1. 2021;24;263-273Use of Bone Marrow Concentrate to Treat Pain and Musculoskeletal Disorders: An Academic Delphi Investigation
   Delphi Panel Survey
   R. Amadeus Mason, MD, Ian Stemper, MS, Michael J. DePalma, MD, Gerard A. Malanga, MD, Shane Shapiro, MD, Ken Mautner, MD, Mairin A. Jerome, MD, Sarah M. Pastoriza, DO, Christopher J. Centeno, MD, and Ehren Dodson, PhD.

BACKGROUND: 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.

OBJECTIVES: 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.

STUDY DESIGN: Delphi panel technique.

SETTING: The study was first announced at a national meeting and continued remotely across the United States via 4 rounds of online surveys.

METHODS: 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.

RESULTS: 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.

LIMITATIONS: 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.

CONCLUSIONS: There is significant consensus among a panel of physicians performing bone marrow concentrate injections regarding best practice guidelines for musculoskeletal conditions.

KEY WORD: Bone marrow concentrate, musculoskeletal, BMC, BMAC, injections, orthopedic, orthobiologic, Delphi method, regenerative medicine, bone marrow aspirate