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.

We had a great visit to Stanford, spending time with Bob Harrington, Rhonda Larsen and many other friends.  It is an amazing campus with even more amazing weather this time of year.  Bob has his work cut out with an ambitious agenda to build translational medicine, population healt, and clinical care.  The resources are substantial.  The visit confirmed the opportunity to take advantage of the loss of 2 great friends and collaborators by strengthening the depth of the research and education team.

Along the way, I stopped at the EXSCEL Trial rejuvenation.  Despite the many trials I’ve done, it’s still a thrill to think about a trial in mid-course.  In this case, we have a potent drug that lowers blood sugar, reduces weight and waist size, and lowers blood pressure and LDL while raising HDL.  The only negative biomarker is a small increase in heart rate.  The trial is underway and in a crucial phase; Amilyn was bought by BMS and Astra Zeneca.  This will cause important changes in the trial, but it’s fair to say that the basic design will remain and, given the enthusiasm of the study coordinators, we will get the answer!

Together with Underwriters Laboratory, we have launched CREATe (Clinical Research Education and Training) in the US, China, and India.  We see particular value for this effort in Asia where the world of clinical research is rapidly expanding and the need is great for clinicians to learn and stay abreast of the fundamentals of how to participate in generating knowledge relevant to their practices.  It is estimated that globally, the number of clinical research sites is growing at 15% per annum.  CREATe has 3 fundamental levels: Tier 1 includes an introduction to clinical research, a review of key principles and GCP training; Tier 2 brings in a clinicians view of research methods, biostatistics and clinical trial design; Tier 3 focuses on analysis, dissemination, interpretation and application.  The plan includes the educational program, a communication and collaboration portal and a registry of trained researchers and research sites.  CREATe is not meant to produce independent investigators who can compete for peer-reviewed funding based on their views of study design.  Rather, the goal is to produce a large workforce of healthcare providers and study coordinators who can contribute to the generation of knowledge by participating in clinical research, well informed not only about their regulatory obligations, but also about their roles as advocates for their patients in a complex world in which research sponsors have multiple motives.

We know that CREATe is not the only internet based effort to provide education about clinical research conduct, but we hope that it will contribute to a more effective global system of evidence generation and intelligent consumption of evidence in practice.  Rhonda Larsen and Angela Rice-Warren have done a great job of bringing this together in conjunction with Krishna Udayakumar, DukeMed Global and the DCRI.

Its also clear that “internet only” will not suffice.  It will be challenging, but we will need face to face reinforcement, especially in the context of trials conducted through the DCRI.

After leaving Beijing last week, I made the pilgrimage to Singapore and wish to comment on 2 aspects:

1. Duke-NUS School of Medicine:  By all accounts this effort has been a success. It has been a team effort resulting in a first rate medical school that is breaking many barriers in the US-Asian differences in approaches to educating physicians and biomedical scientists.  With a second class graduated, there is comfort that we are in it together for the long haul.

Many people know that I’ve been frustrated by the slow progress in clinical research.  It seems to be the last frontier, when I think it should be one of the fundamental pillars of a medical school (after all, people come to doctors to help them decide what to do and to make sure the recommendations are enacted effectively—these are information-based disciplines and doctors should be educated to generate and consume evidence in their practice).  Others, of course, argue that basic biological science should be the basis and clinical research should be added later—that’s what has happened in Singapore.

Be that as it may, on this visit I’m leaving optimistic about the path forward.  In many ways, the issues in Singapore with developing a true academic medical center mirror our own issues in Durham—balancing the academic mission with the crushing need to deliver care.  With Dr. Ivy Ng now in charge as CEO of the SingHealth system, I have confidence that the building blocks will be put into place to enable a gradual evolution of a first-rate system of clinical and translational medicine.  It will still take time.  Dean Ranga Krishnan has a lot more patience than do I, which is a good thing.

