Abstract
Background
The ills of the United States health care system have been debated for decades. Imbalance in the system’s strengths and performance shortfalls stem from misalignments among system participants.
Methods
We examine the conflicts that health care system participants provoke in essential features of health care—information, products, services, and access—using a two-part model. The first part comprises patient-provider relationships that give rise to patient-centred care. The second part includes stakeholders that influence patient-provider relationships but do not provide direct patient care. Misalignments between these parts interfere with the system’s quadruple aim: to improve population health, enhance both patient and provider care experiences, and reduce per-capita costs.
Results
Knowledge-sharing and documented practices and tools to implement patient-centred care and use real-world data can help to align the health care system. Patients, providers, and stakeholders should meet patient-centred care objectives because the patient should be the centre of all health care system operations. Alignment is driven by patient-centred real-world data generated by patient-provider relationships and used by stakeholders. Patient-centred real-world data reveal informative portrayals of patient preferences, health outcomes, resource utilization, and costs across subpopulations. These data enable stakeholders to produce patient-centred information, products, services, and access. These stakeholder outputs meet patients’ individual needs, support providers’ personalized care, and improve system-wide care quality, satisfaction, outcomes, and cost-effectiveness.
Conclusions
Patient-centred real-world data are valuable commodities and an aligning force. The United States health care system must remove barriers to providers’ patient-centred care practices, use patient-centred real-world data generated from ideal patient-provider relationships, and prioritize patient-centred care among all participants.
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1 Background
The US health care system is both admired and criticized. Its strengths include robust investment in research by government, foundations, and industry, international leadership in education and advancing scientific understanding of diseases, development and delivery of life-saving interventions, and provision of the highest quality care in many settings. The system’s shortfalls include the challenges of operating in a diverse, populous country, disparities in health care access, inferior performance compared with peer countries, discouragement among providers, and frustrations among patients.
The imperatives to reform the system and improve health care for the US populace are evident. Opinion polls, books, and articles report dissatisfactions and system inadequacies, justifying the need to assess new models. A November 2018 Gallup poll [1] revealed that 70% of respondents described the US system as being in a state of crisis or having major problems. Decades-old reports document a splintered or broken system. They show poor coordination, diminished quality of care, and inferior population-based health outcomes at much greater costs than in other economically developed nations [2,3,4,5,6].
Many opinions are offered to explain the state of the US health care system. Examples of these include limitations in statutes, how the system is organized, health care as a right or privilege, dysfunctional competition among stakeholders, adversarial dynamics, contradictory forces on clinicians, and unaffordable and inconsistent quality of care [2,3,4,5,6]. What is implied but not explicitly expressed is that misalignment among system participants is a key factor.
What is misalignment? It is an incorrect arrangement or position of one object with another; it is like a rowing team’s inefficiency when oar strokes are not simultaneous. Misalignment is not only categorical; it is magnified by the number of incorrect arrangements of parts. In any system, failure of participants to align on aims and how to achieve them precludes success. Misalignment is a principal aspect of the US health care system’s dysfunction.
We model the US health care system as two parts: patient-provider relationships (PPRs) and stakeholders. This permits examination of each part’s context and expectations about essential features of health care delivery—information, products, services, access—and systemic interactions between the parts. Table 1 lists definitions of acronyms, initialisms, and terms used in this review.
First are patient-provider dyads comprising PPRs—interpersonal channels that effectuate patient-centred care (PCC) [7]. PCC is defined as care that is respectful of and responsive to individual patient preferences and needs, which ensures that patient values guide all clinical decisions [8]. The principles of PCC apply to providers in all primary care and clinical specialties.
Second are stakeholders—entities outside of but influencing PPRs: policymakers, academic suppliers, industry (commercial) suppliers, health authority regulators (Food and Drug Administration [FDA]), payers, administrators (access regulators), professional and patient groups, and provider organizations. Stakeholders do not provide direct care, but they should support effective, high-quality PCC achieved through PPRs.
Many participants in the US health care system seem to have different aims. As a result, it operates in a misaligned and costly manner. Overarching aims of the system are delineated as the quadruple aim: to improve population health, enhance both patient and provider care experiences, and reduce per capita costs [9, 10]. In this review, we describe misalignments among participants against the quadruple aim and review how documented practices and tools can help to align the health care system.
