Galileo: Charting the Future of O&#038;P

Galileo Galilei had a problem with data. The titan among Renaissance scientist-philosophers had exhorted his fellows to "measure what is measurable and make measurable what is not so," and in following his own advice confirmed a new view of the universe—that the earth revolved around the sun, rather than vice versa. The Roman Inquisition condemned his facts as "false and contrary to Scripture," but Galileo stood by his findings. He was placed under house arrest for much of his old age but entered immortality as a champion of truth. Stevens The O&P profession also has a problem with data—not that it is condemned for the data it has, but that it's circumscribed by what it lacks. The knowledge base that proves how O&P care assists patients is minuscule compared with the knowledge base of many other healthcare fields, and, according to Phil Stevens, MEd, CPO, FAAOP, many O&P practitioners rarely collect clinical outcomes data in the clinic, and instead rely heavily upon patient self-reports to help guide clinical decisions. When clinicians do use objective measures, he says, they risk choosing the wrong data points or collecting and interpreting their data inaccurately. Further, the processes of collecting, analyzing, and reporting such outcomes can be prohibitively time-consuming, and there's no guarantee that payers will necessarily accept the resultant data. This helps fuel payers' reluctance to pay for devices, particularly high-tech ones. In modern practice, these are serious problems. Hospitals, insurance companies, and Medicare are increasingly demanding that providers include outcomes metrics in reimbursement documentation. Patients, now more than ever, expect care that is based on fact rather than speculation. And the slow economy means that clinics need meaningful feedback about the quality of their work in order to operate at highest efficiency. McCormack To help address these needs, Orthocare Innovations, Oklahoma City, Oklahoma, developed the Galileo Clinical Outcomes Assessment™ system. The system, which Orthocare CEO Doug McCormack calls a "broad-based clinical outcomes platform," utilizes a combination of wearable electronics, software, a database, proprietary algorithms, and reporting capacities to collect, analyze, store, and document physical outcomes data from O&P patients. It integrates with much of Orthocare's current product line, including the StepWatch™ activity monitor, the Computerized Prosthetic Alignment System (Compas™), and the Smart Pyramid™, to do this. Though the system won't be released until fall 2010, it has already garnered an R&D 100 award, one of the nation's top accolades for innovation. Boone Orthocare's Chief Technical Officer, David Boone, CP, MPH, PhD, explains, "As a company, we looked at the problems with collecting clinical data in O&P and asked, 'What are the barriers to the individual really doing a good job at documenting care and using that information for evidence-based practice?'" They concluded, he says, that it currently takes clinicians too much labor to manually track physical functional outcomes, much less to choose the right measure and document findings in such a way that payers will understand and accept. The Galileo system, Boone says, is meant to solve that problem by allowing clinicians to perform most of the tasks of evidence-based practice, including reporting to payers, "with the absolute minimal work ever required from the clinician" and at a low cost. The Functional Levels Assessment System The Galileo system collects, analyzes, and reports objective, quantified outcomes data from O&P patients. Images courtesy of Orthocare Innovations. The first program Orthocare will make available through Galileo is the Functional Levels Assessment System (FLAS), which utilizes the StepWatch ankle monitor to develop a detailed, week-long assessment of the lower-limb patient's mobility. The StepWatch's accuracy has been validated in more than 80 peer-reviewed articles and, according to Orthocare, it is the activity monitor of choice at major research institutions including the Mayo Clinic and Cornell University. The StepWatch samples the number of steps that the patient takes within a specified interval of time, from a few seconds to a few minutes, and stores the data. For the FLAS, the patient wears the StepWatch for a full week, then returns it to the clinician, who uploads the monitor's data into the Galileo software, along with the clinician's personal assessment of the patient's K-level. The software transmits the data via a Health Information Portability and Accountability Act (HIPAA)-compliant system to Orthocare, where it is processed using proprietary algorithms. Orthocare then returns to the clinician a report titled the "Evidence-Based Performance Analysis for K-Level Determination." The report lists K-level-style indexes derived from three factors in the week's data: