基于高水平证据比较股髋臼撞击综合征干预措施的研究中统计显著结果的连续脆弱性指数

Juan Bernardo Villarreal-Espinosa, Zeeshan A. Khan, Kyleen Jan, Rodrigo Saad Berreta, Michael J. Murray, Felicitas Allende, Shane J. Nho, Jorge Chahla
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The continuous fragility index (CFI) allows for frailty interpretation of any given study's continuous outcome results.Purpose:To calculate the CFI of high-level quality studies reporting significant continuous outcomes on comparison of treatment modalities for management of femoroacetabular impingement syndrome.Study Design:Meta-analysis; Level of evidence, 2.Methods:Three databases (PubMed, Embase, Cochrane) were queried from inception to February 2024 utilizing Boolean operators to combine variations of the following search terms: “femoroacetabular impingement, randomized controlled trials or prospective cohort.” Studies were included if level of evidence 1 or 2, and a statistically significant outcome was reported for any continuous outcome. CFI calculation was performed for all significant outcomes to obtain a study-specific mean CFI and also for the primary outcome of each study. Mean CFI was also calculated for outcomes reported to be significant in >3 studies. 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引用次数: 0

摘要

背景:具有高水平证据的研究的批判性分析依赖于报告的P值所设定的显著性。然而,这种策略引导读者对数据进行分类解释;因此,需要一种更全面的数据分析方法。连续脆弱性指数(CFI)允许对任何给定研究的连续结果进行脆弱性解释。目的:计算高质量研究的CFI,这些研究报告了股骨髋臼撞击综合征治疗方式比较的显著连续结果。研究设计:荟萃分析;证据等级2。方法:三个数据库(PubMed, Embase, Cochrane)从成立到2024年2月进行查询,使用布尔运算符组合以下搜索词的变化:“股髋臼撞击,随机对照试验或前瞻性队列”。如果证据水平为1或2,并且对于任何连续结果都报告了具有统计学意义的结果,则纳入研究。对所有重要结果进行CFI计算,以获得研究特定的平均CFI以及每项研究的主要结果。对于在3项研究中报告的显著结果,也计算了平均CFI。此外,多变量线性回归用于评估与实现更高CFI相关的变量。结果:13项研究共1316例患者纳入分析:11项证据水平为1,2项证据水平为2。共提取了48个具有显著性的结局,其中8个为主要结局。研究特异性平均(SD) CFI为8(9.3),而主要结局平均CFI为12.5(12)。在13项研究中,有4项研究的随访丢失髋关节数量大于研究CFI。获得了3项研究中报告的5个结果的结果特异性平均CFI。多变量线性回归显示,样本量越大、期刊影响因子越大,总体CFI值越高(P <;. 05)。结论:扭转连续结局(即CFI)的显著性所需的患者结局事件的平均(SD)数为8.0(9.3)。近三分之一的研究的CFI小于报告的随访损失,反映出需要更好的患者依从性来获得更不脆弱的统计结果。较大的样本量和较大的期刊影响因子都预示着较高的CFI。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
The Continuous Fragility Index of Statistically Significant Findings in Studies Based on High Levels of Evidence Comparing Interventions for Femoroacetabular Impingement Syndrome
Background:Critical analysis of studies with high level of evidence has relied on the significance set by the reported P values. However, this strategy steers readers toward categorical interpretation of the data; therefore, a more comprehensive approach of data analysis is warranted. The continuous fragility index (CFI) allows for frailty interpretation of any given study's continuous outcome results.Purpose:To calculate the CFI of high-level quality studies reporting significant continuous outcomes on comparison of treatment modalities for management of femoroacetabular impingement syndrome.Study Design:Meta-analysis; Level of evidence, 2.Methods:Three databases (PubMed, Embase, Cochrane) were queried from inception to February 2024 utilizing Boolean operators to combine variations of the following search terms: “femoroacetabular impingement, randomized controlled trials or prospective cohort.” Studies were included if level of evidence 1 or 2, and a statistically significant outcome was reported for any continuous outcome. CFI calculation was performed for all significant outcomes to obtain a study-specific mean CFI and also for the primary outcome of each study. Mean CFI was also calculated for outcomes reported to be significant in >3 studies. Additionally, multivariable linear regression was utilized for assessment of variables associated with achievement of a higher CFI.Results:Thirteen studies totaling 1316 patients were included for analysis: 11 level of evidence 1 and 2 level of evidence 2 studies. A total of 48 outcomes reaching significance were extracted, with 8 representing primary outcomes. Study-specific mean (SD) CFI was 8 (9.3), whereas primary outcome mean CFI was 12.5 (12). In 4 of the 13 studies, the number of hips lost to follow-up was greater than the study CFI. Outcome-specific mean CFI was obtained for 5 outcomes reported in >3 studies. Multivariable linear regression revealed that larger sample size and greater journal impact factor had a significant positive association with a higher overall CFI value ( P < .05).Conclusion:The mean (SD) number of patient outcome events needed to reverse the significance of a continuous outcome (ie, CFI) was 8.0 (9.3). Nearly one-third of studies had a CFI less than the reported loss to follow-up, reflecting the need for better patient compliance to attain less fragile statistical results. Larger sample size and greater journal impact factor were both predictive of a higher CFI.
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