GRADE guidelines 6. Rating the quality of evidence-imprecision
GRADE guidelines 6. Rating the quality of evidence-imprecision
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DOI：
10.1016/j.jclinepi.2011.01.012
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发表时间：
2011-12-01
影响因子：
7.2
通讯作者：
Schuenemann, Holger J.
中科院分区：
文献类型：
--
作者：
Guyatt, Gordon H.;Oxman, Andrew D.;Schuenemann, Holger J.
GRADE 建议检查 95% 置信区间 (CI) 为有关不精确性的决策提供最佳的主要方法。对于实践指南，如果 CI 的上限和下限代表事实，临床行动会有所不同，则需要降低证据质量（即对效果估计的置信度）。当效应很大时，会出现此规则的例外情况，并且单独考虑 CI 表明效应较强，但总样本量不大且事件数量较少。在这种情况下，人们应该考虑因不精确而降低评级。为了做出这一决定，我们可以计算一次足够有力的个体试验所需的患者数量（称为“最佳信息量”[OIS]）。对于连续变量，我们建议采用类似的过程，首先考虑 CI 的上限和下限，然后计算 OIS。系统评价需要采用稍微不同的方法。如果 95% CI 排除 1.0 的相对风险 (RR)，并且事件或患者总数超过 OIS 标准，则精度是足够的。如果 95% CI 包括明显的益处或危害（我们建议 RR 低于 0.75 或高于 1.25 作为粗略指导），即使满足 OIS 标准，因不精确而降低评级也可能是适当的。 (C) 2011 Elsevier Inc. 保留所有权利。
GRADE suggests that examination of 95% confidence intervals (CIs) provides the optimal primary approach to decisions regarding imprecision. For practice guidelines, rating down the quality of evidence (i.e., confidence in estimates of effect) is required if clinical action would differ if the upper versus the lower boundary of the CI represented the truth. An exception to this rule occurs when an effect is large, and consideration of CIs alone suggests a robust effect, but the total sample size is not large and the number of events is small. Under these circumstances, one should consider rating down for imprecision. To inform this decision, one can calculate the number of patients required for an adequately powered individual trial (termed the "optimal information size" [OIS]). For continuous variables, we suggest a similar process, initially considering the upper and lower limits of the CI, and subsequently calculating an OIS.Systematic reviews require a somewhat different approach. If the 95% CI excludes a relative risk (RR) of 1.0, and the total number of events or patients exceeds the OIS criterion, precision is adequate. If the 95% CI includes appreciable benefit or harm (we suggest an RR of under 0.75 or over 1.25 as a rough guide) rating down for imprecision may be appropriate even if OIS criteria are met. (C) 2011 Elsevier Inc. All rights reserved.