A first principle is a basic, foundational, self-evident proposition or assumption that cannot be deduced from any other proposition or assumption. The concept of first principles thinking has been advocated by everyone from Aristotle to Elon Musk, and can be useful for helping one to achieve focus, gain perspective, and distinguish priorities despite the waxing and waning distractions of life.
The application of first principles thinking to clinical pathways always directs me to the patient, the individual for which each clinical pathway is tailored, and the improvement of whose experiences and outcomes clinical pathways are intended. The patient is primary within the health care industry’s stated commitment to the concept of “value-based health care”1 reform, as defined by the Institute for Healthcare Improvement “Triple Aim”2: (1) improving the patient experience of care (including quality and satisfaction); (2) improving the health of populations; and (3) reducing the per capita cost of health care.
In the case of oncology, the health care economy continues to be shaped by advances in technology, the rising value of data as currency, and inspiring scientific insights. Thus, we see developing oncology trends characterized by:
- The rapid introduction of new cancer treatments and novel paradigm shifts;
- Centers for Medicare & Medicaid Services efforts to drive reform of the cancer care delivery system through such initiatives as the Oncology Care Model3 and the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA),4 in order to increase coordination, improve quality, and reduce cost;
- The growing consumerism on the part of patients and organization of patient advocacy efforts; and
- Process standardization through the use of clinical pathways.
Increasingly, authoritative clinical practice guidelines, such as those developed by the National Comprehensive Cancer Network (NCCN),5 have presented operational limitations for clinical providers and practices contending with a growing subspecialty knowledge base and the need to discern between a relative plethora of treatment choices for any given patient. Clinical pathways have been advanced as an alternative approach in line with the current evolution of care management to achieve financial, payment, and practice reform goals. Legitimacy of the clinical pathways concept was supported with evidence that, at least by 2003, more than 80% of US hospitals were using pathways for select patients to optimize efficiency of treatment goals.6 While their multidisciplinary development and implementation were considered tedious, the endeavors were sanctioned by health care managers who had “embraced clinical pathways as a method to reduce variation in care, decrease resource utilization, and potentially improve health care quality.”7
In oncology, the distinction between clinical pathways and clinical guidelines like the NCCN Guidelines or the American Society of Clinical Oncology (ASCO) Clinical Practice Guidelines8 was not initially clear. However, as the economic implications of cancer treatment quickly rose to the forefront of national debate, clinical pathways distinguished themselves as offering a value-based balance of clinical management with clinical and nonclinical resource management, clinical audit, and financial management.9 Spurred by the approvals of new cancer agents, many oncology practices and health care delivery organizations had already been evaluating, developing, and/or adopting clinical pathways platforms. Efforts to develop payer-initiated clinical pathways went on to be matched by provider-initiated clinical pathway programs, some of which have spun off growing for-profit vendor platforms and services.
At the same time, ASCO properly sought to gain perspective by establishing its own Task Force on Clinical Pathways to promote provider adherence to evidence-based medicine, reduce unwarranted treatment variations, and to evaluate concerns of ASCO members and other stakeholders over clinical pathway initiatives. In 2016, ASCO published its policy statement recognizing a true opportunity for clinical pathways “to improve and preserve high-quality cancer care while addressing health care’s soaring costs.”10 Moreover, the ASCO policy statement insisted that clinical pathways in oncology ultimately “enhance—not diminish—patient care.”10 Significantly, although ASCO provided an important cautionary note highlighting that “no current mechanism exists to ensure the integrity, efficient implementation, and outcome assessments for treatment management tools,”10 they did publish a set of criteria for high-quality clinical pathways reflecting a focus on three key areas, namely development, implementation/use, and analysis.11
Debunking the Clinical Pathway Value Chain Model of Cancer Care Delivery
The scope of a clinical pathway may range from the administration of an ancillary medication like granulocyte-macrophage colony-stimulating factor after chemotherapy to a comprehensive neoadjuvant gemcitabine/cisplatin chemotherapy treatment plan, but each clinical pathway represents a value chain with a curated offering of options, one-dimensional prioritization of actions, and binary categorization of goals. A scoped-down clinical pathway that structures everyday clinical practices neatly facilitates the evidence-based management objectives of treatment plan standardization, evidence-based sequencing of regimens, and narrowing of clinical outcomes.
From a “value” perspective, clinical pathways have played a progressive role in allowing health care systems to carry out objective care delivery assessments along the care delivery value chain. The notion of clinical pathways as part of a value-based management strategy12 is judged by the shared value they create and capture for the enterprise stakeholders. They must have the capacity to distinguish and balance enterprise priorities, define and process data assets that effect enterprise objectives, and drive point-of-care clinical decision optimization by reconciling between conflicting enterprise objectives and priorities.
Of course, given the different stakeholders invested in clinical pathways, each stakeholder may define and prioritize value attainment differently. Having developed, advised, and implemented clinical pathways across culturally, operationally, and resourcefully diverse enterprises, I can attest that, ultimately, the true target of these clinical care delivery optimization initiatives has been the patient. Indeed, the organizational insights gained through my experiences allowed me to see care delivery as a fundamentally human enterprise.