2. TEMASEK: I had a chance to spend time with Temasek, the investment corporation for the country of Singapore.  This group is charged with investing Singapore’s national assets, much like the Duke Management Corporation (DUMAC) manages the Duke University’s investments.  They have done a remarkable job of investing over the years and now have a large fund.  I was impressed by the collegiality and breadth of knowledge of the staff and the joy they take in making money that then benefits the people of Singapore.  It is easy to depict the down sides of a less free and open environment, but I believe we have a lot to learn from the amazing success of Singapore and the general collegiality of their people.  A country of just over 5 million people with a huge global impact and a very high standard of living is obviously doing a lot of things right.  I am grateful for the perspective of seeing a country with such dedication to achievement, amazing tolerance for religious difference, and approaches that encourage the melting of Western and Eastern approaches.

Many faculty have asked me why I’m spending time in China and whether its just a distraction from the everyday business of running an academic enterprise in North Carolina. Other than the fact that 1.4 billion people live there, I believe the time is right for collaboration for the benefit of both countries.

Like most major clinical research coordinating centers, we are conducting multiple clinical research projects in China.  Most of our global trials have significant participation of Chinese sites.  We have evolved through a period in which the efforts were considered novel into one in which much has been learned and new, more effective strategies can be developed in 4 key domains.

Over the past half-century, public health projects involving US collaborators or funders have been a part of the Chinese research landscape.  Until recently, these efforts have been put forward as a chance for knowledge transfer from US (or Western European) universities into China.   Now there is mutual transfer of information about public health, gene-environment interactions, and effective interventions.  Linking of public health entities, such as our Global Health Institute with Schools of Public Health in China, can broaden our mutual knowledge base.

More recently, clinical trials funded by US industry or major academic centers were moved into China.  Initially this approach represented arbitrage in which the sponsors could achieve substantial improvements in recruitment at much lower costs to “test” drugs and devices, often in the setting more “treatment naïve” patients.  Over time, this situation has become much more complex and positive, as the Asian market is rapidly expanding and the Chinese themselves are developing drugs and devices for use in their own population and for expert to the West.   Globalization, with the recognition that we all need to do relevant clinical trials for our populations and practice patterns, is replacing offshoring, which has a much more negative connotation.

Recently, China has been investing heavily in fundamental technologies for translational medicine.  As capital has moved East and China has become a more significant direct participant in the global knowledge network, it is moving to become a leader.  The scale of some of these investments is now unimaginable in the current environment in the US and Western Europe.  By developing collaborations, we can enhance the degree to which we unravel the biological basis of health and disease.

Finally, we have a mutual interest in implementation science.  Given an understanding of what works, both the US and China have enormous disparities in health outcomes and failure to deploy knowledge in the most effective manner.  In many ways the US has been locked into a system which limits our ability to innovate, while the Chinese have an opportunity to create new systems with their rapidly changing society.

In my view we have 2 choices: 1) ignore China and hope it doesn’t overtake us or 2) collaborate wholeheartedly, always reflecting on what we are learning and what strategies will optimize our chances of both countries doing well.  I think Option 2 is best, and its the chance to accelerate knowledge that makes the jet lag worth it!

Last week, I had the privilege of presenting a view of the role Duke could play as a collaborator in the annual Sino-American Science of Clinical and Translational Medicine (SAS-CTM) meeting in Shanghai.  In this 3^rd year of the meeting, it was really clear that China is continuing to make a huge investment in both technology and human capital in this area.  We heard about 75 new translation medicine centers that have been funded by the government, massive biobanks, and significant investment in omics technology.   The Ministry of Health, the Chinese Academy of Medicine, (its NIH equivalent) and its universities are applying major energy to the effort.

Almost all major American universities are developing collaboration with institutions and investigators in China, but few have an entire campus underway as we have with Duke-Kunshan University.  Although this project has been controversial, I found our Chinese colleagues to be enthusiastic about what can be accomplished there.

