scholarly journals Use of Bone Marrow Concentrate to Treat Pain and Musculoskeletal Disorders: An Academic Delphi Investigation

2021 ◽  
pp. 263-273
Author(s):  
Ehren Dodson
Keyword(s):  
Bone Marrow ◽  
Regenerative Medicine ◽  
Musculoskeletal Disorders ◽  
Practice Guidelines ◽  
Best Practice ◽  
Likert Scale ◽  
Delphi Panel ◽  
Level Of Evidence ◽  
Bone Marrow Concentrate ◽  
Strongly Agree

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

scholarly journals Bone Marrow Concentrate Injection Treatment Improves Short-term Outcomes in Symptomatic Hip Osteoarthritis Patients: A Pilot Study

2020 ◽  
Vol 8 (12) ◽  
pp. 232596712096616
Author(s):  
Kaitlyn E. Whitney ◽  
Karen K. Briggs ◽  
Carolyn Chamness ◽  
Ioanna K. Bolia ◽  
Johnny Huard ◽  
...  
Keyword(s):  
Bone Marrow ◽  
Rating Scale ◽  
Short Form ◽  
Case Series ◽  
Hip Osteoarthritis ◽  
The United States ◽  
Harris Hip Score ◽  
Level Of Evidence ◽  
Promising Alternative ◽  
Bone Marrow Concentrate

Background: Osteoarthritis (OA) is one of the leading causes of disability in the United States, the hip being the second most affected weightbearing joint. Autologous bone marrow concentrate (BMC) is a promising alternative therapy to conventional treatments, with the potential to mitigate inflammation and improve joint function. Purpose: To investigate the effectiveness of a single intra-articular BMC injection for patients with symptomatic hip OA. Study Design: Case series; Level of evidence, 4. Methods: A total of 24 patients diagnosed with symptomatic hip OA who elected to undergo a single BMC injection were prospectively enrolled in the study. Patients were excluded if they reported a preinjection Numeric Rating Scale (NRS) score for pain with activity of <6 points out of 10. The Western Ontario and McMaster Universities Arthritis Index (WOMAC), modified Harris Hip Score (mHHS), Hip Outcome Score–Activities of Daily Living (HOS-ADL), 12-Item Short Form Health Survey (SF-12), and NRS pain scores were collected before and after the procedure (6 weeks, 3 months, and 6 months). Joint space and Tönnis OA grade scores were recorded on preinjection anteroposterior pelvis radiographs. Results: A total of 18 hips from 16 patients (7 male and 9 female) (mean age, 57.6 ± 11; mean body mass index, 25.9 ± 3.6 kg/m2) were used in the final analysis. Significant improvements were observed in NRS pain with activity (from 8 to 4.5; P < .001) and without activity (from 5 to 1; P < .001), WOMAC (from 31 to 16; P = .006), mHHS (from 63 to 80; P = .004), and HOS-ADL (from 71 to 85; P = .014) over 6 months. At 6 months, all patients maintained their improvements and did not return to preprocedure status. BMI significantly correlated with baseline WOMAC scores ( P = .012) and inversely correlated with 6-month SF-12 Physical Component Summary ( P = .038). Tönnis grades 2 and 3 were inversely correlated with 6-week SF-12 Mental Component Summary ( P = .008) and 3-month pain with activity ( P = .032). No serious adverse events were reported from the BMC harvest or injection procedure. Conclusion: A single BMC injection can significantly improve subjective pain and function scores up to 6 months in patients with symptomatic hip OA. Further studies are warranted to evaluate BMC treatment against other therapeutics in a larger sample size and compare the biological signature profiles that may be responsible for the therapeutic effect.

scholarly journals Bone Marrow Concentrate (BMC) Therapy in Musculoskeletal Disorders: Evidence-Based Policy Position Statement of American Society of Interventional Pain Physicians (ASIPP)

2020 ◽  
Vol 2;23 (4;2) ◽  
pp. E85-E131 ◽  
Author(s):  
Christopher J. Centeno
Keyword(s):  
Bone Marrow ◽  
Musculoskeletal Disorders ◽  
Conflicts Of Interest ◽  
Evidence Synthesis ◽  
Relevant Literature ◽  
Cellular Tissue ◽  
Evidence Based ◽  
Medical Specialties ◽  
Bone Marrow Concentrate ◽  
Best Evidence Synthesis

