Dr. Joe Selby, Executive Director of the Patient Centered Outcomes Research Institute

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Mark Masselli: This is C onversations on Health Care . I’m Mark Masselli.

Margaret Flinter: And I’m Margaret Flinter.

Mark Masselli: Well Margaret, the negotiations continue in Washington over the
much talked about fiscal cliff.

Margaret Flin ter: And it’s interesting to know Mark that words like compromise
and common ground are cropping up more frequently in the discussion over what
to do about those fiscal changes looming on January 1, 2013.

Mark Masselli: It rings in the New Year and al so it might ring out the Bush era
st
tax cuts which expire January 1 and spending for a number of social programs,
including Medicaid will see an instant reduction unless some kind of negotiation
is found.

Margaret Flinter: The President wants to see ta xes increase only on the
wealthiest Americans while the Republican leadership is still calling for those
social programs to be put on the table for discussion, including the Health Care
Law, hard to see those as social programs.

Mark Masselli: It’s true. Déjà vu, all over again because there really hasn’t been
much progress from either side on their respective ideas about how to solve the
problem, but it is interesting to note that more politicians in the GOP are backing
off of their no - tax increase pled ge. Mr. Nordquist may not be happy about that.

Margaret Flinter: So we’ll see how the negotiation progresses in Washington
with fewer politicians perhaps strong armed into just saying no.

Mark Masselli: Whatever the outcome of the fiscal cliff discuss ions could have a
big impact on the areas including health care education and infrastructure
rebuilding and probably even social security.

Margaret Flinter: But it’s also unlikely that the Affordable Care Act will be
dismantled or in my opinion, tempered with to any significant degree to make
way for that tax compromise, but we’ll see if I’m wrong.

Mark Masselli: That would be good news for today’s guest, Dr. Joe Selby who is
the executive director of the Patient - Centered Outcome Research Institute, a lso
known as PCORI.

Margaret Flinter: PCORI is one of the not so well - known provisions within the
Affordable Care Act and Dr. Selby is one of the nation’s top health care
researchers and is using his expertise and particularly his focus on the patient

ex perience to advance PCORI’s mission of promoting research that gives us the
data on health care practices that yield the best outcome for patients.

Mark Masselli: And we’ll hear from Factcheck.org ’s Lori Roberts on who looks at
claims on Capitol Hill on the Health Care Law, but no matter what the topic, you
can hear all of our shows by Googling CHC Radio.

Margaret Flinter: And don’t forget, if you have comments email us at
CHCRadio.com or find us on Facebook or Twitter because we love to hear from
you.

Mark Masselli: We’ll get to our interview with Dr. Joe Selby in just a moment.

Margaret Flinter: But first, here is our producer Marianne O’Hare with this week’s
headli ne news.

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Marianne O’Hare: I’m Marianne O’Hare, with these health care headlines. The
Health Care Law continues to be a topic of contention, legally and politically.
Discussions are under way this week on how Congress plans to deal with the
upc oming fiscal cliff when a number of social programs see their financial support
ending and a number of Bush era tax cuts are due to expire.

Republican House minority leader John Boehner says, “There can be no
discussion about compromise on revenues withou t the Health Care Law being
part of that discussion.” And the Supreme Court has cleared the way for another
legal challenge to the law; Liberty University and Christian College in Lynchburg,
Virginia claims the law forces their organization to subsidize abortions and the
contraception. The High Court has decided to allow their challenge to be heard
th
in oral arguments in the 4 District Court of Appeals, paving the way for the
challenge to move closer to a hearing before the High Court. There are
numerou s other religious - based challenges to the Health Care Law waiting in the
wings.

Meanwhile, the American Academy of Pediatrics is weighting into this
controversial territory. They issued a statement this week, urging pediatricians to
pre - prescribe emergen cy contraception, known as Plan B ahead of time to all
teenage girls under 18. Plan B is available without a prescription for those 18
and older. This would eliminate the need to seek out a doctor for teens worried
about the possibility of a pregnancy.