2 Misalignments between PPRs and stakeholders: a view from fifty thousand feet
The imbalance of strengths and shortfalls of the US health care system demonstrate misalignments between PPRs and stakeholders. These occur in three areas: types of pursuits, focuses of activities, and interactions of the two parts. Differences in priorities between PPRs and stakeholders disrupt the former. Coincident misalignments of many stakeholders with PPRs amplify disruptions and increasingly compromise PPR dynamics.
First, the system spotlights biomedical research [11] that is driven by many stakeholders. By contrast, despite the value of scientific investigation, the system somewhat side tracks application of research advances to broadly support PCC in health care delivery through PPRs.
Second, stakeholders focus on populations but PPRs centre on individuals. This approach steers biopharmaceutical companies to market more of a medicinal product for the approved patient population. For PPRs, however, the treatment might not be the best option for some patients. Another example is overloading providers’ clinic schedules or inequitable assignment of the number of patients to individual providers in practices and provider organizations, which hinders PPRs [12]. The population focus of all stakeholders influences their objectives and can disrupt PPRs: stakeholders’ policies and communications related to information, products, services, and access do not apply to everyone. Stakeholders’ operating models that emphasize populations inherently limit attention to individualized, personalized health needs. Not prioritizing individuals undermines PPRs and assurances of PCC [7]. This creates misleading or ambiguous situations for PPRs and impedes the quadruple aim.
Third, the way PPRs and stakeholders interact is misaligned. PPRs are positioned as dependent recipients of a one-way, regulated flow of information, products, and services. Stakeholders drive these to the patient-provider dyad. Access to products and services is governed by other stakeholders. A paternalistic, non-PCC delivery continuum results. As depicted in Fig. 1, there is no system-wide feedback from PPRs to influence stakeholder behaviour reciprocally in a paradigm that has existed for decades with no incentives for change.
Current paradigm: unidirectional health care delivery continuum from stakeholders to providers and patients. Stakeholders position providers and patients as dependent end-users of information and Dx and Rx products of academic and industry suppliers’ R&D. Products are regulated (checked, controlled, and contained) by other stakeholders in this paternalistic, non-patient-centred paradigm. Dx, diagnostic; R&D, research and development; Rx, treatment
3 Misalignments among health care system participants: a view on the ground
Misalignments can exist within PPRs, between PPRs and stakeholders, and among stakeholders in prioritizing PCC and sourcing data that gives rise to the essential features of health care.
3.1 Misalignments within PPRs
Providers and patients can contribute to PPR dysfunction. Providers disrupt PPRs if they sustain paternalistic practices and deny shared decision-making with patients [7]. They disrupt PPRs if they overutilize technologies through supply-driven health care and practise variation [13, 14]. How providers engage with patients can limit the quality of PPRs: those who choose detached, intellectual involvement to bolster clinical objectivity [15] as a practice style or psychological defence [16], or schedule heavy patient loads, do so at the expense of PPRs. Patients might undermine relationships with providers by not voicing questions and concerns, not taking responsibility for their care, and expecting providers to have ‘all the answers’ [7, 17, 18].
3.2 Misalignments between PPRs and stakeholders
Stakeholders contribute to essential functions in the health care delivery continuum. They form a supply chain that begins with research and yields information, products, and services that are regulated and administered for patients and providers (Fig. 1). Categories of stakeholders and examples of their members, missions, and misalignments with aims of PPRs are listed in Table 2. Readers can examine entities’ websites for specific information.
Stakeholders might disrupt PPRs in several ways: Stakeholders lack knowledge of individual patient needs. Missions and policies might favour interests of other stakeholders over those of patients. Aberrant actions by employees that self-enrich and do not comply with organizational policies do not serve PPR interests. Funding research for basic science rather than health care delivery does not yield immediate benefits to PPRs [11]. Operating a health care system in for-profit, competitive, investor-driven, business settings thwarts the quadruple aim.
