The new Patient-Centered Outcomes Research Institute (PCORI) has been asking different stakeholders about the most important issues to address with the hundreds of millions of dollars the quasi-governmental group will shortly be doling out in grants. Not surprisingly, the stakeholders have been more than happy to respond.

PCORI’s most recent day of dialogue, which I attended as a representative of the Society for Participatory Medicine (SPM), was characterized by genteel civility and a big question mark: “Is PCORI serious about transforming health care?” When I asked directly, I didn’t get much of an answer. The reason, I suspect, goes to PCORI’s origins. It is the offspring of a shotgun marriage between goo-goos and pinky-ringers, and no one is quite sure yet what this child will be once it grows up.

Let me pause here a moment to parse the political shorthand. “Goo-goos” are “good government” types, the kind of folks who trumpet the need for transparency in government or better public transit. Goo-goos, seeing the half trillion dollars or so of waste in U.S. health care system, called for a new national organization to carry out comparative effectiveness research in order to help Americans get the most value for our money.

The goo-goos pointed out that our current regulatory structure is designed to ensure that treatments are safe and effective, not compare them. Nor does the private sector have much incentive to pay for comparative studies that may undermine products currently selling quite nicely, thank you.

In contrast to the goo-goos are the pinky-ring set of political realists, whose motto was succinctly described by the late columnist Mike Royko: “Where’s mine?” Though some political pragmatists gush with goo-goo intentions – pacem Rahm Emanuel ­­­–they did not attain power by pulling all-nighters with a civics textbook.

Pinky-ringers know that one man’s waste is another man’s comfortable income, and that what looks like a rational buying decision to one person can appear to be rationing by bureaucratic fiat to another. Or, as I heard a drug company official put it a couple of years ago, comparative effectiveness research opens the door for telling kids with cancer it’s not worth funding an effort to find drugs to treat it.

To head off this perceived threat, the pinky-ringers formed the Partnership to Improve Patient Care, which – according to the Wall Street Journal– included “the lobbying arms of the drug, device and biotechnology industries, as well as patient-advocacy groups and medical-professional societies.” The partnership says it favors “well-designed” comparative effectiveness research, but is concerned about research that might be used “in an inappropriate manner that may limit treatment options for patients.”

As the Affordable Care Act inched towards law in 2010, the goo-goos and pinky-ringers reached a compromise. PCORI was set up as an independent non-profit, with a budget coming from ACA monies without need for a yearly Congressional appropriation. However, the agency’s mission was carefully defined, any reference to “comparative effectiveness” was taken out of the title and “cost effectiveness” became a no-no.

The organization’s vaguely upbeat name, however, has drawbacks. “Patient-centered outcomes research” is really a euphemism for “comparative clinical effectiveness research,” which might be confused with “cost-effectiveness” which might remind someone of rationing. Since the whole point of a euphemism is not to acknowledge it, PCORI and academics with dollar signs in their eyes have to pretend they’re inventing something new. Sometimes they are, sometimes they aren’t.

At the workshop I attended PCORI gave the example of a 77-year-old black male with diabetes and hypertension who’d had a heart attack and needed to choose between a stent and bypass surgery. What patient-oriented research was needed?

Sadly, I’m not sure PCORI’s statement of principles ­– “elevating and repositioning patients, caregivers and others as valuable but previously untapped partners in the patient-centered research enterprise” – has much to add here.  The conventional outcome measure of mortality seems to me as patient-centric as you can get, whether or not patients were involved with the study design. “Don’t kill or injure me” will always rank high on any patient’s list of “preferences and values.”

A couple of attendees suggested a more patient-centered target would be a middle-aged woman. That’s confusing two separate issues. Research to save a woman’s life is intrinsically no more patient-centric than research to save a man’s life; we, too, worry about “our bodies, ourselves.” Expanding the diversity of clinical research is a separate issue, but PCORI is hardly the first to address it.

Similarly, traditional clinical research on chronic disease is moving by necessity to include “patient-centered outcomes” such as pain and functional status. PCORI will accelerate that trend. But whether PCORI will push researchers towards breakthroughs in patient-centeredness or more creative relabeling remains to be seen.