I presented 5 key areas in CTM where Duke can play a role that will provide mutual benefit for Duke and for China:

1. Participate in and coordinate global clinical and translational research projects
2. Work with Chinese collaborators on sharing knowledge and developing policy on implementation science for health improvement
3. Develop a physical presence as a university
4. Disseminate fundamental knowledge about clinical research through internet based training and education
5. Mutually develop the new workforce needed to drive translation, focusing on the quantitative discipline (biostatistics, informatics, clinical research, global health/epidemiology and health sector management)

I was heartened by the positive response at the meeting and the excitement about the potential for expanding our joint knowledge base.

I had the chance to commune with our cardiovascular practice last night.  It was a remarkable experience.

Almost 30 years ago, the practice of medicine at Duke Hospital was a one person individual effort.  Every doctor was a member of the Private Diagnostic Clinic (PDC), but beyond that each doc saw patients as an individual with a team that typically included students, house staff and fellows.  Harry Phillips and I found ourselves in the hospital every evening as I was developing the CCU as a place to intervene in the new era of reperfusion for myocardial infarction and Harry was busy building a cath lab practice. In those days, we would round on up to 30-40 patients a day, including every other weekend.  Being on call every other night and every other weekend was a great improvement in quality of life.  After a while we decided to join forces with the blessing of Joe Greenfield and we formed a 2 person group.  Within several years we were up to 5 as others joined in.

Now, of course, like most large academic and private practices we work in functional groups–general cardiology, EP, intervention, imaging, valvular and congenital, heart failure.  These groups have become integrated practices with multiple physicians, advanced practice providers (nurse practitioners, PAs) and staff.  We are closely aligned with the hospital units and clinic staff where we work.

Last night, Chris Granger and Kristin Newby, who head our general cardiology practice group, hosted a get together for many of the faculty, fellows, nurses, pharmacists, PAs and other associated staff.  The event was dominated by the dozens of children, direct progeny of their parents.  But the progeny of our training programs and educational system were equally evident.  Lloyd Smith, my Chair of Medicine at UCSF in 1978-80, gave a great lecture once on “Academic Progeny”.  His point was that academic medical centers are an amazing melting pot of people from all over who convene to learn and practice.  Most of these people move on to teach, learn, and practice elsewhere and some stay with us.  The influence one can have in this environment is remarkable.

Much of the conversation was about children, but we also talked about friends and colleagues who have recently left or soon will leave to spread aspects of our knowledge and culture elsewhere.  The same opportunity exists as we take in trainees and faculty from elsewhere.  We need to remind ourselves more often that our greatest impact in a place like Duke may be in the imprint we leave on people who go elsewhere.

There has been a slight upturn in people approaching me to express concern that anxiety levels are high among people affected by the leadership change in the DCRI, and more broadly, the impact on other components of DTMI.  Many cliches and aphorisms exist to capture the risk and opportunity of anxiety, so I will refrain from using one at this point.

Everyone should be assured that in numerous meetings with leaders and team members across the enterprise, no one has suggested a change in fundamental direction.  Indeed, we have been through our budget meetings with institutional leadership and several presentations–the major message is one of stability and acknowledgement of the successes of the organization.  If anything, the major motivation for change is coming from the continuing evolution of our environment, ranging from continued pressures on the NIH, to globalization and the opportunities derived from the ongoing divestment of R&D from large pharma.

Most recently, there is an uptick in national discussion about the need to change the clinical trials model from its current state to one in which electronic health records and patient-reported outcomes are used as the major source of data for trials with additional structured data as needed.  We hope the DCRI and other elements of DTMI will be leaders in this transition, which has been an increasing focus of our public private partnership with the FDA (Clinical Trials Transformation Initiative).

The institutional effort to find a replacement for Dr. Harrington continues, and I am hopeful that we will have a new leader during the month of March.  In the interim, Bob remains engaged as the leader and I have complete confidence in his loyalty to the well-being of the institution and the many people making a contribution across DTMI.  So, I continue to believe that turning anxiety into creative thinking and action will lead us to a better place.

On another note, if you have not been on the tour of the new Cancer Institute, I recommend that you do it.  Its a fascinating peak at where medicine is headed and should give our cancer patients and their families a first-rate place for caring treatment.