Master, Zubin

Background: Platelet-rich plasma (PRP) is an emerging therapy that demonstrates potential benefits for knee osteoarthritis (OA); however, the accessibility of PRP remains limited, in part, because its use is not covered by insurance. Purpose: To identify factors contributing to health disparities in PRP treatment for knee OA using machine learning models. Study Design: Cross-sectional study; Level of evidence, 3. Methods: The authors collected data from electronic medical records at 2 upper Midwest medical centers (Mayo Clinic and Detroit Medical Center) from 2022 to 2023 encompassing demographic, socioeconomic, and clinical factors. Data collection encompassed age, sex, race, ethnicity, area deprivation index, marital status, income, rurality, insurance, employment, language, religion, treatment site, and region. Logistic regression and random forest models were applied to 3667 samples (80% training, 20% testing), comparing PRP recipients against a standard care group. Models were evaluated using 10-fold cross-validation to ensure robust performance assessment. Results: Logistic regression revealed that increased age, widowed status, lower income, rural residence, unemployment/disability, and Medicaid/Medicare insurance were associated with lower odds of receiving PRP. Upper-middle income, contracted insurance, and treatment at the Mayo-Arizona and Mayo-Florida sites were associated with higher odds. The model achieved areas under the curve of 0.83 (training set) and 0.82 (testing set). Random forest analysis identified distance to care, age, area deprivation index, income, and treatment site as top predictors, with areas under the curve of 0.92 (training) and 0.87 (testing). Conclusion: The current study demonstrated that both models discerned key barriers (income, distance to care, retirement status) and facilitators (regional differences) affecting PRP accessibility. These findings provide potential policy initiatives aimed at improving PRP access for underserved demographics, offering a quantitative blueprint to foster equitable access to regenerative therapies for knee OA.

Introduction The unproven stem cell intervention (SCI) industry markets stem cell products to patients navigating chronic and serious conditions who seek alternative options when conventional treatments no longer offer relief or improvement. This market is often characterized by providers using deceptive advertising to misinform potential consumers to seek stem cells that have not been shown to be safe and/or effective through clinical studies. Objective This study examines how patients describe interpersonal and institutional trust in relation to their interest in and decisions about unproven SCIs among two distinct and divergent chronic disease patient groups: patients with little or no interest in unproven SCIs (low seekers) and those with high interest or have undertaken an unproven SCI (high seekers). Methods A semi-structured interview guide was developed deductively and modified inductively based on the Unified Theory of Health Behavior. Qualitative interviews among 36 patients and carers were conduct and transcripts were analyzed using constant comparison based on the principles of grounded theory. Results Trust varies across social contexts as low seekers expressed strong reservations about the commercialization elements of the SCI industry placing greater confidence in conventional medicine. In contrast, high seekers questioned the advice of conventional providers and motives of medical regulators. Across both, personal relationships were commonly described as influential in how participants evaluated unproven SCIs. Conclusion These findings suggest that communication efforts in clinical settings should account for the relational and emotional dimensions of trust. Interventions aimed at countering misleading information and promoting informed choices should engage trusted messengers and address the broader social and psychological contexts in which patients may seek unproven SCIs.

Abstract Regenerative medicine is a rapidly advancing field, particularly within the field of physical medicine and rehabilitation. While orthobiologics are currently being used in clinical practice, there remains a need for high-quality clinical trials and translational research to standardize treatments and improve patient outcomes. Education is vital for streamlining development of evidence-based, practical, and effective treatments. In this article, we highlight the need for a 1-yr advanced fellowship in translational orthobiologics aiming to create a standardized core curriculum targeting physicians involved in treating musculoskeletal diseases. The fellowship’s objectives include advancing translational orthobiologics research, ethical considerations, and promoting effective communication regarding orthobiologic therapies. Such a program would serve as a foundation for physicians interested in conducting clinically oriented orthobiologics research for musculoskeletal disorders while improving the development of safe and effective therapeutics related to musculoskeletal disorders.

