Abstract
INTRODUCTION: In January 2019, the WHO reviewed evidence to develop global recommendations on self-care interventions for sexual and reproductive health and rights (SRHR). Identification of research gaps is part of the WHO guidelines development process, but reliable methods to do so are currently lacking with gender, equity and human rights (GER) infrequently prioritised. METHODS: We expanded a prior framework based on Grading of Evidence, Assessment, Development and Evaluation (GRADE) to include GER. The revised framework is applied systematically during the formulation of research questions and comprises: (1) assessment of the GRADE strength and quality rating of recommendations; (2) mandatory inclusion of research questions identified from a global stakeholder survey; and (3) selection of the GER standards and principles most relevant to the question through discussion and consensus. For each question, we articulated: (1) the most appropriate and robust study design; (2) an alternative pragmatic design if the ideal design was not feasible; and (3) the methodological challenges facing researchers through identifying potential biases. RESULTS: We identified 39 research questions, 7 overarching research approaches and 13 discrete feasible study designs. Availability and accessibility were most frequently identified as the GER standards and principles to consider when planning studies, followed by privacy and confidentiality. Selection and detection bias were the primary methodological challenges across mixed methods, quantitative and qualitative studies. A lack of generalisability potentially limits the use of study results with non-participation in research potentially highest in more vulnerable populations. CONCLUSION: A framework based on GRADE that includes stakeholders' values and identification of core GER standards and principles provides a practical, systematic approach to identifying research questions from a WHO guideline. Clear guidance for future studies will contribute to an anticipated 'living guidelines' approach within WHO. Foregrounding GER as a separate component of the framework is innovative but further elaboration to operationalise appropriate indicators for SRHR self-care interventions is required.