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.

scholarly journals Evidence summaries and recommendations from the international evidence-based guideline for the assessment and management of polycystic ovary syndrome: assessment and treatment of infertility

2019 ◽  
Vol 2019 (1) ◽  
Author(s):  
M F Costello ◽  
M L Misso ◽  
A Balen ◽  
J Boyle ◽  
L Devoto ◽  
...  
Keyword(s):  
Conflicts Of Interest ◽  
Guideline Development ◽  
Polycystic Ovary ◽  
Evidence Synthesis ◽  
Evidence Based ◽  
Agree Ii ◽  
Infertile Women ◽  
International Evidence ◽  
Consumer Organizations ◽  
Evidence Based Guideline

Abstract STUDY QUESTION What is the recommended assessment and management of infertile women with polycystic ovary syndrome (PCOS), based on the best available evidence, clinical expertize and consumer preference? SUMMARY ANSWER International evidence-based guidelines, including 44 recommendations and practice points, addressed prioritized questions to promote consistent, evidence-based care and improve the experience and health outcomes of infertile women with PCOS. WHAT IS KNOWN ALREADY Previous guidelines on PCOS lacked rigorous evidence-based processes, failed to engage consumer and multidisciplinary perspectives or were outdated. The assessment and management of infertile women with PCOS are inconsistent. The needs of women with PCOS are not being adequately met and evidence practice gaps persist. PARTICIPANTS/MATERIALS, SETTING, METHODS Governance included a six continent international advisory and a project board, a multidisciplinary international guideline development group (GDG), consumer and translation committees. Extensive health professional and consumer engagement informed the guideline scope and priorities. The engaged international society-nominated panel included endocrinology, gynaecology, reproductive endocrinology, obstetrics, public health and other experts, alongside consumers, project management, evidence synthesis and translation experts. Thirty-seven societies and organizations covering 71 countries engaged in the process. Extensive online communication and two face-to-face meetings over 15 months addressed 19 prioritized clinical questions involving nine evidence-based reviews and 10 narrative reviews. Evidence-based recommendations (EBRs) were formulated prior to consensus voting within the guideline panel. STUDY DESIGN, SIZE, DURATION International evidence-based guideline development engaged professional societies and consumer organizations with multidisciplinary experts and women with PCOS directly involved at all stages. A (AGREE) II-compliant processes were followed, with extensive evidence synthesis. The Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) framework was applied across evidence quality, desirable and undesirable consequences, feasibility, acceptability, cost, implementation and ultimately recommendation strength. The guideline was peer-reviewed by special interest groups across our partner and collaborating societies and consumer organizations, was independently assessed against AGREE II criteria and underwent methodological review. This guideline was approved by all members of the GDG and has been approved by the NHMRC. MAIN RESULTS AND THE ROLE OF CHANCE The quality of evidence (QOE) for the EBRs in the assessment and management of infertility in PCOS included very low (n = 1), low (n = 9) and moderate (n = 4) quality with no EBRs based on high-quality evidence. The guideline provides 14 EBRs, 10 clinical consensus recommendations (CCRs) and 20 clinical practice points on the assessment and management of infertility in PCOS. Key changes in this guideline include emphasizing evidence-based fertility therapy, including cheaper and safer fertility management. LIMITATIONS, REASONS FOR CAUTION Overall evidence is generally of low to moderate quality, requiring significantly greater research in this neglected, yet common condition. Regional health systems vary and a process for adaptation of this guideline is provided. WIDER IMPLICATIONS OF THE FINDINGS The international guideline for the assessment and management of infertility in PCOS provides clinicians with clear advice on best practice based on the best available evidence, expert multidisciplinary input and consumer preferences. Research recommendations have been generated and a comprehensive multifaceted dissemination and translation program supports the guideline with an integrated evaluation program. STUDY FUNDING/COMPETING INTEREST(S) The guideline was primarily funded by the Australian National Health and Medical Research Council of Australia (NHMRC) supported by a partnership with ESHRE and the American Society for Reproductive Medicine (ASRM). GDG members did not receive payment. Travel expenses were covered by the sponsoring organizations. Disclosures of conflicts of interest were declared at the outset and updated throughout the guideline process, aligned with NHMRC guideline processes. Dr Costello has declared shares in Virtus Health and past sponsorship from Merck Serono for conference presentations. Prof. Norman has declared a minor shareholder interest in the IVF unit Fertility SA, travel support from Merck and grants from Ferring. Prof. Norman also has scientific advisory board duties for Ferring. The remaining authors have no conflicts of interest to declare. This article was not externally peer-reviewed by Human Reproduction Open.

