IF 2.9 2区 医学 Q1 ORTHOPEDICS Journal of Shoulder and Elbow Surgery Pub Date : 2025-02-13 DOI:10.1016/j.jse.2024.12.047
Auston R Locke, Niklas H Koehne, Matthew D Ramey, Jackson L Oxner, Avanish Yendluri, Michael N Megafu, John J Corvi, Nikan K Namiri, John D Kelly, Robert L Parisien
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引用次数: 0

摘要

简介:随机对照试验(RCT)对肩关节粘连性囊炎(AC)的一系列治疗方法进行了评估,但对于最有益于临床的治疗方案,结果却相互矛盾。本研究使用脆性指数(FI)、反向脆性指数(rFI)和脆性商数(FQ)来评估评估肩关节粘连性囊炎治疗效果的随机对照试验报告结果的统计脆性:方法: 我们在 PubMed 和 Embase 中系统检索了 2004 年 1 月 1 日至 2024 年 5 月 1 日期间评估肩关节 AC 治疗效果的 RCT。我们对FI和rFI进行了量化,它们分别代表了改变显著性和非显著性结果统计显著性所需的结果事件逆转量。我们对与临床疗效、患者满意度、疼痛和不良事件相关的结果进行了子分析。FQ由FI除以研究样本量得出:在筛选出的 468 篇文章中,共分析了 38 项 RCT,得出了 67 项相关结果。在这 67 项结果中,FI 的中位数为 3(IQR [四分位间范围] 2-6),FQ 的中位数为 0.075(IQR 0.034-0.100)。17项具有统计学意义的结果的FI中位数为2(IQR 1-4),FQ中位数为0.050(IQR 0.018-0.091)。其余 50 项结果无统计学意义,FI 中位数为 4(IQR 2-6),FQ 中位数为 0.079(IQR 0.037-0.102)。值得注意的是,在所有结果中,有 40.3% 的随访损失大于或等于结果各自的 FI 或 rFI。最脆弱的结果与患者满意度(FI 2)和不良事件(FI 2.5)有关:结论:研究性试验中有关粘连性关节囊炎治疗的结果在统计学上比较脆弱,其中最明显的是显著结果和与患者满意度有关的结果。围绕粘连性关节囊炎治疗方法的研究性试验结果仍无定论;因此,将 P 值与 FI 和 FQ 指标相结合可能会改善对粘连性关节囊炎治疗方法临床结果的解释。未来的临床 RCT 可通过提高随访率和增加患者样本量来减少结果的脆弱性。
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The Statistical Fragility of Treatments for Adhesive Capsulitis: A Systematic Review of Randomized Controlled Trials.

Introduction: Randomized controlled trials (RCTs) have assessed a range of treatments for shoulder adhesive capsulitis (AC), with conflicting results over the most clinically beneficial options. This study used the fragility index (FI), reverse fragility index (rFI), and fragility quotient (FQ) to evaluate statistical fragility of the outcomes reported in RCTs assessing the efficacy of shoulder AC treatments.

Methods: PubMed and Embase were systematically searched for RCTs from January 1, 2004, to May 1, 2024 that assessed shoulder AC treatments. We quantified FI and rFI, which represent the amount of outcome event reversals necessary to change statistical significance for significant and non-significant findings, respectively. Subanalyses were performed for outcomes relating to clinical efficacy, patient satisfaction, pain, and adverse events. The FQ was determined by dividing the FI by the study sample size.

Results: Of 468 articles screened, there were a total of 38 RCTs analyzed that yielded 67 outcomes of interest. Across the 67 outcomes, the median FI was 3 (IQR [Interquartile Range] 2-6) and the median FQ was 0.075 (IQR 0.034-0.100). The 17 statistically significant outcomes had a median FI of 2 (IQR 1-4) and a median FQ of 0.050 (IQR 0.018-0.091). The remaining 50 outcomes were statistically nonsignificant, with a median FI of 4 (IQR 2-6) and a median FQ of 0.079 (IQR 0.037-0.102). Notably, in 40.3% of all outcomes, loss-to-follow-up was greater or equal to the outcome's respective FI or rFI. The most fragile outcomes were related to patient satisfaction (FI 2) and adverse events (FI 2.5).

Conclusion: The outcomes of interest regarding treatments for adhesive capsulitis from RCTs are statistically fragile, most notably significant outcomes and those pertaining to patient satisfaction. RCT results surrounding adhesive capsulitis treatments remain inconclusive; thus, combining p-values with both FI and FQ metrics may improve the interpretation of clinical findings regarding treatment modalities for adhesive capsulitis. Future clinical RCTs may reduce outcome fragility by improving follow-up rates and increasing patient sample sizes.

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来源期刊
CiteScore
6.50
自引率
23.30%
发文量
604
审稿时长
11.2 weeks
期刊介绍: The official publication for eight leading specialty organizations, this authoritative journal is the only publication to focus exclusively on medical, surgical, and physical techniques for treating injury/disease of the upper extremity, including the shoulder girdle, arm, and elbow. Clinically oriented and peer-reviewed, the Journal provides an international forum for the exchange of information on new techniques, instruments, and materials. Journal of Shoulder and Elbow Surgery features vivid photos, professional illustrations, and explicit diagrams that demonstrate surgical approaches and depict implant devices. Topics covered include fractures, dislocations, diseases and injuries of the rotator cuff, imaging techniques, arthritis, arthroscopy, arthroplasty, and rehabilitation.
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