Analysis of Shifting Paradigms: Provider-Centered to Patient-Centered Care & Research

Doctors Know Best, but Doctors Sometimes Do NOT Know Best

—THE NEW YORK TIMES, 2012

In current clinical practice, providers focus on assessing disease severity and evaluating drug and treatment effectiveness. There is less emphasis on patient involvement in decisions about care or on the specific needs of patients that affect their quality of life. Despite expensive, highly specialized, and technologically advanced care practices; this disease-centered approach to care has resulted in poor quality outcomes. In terms of research, knowledge gained from clinical research does not directly answer the primary clinical questions of what is best for the patient at hand.

Physician centered practice developed from a system that allowed mounting utilization of diagnostic testing, prescriptions, hospitalizations, and referrals without regard for specific patient needs or desires. It is considered “depersonalized medicine” or “illness- oriented care”, with the aim to treat the illness, not the patients with the illness. The long held assumption that “Dr. knows best” is now being challenged as payers and consumers demand better bang (better outcomes) for the buck.

Assumptions
Provider Centered Care	Patient Centered Care
Disease focused	Patient focused
Physicians know best:  the experts	Physicians collaborate: the enablers
Physician oriented outcomes: What is best for the disease or illness	Patient oriented outcomes: What is best for individual patient
The best intervention for the typical patient	The best intervention under what conditions works for which patient
Patients as passive: complying with physician’s orders	Patients as active: “Nothing About Me Without Me”
Patients voice is ignored	Patient voice guides clinical decision making
“What’s the matter” with patients	“What matters” to patients
Fee for service, Shorter, more frequent visits, less reimbursement	A variety of qualified primary care providers – including nurse practitioners
Consumers unaware what healthcare $$ buys	Consumer informed – demanding better deal
Provider Centered Research	Patients Centered Research
Absolute efficacy	Comparative effectiveness
Homogeneity	Heterogeneity
Generality	Individualizations
Statistical significance	“What matters” to patients

“Nothing About Me Without Me.”

--PATIENT'S VOICE

Consumers are demanding that the role of the healthcare professional should change “from experts who care for patients to enablers who support patients to make decisions.” Rapid advances in technology create a forum for improved health literacy and curiosity among the public. Health care consumers no longer are interested in playing passive roles, but rather expect to be listened to, respected and treated with dignity and earnestness. Published reports from regulatory agencies call out the health care industry to either improve morbidity and mortality or face consequences of limited reimbursement and penalties. Comparative effectiveness research (CER) moves scholarship in a direction that engages the population as partners, addressing diversity and creating personalized approaches. A consumer movement advocates that patient-centered care become a goal of most healthcare practitioners and researchers worldwide.

Effective partnership with patients has been reported being associated with a large variety of positive patient outcomes, such as adherence to treatment, improved health, and satisfaction. Today, patient-centered care is thus termed as one of six indicators of quality care. Patient-centered care requires more than a respectful attitude toward patients, it requires personalized clinical interventions.  It is not necessarily giving patients what they want regardless of values or costs, but rather requires knowing the patient as a person and engaging the patient as a partner in his or her own care. 

Similarly, patient-oriented research should not be based on the evaluation of medical interventions in the average patient, but “on the identification of the best intervention for every individual patient. Patient oriented research focuses on the study of heterogeneity and places greater value on observations and exceptions-especially as they occur in real life versus under experimental conditions”. The outcome measures should shift from what are most important to the doctors to what are most important to the patients.  “A difference, to be a difference, must make a difference”. The Patient Centered Outcomes Research Institute (PCORI) is a corporation authorized under the Affordable Care Act of 2010 that incorporates patient-centered principles in their goal.

