PDF(Pubmed)
Abstract：
OBJECTIVE: This study employs both the fragility index (FI) and fragility quotient (FQ) to assess the level of robustness in the cervical disc arthroplasty (CDA) literature. We hypothesize that dichotomous outcomes involving CDA would exhibit statistical vulnerability.
METHODS: A PubMed search was conducted to evaluate dichotomous data for randomized controlled trials (RCTs) in CDA literature from 2000 to 2023. The FI of each outcome was calculated through the reversal of a single outcome event until significance was reversed. The FQ was calculated by dividing each fragility index by the study sample size. The interquartile range (IQR) was also calculated for the FI and FQ.
RESULTS: Of the 1561 articles screened, 111 met the search criteria, with 35 RCTs evaluating CDA included for analysis. Six hundred and ninety-three outcome events with 130 significant (P < 0.05) outcomes and 563 nonsignificant (P ≥ 0.05) outcomes were identified. The overall FI and FQ for all 693 outcomes were 5 (IQR 3-7) and 0.019 (IQR 0.011-0.043). Fragility analysis of statistically significant outcomes and nonsignificant outcomes both revealed an FI of 5. All of the studies reported loss to follow-up (LTF) data where 65.7% (23) did not report or reported an LTF greater or equal to 5.
CONCLUSIONS: The literature regarding CDA RCTs lacks statistical robustness and may misrepresent the conclusions with the sole use of the P value. By implementing the FI and FQ along with the P value, we believe the interpretation and contextualization of the clinical data surrounding CDA will be better understood.
METHODS: A PubMed search was conducted to evaluate dichotomous data for randomized controlled trials (RCTs) in CDA literature from 2000 to 2023. The FI of each outcome was calculated through the reversal of a single outcome event until significance was reversed. The FQ was calculated by dividing each fragility index by the study sample size. The interquartile range (IQR) was also calculated for the FI and FQ.
RESULTS: Of the 1561 articles screened, 111 met the search criteria, with 35 RCTs evaluating CDA included for analysis. Six hundred and ninety-three outcome events with 130 significant (P < 0.05) outcomes and 563 nonsignificant (P ≥ 0.05) outcomes were identified. The overall FI and FQ for all 693 outcomes were 5 (IQR 3-7) and 0.019 (IQR 0.011-0.043). Fragility analysis of statistically significant outcomes and nonsignificant outcomes both revealed an FI of 5. All of the studies reported loss to follow-up (LTF) data where 65.7% (23) did not report or reported an LTF greater or equal to 5.
CONCLUSIONS: The literature regarding CDA RCTs lacks statistical robustness and may misrepresent the conclusions with the sole use of the P value. By implementing the FI and FQ along with the P value, we believe the interpretation and contextualization of the clinical data surrounding CDA will be better understood.
摘要：
目的：本研究采用脆性指数（FI）和脆性商（FQ）来评估颈椎间盘置换术（CDA）文献中的稳健性水平。我们假设涉及CDA的二分结果将表现出统计脆弱性。
方法：进行了PubMed搜索，以评估2000年至2023年CDA文献中随机对照试验（RCT）的二分数据。通过单个结果事件的逆转计算每个结果的FI,直到显著性被逆转。通过将每个脆性指数除以研究样本量来计算FQ。还计算了FI和FQ的四分位间距(IQR)。
结果：在筛选的1561篇文章中，111符合搜索标准，纳入35个评估CDA的RCTs进行分析。共发现63起结局事件，其中130起显著(P<0.05)结局和563起不显著(P≥0.05)结局。所有693个结局的总体FI和FQ分别为5（IQR3-7）和0.019（IQR0.011-0.043）。对具有统计学意义的结果和无统计学意义的结果的脆弱性分析均显示FI为5。所有研究都报告了随访丢失（LTF）数据，其中65.7％（23）没有报告或报告LTF大于或等于5。
结论：关于CDA随机对照试验的文献缺乏统计学上的稳健性，可能仅使用P值就错误地陈述了结论。通过实现FI和FQ以及P值，我们相信将更好地理解CDA相关临床数据的解释和情境化.
方法：进行了PubMed搜索，以评估2000年至2023年CDA文献中随机对照试验（RCT）的二分数据。通过单个结果事件的逆转计算每个结果的FI,直到显著性被逆转。通过将每个脆性指数除以研究样本量来计算FQ。还计算了FI和FQ的四分位间距(IQR)。
结果：在筛选的1561篇文章中，111符合搜索标准，纳入35个评估CDA的RCTs进行分析。共发现63起结局事件，其中130起显著(P<0.05)结局和563起不显著(P≥0.05)结局。所有693个结局的总体FI和FQ分别为5（IQR3-7）和0.019（IQR0.011-0.043）。对具有统计学意义的结果和无统计学意义的结果的脆弱性分析均显示FI为5。所有研究都报告了随访丢失（LTF）数据，其中65.7％（23）没有报告或报告LTF大于或等于5。
结论：关于CDA随机对照试验的文献缺乏统计学上的稳健性，可能仅使用P值就错误地陈述了结论。通过实现FI和FQ以及P值，我们相信将更好地理解CDA相关临床数据的解释和情境化.
