■在过去的十年中,膝关节骨关节炎的富血小板血浆(PRP)治疗呈指数级增长;然而,它的科学评价是高度可变的。美国骨科医师学会通过于2017年5月发布《骨科生物制剂研究评估最低信息》(MIBO)指南,解决了骨科研究标准化的需求。总的来说,MIBO指南分为12类,包括23个清单项目。
■本研究的目的是分析PRP干预膝骨关节炎的随机对照试验(RCTs)与MIBO指南的一致性。我们假设大多数文章将报道MIBO标准的<80%。
■系统评价;证据水平,1.
■PRISMA(系统评价和荟萃分析的首选报告项目)指南用于在PubMed/MEDLINE和WebofScience数据库中进行系统评价。纳入标准包括评估PRP对膝骨关节炎干预的英语RCT,并报告在2017年6月或更晚开始患者登记。最初的23个MIBO检查表项目被分离并修改为44点检查表。通过计算每篇文章从44点核对表中充分和明确报告的核对表项目的总百分比来确定遵守情况。
■本研究共纳入25例RCTs(2356例患者)。加权平均年龄为57.7±4.4岁,42.9%是男性。平均而言,只有53.1%±10.4%(范围,每篇文章报告了44点MIBO检查表项目的31.8%-77.3%)。没有文章的依从率≥80%,5(20.0%)的比率在60%到79.9%之间,20例(80.0%)的发病率≤59.9%。类别在依从性上波动,“干预”的依从性最高(100.0%),“激活”的依从性最低(14.0%)。此外,4个(33.3%)类别的依从率≥80%,0的比率从60%到79.9%,其中8人(66.7%)的发病率≤59.9%。
■RCT对膝关节骨关节炎PRP干预的MIBO指南的总体平均依从性为53.1%。为了增加再现性,提高透明度,并评估未来PRP研究的治疗效果,应改进MIBO指南的报告。
UNASSIGNED: Platelet-rich plasma (
PRP) treatment for knee osteoarthritis has grown exponentially over the past decade; however, its scientific evaluation is highly variable. The American Academy of Orthopaedic Surgeons addressed the need for the standardization of orthobiologics studies by publishing the Minimum Information for Studies Evaluating Biologics in Orthopaedics (MIBO) guidelines in May 2017. In total, the MIBO guidelines are divided into 12 categories, encompassing 23 checklist items.
UNASSIGNED: The purpose of this study was to analyze how well randomized controlled trials (RCTs) on PRP interventions for knee osteoarthritis adhered to the MIBO
guidelines. We hypothesized that most articles would report <80% of the MIBO criteria.
UNASSIGNED: Systematic review; Level of evidence, 1.
UNASSIGNED: PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines were used to perform a systematic review in the PubMed/MEDLINE and Web of Science databases. Inclusion criteria included English-language RCTs that assessed PRP interventions for knee osteoarthritis and reported beginning patient enrollment in June 2017 or later. The original 23 MIBO checklist items were separated and modified into a 44-point checklist. Adherence was determined by calculating the total percentage of checklist items that each article adequately and clearly reported from the 44-point checklist.
UNASSIGNED: A total of 25 RCTs (2356 patients) were included in this study. The weighted mean age was 57.7 ± 4.4 years, with 42.9% being male. On average, only 53.1% ± 10.4% (range, 31.8%-77.3%) of the 44-point MIBO checklist items were reported per article. No articles had adherence rates ≥80%, 5 (20.0%) had rates between 60% and 79.9%, and 20 (80.0%) had rates ≤59.9%. Categories fluctuated in adherence, with \"Intervention\" having the greatest adherence (100.0%) and \"Activation\" having the lowest (14.0%). Additionally, 4 (33.3%) categories had adherence rates ≥80%, 0 had rates from 60% to 79.9%, and 8 (66.7%) had rates ≤59.9%.
UNASSIGNED: The overall mean adherence to MIBO
guidelines by RCTs on
PRP interventions for knee osteoarthritis was 53.1%. To increase the reproducibility, improve transparency, and assess the treatment efficacy of future
PRP studies, reporting of MIBO
guidelines should be improved.