在膝关节前交叉韧带重建中，比较股四头肌肌腱自体移植与腘绳肌或髌腱-骨自体移植的随机对照试验在统计学上有多不可靠？
How statistically fragile are randomized controlled trials comparing quadriceps tendon autografts with hamstring or bone-patellar tendon-bone autografts in anterior cruciate ligament reconstruction?
作者信息
Dworsky-Fried Joshua, Bernardini Luca, Vivekanantha Prushoth, Gyemi Lauren, Meena Amit, Tapasvi Sachin, Fink Christian, de Sa Darren
机构信息
Michael DeGroote School of Medicine, McMaster University, Hamilton, Ontario, Canada.
School of Graduate Studies, Faculty of Health Sciences, McMaster University, Hamilton, Ontario, Canada.
出版信息
Knee Surg Sports Traumatol Arthrosc. 2024 Nov 4. doi: 10.1002/ksa.12535.
PURPOSE
To determine the statistical fragility of randomized controlled trials (RCTs) which compare the use of quadriceps tendon (QT) autografts to either hamstring tendon (HT) or bone-patellar tendon-bone (BPTB) autografts in anterior cruciate ligament reconstruction (ACLR).
METHODS
A search was conducted across PubMed, MEDLINE and EMBASE databases for RCTs comparing QT autografts to HT or BPTB autografts in ACLR from inception to 21 April 2024. Studies that reported ≥1 statistically significant continuous outcome, statistically significant dichotomous outcome and/or nonsignificant dichotomous outcome were included for analysis. The fragility index (FI), continuous fragility index (CFI) and reverse fragility index (RFI) were calculated for significant dichotomous outcomes, significant continuous outcomes and nonsignificant dichotomous outcomes, respectively.
RESULTS
A total of 11 RCTs comprising 716 patients were included. The mean sample size was 65.8 patients. The median FI among nine outcomes from four studies was 1.0 (interquartile range [IQR], 0.5; 95% confidence interval [CI], 0.6-1.4; range 0.5-1.5). The number of patients lost to follow-up at the final follow-up period was more than the study-specific FI in three (75%) studies. The median CFI among 30 outcomes from six studies was 4.9 (IQR, 10.1, 95% CI, 3.9-8.2; range 0-18.2). The number of patients lost to follow-up at the final follow-up period was more than the study-specific CFI in four (66.7%) studies. The median RFI among 10 outcomes from five studies was 5.0 (IQR, 3.5; 95% CI, 3.4-6.6; range 1.0-9.0). The number of patients lost to follow-up at the final follow-up period was more than the study-specific RFI in four (80%) studies.
CONCLUSION
This systematic review revealed that regardless of the metric used, RCTs comparing QT autografts to HT or BPTB autograft options in ACLR are statistically fragile. While the indices of statistical fragility evaluated in this study are important metrics of robustness to consider, their application in research and clinical practice needs to be further elucidated.
LEVEL OF EVIDENCE
Level I.
目的
确定在膝关节前交叉韧带重建术（ACLR）中，比较使用股四头肌肌腱（QT）自体移植物与腘绳肌肌腱（HT）或髌腱-骨-髌腱（BPTB）自体移植物的随机对照试验（RCT）的统计脆弱性。
方法
在PubMed、MEDLINE和EMBASE数据库中进行检索，查找从数据库建立至2024年4月21日期间，在ACLR中比较QT自体移植物与HT或BPTB自体移植物的RCT。纳入报告了≥1项具有统计学意义的连续结局、具有统计学意义的二分结局和/或无统计学意义的二分结局的研究进行分析。分别针对具有统计学意义的二分结局、具有统计学意义的连续结局和无统计学意义的二分结局计算脆弱性指数（FI）、连续脆弱性指数（CFI）和反向脆弱性指数（RFI）。
结果
共纳入11项RCT，涉及716例患者。平均样本量为65.8例患者。四项研究的九个结局的中位FI为1.0（四分位间距[IQR]，0.5；95%置信区间[CI]，0.6 - 1.4；范围0.5 - 1.5）。在三项（75%）研究中，最终随访期失访患者数量超过了研究特定的FI。六项研究的30个结局的中位CFI为4.9（IQR，10.1，95% CI，3.9 - 8.2；范围0 - 18.2）。在四项（66.7%）研究中，最终随访期失访患者数量超过了研究特定的CFI。五项研究的10个结局的中位RFI为5.0（IQR，3.5；95% CI，3.4 - 6.6；范围1.0 - 9.0）。在四项（80%）研究中，最终随访期失访患者数量超过了研究特定的RFI。
结论
本系统评价显示，无论使用何种指标，在ACLR中比较QT自体移植物与HT或BPTB自体移植物选择的RCT在统计学上是脆弱的。虽然本研究中评估的统计脆弱性指标是需要考虑的稳健性的重要指标，但其在研究和临床实践中的应用需要进一步阐明。
证据水平
I级。
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