Design and validation of a bioethical assessment instrument for public health policies involving behavioral change: A mixed-methods study

Objectives: Growing interest in developing bioethical evaluation models for public health, together with limited consensus on fundamental moral values, highlights the need for a framework to guide ethical decision-making in this field. The Nuffield model has been proposed as an alternative for addressing ethical conflicts at the population level, as it offers a more suitable approach to the complexities of behavioral-change interventions than traditional clinical bioethics. Consequently, methodological tools are needed to guide decision-makers. This study sought to design and validate an instrument for the ethical evaluation of public health policies involving behavioral change. Study design: Scale development and validation content study. Methods: Reflective equilibrium was used as the overarching methodological strategy for instrument development. A three-phase mixed-methods (qualitative-quantitative) process was conducted, which included semi-structured interviews and expert validation using the Delphi technique. Results: We developed an instrument for the bioethical evaluation of public health policies that include a behavioral-change component, comprising nine domains and 32 items. Two Delphi rounds were carried out for expert validation, followed by a pilot test that informed adjustments to the final version of the instrument. Conclusions: The methodological approach enabled the construction of the instrument by contrasting and ensuring coherence among predefined domains and the theoretical frameworks analyzed. Through the application of reflective equilibrium, new domains, integrity, participation, and interculturality, emerged in addition to those identified in the literature, resulting in an instrument with a strong theoretical foundation and expert validation.