Abstract Introduction Most US businesses offering unproven stem cell interventions (SCIs) are run by physicians, many of whom operate outside their scope of training. To date, little effort has been made to educate practicing physicians about SCIs. To circumvent the need, several businesses have begun advertising training opportunities for physicians. Objective To understand the current training landscape for physicians, we undertook a systematic content analysis of stem cell courses advertised on the internet. Methods We conducted Google searches using keywords and included onsite, online, and hybrid training programs targeting physicians or other clinicians. We systematically examined all information and identified 14 courses (6 onsite, 4 online, and 4 hybrid) offered by 11 different organizations. Courses ranged from single-day workshops to year-long programs with an average cost of $4,919 and ranged from $500 to $22,000. Results Nine courses listed a practicum component and ten courses listed 63 affiliated clinics, companies, and non-profit institutions. Eight organizations included learner testimonials as text and/or video with most authored by physicians and all expressed a positive tone. We analyzed marketing language used by training organizations that 6 of 14 explicitly mentioned offering assistance in marketing and/or revenue growth to learners. We also examined the backgrounds of physician faculty among organizations. Of the 7 businesses which listed faculty, a total of 172 faculty were found ranging from 4 to 71 individuals. Among the 172 faculty, 121 were physicians where we were able to determine whether they provided unproven, questionable or proven treatments within their practice. The majority of physician faculty (66%) were associated with unproven treatments, 21% offered proven treatments, and 13% offered questionable treatments. Nearly half the faculty (48%) provided 3-5 unproven therapies, 35% provided 1-2 unproven therapies, and 17% provided 6 or more unproven therapies. Conclusions Our results indicate that current pedagogical offerings for physicians interested in SCIs are likely to offer questionable training that is not rooted in evidence. Physicians interested in SCIs should seek training from nationally accredited organizations. The scientific community should invest in physician training surrounding SCIs. Disclosure No.

Abstract Background For gravely ill patients who have no treatment options and who are ineligible for clinical trials, the US Food and Drug Administration (FDA) established the Expanded Access Program (EAP). Motivated by efforts to weaken FDA regulation and sold as providing greater access to experimental drugs, the federal Right to Try Act (RTT) was passed in 2017. It reduces FDA oversight by not requiring physicians to report safety data and foregoes approval of protocols by local institutional review boards. Methods This study explored the views of 17 neuro-oncologists from 15 different academic medical centers with varying experience with EAP and RTT using convenience sampling. We conducted semi-structured interviews and qualitative analysis to identify emerging themes. Results Most oncologists were confused between the two pathways, had little familiarity with RTT, and had little knowledge about experimental medicine available through either pathway. Oncologists reported a preference of enrolling patients in clinical trials over off-trial preapproval pathways with scant data. As a result, oncologists revealed concerns over properly evaluating risks for their patients. Conclusion Our findings suggest that neuro-oncologists need better resources and clearer mechanisms at their institutions to help navigate EAP and RTT in order to counsel patients interested in experimental medicine.

Introduction: Direct to consumer stem cell and regenerative interventions (SCRIs) for various medical conditions have increased in popularity due to unmet medical needs and the promise of SCRIs to meet those needs. These interventions may have varying levels of safety and efficacy data and many lack sufficient scientific data to be marketed. The direct to consumer SCRI industry has received significant attention due to potential physical, economic, and emotional harms to patients. Patients may seek the counsel of their primary care providers when considering stem cell therapy for their condition. Methods: Here we describe strategies primary care providers can utilize when counseling patients. Results: Although we recommend constructing these discussions around individual patients’ needs, one can utilize a general approach consisting of 4 parts. First, providers should recognize what information the patient is seeking and what is their understanding of stem cell and regenerative medicine. Next, providers should convey evidence-based information at the level of patients understanding so that they are aware of the risks, benefits, and descriptions of possible procedures. Throughout the conversations, attempts should be made to guide patients to a trusted resource that can provide additional information. Finally, providers should make an effort to address misinformation in a way that is nonjudgmental and patient-centered to make the patient feel safe and comfortable. Conclusion: Effectively communicating risk information by primary care providers to patients is important given the harms reported from direct-to-consumer SCRIs. Correcting misinformation remains a priority when discussing SCRI’s. Providers should strive to offer patients with additional resources such as the opportunity for consultation with a specialist or a consultation service dedicated to informing patients about regenerative medicine.

Abstract: Many sports medicine physicians are currently considering introducing regenerative medicine into their practice. Regenerative medicine and the subclassification of orthobiologics are a complicated topic and have produced widely varying opinions. Although there is concern by government regulators, clinicians, scientists, patient advocacy organizations, and the media regarding the use of regenerative medicine products, there is also excitement about the potential benefits with growing evidence that certain regenerative medicine products are safe and potentially efficacious in treating musculoskeletal conditions. Sports medicine physicians would benefit from decision-making guidance about whether to introduce orthobiologics into their practice and how to do it responsibly. The purpose of this position statement is to provide sports medicine physicians with information regarding regenerative medicine terminology, a brief review of basic science and clinical studies within the subclassification of orthobiologics, regulatory considerations, and best practices for introducing regenerative medicine into clinical practice. This information will help sports medicine physicians make informed and responsible decisions about the role of regenerative medicine and orthobiologics in their practice.