Key drivers of this paradigm shift:

 

      Personalized medicine and tailored therapeutics;

      Advances in pharmacogenomics and technology;

      Medical costs forecasted to be 20% of GDP in 2020;

      Pressing shortage of primary care providers;

      Growing chronic conditions and increased medical complexity;

      Affordable Care Act- 16% of citizens uninsured

      

“Be Careful Not To Assume”  

  --Légaré et al., 2010

Determining what patients want does not require complex scales or sophisticated statistical tests.   Instead, providers must move from “what’s the matter” with our patients to “what matters” to our patients.  Often what the patient craves is a listening ear, compassionate interactions, access to information, and attention to their care.  Other factors such as level of adherence to medication, degree of tolerance to an adverse effect, past experience, and health objectives can have a decisive influence on the patient’s preferences. When more engaged with care, patients and families can help prevent drastic mistakes or oversights, such as identifying a wrong drug or dose they get from the pharmacy or notifying a doctor about a strange medication side effects.

Quality Equals Reduced Cost, Better Outcomes and Patient Satisfaction

The National Quality Strategy (NQS) promotes quality health care in which the needs of patients, families, and communities guide the actions of all those who deliver and pay for care; there are three broad aims: Better care; healthy people/healthy communities; and affordable care .  To advance these aims, they propose six priorities, of which “ensuring that each person and family is engaged as partners in their care” is one that pertains to patient centeredness. This priority is based on the latest research, input from a broad range of stakeholders, and examples from around the country and has great potential for rapidly improving health outcomes and increasing the effectiveness of care for all populations.

Healthcare Providers: "Nice, But Not Necessary"

Patients: "That's What I'm Paying You For"

--NURS 7106-001

It is important to explore tensions that lie between the margins of traditional medical models and stakeholder engagement models. As patients advocate for better care, providers may feel justified in taking a patriarchal stance given level of education and training. There has to be a change in how health care providers are educated in order to make this shift. Not only are schools of medicine and nursing going to need to teach how to recognize and treat diseases but also they are going to have to be innovative in their curriculum in order to teach their students how to enable their patients.

Some patients may expect the provider, who has the expertise, to take the lead in patient care. This expectation is summed up by the idea of "that's what I'm paying you for". If patients are to be taking charge of their own care, there needs to be a change in expectations. Responsibility should be shared in appropriate ways. The goals of the provider may be disparate from those of the patient when there is a misalignment in worldviews between provider and patient. A common challenge is one of respecting religious/cultural values. It is important to honor the patient's wishes as part of providing evidence based care.

There are myths about patient-centered care models - such as it is more expensive, takes more time, and really falls into that "nice but not necessary" category. As more evidence accumulates, these myths will be challenged. However, time constraints pose a real threat in the current environment. Patients or family members may be afraid to request something of the provider because they feel like they are rushed or the provider does not have time for them. Transparent communication about the time constraints and the need to schedule multiple appointments, using other team members as indicated, and prioritizing the patient's concerns can occur up front and mitigate this tension.

Fundamentally, a key challenge going forward will be the ability to demonstrate that positive patient-centered outcomes correlate with positive general health outcomes. One elephant in the room is reimbursement. Primary care provider (PCP) visits do not generate high levels of reimbursement so providers compensate by seeing as many patients as they can per day. Some would argue that to keep afloat until the major stakeholders - insurance and CMS gets behind this—patient centered care is not possible. New payment models are coming however –as soon as 2015 for patients with complex chronic conditions.

Patient-Centered Care is NOT Only the Job of Nurses,

But Will Transcend Across Disciplines.

--NURS 7106-001

Patient-centeredness must transcend across disciplines. Achieving this level of collaboration poses the greatest challenge. As care becomes more focused on populations, across the episodes of care and including prevention, interdisciplinary team care will become the norm and the entire team will need to partner with patients and families.  Not only will disciplines need to be able to communicate better, but also specialties will need to be able to communicate better with the primary care team. All will be challenged to communicate differently in a patient-centric model.

References

Boult, C., & Wieland, G. D. (2010). Comprehensive primary care for older patients with multiple chronic conditions:“nobody rushes you through”. JAMA, 304(17), 1936-1943.