It’s certainly encouraging that PCORI board and staff are walking the walk when it comes to modeling partnering. Towards meeting’s end, I felt the urge to rush the stage and present various PCORI luminaries with SPM membership cards to recognize their participatory props. Except we don’t have membership cards.

In any event, by then my SPM goo-goo side was too busy arguing with the pinky-ring part of me that’s spent way too much time at Washington meetings. Here’s how it went:

Goo-goo: PCORI is spending more than $100 million this year, $300 million in 2013 and $400 million in 2014 on patient-centered outcomes research. What a tremendous victory for patients!

Pinky-ring: Sure, they deserve kudos for prodding a closed research community to make sure the patient’s voice becomes an integral part of the process. But let’s wait and see whether that includes patients saying something other than, “My disease needs a lot more funding.” Not that there’s anything wrong with that.

Goo-goo: PCORI’s statement of principles declares: “Patients and those who care for them should be involved in every stage of the research process.” That’s very close to the SPM goal of “active involvement by patients, professionals, caregivers and others on all issues related to an individual’s health and health care.” I see the beginning of a beautiful friendship.

Pinky-ringer: Yes, welcoming patients as research partners is an important step SPM fully supports. But it’s only part of the picture. When you’re at your doctor’s office, or searching the web for information about your illness, you’re not involved in formal research. What’s PCORI doing that affects health care today?

Goo-goo: They want patients to have better tools to “make informed health care decisions.”

Pinky-ringer: So does SPM. And the first crop of PCORI awardees could publish promising ideas on how to do that somewhere around 2016.

Goo-goo: You seem to forget that one PCORI priority is “communication and dissemination.” It says right here: “empowering people to ask for and use information and supporting shared decision-making.”

Pinky-ringer: “Communication and dissemination research.” You want to support three PhDs and a statistician studying patient-centered communication, or dissemination of innovations, PCORI is your go-to place. You want to persuade people to change their behavior today, based on the evidence we know today about patient engagement, you’re on your own. Funding research that someone can use sometime to transform American medicine someday is a worthy endeavor, but irrelevant to activists pushing for change now.

The pinky-ring part of my personality has been reinforced by critical articles from respected PCORI observers such as Harold Sox and Douglas Kamerow. Still, PCORI could evolve. Maybe PCORI plans over time to pair activism with its knowledge gathering. Maybe PCORI’s outreach will build bridges of trust that allow it to have a more sweeping impact on patient’s lives in a shorter period than now appears likely. Or maybe my expectations of a research organization looking towards Congressional renewal of its mandate in 2019 are unrealistic.

At the workshop, the president-elect of the American Medical Association, Dr. Ardis Dee Hoven, repeatedly urged PCORI to quickly produce decision tools for doctors that are “relevant at the point-of-care.” She also was careful to endorse shared decision-making. I took that as a hopeful sign.

Because I can’t think of anything more patient-centered working with my participatory doctor to make sure that the very best outcomes happen to me.

Michael L. Millenson is president of Health Quality Advisors LLC in Highland Park, IL; the Mervin Shalowitz, MD Visiting Scholar at the Kellogg School of Management; and a board member of the Society for Participatory Medicine.

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18 Responses for “Patient Politics: the PCORI Puzzle”

  1. Roy Fouts says:

    Health care has a penchant for nonsense names. Your article points out the difference between the well intended and purposefully disguised. Sadly not many will recognize the difference. Kind of like the ignoring of the value of being doctored and not.

  2. Yasmine says:

    I wish to complete the Medical Career Specialists’ 2-day Phlebotomy Training to work in this field. What kind of advice may you give to me? Is it not good field to enter at this time?

  3. The semantics game is really irritating. “Patient-centered outcomes research” sounds more like investigating whether it’s better to pray or sing kum-by-ah. “Comparative clinical effectiveness research”, if that’s what it really is, should be an honest evaluation of what interventions work the best. If those research results mean that the less effective interventions will be “less available” (read “rationed” if you like), isn’t that the whole idea?

