Dicing with chance, life and death in systematic reviews and meta-analyses: DICE 3, a simulation study

Dicing with chance, life and death in systematic reviews and meta-analyses: DICE 3, a simulation study
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DOI:
10.1177/0141076813514574
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发表时间:
2014-03-01
影响因子:
17.3
通讯作者:
Halsey, Jim
Halsey, Jim
中科院分区:
医学2区
文献类型:
--
作者:
Clarke, Mike;Halsey, Jim

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目标:展示机会对荟萃分析的影响,以及一项有利的试验提示进行荟萃分析的潜在危险。设计:使用癌症试验对照组的数据,总共模拟了 100,000 项试验,并将其合并为 10,000 项荟萃分析。每个参与者记录被随机编码以模拟分配到“治疗”或“对照”。设置:模拟研究。参与者:来自癌症试验对照组的 578 名患者的去识别记录,其中 147 人死亡。主要结果指标:任何原因死亡的时间。结果:在 100,000 项试验中,4897 项 (4.9%) 在 2p < 0.05 时具有统计学显着性,并且10,000 项荟萃分析中有 123 项 (1.2%) 在 2p < 0.01 时显着。最极端的结果是“治疗”组的年死亡几率降低了 20%(99% CI:0.70-0.91;2p = 0.00002)。如果荟萃分析至少包含一项具有统计显着性结果(2p < 0.05)的试验,则荟萃分析显着性(2p < 0.01)的可能性会显着增加。例如,在 473 项荟萃分析中,一批 10 项试验中的第一项试验具有统计显着性(2p < 0.05),其中 18 项 (3.8%) 支持 2p < 0.01 时的治疗。结论:无论荟萃分析进行得如何,机会都会影响荟萃分析的结果。研究人员在计划荟萃分析和报告结果时不应忽视这一点。阅读他们报告的人们也应该保持警惕。当一项或多项纳入研究的结果影响荟萃分析的决定时,谨慎尤为重要。
Objectives: To show the effects of chance on meta-analyses, and the potential dangers of being prompted to do a meta-analysis by one favourable trial.Design: In total, 100,000 trials were simulated and combined into 10,000 meta-analyses, using data from the control group of a cancer trial. Each participant record was randomly coded to simulate allocation to 'treatment' or 'control'.Setting: Simulated study.Participants: De-identified records for 578 patients from the control group of a cancer trial, of whom 147 had died.Main outcome measure: Time to death from any cause.Results: Of the 100,000 trials, 4897 (4.9%) were statistically significant at 2p < 0.05 and 123 (1.2%) of the 10,000 meta-analyses were significant at 2p < 0.01. The most extreme result was a 20% reduction (99% CI: 0.70-0.91; 2p = 0.00002) in the annual odds of dying in the 'treatment' group. If a meta-analysis contained at least one trial with a statistically significant result (at 2p < 0.05), the likelihood of the meta-analysis being significant (at 2p < 0.01) increased strikingly. For example, among the 473 meta-analyses in which the first trial in a batch of 10 was statistically significant (at 2p < 0.05), 18 (3.8%) favoured treatment at 2p < 0.01.Conclusions: Chance can influence the results of meta-analyses regardless of how well they are conducted. Researchers should not ignore this when they plan a meta-analysis and when they report their results. People reading their reports should also be wary. Caution is particularly important when the results of one or more included studies influenced the decision to do the meta-analysis.