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Defining Personalized Health Care

As a result of the announcement of the Precision Healthcare Initiative by President Obama at the end of January, innovative structures for improving healthcare are in the spotlight.  In the media, there has been a lot of conversation about healthcare in the United States and what kind of changes can be made to improve quality and access to care. Buzzword phrases like prospective healthcare, precision medicine and personalized medicine have been used interchangeably; however, they have distinct meanings. These terms share a common thread in that they promote individualized planning and treatment, but recognizing the differences between them and understanding related terms is important. This post seeks to remedy confusion and provide clarification.

Precision healthcare is primarily focused on improving health outcomes through genomics. Genome sequencing allows for better understanding of which genes or combination of genes lead to onset of diseases, and which genes can provide resiliency against diseases. Based on a multi-level analysis of genes and other data, precision healthcare allows physicians and pharmaceutical companies to strengthen their understanding of gene-environment interactions and understand how to treat particular diseases given a set of mutations Precision healthcare also emphasizes the importance of diagnostic testing, as this allows doctors to identify the best treatment for an individual’s particular disease. Precision medicine is already at work in treatment of cancer and fibromyalgia.

Personalized healthcare, which is the focus of this Center, rallies around four core tenets. Prospective healthcare promotes 4Ps: predictive, preventive, patient engagement, and personalized care. In integrating these four concepts, personalized healthcare creates a model that emphasizes long range planning rather than costly reactionary care. Chronic, preventable diseases make up the bulk of spending on American healthcare provision. Personalized healthcare seeks to remedy spending on chronic care by encouraging healthy behavior and planning. It emphasizes doctors spending more time with their patients, looking at their health history, and identifying disease risk early-on. The physician and patient work together to create a health plan, and the patient is expected to engage in his/her own health management. Studies using this more prospective approach at Duke have shown that this model improves health outcomes. 

Personalized medicine falls under the umbrella of personalized healthcare but the terms are unique. Personalized medicine is rooted in therapies that are tailored to fit an individual based on their genetic, genomic, and clinical information. Armed with this information, accurate predictions can be made about a person's vulnerability to particular diseases and understanding their responses. In addition, gene based therapies or interventions can be customized for the individual and their genetic susceptibilities. Despite these differences, personalized medicine and the broader personalized health care movement are upon us and has the potential to shift health care to a more proactive model rooted in preventive medicine and patient engagement. 

Phoebe Long, is a senior at  Duke University and a research intern at Duke’s Center for Research on Personalized Health Care.

Looking Abroad for Examples of a More Personalized Approach to Health Care

In the current healthcare system, there is a lack of time for quality education, communication, and follow-up from the physician. The lack of patient engagement is exacerbated by a fragmented healthcare system where insurance coverage is tied to employment and patients must change providers when they change jobs.

The United Kingdom has been one of most successful in diabetes management out of all developed countries. This achievement is very much a result of a single-payer insurance system and strong patient engagement. Under the National Health System (NHS), health insurance is provided by a single-payer – the government - and funded by taxes. Patients are assigned to physicians to maintain the continuity of care. Because Government insurance also eliminates copays and caps on clinic visits, which allow patients to get more frequent preventive care. A large supply of nurses facilitates the sharing of health decisions with the patients through house visits and group education. For example, diabetes-trained nurses help engage the patients in self-care through educational and self-management courses like the Diabetes Education and Self-Management for Ongoing and Diagnosed (DESMOND) or the Dose Adjustment For Normal Eating (DAFNE). Community matrons or nurses can provide in-home continuing care to chronic patients, and help with physical and psychosocial wellbeing, which in turn reduces visits to the physician or hospital admission.

Personalized healthcare, an approach being developed at Duke University, focuses on patient-centered healthcare, personalized health planning (PHP), and patient engagement. Patients are given the opportunity to engage with their own health by identifying areas in their life where they are motivated to make changes for their health. In initial visits, physicians assess the patients’ risk including family history, genetic markers, lifestyle habits, and other biometric data during the appointment. Then, the physician and patient work to create a timeline for health improvement. Through the time frame of the plan, health coaches and nurses monitor the patients’ progress and help them meet their health goals. It promotes the use of health coaches and nurses to provide education, support, and outcome tracking for the patients, similar to the United Kingdom approach. Shared Medical Appointments (SMA) allow patients with the same diagnosis to receive group education from Medical Health Technicians, discuss their goals with each other, receive psychosocial support, and access a medical team together to improve the efficiency of physician visits.

