Abstract
BACKGROUND: Medical artificial intelligence (AI) has significantly contributed to decision support for disease screening, diagnosis, and management. With the growing number of medical AI developments and applications, incorporating ethics is considered essential to avoiding harm and ensuring broad benefits in the lifecycle of medical AI. One of the premises for effectively implementing ethics in Medical AI research necessitates researchers' comprehensive knowledge, enthusiastic attitude, and practical experience. However, there is currently a lack of an available instrument to measure these aspects. OBJECTIVE: The aim of this study was to develop a comprehensive scale for measuring the knowledge, attitude, and practice of ethics implementation among medical AI researchers, and to evaluate its measurement properties. METHODS: The construct of the Knowledge-Attitude-Practice in Ethics Implementation (KAP-EI) scale was based on the Knowledge-Attitude-Practice (KAP) model, and the evaluation of its measurement properties was in compliance with the COnsensus-based Standards for the selection of health status Measurement INstruments (COSMIN) reporting guidelines for studies on measurement instruments. The study was conducted in 2 phases. The first phase involved scale development through a systematic literature review, qualitative interviews, and item analysis based on a cross-sectional survey. The second phase involved evaluation of structural validity and reliability through another cross-sectional study. RESULTS: The KAP-EI scale had 3 dimensions including knowledge (10 items), attitude (6 items), and practice (7 items). The Cronbach α for the whole scale reached .934. Confirmatory factor analysis showed that the goodness-of-fit indices of the scale were satisfactory (χ(2)/df ratio:=2.338, comparative fit index=0.949, Tucker Lewis index=0.941, root-mean-square error of approximation=0.064, and standardized root-mean-square residual=0.052). CONCLUSIONS: The results show that the scale has good reliability and structural validity; hence, it could be considered an effective instrument. This is the first instrument developed for this purpose.