Developing a tool for supporting health-system guidance implementation paper 2: a developmental and formative evaluation study

Objectives To develop a practical tool to support the implementation of health-system guidance (HSG). Study Design and Setting The study followed a three-phase process: (1) organizing the components derived from a preceding Delphi study into a structured layout and refining it through team discussions using selected HSG examples; (2) conducting a formative evaluation to assess the tool's face validity and perceived usability through semistructured qualitative interviews and a think-aloud approach; and (3) finalizing the tool's structure and layout based on the findings from the formative evaluation. Results The HSG implementation tool, consisting of a quick reference guide and a checklist, underwent formative evaluation as part of its development process. A total of 17 interviews were conducted from 11 countries, resulting in the identification of nine key themes. Four of these themes were related to the tool's face validity: appropriate overall structure, comprehensive and relevant items, helpful illustrative considerations, and interactive comment section. Most participants expressed a willingness to use the tool, provided insights into potential application scenarios, and suggested areas for further refinement. Conclusions This study developed a practical tool to support HSG implementation, offering a structured approach to help policymakers and other relevant actors systematically consider essential factors and strategies when planning HSG implementation.