Clayton, M. F., Latimer, S., Dunn, T. W., & Haas, L. (2011). Assessing patient-centered communication in a family practice setting: how do we measure it, and whose opinion matters? Patient Education and Counseling, 84(3), 294-302. doi: 10.1016/j.pec.2011.05.027

Epstein, Ronald M, Fiscella, Kevin, Lesser, Cara S, & Stange, Kurt C. (2010). Why the nation needs a policy push on patient-centered health care. Health Affairs, 29(8), 1489-1495.

Findley, L.J., & Baker, M.G. (2002). Treating neurodegenerative diseases. British Medical Journal, 324(7352), 1466-1467.

Godlee, Fiona. (2012). Outcomes that matter to patients. BMJ, 344.

Institute of Medicine Committee on Quality of Health Care in America. (2001) Crossing the quality chasm: a new health system for the 21st century. Washington (DC): National Academies Press (US).

Katon, W., Russo, J., Lin, E. H., Schmittdiel, J., Ciechanowski, P., Ludman, E., Von Korff, M. (2012). Cost-effectiveness of a multicondition collaborative care intervention: a randomized controlled trial. Archives of General Psychiatry, 69(5), 506-514. doi: 10.1001/archgenpsychiatry.2011.1548

Marshall, M., & Bibby, J. (2011). Supporting patients to make the best decisions. British Medical Journal, 342(d2117), 10.1136.

Picker Institute. (2008). About the patient-centered care improvement guide. Retrieved from http://www.patient-centeredcare.org/inside/abouttheguide.html

Rickert, J. (2012). Patient-centered care: what it means and how to get there. Retrieved from http://healthaffairs.org/blog/2012/01/24/patient-centered-care-what-it-means-and-how-to-get-there/

Sacristan, J. A. (2011). [Patient-centered medicine and comparative effectiveness research]. Medicina Clínica (Barc), 136(10), 438-440. doi: 10.1016/j.medcli.2010.11.014

Sacristan, J. A. (2013). Patient-centered medicine and patient-oriented research: improving health outcomes for individual patients. BMC Medical Informatics and Decision Making, 13, 6. doi: 10.1186/1472-6947-13-6

The National Quality Strategy. (n.d.). The national quality strategy overview. Retrived from http://www.ahrq.gov/workingforquality/toolkit.htm

Van der Eijk, M., Nijhuis, F. A., Faber, M. J., & Bloem, B. R. (2013). Moving from physician-centered care towards patient-centered care for Parkinson's disease patients. Parkinsonism & Related Disorders, 19(11), 923-927. doi: 10.1016/j.parkreldis.2013.04.022

Wynia, M., & Matiasek, J. (2006). Promising practices for patient-centered communication with vulnerable populations: examples from eight hospitals. The Commonwealth Fund, 1-94.

Key Links and Resources

1.        Agency for Healthcare Research and Quality. (n.d.). Working for quality. Retrieved from http://www.ahrq.gov/workingforquality/index.html

2.        Agency for Healthcare Research and Quality. Retrieved from http://www.ahrq.gov/research/findings/factsheets/patient-centered/ria-issue5/index.html

3.        Patient-Centered Outcomes Research Institute. Retrieved from http://www.pcori.org/

4.        Wen, L. (2012). From doctor-centered to patient-centered care. Psychology Today. Retrieved from http://www.psychologytoday.com/blog/the-doctor-is-listening/201211/doctor-centered-patient-centered-care

5.        Zickmund, S. (n.d). Incorporating stakeholder engagement into VA research: What can we learn from the patient-centered outcomes research institute (PCORI)? Retrieved from http://www.hsrd.research.va.gov/for_researchers/cyber_seminars/archives/777-notes.pdf

6.        Institute of patient-and family centered care center at http://www.ipfcc.org/advance/topics/videos.html

7.        The National Quality Strategy (NQS): six priorities at http://www.ahrq.gov/workingforquality/toolkit.htm

8.        The Doctor is Listening by Leana Wen. (2012, November).  Psychology Today at http://www.psychologytoday.com/blog/the-doctor-is-listening/201211/doctor-centered-patient-centered-care