While we are working on developing more effective approaches to chronic disease management, we also need to develop better infrastructure to support patient engagement. The central ideas of personalized healthcare planning – intensifying the patient’s role in health management, establishing a personalized health plan, and tracking the execution of health goals – guide us in the right direction. The United Kingdom should serve as a reference for us as we integrate prospective healthcare into our healthcare system and begin to focus on preventive health.

Shelley Chen, is a senior at  Duke University and a research intern at Duke’s Center for Research on Personalized Health Care.

The Need for An Improved Electronic Health Record

Effective October 1, 2012, the Affordable Care Act mandated that health plans begin the process of adopting systems for the electronic exchange of health information. From 2006 to 2013, the adoption of basic Electronic Medical Record systems by office-based physicians increased by 37% according to a national survey carried out by the Center for Disease Control’s National Center for Health Statistics.

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The pros and cons of EMRs are varied; some physicians say that implementing Electronic Health Record (EHR) Systems is costly, time consuming, and disrupts the doctor-patient relationship. Others maintain that once providers adjust and incorporate EMRs into their daily workflow, they will reduce paperwork, cut costs, and improve the way we care for patients. Regardless of complaints about EHR systems, physicians and hospitals are adopting them, and it is time we worked to improve their sustainability and efficacy within the health space.

Challenges facing EHR systems must be addressed if meaningful use standards are to be met and patients are to benefit. First, we must find ways to increase patient trust in the security of their health information. If individuals do not believe that their medical records are safe, they will not be motivated to access or share them. Related to this, patients must be educated in all of the ways they can use their EHR, whether that be through sharing their information to further research, tracking personal health goal progress, receiving clinical reminders, or asking questions through patient portals. EHR systems do nothing if patients do not take advantage of their expansive capabilities to connect them with their physicians and their health information.

Physician input is integral in determining ways in which EHRs can be more clinically useful. Physician complaints of EHRs include difficulty taking notes on patient concerns, a confusing checkbox system, and an overall non-user friendly interface. Though the platforms for EHR systems may be successful in transferring and storing records, the way EHRs are used in daily appointments needs to be re-assessed.

Finally, EHR data input systems must be revamped so that personalized health planning is the fundamental backbone of the EHR. Patient goals and questions about their health should be some of the first things a physician sees upon opening the EMR, and the priority to address during the appointment. Inputting this information should fit seamlessly into the clinical workflow in order to avoid one of the most common complains of electronic health record systems; that they reduce the clinical encounter to a physician typing into a computer.

            While Accountable Care Organizations continue to form and EHR systems are consolidated and improved, hospitals and health systems should set Health Information Technology goals that continue to address the major current issues with EHRs. The potential for positive impact of the EHR in our research, patient appointments, and overall health system in the future highlights the need to fix problems with the technology as soon as possible.

Caroline Meade, is a senior at  Duke University and a research intern at Duke’s Center for Research on Personalized Health Care.

Precise But (Not Yet) Personal

Despite great advance in the field of personalized medicine and precision care therapies, there is still a dearth of progress in clinical models that use these emerging technologies to enhance preventive medicine.
Precise But (Not Yet) PersonalRALPH SNYDERMAN

President Obama’s new initiative to fund genetic sequencing could be a powerful tool for good in improving U.S. health care—but only if the medical establishment welcomes it.

On January 30, 2015, President Obama announced a bold funding initiative to support the sequencing of the genomes of a million volunteers and correlate the data with clinical information to allow a better understanding of the roles genes play in health and disease. This information will boost precision or personalized medicine and allow appropriate therapeutics to be targeted to those who need them — that is, getting the right drug to the right person. This is in contrast to our current “one-size-fits-all” approach to care, where more than half of major drugs are ineffective or cause unwanted side effects, and drug expenditures are currently about $320 billion a year and rising. Replacing that approach with one designed to meet the precise needs of the patient would not only be better medicine, but also more cost-effective.

