Tiao Justin, Song Junho, Hoang Ryan, Restrepo Mejia Mateo, Rajjoub Rami, Bhadouria Neharika, Koehne Niklas H, Locke Auston R, Yendluri Avanish, Huang Jonathan J, Corvi John J, Namiri Nikan K, Chaudhary Saad B, Iatridis James C, Hecht Andrew C
Leni and Peter W. May Department of Orthopaedics, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
Department of Orthopaedics, UCI School of Medicine, Irvine, CA, USA.
Global Spine J. 2025 Aug 9:21925682251368313. doi: 10.1177/21925682251368313.
Study DesignSystematic Review of Randomized Controlled Trials.ObjectivesTo assess the statistical fragility of randomized controlled trials (RCTs) comparing lumbar fusion and lumbar disc arthroplasty (LDA).MethodsFollowing PRISMA guidelines, PubMed, Embase, and Medline databases were searched for RCTs on lumbar fusion and LDA published between January 1, 2000 and August 1, 2023. Eligible studies reported dichotomous, categorical outcomes. A two-tailed Fisher's exact test was used to confirm reported -values (α = 0.05) for each outcome.Results18 RCTs met the inclusion criteria for analysis. Across the 18 studies, 146 dichotomous outcomes were identified. The median fragility index (FI) for all outcomes was 5 (IQR: 2.0-9.0), while the median fragility quotient (FQ) was 0.022 (IQR: 0.008-0.046). Subgroup analysis revealed that adjacent segment disease outcomes had a median FI of 3 (IQR: 2.75-3) and an FQ of 0.013 (IQR: 0.013-0.014). Industry-funded studies had a significantly higher FI (6 vs 4, = 0.036) and lower FQ (0.019 vs 0.040, = 0.023) compared to non-industry-funded studies.ConclusionsThis systematic review demonstrates that the statistically significant findings from RCTs comparing LF to LDA are susceptible to small changes in event outcomes. Of note, industry-funded studies were found to be significantly more statistically fragile compared to non-industry-funded studies.
研究设计
随机对照试验的系统评价。
目的
评估比较腰椎融合术和腰椎间盘置换术（LDA）的随机对照试验（RCT）的统计脆弱性。
方法
按照PRISMA指南，检索PubMed、Embase和Medline数据库，查找2000年1月1日至2023年8月1日发表的关于腰椎融合术和LDA的RCT。符合条件的研究报告了二分法、分类结局。采用双尾Fisher精确检验来确认每个结局报告的P值（α = 0.05）。
结果
18项RCT符合纳入分析标准。在这18项研究中，共确定了146个二分法结局。所有结局的中位脆弱性指数（FI）为5（四分位间距：2.0 - 9.0），而中位脆弱性商数（FQ）为0.022（四分位间距：0.008 - 0.046）。亚组分析显示，相邻节段疾病结局的中位FI为3（四分位间距：2.75 - 3），FQ为0.013（四分位间距：0.013 - 0.014）。与非行业资助的研究相比，行业资助的研究FI显著更高（6对4，P = 0.036），FQ更低（0.019对0.040，P = 0.023）。
结论
本系统评价表明，比较腰椎融合术与LDA的RCT中具有统计学意义的结果容易受到事件结局微小变化的影响。值得注意的是，发现行业资助的研究在统计学上比非行业资助的研究更脆弱。
