The way Joe Selby, MD, MPH tells it, the naming of the $3.2-billion Patient Centered Outcomes Research Institute (PCORI) – which from the outset had a charge to explore the comparative effectiveness of complementary and alternative medicine methods – was both serendipitous and brilliant. At the time the quasi-public agency was established as part of the Affordable Care Act, the idea of “comparative effectiveness research (CER)” a hot-potato for the medical industry. Medicine’s waste, morbidity, mortality and cost prompted interest in real-world, decision-oriented research. But powerful medical stakeholders were worried enough about the comparative effectiveness of their part of the status quo that elevating a “CER Institute” was not attractive. The patient centered name was a political compromise. It captured something of the real world. And what politician or stakeholder could oppose a name like that? In this interview at the end of his 9 year stint as PCORI’s founding executive director, Selby shares some of the “undeniable influence” – including at the NIH and the FDA and in discovering influences on cost savings that is growing out of PCORI’s active placement of patients at the table in decision-making.

[This is Part 1 of a two-part series that will continue next Integrator with an interview with the new chair of the PCORI Board of Governors, Christine Goertz, DC, PhD.]

Selby is a family physician with health services research training who worked 27 years at Kaiser. He has some familiarity with the complementary and integrative medicine movement. The CER dialogue included interest in research to evaluate the comparative effectiveness of complementary and alternative medicine practices.  In fact, PCORI’s enabling language required that at least one licensed “CAM” practitioner be on the institute’s Board of Governors. (In a remarkable move, that individual, Christine Goertz, DC, PhD, was recently chosen to chair that Board.)  Early in his term, Selby organized a “listening session” for his Board on these emerging fields from Dan Cherkin, PhD, Bob Mootz, DC, Michelle Simon, ND, PhD, Carlo Calabrese, ND, MPH with which I also participated. Through Goertz, I invited Selby to a webinar on PCORI for what is now the Academic Collaborative for Integrative Health.  CAM researchers served on multiple PCORI committees. This exit interview was thus something of an end-parenthesis since we’d last communicated 7 years ago. Notably, the interim executive director during PCORI’s search for a replacement for Selby is former NIH National Center for Complementary and Integrative Health director Josephine Briggs, MD.

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Integrator: Well, let’s jump right in. To what extent do you believe that PCORI has had an impact on the broader research enterprise?

Selby: It has had undeniable influence in the simple fact of what it has done in making the case that research is better with patients involved. Patient involvement went from being an idea that stirred fear in the hearts of researchers, of pharmaceutical companies, of the industry to something that everyone now subscribes to. It was kind of a no-brainer, but somebody had to take it up. The name required it of us. The change in respect and use for patient involvement came because they they found having patients engaged was rewarding.

How CER showed up as “patient-centered outcomes research”

Integrator: You mentioned that the name itself was somewhat serendipitous.

Selby: When I got to D.C., the first thing I asked was how it got that name. The talk when planning for the agency was all about comparative effectiveness research. The mind doesn’t immediately move to the patient when they thought of CER. But in 2009, nobody wanted to call it the Comparative Effectiveness Research Institute.  The name that they chose – the one we have – seemed to be not that well thought through. But it was palatable to everyone. I think we were very fortunate that this is what they chose. The people who gave us that name put the wheels in motion for putting patients in the center. We had to keep them there.

Integrator: So what is better with patients involved in research?

Selby: Well, as soon as we started bringing them in we found that they went to work. They liked being involved. They are very good at helping us ask questions that are meaningful. Part of our interest was in ending waste in research. We wanted research questions that would discover things that would be useful, that would help people make decision. The patients are very good at that.

Integrator: Have you seen PCORI’s engagement with patients carry over to the NIH?

Selby: First, NIH has a very different mission – it’s more about discovery, and ours at PCORI is 100% how to help people make decisions. I do know that at NIH as well as at the FDA we are seeing greater efforts to incorporate patients into research and looking at the impact of research. I think that this will grow at the NIH.

Controversy over funding “cost effectiveness research”

Integrator: Early on there was controversy about whether funding for CER could be used to examine comparative costs. This always seemed to make a good deal of sense given the cost problems in US medicine. But there was opposition and it was explicitly written into the enabling legislation that PCORI couldn’t do cost effectiveness research. Is that still true?