9.        Patient- and Family-Centered Care: Why it Matters and How to Practice It. At https://www.youtube.com/watch?v=7g-5I7DO1rQ&feature=related   

10.    Patient-Centered Care: What It Means And How To Get There at http://healthaffairs.org/blog/2012/01/24/patient-centered-care-what-it-means-and-how-to-get-there/

11.    The Values and Value of Patient-Centered Care. At http://www.annfammed.org/content/9/2/100

12.    The Ideal Medical Practice Model: Improving Efficiency, Quality and the Doctor-Patient Relationship at http://www.aafp.org/fpm/2007/0900/p20.html

13.    About the patient-centered care improvement guide at http://www.patient-centeredcare.org/inside/abouttheguide.html

14.    The Trouble With ‘Doctor Knows Best’ at http://www.nytimes.com/2012/06/05/health/views/essay-urging-doctors-to-do-less-may-fall-on-deaf-ears.html?_r=0

15.    Patient-Centered Care Improvement Guide at http://planetree.org/wp-content/uploads/2012/01/Patient-Centered-Care-Improvement-Guide-10-28-09-Final.pdf

Created by Participants in Nursing 7106 Context for Advancing Science (and Improving Health)

University of Utah College of Nursing PhD Program Summer 2014 

Submitted by: By Sara Hawkins RN MSN & Rumei Yang RN MS

(Lead Authors)

Navigating the Road from Disease to Health: Why Is There No Wellness General?

Moving from a disease focus to a health focus encompasses a way of being beyond lifestyle modifications or promotion of certain behaviors. Changing this paradigm examines how we live day to day and across a lifetime, and how many of the health challenges we encounter automatically occur as a byproduct of our modern way of life.  Many of us work sedentary jobs, with routines that can easily remove us from healthy ways of life. These issues are larger than individual, and must be addressed by communities, societies, and nations. Ultimately these are global problems.

How is the old model or paradigm outmoded or dysfunctional? Currently, we have a healthcare system which is actually a “sick care system”.  It is provider-centric, not patient-centric.  In our current system, the doctor “knows everything” and the patient “knows little” and is therefore unaccountable.  A larger issue of urgency exists in the culture as well: the public (i.e. patients) wants a “quick fix” (i.e. treatment).  If we want to affect the health of populations, we must find ways to move from our current reactive medical model to a more proactive social model.

What are the assumptions?  

A major assumption is that answers reside with medicalization and medical technology; it is a system set up to respond to acute illness, not preventive management of chronic disease processes. Medication is the predominant treatment strategy.  There is a “pass the pill” approach to disease management, and pharmaceuticals are viewed as a “cure all” approach in the treatment process. Change is needed. For example, instead of funding research on the treatment of heart disease, money could be rechanneled into primary prevention techniques to avoid the disease in the first place.

Another assumption is that technology is unilaterally a good thing and should be embraced, yet technology also presents complications. For example, gaming consoles and a culture of indoor, sedentary “play” has contributed to a childhood obesity epidemic, with our First Lady encouraging children to get outside and move. This would have been unimaginable a few decades ago.

A related assumption is that food is comfort: we celebrate with food and punish with exercise. A good grade is rewarded with an ice cream cone, not a run around the block.

We also have an assumption that teaching someone something means they will learn it, accept it, and adopt it.  Yet we face challenging cultural perspectives, where “being obese is a status symbol,” or cultures where certain ethnic foods are part of cultural identity.

An associated assumption is that behavior is individual; it’s actually social and community-based. Current health promotion models are too individualized, expecting individuals to make changes that need to be adopted systemically. New, innovative community, societal and national approaches to increasing public health will move health promotion forward.

What are the barriers? 

A central barrier is simply that change is hard. This is evidenced by the fact that our own National Prevention, Health Promotion, and Public Health Council (http://www.surgeongeneral.gov/initiatives/prevention/2013-npc-status-report.pdf, p. 2) is chaired by the Surgeon General. How is surgery the center of health promotion?  Why isn’t there a Wellness General? Below is a brief list of additional barriers we see:

§  Companies who profit from treating sick people will lose revenue if we become a healthier society.

