The Rise of PROs

Cancer care is becoming value-based. Evidence of this evolution is widespread, from the rise of the oncology medical home and the Cancer Care Payment Reform Act H.R. 1934, to successful payer pilots such as UnitedHealthcare’s episode payment model and the University of Alabama at Birmingham’s Patient Care Connect Program.

In this changing landscape, the interests of cancer patients and healthcare providers have never been more aligned as treatment decisions are driven with the common goal of better outcomes at lower costs. But to realize these common goals, cancer care needs to become more proactive. What will make this transformation possible is the rise of patient-reported outcomes (PROs).

PROs, as defined by the FDA, are any reports of a patient’s health status that come directly from the patient. In other words, PRO is an umbrella term for essentially anything that a patient deems appropriate to report regarding his or her health-related experience. This can include symptoms, side effects, quality of life, psychoemotional distress, satisfaction with care, and medication adherence.

Historically, pencil and paper PRO questionnaires (also referred to as instruments or tools) have played a limited but distinct role in cancer clinical research, to assess quality of life (QoL) and functional status. However, little attention was paid to understanding the clinical significance these PRO findings.

Just this month, the FDA launched its first-ever Patient Engagement Advisory Committee. In their blog post announcing the launch, the Agency stated that “We are entering an era of patient-centered medicine, in which patients and their care partners participate actively in decision-making and priority-setting about all aspects of health care.”

Patients’ views often differ from clinicians’ assessments and may not even correlate with objective endpoints, such as tumor shrinkage or overall survival. But clinicians are recognizing that symptoms sometimes go under-detected, which means that the burden of side effects is underreported in clinical research. This happens when patients either don’t recall or are reluctant to share their symptoms in the limited face-to-face time they have with clinicians. And clinicians may not always document what patients tell them. As they become more common in clinical studies, PROs will shed new light on factors that directly impact health outcomes, such as the actual burden of disease and what patients can expect to experience while on therapy. And as patient participation becomes the norm, the ROI for drug labels that speak to the patient experience will likely increase in stride.

Advances in technology and the rapid proliferation of mobile devices enable patients to share their experiences with the same ease-of-use to which they are accustomed in today’s digitized world. This opportunity for patients to provide responses at their convenience, and with greater frequency than ever before, will enable a real-time view into the patient experience. And when patients gain a connectivity with their health care providers outside of the four walls of the clinic, providers will have the opportunity to intervene before symptoms and side effects can escalate into hospitalizations and other unwanted outcomes.

Common causes for unplanned hospitalizations, especially among the elderly, are fluid and electrolyte disorders. These are readily prevented through proactive care coordination and comorbidity management. But will older patients use technology to report their symptoms and side effects electronically? According to a recent report from Accenture on patient engagement, most (67%) of Americans 
age 65 and older say that accessing their medical information online is very or somewhat important. Currently, approximately 64% of American adults own a smartphone, and smartphone users check their phones, on average, 150 times a day. This means that most people carry their phones with them wherever they go. And in our own early experience launching a care management mobile app, the majority (67%) of patients were between the ages of 60 and 80 years old and of these,  62% checked-in every day. Taken together, these findings point to the critical role that a user-friendly mobile or web-based tool could have in facilitating the collection of PROs, for patients young and old.

Considering the degree of computerization of other aspects of healthcare (think electronic records, robotic-surgery, advanced imaging and biomonitors), the routine use of electronic PROs has lagged. With recent FDA initiatives such as the Patient Engagement Advisory Committee, Patient-Focused Drug Development and PRO Guidance, this is poised to change. And just for the record, we feel good about that.

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