Financial interests prod many stakeholders to zero-sum competition [3], defined as one entity gaining by causing another to lose. We focus on its harm to PPRs: it manifests as cost-shifting, e.g. co-pays, limited coverages, and switching insurance premium payments to employees from employers. It happens with restricting providers’ treatment choices and services and patients’ access to out-of-network care. Consolidation to increase bargaining power can reduce competition and increase costs. The rise of intermediary stakeholders affects costs for patients. Other competitive actions drive revenue shifts that disadvantage patients and increase health care resource utilization (HCRU). These economics-driven actions restrict options for patients, misalign with the aims of PPRs, and further compromise the quadruple aim.
Administrators, payers, service providers, and health plans affect access to and costs for products and services in a misaligned manner. Policies and practices that focus on cost-reduction disrupt PPRs. Payers’ refusals to pay for treatments and services do not align with providers’ recommendations for individual patients. Universal access to all products and services that exist in the health care marketplace is not granted in all entities and is not available at the same costs. Access is neither uniform in all entities nor consistent for any one entity over time. Such misalignments emerge when patients change plans and coverages or when providers manage patients with similar needs but different plans and coverages.
Other examples of misaligned actions of stakeholders and PPRs are electronic medical records (EMRs) [23, 24] and health administration. Provider organizations, hospitals, health plans, and government agencies employ quality care initiatives, Hospital Consumer Assessment of Healthcare Providers and Systems surveys, sponsored by the US Centers for Medicare and Medicaid Services, and other documentation requirements. These procedures are intended to address stakeholders’ objectives, e.g. improve clinicians’ care and efficiency, collect patient feedback, increase reimbursements, and support organizational and revenue goals. However, the corresponding implementation processes distract from and reduce the quality of PPRs [7].
3.3 Misalignments among stakeholders
In addition to zero-sum competition discussed above, misalignments among stakeholders are often based on discrepancies in access to and use of different types of data sources. We address this topic in greater detail below.
3.4 Misalignments on PCC
System participants lack a common aim to prioritize individualized, personalized care. The above-described examples of misalignments within PPRs and between PPRs and stakeholders indicate that the health care system is not universally patient-centred. Patients might not believe their providers always focus on their health needs and routinely invite them to be collaborative partners. Stakeholders’ missions might not truly align with PCC. Some system participants might not adequately factor in patient illness experiences [25, 26].
If patients read stakeholders’ vision and mission statements, they might perceive them as disconnected from their clinical and psychosocial needs. A patient might wonder whose interests are primarily addressed when stakeholders seek to serve patients and satisfy investors. Some stakeholders cite ‘customers’ or ‘clients’ without emphasis or mention of ‘patients’. The term ‘patient’ might be avoided because advocacy groups prefer ‘people’ or ‘person’ in pursuing more collaborative relationships between stakeholders and health care recipients. However, patients might object to what seems to be a dismissal of their maladies. If stakeholders and PPRs are truly patient-centred, then the terms ‘patient’ and ‘provider’ appropriately define the partnership, with each engaging in their respective roles in the PPR.
Stakeholders comprise disparate entities with overlapping but different missions. Their aims include improving societal health, but stakeholders do not always address an individual patient’s specific clinical needs. This is true when patients’ circumstances do not equate to those of their respective population groups. As another example, some stakeholders prioritize investigation of the molecular basis of diseases. Such research could inform future precision medicine standards but does not address an individual’s current suffering.
3.5 Misalignments on data sources that give rise to the essential features of health care
Misalignments on information, products, services, and access can occur because of mismatches between data sources that inform these essential features of health care. The impact of varied data sources as a misaligning force is driven by stakeholders’ use of the data → information → knowledge → understanding → wisdom (DIKUW) process [27]. This process encompasses data collection, analysis, and interpretation that informs learning and activities.
The dynamic of PPRs is an example of a DIKUW process. Classically, providers collect data from patients through dialogue, history, physical examination, and tests as part of the process of differential diagnosis. They integrate and interpret these data to yield information: a diagnosis. The diagnosis unlocks knowledge of treatments to discuss with the patient. Observation of treatment effects yields understanding of how to optimize clinical management. Experience with this approach with multiple patients, including their diverse preferences and responses, yields wisdom (knowledge and experience). This enables higher quality knowledge- and decision-sharing with other patients with the same diagnosis. Thus, the DIKUW process encompasses virtuous cycles of learning in a provider’s clinical practice that informs uses of products (diagnostic tests and treatment interventions) and services. Learning is enhanced by experience-sharing among providers in group practices and larger provider organizations [3].
