{"id":13817,"date":"2012-12-11T15:33:28","date_gmt":"2012-12-11T20:33:28","guid":{"rendered":"http:\/\/pmedicine.org\/epatients\/?p=13817"},"modified":"2012-12-11T16:49:20","modified_gmt":"2012-12-11T21:49:20","slug":"pcori-puzzle-can-a-marriage-of-goo-goos-and-pinky-ringers-transform-health-care","status":"publish","type":"post","link":"https:\/\/participatorymedicine.org\/epatients\/2012\/12\/pcori-puzzle-can-a-marriage-of-goo-goos-and-pinky-ringers-transform-health-care.html","title":{"rendered":"PCORI Puzzle: Can a Marriage of Goo-Goos and Pinky-Ringers Transform Health Care?"},"content":{"rendered":"

The new\u00a0Patient-Centered Outcomes Research Institute<\/a>\u00a0(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.<\/p>\n

PCORI\u2019s\u00a0most recent day of dialogue<\/a>, which I attended as a representative of the\u00a0Society for Participatory Medicine<\/a>\u00a0(SPM), was characterized by genteel civility and a big question mark: \u201cIs PCORI serious about transforming health care?\u201d When I asked directly, I didn\u2019t get much of an answer. The reason, I suspect, goes to PCORI\u2019s 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.<\/p>\n

Let me pause here a moment to parse the political shorthand. “Goo-goos” (Wikipedia<\/a>) are “good government” types, the kind of folks who trumpet the need for\u00a0transparency in government<\/a>\u00a0or 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.<\/p>\n

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.<\/p>\n

In contrast to the goo-goos are the pinky-ring set of political realists, whose motto was succinctly described by the late columnist\u00a0Mike Royko<\/a>: \u201cWhere\u2019s mine?\u201d Though some political pragmatists gush with goo-goo intentions \u2013\u00a0pacem<\/em>\u00a0Rahm Emanuel \u00ad\u00ad\u00ad\u2013they did not attain power by pulling all-nighters with a civics textbook.<\/p>\n

Pinky-ringers know that one man\u2019s waste is another man\u2019s 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\u2019s not worth funding an effort to find drugs to treat it.<\/p>\n

To head off this perceived threat, the pinky-ringers formed the\u00a0Partnership to Improve Patient Care<\/a>, which \u2013\u00a0according to the\u00a0Wall Street Journal<\/em><\/a>\u00a0\u2013 included \u201cthe lobbying arms of the drug, device and biotechnology industries, as well as patient-advocacy groups and medical-professional societies.\u201d The partnership says it favors \u201cwell-designed\u201d comparative effectiveness research, but is concerned about research that might be used \u201cin an inappropriate manner that may limit treatment options for patients.\u201d<\/p>\n

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\u2019s mission was carefully defined, any reference to \u201ccomparative effectiveness\u201d was taken out of the title and \u201ccost effectiveness\u201d became a no-no.<\/p>\n

The organization\u2019s vaguely upbeat name, however, has drawbacks. \u201cPatient-centered outcomes research\u201d is really a euphemism for \u201ccomparative clinical effectiveness research,\u201d which might be confused with \u201ccost-effectiveness\u201d 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\u2019re inventing something new. Sometimes they are, sometimes they aren\u2019t.<\/p>\n

At the workshop I attended PCORI gave the example of a 77-year-old black male with diabetes and hypertension who\u2019d had a heart attack and needed to choose between a stent and bypass surgery. What patient-oriented research was needed?<\/p>\n

Sadly, I\u2019m not sure PCORI\u2019s statement of principles \u00ad\u2013 \u201celevating and repositioning patients, caregivers and others as valuable but previously untapped partners in the patient-centered research enterprise\u201d \u2013 has much to add here. \u00a0The 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. \u201cDon\u2019t kill or injure me\u201d will always rank high on any patient\u2019s list of \u201cpreferences and values.\u201d<\/p>\n

A couple of attendees suggested a more patient-centered target would be a middle-aged woman. That\u2019s confusing two separate issues. Research to save a woman\u2019s life is intrinsically no more patient-centric than research to save a man\u2019s life; we, too, worry about \u201cour bodies, ourselves.\u201d Expanding the diversity of clinical research is a separate issue, but PCORI is hardly the first to address it.<\/p>\n

Similarly, traditional clinical research on chronic disease is moving by necessity to include \u201cpatient-centered outcomes\u201d 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.<\/p>\n

It\u2019s certainly encouraging that PCORI board and staff are walking the walk when it comes to modeling partnering. Towards meeting\u2019s 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\u2019t have membership cards.<\/p>\n

In any event, by then my SPM goo-goo side was too busy arguing with the pinky-ring part of me that\u2019s spent way too much time at Washington meetings. Here\u2019s how it went:<\/p>\n

Goo-goo<\/em>: 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!<\/p>\n

Pinky-ring<\/em>: Sure, they deserve kudos for prodding a closed research community to make sure the patient\u2019s voice becomes an integral part of the process. But let\u2019s wait and see whether that includes patients saying something other than, \u201cMy disease needs a lot more funding.\u201d Not that there\u2019s anything wrong with that.<\/p>\n

Goo-goo<\/em>: PCORI\u2019s statement of principles declares: \u201cPatients and those who care for them should be involved in every stage of the research process.\u201d That\u2019s very close to the SPM goal of \u201cactive involvement by patients, professionals, caregivers and others on all issues related to an individual’s health and health care.\u201d I see the beginning of a beautiful friendship.<\/p>\n

Pinky-ringer<\/em>: Yes, welcoming patients as research partners is an important step SPM fully supports. But it\u2019s only part of the picture. When you\u2019re at your doctor\u2019s office, or searching the web for information about your illness, you\u2019re not involved in formal research. What\u2019s PCORI doing that affects health care today?<\/p>\n

Goo-goo<\/em>: They want patients to have better tools to \u201cmake informed health care decisions.\u201d<\/p>\n

Pinky-ringer<\/em>: So does SPM. And the first crop of PCORI awardees could publish promising ideas on how to do that somewhere around 2016.<\/p>\n

Goo-goo<\/em>: You seem to forget that one PCORI priority is \u201ccommunication and dissemination.\u201d It says right here: \u201cempowering people to ask for and use information and supporting shared decision-making.\u201d<\/p>\n

Pinky-ringer<\/em>: \u201cCommunication and dissemination\u00a0research<\/em>.\u201d 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\u2019re 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.<\/p>\n

The pinky-ring part of my personality has been reinforced by critical articles from respected PCORI observers such as\u00a0Harold Sox<\/a>\u00a0and\u00a0Douglas Kamerow<\/a>. Still, PCORI could evolve. Maybe PCORI plans over time to pair activism with its knowledge gathering. Maybe PCORI\u2019s outreach will build bridges of trust that allow it to have a more sweeping impact on patients’ 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.<\/p>\n

At the workshop, the president-elect of the American Medical Association,\u00a0Dr. Ardis Dee Hoven<\/a>, repeatedly urged PCORI to quickly produce decision tools for doctors that are \u201crelevant at the point-of-care.\u201d She also was careful to endorse shared decision-making. I took that as a hopeful sign.<\/p>\n

Because I can\u2019t think of anything more patient-centered working with my participatory doctor to make sure that the very best outcomes happen to me.<\/p>\n

 <\/p>\n","protected":false},"excerpt":{"rendered":"

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