§  Cost of sick care is profitable. Hospitals have reimbursed based on a fee for service model – thus incentivizing more service. With a shift toward preventive care, who will be reimbursed?

§  While people may understand the importance of eating healthy or increasing physical activity, they may lack motivation to change.

§  Our society does not allow for equal access for health.  Will the Affordable Care Act (ACA) really equalize this?  One annual visit is inadequate.

§  Environmental factors influence health across many facets of life

§  Access: getting healthy foods often requires transportation; exercising in one’s own neighborhood may not be safe

What Are the driving forces? 

Health is multidimensional, and requires a new way of thinking on many levels, not just the individual. Thankfully the shift to wellness and visions of a culture of health have some strong driving forces:

• Health care systems cannot adequately care for all the people in their vicinity.  We need to move toward health focused care in community-based settings and care for patients utilizing a more social model of care. Nurses can play a major role in providing such care.
• The cost of sick care is staggering – both monetarily and to the human being. This model is unsustainable.
• Personal interest is inviting increased knowledge of the long term impacts of lifestyle behaviors that negatively impact health (for example, smoking cessation), prompting personal choices to avoid specific behaviors

Community level drivers:  We see community level drivers within employer-employee relationships, workplace models that create community level change. People are forming their own communities for health (one way is by engaging technology and creating virtual communities using products like FitBit, My Fitness Pal)  Community level drivers also include entities like  local governments, tribal governments, families, neighborhood groups, faith-based groups and organizations, public health departments, teachers, city planning and engineering. Prioritizing health as a part of daily living in the community is exemplified in model communities such as those identified as Blue Zones (Buettner, 2005).

National level drivers:  A key national level driver is the federal government, with strategic plans  like the National Prevention Strategy Report-America’s Plan for Health and Wellness).  The National Council’s report (http://www.surgeongeneral.gov/initiatives/prevention/strategy/report.pdf) outlines both Strategic Directions and Priorities as follows:

Directions:

• Healthy and Safe Community Environments
• Clinical and Community Preventive Services
• Empowered People
• Elimination of Health Disparities

Priorities:

• Tobacco Free Living
• Preventing Drug Abuse and Excessive Alcohol Use
• Healthy Eating
• Active Living
• Injury and Violence Free Living
• Reproductive and Sexual Health
• Mental and Emotional Well-Being

Follow the link above. These are worth a look, illustrating the direction the driving forces can take. As we look at the National Prevention Strategy Report, it also becomes clear that the Department of Health is not the only federal organization responsible for this paradigm shift. Each department on the National Prevention, Health Promotion, and Public Health Council has an significant part to play as we navigate from disease to health. For example, we need to consider how the Departments of Agriculture, Education, and Transportation can all hold stronger roles in making this shift. 

National drivers can also include discipline-oriented and representative organizations (i.e. trade organizations, American Nursing Association, American Medical Association), health education groups, health care organizations, and big industries (i.e. pharmaceuticals, lobbying groups, etc.). Additional key players like the Robert Wood Johnson Foundation are leading the call in promoting a culture of health https://www.youtube.com/watch?v=rs4QSF6mxug.  

International level drivers: Globally, we think of organizations like WHO, Red Cross, and UN that can affect the promotion of health world wide. With a global economy, private institutions can also contribute, and may in fact have more impact on individuals.

Conflict, controversy, and tensions:

The issues of personal freedoms versus how much the government can legislate individual behaviors will continue to be a potential source of conflict and tension.  Examples include legislated safety issues such as wearing helmets for motorcycles and bicycles, using seat belts, and car seats.

Another controversy surfaces when people abandon the science and engage in health focused behaviors that may in fact be dangerously detrimental to their health;  e.g. avoiding vaccines, consuming unpasteurized food products, turning to alternative treatments as a decision fuelled by principles and not informed decisions.

We will continue to face challenges regarding resources, space, clean water, potential antibiotic resistance and superbugs with increased virulence of certain bacteria/viruses, pollution, and potential for increased poverty. 

