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

## TL;DR

This study created and tested a tool to evaluate the ethics of public health policies that aim to change behavior.

## Contribution

A novel bioethical assessment instrument was developed with new domains like integrity and interculturality.

## Key findings

- An instrument with nine domains and 32 items was developed for ethical evaluation of public health policies.
- Expert validation through Delphi rounds confirmed the instrument's coherence and theoretical foundation.
- New domains emerged through reflective equilibrium, enhancing the tool's ethical relevance.

## Abstract

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.

Scale development and validation content study.

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.

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.

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.