RESUMO
BACKGROUND: The aim of this didactic article is to describe the implementation of a clinical outcomes registry within a clinical setting for musculoskeletal regenerative medicine. A patient-centred clinical registry, designed and implemented into the practice of a musculoskeletal clinic specializing in regenerative medicine. METHODS: A focus on patient outcomes at all levels of the patient journey was established to monitor and continually improve care. The registry was designed to monitor the diagnosis, treatment and outcomes of musculoskeletal pathologies of the shoulder, elbow, hip, knee, foot and spine presenting to the clinic. Specifically, the registry was designed for surveillance, tracking, and reporting of efficacy and adverse events of cellular-based therapies. RESULTS: The registry has completed its implementation phase and is now in a pilot period to confirm data collection processes and user feedback. Initial findings indicate suboptimal data entry compliance in key areas that were rectified by refining data fields, reimaging within existing operating systems, and linkage to external supporting documents. CONCLUSIONS: The key impacts of the registry implementation have been to (I) redefine criteria for treatment success and failure within the area of biologic treatments in musculoskeletal practice; (II) instigate discussion, and document standardized treatment pathways, clinical handover processes and shared decision-making with patients; and (III) act as a catalyst to target deficiencies in staff knowledge and skills in the areas of patient management and interaction, clinical documentation and administration processes. A practice registry provides a platform for monitoring treatment safety and efficacy in the context of biologic therapies in musculoskeletal medicine. Registries of this kind will contribute to ongoing discourse regarding best value treatments in the musculoskeletal context.
RESUMO
The economic and human cost of knee osteoarthritis is forecast to increase. This will impact not only aging individuals, but also the working age members of emerging economies. The current treatment pathways are often costly, time-consuming, and insufficient to manage the degeneration of the knee over the ever-increasing lifespan of patients around the world. In response to the shortcomings of a focus on symptom management, international and high-impact regulators, researchers, clinicians, and most importantly patients, are increasingly interested in the possible management of knee osteoarthritis with novel therapies in the field of regenerative medicine treatments. Regenerative medicine is an emerging discipline whose adherents aim to use the tools of the human body to address underlying dysfunction, leading to lasting repair of damaged tissues and structures. The evidence base lacks consensus on issues related to safety, efficacy, cost-efficiency, and treatment specifications. In this current concepts review, we describe the potential impact of regenerative medicine for knee osteoarthritis and evaluate literature of the past decade for elements related to the quality of clinical research. Finally, we discuss strategies for improving the evidence base for the future. The results of the review reveal that the typical follow-up period for most clinical research into the area is between 6 and 12 months; local ethics board approval is commonly reported, and that Platelet-Rich Plasma is the most common option explored. However, several quality elements were lacking in this cohort of recent literature: cost efficacy data, long-term follow-up, and detailed adverse event reporting. In order to address these weaknesses in the literature, patient outcomes registries are needed, in order to satisfy the need for longer follow-up for individuals receiving regenerative treatments, in addition to further clinical trials which address larger and more diverse patient populations. Transparency will be of utmost importance in further research and clinical translation of regenerative medicine for knee osteoarthritis.
RESUMO
BACKGROUND: Osteoarthritis is a progressive multifactorial condition of the musculoskeletal system with major symptoms including pain, loss of function, damage of articular cartilage and other tissues in the affected area. Knee osteoarthritis imposes major individual and social burden, especially with the cost and complexity of surgical interventions. Mesenchymal stem/stromal cells have been indicated as a treatment for degenerative musculoskeletal conditions given their capacity to differentiate into tissues of the musculoskeletal system. METHODS: A systematic search will be conducted in Medline, Embase, Cochrane Library, Scopus and relevant trial databases of English, Japanese, Korean, German, French, Italian, Spanish and Portuguese language papers published or in press to June 2018, with no restrictions on publication year applied. References will be screened and assessed for eligibility by two independent reviewers as per PRISMA guidelines. Cohort, cross-sectional or case controlled studies will be included for the analysis. Data extraction will be conducted using a predefined template and quality of evidence assessed. Statistical summaries and meta-analyses will be performed as necessary. DISCUSSION: Results will be published in relevant peer-reviewed scientific journals and presented at national or international conferences by the investigators. TRIAL REGISTRATION: The protocol was registered on the PROSPERO international prospective register of systematic reviews prior to commencement, CRD42018091763 .
