This is the 16th in a series of interviews between CFAH President and Founder Jessie Gruman and patient and consumer group leaders about their experiences with and attitudes toward comparative effectiveness research (CER).
Gruman: Tell me about yourself and your organization.
Ellen Stovall: I am long-term cancer survivor. I have been diagnosed with three types of cancer over the past 41 years. I am also the former president and CEO of the National Coalition of Cancer Survivorship (NCCS) and currently serve as senior health policy advisor to that organization.
NCCS is a small non-profit policy-focused organization starting its 26th year. Its mission is to advocate for quality cancer care for people with all types of cancer.
Gruman: Where do you see comparative effectiveness research (CER) fitting in the effort to improve the effectiveness of health care?
Ellen Stovall: We think CER is particularly important in the age of personalized approaches to making decisions about cancer treatments and things like genomic testing. Doctors and patients alike are realizing that there are inadequate studies to assess the clinical utility of new interventions. CER fills a critical void between preclinical research and health services research ' and this intersection is that not yet well explored by comparing what's currently used to what might work better.
We are not learning all we need to from clinical trials. CER fills in important gaps in knowledge: are patients doing better with one method of treatment or protocol than another? This gap also exists for behavioral interventions: what works better to support and maintain behavior change relevant to how different people respond to treatment, managing symptoms and side effects, and preventing complications and recurrence? We need more such research. Rather than stifling innovation, I think CER will promote it.
Gruman: Tell me how NCCS views the relationship between CER and patient-centered outcomes research.
Ellen Stovall: I'm not sure I understand. I think it is mostly jargon. The words "patient-centered" are used to make people feel good. I think that unless CER studies are designed to shed light on day-to-day issues that people confront in cancer treatment, they aren't of value. Admittedly, we don't have this now. Clinical trials compare one regimen to another but don't measure patient experience, behaviors, satisfaction, cost improvement, value to the patient or value to the system. CER can start measuring these things and promote innovation where current treatments and approaches are not working.
Gruman: Can you give me an example of how your constituents have been affected by CER?
Ellen Stovall: Here are two areas ripe for policy and delivery reform that would benefit from CER:
One is to compare usual care with the IOM-defined care planning process detailed in the Lost In Transition and Ensuring Quality Cancer Care reports. You'd need to map out a contemplative, deliberate patient education and shared decision making process to create a plan consistent with the IOM definition to set goals for curative or palliative treatment and compare this with usual care. I think the findings would shed light on whether patient engagement improves patient experience and quality of care. Information could be collected about utilization, readmission and overall cost.
The other issue to look at is patient adherence to taking medication as more oral chemotherapy drugs come into market. We have no idea what patients are doing, and it will skew outcomes if we can't get a better handle on whether, when and how they are taking their medications. There are a number of different interventions that aim to improve adherence, and they should be compared to usual care, which is pretty much nothing special. Ultimately, this would help patients adhere to regimens they have chosen with their doctors as well as ensure that clinical trials of chemotherapy agents were more accurate because patients would be more adherent to recommended doses.
Gruman: How do you see the increased attention to CER affecting the care your constituents will receive in the future?
Ellen Stovall: I think CER is mostly positive. Things are so fractured, segmented, uncoordinated, and loosely and unaccountably botched in cancer care right now that just the act of doing the research will send a message that it's not going to be business as usual in the future.
It will be interesting to see if the science that is moving so quickly in cancer will be an excuse not to do CER. On the behavioral side, research is not doing the job in finding out how to support people's experience with cancer. For example, how to give people information that will aid their decision making and lessen their anxiety. The studies to come out of CER will help us do better. Not having the results allows common sense to prevail and we all know that the common sense of health professionals does not always align with the needs of individual patients.
Gruman: Some professionals believe that patients are opposed to comparative effectiveness research. Do you think this is accurate? If so, what do you think is behind this view?
Ellen Stovall: I think that the pharmaceutical industry that supports patient groups (we are one of those groups) has done more to try to shine the light on this research as a potential barrier to accessing innovative therapies. I believe the opposite, however. This research will bring evidence to bear on the truly innovative therapies that can help people. We don't have a lot of evidence right now about what is working. We are being frightened by CER because it hasn't been explained to us well.
Gruman: What are your fears and hopes for CER?
Ellen Stovall: My hopes are for an ongoing iterative experiment in CER that will be the new standard bearer for gathering evidence. Everywhere we turn, the reason we don't know things is that we don't have the data. We have to be able to say something doesn't work without being called heretical. For example, mammography. We have to be able to say that what is being practiced isn't consistent with current evidence. CER is at the foundation of research going forward. I don't see the alternative. People aren't participating in clinical trials. Trials are so expensive they can't be adequately funded, and patients and physicians alike are largely averse to randomization
Patients need to have the evidence about what works. Once given that evidence, we need to rely on people to make the best decision after weighing their options. It's when they are making those decisions without the evidence that they get in trouble. We'll be stuck here until we have the evidence. We've been chasing the cure rather than the care. Keep demanding comparative effectiveness research.