The studies also illustrate the feasibility of leveraging user-friendly technology solutions to collect PRO data in real-time, at the point of care. The research will be featured at the International Society of Pharmacoeconomic and Outcomes Research (ISPOR) 20th Annual International Meeting in Philadelphia, May 16-20, 2015. Here, Dr. Bruce Feinberg gives us a first look at this research, and its implications for the treatment of patients living with complex diseases.
Q: Tell us why patient-reported outcomes (PRO) have become an important focus of clinical research.
A: The research we’re sharing this year at ISPOR reinforces a simple truth – if we want to find ways to improve the quality and reduce the costs of caring for patients with complex diseases, we need to start by talking to patients themselves.
I was a practicing oncologist for more than 20 years, so I know firsthand that determining treatment plans has historically been considered the realm of the physician. In a patient-centered model, that dynamic changes. We reframe the way we think about care to include not only the clinical effectiveness and toxicity of the treatment, but also the burden of the disease and the treatment on the patient. We try to understand whether the treatments we prescribe are actually improving each patient’s health, life and their perceived sense of well-being.
For example, in our research with rheumatology patients, we used a hand-held technology tool to collect PRO at the point of care – asking rheumatology patients to provide specific information regarding the location and severity of joint swelling and joint tenderness, as well as their sense of well-being – as part of an objective scoring system of the disease and treatment burden, called a CDAI SCORE.
Physicians gathered valuable information that helped them determine the most appropriate course of treatment to address not only the disease, but also each patient’s needs.
Q: One of your studies that will be published at this year’s ISPOR annual meeting reveals that rheumatologists significantly underestimated the negative impact of RA treatment on their patients’ sense of well -being. Tell us about that study and what those results may mean for physicians’ treatment decisions.
A: Daniel Kahneman, the Nobel laureate behavioral scientist, in his book “Think Fast, Think Slow,” talks about the two forms of decision making: intuitive and deliberate. In medicine, these two ways of thinking are often in conflict. Our intuition tells us one thing and our deliberate research tells us another.
Our work in RA is a great example of this interplay. Physicians’ and patients’intuition, built on years of clinical trial results and personal observations, are often biased to believe that newer is better. RA patients and their doctors often assume that new biologic treatments are better than old drugs, called DMARDs. As a result of this fast-brain, intuitive response, doctors and patients are more likely to advance treatment to newer and more expensive biologic drugs before DMARD drugs have been given the chance to have their full effect.
When doctors participating in our clinical pathways program engaged their deliberate brains, they thought it rational to defer biologics until the full effect of the DMARD drugs could fully evaluated. But they wanted to be certain that the delay in biologic initiation didn't result in patients’ disease-related suffering.
Our PRO analysis confirmed that the biologics delay had no impact on patients’ sense of well-being. In fact, patient scores slightly improved, likely the result of fewer adverse events caused by biologics. In our study, the PRO feedback was the critical component to gaining the acceptance of both patients and their physicians in delivering value-based RA care.
Our research proves that doctors will engage their deliberate brains and participate in these grand experiments to test their intuition. It proves that PRO can be collected in real time, at the point of care, enabling physicians to test false assumptions. Ultimately, this study also provided rheumatologists the first-hand patient feedback they needed to have confidence that the ‘deliberative’ treatment processes recommended by their clinical pathways programs were, in fact, in the best interest of their patients.
Q: There’s a perception that it’s challenging to collect patient-reported outcomes data in real-time, at the point-of care. What’s your take on that?
A: Yes, one of the problems with PRO has been how to capture and measure this kind of information, because it falls outside of traditional metrics. Our ISPOR research proves that it’s both feasible and important to collect patient-reported outcomes data during a physician visit.
We made the process as easy as possible for physicians and patients alike by loading a decision support tool (called PathWareTM) onto handheld-tablets. We’ve now used this tool to capture tens of thousands of individual patient assessments, across multiple providers, outside of an academic environment.
In one study involving 3,185 RA patients, we were able to collect patient-reported outcomes data during 90% of physician visits through use of this tool. The participating physicians were then able to utilize the data to inform real-time treatment decisions at the point of care.
Q: What role can PRO play in helping improve patient access and adherence to specialty drugs?
A: In one of our ISPOR studies, physicians asked patients a series of questions to identify obstacles to medication access or adherence.
239 oncology and rheumatology patients were contacted at the time of their initial prescription (and thereafter based on a risk algorithm) to provide patient reported outcomes. Twenty eight percent were identified as having problems that either restricted access or adherence to the drug. Armed with this information, interventions and support services were provided to address those challenges. With the support of these interventions, a medication possession ration exceeding 95% was achieved – enabling nearly all patients to initiate or continue treatment.
These results reinforce that when we take the time to listen to the patient, we increase our chances of being able to remove the barriers that often get in the way of even the best-laid treatment plans. If a physician prescribes a treatment that a patient can’t afford, or if a patient can’t travel to the appropriate site of care to have the treatment administered, the patient obviously can’t get the benefit of the therapy. PRO can help identify and overcome those obstacles.
Q: Do you believe that PRO studies like this will eventually be leveraged by payers to develop reimbursement strategies?
A: Payer reimbursement strategies have historically focused on measures like avoidable readmissions or hospital-acquired infection, or objective clinical outcomes. Ironically, these outcomes don’t take into consideration the patient’s own point of view of their own health. The ultimate goal of any treatment plan is not just to avoid negative outcomes, but to meet the needs of the patient.
When it comes to a disease like rheumatoid arthritis, an important treatment goal is to help patients live the life they want, which means addressing financial, physical, emotional and spiritual burdens of disease. The only way we can understand a patient’s healthcare goals – and therefore, the only way we can deliver optimal treatment plans – is to start by asking the right questions of the patient at the right time. We think that is at the point of care, not in surveys months later.
For that reason, I suspect that PRO will only grow in importance in coming years. The Department of Health and Human Services has already indicated that PRO will be factored into Meaningful Use standards.
I also believe it’s only a matter of time before payers will be able to leverage this kind of data to compare PRO results of multiple providers – which ultimately could lay the groundwork for new reimbursement models for comparative effectiveness.
In a value-based model, if payers are going to expect health care providers to prove that they have delivered value to the patient – the only way to obtain that kind of information is by asking the patient.
Get the full abstracts of Cardinal Health Specialty Solutions research being featured at ISPOR 2015.