President Obama’s announcement coincided with the ninth annual Personalized Medicine World Congress in Mountain View, California, which I chaired. At the conference, world leaders in personalized medicine provided a comprehensive overview of the field, spurring me to reflect on both the progress that has been made so far and the promise for the future. I concluded that although we have made a lot of progress in developing precision care therapies and diagnostic capabilities to treat certain diseases better, we haven’t yet started applying these technologies to prevent disease and make America healthier.

The ability to tailor medicine to an individual’s specific need stems in part from the genomic revolution first heralded by President Clinton in 2000, who predicted that the initial sequencing of the human genome would “… revolutionize the diagnosis, prevention, and treatment of most, if not all, human diseases.” Note that genomic research was expected to prevent disease as well as to treat it better. At the time of Clinton’s remarks, sequencing one human genome cost $400 million. Now, with breakthroughs in technologies, the cost has dramatically fallen to about $1,000, a very small fraction of the original cost. That means that performing gene sequencing on millions of people is feasible. Interpreting the clinical meaning of this data will allow a far greater understanding of one’s inborn health risks and the role genes play in disease development.

Reducing the cost of genome sequencing is just one of the advancements we’ve seen in personalized medicine. The pharmaceutical and diagnostic industries have jumped on the personalized medicine bandwagon in a big way. Along with phenomenal progress in genomic technologies, research breakthroughs in the last decade have enabled astounding new treatments for serious diseases and allowed scientists to develop new classes of drugs. Last year alone, five “targeted” drugs were approved for effectively treating lethal forms of cancer based on the specific genetic makeup of individual tumors and, this is just the beginning. Immunotherapy, cancer vaccines, gene therapy, and other approaches will provide major improvements in treating cancer, rheumatic diseases, liver disease, diabetes, cystic fibrosis, and others. It is estimated that by 2020, half of the major new therapies will be personalized medicines. Similarly, genomic sequencing is being used to develop diagnostics for early detection of cancer, fetal abnormalities, and transplantation graft rejection. Tools are being developed to assess an individual’s likelihood of developing various diseases as well as to determine how serious those diseases would be. Finally, genomic and related research is giving insight into basic disease mechanisms and fostering the design of therapies that are targeted to a given individual.

What I find surprising about the progress of personalized medicine is the great technical strides we’ve made in genome sequencing and in developing predictive diagnostics and targeted therapies. But equally surprising is the slow clinical adoption of personalized medicine as a means for prevention. As I said in my 2002 Chair’s address to the Association of American Medical Colleges (AAMC), personalized medicine was an opportunity to transform concepts of health care from focusing on treating established disease to an approach that would be personalized, predictive, preventative, and would engage patients in their care. If disease developed, therapies would be targeted to the needs of the specific individual. By 2003, we believed that the convergence of new technologies—including genomics, proteomics, and metabolomics—with the ability to amass great clinical data bases and the power of bioinformatics to understand the data could, in the aggregate, lead to a more rational form of preventative health care. The biggest payoff of genomics and other predictive technologies was anticipated to be in their ability to prevent diseases before precision therapies were needed.

But conventional medicine continues to focus heavily on treating established disease with a “find-it and fix-it” mentality. Care is reactive, focused on complications of disease, and uncoordinated. As a result, we have a health care delivery system costing almost $3 trillion a year. Eighty percent of our enormous health care budget is for the treatment of largely preventable chronic illnesses, such as heart disease and diabetes, which develop over long periods of time. Our nation is facing an epidemic of preventable chronic diseases and we can’t afford the consequence. Precision medicine will allow us to treat disease better but that is far from the whole story. Using genomics and other predictive technologies to quantify each individual’s disease susceptibilities would allow us to employ strategies to prevent these costly diseases before they develop. This is what personalized health care, the model I described to the AAMC in 2002, does. In this personalized, preventative approach, an individual’s health risks, whether determined by genomics or other risk assessment tools, would be used to develop a proactive health plan to improve that person’s health, minimize their disease risks, and provide them with precision therapy if needed. What people do before they get sick, particularly if they know they are at risk, can prevent the development of disease or greatly diminish its effects. This being the case, personalized health care engages patients as key drivers of their care by giving them the information they need to modify their behavior early.

