证据质量升级的最常见原因是效应量大。当方法学严谨的观察性研究表明风险至少降低或增加2倍时，GRADE建议考虑将证据质量升高1级；当风险至少降低或增加5倍时，考虑将证据质量升高2级。当存在剂量-反应关系，或所有合理的混杂、偏倚会降低明显的治疗效应，或混杂、偏倚使得结果无效为假效应时，系统评价作者和指南制定者也可考虑升高证据质量。其他考虑因素包括起效迅速、潜在的疾病（状态）趋势以及间接证据。
Objective To explore the methodological characteristics of Chinese clinical practice guidelines/expert consensus based on usage of GRADE. MethodsCNKI, PubMed, WanFang Data databases, and Medlive.cn were electronically searched to collect Chinese clinical practice guidelines/expert consensus over the past 11 years from January 1st 2010 to December 31st 2020. Four reviewers independently extracted data according to the content of appraisal of guidelines quality evaluation tool AGREE Ⅱ. The clinical practice guidelines/expert consensus were divided into two groups based on whether GRADE was used or not. The changes and development of methodological quality in the past 11 years were explored between the two groups. ResultsIn recent years, the number of clinical practice guidelines/expert consensus which used the GRADE in China had increased annually. The practice guidelines/expert consensus which did not use GRADE had lower methodology quality (P<0.01). ConclusionsThe use of GRADE in clinical practice guidelines/expert consensus requires improvement, and mastering GRADE methodology can effectively improve the methodological quality of the clinical practice guidelines/expert consensus.
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.