Another example of a DIKUW process is the approach of the FDA and biopharmaceutical companies to protect public health. Controlled clinical trials establish risk–benefit profiles for approved drugs. However, post-marketing pharmacovigilance is necessary to determine a drug’s safety profile in larger, more diverse populations. Adverse event reports (data) are prospectively collected via surveillance processes such as MedWatch and company reporting to the FDA. Event frequency, severity, chronology, and other factors are assessed and yield information about a possible causal relationship to the drug. Prospective monitoring for these adverse events provides knowledge about the magnitude of risk. This enables understanding and wisdom that informs potential actions on use of prescription drug products, e.g. revising prescribing information, adding warnings and precautions, implementing restrictions on use, or withdrawing the drug from the market unless drug treatment benefits continue to outweigh newly appreciated risks.
As seminal initiators of DIKUW processes used by health care system participants, data contribute to misalignments in several ways.
Data access and standards vary among stakeholders. Differences in data access reflect laws, policies, and the proprietary nature of some data sets. Health information databases, including personalized medical information subject to privacy and security provisions to safeguard these data per the US Health Insurance Portability and Accountability Act, data captured via patient-reported outcome measures (PROMs) questionnaires (such as those administered in the national PROMs programme in the UK), disease registries, and administrative claims, are not uniformly available to or used by all stakeholders. Misalignment is inevitable if system participants lack the same data access. Varying standards for data and interoperability of data management systems exist [28,29,30,31]. This lack of compatibility across data systems obstructs information sharing. Disagreements also exist about the validity of data collection methods and analyses used by different stakeholders. Different rules and regulations are applied across the various stakeholders for data quality standards, interpretation, and organizational use.
Differences in data sources, management, and dissemination contribute to misalignment between stakeholders and PPRs and within PPRs. Academic and industry suppliers generate data in research settings. Other stakeholders use data from the real-world health care environment. Collectively, these data can disrupt PPRs because of differences in their sources, goals for their use, and how they are communicated.
For example, the FDA determines the content of drug prescribing information that is predominantly informed by controlled trials. This governs what industry suppliers may communicate. However, professional associations and other agencies develop independent guidelines for product use. Professional groups often rely on combinations of evidence-based studies, clinical experience and wisdom, and experts’ consensus. Other data appear in peer-reviewed publications about drug efficacy and safety. Payers and provider organizations share data with plan members and providers without the restrictions imposed by the FDA on drug, diagnostic, and device industry suppliers.
Patient-generated health data (PGHD) can disrupt PPRs. PGHD are health-related real-world data (RWD) created, recorded, gathered, and controlled by patients, family members, or other caregivers. Thus, PGHD differ from RWD generated in clinical settings during encounters with providers [32,33,34,35]. PGHD include medical and treatment history, symptoms, lifestyle information, and biometric data from health apps. However, PGHD are not necessarily contextualized by the benefits of an ideal PPR in which PCC is practised. Nevertheless, stakeholders regard PGHD as an expression of patient voice and can be important, accessible data that inform stakeholders’ patient-centred activities. PGHD offer opportunities to improve health care delivery by providers. However, the use of PGHD in real-world clinical practice faces hurdles like the issues with EMRs because of problems with implementation and decision support [36].
PPRs are hampered by disparities and quantities of data. Providers use clinical experience and judgement, which industry representatives influence. Patients depend on information from their providers. Patients also increasingly rely on digital information from social media, web searches, and chat rooms [37,38,39]. The sources, quality, and integrity of that information might not be well scrutinized and are subject to trade-offs: for example, online patient communities offer value by enabling patients with the same medical disorder to share personal experiences. High quality, peer-reviewed data may be inaccessible behind paywalls. Even if these data are published open access, they may lack plain language summaries, restricting accessibility. Access to quality information can counter misinformation; when the first is not accessible or understandable, the second fills the vacuum. Promotion of misinformation about diseases and their treatments is as troubling to professional participants of the health care system as it is disruptive to PPRs.
The barrage of data directed at patients and providers has a knock-on effect on PPRs. Time is spent reconciling differences between patients and providers on disparate data to inform clinical decisions. Providers must balance the use of web-based content with information from conventional, contemporary clinical sources.
