The formation, evaluation and grade division of real-world evidence (RWE) are bottlenecks restricting the in-depth development and scientific application of real-world study methods. This paper briefly reviewed the design grade and evidence grade of clinical medical research, and proposed the key points of evidence grade of real-world clinical research, including emphasizing the comprehensive evaluation of internal authenticity and external authenticity, determining the "starting point" of real-world evidence, and using the real-world evidence quality evaluation method. Based on the internationally recognized "grading of recommendations assessment, development, and evaluation (GRADE)", combined with the classification and characteristics of real-world evidence, a preliminary grading scheme was formed. An example was given to illustrate the grading suggestion.
By employing the nominal group technique, as per the process standard of the EQUATOR Collaboration Network, experts were selected through purposeful sampling. Two rounds of nominal group discussions were conducted, and the essential information of the utilization of the consensus method was extracted from the literature. After comparison, discussion, evaluation, and optimization, a list of 3 fields, 11 themes, 63 necessary items, and 28 supplementary items was eventually constructed to upgrade the standardization and rigor of the application of the consensus method in the future, assisting guideline developers to plan the consensus process.
