目的:评估当新数据可用时,总体证据质量表明观察到的干预效果估计值发生了多大程度的变化。
方法:我们进行了Meta-流行病学研究。我们从Cochrane评论的随机试验的荟萃分析中获得了证据,该研究涉及与2016年1月至2021年5月期间更新的其他数据相同的医疗保健问题。
方法:我们从荟萃分析和相应等级(建议评估的分级,发展,和评估)评估第一个和最后一个更新的评论版本中主要结果的任何干预比较。我们考虑了报告的总体证据质量(确定性)(CoE)和具体的证据限制(没有,严重或非常严重的偏见风险,不精确,不一致,和/或间接性)。我们使用比值比(ROR)评估了原始证据和更新证据之间的合并效应估计的变化,绝对ROR(aROR),标准误差比(ROSE),影响方向,和统计显著性水平。
结果:无限制的高CoE特征为在150篇中包含原始Cochrane评论的19.3%(n=29)。额外数据的更新并没有系统地改变效应估计(平均ROR1.00;95CI0.99-1.02),与旧估计值(AROR中位数;IQR:1.01-1.15)偏离1.06倍,获得的精度(中位数ROSE0.87;IQR0.76-1.00),并且在93%(29例中的27例)的病例中保持相同的方向,具有相同的统计意义。具有局限性的较低CoE以121条原始评论为特征,并在30.0%(150个中的45个)中被评为中等CoE,低CoE为32.0%(150个中的48个),18.7%(150篇中的28篇)的CoE非常低。他们的更新具有更大的绝对偏差(中位数aROR1.12至1.33)和更大的精度增益(中位数RoSE0.78至0.86),这些类别的CoE之间没有明显和一致的差异。效应方向或统计学意义的变化在低质量证据中也更常见,同样,不同类别的程度相似(75.6%没有变化,64.6%,中等比例为75.0%,低,非常低的CoE)。随着限制的增加,效应估计偏差更大(aROR1.05,零,1.11与一个,1.25有两个,1.24有三个限制),方向或意义的变化变得更加频繁(93.2%稳定,没有限制,74.5%与一个,68.2%,两个,和61.5%,有三个限制)。
结论:没有方法学缺陷的高质量证据是值得信赖和稳定的,当更新新数据时,提供可靠的干预效果估计。中度和低质量的证据可能同样容易不稳定,并且不能表明可用的效果估计是否正确,夸张,或被低估。
OBJECTIVE: To assess to what extent the overall quality of evidence indicates changes to observe intervention effect estimates when new data become available.
METHODS: We conducted a meta-epidemiological study. We obtained evidence from meta-analyses of randomized trials of Cochrane reviews addressing the same health-care question that was updated with inclusion of additional data between January 2016 and May 2021. We extracted the reported effect estimates with 95% confidence intervals (CIs) from meta-analyses and corresponding GRADE (Grading of Recommendations Assessment, Development, and Evaluation) assessments of any intervention comparison for the primary outcome in the first and the last updated review version. We considered the reported overall quality (certainty) of evidence (CoE) and specific evidence limitations (no, serious or very serious for risk of bias, imprecision, inconsistency, and/or indirectness). We assessed the change in pooled effect estimates between the original and updated evidence using the ratio of odds ratio (ROR), absolute ratio of odds ratio (aROR), ratio of standard errors (RoSE), direction of effects, and level of statistical significance.
RESULTS: High CoE without limitations characterized 19.3% (n = 29) out of 150 included original Cochrane reviews. The update with additional data did not systematically change the effect estimates (mean ROR 1.00; 95% CI 0.99-1.02), which deviated 1.06-fold from the older estimates (median aROR; interquartile range [IQR]: 1.01-1.15), gained precision (median RoSE 0.87; IQR 0.76-1.00), and maintained the same direction with the same level of statistical significance in 93% (27 of 29) of cases. Lower CoE with limitations characterized 121 original reviews and graded as moderate CoE in 30.0% (45 of 150), low CoE in 32.0% (48 of 150), and very low CoE in 18.7% (28 of 150) reviews. Their update had larger absolute deviations (median aROR 1.12 to 1.33) and larger gains in precision (median RoSE 0.78-0.86) without clear and consistent differences between these categories of CoE. Changes in effect direction or statistical significance were also more common in the lower quality evidence, again with a similar extent across categories (without change in 75.6%, 64.6%, and 75.0% for moderate, low, very low CoE). As limitations increased, effect estimates deviated more (aROR 1.05 with zero, 1.11 with one, 1.25 with two, 1.24 with three limitations) and changes in direction or significance became more frequent (93.2% stable with no limitations, 74.5% with one, 68.2% with two, and 61.5% with three limitations).
CONCLUSIONS: High-quality evidence without methodological deficiencies is trustworthy and stable, providing reliable intervention effect estimates when updated with new data. Evidence of moderate and lower quality may be equally prone to being unstable and cannot indicate if available effect estimates are true, exaggerated, or underestimated.