Data inform product development, clinical services, and access decisions. Differences in data sources divide patients, providers, suppliers, and payers on access to and payment for products and services. Stakeholders emphasize how products and services benefit patients, but attention is needed for patients for whom these stakeholder outputs do not work or are not available. In fact, the system’s one-way supply chain (Fig. 1) is misaligned because it does not accommodate consolidated, real-world experiential reporting from PPRs back to stakeholders. As an example, mechanisms do exist for patients and providers to report adverse reactions to prescription drugs to health authorities and biopharmaceutical companies, but the proportion of events that is reported is low. More robust and effective feedback loops should exist to support communication of crucial data on treatment safety, as well as efficacy, access, costs, and other factors, about how stakeholders’ information, products, and services can be misdirected, irrelevant, or unavailable for PPRs. This should lead to enhanced personalization and improvements in care.
Another example is industry research and development, FDA requirements, and payer coverage decisions for new drugs for adults versus children, acknowledging the scientific and ethical limitations of generating data from paediatric research. An additional example is the ‘one size not fitting all’ in drug development related to data on interindividual variation in drug metabolism or specific genetic polymorphisms that affect susceptibility to adverse reactions or the drug’s effectiveness in individual patients. Both types of data emerge from biological differences among patients and have substantial implications for drug products’ overall safety and efficacy. Ideally, drug development should go beyond accounting for higher-level, less specific differences in patient subpopulations to address personalized needs for dose levels, dosing frequency, and clinical monitoring. Such information would reset expectations about the risks and benefits of the drug for individual patients.
One more example is traditional drug development to treat obesity which focused on reducing long-term complications of cardiac disease and diabetes. However, this approach did not account for data on patients’ interests in near-term outcomes of improved physical functioning and quality of life achieved with weight loss. This illustrates how misalignments on data can diminish the value of information, products, and services. Fortunately, more patient-centred approaches to obesity management evolved [40].
4 Aligning PPRs and stakeholders: a new view from fifty thousand feet
The US health care system should match the essential features of health care created and administered by stakeholders with the needs of PPRs. Several options for health care reform have been put forward, such as improving general access to products and services, removing disparities in access, providing universal insurance coverage, and guaranteeing health benefits. Collaboration between PPRs and stakeholders might necessitate new laws and policies to stimulate reciprocal information exchange. Directives could limit costs and financial gains and redefine incentives to achieve the quadruple aim. We suggest adjusting the system’s dynamics rather than relying on legislative interventions that could yield uncertain outcomes [41].
Prioritizing PCC should be the pervasive objective of reform to align and improve the health care system. We propose an integrated, two-pillar framework based on documented practices and tools: (1) comprehensive implementation of PCC; and (2) use of patient-centred RWD generated by PPRs committed to PCC.
PCC should be prioritized by patients, providers, and stakeholders. Patient-centred RWD should be used by all participants. RWD reflect real-world health activities. Patient-centred RWD constitute more valuable commodities—higher quality RWD—and can be an aligning force: PPRs engage in PCC. Knowledge derived from patient-centred RWD is shared with stakeholders. Stakeholders pursue patient-centred activities to improve personalization of care. Patient-centred RWD-based knowledge-sharing between PPRs and stakeholders is much like what occurs between patients and providers in an ideal PPR [7]. This approach also aligns with current, prevalent use of RWD in health care.
Barriers to PCC exist and there are compelling reasons to overcome them. Each of us will use the health care system more as we grow older. We expect to be treated as individuals and receive personalized care from providers. Demands on the system by an ageing population [42, 43] and epidemics of obesity, diabetes, fatty liver disease, dementias, and other chronic disorders require collaboration among system participants. Empathy for patients and families argues for PCC and availability of more personalized products and services.
An aligned health care system emphasizes ideal PPRs that practice PCC and yield patient-centred RWD as the most crucial commodities. We envision sequential processes for improving the system and achieving the quadruple aim: bridging controlled research with patient-centred RWD will refine understanding of subpopulations with a specific disorder. This will enable stakeholders to develop more patient-centred, customized solutions. Prioritizing the needs of individual patients and collaboration between PPRs and stakeholders will lead to more effective personalized care and reduced costs. Strengthened by knowledge-sharing, the US health care system will evolve through virtuous cycles of learning and continuous improvement [44,45,46] to precision medicine standards.