What does personalized health care look like? Here’s one example. Rather than the current annual physical, which has been derided as a waste of money because it does not prevent disease or decrease mortality, imagine an annual personalized health care physical. The exam would be comprised of three components: first, assessing the patient’s unique risks for developing specific diseases; second, enhancing the patient’s understanding of their risks, increasing their engagement in their care through better awareness of what they can do to improve their health; and third, establishing actionable goals along with a plan to meet these goals over the course of a year and the support to realize that plan. Personalized health care is also an approach to more effectively minimize disease once it develops. Studies are ongoing to use personalized health care to slow or reverse the progress of diabetes and other chronic diseases. The personalized health care approach is being developed at Duke and elsewhere, and early indications are encouraging. In 2013, the Veterans Health Administration chose personalized, proactive, patient-driven care as one of its three strategic goals.

While the health care scene in the United States is changing to embrace prevention, one reason for the slow adoption of personalized health care is our medical culture that is steeped in approaches developed a century ago and resistant to new concepts. Perhaps even more important, the current reimbursement system rewards more reactive disease interventions—the more technical, the better—and does not reward treatments that heavily involve the physician’s time with the patient, a central feature of personalized health care. However, changes in reimbursement are beginning to encourage greater continuity of care and preventative approaches. The President’s initiative, along with bipartisan support to fund research to make disease treatment more precise, is laudable. When paired with a focus on personalized health care and changes in health care reimbursement, our current “disease care system” could change into one that will improve health, prevent disease when possible, treat it effectively if it occurs, and thereby, achieve financial sustainability.

Ralph Snyderman, M.D., is chancellor emeritus of Duke University and former president and CEO of the Duke University Health System and director of Duke’s Center for Research on Personalized Health Care.

Obama to Request Research Funding for Treatments Tailored to Patients’ DNA

President Obama is seeking hundreds of millions of dollars to develop medical treatments tailored to the individual. Dr Snyderman offers his insight in the following NYTimes article regarding this precision medicine initiative.

President Obama will seek hundreds of millions of dollars for a new initiative to develop medical treatments tailored to genetic and other characteristics of individual patients, administration officials say.

The proposal, mentioned briefly in his State of the Union address, will be described in greater detail in his budget in the coming weeks. The effort is likely to receive support from members of both parties, lawmakers said.

“This is an incredible area of promise,” said Senator Bill Cassidy, Republican of Louisiana and a gastroenterologist. “There will be bipartisan support.”

Mr. Obama called it precision medicine, but the terms “personalized medicine” and “individualized medicine” are also widely used to describe the evolving field in which, for example, a doctor prescribes a medication that targets a specific mutation in a patient’s genes.

The money would support biomedical research at the National Institutes of Healthand the regulation of diagnostic tests by the Food and Drug Administration, officials at the two agencies said.

The tests analyze the DNA in normal or diseased tissue. Doctors use that information to identify patients with cancer or other diseases who are most likely to benefit from a particular treatment — and those who would be harmed or not respond at all.

“In some patients with cystic fibrosis, this approach has reversed a disease once thought unstoppable,” Mr. Obama said in his address to Congress last week.

The gene responsible for cystic fibrosis was discovered by a team that included Dr. Francis S. Collins, who is now director of the National Institutes of Health and an architect of the new initiative. The F.D.A. has approved a drug for patients with a genetic mutation responsible for some cases of the disease, which clogs the lungs with thick, sticky mucus.

A patient taking that drug, William Elder Jr., a 27-year-old medical student in Ohio, was a guest of Michelle Obama at the State of the Union speech.

Representative Fred Upton, Republican of Michigan and chairman of the Energy and Commerce Committee, and Representative Diana DeGette, a Colorado Democrat who is on the committee, welcomed Mr. Obama’s proposal. After holding hearings and round-table discussions last year, they said they were drafting a bill to encourage biomedical innovations, including personalized medicine.

As a senator in 2006 and 2007, Mr. Obama offered a bill to do just that — the Genomics and Personalized Medicine Act. Senator Richard M. Burr, Republican of North Carolina, was a co-sponsor of the 2007 bill.

“Personalized medicine represents a revolutionary and exciting change in the fundamental approach and practice of medicine,” Mr. Obama said then. He cited the drug Herceptin, for the treatment of a particularly aggressive form of breast cancer, as an example.