Background: The use of bone marrow concentrate (BMC) for treatment of musculoskeletal disorders has become increasingly popular over the last several years, as technology has improved along with the need for better solutions for these pathologies. The use of cellular tissue raises a number of issues regarding the US Food and Drug Administration’s (FDA) regulation in classifying these treatments as a drug versus just autologous tissue transplantation. In the case of BMC in musculoskeletal and spine care, this determination will likely hinge on whether BMC is homologous to the musculoskeletal system and spine. Objectives: The aim of this review is to describe the current regulatory guidelines set in place by the FDA, specifically the terminology around “minimal manipulation” and “homologous use” within Regulation 21 CFR Part 1271, and specifically how this applies to the use of BMC in interventional musculoskeletal medicine. Methods: The methodology utilized here is similar to the methodology utilized in preparation of multiple guidelines employing the experience of a panel of experts from various medical specialties and subspecialties from differing regions of the world. The collaborators who developed these position statements have submitted their appropriate disclosures of conflicts of interest. Trustworthy standards were employed in the creation of these position statements. The literature pertaining to BMC, its effectiveness, adverse consequences, FDA regulations, criteria for meeting the standards of minimal manipulation, and homologous use were comprehensively reviewed using a best evidence synthesis of the available and relevant literature. Results/Summary of Evidence: In conjunction with evidence-based medicine principles, the following position statements were developed: Statement 1: Based on a review of the literature in discussing the preparation of BMC using accepted methodologies, there is strong evidence of minimal manipulation in its preparation, and moderate evidence for homologous utility for various musculoskeletal and spinal conditions qualifies for the same surgical exemption. Background: The use of bone marrow concentrate (BMC) for treatment of musculoskeletal disorders has become increasingly popular over the last several years, as technology has improved along with the need for better solutions for these pathologies. The use of cellular tissue raises a number of issues regarding the US Food and Drug Administration’s (FDA) regulation in classifying these treatments as a drug versus just autologous tissue transplantation. In the case of BMC in musculoskeletal and spine care, this determination will likely hinge on whether BMC is homologous to the musculoskeletal system and spine. Objectives: The aim of this review is to describe the current regulatory guidelines set in place by the FDA, specifically the terminology around “minimal manipulation” and “homologous use” within Regulation 21 CFR Part 1271, and specifically how this applies to the use of BMC in interventional musculoskeletal medicine. Methods: The methodology utilized here is similar to the methodology utilized in preparation of multiple guidelines employing the experience of a panel of experts from various medical specialties and subspecialties from differing regions of the world. The collaborators who developed these position statements have submitted their appropriate disclosures of conflicts of interest. Trustworthy standards were employed in the creation of these position statements. The literature pertaining to BMC, its effectiveness, adverse consequences, FDA regulations, criteria for meeting the standards of minimal manipulation, and homologous use were comprehensively reviewed using a best evidence synthesis of the available and relevant literature. Results/Summary of Evidence: In conjunction with evidence-based medicine principles, the following position statements were developed: Statement 1: Based on a review of the literature in discussing the preparation of BMC using accepted methodologies, there is strong evidence of minimal manipulation in its preparation, and moderate evidence for homologous utility for various musculoskeletal and spinal conditions qualifies for the same surgical exemption.

Opioid crisis in primary care? An audit of high-dose opioid prescribing at Bangholm GP Practice

2020 ◽  
Vol 70 (suppl 1) ◽  
pp. bjgp20X711581
Author(s):  
Charlotte Greene ◽  
Alice Pearson
Keyword(s):  
Chronic Pain ◽  
Back Pain ◽  
Practice Guidelines ◽  
Best Practice ◽  
Evidence Base ◽  
High Dose ◽  
Opioid Prescription ◽  
Opioid Prescribing ◽  
Best Practice Guidelines

BackgroundOpioids are effective analgesics for acute and palliative pain, but there is no evidence base for long-term pain relief. They also carry considerable risks such as overdose and dependence. Despite this, they are increasingly prescribed for chronic pain. In the UK, opioid prescribing more than doubled between 1998 and 2018.AimAn audit at Bangholm GP Practice to understand the scale of high-strength opioid prescribing. The aim of the audit was to find out if indications, length of prescription, discussion, and documentation at initial consultation and review process were consistent with best-practice guidelines.MethodA search on Scottish Therapeutics Utility for patients prescribed an average daily dose of opioid equivalent ≥50 mg morphine between 1 July 2019 and 1 October 2019, excluding methadone, cancer pain, or palliative prescriptions. The Faculty of Pain Medicine’s best-practice guidelines were used.ResultsDemographics: 60 patients (37 females), average age 62, 28% registered with repeat opioid prescription, 38% comorbid depression. Length of prescription: average 6 years, 57% >5 years, 22% >10 years. Opioid: 52% tramadol, 23% on two opioids. Indications: back pain (42%), osteoarthritis (12%), fibromyalgia (10%). Initial consultation: 7% agreed outcomes, 35% follow-up documented. Review: 56% 4-week, 70% past year.ConclusionOpioid prescribing guidelines are not followed. The significant issues are: long-term prescriptions for chronic pain, especially back pain; new patients registering with repeat prescriptions; and no outcomes of treatment agreed, a crucial message is the goal is pain management rather than relief. Changes have been introduced at the practice: a patient information sheet, compulsory 1-month review for new patients on opioids, and in-surgery pain referrals.