When you think of foods that seem synonymous with a healthy diet, grapefruit
comes to mind but folks taking any number of medications should take note. A
study out of Canada shows that properties in grapefruit can alter or inhibit the
efficacy of as many as 85 different kinds of drugs, including statins; commonly

prescribed for cholesterol and high blood pressure. The side effects occur when
fouranocoumarin, a chemical in grapefruits, binds with enzymes and prevents
them from properly breaking down the dr ugs. ABC News has posted a full list of
the drugs at list on their news website.

I’m Marianne O’Hare, with these health care headlines.

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Mark Masselli: We’re speaking today with Dr. Joe Selby, executive director of
the Patient - Centered Outcom es Research Institute, known as PCORI, an
independent nonprofit health research organization, authorized by the Affordable
Care Act. PCORI was created to provide patients and providers the most
informed prevention, diagnosis and treatment options in healt h care by
conducting rigorous research on national patient outcomes. Dr. Selby is a family
physician, a clinical epidemiologist and recently served as the director of the
Division of Research at Kaiser Permanente where he oversaw 500 research
clinicians a nd 250 ongoing studies. Dr. Selby is an author of more than 200
peer - reviewed articles and continues to focus his study efforts on diabetes and
quality improvement. Dr. Selby, welcome to Conversations on Health Care.

Dr. Selby: Thank you very much, Mar k and Margaret. It’s a real pleasure to be
here.

Mark Masselli: Well, we saw that President Obama is re - elected, which really
bodes well for the continued advancement laid out in the Affordable Care Act
which established PCORI to shift the focus in hea lth care research to really take
into account the patient - centered experience and to evaluate patient outcomes
so that improved quality on patient outcomes, government health policy and
practices. Could you tell our listeners a little more about PCORI and what’s new
and innovative about your approach, and what kind of impact you expect to have
on patient outcomes in health care?

Dr. Joe Selby: Yes. PCORI’s brand new and I want to emphasize that PCORI is
a research funding organization, so we will be pro viding funding to researchers,
to clinicians, to patients; particularly when they join together to apply for funding
and we are interested in research questions that provide useful information to
patients and their caregivers and their clinicians as they f ace critical health care
decisions. It’s the existence of PCORI and its placement in the Affordable Care
Act recognize that despite the fact that we actually spend $150 billion or $160
billion a year on clinical research in this country alone, it’s still the case that
patients often get to a decision point and don’t have practical information that
really compares two or more options that form a decision that patients have to
make. So, we focus on trying to fill that void, provide that clinical information and
we pay particular attention to what works for whom. So we recognize that the

same treatment doesn’t work exactly as well for every patient and sometimes,
one has to tailor these treatments to who the patient is.

Margaret Flinter: So Dr. Selby, th e PCORI model set out to establish a new
format for researching outcomes to involve patients and their providers, and to do
it using comparative clinical analysis and in an article in Health Affairs, you
outlined really two very different research approach es; investigative generated
research such as clinical drug trials by pharmaceutical companies or testing of
surgical devices, but also a patient - stakeholder led approach. Tell us about the
difference between these two research protocols and how does that play out in a
research protocol. What does it mean to have a patient - stakeholder approach?

Dr. Joe Selby: Well, we’re trying to get the patient’s voice and the clinician’s
voice into the research process, and we think that if we do that it’s more likely
that when the research is done it’ll answer the right questions. Often times, the
research is done; it’s a very elegant research, it just doesn’t quite answer the
question that clinicians were asking or patients were asking. So, we have two
approaches t o getting those right questions.

They can both be just about any kind of clinical questions and we really think
both pathways are important. We send out broad announcements, explaining
the kinds of research comparisons that we’re interested in. We say, send us the
most compelling questions and when you do, join with patients, join with the
relevant clinicians and tell us why this question is important to patients. So we’re
very open and interested in what researchers and patients and other
stakeholders come up with on their own and submit to us, but sometimes
patients and clinicians and others aren’t really prepared to just sit down and write
a research proposal, and so we engage patients and their patient organizations,
clinicians and their organization s in a kind of ongoing brainstorming session that
looks for the right questions, and then we invite them to join us in prioritizing
them and helping us decide which questions, if answered, would be the most
likely to provide information that’s lacking now; the most likely to change practice,
the most likely to improve outcomes.

Mark Masselli: Dr. Selby, you bring a nice combination of qualities to your
position; you are a brilliant research leader and you are a tireless patient
advocate. You’ve identif ied five key target areas in particular. Can you tell us a
little more about what they are and how will they govern where PCORI grants go
in the future?