5 Aligning health care system participants
5.1 PCC
The principles of PCC apply to both PPRs and stakeholders. PCC or interpersonal medicine is delivery of health care responsive to patients’ circumstances, capabilities, and preferences [47]. PCC by PPRs and patient-centred activities by stakeholders are services and solutions designed around patients, evocatively framed as no decision about the patient, without the patient [48]. PCC is collaboration among system participants to place patients first in knowledge-sharing and informed decision-making and compassionately achieve the best experience and outcome for those persons and their families [49]. PCC is following principles for patient and family partnership in care [50].
There are well-documented incentives for consistent practices of PCC. Training of providers in skills to enhance the quality of PPRs—communications, empathy, attending to psychosocial needs, presenting options for treatment, sharing decisions with patients—improves health outcomes, improves patient and provider experiences, and lowers costs [7, 17, 18, 51]. These accomplishments align perfectly with the quadruple aim.
PCC is not reserved for PPRs: Stakeholders should also prioritize patient-centred aims in their missions and objectives. The FDA includes patients on advisory committees to help determine product risk–benefit, marketing approval, and labelling decisions. Some biopharmaceutical companies engage patient focus groups to understand unmet medical needs that inform product development, feasibility of clinical trial procedures, and avenues for patient-centred marketing of approved products.
More can be done by PPRs and stakeholders to advance consistent PCC practices. However, definitions for PCC do not address the diverse illness experiences, dissatisfaction, and frustrations of patients in the care environment. Thus, stakeholders need new informational channels to gain insights. Health care system deficiencies are exposed during enlightening conversations among employees of stakeholders and their leaders about personal or family members’ challenges with the system. Discourse with patient advocates, ‘clients’, or ‘customers’ of stakeholders provide important perspectives. Conversations between patients and the employees of stakeholders can be orchestrated by patient affairs departments led by chief patient officers attuned to real-world patient needs and clinical practice. Increased understanding of the patient illness experience can inspire all participants to focus on PCC.
5.2 Patient-centred RWD
RWD come from EMRs, claims, prescription records, billings, product and disease registries, patients’ devices, and health applications [52]. The opportunities of RWD were contemplated in the 1990s to address clinical and sociodemographic differences between patients in controlled clinical trials and actual practice [53, 54]. RWD are described as heralding new innovations to transform US health care [55].
Controlled research data do not suffice for real-world clinical management of every patient. As noted, providers also use RWD derived from non-clinical or uncontrolled clinical settings [52, 56, 57]. Likewise, stakeholders depend on RWD and controlled clinical data to inform their activities. In fact, RWD, which include PGHD, are valued, sought, and used by all stakeholders, including academic and industry suppliers, the FDA, and payers [52, 56,57,58,59,60,61,62,63]. RWD are invaluable to stakeholders whose activities are directed at heterogeneous patient populations.
RWD are used to fill information gaps in assessments of new drugs. For traditional, prospective, controlled trials, patients must meet eligibility criteria to enrol. These are used for safety reasons and avoid confounding of trial results by coincident medical conditions, clinical demographics, concomitant medications, and other factors. Thus, patients studied in controlled trials comprise an incomplete segment of more diverse real-world patients ultimately treated with a new drug. RWD help to address the effects of medications in populations with different characteristics to those studied in controlled trials, or to evaluate comparative effectiveness of different drugs in populations for which prospective, randomized trials are not feasible to conduct.
Patient-centred RWD are higher quality and more relevant than RWD from clinical practice and PGHD that are currently available because PCC is not universally practised. Earlier, we described how better health outcomes are achieved when providers are trained in skills to improve PPRs [51]. Yet only a minority of clinicians implement such PCC practices [64]. This may reflect barriers to implementation of PCC throughout the health care system [65,66,67,68,69,70,71,72,73,74].
