Everybody knows about evidence-based medicine, especially evidence-based medicine around the use of pharmaceuticals—and especially in oncology. Provider and payer organizations, many of them, strive to standardize care pathways around that evidence-based medicine. Here is the thing: I’ve heard it said that doctors and patients at the point of care are not particularly interested in evidence-based medicine. What they want right then is medicine-based evidence: If this patient takes this medicine, what will the outcome be?
Is there a name for this medicine-based evidence? Why, yes there is! It’s otherwise known as patient-reported outcomes, or PROs. And the high demand for meaningful PRO data has been clear across the spectrum of stakeholders but especially when it comes to patients and doctors who are actually making treatment decisions. This demand is really acute for oncology patients and their doctors, where the stakes are high and adverse events are definitely not trivial.
PROs can be collected for drugs that are already FDA approved but also for drugs in development. It’s been said that a Pharma these days who skips collecting PROs in cancer drug development does so at its own peril.
Here’s something that Dr. Ethan Basch said. He said, “When I sit down with a patient to think about starting a new treatment, almost invariably the first question that they ask is how they will feel with this product.” Dr. Ethan Basch, by the way, I interviewed in EP157. He’s the director of the Cancer Outcomes Research program at the University of North Carolina.
In that interview, you can hear about how Dr. Basch and his colleagues found that by collecting patient-reported outcomes and acting on them, patient survival time improved something like 5 months. So put this in perspective: Those drugs that cost hundreds of thousands of dollars that are coming out … they don’t increase survival time that long.
Let’s bring this full circle. How is all of this relevant to evidence-based medicine? It’s relevant because all of those evidence-based pathways that we’re working on these days should lead to not “better patient outcomes.” They should lead to the outcomes that matter for this patient. And what matters is not some kind of universal truth. Patients at different points in their lives with different goals are going to have different ideas of what good looks like to them. We all know that what gets measured gets managed. So, if achieving patient outcomes or being patient-centric is the goal here and we’re not measuring PROs, then we’re not managing them either.
In this health care podcast, I speak with Nadine Jackson McCleary, MD, MPH, BSN. Dr. McCleary is an oncologist at Dana-Farber Institute and an assistant professor in medicine at Harvard Medical School. She is currently working on a project to collect patient-reported outcomes and make them actionable. I interviewed Dr. McCleary at the NODE Digital Medicine Conference in New York City recently.
You can learn more by connecting with Dr. McCleary on Twitter at @DrNJMcCleary.
Nadine Jackson McCleary, MD, MPH, BSN, is an assistant professor of medicine at Harvard Medical School, senior physician of the Dana-Farber Cancer Institute (DFCI), and medical director for the DFCI Patient-Reported Data Program in the department of informatics and analytics. As an active member of the Gastrointestinal Cancer Center, she specializes in gastrointestinal oncology with a unique clinical focus on those at the extremes of age (younger than 20 and older than 80). She serves as the liaison for the Gastrointestinal Cancer Center to the DFCI satellite and collaborative members.
As a clinical innovator in oncology, Dr. McCleary leverages her background in nursing and medicine to evaluate cancer care delivery for older adults diagnosed with colorectal cancer as a member of the Alliance Gastrointestinal Cancer committee and Cancer in Elderly committee. She also focuses on the development and implementation of clinical informatics to cancer care delivery and shared decision making between providers and patients. Her specific research objective is to refine implementation strategies for clinical informatics applications at the point of care and demonstrate improvement in cancer care delivery.
She serves as principal investigator of an implementation study evaluating the impact of electronic patient-reported outcomes on oral cancer therapy adherence. She is also part of the multisite implementation SIMPRO study under the NCI Moonshot Initiative IMPACT grant to develop, implement, and evaluate a multicomponent electronic patient-reported outcomes reporting and management system to improve symptom control for patients recovering from cancer surgery or patients receiving palliative chemotherapy in community cancer centers.
03:43 What percentage of patient outcomes are being reported?
04:16 Why only about 50% of outcomes are being reported by the physician.
06:35 Why reporting patient outcomes really does matter.
08:12 How survival and quality of life are significantly improved by patients who report on their symptoms.
08:57 The delta between wanting to collect patient outcomes and actually collecting those patient outcomes.
10:21 What Dana-Farber is actually doing when interacting with patients.
12:14 How long does it take to collect these patient-reported symptoms?
13:42 The cultural shift required to make this change at Dana-Farber.
14:26 How Dana-Farber is working toward using this data collection for population health management.
15:56 How Dana-Farber is improving one of the most reported patient symptoms: insomnia.
17:00 How collecting patient-reported symptoms and using health technology for this is actually eliminating tasks on the provider’s plate.
17:51 EP233 with Glenn Sabin.
19:03 How the patients feel about reporting their symptoms.
19:50 Barriers that Dana-Farber has had to overcome in incorporating these patient-reported symptom practices.
21:07 “The evidence is there, the support is there … but we still don’t have a clear how.”
22:20 “There is … a growing inequity in how big data is leveraged.”