Applying First Principles Thinking to Cancer Care Delivery
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.