METHODS: We conducted a systematic review of randomized controlled trials (RCTs) comparing implant revision rates between DA and other approaches in THA, defined as all those different from DA. Our primary outcome was the RFI, which gauges the number of events needed for a nonsignificant result to become significant, in the revision rate between DA and other approaches. We also calculated the reverse fragility quotient by dividing the RFI by each study\'s sample size. Median values and interquartile ranges (IQRs) were displayed.
RESULTS: A total of 10 RCTs with a total of 971 patients were included. The median RFI was 5 (IQR, 4 to 5), indicating the study\'s results would be statistically significant if the outcomes of 5 patients in 1 treatment arm were reversed. The median reverse fragility quotient was 0.049 (IQR, 0.04 to 0.057), indicating that a change of outcome in 4.9% of patients would render the revision rate significant. The median number of patients lost to follow-up was 4 (IQR, 0 to 7). Of the 10 RCTs, 6 had more patients lost to follow-up than their respective RFI values.
CONCLUSIONS: Notable fragility was evidenced in most studies comparing DA to other approaches for THA. Surgeons should not solely rely on the P value to determine clinical significance and instead use multiple metrics.
METHODS: II.
方法:我们对比较DA和其他方法在THA中的植入物翻修率的随机对照试验(RCT)进行了系统评价,定义为所有与DA不同的人。我们的主要结果是RFI,衡量非重要结果变得重要所需的事件数量,DA和其他方法之间的修订率。我们还通过将RFI除以每个研究的样本量来计算反向脆弱性商(RFQ)。显示了中值和四分位间距(IQR)。
结果:共纳入10个RCTs,共971例患者。RFI中位数为5(IQR,4至5),这表明,如果一个治疗组中的5名患者的结局逆转,研究结果将具有统计学意义。询价中位数为0.049(IQR,0.04至0.057),这表明4.9%患者的结局变化将使翻修率显着。失去随访的患者中位数为4(IQR,0至7)。在十个RCT中,6例失访患者多于各自的RFI值.
结论:在将DA与其他THA方法进行比较的大多数研究中证明了显著的脆弱性。外科医生不应仅仅依靠P值来确定临床意义,而是使用多个指标。