  4. Dan Smith says:

    There are some amazing research findings lately on Vitamin D. This hormone affects practically every major system in the body and prevents diseases. But practically everyone is deficient and not receiving this protection. Increasing Vitamin D intake is the singlest best way to improve health across the board for Americans. This would definitely cut healthcare costs. Any entity desiring to cut their healthcare costs should look now at Vitamin D. The research is amazing. Increased Vitamin D intake (blood level of 40 – 60 ng/mL) is required to reach therapeutic levels. Folks with this level are rare. These folks stay well while those around fall sick for one reason or another. The benefits of a higher Vitamin D level are becoming clearer as research identifies the mechanism by which the body uses Vitamin D. This information is not reaching the general public and our lawmakers. So the medicial lag is costing us greatly in neededless healthcare costs resulting from this general ignorance. There needs to be a National Vitamin D Awareness Program. How do we get this started?

  5. Michael, a wonderfully clever and insightful piece, as usual.

    But it’s pretty clear that, when the big health care interests – e.g., drug, device and supplies vendors – come together, they’re focused on killing meaningful 1) comparative research and 2) market forces. You can put all the lipstick on the pig you want, but what they want is a clear path for their solution, whether it works or not and at whatever cost they can get away with, to be the one that’s used, preferably with no competition. There is so much unabashed experience on this point that it is simply not useful to suggest the benefit of a doubt.

    For the government to set up a quasi-governmental entity, and for that organization to get the complicity of the participatory medicine community, is a brilliant scam, but a scam nonetheless. The Society for Participatory Medicine needs to be careful of who it lies down with, lest it get up with fleas. It should be very concerned with getting compromised in this situation.

  6. southern doc says:

    As long as we refuse to pay physicians to sit down and talk with the 77-year old black male or the middle-aged woman and discuss their choices, isn’t the whole process a waste of time?

  7. Paying physicians to sit down and talk is only part of the issue. They do, indeed, need to know what they’re talking about. As should their patients. That’s why the president-elect of the AMA called for more and better point-of-care information.

    Of course, a key question is whether information that goes against the interests of some major corporation will be the subject of a concerted campaign to discredit it. I do not think PCORI is either useless or a scam. I do not know, however, whether the grants that they give out will lead to high-value, transformational research that addresses the pressing need for controlling costs while improving quality.

    Maybe, as long as they don’t use the words “value” or “cost,” they’ll be able to accomplish this task. Maybe.

  8. Peter1 says:

    Discussing treatments with patients is like forecasting the weather. Weather people always provide a percentage of accuracy so that they’re never wrong.

    How is the patient going to make the proper decision even when given a 1% chance of success – especially when it costs them nothing.

    I listened to a radio discussion on the benefits and risks of mammograms. No matter the risks there was always that kernel of not knowing fear that ultimately drove patients and their doctors to test, test, test. Add to that are the anecdotes (sans meaningful information) about someone’s close relative being saved by one of those tests.

    Health providers are adept at using those kernels of fear and doubt to drive profits, especially when used with their lobbying power.

  9. southern doc says:

    Don’t discuss the pros and cons of mammograms with radiologists.
    Don’t discuss PSAs with urologists.
    Don’t discuss stents with interventional cardiologists.

    Get it?

    • Peter1 says:

      There wasn’t a radiologist on the panel.

      So, does that also mean to avoid all specialties for advice or they’ll just put you in their operative queue?

  10. southern doc says:

    Don’t get advice (or at least evaluate it appropriately) from someone with a conflict of interest.

    • Peter1 says:

      Then who would patients trust to have the best information other than a specialist in that field who’s seen hundreds, if not thousands, of similar cases?

      Where in health care exists consultants who have no monetary interest and who have the best information and hands on experience?

  11. Peter1, there are lots of specialists who are salaried and therefore don’t have a financial conflict of interest. Academic medical centers, for example, and many top-of-the-line institutions. This is one reason why Walmart just cut a deal with 6 Centers of Excellence – Mayo, Cleveland, Geisinger, Scott & White, Virginia Mason and Springfield – for spinal, heart and transplant surgeries. When the care decision isn’t influenced by personal financial gain, unnecessary surgeries are reduced, and a host of other benefits accrue.

    Some years back Health Affairs ran a highly credible study of 2 million cancer patients showing that, while academic oncologists tended to follow evidence-based best practice guidelines, community oncologists, who were in private practice and making significant margins on cancer drugs, would often move their patients away from more appropriate drugs that were less profitable, and to drugs that were more profitable.