As of yet, I do not believe clinical pathways deliver on what the human enterprise needs, though this flaw is one that characterizes the health care industry in general over the last century. Therefore, the path forward is to recognize and address these barriers to attaining value for patients.
The Value Cycle: An Alternative Model of Cancer Care Delivery
Within oncology, decision-making at the provider-patient level is not as linearly compartmentalized and static as clinical pathways may suggest. Fundamentally, decisions represent the results of decision rules or policies to information about perceived daily “data inputs” all around us, usually with a specific outcome in mind.13 Similarly, each clinical decision entails a multidimensional parallel processing of real-time quantitative/qualitative patient information; ie, data inputs that culminate in a clinical action with intent of a target clinical outcome/state.
Furthermore, because the goal clinical outcome/state is seldom achieved by a single decision in one fell swoop, the processing of a patient’s data inputs continue, being vigilant to account for any time-based patterns that can greatly influence the dynamics of clinical goal attainment by each decision. Such continues the care delivery cycle of data input processing for gaps between actual and target clinical outcome/state that prompt decisions to act, ideally until the clinical goal is actualized, or is changed. In essence, each feedback process14 of data inputs, decision to act, and consequent outcome creates a value cycle15 by informing the optimal clinical outcome/state that can be achieved over time, which in many cases of cancer will entail the evolution of patient goals (Figure 1).
From the perspective of cancer care delivery as a human enterprise, the refactoring of clinical pathways as dynamic clinical value cycles presents the opportunity to engineer a value-based health care management system that creates and captures shared value for stakeholders.
Delivering on the Promise of Clinical Pathways
Another exercise in first principles thinking is the acknowledgment that not all cancer care delivery organizations operate based on equally available resources. To the end that “value” entails a definite economic component, operations management of cancer care delivery cannot compromise on the standard of patient outcomes and still qualify as creating shared value.
Addressing this value dilemma in operations management of dynamic clinical value cycles is the intention of this article series. Through “Pathways in Focus” we will highlight real-world examples of successes and lessons learned from challenges that will naturally include those of value cycle sustainability as well as scalability. Focusing on actionable components, the following will be expanded on and integrated for value creation:
- Resource assessment and accumulation, including intangible assets and strategic deployment;
- Identification of value drivers,12 their dynamic influence on decisions, and outcome operations;
- Importance and challenge of gaining operational insight from outcome objectives performance measures given the dynamic relationships within increasingly complex organizations with interrelated value cycles; and
- Identification and navigation of component misalignments, conflicts, and just-in-time needs that arise without compromising on first principles or the leverage of systems thinking in maintaining the focus on shared value creation and capture.
I look forward to engaging the readership through their comments and submissions to “Pathways in Focus,” all with the good intention of actualizing health care delivery as a human enterprise that reflects our common humanity.
References
1. Porter ME. A strategy for health care reform—toward a value-based system. N Engl J Med. 2009(2); 361:109-112.
2. Berwick DM, Nolan TW, Whittington J. The triple aim: care, health, and cost. Health Aff (Millwood). 2008;27(3):759-769.
3. Oncology care model. Centers for Medicare & Medicaid Services website. https://innovation.cms.gov/initiatives/oncology-care/. Accessed June 28, 2017.
4. MACRA–Delivery System Reform, Payment System Reform. Centers for Medicare & Medicaid Services website. https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/MACRA-MIPS-and-APMs/MACRA-MIPS-and-APMs.html. Accessed June 28, 2017.
5. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology. https://www.nccn.org/professionals/physician_gls/f_guidelines.asp. Accessed June 23, 2017.
6. Pearson SD, Goulart-Fisher D, Lee TH. Critical pathways as a strategy for improving care: problems and potential. Ann Intern Med. 1995;123(12):941-948.
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8. American Society of Clinical Oncology. ASCO Clinical Practice Guidelines. https://ascopubs.org/jco/site/misc/specialarticles.xhtml. Accessed July 5, 2017.
9. Stern D, ed. EMD Serono Specialty Digest: Managed Care Strategies for Specialty Pharmaceuticals, 10th ed. EMD Serono; 2014.
10. Zon RT, Frame JN, Neuss MN, et al. American Society of Clinical Oncology policy statement on clinical pathways in oncology. J Oncol Pract. 2016;12(3):261-266.
11. Zon RT, Edge SB, Page RD, et al. American Society of Clinical Oncology criteria for high-quality clinical pathways in oncology. J Oncol Pract. 2017;13(3):207-210.
12. Knight JA. Value Based Management. New York, NY: McGraw-Hill; 1997.
13. Forrester JW. Industrial Dynamics. Cambridge, MA: M.I.T. Press; 1961.
14. Sterman JD. Learning in and about Complex Systems. Syst Dynam Rev. 1994;10(2-3):291-330.
15. Stevenson RW, Wolstenholme EF. Value Chain Dynamics. Presented at: The 17th International Conference of The System Dynamics Society. July 20-23, 1999. Wellington, New Zealand.
