PROs provide objective information about where a patient is in the disease process compared to the larger population and whether the patient is a candidate for certain procedures.
This article first appeared in the December 2015 issue of HealthLeaders magazine.
Even as the healthcare industry emphasizes patient-centered care and patient engagement, and health systems hire chief experience officers, one of the strongest elements of this strategy remains unrealized by many provider organizations: patient-reported outcomes.
Patient-reported outcomes, as defined by the National Quality Forum, are "any report of the status of a patient's health condition that comes directly from the patient, without interpretation of the patient's response by a clinician or anyone else."
For areas such as orthopedics, cancer, and HIV, the direct input of the patient is essential for proper diagnosis and treatment. But patient-reported outcomes have not had substantial adoption, in part because integration with most electronic health systems is kludgy, and providers have not figured out how to blend PROs into the workflow of their daily practice.
"I do not believe that there has been a resistance to physicians using PROs," says David Ayers, MD, director of the Orthopedic Center of Excellence at UMass Memorial Health Care. "Traditionally, PROs have been used in research and have been well accepted and validated. But the use of PROs in office practice has been slowed by the lack of integration into patient flow in the clinical setting.
"Trying to do patient-reported outcomes on your own with pen and paper is very difficult. You need them to be computerized and available on Internet-based platforms so information can be immediately analyzed, scored, and utilized," he says.
Ayers is passionate about the need for widespread use of PROs in orthopedics, and their ability to improve quality. PROs provide objective information about where a patient is in the disease process compared to the larger population and whether the patient is a candidate for joint replacement surgery, he says.
Five years ago, Ayers, who also is chair of the Orthopedics and Physical Rehabilitation department at the University of Massachusetts Medical School, helped obtain a $12 million grant from the Agency for Healthcare Research and Quality to develop an orthopedic joint replacement registry. FORCE-TJR, which stands for Function and Outcomes Research for Comparative Effectiveness in Total Joint Replacement, is an independent data collection, analysis, and reporting system used to guide best practices in total joint replacement surgical practices.
"FORCE-TJR has developed an integrated way to collect PROs in the office setting in an efficient and patient- and staff-friendly way."
The registry, available in 26 states, has collected data from more than 25,000 patients. Patients are questioned about their pain and function levels using the standard SF-36 form and a joint-specific questionnaire before surgery and at regular intervals post-surgery.
Surgeons can access the data to see how they stack up against their peers across the country in the management of patient pain and function levels as well as implant successes/failures.
"FORCE-TJR has developed an integrated way to collect PROs in the office setting in an efficient and patient- and staff-friendly way," Ayers says. "In addition, FORCE-TJR can provide members with electronic-based platforms to collect and score the PROs in real time so that the PROs' scores can be used for shared decision-making and thus can be an important part of clinical practice."
At his practice, Ayers has patients submit PROs via a registry app on a tablet just before an exam. The app analyzes the data and delivers a score that Ayers can share with a patient during the exam and use to help determine the need for a knee or hip replacement. The results show patients how they are tracking over time and put their case in perspective. "Data from the FORCE-TJR is remarkably consistent in patient self-reported pain and function scores across surgeons before total joint replacement," he says, which enables him to trust the analytics.
The PRO-based score also opens the door to engage the patient in shared decision making. "Using validated tools facilitates the information from the patient through his or her history and physical exams that the clinician has to help the patient and the doctor make decisions and gauge their progress," he says. For instance, if a patient scores 55 and the median is 50, then he or she is likely not a candidate for surgery. "We're not just relying on our clinical impression anymore."
Patients who are candidates for surgery typically have severe pain and significant physical limitations so that their physical function score is roughly two standard deviations below the mean, Ayers explains. When using the SF-36, the mean physical function score is 50 and one standard deviation is 10 points. Patients and surgeons typically, through shared decision-making, choose elective joint replacement when scores are around 30 to 33 points.
As PROs find a foothold in orthopedics, Ethan Basch, MD, MSc, director of the Cancer Outcomes Research Program at the University of North Carolina at Chapel Hill, says he is hoping a similar trajectory will occur in oncology.
"There can be a real downside to the treatments I recommend, and I want to understand how other patients have experienced it," Basch says, adding firmly that "patient-reported outcomes should be a key part of every clinical trial in oncology."
In addition to improving drug development, PROs also enable insight for symptom management by individual doctors and nurses as well as quality assessment among practices. "Symptoms such as pain are hugely under-detected and undertreated [in oncology]," he says. "Until we systematically collect this information from our patients, we will be limited in our ability to optimally manage patients' symptoms."
Basch says individual oncology clinics, hospitals, and practices are starting to use PROs, but mostly piecemeal. He would like to see usage standardized, easily interfaced via plug-ins to EHR systems, and available via the Web, mobile devices, and interactive voice response phone systems. Also, patients and doctors should be able to access data via patient portals. "EHR vendors today have rudimentary patient-reported outcomes platforms, but the information is hard to find, hard to use, and not part of the workflow. That has to improve," he says.
That day will come, he says, when PROs become a quality metric that is an expectation for reimbursement. "It is my hope that it will be done well and systematically," Basch says.
Albert Wu, MD, MPH, FACP, a professor and director of the Center for Health Services and Outcomes Research at the Johns Hopkins Bloomberg School of Public Health, also says he believes that PROs will be widely adopted. After all, he has seen tremendous change in acceptance of PROs since he first started working with them in 1987.
Back then, he championed the introduction of PROs as part of HIV clinical drug trials in San Diego and San Francisco as a way to monitor patient response to quality of life, symptoms, and adherence to protocols.
Today, he has extended his PRO expertise to cancer and kidney disease, as well as other conditions such as asthma.
"There really is an overall growing acceptance that outcomes from a patient's perspective through patient-reported outcomes are the best and most convenient way to get perspective into research and then into practice," Wu says.
Standards are being worked on. As an example, he points to PROMIS (Patient Reported Outcome Measurement Information System), the National Institutes of Health's assessment system for self-reported health that provides clinicians and researchers with "efficient, precise, valid, and responsive adult- and child-reported measures of health and well-being," according to the project's website.
Even those Wu refers to as conservative forces regulators who require data collected and reported on paper will be convinced to move to the electronic world soon, he predicts.
Wu says he believes a link to reimbursements such as offering a certain dollar amount for each PRO collected could drive greater adoption of the practice of collecting and using the information.
Reprint HLR1215-2