Background:Based in part on the results of randomized controlled trials (RCTs) that suggest a beneficial effect over alternative treatment options, the use of platelet-rich plasma (PRP) for the management of knee osteoarthritis (OA) is widespread and increasing. However, the extent to which these studies are vulnerable to slight variations in the outcomes of patients remains unknown.Purpose:To evaluate the statistical fragility of conclusions from RCTs that reported outcomes of patients with knee OA who were treated with PRP versus alternative nonoperative management strategies.Study Design:Systematic review and meta-analysis; Level of evidence, 2.Methods:All RCTs comparing PRP with alternative nonoperative treatment options for knee OA were identified. The fragility index (FI) and reverse FI were applied to assess the robustness of conclusions regarding the efficacy of PRP for knee OA. Meta-analyses were performed to determine the minimum number of patients from ≥1 trials included in the meta-analysis for which a modification on the event status would change the statistical significance of the pooled treatment effect.Results:In total, this analysis included outcomes from 1993 patients with a mean ± SD age of 58.0 ± 3.8 years. The mean number of events required to reverse significance of individual RCTs (FI) was 4.57 ± 5.85. Based on random-effects meta-analyses, PRP demonstrated a significantly higher rate of successful outcomes when compared with hyaluronic acid ( P = .002; odds ratio [OR], 2.19; 95% CI, 1.33-3.62), as well as higher rates of patient-reported symptom relief ( P = .019; OR, 1.55; 95% CI, 1.07-2.24), not requiring a reintervention after the initial injection treatment ( P = .002; OR, 2.17; 95% CI, 1.33-3.53), and achieving the minimal clinically important difference (MCID) for pain improvement ( P = .007; OR, 6.19; 95% CI, 1.63-23.42) when compared with all alternative nonoperative treatments. Overall, the mean number of events per meta-analysis required to change the statistical significance of the pooled treatment effect was 8.67 ± 4.50.Conclusion:Conclusions drawn from individual RCTs evaluating PRP for knee OA demonstrated slight robustness. On meta-analysis, PRP demonstrated a significant advantage over hyaluronic acid as well as improved symptom relief, lower rates of reintervention, and more frequent achievement of the MCID for pain improvement when compared with alternative nonoperative treatment options. Statistically significant pooled treatment effects evaluating PRP for knee OA are more robust than approximately half of all comparable meta-analyses in medicine and health care. Future RCTs and meta-analyses should consider reporting FIs and fragility quotients to facilitate interpretation of results in their proper context.

中文翻译：

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富含血小板血浆与替代注射治疗膝骨关节炎：随机对照试验的系统回顾和基于统计脆性指数的荟萃分析

背景：部分基于随机对照试验 (RCT) 的结果表明，富血小板血浆 (PRP) 治疗膝骨关节炎 (OA) 的应用比其他治疗方案更有益，而且这种情况正在不断增加。然而，这些研究在多大程度上容易受到患者结果轻微变化的影响仍然未知。 目的：评估随机对照试验结论的统计脆弱性，这些随机对照试验报告了接受 PRP 治疗的膝骨关节炎患者与其他非手术治疗策略的结果.研究设计：系统评价和荟萃分析；证据级别，2。方法：确定了所有比较 PRP 与膝关节骨关节炎非手术治疗方案的随机对照试验。应用脆性指数 (FI) 和反向 FI 来评估 PRP 对膝关节 OA 疗效结论的稳健性。进行荟萃分析以确定荟萃分析中包含的 ≥1 项试验的最少患者数量，其中事件状态的修改将改变汇总治疗效果的统计显着性。结果：总的来说，该分析包括结果来自 1993 名患者，平均±标准差年龄为 58.0±3.8 岁。扭转单个随机对照试验 (FI) 重要性所需的平均事件数为 4.57 ± 5.85。根据随机效应荟萃分析，与透明质酸相比，PRP 的成功率显着更高（P = .002；比值比 [OR]，2.19；95% CI，1.33-3.62），并且更高患者报告的症状缓解率（P = .019；OR，1.55；95% CI，1.07-2.24），初始注射治疗后不需要重新干预（P = .002；OR，2.17；95% CI，1.33） -3.53），与所有替代非手术治疗相比，疼痛改善达到最小临床重要差异（MCID）（P = 0.007；OR，6.19；95% CI，1.63-23.42）。总体而言，改变汇总治疗效果的统计显着性所需的每次荟萃分析的平均事件数为 8.67 ± 4.50。结论：从评估 PRP 治疗膝关节 OA 的各个 RCT 中得出的结论显示出轻微的稳健性。荟萃分析表明，与其他非手术治疗方案相比，PRP 表现出优于透明质酸的显着优势，并且可以改善症状缓解、降低再干预率、更频繁地实现疼痛改善的 MCID。评估 PRP 对膝关节 OA 的统计显着性汇总治疗效果比医学和保健领域所有可比荟萃分析中约一半的结果更为稳健。未来的 RCT 和荟萃分析应考虑报告 FI 和脆弱性商数，以便于在适当的背景下解释结果。