Robert M. Califf, MD

I survived 8 hours of training and even passed the test at the end.  It had very impressive organization and a highly disciplined systematic approach to the orientation. It is a lot of pointing and clicking and it seems clear that busy clinicians will do well with the system, but there are many complex and non-intuitive shortcuts that will make it more difficult for “part-time” clinicians like me.

Despite the many positive aspects of Maestro Care, I admit to slight remorse about the end of the “glory” days of medicine.  The red light, blue light, green light system enables every step of the clinician to be traced:  process engineering is here to stay!  The “role” of the doctor as a “provider” is a cog in a system.  If handled well, systems analysis and improvement will almost surely lead to better outcomes for populations and patients.  I just have to admit that its a little disconcerting to be demystified.  It was very gratifying to be “the doctor” instead of the “provider role”!

The second issue that we’ll need to work on with the may other EPIC sites is how to pay attention to the patient while so much energy is spent minding the keyboard.  This will be a new skill for the doctor, especially for my generation.  The younger generation will probably do well with this.

Third issue: research wasn’t mentioned.  Given the amazing resilience of our faculty to persist in doing research, it was hard for me to sit there and not point out that we have a spectacular plan to deal with this, started by Asif Ahmad before most people were thinking about it, and hyper-accelerated by Jeff Ferranti, Art Glasgow, Howard Shang and many others in DHTS, now including Iain Sanderson who brings great vision to this.  Finally, we will have codified data for simple items like BP, heart rate, weight, cigarette smoking.  It still astounds lay people when they hear that we don’t have this already in a systematic fashion. The Enterprise Data Warehouse at Duke will be a phenomenal resource for researchers as well as clinical quality leaders, administrators and health system planners.

If we use the data we generate wisely, all of our patients will benefit as individuals.

All in all, a price well worth it, and a big shift in the practice of medicine.  But its not as if anyone is satisfied that we’ve figured out exactly how to implement system wide electronic records in the optimal way.  To really make it worth it, all of us should constantly question the approaches being advocated and provide the feedback needed so that in the end we produce higher quality, more efficient care (lower cost per successful clinical care) and great research that will enable us to more often have confidence that our practices are correct.

Tomorrow I get to start my 8 hours of EPIC Training. At this stage of my career, being able to practice medicine is an amazing privilege, as my research and administrative duties are all consuming.  My many years of intense coronary care and clinic have left me with an unbreakable bond to the awesome responsibility of seeing patients and helping them solve their problems.

EPIC now plays a legendary role in American medicine.  It has become the dominant academic system EHR.  According to some, it is a Godsend–the Microsoft Word of medicine, and to others it is an evil embodiment of the captivation of caring medical attention by the mouse and keyboard.  The potential of EPIC to provide a basis for medical practice based on evidence is profound, but its dominant position has clear dangers.  What if EPIC is bought by a different business?  Will it try to dominate the data warehouse business?   What if prices continue to escalate, but the huge sunk costs make it impossible for systems to extricate themselves–this has been termed “kudzu” by other software businesses.

Some informatics experts and techies are claiming that EPIC is too clunky and won’t adapt to a rapidly approaching world of apps on personal devices.

I have no answers to these questions, but am hopeful that EPIC will be part of the solution in a world that could advance considerably with high quality data that could unlock the secrets of biology and response to treatment.  I’m impressed with the plan for Maestro Care at Duke and hope we can implement the kind of system we used to dream about with Gene and Bill Stead, Ed Hammond, Bob Rosati and David Pryor in the early 1980′s!

We’ll see if I’m still standing at 10pm tomorrow when I finish my training.

There are two provocative articles in today’s NEJM:

Swedish investigators show a dramatic reduction in progression to Type 2 Diabetes with bariatric surgery and demonstrate no relationship between baseline BMI and treatment effect.  In other words, this treatment appears as effective in moderately overweight and very obese patients.  Before we rush to line up in the surgery clinic, we should read our own Danny Jacobs (on his way to be Dean at UT Galveston), who opines that we need to do more research to define in whom the treatment is worth it.  A second relatively unnerving finding is that followup was up to 15 years.  I had dismissed short term studies of this technology because of the other profound metabolic effects that could turn out to be detrimental in the long run.

The second article is from a team of ethicists relaying conclusions of an IOM study of the TIDE Trial.  TIDE arose out of the controversy on rosiglitazone when overviews showed excess cardiovascular events with this drug that had been touted as a super drug for diabetes.  Our friends Hertzel Gerstein and Salim Yusuf designed the trial and were conducting it when the FDA halted it on the basis of safety concerns.  I personally feel that the editorial was off base and assumed as fact findings on rosiglitazone that were unproven signals.  I wish the trial had been completed and remain unsure that the “politically correct” view on rosiglitazone is really correct.  After all, who would have thought that bariatric surgery would so profoundly reduce progression to diabetes?

I surely agree with this statement in the editorial: “Reactive policy making is tempting but problematic.  The history of regulation of human subjects research suggest that rules that are ‘born in scandal and reared in protectionism often fall short of providing meaningful protections to research participants and than, once adopted, regulations can ossify and become difficult to dislodge’.”

If GSK had commissioned proper, academically independent outcome studies early in the life cycle of rosiglitazone, the truth would be known and GSK and people with diabetes would be a lot better off.