Scientists said they now viewed breast cancer not as a single disease, but rather as a group of several subtypes, each with a distinct molecular signature. This, they said, helps explain why some tumors respond better than others to specific cancer-fighting drugs.

“Most medical treatments have been designed for the average patient,” said Jo Handelsman, associate director of the White House Office of Science and Technology Policy. “In too many cases, this one-size-fits-all approach is not effective.”

Dr. Ralph Snyderman, a former chancellor for health affairs at Duke University, often described as the father of personalized medicine, said he was excited by the president’s initiative.

“Personalized medicine has the potential to transform our health care system, which consumes almost $3 trillion a year, 80 percent of it for preventable diseases,” Dr. Snyderman said.

Although the new tests and treatments are often expensive, he added, personalized medicine can save money while producing better results. “It focuses therapy on individuals in whom it will work,” he said. “You can avoid wasting money on people who won’t respond or will have an adverse reaction.”

The new techniques can also help prevent disease by predicting patients’ susceptibility, Dr. Snyderman said. “If an individual has a much greater likelihood of developing colon cancer, a genetically based disease,” he said, “you can begin screening at a much younger age, 30 rather than 50, for example.”

Dr. Margaret A. Hamburg, the F.D.A. commissioner, has reorganized her agency to speed the review of drugs and diagnostic tests used in personalized medicine. But Senator Cassidy said he was still skeptical. To fulfill the promise of personalized medicine, he said, will require “a much more nimble federal bureaucracy.”

On Friday, federal officials released a proposal under which Medicare would cover genetic tests of tumors in some people with advanced lung cancer. The tests could help identify Medicare beneficiaries who would respond favorably to particular cancer drugs.

“This is a watershed event,” said Dr. Bruce Quinn, a health-policy specialist at the law firm Foley Hoag. “It means that policy makers now believe these tests are worth paying for.”

Mr. Obama’s budget will also propose increased federal spending to combat antibiotic-resistant bacteria. The plan would nearly double spending from its current level of $450 million a year.

White House officials described antibiotic resistance as a threat to public health and national security. They said at least 23,000 people in the United States die each year as a result of infections caused by such drug-resistant germs.

Your Annualized Personalized Health Check-up

In a January 10, 2015 editorial in the NewYork Times, Dr. Ezekiel Emmanuel derides the annual physical exam as a multi-billion dollar waste of time.  The exam in current practice is indeed ineffective in preventing disease and reflects the inadequacy of a reactive approach to health care which costs almost $3 trillion/year of which two-thirds is for treating preventable chronic diseases.  Not only is the current annual exam a waste of resources, it is more importantly, a waste of an opportunity to fix a bigger problem – our health care system’s expensive focus on treating established diseases, most of which are preventable.  Rather than a cursory look for disease with inadequate tools, the annual physical could be made to focus on three health enhancing activities:  first, assessing the patient’s specific risks of developing diseases; second, enhancing the patient’s awareness of their health risks, the value of their health to them and their ability to impact their health through what they do and; third, developing shared goals and a yearly plan to promote their health and prevent diseases to which they are susceptible.

This approach, termed “personalized health care," is being developed at Duke University and is a proactive strategy that is taking hold as a far more effective way to deliver health care.  Rather than treating established disease, it proactively provides personalized disease prevention with the engagement of individuals as partners in improving their health.  Capabilities to measure each individual’s risk of disease, track its development, and treat it specifically are becoming available through advances in genomics, digital and biotechnologies.  

Sophisticated health assessment tools, along with a deeper understanding of the need to truly engage patients in their care are leading to the modern version of the annual checkup that can foster health promotion and disease prevention. An annual physical, using the personalized health care approach, could be the key to promoting the nation’s health, preventing chronic diseases, and reducing needless health expenditures. 

Unlike the current “worthless” annual physical, the personalized health care annual exam or approaches like it could be the linchpin for preventing diseases and the waste of our precious health resources. Health, after all, is a terrible thing to waste.

Ralph Snyderman, MD is Chancellor Emeritus at Duke University, former president and chief executive officer of the Duke University Health System and director of Duke’s Center for Research on Prospective Health.