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Biologic Association Annual Summit: 2020 Report

Frank, Rachel M; Sherman, Seth L; Chahla, Jorge; Dragoo, Jason L; Mandelbaum, Bert; Anz, Adam W; Bradley, James P; Chu, Constance R; Cole, Brian J; Farr, Jack; Flanigan, David C; Gomoll, Andreas H; Halbrecht, Joanne; Horsch, Kay; Lattermann, Christian; Leucht, Philipp; Maloney, William J; McIntyre, Louis F; Murray, Iain; Muschler, George F; Nakamura, Norimasa; Piuzzi, Nicolas S; Rodeo, Scott A; Saris, Daniel B F; Shaffer, William O; Shapiro, Shane A; Spindler, Kurt P; Steinwachs, Matthias; Tokish, John M; Vangsness, C Thomas; Watson, John Tracy; Yanke, Adam B; Zaslav, Kenneth R
Interest and research in biologic approaches for tissue healing are exponentially growing for a variety of musculoskeletal conditions. The recent hype concerning musculoskeletal biological therapies (including viscosupplementation, platelet-rich plasma, and cellular therapies, or "stem cells") is driven by several factors, including demand by patients promising regenerative evidence supported by substantial basic and translational work, as well as commercial endeavors that complicate the scientific and lay understanding of biological therapy outcomes. While significant improvements have been made in the field, further basic and preclinical research and well-designed randomized clinical trials are needed to better elucidate the optimal indications, processing techniques, delivery, and outcome assessment. Furthermore, biologic treatments may have potential devastating complications when proper methods or techniques are ignored. For these reasons, an association comprising several scientific societies, named the Biologic Association (BA), was created to foster coordinated efforts and speak with a unified voice, advocating for the responsible use of biologics in the musculoskeletal environment in clinical practice, spearheading the development of standards for treatment and outcomes assessment, and reporting on the safety and efficacy of biologic interventions. This article will introduce the BA and its purpose, provide a summary of the 2020 first annual Biologic Association Summit, and outline the future strategic plan for the BA.
PMCID:8191082
PMID: 34164559
ISSN: 2325-9671
CID: 4918582

Economic Impact of Orthopedic Adult Reconstruction Office Practice: The Implications of Hospital Employment Models on Local Economies

Iorio, Richard; Fehring, Thomas; York, Sally; Froimson, Mark; Halsey, David; Odum, Susan; Davis, Charles M; Santore, Richard; McIntyre, Louis F
The purpose of this study was to evaluate the economic attributes of private practice adult reconstruction (AR) offices. 458 AAHKS surgeons responded; 65% were in private practice (fee-for-service, non-salaried, non-employed AR surgeons). 54% had considered hospital employment in the past two years. The average group employs 13.4 orthopedic surgeons (3.4 AR), and 105 other employees. The average total budget is $12.5 million per year with $4 million in salaries, and $238,000 in tax revenue generated. Co-management joint ventures are a better model than hospital employment for aligning AR surgeons and hospitals and realizing the cost effectiveness and quality improvement goals of PPACA and AARA while preserving the economic impact of AR private practice.
PMID: 25707995
ISSN: 0883-5403
CID: 1473622

Safety and efficacy of US-approved viscosupplements for knee osteoarthritis: a systematic review and meta-analysis of randomized, saline-controlled trials