As I’m delving into the great things going on at DCRI as we look to the future, one that ties a lot of the effort together is the Center for Educational Excellence (CEE).  The concept that health care providers will need lifelong education after completing fundamental training and graduate medical education is not a new concept.  The question, of course, is “who should be responsible for this”.  What seems to be evolving is a complex maize of professional societies and academic institutions.  The older supposition that the medical products industry should provide education for healthcare providers has fallen into disfavor because of concerns about conflicted presentation of knowledge.

In addition to lifelong education, globalization is another key theme.  Interactive education using the internet and cell phone technology will almost certainly drive future continuing education.   The best materials for basic education will consolidate into a smaller basic set, but this will enable educational entrepreneurs to move from “Education 101″ to “Education 200 and beyond”–taking the basic material and making it much more interactive and specialized.

The third theme is the learning health system concept.  This idea, developed by the IOM, is a modern version of something started here by Eugene Stead in the cardiovascular database.  We can learn continuously from our experience if we collect, coded, analyzable data as part of our routine in healthcare delivery.

We are in a great position to weave these themes together to become an important part of a network that can provide practitioners with what they need to know to generate and consume evidence to enable the best choices for patients.  Our Duke-NUS School of Medicine, the Medanta Duke Research Institute, the Brazilian Clinical Research Institute  and the Duke-Kunshan University give us nodes in a virtual network, reaching the major global population.

At the core of all this, of course, is fundamental high quality and high integrity research and transformation of that research into knowledge that can drive better healthcare.  That will remain the core value of DCRI and its parent organization, DTMI.

We are now meeting under the auspices of a new School of Medicine Committee on Clinical Research, chaired by Dean Andrews and including myself, Scott Gibson (Exec Vice Dean for Admin,), Mark Stacy (Vice Dean for Clinical Research), Jeff Ferranti (CMIO for Duke Medicine), the DCRI Director and Sally Kornbluth (Vice Dean for Basic Science). Becky Moen MBA has taken on the job of administration for the TMQF effort and the implementation  is really taking shape with her involvement.

We are struggling with a number of difficult issues where the right balance is not entirely clear, including:

1.  How do we define accountability of the quality of translational research?

2.  In the basic science labs, is documentation of data provenance (“reproducible research”) a requirement or is it optional?

3.  In human research, how far do we go in mandating reproducible data systems and significant input/collaboration/oversight by biostatistics?

4.  How do we structure a system to oversee management of conflict of interest in translational research (we’re confident that we have a system for identifying COI and designing plans for management; its the execution that needs work)?

There is an interesting set of issues around the economy of site based research that will be the topic of serious discussion involving the SBR directors.

I hope that people will join in a vigorous debate about the topics so that we can go forward with a plan that has the support of the faculty and staff because the development of the plan has been inclusive.

Interest in this issue will be heightened when the case of Anil Potti airs on 60 Minutes, which I’m told likely to happen on Feb 12th, although decisions on airing are held tightly by CBS for obvious reasons.

We are working on a proposal for a cooperative agreement with CMS as part of their CMS Healthcare Innovations Challenge in which they are allocating $1B (yes that’s one billion dollars) to 3 year implementation efforts to meet the “triple aim” of improving healthcare, improving health outcomes and reducing costs.  Doing all 3 of these at the same time is a real challenge, as pointed out by a recent Federal report that found that so far, most efforts to meet the triple aim have improved healthcare and/or health outcomes, but they have increased costs!

Our system of fee for service is a real problem in that regard.  Consider that African American patients in our region have a very high rate of amputation due to peripheral arterial disease.  This, of course, is a source of expertise for our hospitals and vascular surgeons.  If you needed an amputation, you’d want an expert; to become an expert requires volume, and we’re producing volumes by failing in our efforts to treat diabetes effectively.  We also know that treating diabetes more effectively will involve an upgrade of outpatient service, including more home visits and follow-up by advanced practice providers (NPs, PAs).  These services are not well reimbursed and, on balance, lose money. Since many African American patients are less well off, the cutbacks in funding of Medicaid and Medicare impact this situation even more.  On the other hand, amputations make money!

It seems clear that we want to reduce amputations while maintaining the expertise that is so valuable to all patients from high volume procedural specialists.  This would require more centralization of procedures and a change in payment to enhance valuable outpatient services.  Or, it is likely that we will continue to reinforce a system that is associated with a decline in our national health status relative to other economically developed countries.

We have a team, including Dr. Susan Spratt, dedicated to reducing amputation rates, but I’ll bet they would be more successful if they were swimming downstream instead of battling the upstream currents!

As we are preparing a response to the CMS Healthcare Innovations Challenge, a well known issue is becoming clear.  Taking accountability for a geographically completed population is a very different issue than selecting a population of interest based on disease or insurance status or whether they come to your facility.  The “triple aim” of better healthcare, better health outcomes and lower cost sounds eerily like the well known slogan of project managers (better, faster, cheaper–can you really expect all 3?).

Consider a hospital and practitioners who wish to achieve excellent outcomes at a low cost in heart failure.  The likelihood of success is likely to be very dependent on the selection of a population that is well educated with excellent social support and a high level of  compliance.  In fact the selection of those types of patients will make the providers look good, while actually making the other providers in the geographic region look worse!

Perhaps this is what explains the paradox in cardiology that many of our best known heart centers (CCF, Duke, Hopkins, UAb) have terrible CV mortality and morbidity rates in their home counties.  This won’t be fixed until we are forced to be accountability for the entire population as far as I can see.