间充质间质细胞治疗膝骨关节炎临床试验中自旋的评价:一项系统综述

Katherine Woolley, Nesa Milan, Zubin Master, Brian T. Feeley
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引用次数: 0

摘要

背景:间充质基质细胞(MSCs)的再生潜力引起了人们对其用于膝关节骨关节炎的兴趣。与此同时,关于科学期刊上的数据是如何报道的,以及它们如何影响读者的解释,或“旋转偏见”,也进行了调查。这些研究存在偏倚风险,因为患者数量有限,且盲法或对照不一致。自旋偏差的风险也使解释复杂化,因为结果可能以有利于特定结果的方式呈现。目的:量化和表征MSCs治疗膝关节骨关节炎的临床试验中的自旋偏倚。研究设计:系统评价。方法:使用“间充质干细胞”或“MSCs”、“膝关节关节炎”或“骨关节炎”、“治疗”或“再生”等术语进行PubMed和Embase搜索。总体而言,2名独立审稿人将自旋分为高、中、低,并分为3种类型:(1)强调统计上显著的结果,(2)将不显著的结果解释为治疗效果,(3)尽管结果不显著,但仍声称治疗有益。期刊分为骨科类和非骨科类。采用描述性统计、卡方检验和Fisher精确检验对数据进行分析,alpha集为P <;. 05。结果:54篇研究中,80.0%的文章存在自旋,其中高自旋占14.5%,中度自旋占25.5%,低自旋占40.0%。1型占54.5%,2型占18.2%,3型占29.1%。与摘要相比,文章方法部分中Spin的出现频率较低(17.52;P = .003)。与其他来源的MSCs相比,关于脂肪来源的MSCs的报道与更高的自旋频率和水平相关(18.92;P = .026)。骨科和非骨科期刊的旋转频率没有差异(0.48;P = .49),与影响因子无相关性(5.34;P = .07)。spin和财务披露之间没有关联(0.02;P = .577)。结论:自旋偏倚存在于大多数与骨髓间充质干细胞相关的膝关节骨关节炎试验中,在使用脂肪来源的骨髓间充质干细胞的试验中出现的频率更高。了解自旋的普遍性和策略可以减轻对研究结果的任何潜在误解。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Evaluation of Spin in Clinical Trials of Mesenchymal Stromal Cells for the Treatment of Knee Osteoarthritis: A Systematic Review
Background:The regenerative potential of mesenchymal stromal cells (MSCs) has sparked interest in their use for knee osteoarthritis. Concurrently, there have been investigations on how data in scientific journals are reported and how they may influence readers’ interpretations, or “spin bias.” These studies are at risk for bias, given the limited number of patients and inconsistent blinding or controls. The risk of spin bias also complicates the interpretation, as results may be presented in a way that favors a particular outcome.Purpose:To quantify and characterize spin bias in clinical trials of MSCs for knee osteoarthritis.Study Design:Systematic review.Methods:PubMed and Embase searches were conducted using the terms “mesenchymal stem cells” or “MSCs” and “knee arthritis” or “osteoarthritis” and “therapy” or “treatment” or “regeneration.” Overall, 2 independent reviewers classified spin as high, moderate, or low and as 1 of 3 types: (1) emphasizing statistically significant results, (2) interpreting nonsignificant results as treatment effectiveness, and (3) claiming treatment benefits despite nonsignificant results. Journals were categorized as orthopaedic or nonorthopaedic. Descriptive statistics, the chi-square test, and the Fisher exact test were used to analyze the data, with alpha set at P < .05.Results:Among the 54 studies, spin was found in 80.0% of articles, with 14.5% having high, 25.5% moderate, and 40.0% low levels of spin. Type 1 was found in 54.5% of articles, type 2 in 18.2%, and type 3 in 29.1%. Spin was less frequently observed in the Methods section of articles compared with the abstract (17.52; P = .003). Reports on adipose-derived MSCs were associated with a higher frequency and level of spin compared with reports on MSCs from other sources (18.92; P = .026). There was no difference in the frequency of spin between orthopaedic and nonorthopaedic journals (0.48; P = .49) and no association with the impact factor (5.34; P = .07). There was no association between spin and financial disclosures (0.02; P = .577).Conclusion:Spin bias was present in most MSC-related trials for knee osteoarthritis, with a higher frequency among those that utilized adipose-derived MSCs. Understanding the prevalence and strategies of spin can mitigate any potential misinterpretations of study outcomes.
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