cadence variability, peak performance, and ambulation energy. It also lists the clinician's K-level estimate, which is weighted equally to the three indexes to yield a final, definitive K-level. Boone says that during Orthocare's beta testing, the system has proven to be more than 98 percent accurate at assigning K-levels when compared to the clinical observations of highly qualified prosthetists. However, unlike the standard K-levels, which are assigned as whole numbers, all FLAS K-levels are graded to a tenth of a point, from K0.0 to K4.9. StepWatch These finer gradations may make it easier for a clinician to see and predict a patient's clinical trajectory. A patient who scores as a K2.8, for example, may be an excellent candidate for K3 componentry. Conversely, if a patient declines from a 2.6 to a 2.1 within a year, the clinician might recommend to the care team that the patient undergo a general health assessment to determine if such measures as increased physical therapy sessions would be beneficial. The FLAS report also includes a graph of the patient's mobility patterns, which, according to Michael Orendurff, MS, editor in chief of Gait & Posture and Orthocare's director of activity monitoring and outcomes services, can head off the serious patient mischaracterizations that both patient reports and clinical observation are vulnerable to. Quantum Leap Nelson Kenneth Nelson, MD, MPH, who is a member of Orthocare's scientific advisory board and who served as a medical director for the Statistical Analysis Durable Medical Equipment Regional Carrier (SADMERC), describes the change that Galileo makes possible as the "move from subjective to objective...[which] is really a quantum leap in managing patients." He explains, "To my way of thinking, it is in the order of what it was like trying to deal with diabetics before and after we could measure blood sugar.... It will probably have even more ramifications as we begin to see activity changes as people have better or worse alignment or as other factors intervene with patients' ability to ambulate." Easing Reimbursement According to McCormack, one of Orthocare's main goals in providing this insight into function was to provide a mechanism to assist clinicians in pre-approvals and appeals with payers. Since Galileo went into development, Nelson notes, Orthocare has contacted public and private groups about the system. Nelson says that medical directors of some payers were "quite excited" about the system, and he paraphrases them as stating that they would find it "valuable and of interest" to have an objective way to quantify functional levels. For them, Nelson says, Galileo may help prevent fraud and misreporting of patient needs. Reports from the Field At the time of this writing, the Galileo system was in beta testing at 25 O&P facilities nationwide. According to McCormack, the feedback from users has been overwhelmingly positive. Jason Wening, MS, CP, the director of clinical research at beta tester Scheck & Siress, Chicago, Illinois, confirms, "The suggested K-levels have been in line with my clinical judgment most of the time, and as a clinician, that's reassuring because it means I'm not looking for things that aren't there or imagining potential for a patient that really doesn't exist." As a researcher, he also values that the Galileo database allows clinicians to "potentially accumulate data from all over the world—anyone who has access to the StepWatch system and an Internet connection can send data to this database, so you can develop a really powerful picture of what the amputee population is doing when they're out of the office. We've never had access to that before." He adds that the potential to track patients' progress over multiple Galileo reports "gets past what the patients are telling you they've done with the prosthesis, which is sometimes accurate and sometimes really not accurate." According to Orthocare, Galileo's reports will be proactively updated to meet or exceed payer requirements, and based on tester feedback, the company is considering adding to the system customized-reporting capabilities that are based on specific payers' requirements. In the future, clinicians may be able to select a report based on the data collected in the Galileo system that would be customized for the requirements of particular payers. Nelson concludes that Galileo can serve O&P not only on the reimbursement and clinical fronts, but in research as well. "The ability to compare performance in an objective manner opens an opportunity to have much more sophisticated management of the patient," he says. "When we have nondestructive, objective measuring tools that provide quantitative data, then we are able to advance in our understanding.... The more that we can measure, the more that we can prove." Morgan Stanfield can be reached at linkEmail('morgan','opedge.com');

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