Strand, Vibeke; McIntyre, Louis F; Beach, William R; Miller, Larry E; Block, Jon E
BACKGROUND: Intra-articular injection of hyaluronic acid is a common, yet controversial, therapeutic option for patients with knee osteoarthritis (OA). The purpose of this research was to determine the safety and efficacy of US-approved viscosupplements for symptomatic knee OA. METHODS: We searched MedLine and EMBase for randomized, sham-controlled trials evaluating safety and/or clinical efficacy of US-approved viscosupplements in patients with symptomatic knee OA. Knee pain severity and knee joint function were assessed at 4 to 13 weeks and 14 to 26 weeks. Safety outcomes included serious adverse events, treatment-related serious adverse events, patient withdrawal, and adverse event-related patient withdrawal occurring at any time during follow-up. RESULTS: A total of 29 studies representing 4,866 unique patients (active: 2,673, control: 2,193) were included. All sham-controlled trials used saline injections as a control. Viscosupplementation resulted in very large treatment effects between 4 and 26 weeks for knee pain and function compared to preinjection values, with standardized mean difference values ranging from 1.07 to 1.37 (all P<0.001). Compared to controls, standardized mean difference with viscosupplementation ranged from 0.38 to 0.43 for knee pain and 0.32 to 0.34 for knee function (all P<0.001). There were no statistically significant differences between viscosupplementation and controls for any safety outcome, with absolute risk differences of 0.7% (95% confidence interval [CI]: -0.2 to 1.5%) for serious adverse events, 0% (95% CI: -0.4 to 0.4%) for treatment-related serious adverse events, 0% (95% CI: -1.6 to 1.6%) for patient withdrawal, and 0.2% (95% CI: -0.4 to 0.8%) for adverse event-related patient withdrawal. CONCLUSION: Intra-articular injection of US-approved viscosupplements is safe and efficacious through 26 weeks in patients with symptomatic knee OA.
PMCID:4428363
PMID: 26005358
ISSN: 1178-7090
CID: 1602932

Authors' reply [Letter]

McIntyre, Louis F; Bannuru, Raveendhara R; Vaysbrot, Elizaveta E
PMID: 24862695
ISSN: 0749-8063
CID: 1013242

Did the American Academy of Orthopaedic Surgeons osteoarthritis guidelines miss the mark?

Bannuru, Raveendhara R; Vaysbrot, Elizaveta E; McIntyre, Louis F
The American Academy of Orthopaedic Surgeons (AAOS) 2013 guidelines for knee osteoarthritis recommended against the use of viscosupplementation for failing to meet the criterion of minimum clinically important improvement (MCII). However, the AAOS's methodology contained numerous flaws in obtaining, displaying, and interpreting MCII-based results. The current state of research on MCII allows it to be used only as a supplementary instrument, not a basis for clinical decision making. The AAOS guidelines should reflect this consideration in their recommendations to avoid condemning potentially viable treatments in the context of limited available alternatives.
PMID: 24384274
ISSN: 0749-8063
CID: 952452

Exploring new practice models delivering orthopedic care: can we significantly decrease delivery costs and improve quality?

McIntyre, Louis F
Health care delivery models are undergoing rapid transformation in response to market, regulatory, and demographic trends. Many of the new models of delivery are centrally planned structures with attributes dictated by statute. An understanding of these models is essential if physicians wish to retain an influential voice in patient care. Accountable Care Organizations, Medical Homes, Bundled Payment, and Episode of Care are terms even sports medicine physicians must become familiar with to positively affect the delivery of health care in the near future. By embracing both the clinical and economic aspects of health care, surgeons will be in a better position to make health care reform responsive to actual patient needs.
PMID: 23924747
ISSN: 1062-8592
CID: 498212

The changing world of healthcare delivery

Beach, Bill; McIntyre, Louis F
PMID: 23924744
ISSN: 1062-8592
CID: 498222

Evidence-based medicine, appropriate-use criteria, and sports medicine: how best to develop meaningful treatment guidelines

McIntyre, Louis F; Beach, William R; Higgins, Laurence D; Mordin, Margaret M; Mauskopf, Josephine; Sweeney, Carolyn T; Copley-Merriman, Catherine
We propose using appropriate-use criteria (AUC) as the methodology of choice for formulating and disseminating evidence-based medicine guidelines in sports medicine and arthroscopy. AUC provide a structured process for integrating findings from the scientific literature with clinical judgment to produce explicit criteria for determining the appropriateness of specific treatments. The use of AUC will enable surgeons to treat patients in a more consistent manner based on expert clinical consensus and evidence-based medicine. This methodology also will ensure that guidelines represent all stakeholders and available evidence.
PMID: 23510944
ISSN: 0749-8063
CID: 498232

AAOS rotator cuff clinical practice guideline misses the mark [Editorial]

Lubowitz, James H; McIntyre, Louis F; Provencher, Matthew T; Poehling, Gary G
PMID: 22542430
ISSN: 0749-8063
CID: 498242

The health care bill [Letter]

McIntyre, Louis F
PMID: 20141977
ISSN: 0749-8063
CID: 498252