Dr. Joe Selby: The statute itself told us that before we get started funding
research we had to get together with the stakeholder community and identify the
priorities that would guide our research. Now they could’ve been very narrow
priorities. We could have focused in just on five diseases, if you wanted. We
didn’t. We named five broad priority are as and I’ll them to you in just a minute
but I’ll just say that we think they fit together nicely. So here is the first one; it’s

called Assessment of Options for Prevention, Diagnosis and Treatment. That
really gets at questions at the patient level abo ut which treatment or which
preventive measure works best for me. That’s kind of the classic comparative
effect in this research paradigm, and that’s only one of our five priorities.

The second one is called the Improving Health Care Systems, and so that just
recognizes what I know, you two know, that the system where patients get their
care has a lot to do with whether they hear the options, whether they get the
options, whether they get follow - up, whether their care is coordinated. Best for
whom, so im proving health care system is the second.

The third is called Communication and Dissemination Research and that just
recognizes the fact that once you get the evidence collected and established,
you’ve got to find ways to get it out so that people are awa re of the evidence.

The fourth is Addressing Disparities, and that just is based on the widely
recognized fact now that treatments don’t work the same for everybody. So, we
start from the fact that there are disparities and we say, we will fund research that
addresses ways to eliminate those disparities.

And the fifth is a priority about building the infrastructure to do more of this
research. We really think we need to change the culture in this country so that
out in the clinics, out in the hospitals, out in the health care systems we are
asking and answering these questions all the time that patients and our clinicians
come to recognize that when you don’t know the answer; when you’re making
decisions and advising patients on what to do and you realiz e you don’t really
know the answer, the best thing to do is ask the question and get the answer,
and for that you need an infrastructure. You need to put clinical data together
into large databases. You need to find ways to analyze those data more
effect ively so you need better methods, and we need to train both researchers
and clinicians, and patients to participate in this research. That’s the fifth one,
our infrastructure priority.

Margaret Flinter: That third piece; the community participatory appr oach can be
very challenging. I wonder if you could share with our audience what you’ve
seen around the country in terms of best practices of how people are bringing
communities of patients together, what are people using as strategies to get at
that pati ent - stakeholder involvement that you’ve seen as being successful.

Mr. Joe Selby: Well, first let me say Margaret that I completely agree with you. I
like to say sometimes that what we do here at PCORI is community - based
participatory research applied to clinical questions. We are not by and large
studying issues in the community as much as issues in clinical decision making,
but we use all the principles that led to the development of this community - based
participatory research movement and we’ve starte d, we have a very active
website with lots of ways for patients to get engaged with us. We talk about

building a patient and patient advocacy community across the country and that’s
growing rapidly.

We have online ways for patients to submit questions t hat we then process and
put into the prioritization scheme. Very exciting, patients have a hand in
formulating the questions and in collecting and looking at the data, and that is
just one of many, many examples. Many online communities are already forme d;
often organized around a particular disease, often around rare diseases and
those patients have come together in substantial part because they want to
contribute to research. So, we’re looking for ways to partner with them, we’re
looking for ways to li nk these kinds of online communities with the clinical data
that exists for them in electronic health records. So we think that’s a part of the
solution.

We think that surveys and particularly social media type of surveys are a good
way to keep our finge r on the pulse. We look for a lively, vibrant, two - way
program of communication. We also are forming advisory panels. So these will
be smaller numbers of people but selected from large pools of applicants to be
representative to help guide PCORI and adv ise PCORI. So they’ll watch with us
over time and keep us hopefully on the cutting edge of patient engagement.
There is a lot to be learned, just about how to do it right.

Mark Masselli: We’re speaking today with Dr. Joe Selby, executive - director of
th e Patient - Centered Outcomes Research Institute, an independent nonprofit
health research organization, authorized by the Affordable Care Act. PCORI was
created to provide patients and providers the most informed prevention,
diagnosis and treatment options in health care by conducting rigorous research
on national patient outcomes.

