Development and validation of a clinical practice guidelines implementability assessment tool (CPG-IAT) based on the COSMIN framework

Introduction: We define guideline implementability as the characteristics of the guideline that reflect the extent to which it is likely to be adopted in clinical practice. Improving the intrinsic quality (e.g., context, format, language etc.) of clinical practice guidelines (CPGs) may be a cost-effective and broadly applicable approach. This study was aimed to develop the clinical practice guidelines implementability assessment tool (CPG-IAT) and test its psychometric properties. Methods: The study used the 2022 CPGs recorded in the STAR guideline repository as the evaluation sample. The evaluation team consisted of 60 members with clinical, guideline development, or prior rating experience, responsible for assessing the included guidelines. Guideline evaluation data were randomly assigned to be utilized for an exploratory factor analysis (n=131) or for a confirmatory factor analysis (n=130). Reliability and validity analyses were then conducted with the full sample. Results: The exploratory factor analysis resulted in a 16-item tool with four dimensions representing Methodological Rigor and Transparency, Recommendation Clarity and Interpretability, clinical relevance and actionability. Confirmatory factor analysis supported a priori factor structure. The tool demonstrated excellent internal consistency reliability, convergent validity, construct reliability, split-half reliability, test-retest reliability, inter-rater reliability and pragmatic. Conclusions: The CPG-IAT serves as a good tool for standardizing guideline development prior to their creation and for evaluating guideline implementability after development. The tools developed in this study not only provide a scientific basis for assessing the implementability of CPGs but also offer robust support for future research and practice in related fields. Trial Registration: China Clinical Trails Registry (ChiCTR2400086931); registered July 15, 2024. https://www.chictr.org.cn/