Lameire Darius L, Abdel Khalik Hassaan, Sritharan Praveen, Jain Varun, Cheng Alan, Khan Moin, Chahal Jaskarndip
Division of Orthopaedic Surgery, University of Toronto, Toronto, Ontario, Canada.
Division of Orthopaedic Surgery, McMaster University, Hamilton, Ontario, Canada.
Arthroscopy. 2025 Jul;41(7):2668-2679.e2. doi: 10.1016/j.arthro.2024.09.054. Epub 2024 Oct 10.
To assess the statistical fragility of randomized controlled trials that assess the use of platelet-rich plasma (PRP) for the treatment of knee osteoarthritis (OA) and report a continuous primary outcome measure with statistical significance.
A systematic electronic search of MEDLINE, EMBASE, and Cochrane database was performed on August 10, 2024. All randomized controlled trials addressing the use of PRP for the treatment of symptomatic knee osteoarthritis were included that reported statistically significant primary continuous outcomes. The continuous fragility index (CFI) and continuous fragility quotient (CFQ) were calculated using approximative method, as previously described using the mean and standard deviation of the outcomes of interest.
There were a total of 34 eligible outcomes available for analysis. The overall median CFI across all included studies was 5.7 (IQR: 4.8-9.9). The overall median CFQ across all included studies was 0.131 (IQR: 0.055-0.243). Loss to follow-up was greater than the CFI in only 3 of 34 eligible outcomes (8.8%). The most analyzed outcome was the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score (n = 9) with a median CFI of 6.6 and median CFQ of 0.250. The outcome with the highest median CFI was the WOMAC stiffness subscale at 93. Spearman correlation analysis demonstrated a nonstatistically significant trend toward decreasing CFI (-0.497) and a statistically significant decrease in CFQ (-0.681; p = 0.03) with increasing grades of osteoarthritis.
There was an overall median CFI of 5.7 and CFQ of 0.131 for RCTs that report statistically significant continuous outcomes for the use of PRP in treating symptomatic knee OA. Although there are no current guidelines regarding statistical fragility of continuous outcomes, these results can be considered fragile given statistical significance may be reversed with only a few changes in patient outcomes.
II; systematic review of Level I and II studies.
评估评估富血小板血浆（PRP）用于治疗膝关节骨关节炎（OA）的随机对照试验的统计脆弱性，并报告具有统计学意义的连续性主要结局指标。
于2024年8月10日对MEDLINE、EMBASE和Cochrane数据库进行了系统的电子检索。纳入所有探讨PRP用于治疗有症状膝关节骨关节炎且报告了具有统计学意义的主要连续性结局的随机对照试验。使用近似方法计算连续性脆弱性指数（CFI）和连续性脆弱性商数（CFQ），如之前使用感兴趣结局的均值和标准差所描述的那样。
共有34个合格结局可供分析。所有纳入研究的总体CFI中位数为5.7（四分位间距：4.8 - 9.9）。所有纳入研究的总体CFQ中位数为0.131（四分位间距：0.055 - 0.243）。在34个合格结局中，仅有3个（8.8%）的失访人数大于CFI。分析最多的结局是西安大略和麦克马斯特大学骨关节炎指数（WOMAC）总分（n = 9），CFI中位数为6.6，CFQ中位数为0.250。CFI中位数最高的结局是WOMAC僵硬子量表，为93。Spearman相关性分析显示，随着骨关节炎等级增加，CFI呈非统计学显著下降趋势（-0.497），CFQ有统计学显著下降（-0.681；p = 0.03）。
对于报告PRP用于治疗有症状膝关节OA具有统计学意义的连续性结局的随机对照试验，总体CFI中位数为5.7，CFQ中位数为0.131。尽管目前尚无关于连续性结局统计脆弱性的指南，但鉴于仅患者结局的一些变化就可能使统计学意义逆转，这些结果可被认为是脆弱的。
II；对I级和II级研究的系统评价。
Zotero 插件