Development of the implementability assessment tool for clinical practice guidelines based on the COSMIN framework and factorial experiment: a study protocol.

Abstract

Introduction: Clinical practice guidelines are essential tools for standardizing medical practices and improving healthcare quality. However, current guideline implementation is unsatisfactory. Barriers to guideline implementation include external environmental factors (e.g., medical personnel, medical institutions, local policies) and intrinsic characteristics (e.g., context, format, language etc.), with the latter being addressable by optimizing the guidelines themselves. This study aims to develop an appraisal tool to promote effective guideline implementation. Existing guideline implementability appraisal tools lack a clear theoretical basis, evidence of reliability and validity, and/or empirically-based guidance for effective implementation, all of which will be addressed in this study.

Methods and analysis: The research is divided into four phases: (1) Generating a theoretical framework for guideline implementability (i.e., scoping review and concept analysis method); (2) Conducting a factorial experiment (i.e., guideline users simulate the use of different guideline versions to examine the relationship between constructs in the framework and implementability), and removing constructs with weak relationships to form the final implementability theoretical framework; (3) Generating dimensions and items for the guideline implementability appraisal tool based on the constructs in the theoretical framework, conducting comprehensive reliability and validity testing, usability testing, and iterative optimization according to the COSMIN guidelines; (4) Integrating the validated tool with the STAR guideline rating system for guideline appraisal and feedback to promote guideline implementability. STRENGTHS AND LIMITATIONS: (1) Our research will follow a standardized and rigorous process for developing measurement scales, ensuring that the resulting evaluation scale for the implementability of CPGs is theoretically grounded, internally consistent between theory and practice, and reliable and valid. (2) The theoretical framework developed in our study will strengthen the validity and rationality of constructs in the real world. (3) In the confirmatory factor analysis, this study will determine the dimensions and items' weight through factor loadings, allowing for the quantification of the implementability of CPGs and providing users of the guidelines with objective evaluative results. In addition, the clinical practice guideline implementability evaluation tool developed in this study can assist guideline developers in enhancing implementability before, during, and after guideline formulation.