressed in guidelines. This suggests that at some point of the guideline development process the integration of sex/gender factors into clinical practice guidelines gets impeded. The study aimed at evaluating the consideration given to sex/gender factors in guideline method reports and their current uptake in guidelines, using the example of National Disease Management Guidelines (NDMG) in Germany. Furthermore, the study was directed at identifying barriers and facilitators for the systematic consideration and integration of sex/gender differences in the guideline development process to finally formulate recommendations for the development of sex/gender sensitive guidelines. Methods: Through document analyses of NDMG program method reports and guidelines the current uptake and the representation of sex/gender differences were assessed. Furthermore, barriers and facilitators for the development of sex/gender sensitive guidelines were identified and supporting measures discussed by means of semi-structured interviews with twelve guideline developers (f = 66.7%). The interview data was analyzed using qualitative content structuring methods according to Mayring. To assure a theoretically sound analysis of the interview data, a theoretical framework model was developed based on existing literature. The pre-determined categories were open for adjustment and alterations during the whole analysis. Results: The evaluation of the current representation of sex/gender revealed that generally sex/gender factors are seldom stated in the method report of the NDMG program and accordingly also in the evaluated guidelines. An underrepresentation of women was found in most of the guideline development groups and little attention was paid to sex/gender factors during the formulation of key questions, the definition of the target population, the literature searches, and the evidence appraisal. On average only 6.5% of the recommendations in the identified guidelines referred to sex/gender differences. The statements in the interviews on barriers and facilitators were allocated to the main categories Innovation, Individual/Professional, Social, Organizational, and Political Context and summarized in ten subcategories. The identified barriers mainly addressed the increasing complexity of guidelines, the lack of availability and quality of sex/gender sensitive evidence, and the shortage of resources. Furthermore, barriers were identified in an individual/professional context, such as deficiencies in awareness/knowledge about relevant sex/gender differences. The results of facilitating factors showed that experts see the support of policies and standards from guideline organizations as facilitating factors for the consideration of sex/gender factors in guideline development. In this context, the experts emphasized the need for specific measures and tools for successful implementation. To begin to address the described challenges, supporting measures were discussed with the experts, e.g., focus groups and sex/gender sensitive search strategies. Based on the results of the present study fifteen recommendations for the development of sex/gender sensitive guidelines were formulated. Conclusion: The development of sex/gender sensitive guidelines will contribute to the transfer of sex/gender sensitive evidence into clinical practice, thereby supporting the prevention of inadequate and inappropriate treatment and the improvement of health outcomes for both women and men. The recommendations developed in the present study can be taken as a first step to enhance the identified facilitators and diminish the barriers. The objective of the formulated recommendations is not to replace existing standards or checklists, but instead to supplement and complete existing structures of guideline developing organizations. Yet, to achieve optimal healthcare for women and men further research and interventions are needed to reach consideration of sex/gender factors in all areas of healthcare, including basic and clinical research, knowledge transition, and medical education and training, to have a positive effect on healthcare practice