Research Agency for Clinical Practice Guidelines, Research Center, Korean Academy of Medical Sciences, Seoul, Korea.
Department of Medical Sciences, Ewha Womans University Graduate School, Seoul, Korea.
J Korean Med Sci. 2018 Feb 19;33(8):e79. doi: 10.3346/jkms.2018.33.e79.
A standardized systematic approach to grade evidence and the strength of recommendations is important for guideline users to minimize bias and help interpret the most suitable decisions at the point of care. The study aims to identify and classify determinants used to make judgement for the strength of recommendations among 56 Korean clinical practice guidelines (CPGs), and explore strong recommendations based on low quality of evidence.
Determinants used in the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach among 34 CPGs which have reported both strength of recommendations and level of evidence were reviewed.
Five of 34 CPGs (14.7%) considered quality of evidence, benefits and harms, patients' values and preferences, and costs. And 24 of 34 CPGs (70.6%) considered both magnitude of effect and feasibility as additional determinants. Judgement table was not widely provided for use to translate evidence into recommendations. Eighty-two of 121 recommendations (67.8%, ranged 20.0% to 100.0%) among 11 CPGs using the same judgement scheme showed 'strong' strength of recommendations based on low or very low quality of evidence. Among 5 paradigmatic situations that justify strong recommendations based on low or very low evidence, situation classified as 'potential equivalence, one option clearly less risky or costly' was 87.8% for 82 strong recommendations. Situation classified as 'uncertain benefit, certain harm' was 4.9%.
There is a need to introduce and systematize an evidence-based grading system. Using judgement table to justify the strength of recommendations and applying the 5 paradigmatic situations mentioned above is also recommended in the near future.
为了使用户在决策时最大限度地减少偏见并帮助解释最适合的决策，对指南用户而言，采用标准化系统方法来对证据等级和推荐强度进行分级至关重要。本研究旨在确定并分类用于对 56 项韩国临床实践指南（CPG）中的推荐强度进行判断的决定因素，并探讨基于低质量证据的强推荐。
对报告了推荐强度和证据水平的 34 项 CPG 中 GRADE 方法使用的决定因素进行了回顾。
5 项 CPG（14.7%）考虑了证据质量、获益和危害、患者价值观和偏好以及成本。24 项 CPG（70.6%）考虑了效应幅度和可行性作为其他决定因素。判断表未广泛提供使用，以将证据转化为推荐。11 项 CPG 中有 82 项（67.8%，范围 20.0%至 100.0%）使用相同判断方案的 121 项建议中的 82 项（67.8%，范围 20.0%至 100.0%）显示出基于低质量或极低质量证据的“强”推荐强度。在基于低质量或极低质量证据证明强推荐合理的 5 种典型情况下，将分类为“潜在等效，一种选择风险明显较小或成本更低”的情况占 87.8%，对于 82 项强推荐。将分类为“不确定获益，确定危害”的情况占 4.9%。
有必要引入和系统地建立一个基于证据的分级系统。建议在不久的将来使用判断表来证明推荐强度的合理性，并应用上述 5 种典型情况。
