Poor adherence rates to the minimum information for studies evaluating biologics in orthopaedics (MIBO) guidelines for clinical studies on platelet-rich plasma for osteochondral lesions of the talus: A systematic review.

IF 1.9 3区 医学 Q2 ORTHOPEDICS Foot and Ankle Surgery Pub Date : 2024-11-20 DOI:10.1016/j.fas.2024.11.006
James J Butler, Davis Hedbany, Sebastian Krebsbach, Lawrence J Lin, Nathaniel P Mercer, Sehar Resad, John G Kennedy
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Abstract

Introduction: The Minimum Information for Studies Evaluating Biologics in Orthopaedics (MIBO) guidelines were developed in 2017 in order to establish a standardized approach for reporting key characteristics in platelet rich plasma (PRP)-based studies. However, the adherence to the guidelines from authors publishing data on studies related to the use of PPR in the management of osteochondral lesions of the talus (OLTs) has not yet been determined. The purpose of this study was to analyze how well clinical trials on PRP interventions for OLTs adhered to the MIBO guidelines.

Methods: PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines were used to perform a systematic review of the PubMed, Embase and Cochrane Library databases. Inclusion criteria clinical studies that assessed PRP interventions for OLTs. The original 23 MIBO checklist items were separated and modified into a 46-point checklist. Adherence was determined by calculating the total percentage of checklist items that each article adequately and clearly reported from the 46-point checklist.

Results: A total of 9 studies (356 patients) with a weighted mean age of 42.1 ± 6.1 years were included in this study. The weighted mean follow-up was 32.2 ± 8.7 months. Overall, only 42.8 % ± 5.2 % of the 46-point MIBO checklist items were reported per article with no articles displaying adherence rates of 100 %. No articles had adherence rates ≥ 50 %, 6 (66.7 %) had adherence rates between 40.0 % and 49.9 % and 3 (33.3 %) had adherence rates less than 39.9 %. There was no difference in mean adherence rates between studies published prior to publication of the MIBO guidelines in May 2017 (41.7 %) and after publication of the MIBO guidelines in May 2017 (44.0 %) (p = 0.6473). There was variation in adherence rates between categories with the "Postoperative Care" category having the highest adherence rate (83.3 %) while the "Activation" category and the "Whole Blood Processing" had the lowest adherence rates (5.6 %).

Conclusion: This systematic review demonstrated that clinical studies evaluating outcomes following the use of PRP in the setting of OLTs poorly adhered to MIBO guidelines. None of the included studies had adherence rates ≥ 50 % and only 1 of the 12 MIBO categories had adherence rates ≥ 80 %. Interestingly, there was no difference in the mean adherence rates in studies conducted before and after publication of the MIBO guidelines in May 2017. This study underscores the need for superior reporting of critical data related to PRP in studies evaluating outcomes in patients with OLTs augmented with PRP.

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富血小板血浆治疗距骨软骨损伤临床研究对骨科生物制剂评估研究最低信息要求(MIBO)指南的遵守率较低:一项系统性综述。
导言:骨科生物制剂评估研究最低信息(MIBO)指南于 2017 年制定,旨在为基于富血小板血浆(PRP)的研究建立一种报告关键特征的标准化方法。然而,发表富血小板血浆用于治疗距骨软骨损伤(OLTs)相关研究数据的作者对指南的遵守情况尚未确定。本研究旨在分析PRP干预OLTs的临床试验在多大程度上遵守了MIBO指南:方法:采用 PRISMA(系统综述和元分析首选报告项目)指南对 PubMed、Embase 和 Cochrane Library 数据库进行了系统综述。纳入标准是评估PRP干预OLT的临床研究。将 MIBO 最初的 23 个核对表项目分开并修改为 46 点核对表。通过计算每篇文章从 46 点核对表中充分、清晰地报告的核对表项目的总百分比来确定是否符合要求:本研究共纳入 9 项研究(356 名患者),加权平均年龄为 42.1 ± 6.1 岁。加权平均随访时间为 32.2 ± 8.7 个月。总体而言,每篇文章仅报告了46点MIBO检查表项目中的42.8%±5.2%,没有一篇文章的坚持率达到100%。没有一篇文章的坚持率≥50%,6篇文章(66.7%)的坚持率介于40.0%和49.9%之间,3篇文章(33.3%)的坚持率低于39.9%。在2017年5月MIBO指南发布之前(41.7%)和2017年5月MIBO指南发布之后(44.0%)发表的研究之间,平均依从率没有差异(P = 0.6473)。不同类别的遵守率存在差异,"术后护理 "类别的遵守率最高(83.3%),而 "激活 "类别和 "全血处理 "类别的遵守率最低(5.6%):本系统性综述表明,评估在OLT中使用PRP后效果的临床研究很少遵守MIBO指南。纳入的研究中,没有一项研究的依从率≥50%,12个MIBO类别中只有1个类别的依从率≥80%。有趣的是,在2017年5月MIBO指南发布前后进行的研究中,平均依从率并无差异。这项研究强调,在评估使用PRP增强OLT患者疗效的研究中,需要对与PRP相关的关键数据进行更完善的报告。
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来源期刊
Foot and Ankle Surgery
Foot and Ankle Surgery ORTHOPEDICS-
CiteScore
4.60
自引率
16.00%
发文量
202
期刊介绍: Foot and Ankle Surgery is essential reading for everyone interested in the foot and ankle and its disorders. The approach is broad and includes all aspects of the subject from basic science to clinical management. Problems of both children and adults are included, as is trauma and chronic disease. Foot and Ankle Surgery is the official journal of European Foot and Ankle Society. The aims of this journal are to promote the art and science of ankle and foot surgery, to publish peer-reviewed research articles, to provide regular reviews by acknowledged experts on common problems, and to provide a forum for discussion with letters to the Editors. Reviews of books are also published. Papers are invited for possible publication in Foot and Ankle Surgery on the understanding that the material has not been published elsewhere or accepted for publication in another journal and does not infringe prior copyright.
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