PPRs and stakeholders have different responsibilities, but their alignment can improve if they draw from a common source of data to gain knowledge. “Ipsa scientia potestas est” (“Knowledge itself is power”) is attributed to Francis Bacon [75]. Perhaps he intended “having and sharing knowledge is the cornerstone of reputation and influence, and therefore power; all achievements emanate from this” [76]. Knowledge derived from patient-centred RWD can help to align the health care system subject to the following conditions:
5.2.1 PCC is consistently practised within PPRs to generate patient-centred RWD
PCC becomes the norm to evolve current RWD to more robust, patient-centred RWD. In general, RWD provide more comprehensive information than controlled research data: unselected, heterogeneous versus selected, homogeneous patient populations; more abundant data (millions of patients versus hundreds or thousands); and billions more data points on multiple factors. RWD are used by all system participants [37,38,39, 52, 56,57,58,59,60,61,62,63, 77,78,79,80,81,82,83,84,85,86].
Given its robustness, patient-centred RWD offer substantial value to PPRs and stakeholders because they better qualify and quantify different characteristics of subpopulations than randomized, controlled research studies. Patient-centred RWD provide more thorough understanding of differential treatment responses, health outcomes, and economic impacts. This occurs by integrating multiple parameters, e.g. age, gender, race, and demographics, clinical characteristics, psychosocial status, patient preference, medication adherence, and clinical compliance, safety and effectiveness of treatments, HCRU (hospitalizations, emergency department and office visits, diagnostics, treatments) and costs, and other factors (Table 3).
5.2.2 Patient-centred RWD is shared to improve alignment between PPRs and stakeholders
PPRs operate in provider organizations. These are health care delivery stakeholders comprising solo and group practices, larger provider groups, health plans, free-standing clinics, urgent care centres, and hospitals. These stakeholders use RWD generated by their providers. Thus, provider organizations are positioned to adapt and consolidate their data systems to leverage PCC by sharing patient-centred RWD.
Provider organizations should be structured to aggregate and share patient-centred RWD with other stakeholders. All stakeholders should contribute and collaborate to create suitable infrastructures. To integrate and manage the big data aspects of these enormous arrays of patient-generated, clinical, HCRU, and cost information, platforms for data aggregation and sharing [87, 88] and computational techniques (artificial intelligence machine learning) [89] must improve. Ultimately, predictive analytics could enable use of these data to inform care of individual patients.
5.2.3 Stakeholders create more personalized information, products, services, and access by using shared patient-centred RWD
Patient-centred RWD are essential to all system participants: a common data source aligns PPRs and stakeholders because of their reliance on DIKUW processes [27]. In addition, these data yield more refined information on patient subpopulations, which interests PPRs and stakeholders. Providers perform subgrouping exercises in differential diagnosis. Academic suppliers stratify populations for prospective, observational research. The FDA and commercial suppliers stratify populations to understand variances in risk–benefit of drugs. Commercial suppliers perform market segmentation analyses to inform product development in efforts to address the needs of selected patient populations. Payers analyse patient subsets to determine access eligibility and reimbursement for products and services. Stakeholder activities become more personalized with better understanding of subpopulations and, ultimately, more specific, individual patient needs.
Patient-centred RWD improve customization of evidence generation, drug, device, and diagnostic development, point-of-care tools, patient portals, regulation, and administration. Sharing these data will foster a new, collaborative bidirectional health care delivery dynamic that balances the roles of PPRs and stakeholders. As illustrated in Fig. 2, patient-centred RWD that are shared by provider organizations with stakeholders enable a systemic feedback process that is missing in the current health care delivery paradigm. As noted, stakeholders welcome refined, patient-centred RWD that improve segmentation of patient populations. This enables stakeholders to optimize how they function and compete, champion stewardship of better products, services, and administration, improve efficiencies, succeed in patient-centred organizational missions, and support PPRs.
New paradigm: bidirectional health care delivery dynamic of PPRs and stakeholders. PPRs foster collaborative development of information and products with stakeholders with patient-centred RWD generated through PCC. In this patient-centred paradigm, PPRs influence the information, products, services, and access agendas (aligned, focused, relevant) of stakeholders. Dx, diagnostic; PCC, patient-centred care; PPR, Patient-provider relationship; R&D, research and development; RWD, real-world data; Rx, treatment
6 Aligning the US health care system depends on leadership and behavioural change
Most participants desire an improved, aligned health care system. PCC and patient-centred RWD form a rising tide upon which all boats rise: PPRs are empowered, stakeholders are successful in their missions, and the quadruple aim is achieved. However, driving behavioural change to create alignment in any organization is hard and ultimately poses a leadership challenge. Effecting this in the US health care system, although challenging, is the responsibility of those in authority: providers in PPRs, directors of stakeholders, and overseers of the health care system itself. Leadership is required to re-establish ideals and principles [90,91,92,93,94,95] to govern sequential adjustments that will yield transformation. Obstacles to PCC that permeate the system [65,66,67,68,69,70,71,72,73,74] must be overcome.