    You can’t make this stuff up.

    • Peter1 says:

      Brian, from this article it appears that Walmart is using bundled payments to reduce its costs because it can plan on the expense. Surgery is still surgery, but a contracted bundled payment allows for better budgeting and forecasting.

      http://www.advisory.com/Daily-Briefing/2012/10/12/Wal-Mart-six-hospitals-launch-bundled-payments

      I fully agree that salary is the solution for U.S. healthcare, but you’ll have to also convince the hospitals that lower revenue is good.

      I don’t even know which ” academic” I’d be able to see where I live even given that the University of North Carolina is just down the road.

      As for hips or knees you can get a cortisone injection that will give you some time before needing surgery, but surgery is the only real choice.

  12. Here’s a study that just came out that reinforces Brian’s point on oncology.

    The answer to dealing with conflict of interest AND the “enthusiasm problem” (surgeons genuinely believe in surgery) is second opinions to different specialists and patients doing research on their own. Not always easy for all income groups and education levels, but we are in this country, slowly, evolving tools for all.

    Below is the study.

    International Journal of Health Care Finance and Economics
    December 2012, Volume 12, Issue 4, pp 285-302
    Physician response to financial incentives when choosing drugs to treat breast cancer
    Andrew J. Epstein, Scott J. Johnson
    Abstract
    This paper considers physician agency in choosing drugs to treat metastatic breast cancer, a clinical setting in which patients have few protections from physicians’ rent seeking. Physicians have explicit financial incentives attached to each potential drug treatment, with profit margins ranging more than a hundred fold. SEER-Medicare claims and Medispan pricing data were formed into a panel of 4,503 patients who were diagnosed with metastatic breast cancer and treated with anti-cancer drugs from 1992 to 2002. We analyzed the effects of product attributes, including profit margin, randomized controlled trial citations, FDA label, generic status, and other covariates on therapy choice. Instruments and drug fixed effects were used to control for omitted variables and possible measurement error associated with margin. We find that increasing physician margin by 10% yields between an 11 and 177% increase in the likelihood of drug choice on average across drugs. Physicians were more likely to use drugs with which they had experience, had more citations, and were FDA-approved to treat breast cancer. Oncologists are susceptible to financial incentives when choosing drugs, though other factors play a large role in their choice of drug.

  13. Peter1, I also wrote about the Walmart Center of Excellence (COE) here: http://thehealthcareblog.com/blog/2012/10/18/walmart-moves-health-care-forward-again/.

    That deal leverages a lot more than just bundled payments. First, it isn’t necessarily so that “surgery is still surgery.” There’s a mountain of data showing that north of 1/3 of surgeries are unnecessary and inappropriate, so 2nd opinions from independent COE physicians often reveal misdiagnosis. (Mayo reportedly sends home a high percentage of patients referred to them for transplants, because it finds that patients don’t need them.)

    The Walmart deal also insists that the participating COEs exhange their surgical protocols and extensive performance. This way Walmart can see which systems are getting the best outcomes, and who, for example is doing the best job coordinating care with the physician back home. It is a very thoughtful comprehensive approach that uses its volumes to exert leverage, going considerably beyond simply bundling the reimbursements.

  14. Peter1 says:

    “Physicians have explicit financial incentives attached to each potential drug treatment,”

    Michael, isn’t it the hospital that has those financial incentives?

    This conversation is all good, but how do you get past the political and business lobby hurdles to get us to a different place? You’d also have to ban retail drug ads that drug companies use to circumvent best practice.

  15. Peter, the wording you quote comes directly from the journal article, not me, so I presume it is accurate. Of course, hospitals can also have financial incentives.

    There is no way to circumvent human nature, be it of patients, doctors or profit-maximizing others, but having financial incentives pushing in the right direction and point-of-care information for doctors and patients alike is where we need to go and where the Affordable Care Act starts to take us. No nirvana on the horizon, but, fortunately (?), our system is so wasteful that taking out even a small chunk of a $2.7 trillion budget is a lot of money.

    I’m not a believer in panaceas, just hard work.

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