Centeno-Schultz Clinic, Broomfeld, CO; Regenexx, LLC, Des Moines, IA.
Centeno-Schultz Clinic, Broomfeld, CO.
Pain Physician. 2021 May;24(3):263-273.
Acute and degenerative musculoskeletal disorders are among the most common etiologies of disability worldwide. Recently, there has been interest in the field of regenerative medicine to bridge the gap between conservative and surgical management of these conditions. Autologous bone marrow concentrate is one type of injectate that has increased in popularity over the last few decades. Though there is promising evidence supporting its efficacy, standard of care practice guidelines to govern the appropriate use and implementation of such technology are currently lacking.
The aim of this article is to report findings from a survey administered using the Delphi technique to a group of physicians using bone marrow concentrate in practice to determine best practice consensus regarding optimization of patient safety and education.
Delphi panel technique.
The study was first announced at a national meeting and continued remotely across the United States via 4 rounds of online surveys.
An initial panel of 30 expert members was convened and a 5-member steering committee was established. Four rounds of consensus questionnaires totaling 11 unique questions were distributed. Ten questions included a 5-point Likert scale from "Strongly Agree" to "Strongly Disagree," and one question had a selection of 5 options regarding minimum level of evidence required. The anonymized aggregate results of each round were shared with the group prior to voting in the subsequent round in accordance with the Delphi process. Consensus was defined as 80% agreement of the statements indicating either "Strongly Agree" or "Agree" for the 10 questions with the Likert Scale and 80% agreement among 2 of 5 choices in the question regarding levels of evidence.
Three invited participants were excluded by the second round of questions due to lack of response in a timely manner, leaving 27 physicians queried. Nine of the 11 questions met criteria for > 80% consensus. Areas of agreement included importance of a treatment registry, candidacy grading, expanded informed consent, scientific accuracy in advertising, institutional review board approval for novel uses, performance of procedures by only licensed physicians or mid-level providers with direct physician oversight, use of image guidance for injections, data submission for publication in peer reviewed literature, and a minimum requirement of case-series level of evidence for use of bone marrow concentrate in musculoskeletal medicine. The 2 areas that did not meet criteria for consensus included online publishing of individual clinic data and standards around cell counting for dosing.
The Delphi panel of experts was convened on a voluntary basis rather than a nomination process. Our panel of experts were all physicians who use bone marrow concentrate in practice, therefore it is possible that a different panel of experts within other disciplines would reach different conclusions.
There is significant consensus among a panel of physicians performing bone marrow concentrate injections regarding best practice guidelines for musculoskeletal conditions.
急性和退行性肌肉骨骼疾病是全球最常见的残疾病因之一。最近，再生医学领域对这些疾病的保守治疗和手术治疗之间的差距产生了兴趣。自体骨髓浓缩物是一种在过去几十年中越来越受欢迎的注射剂。尽管有支持其疗效的有希望的证据，但目前缺乏管理此类技术的适当使用和实施的标准护理实践指南。
本文的目的是报告一项使用德尔菲技术对使用骨髓浓缩物进行实践的医生进行调查的结果，以确定优化患者安全和教育的最佳实践共识。
德尔菲小组技术。
该研究首先在一次全国会议上公布，并通过在美国的 4 轮在线调查继续远程进行。
召集了一个由 30 名专家组成的初始小组，并成立了一个 5 人指导委员会。共进行了四轮共识问卷调查，共 11 个独特问题。十个问题包括从“非常同意”到“非常不同意”的 5 分李克特量表，一个问题有 5 个选项，涉及所需的最低证据水平。根据德尔菲流程，在随后的一轮投票之前，将每一轮匿名汇总的结果与小组共享。共识定义为 10 个问题中的 80%的回答表示“非常同意”或“同意”的李克特量表，以及关于证据水平的 5 个选项中的 2 个选择的 80%的同意。
由于第二轮问题未及时回复，有 3 名受邀参与者被排除在外，共有 27 名医生接受了询问。11 个问题中有 9 个达到了>80%的共识标准。达成一致的领域包括治疗登记的重要性、候选资格分级、扩大知情同意、广告中的科学准确性、机构审查委员会对新用途的批准、只有持牌医生或具有直接医生监督的中级提供者进行手术、注射时使用图像引导、数据提交用于同行评审文献的出版，以及肌肉骨骼医学中使用骨髓浓缩物的最低病例系列证据要求。未达到共识标准的两个领域包括个别诊所数据的在线发布和剂量细胞计数标准。
专家德尔菲小组是基于自愿原则而不是提名程序召集的。我们的专家小组都是在实践中使用骨髓浓缩物的医生，因此，在其他学科内，一个不同的专家小组可能会得出不同的结论。
进行骨髓浓缩物注射的医生小组对肌肉骨骼疾病的最佳实践指南达成了重要共识。
