Person-Centricity: Promoting Self-Determination and Responsibility in Health and Health Care.

The transition from a system focused on the delivery of sickness and illness services to one with a heavy focus of helping people become and remain healthier requires a major shift in how we view the patient and person. The health care system attempts to magically transform us from persons to patients in a context of sickness and disease, in need of medical procedures and interventions. Those few hours we spend a year in formal medical and health care contexts do not define us in the broader life space. We contend that "person-centricity" is more reflective of the life space and as such better supports that shift than do models of consumer or patient empowerment, centeredness, engagement, or activation. "Person-centricity" represents the complexity of how individuals make decisions including health and health care decisions, within the broader context of their lives, and accurately addresses the needs and aspirations of people throughout their life journey. This is not simply a shift in semantics, but an entirely new paradigm that frees the individual from assuming and succumbing to the passive and subservient patient role and dramatically changes the way in which we view ourselves and interact with the health care system.The changes required to create a healthier America and affect costs associated with lifestyle-related diseases need to happen on a personal level, coupled with a supportive infrastructure and public policies to promote and sustain them. This shift is critical to our transition from health care to a healthier way of living and of controlling avoidable costs.

Toward a National Conversation on Health: Disruptive Intervention and the Transformation from Health Care to Health.

Over a century ago, Abraham Flexner's landmark report on medical education resulted in the most extensive reforms of medical training in history. They led to major advances in the diagnosis and treatment of disease and the relief of suffering. His prediction that "the physician's function is fast becoming social and preventive, rather than individual and curative," however, was never realized.Instead, with the rise of biomedical science, the scientific method and the American Medical Association, the health care system became increasingly distanced from a holistic approach to life that recognizes the critical role social determinants play in people's health. These developments created the beginning of the regulatory controls that have come to define and shape American health care - and our unhealthy obsession with illness, disease and curative medicine that has resulted in a system that has little to do with health.To realize Flexner's prediction, and to transform health care into a holistic system whose primary goals are focused on health outcomes, six disruptive interventions are proposed. First, health needs to be placed in the context of community. Second, the model of primary care needs to be revised. Third, big data need to be harnessed to provide personalized, consumable, and actionable health knowledge. Fourth, there needs to greater patient engagement, but with fewer face-to-face encounters.Fifth, we need revitalized, collaborative medical training for physicians. And finally, true transformation will require market-driven, not regulatory-constrained, innovation. The evolution from health care to health demands consumer-driven choices that only a deregulated, free market can provide.

Person-centric clinical trials: defining the N-of-1 clinical trial utilizing a practice-based translational network.

A person-centric clinical trial is inclusive of both the investigator and the person and as such represents point-of-use data generated at the practice level and encompasses both health and disease. Raising the clinical encounter to a research encounter and providing an infrastructure to support a level of quality assurance creates a synergy for efficiency for healthcare delivery. The interface of translational studies and clinical research poses an opportunity, whereby person-centricity can support transparency, facilitate informed consent, improve safety, enhance recruitment and compliance, improve dissemination of results, implement change and help close the translational gap. The model represents robust clinical data from persons of record allowing for improved interpretation of drug/device side-effects and for regulatory reviewers to expedite the approval process.

Person-centric clinical trials: Ethical challenges in recruitment and data transparency for improved outcomes.

Practitioners participating in clinical studies are faced with a number of ethical issues related to recruitment, informed consent, handling and transparency of data. Practitioners educated in Good Clinical Practice, applying the philosophy of person-centricity within a network utilizing risk-based monitoring and remote data entry can provide the requisite infrastructure and oversight to support person-centric clinical studies. While "patient-centered" clinical studies allow for a broader clinical outcome perspective beyond the investigator, the person-centric approach, accounts for the comprehensiveness and complexity of how we make health and healthcare decisions. Augmenting person centricity with comparative effectiveness studies allow for the inclusion of individual data significantly contributing to the aggregation of multiple data sets about individuals and populations. This enables more powerful and personal analytics and care and everyone is afforded the opportunity and privilege to contribute to improve clinical outcomes and in controlling and containing costs. Policy and institutional investment in infrastructure are prerequisite to accommodate these opportunities, to minimize abuses, and provide pathways for analyzing alternative healthcare patterns. Data provided will be comprehensive and robust, representative of use, with safety data more easily discernible from persons with a known past medical and health history.

Person-centric clinical trials: an opportunity for the good clinical practice (GCP)-practice-based research network.

Practice-based research networks (PBRNs) can function as a platform for delivery of patient-centered care consistent with the Patient Protection and Affordable Care Act. Patient-centered (centric) clinical studies encourage the patient to be an integral part of study design and outcome. The patient's electronic health record contributes to the shared national health care data set. PBRNs integrate health care data in real time at the point of care and reflect the full context of the person's health. PBRNs designed under the principles of good clinical practice (GCP) validate studies related to comparative effectiveness research and drug development. PBRNs can generate large amounts of data from known patient histories so that side effects can be assessed in their totality. The larger and more diverse number of patients recruited suggests that point-of-care-data, where both provider and patient participate in the treatment, may be more robust in that side effects, drug-drug interactions and number of concomitant medications used may be identified earlier in the development process. The GCP PBRN concept affords continuous patient information for both care and research purposes. These all contribute to an ethical approach for the pharmaceutical industry to generate clinical research data for regulatory submission and to contribute to a HIPAA-compliant national database that could contribute to improved health care delivery and pharmacovigilance.

Defining Patient-Centricity: Opportunities, Challenges, and Implications for Clinical Care and Research.

The Patient-Centered Outcomes Research Institute (PCORI), created and funded by the Affordable Care Act, is charged with bringing the patient perspective to clinical research design and the outcomes that are studied. However, there is no consensus definition of "patient-centeredness" or "patient-centricity." This paper distinguishes between the terms and describes an infrastructure for supporting the concept of patient-centricity. The patient's role needs to be described in a way that makes it feasible to implement health care delivery and support parameters to conduct clinical research over a sustained period of time. The authors propose the use of a structured Practice-Based Clinical Research Network to perform patient-centered outcomes research consistent with the requirements of the pharmaceutical sector in a safe, ethical, and effective manner and congruent with the principles of Good Clinical Practice (GCP).