Looking to the future 

So what does the future hold? What roles will need to change for everyone in this nation, including clients, communities, and health care providers alike?  A sorely needed Wellness General could concentrate efforts, and focus on improving health and infrastructure in every community – emphasizing healthy lifestyles, advertising healthy behaviors, and monitoring unhealthy products. We anticipate that hospitals will continue to serve intense, acute-care, research and observation needs, with a shift toward more registered nurses leading and coordinating interdisciplinary care in community-based wellness and health centers. The National Prevention Council’s National Prevention Strategy is a vital blueprint for future direction. Prevention is the new multidimensional model; “it takes a village” to keep people healthy.

References:

Buettner, D. (2005). Who’s best at living longest: The secrets of longevity. National Geographic, November, 6-26.

Christakis, N. A. and Fowler, J. H. (2007). The spread of obesity in a large social network over 32 years. . The New England Journal of Medicine, 357, 370-379.

Glass. T. A., and McAtee, M. J. (2006). Behavioral science at the crossroads in public health: Extending horizons, envisioning the future. Social Science and Medicine, 62(2006), 1650-1671.

National Prevention Council, National Prevention Strategy, Washington, DC:  U.S. Department of Health and Human Services, Office of the Surgeon General (2011).

Schroeder, S. A. (2007). We can do better – improving the health of the American people. The New England Journal of Medicine, 357, 1221-1228.

Links to Resources:

Surgeon General.gov http://www.surgeongeneral.gov/about/

Healthy People 2020  http://www.healthypeople.gov/2020/default.aspx

Social Security’s Financial Outlook http://crr.bc.edu/briefs/social-security%E2%80%99s-financial-outlook-the-2013-update-in-perspective/

Healthcare Paradigm Shifts http://www.njspotlight.com/stories/14/05/29/as-healthcare-paradigm-shifts-nj-hospitals-face-uncertain-future/

Health Issues  http://www.globalissues.org/issue/587/health-issues

Created by Participants in Nursing 7106 Context for Advancing Science (and Improving Health)

University of Utah College of Nursing PhD Program Summer 2014 

Submitted by:

Susan Gallagher, RN, MSN, GCNS-BC and Katarina Friberg Felsted, MS

(Lead Authors)

Personalized medicine-Leveraging what makes a person unique rather than usual or typical

THE SHIFT TO PERSONALIZED MEDICINE

A significant shift to “personalized” medicine is influencing practice, education, and research. Currently we practice based on the evidence generated from randomized clinical trials that demonstrate efficacy of a particular intervention. So we focus on the so called middle of the curve and what works for the majority, the average, the typical individual. We base our practice on a generalized perspective. As an example, we choose antibiotics or other medications based on how the patient presents and what we know works typically in similar cases. While this view point will continue to be prevalent and useful, the idea of “personalized” medicine is founded on the particulars and specifics of what makes that person or family unique, not usual or typical. This approach is actually a very significant shift in the foundations of our thinking.

Personalized Medicine

Personalized medicine is an emerging practice of medicine that uses an individual's genetic profile to guide decisions made in regard to the prevention, diagnosis, and treatment of disease. Knowledge of a patient's genetic profile or proteomics can help doctors select the proper medication or therapy and administer it using the proper dose or regimen. Personalized medicine is being advanced through data from the Human Genome Project. Consideration of characteristics such as age, coexisting conditions, preferences, and the crafting an individual management strategy augments the use of advanced individual genomic information in choosing a biologic agent tailored to the patient’s needs. Customized monoclonal antibodies and vaccines are examples of personalized medicine. Personalized medicine is a medical model intended to customize healthcare with the use of molecular analysis: tailoring medical decisions, and products to the individual patient to prescribe the right drug or treatment, to the right disease, at the right time, with the right dosage.

