Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.
Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada; Department of Pediatrics, McMaster University, Hamilton, Ontario, Canada.
J Clin Epidemiol. 2020 Apr;120:116-120. doi: 10.1016/j.jclinepi.2019.11.019. Epub 2019 Dec 19.
The Grading of Recommendations Assessment, Development, and Evaluations (GRADE) system for assessing certainty in a body of evidence currently uses two levels, serious and very serious, for downgrading on a single domain. In the context of newer risk of bias instruments, such as Risk of Bias in Non-Randomized Studies I (ROBINS-I), evidence generated by nonrandomized studies may justify rating down by more than two levels on a single domain. Given the importance users of GRADE assign to terminology, our objective was to assess what term GRADE stakeholders would prefer for rating down certainty by three levels.
We conducted a purposefully sampled online survey of GRADE stakeholders to assess possible terms including "critically serious," "extremely serious," "most serious," and "very, very serious" and conducted a descriptive and thematic analysis of responses. We then facilitated a GRADE working group workshop to generate consensus.
A total of 225 respondents ranked and rated "extremely serious" highest, closely followed by "critically serious." Respondents felt that "extremely serious" was "more understandable" and "easiest to interpret". GRADE working group members described that the terms "extremely serious" appeared clearer and easier to translate in other languages.
Based on this stakeholder-driven study, "extremely serious" is the preferred term to rate down certainty of evidence by three levels in the GRADE approach.
目前，用于评估证据整体确定性的推荐评估、制定和评估（GRADE）系统在单一领域使用“严重”和“非常严重”两个级别进行降级。在新的偏倚风险工具（如非随机研究偏倚风险工具 I（ROBINS-I））的背景下，非随机研究产生的证据可能需要在单个领域内降低超过两个级别。鉴于 GRADE 用户对术语的重视，我们的目标是评估 GRADE 利益相关者会更喜欢哪些术语来将确定性降低三个级别。
我们对 GRADE 利益相关者进行了有针对性的在线调查，以评估可能的术语，包括“极严重”、“非常严重”、“最严重”和“非常非常严重”，并对回复进行了描述性和主题分析。然后，我们促进了 GRADE 工作组研讨会以达成共识。
共有 225 名受访者对“非常严重”进行了评分和评级，排名最高，其次是“极严重”。受访者认为“非常严重”“更易于理解”且“更容易解释”。GRADE 工作组的成员表示，“极严重”这个术语在其他语言中似乎更清晰，也更容易翻译。
基于这项由利益相关者驱动的研究，“非常严重”是 GRADE 方法中降低证据确定性三个级别的首选术语。
