Kyriakides Peter William, Schultz Blake Joseph, Egol Kenneth, Leucht Philipp
Georgetown University School of Medicine, Washington, DC, USA.
Department of Orthopedic Surgery, NYU Langone Health, New York, NY, USA.
Eur J Trauma Emerg Surg. 2022 Dec;48(6):4545-4552. doi: 10.1007/s00068-021-01684-2. Epub 2021 May 31.
The quality of evidence of the orthopedic literature has been often called into question. The fragility index (FI) has emerged as a means to evaluate the robustness of a significant result. Similarly, reverse fragility index (RFI) can be used for nonsignificant results to evaluate whether one can confidently conclude that there is no difference between groups. The analysis of FI and RFI in proximal humerus fracture (PHF) management is of particular interest, given ongoing controversy regarding optimal management and patient selection. The aim of this study was to report the FI, RFI and quality of the evidence in the proximal humerus fracture literature.
A systematic review was conducted based on the PRISMA (preferred reporting items for systematic reviews and meta-analyses) guidelines, which utilized EMBASE, MEDLINE and Cochrane Library databases. Inclusion criteria included randomized controlled clinical trials related to the management of proximal humerus fractures, published from 2000 to 2020 with dichotomous outcome measures and 1:1 allocation. The FI and RFI were calculated by successively changing one nonevent to an event for each outcome measure until the result was made nonsignificant or significant, respectively. The fragility quotient, (FQ), calculated by dividing the FI by the total sample size, was calculated as well.
There were 25 studies that met our criteria with 48 outcome measures recorded. A total of 21 studies had at least one fragile result, with ten studies including a fragile result in the conclusion of the abstract. A total of 31 outcome measures had nonsignificant results and the median RFI was found to be 4, with 71% greater than number of patients lost to follow up. Seventeen outcomes had significant results, with a median FI of 1, with 65% greater than or equal to the number patients lost to follow up. A total of 18 of 25 studies (72%) included a power analysis. In particular, ten studies reported a statistical analysis of complication rates, 90% of which were fragile. The median FQ was found to be 0.037.
The literature on PHF management is frequently fragile. Outcome measures are often fragile, particularly with regards to comparing complication rates and reoperation rates in treatment arms. Comparing to the studies in other subspecialties PHF RCTs are relatively more fragile and underpowered. Standardized reporting of FI, FQ and RFI can help the reader to reliably draw conclusions based on the fragility of outcome measures.
骨科文献的证据质量常常受到质疑。脆弱性指数（FI）已成为评估显著结果稳健性的一种手段。同样，反向脆弱性指数（RFI）可用于非显著结果，以评估是否可以自信地得出组间无差异的结论。鉴于近端肱骨骨折（PHF）治疗的最佳管理和患者选择一直存在争议，对近端肱骨骨折治疗中FI和RFI的分析尤其令人关注。本研究的目的是报告近端肱骨骨折文献中的FI、RFI和证据质量。
根据PRISMA（系统评价和Meta分析的首选报告项目）指南进行系统评价，该指南利用了EMBASE、MEDLINE和Cochrane图书馆数据库。纳入标准包括2000年至2020年发表的与近端肱骨骨折治疗相关的随机对照临床试验，采用二分法结局指标和1:1分配。通过依次将每个结局指标的一个非事件改为事件来计算FI和RFI，直到结果分别变为非显著或显著。还计算了通过将FI除以总样本量得到的脆弱性商数（FQ）。
有25项研究符合我们的标准，记录了48个结局指标。共有21项研究至少有一个脆弱结果，其中10项研究在摘要结论中包含脆弱结果。共有31个结局指标结果不显著，发现RFI中位数为4，超过失访患者数量的71%。17个结局结果显著，但FI中位数为1，超过或等于失访患者数量的65%。25项研究中有18项（72%）进行了效能分析。特别是，10项研究报告了并发症发生率的统计分析，其中90%是脆弱的。发现FQ中位数为0.037。
PHF治疗的文献往往很脆弱。结局指标常常很脆弱，特别是在比较治疗组的并发症发生率和再次手术率方面。与其他亚专业的研究相比，PHF随机对照试验相对更脆弱且效能不足。FI、FQ和RFI的标准化报告可以帮助读者根据结局指标的脆弱性可靠地得出结论。
