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间充质干细胞干预与膝关节骨关节炎的研究在多大程度上符合评估生物制品指南的研究最低信息要求?一项随机对照试验的系统评价。

How Well Do Studies of Mesenchymal Stem Cell Intervention and Knee Osteoarthritis Adhere to the Minimum Information for Studies Evaluating Biologics Guidelines? A Systematic Review of Randomized Controlled Trials.

作者信息

Abed Varag, Jacobs Cale, Skinner Matthew, Owens Mitchell, Keshishi Dro, Stone Austin V

机构信息

Department of Orthopaedic Surgery and Sports Medicine, University of Kentucky, Lexington, KY, USA.

Massachusetts General Brigham Sports Medicine, Brigham and Women's Hospital, Boston, MA, USA.

出版信息

HSS J. 2024 Nov;20(4):544-549. doi: 10.1177/15563316231200496. Epub 2023 Sep 26.

Abstract

BACKGROUND

The Minimum Information for Studies Evaluating Biologics in Orthopaedics (MIBO) guidelines for mesenchymal stem cell (MSC) research, published in 2017, contain a suggested checklist for reporting items in manuscripts involving MSCs.

PURPOSE

We sought to determine how well randomized controlled trials (RCTs) on MSC intervention for knee osteoarthritis (OA) adhered to the MIBO guidelines.

METHODS

A comprehensive literature search was performed in the PubMed/MEDLINE and Web of Science databases. Inclusion criteria included English-only RCTs that assessed MSC intervention for knee OA published between 2018 and 2022. Metrics were extracted, including year of publication, study design, first author name, journal name, patient demographics, and MIBO checklist criteria.

RESULTS

In 27 RCTs analyzed, 1006 patients were included, with a weighted male percentage of 41.8% and weighted mean age of 60.5 ± 7.2 years. On average, 70.5% (range, 30.2%-90.6%) of the modified 53-point MIBO checklist elements were reported per article. Seven (25.9%) articles had adherence rates of 80% or more, 13 (48.1%) had rates between 60% and 79.9%, and 7 (25.9%) had rates of 59.9% or less. The MIBO "intervention" category had the greatest adherence (100%), while the other categories had more variability. Six (50.0%) categories had an adherence level of 80% or more, 3 (25.0%) had adherence levels of 60% to 79.9%, and 3 (25.0%) had an adherence level of 59.9% or less.

CONCLUSION

The overall mean adherence to MIBO guidelines of RCTs on MSC intervention for knee OA was 70.5%. Authors should better integrate the MIBO guidelines into their methodology to improve transparency, reproducibility, and reporting.

摘要

背景

2017年发布的《骨科生物制品研究最低信息标准(MIBO)》中关于间充质干细胞(MSC)研究的指南包含了一份关于在涉及MSC的稿件中报告项目的建议清单。

目的

我们试图确定关于MSC干预膝关节骨关节炎(OA)的随机对照试验(RCT)对MIBO指南的遵循程度。

方法

在PubMed/MEDLINE和Web of Science数据库中进行了全面的文献检索。纳入标准包括2018年至2022年期间发表的仅用英文撰写的评估MSC干预膝关节OA的RCT。提取了相关指标,包括发表年份、研究设计、第一作者姓名、期刊名称、患者人口统计学信息以及MIBO清单标准。

结果

在分析的27项RCT中,纳入了1006例患者,加权男性比例为41.8%,加权平均年龄为60.5±7.2岁。每篇文章平均报告了修改后的53分MIBO清单项目的70.5%(范围为30.2% - 90.6%)。7篇(25.9%)文章的遵循率达到80%或更高,13篇(48.1%)的遵循率在60%至79.9%之间,7篇(25.9%)的遵循率为59.9%或更低。MIBO“干预”类别遵循率最高(100%),而其他类别差异更大。6项(5

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