Genomics

Genomics is seen as a blue print for growing organisms including humans. It is giant umbrella topic covering the many areas of the natural sciences including biology, health sciences, and zoology. Breakthroughs in genomic research and the sequencing of the human DNA now allow scientists to study the interactions of environmental and genetic factors that impact the disease process. Moreover, the potential now exists to develop genome-based pharmaceuticals for specifically targeted therapies. The Human Genome Project (http://www.genome.gov/10001772 ) was a process of phenomenal scientific discovery that has advanced medical science to allow for treatments to be targeted to the unique genetic makeup of an individual.

Genome-wide association studies rapidly scan markers across complete sets of DNA of many people to find genetic variations associated with a specific disease or phenotype. The studies are comparative case control studies that involve comparing individuals who have the disease phenotype to non-diseased individuals. These studies are possible now because of the availability of research tools, tissue banks that contain the reference human genome sequence, maps of human genetic variation and sets of new technologies that can quickly and accurately analyze whole-genome samples for genetic variations that contribute to or prevent the onset of a disease.

Genome-wide association studies have found genetic variations that contribute to the risk of type II diabetes, Parkinson's disease, heart disorders, obesity, Crohn's disease and prostate cancer, as well as genetic variations that influence responses to anti-depressant and anti-coagulant medications.  Genetic variants have also been identified for age related macular degeneration, a common cause of blindness.

Researchers can access data from genome-wide association studies through The National Center for Biotechnology Information (NCBI), which is a part of NIH's National Library of Medicine. The NCBI is this resource for use by the research community and have archives of data from genome-wide association studies on a variety of diseases and conditions. These are all accessed through the NCBI Web site: Database of Genotype and Phenotype (dbGaP) located at: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=gap.6. NIH requires that researchers who are funded to do a GWAS share their data so the data base will expand and grow and become more of a resource to other researchers, scientists and consumers. These big data will promote a discovery paradigm in science.

P4 Medicine

P4 Medicine is a conversion from a reactive mode, focused on disease, to a model of prediction, prevention, personalization and participatory medicine. P4 Medicine will improve the quality of care delivered to patients through better diagnoses and targeted therapies. These advances facilitate new forms of active participation by patients and consumers in the collection of personal health data that will accelerate discovery science. Soon a virtual data cloud of billions of health-relevant data points will surround each individual. Through P4 Medicine, we will be able to reduce this complex data to simple hypotheses about how to optimize wellness and minimize disease for each individual.

Systems Biology and Big Data

The study of systems biology is quantitative measurement and study of the interacting components in genomics using bioinformatics and proteomics, which then have a mathematical computation models applied for prediction and description of the dynamic biological system. Systems biology is now pioneering actionable understandings of disease and wellness as a continuum of network states, unique in time and space to each individual human being. Scientists at the Institute for Systems Biology are exploring new techniques and strategies that will make blood a window for health and disease, which is a critical platform for P4 Medicine and new advances in drug targeted discoveries. The emergence of big data and computing power has transformed how scientists and healthcare systems are disentangling the complexities of disease and wellness. Currently, new tools for mining, integrating and modeling big data sets of heterogeneous biological data are generating predictive and actionable models of health and disease that translate directly to individual health.

Another factor that will become important to personalized medicine is tissue regeneration. Advances in the ability to create tissue from pluripotent stem cells and the ability to use 3-D printing to create personalized body parts are game changers.

The future is provision of personalized care using individualized patient information obtained from DNA sequencing and proteomic analysis. The care will involve predicting the risk of developing certain diseases, hence tailored disease prevention programs, and the provision of personalized treatments based on genotypic and biologic information. This approach will result in the least adverse reactions in a particular patient because the treatment will be developed with that specific person’s genomics in mind. As personalized medicine evolves, it will be essential for patients and family consumers to become engaged in how personalized care is delivered.

DRIVING FORCES
The driving forces leading to the paradigm shift include knowledge of human genome and less expensive sequencing, knowledge of systems biology, and advance in tissue regeneration. The internet and cloud technology provide the potential capacity to a share data worldwide. The power of crowdsourcing science is immense.