Selby: This has remained true. We cannot use QUALY (Quality Adusted Life Years) as a measure. However, most cost-effectiveness analysis does include effectiveness research that uses QUALY. We are very happy to be doing the CER that underlies such cost-effectiveness analysis. We’re happy to not do cost-effectiveness – but at the same time we are doing many things that have to do with cost. We have for example done a good deal and could do a lot more on the impact of utilization on costs.

Integrator: You said that the engagement of the patient is particularly useful here.

Selby: We find that if we make research more patient-centered, we’re more likely to get the care right. We are more likely to have a decrease in utilization and less waste. When we get care coordination right, when we get access right – both key issues for patients — we see reduced hospitalization, fewer ER visits. I think we will focus even more that next round on studies that look at reducing utilization.

Integrator: PCORI’s first cycle of funding and action is up. How is your renewal going with Congress?

Selby: We are looking to be re-authorized. We are very hopeful. We have bipartisan champions and support in both the House and the Senate.. We are optimistic that Congress will get it done by the end of the year.

Integrator: The funding level?

Selby: We anticipate that our funding levels will be consistent with what they have been during our first ten years, so we expect annual funding levels tp be aligned with previous years.

New characteristics needed in the research workforce

Integrator: Anything you expected to see happen at PCORI that you haven’t got done?

Selby: What we have done differently than I anticipated is that our portfolio has a lot of research on patient-centered care. I expected more head-to-head comparisons of treatment choices. I think going forward we will try to continue to pull the research community toward patient-centered care, to care coordination, etc. and we have a mandate to do comparative effectiveness.

Integrator: Any challenges for the research workforce with PCORI’s direction?

Selby: We’ve seen the workforce change to a substantial degree. They have to be able to get into a room with patients and other stakeholders. There may be a portion that yet thinks they don’t have to, but we make a strong case that research is better when patients are part of it. As I’ve said, there are signs that engagement makes it better. We also need to have researchers who can work in real world settings. Much of academic research is in institutes and that may be good for internal validity but not for real world outcomes. We need to have more training of researchers to be comparative effectiveness researchers inside of healthcare systems – and who know how to do the research without getting in the way. We do some training in this area.

Integrator: Before we go I have to ask – a distinctive feature of PCORI for many in the integrative health community was the requirement to fund comparative effectiveness research in the complementary and alternative space – and that one of your Governors come from these fields. It was a sort of arrival for some of us involved with these fields.  Could you comment on that part of PCORI’s portfolio – any characteristics, surprises, or next steps?

Selby:  We see integrative health interventions being studied in PCORI projects across a broad range of clinical conditions: from chronic pain, to cancer, mental health and substance abuse.  These are interventions that patients as well as researchers and payers have a great deal of interest in. We see comparisons between integrative medicine approaches and others that compare traditional medical care with integrative approaches.

Integrator: A remarkable recent development is the appointment of Christine Goertz, DC, PhD to chair the PCORI Board of Governors. Anyone with memory of the battles between medical doctors and chiropractors has to appreciate the power in a chiropractor leading a major federally-funded healthcare agency. And comments on Christine’s work there?

Selby:  Christine has provided leadership on the Board in a range of positions since Day One. I credit the GAO (Government Accountability Office) with having the wisdom to recognize her as an obvious choice to serve as PCORI’s next Board Chair.  Don’t forget that she is both a practitioner of integrative medicine – a chiropractor – and a brilliant clinical researcher.

Integrator: A last question: What’s next? for you

Selby: Grandchildren. Piano. Spanish. And returning to and reconnecting with my community in the Bay Area.

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I said good-bye to Selby by sharing a favorite piano piece from Eric Satie I’d recently re-discovered. Selby made note of it, and that he was thinking of learning a Satie piece. It has been a stoke of good fortune – less serendipitous than the choice of PCORI’s name given Selby’s exceptional fit for the PCORI post – to have this California family doctor, Kaiser physician and health services researcher serving in this transformative role for patient-involvement in US research. Putting patients at the center of research is being found to have remarkable benefits beyond what one might have expected. (Next issue: interview with chiropractor and PCORI Board of Governors chair Christine Goertz, DC, PhD.)