Use Patient-Reported Data to Advance the Use of and Confidence in Orthobiologics | OBERD
Growth and Limitations: One of the first known recorded observations of tissue regeneration in a living creature was in 330 b.c., when Aristotle observed that the lost tip of a lizard’s tail would grow back1. In humans, certain tissues maintain the capacity for recuperative regeneration. This would include—but is not limited to—musculoskeletal, collagenous, and hematologic tissues. Technology to encourage this regeneration is being increasingly applied in orthopedic settings to address treatment and recovery from surgical and non-surgical approaches to osteoarthritis and similar morbidities. And, new classes of molecules that inhibit one or more of the disease processes of Osteoarthritis are under evaluation for their potential to alter the degenerative process. These approaches are attractive to patients as they are far less invasive than surgery. These approaches are also attractive to orthopedists as they offer another and/or complementary ways to address patients’ presented conditions.
The growth in the use of this technology has been significant. The American Association of Orthopedic Surgeons (AAOS) has been monitoring this growth and recently observed that because a recent study showed that more than 85 percent of 351 businesses, which represent 570 clinics across the country, were marketing “stem cell” treatments for orthopedic problems2. Yet even with this growth the adoption and application is limited, primarily due to the out-of-pocket payment required by patients and their uncertainty of the outcomes, coupled with the lack of FDA approval for the therapy and thus payer reluctance to reimburse for the treatment.
Using PRO Data to Prove Orthobiologics: There are ways to progress with both of these limiting factors through the collection and use of Patient Reported Outcomes (PRO) data. Relevant and personalized data can be of substantial value in discussing these opportunities with patients to encourage their willingness to be treated, where appropriate, and explaining the benefits post-treatment. Aggregated and standardized data can form the basis for proof statements leading to regulatory and payer approval. And, this activity is encouraged by the AAOS in their position statement on the Use of Emerging Biologic Therapies3 in which they say, “Orthopaedic surgeons and their organizations/facilities should support and participate in orthopaedic registries and other data collection systems. Documentation and reporting are critical to establishing the body of evidence needed to demonstrate the safety and effectiveness of emerging biologics.”
Fortunately, there are professional organizations committed to the development and use of this data for these purposes. Perhaps the most singularly dedicated organization is the Regenerative Orthobiologics Registry (ROR). Founded by OBERD and Regen Health Solutions, ROR is a multi-stakeholder, independent organization with diverse national and international constituents led by top Interventionalists and Physiatrists. ROR’s objective is to connect and support the orthobiologics community with an international data registry and services to support physicians’ collection, storage and effective use of this data.
ROR offers dedicated services to collect, store, report and benchmark outcomes and patient experience data from orthobiologic procedures. Using protocols and survey instruments approved by the AAOS, ROR provides nearly all of the collection services that are highly efficient for patients to complete, and are non-disruptive to the medical practice workflow as nearly of the collection activity is conducted outside of the practice on any digital device (e.g., computer, tablet, smartphone) that can access the Internet. And, the collection and storage processes and resources are all highly secure and HIPAA-compliant.
Using PRO Data to Grow the Orthobiologics Practice: The data collected by ROR for physician practices can be easily accessed online in report or file format, and there are many productive uses for this data. An immediately productive use is to benchmark a physician’s patient outcomes and experience ratings against those from the ROR database. This provides an opportunity to assess, and perhaps improve, individual and overall organization performance with the biologic procedures against credible, approved and standardized data sets.
The data can also be used to support data-driven conversations with potential and actual patients. Discussions prior to any procedure can provide an opportunity to set expectations, provide further information to guide informed-consent decisions, and enable shared-decision making with patients which will usually inspire confidence in the procedure. Post-treatment, conversations about a patient’s outcomes relative to others having the same procedure will help to articulate outcomes and provide the patient with more detailed understanding of what has been accomplished. Assuming relatively favorable outcomes, this detail enables patients to share the benefits of their procedure and their physician evaluations in positive word-of-mouth marketing to other potential patients.
And speaking of marketing, having a bolus of benchmarked data to use in communicating proactively with patients, employers and payers will provide a solid basis for differentiating the physician’s practice and attracting additional patients for this treatment option. The data can be presented on practice web sites, prepared in professional formats and shared with referring physicians, and provided to payers and employers who are always seeking cost-effective approaches to orthopedic morbidities.
Finally, for practices who invest themselves in the conduct and publication of research, outcomes and experience data offer a robust complement to clinical approach investigations. In particular, researching the relationship between patient-reported outcomes and orthobiologic treatments is a research area that is very promising for attention and activity.
Conclusion: Orthobiologics are emerging as an important and patient-friendly option in the treatment of orthopedic morbidities. Collecting, analyzing and using PRO data offers many and varietal benefits to grow and improve practices that choose to engage in orthobiologics treatments. The ROR is an organization led by physicians that is dedicated to assessing and where earned proving the value of orthobiologics treatments. Physicians interested in learning more about orthobiologics and/or the ROR can do so at https://biologicsfoundation.org/about/.
Orthobiologics: A Survey of Materials and Techniques Glenn M. Weinraub, DPM; Clin Podiatr Med Surg 22 (2005) 509 – 519
Biologics Symposium Paper; AAOS Tackles Controversies Surrounding the Use of Biologics in Orthopaedic Surgery, Constance R. Chu, MD
AAOS Position Statement: Use of Emerging Biologic Therapies