THE CHALLENGES 

Once people are aware of their disease risk, we will still face the ongoing challenge of improving health behaviors including self-monitoring, nutrition, physical activity and other wellness practices. There is a need to develop educational tools so that the providers and the patient/ family are not overwhelmed with their biologic and genetic data.

Controversy and Issues to Consider: Genetic Discrimination

Many Americans fear that undergoing genetic testing will lead to discrimination based on their genetics. A challenge to genomic research and personalized medicine exists as people may be fearful and dissuaded from participation because of privacy issues, genetic discrimination in employment, and the potential of being denied insurance.

The 2008 Genetic Information Nondiscrimination Act (GINA) prohibits discrimination based upon genetic information in the workplace and by health insurance issuers. GINA protects Americans from discrimination based on their genetic information in both health insurance (Title I) and employment (Title II). Title I amends the Employee Retirement Income Security Act of 1974 (ERISA), the Public Health Service Act (PHSA), and the Internal Revenue Code (IRC), through the Health Insurance Portability and Accountability Act of 1996 (HIPAA), as well as the Social Security Act, to prohibit health insurers from engaging in genetic discrimination.

Other Issues for Consideration

One of the issues to be considered is whether personalized medicine can actually lower health care costs while making care more individually applicable through genomics. Will it be possible to personalize medicine, provide improved care, and eventually slow and stabilize the cost of care? Funding and costs are essential parts of the healthcare equation.

There may also be the potential to add to health disparities. Would this customization only be available of those with financial resources or high health literacy? There is also the possibility that the lab testing and counseling that currently is essential to personalized medicine would not be covered by all private insurance or Medicare.

The digitalization of medicine and the provision of tools to manage each individual’s billions of data points and creates actionable diagnosis from one molecule, one gene, one genome, or one tissue. This will transform one of the biggest engines of economic growth, the healthcare industry. Opportunities exist for the emergence of new companies, some of which do not even exist today. For example, manufacturing equipment and processes will be needed to create the new tissues and organs. Related concerns include quality regulation of the processes and long-term durability of the tissue once it is created. 

The conflicts, controversy, and tensions between the paradigms are many. What will be the role of the physician and other providers? There are concerns about costs, privacy, and ethical concerns about objectification of a human to a sequence of letters. Danger exists of purposely manipulating human genes for unethical reasons or potentially extending life to a detriment. Many stakeholders: policymakers, payers, providers, and the public are wary of unintended consequences of personalized health care.

RECOMMENDED READINGS OR LINKS FOR MORE INFORMATION

http://www.ted.com/talks/richard_resnick_welcome_to_the_genomic_revolution

http://www.genome.gov/20019523

http://www.youtube.com/watch?v=r6nSmSTKHGc

https://www.youtube.com/PatientsLikeMe

https://www.youtube.com/watch?v=tKpClbqc4QY

http://www.webmd.com/

http://thecolbertreport.cc.com/videos/udr4lu/eric-topol

http://learn.genetics.utah.edu/

http://thomas.loc.gov/cgi-bin/bdquery/z?d110:h.r.00493

https://www.genome.gov/20019523

https://www.youtube.com/watch?v=r6nSmSTKHGc

https://www.youtube.com/watch?v=xoStO0qkqYA

http://www.genome.gov/glossary/index.cfm?id=150&textonly=true

http://p4mi.org/

http://www.ted.com/talks/richard_resnick_welcome_to_the_genomic_revolution

http://thomas.loc.gov/cgi-bin/bdquery/z?d110:h.r.00493

http://www.genome.gov/24519851

http://www.cancer.gov/aboutnci/servingpeople/cancer-research-progress/therapeutic-platform

http://ghr.nlm.nih.gov/glossary=personalizedmedicine

http://thecolbertreport.cc.com/videos/udr4lu/eric-topol

Created by Participants in Nursing 7106 Context for Advancing Science (and Improving Health)

University of Utah College of Nursing PhD Program Summer 2014 

Submitted by: 
Linda C. Hofmann, MSN, RN, NEA-BC, NE-BC and Angela Njenga MHA, RN

(Lead Authors)