Hemopoiesis Regulated Negatively In Aged Monkeys

Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 5415-5415
Author(s):  
Ming Li ◽  
Susumu Ikehara
Keyword(s):  
Bone Marrow ◽  
Bone Marrow Cells ◽  
Conflicts Of Interest ◽  
Collagen Gel ◽  
Cellular Tissue ◽  
Biological Aging ◽  
Marrow Stroma ◽  
Bone Marrow Stroma Cells ◽  
Marrow Cells

Biological aging is associated with a progressive loss of regulation of cellular, tissue and organ interaction, ultimately resulting in senescence. In humans, accelerated marrow adipogenesis has been associated with aging and several chronic conditions, including diabetes mellitus and osteoporosis. Studies of the hemopoietic system using nonhuman primates have provided important information for understanding the mechanism of human hemopoiesis. Excellent reconstitution of donor hemopoietic cells in a collagen gel group has been observed in the long term in mice. We therefore investigated whether the method would be helpful for reconstituting hemopoiesis in the fatty tibias of monkeys. Nine- to 11-year-old monkeys were used for this study to examine if hemopoiesis could be restored in the fatty marrow of old monkeys. Bone marrow cells were collected from the humerus using the perfusion method, mixed with cultured bone marrow stroma cells in collagen gel, and then injected into the tibia of the same monkey. Clot sections were made from the tibias 1, 2 and 6 weeks after the bone marrow transplantation. However, no bone marrow cells were observed at any of the time points. These results suggested that adipocytes negatively regulate bone marrow reconstitution. Disclosures: No relevant conflicts of interest to declare.

The Concrete–Representational–Abstract Approach for Students With Learning Disabilities: An Evidence-Based Practice Synthesis

2017 ◽  
Vol 39 (4) ◽  
pp. 211-228 ◽  
Author(s):  
Emily C. Bouck ◽  
Rajiv Satsangi ◽  
Jiyoon Park
Keyword(s):  
Learning Disabilities ◽  
Students With Disabilities ◽  
Quality Indicators ◽  
Evidence Based Practice ◽  
Evidence Synthesis ◽  
Evidence Based ◽  
Students With Learning Disabilities ◽  
Instructional Framework ◽  
Abstract Approach ◽  
Best Evidence Synthesis

As researchers and practitioners have increasingly become interested in what practices are evidence based and for whom in education, different sets of quality indicators and evidence-based practice standards have emerged in the field of special education. Practices are commonly suggested as evidence based, even without a best evidence synthesis on the existing research, such as the case with the concrete–representational–abstract (CRA) instructional framework to support students with disabilities in mathematics. This study sought to support the classification of the CRA instructional framework as an evidence-based approach for students with learning disabilities by applying quality indicators and standards of evidence-based practice by Cook et al. (2014). Based on the application of the indicators and standards, the CRA instructional framework was determined to be an evidence-based practice for students with learning disabilities who struggle in mathematics relative to computational problems, such as addition, subtraction, and multiplication, largely with regrouping.

A New Net to Go Fishing: Messages From International Evidence-Based Research and Kaupapa Māori Research

2011 ◽  
Vol 40 ◽  
pp. 92-101 ◽  
Author(s):  
Richard F. Manning ◽  
Angus H. Macfarlane ◽  
Mere Skerrett ◽  
Garrick Cooper ◽  
Vanessa De Oliveira (Andreotti) ◽  
...  
Keyword(s):  
New Zealand ◽  
Research Team ◽  
Evidence Synthesis ◽  
Evidence Based ◽  
Ministry Of Education ◽  
International Evidence ◽  
Best Evidence Synthesis ◽  
Education Strategy ◽  
Kaupapa Māori ◽  
The University