I want to sort of pull the thread on one of the five priorities that you talked about
before and that was really on communication and dissemination. I know we’re
engaged with the Dartmouth Institute on the clinical microsystems change
process and I know one of the biggest problems and challenges that we have;
there are a lot of good practices and important things for people to do, but that
change process is very difficult out in the clinical setting. So past sharing the
information, what other tools in the tool belt are you giving practices to help them
with this transformation that they are all going to go through over the next many
years?

Dr. Joe Selby: It’s a very good qu estion Mark, and you are right that systems
and the clinicians that work in them don’t feel like they have a lot of time on their
hands to sit around and discuss change. It’s happening on the fly; as they are
very busy seeing patients and trying to make d ecisions.

I think one principle that we’re pretty convinced is important is that there has to
be something in this for everybody. So, clinicians and patients have to feel like

they are getting something out of this process of change. It can’t in any wa y be a
top down approach. So that takes us back to our principle of involving these key
players from the beginning. Often, these ideas are not one size fits all ideas. So
the same intervention doesn’t necessarily work for 100% of patients, and if you’re
not careful your interventions will improve care for some patients but they could
actually worsen disparities or differences between patients. So we think that is
done better with patients at the table.

The third thing to say is that we will be funding implementation research, so we’re
very interested in how you take evidence and put it into practice, but a lot to be
learned as you suggest.

Margaret Flinter: But Dr. Selby, I think one of the dichotomies certainly that
we’ve seen historically is that th e research lives within academia, the practice
lives within the community and the gap and the chasm between the two can be
very broad because it takes of course skill and resources, and training to do the
research. Maybe you could speak to us a little bit about how are you seeing
people bridge that gap, how are the universities and the traditional centers of
research connecting with the community - based partners to do this critical work of
designing the research studies that address the five key areas that PCORI is
focusing on?

Dr. Joe Selby: I think it is going to be a change, having been one of those
researchers I think it does represent a change. In our very first announcements
issued last May, we laid out these instructions that you must have relevant
patients and other stakeholders involved in the team and we’ve got on the order
of 1,300 letters of intent, people saying they were submitting applications but
when the application deadline came, we had just 488 and that’s a remarkable
fall - off. And when we polled people; the applicants who had said they were
going to send us proposals, they told us that the main reason they didn’t was
because it was taking more time than they thought to establish these
connections.

So, that’s a signal to us that you’re right, it’s difficult but on the other hand the
availability of research funding and the requirements we put in are having an
effect and over time, we’re going to waste a tremendous opportunity if we don’t
study these interactions and learn from them what works the best, but we are
clearly seeing these partnerships. I mean they were there before we came on
the scene and our funding is strengthening those partnerships. We really hope
also that we see some new players at the table in terms of who is leadin g these
and we’ll be delighted to see applications come in from community clinics and
neighbor health centers, patient organizations; we’ll be delighted to see them in
the lead of these applications and bringing researchers along to make sure we
get the me ssage right.

Mark Masselli: Dr. Selby, we’d like to ask all of our guests this final question;
when you look around the country and around the world, what do you see in
terms of innovation and health care that our listeners at Conversations should be
kee ping an eye on?

Dr. Joe Selby: There is a lot of things going on. I think this appreciation is we’ve
been talking about already of the critical care of systems and the potential for
systems. Most people still get their care in settings that really you’ d have to
admit are not part of organized systems. So there is just a huge potential for
organizing care more thoughtfully for aligning the incentives of the various
players so that the people are talking to each other and they are on the same
page; they are trying to accomplish the same thing which is improved outcomes.

So I think systems have just an amazing amount going for them and the
Affordable Care Act recognizes that in many, many ways. And the second is
this relatively new idea that whether we’ re talking about pills or surgeries, or
systematic approaches to care or health education, they are not going to work
the same for everybody and we have to pay a lot more attention than we have to
the fact that patients are different. So whether we’re tal king again about
medication, surgeries or system interventions; more attention to the patients and
in tailoring those interventions, I think it’s going to lead what some call
personalized medicine but it’s also going to just lead to smarter medicine and
mo re efficient, and goodness knows we need more efficient medicine.

Margaret Flinter: We’ve been speaking today with Dr. Joe Selby, executive -
director of PCORI, the Patient - Centered Outcomes Research Institute which is
an independent nonprofit health resea rch organization committed to providing
patients and providers the most informed prevention, diagnosis and treatment
options in health care by conducting rigorous research on national patient
outcomes. You can find out more about his work by visiting www.PCORI.org .
Dr. Selby, thank you so much for joining us on Conversations on Health Care
today.