scholarly journals Introducing New Guidelines on Geoheritage Conservation in Protected and Conserved Areas

Geoheritage ◽  
2021 ◽  
Vol 13 (2) ◽  
Author(s):  
Roger Crofts ◽  
Dan Tormey ◽  
John E. Gordon
Keyword(s):  
Practice Guidelines ◽  
Best Practice ◽  
Communication To The Public ◽  
The Public ◽  
Best Practice Guidelines ◽  
The World ◽  
New Guidelines ◽  
The Many ◽  
Ethical Basis ◽  
Improve Practice

AbstractThis paper introduces newly published guidelines on geoheritage conservation in protected and conserved areas within the “IUCN WCPA Best Practice Guidelines” series. It explains the need for the guidelines and outlines the ethical basis of geoheritage values and geoconservation principles as the fundamental framework within which to advance geoheritage conservation. Best practice in establishing and managing protected and conserved areas for geoconservation is described with examples from around the world. Particular emphasis is given to the methodology and practice for dealing with the many threats to geoheritage, highlighting in particular how to improve practice for areas with caves and karst, glacial and periglacial, and volcanic features and processes, and for palaeontology and mineral sites. Guidance to improve education and communication to the public through modern and conventional means is also highlighted as a key stage in delivering effective geoconservation. A request is made to geoconservation experts to continue to share best practice examples of developing methodologies and best practice in management to guide non-experts in their work. Finally, a number of suggestions are made on how geoconservation can be further promoted.

scholarly journals Management of Hepatocellular Carcinoma in Japan: JSH Consensus Statements and Recommendations 2021 Update

Liver Cancer ◽  
2021 ◽  
pp. 1-43
Author(s):  
Masatoshi Kudo ◽  
Yusuke Kawamura ◽  
Kiyoshi Hasegawa ◽  
Ryosuke Tateishi ◽  
Kazuya Kariyama ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Clinical Practice ◽  
Public Relations ◽  
Clinical Practice Guidelines ◽  
Practice Guidelines ◽  
Expert Panel ◽  
Clinical Practices ◽  
Fourth Edition ◽  
Level Of Evidence ◽  
Consensus Statements

The Clinical Practice Manual for Hepatocellular Carcinoma was published based on evidence confirmed by the Evidence-based Clinical Practice Guidelines for Hepatocellular Carcinoma along with consensus opinion among a Japan Society of Hepatology (JSH) expert panel on hepatocellular carcinoma (HCC). Since the JSH Clinical Practice Guidelines are based on original articles with extremely high levels of evidence, expert opinions on HCC management in clinical practice or consensus on newly developed treatments are not included. However, the practice manual incorporates the literature based on clinical data, expert opinion, and real-world clinical practice currently conducted in Japan to facilitate its use by clinicians. Alongside each revision of the JSH Guidelines, we issued an update to the manual, with the first edition of the manual published in 2007, the second edition in 2010, the third edition in 2015, and the fourth edition in 2020, which includes the 2017 edition of the JSH Guideline. This article is an excerpt from the fourth edition of the HCC Clinical Practice Manual focusing on pathology, diagnosis, and treatment of HCC. It is designed as a practical manual different from the latest version of the JSH Clinical Practice Guidelines. This practice manual was written by an expert panel from the JSH, with emphasis on the consensus statements and recommendations for the management of HCC proposed by the JSH expert panel. In this article, we included newly developed clinical practices that are relatively common among Japanese experts in this field, although all of their statements are not associated with a high level of evidence, but these practices are likely to be incorporated into guidelines in the future. To write this article, coauthors from different institutions drafted the content and then critically reviewed each other’s work. The revised content was then critically reviewed by the Board of Directors and the Planning and Public Relations Committee of JSH before publication to confirm the consensus statements and recommendations. The consensus statements and recommendations presented in this report represent measures actually being conducted at the highest-level HCC treatment centers in Japan. We hope this article provides insight into the actual situation of HCC practice in Japan, thereby affecting the global practice pattern in the management of HCC.

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