间充质干细胞干预和膝关节骨性关节炎的研究在多大程度上符合生物制剂评估指南的最小信息要求?随机对照试验的系统回顾

IF 1.6 4区 医学 Q3 ORTHOPEDICS Hss Journal Pub Date : 2023-09-26 DOI:10.1177/15563316231200496
Varag Abed, Cale Jacobs, Matthew Skinner, Mitchell Owens, Dro Keshishi, Austin V. Stone
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引用次数: 0

摘要

背景:2017年发布的间充质干细胞(MSC)研究的最小信息研究评估(MIBO)指南包含了涉及间充质干细胞的手稿报告项目的建议清单。目的:我们试图确定MSC干预膝关节骨性关节炎(OA)的随机对照试验(rct)是否符合MIBO指南。方法:在PubMed/MEDLINE和Web of Science数据库中进行全面的文献检索。纳入标准包括2018年至2022年间发表的评估MSC干预膝关节OA的全英文随机对照试验。提取指标,包括发表年份、研究设计、第一作者姓名、期刊名称、患者人口统计数据和MIBO检查表标准。结果:27项随机对照试验共纳入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。平均每篇文章报告了修改后的53点MIBO检查表元素的70.5%(范围30.2%-90.6%)。7篇(25.9%)文章的依从率在80%或以上,13篇(48.1%)的依从率在60%至79.9%之间,7篇(25.9%)的依从率在59.9%或以下。MIBO“干预”类别的依从性最高(100%),而其他类别的差异更大。6个(50.0%)类别的依从性水平在80%及以上,3个(25.0%)类别的依从性水平在60%至79.9%之间,3个(25.0%)类别的依从性水平在59.9%及以下。结论:mscs干预膝关节OA的随机对照试验中,总体平均遵守MIBO指南的比例为70.5%。作者应该更好地将MIBO指南整合到他们的方法中,以提高透明度、可重复性和报告。
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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
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.
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来源期刊
Hss Journal
Hss Journal Medicine-Surgery
CiteScore
3.90
自引率
0.00%
发文量
42
期刊介绍: The HSS Journal is the Musculoskeletal Journal of Hospital for Special Surgery. The aim of the HSS Journal is to promote cutting edge research, clinical pathways, and state-of-the-art techniques that inform and facilitate the continuing education of the orthopaedic and musculoskeletal communities. HSS Journal publishes articles that offer contributions to the advancement of the knowledge of musculoskeletal diseases and encourages submission of manuscripts from all musculoskeletal disciplines.
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