This article draws upon a Māori metaphor to describe the theoretical framework underpinning the methodology and findings of a research project completed by researchers from the University of Canterbury, New Zealand, in 2010. It explains how and why the project required the research team to synthesise key information from four New Zealand Ministry of Education Best Evidence Synthesis (BES) reports as well as kaupapa Māori research associated with the Ministry's Ka Hikitia Māori Education Strategy. The key messages outlined in this article were designed by the research team to serve as a new tool to assist whānau (family) and iwi (tribe) to actively engage in the New Zealand schooling system and assert their rights in accordance with the principles of the Treaty of Waitangi (1840). Given the large number of Māori children attending Australian schools, the findings of this research may be of interest to Australian educationalists.

scholarly journals Guidelines Warfare Over Interventional Techniques: Is There a Lack of Discourse or Straw Man?

2012 ◽  
Vol 1;15 (1;1) ◽  
pp. E1-E26 ◽  
Author(s):  
Laxmaiah Manchikanti
Keyword(s):  
Pain Management ◽  
Evidence Based Medicine ◽  
Conflicts Of Interest ◽  
Guideline Development ◽  
Evidence Synthesis ◽  
Medical Science ◽  
Medical Knowledge ◽  
Evidence Based ◽  
Interventional Pain Management ◽  
Based Medicine

Guideline development seems to have lost some of its grounding as a medical science. At their best, guidelines should be a constructive response to assist practicing physicians in applying the exponentially expanding body of medical knowledge. In fact, guideline development seems to be evolving into a cottage industry with multiple, frequently discordant guidance on the same subject. Evidence Based Medicine does not always provide for conclusive opinions. With competing interests of payers, practitioners, health policy makers, and third parties benefiting from development of the guidelines as cost saving measures, guideline preparation has been described as based on pre-possession, vagary, rationalization, or congeniality of conclusion. Beyond legitimate differences in opinions regarding the evidence that could yield different guidelines there are potentials for conflicts of interest and various other issues play a major role in guideline development. As is always the case, conflicts of interest in guideline preparation must be evaluated and considered. Following the development of American Pain Society (APS) guidelines there has been an uproar in interventional pain management communities on various issues related to not only the evidence synthesis, but conflicts of interest. A recent manuscript published by Chou et al, in addition to previous publications appear to have limited clinician involvement in the development of APS guidelines, demonstrates some of these challenges clearly. This manuscript illustrates the deficiencies of Chou et al’s criticisms, and demonstrates their significant conflicts of interest, and use a lack of appropriate evaluations in interventional pain management as a straw man to support their argument. Further, this review will attempt to demonstrate that excessive focus on this straw man has inhibited critique of what we believe to be flaws in the approach. Key words: Guidelines, interventional pain management, professionalism, discourse, disclosure, conflicts of interest, evidence-based medicine, comparative effectiveness research, Patient-Centered Outcomes Research Institute

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 Responsible, Safe, and Effective Use of Biologics in the Management of Low Back Pain: American Society of Interventional Pain Physicians (ASIPP) Guidelines

2019 ◽  
Vol 22 (22;1s) ◽  
pp. s1-s74
Author(s):  
Laxmaiah Manchikanti
Keyword(s):  
Observational Studies ◽  
Biologic Therapy ◽  
Facet Joint ◽  
Evidence Synthesis ◽  
Evidence Based ◽  
High Quality ◽  
Moderate Quality ◽  
Qualitative Evidence ◽  
Best Evidence Synthesis ◽  
Level I