Patient-centred RWD generated by PCC provide opportunities for initiatives by stakeholders to prioritize personalized patient and provider needs. We cannot predict specific future actions that will come with the adaptation and shapeshifting of patients, providers, and stakeholders. We can, however, provide examples of current initiatives that progress PCC with patient-centred RWD (Table 4).
With PCC, patients and providers mutually achieve optimal health outcomes [7, 17, 18]. As illustrated in Fig. 3, PCC has add-on effects because patient-centred RWD are generated. Stakeholders gain more insights into patient and provider needs with access to patient-centred RWD. These insights are initially used to generate and administer more customized information, products, and services to patient subpopulations (macro level). Over time, more iterations of RWD are generated and used collaboratively by PPRs and stakeholders to create yet more patient-centred solutions. These are achieved by closing data gaps with research and virtuous cycles [3, 115] intrinsic to learning systems [44,45,46]. Repeated cycles advance the health care system to precision medicine standards (micro level). These approaches are modelled in two integrated delivery networks: Geisinger’s genomic medicine program [116] and University of Pittsburgh Medical Center’s inflammatory bowel disease patient-centred medical home [117, 118].
Virtuous cycles of five stages to advance to personalized/precision medicine. In a bidirectional paradigm for the health care delivery continuum: 1 Reinvigorated PPRs drive PCC; 2 PCC yields patient-centred RWD; 3 Patient-centred RWD inform more aligned, patient-centred activities by stakeholders; 4 Stakeholders produce and administer more individualized, patient-focused information, products, and services; and 5 Through collaborative knowledge-sharing and virtuous learning cycles, advances are made to personalized and precision medicine standards in the health care system. PCC, patient-centred care; PPR, Patient-provider relationship; RWD, real-world data
7 Conclusions
This article proposes actions by all US health care system participants. Much depends on alignment on both principles and knowledge as drivers of change. Seminal efforts by patients and providers can ignite possibilities for the system with consistent PCC practices [7]. Stakeholder leaders should recognize the imperatives of PCC and drive alignment on prioritizing PCC and use of patient-centred RWD.
The blueprint for the dedicated practice of PCC within PPRs is a springboard for how the system improves: ensure the patient’s place at the centre of the health care system. Reorient and incentivize providers and stakeholders to generate and use patient-centred RWD. Strides have been made but can be extended to amplify the patient voice via PCC by providers and stakeholders. Creating infrastructures for sharing patient-centred RWD will help to align the health care system with greater balance between PPRs and stakeholders. We envision a health care delivery dynamic characterized by a rich, bidirectional flow of information and more personalized health care. Knowledge-sharing aligns all participants to deliver on a shared, humanitarian purpose that prioritizes individual patients’ clinical and psychosocial needs.
Health care framed by the quadruple aim is a cooperative and mutually accountable endeavour. Examples of what will be done are described. How this will be done depends on leadership and behavioural change by all participants to re-engineer the system’s parts to improve alignment. Cost accountability by all converts zero-sum cost-shifting to positive-sum value-add activities [3, 4] to improve health and care experiences and reduce costs. Sustainable system improvements are based on relentless focus on PCC by PPRs and stakeholders, generation and sharing of patient-centred RWD, and commitment to continuous improvement.
Data availability
Not applicable.
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Acknowledgements
The authors thank Emily Stock PhD of Oxford PharmaGenesis, Oxford, UK for critical review of the manuscript and for providing editorial support. The authors acknowledge Lin Chang, MD; Spencer Dorn, MD, MPH, MHA; and Phil Sarocco, RPh, MSc for their comments and suggestions.
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Levine, D.S., Drossman, D.A. Addressing misalignments to improve the US health care system by integrating patient-centred care, patient-centred real-world data, and knowledge-sharing: a review and approaches to system alignment. Discov Health Systems 1, 8 (2022). https://doi.org/10.1007/s44250-022-00012-8
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DOI: https://doi.org/10.1007/s44250-022-00012-8