Dr. Joe Selby: Thank you, Mark and Margaret.

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Mark Masselli: At Conversation s on Health C are, we want our audien ce to be
truly in the know when it comes to the facts about health care reform and policy .
Lori Robertson is an award - winning journalist and m anaging e ditor of
FactCheck.org, a nonpartisan, nonprofit consumer advocate for voters that aim to
reduce the lev el of deception in US politics. Lori , what have you got for us this
week?

Lori Robertson: Mark and Margaret, we looked into claims about the Affordable
Care Act from a conservative group called Americans for Tax Reform. The group

had posted an image of what it said the IRS would require from individual tax
payers because of the law but it makes false claims. The group said that tax
payers would have to disclose personal health information to the IRS to prove
they have coverage and that failing to compl y with the law would result in
“interest against your property” but the law says the IRS can’t file liens or levies,
such as seizing property against those who don’t have insurance, and IRS
officials have said the Agency won’t collect any personal health i nformation, nor
would it need to.

We don’t know the exact forms or procedures the IRS will use to determine
whether tax payers have coverage or should pay a tax for not having it, but so far
we know that health insurance companies will send the tax paye rs a proof of
coverage form that individuals will then attach to their tax returns. As the former
Commissioner Douglas Shulman explained in 2010; “The IRS will simply ask its
individual tax coverage and name of the company,” he said and “match that
infor mation with the report from the health insurance companies themselves.
Shulman said the IRS’s role has been “way overstated,” and that’s my fact check
for this week. I am Lori Robertson, Managing Editor of FactCheck.org.

(Music)

Margaret Flinter: Fact Check.org is committed to factual accuracy from the
country’s major political players and is a project of the Annenberg Public Policy
Center at the University of Pennsylvania . If you have a fact that you would like
checked, email us at www.chcradio.com . We will have Factcheck.org’s Lori
Robertson check it out for you here on Conversations on Health Care.

(Music)

Mark Masselli: Each week, Conversations highlights a bright idea about how to
make wellness a part of our communities and everyday lives. Low literacy rates
have been linked to poor health outcomes around the globe, so Nicholas
Negroponte decided he should do something about that. The chairman emeritus
of the MIT Media Lab has been on a mission since 200 5, the year he launched
one laptop per child whose mission is exactly that. Negroponte figured his
organization could meaningfully change the lives of about 100 million children
living in the world without access to education. He felt that such a sturdy c hild -
friendly laptop, relying on solar power could change that statistic. What they
found in this stage of the project was pretty astounding; not only were children
learning to read and acquiring knowledge but they were also teaching their
illiterate pare nts how to read.

Nicholas Negroponte: What if we go these parts of the world where there are no
schools, there just aren’t any, there are no literate adults and of course the
children are illiterate. 100 million, what can we learn from the kids teaching their

parents is that we can try and experiment where the kids teach themselves, and
that’s the new story.

Mark Masselli: Negroponte was so inspired by the children teaching the adults
that he tried an experiment in an Ethiopian village that had no teac hers, no
schools, no literacy. That brought boxes of computers to the village, left them
there with no one to instruct the children in any way.

Nicholas Negroponte: Within five days, they were using 47 apps per child, per
day. Within two weeks, they we re singing ABC songs in the village, and within
five months, they had hacked Android.

Mike Masselli: Negroponte, speaking at a recent M - Tech Conference at MIT
says this could enable a whole new way of teaching around the globe that
effectively has the p ower to eliminate illiteracy and one hopes improve the
economic and health figures of these children as well. The One Laptop Per Child
Organization now has deployed three million computers in 40 countries in 25
languages. Distributing a simple durable la ptop into the lives of children who
would have otherwise been left illiterate, changing their world for the better and
offering the promise of a bright future; now, that’s a bright idea.

(Music)

Margaret Flinter: This is Conversation on Health Care. I am Margaret Flinter.

Mark Masselli: And I am Mark Masselli, peace and health.

Conversations on Health Care, broadcast from the campus of WESU at
Wesleyan University, streaming live wesufm.org and brought to you by the
Community Health Center .