Background: Regenerative medicine is a medical subspecialty that seeks to recruit and enhance the body’s own inherent healing armamentarium in the treatment of patient pathology. This therapy’s intention is to assist in the repair, and to potentially replace or restore damaged tissue through the use of autologous or allogenic biologics. This field is rising like a Phoenix from the ashes of underperforming conventional therapy midst the hopes and high expectations of patients and medical personnel alike. But, because this is a relatively new area of medicine that has yet to substantiate its outcomes, care must be taken in its public presentation and promises as well as in its use. Objective: To provide guidance for the responsible, safe, and effective use of biologic therapy in the lumbar spine. To present a template on which to build standardized therapies using biologics. To ground potential administrators of biologics in the knowledge of the current outcome statistics and to stimulate those interested in providing biologic therapy to participate in high quality research that will ultimately promote and further advance this area of medicine. Methods: The methodology used has included the development of objectives and key questions. A panel of experts from various medical specialties and subspecialties as well as differing regions collaborated in the formation of these guidelines and submitted (if any) their appropriate disclosures of conflicts of interest. Trustworthy standards were employed in the creation of these guidelines. The literature pertaining to regenerative medicine, its effectiveness, and adverse consequences was thoroughly reviewed using a best evidence synthesis of the available literature. The grading for recommendation was provided as described by the Agency for Healthcare Research and Quality (AHRQ). Summary of Evidence: Lumbar Disc Injections: Based on the available evidence regarding the use of platelet-rich plasma (PRP), including one high-quality randomized controlled trial (RCT), multiple moderate-quality observational studies, a single-arm meta-analysis and evidence from a systematic review, the qualitative evidence has been assessed as Level III (on a scale of Level I through V) using a qualitative modified approach to the grading of evidence based on best-evidence synthesis. Based on the available evidence regarding the use of medicinal signaling/ mesenchymal stem cell (MSCs) with a high-quality RCT, multiple moderate-quality observational studies, a single-arm meta-analysis, and 2 systematic reviews, the qualitative evidence has been assessed as Level III (on a scale of Level I through V) using a qualitative modified approach to the grading of evidence based on best evidence synthesis. Lumbar Epidural Injections Based on one high-quality RCT, multiple relevant moderate-quality observational studies and a single-arm meta-analysis, the qualitative evidence has been assessed as Level IV (on a scale of Level I through V) using a qualitative modified approach to the grading of evidence based on best evidence synthesis. Lumbar Facet Joint Injections Based on one high-quality RCT and 2 moderate-quality observational studies, the qualitative evidence for facet joint injections with PRP has been assessed as Level IV (on a scale of Level I through V) using a qualitative modified approach to the grading of evidence based on best evidence synthesis. Sacroiliac Joint Injection Based on one high-quality RCT, one moderate-quality observational study, and one low-quality case report, the qualitative evidence has been assessed as Level IV (on a scale of Level I through V) using a qualitative modified approach to the grading of evidence based on best evidence synthesis. Conclusion: Based on the evidence synthesis summarized above, there is Level III evidence for intradiscal injections of PRP and MSCs, whereas the evidence is considered Level IV for lumbar facet joint, lumbar epidural, and sacroiliac joint injections of PRP, (on a scale of Level I through V) using a qualitative modified approach to the grading of evidence based on best evidence synthesis. Regenerative therapy should be provided to patients following diagnostic evidence of a need for biologic therapy, following a thorough discussion of the patient’s needs and expectations, after properly educating the patient on the use and administration of biologics and in full light of the patient’s medical history. Regenerative therapy may be provided independently or in conjunction with other modalities of treatment including a structured exercise program, physical therapy, behavioral therapy, and along with the appropriate conventional medical therapy as necessary. Appropriate precautions should be taken into consideration and followed prior to performing biologic therapy. Multiple guidelines from the Food and Drug Administration (FDA), potential limitations in the use of biologic therapy and the appropriate requirements for compliance with the FDA have been detailed in these guidelines. Key words: Regenerative medicine, platelet-rich plasma, medicinal signaling cells, mesenchymal stem cells, stromal vascular fraction, bone marrow concentrate, chronic low back pain, discogenic pain, facet joint pain, Food and Drug Administration, minimal manipulation, evidence synthesis

Interventions for students with autism in inclusive settings: A best-evidence synthesis and meta-analysis.

2019 ◽  
Vol 145 (5) ◽  
pp. 490-507 ◽  
Author(s):  
Laci Watkins ◽  
Katherine Ledbetter-Cho ◽  
Mark O'Reilly ◽  
Lucy Barnard-Brak ◽  
Pau Garcia-Grau
Keyword(s):  
Evidence Synthesis ◽  
Meta Analysis ◽  
Best Evidence Synthesis ◽  
Inclusive Settings ◽  
Students With Autism
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