Harvard Medical School, Boston, Massachusetts, USA.
Georgetown University School of Medicine, Washington, DC, USA.
Am J Sports Med. 2021 Oct;49(12):3437-3442. doi: 10.1177/0363546521989976. Epub 2021 Mar 1.
The practice of evidence-based medicine relies on objective data to guide clinical decision-making with specific statistical thresholds conveying study significance.
To determine the utility of applying the fragility index (FI) and the fragility quotient (FQ) analysis to randomized controlled trials (RCTs) evaluating the utilization of platelet-rich plasma (PRP) in rotator cuff repairs (RCRs).
Systematic review and meta-analysis.
RCTs pertaining to the utilization of PRP in surgical RCRs published in 13 peer-reviewed journals from 2000 to 2020 were evaluated. The FI was determined by manipulating each reported outcome event until a reversal of significance was appreciated. The associated FQ was determined by dividing the FI by the sample size.
Of the 9746 studies screened, 19 RCTs were ultimately included for analysis. The overall FI incorporating all 19 RCTs was only 4, suggesting that the reversal of only 4 events is required to change study significance. The associated FQ was determined as 0.092. Of the 43 outcome events reporting lost to follow-up data, 13 (30.2%) represented lost to follow-up >4.
Our analysis suggests that RCTs evaluating PRP for surgical RCRs may lack statistical stability with only a few outcome events required to alter trial significance. Therefore, we recommend the reporting of an FI and an FQ in conjunction with value analysis to carefully interpret the integrity of statistical stability in future comparative trials.
Clinical decisions are often informed by statistically significant results. Thus, a true understanding of the robustness of the statistical findings informing clinical decision-making is of critical importance.
循证医学的实践依赖于客观数据，通过特定的统计学阈值来指导临床决策，以传达研究的意义。
确定应用脆弱指数（FI）和脆弱性分数（FQ）分析评估富含血小板的血浆（PRP）在肩袖修复（RCR）中应用的随机对照试验（RCT）的效用。
系统评价和荟萃分析。
评估了 2000 年至 2020 年在 13 种同行评议期刊上发表的关于 PRP 在手术 RCR 中应用的 RCT。通过操纵每个报告的结局事件来确定 FI，直到观察到意义的逆转。相关的 FQ 通过将 FI 除以样本量来确定。
在筛选的 9746 项研究中，最终有 19 项 RCT 被纳入分析。总体 FI 纳入了所有 19 项 RCT，仅为 4，表明仅需改变 4 项事件即可改变研究的意义。相关的 FQ 被确定为 0.092。在报告失访数据的 43 项结局事件中，有 13 项（30.2%）表示失访>4。
我们的分析表明，评估 PRP 用于手术 RCR 的 RCT 可能缺乏统计学稳定性，只需少数结局事件即可改变试验的意义。因此，我们建议在未来的比较试验中报告 FI 和 FQ 以及 值分析，以仔细解释统计稳定性的完整性。
临床决策通常是基于具有统计学意义的结果。因此，真正了解告知临床决策的统计发现的稳健性至关重要。
