Gordon Kuntz is a health care consultant and strategic advisor with over 30 years’ experience in a multitude of health care settings, working with payers and providers, and in technology and strategy. He began his involvement with oncology care pathways in 2004 as a consultant with US Oncology as they were deploying Level 1 pathways. He subsequently led payer strategy with ION Solutions, a division of AmerisourceBergen, where he gained familiarity with many other pathways vendors, especially in the context of the oncology medical home model. As Senior Director of Strategy for Via Oncology, he deepened his knowledge of the pathway development process, physician adoption, and how both impact cancer center strategies. Gordon now provides support in strategy and product design as well as assistance in navigating the cancer care ecosystem to established and emerging companies.
For those new to the world of clinical pathways, the jargon, development process, and ramifications of pathways can seem mysterious and obscure. To put clinical pathways into context, many disease or medical treatment categories use order sets or treatment protocols to define the testing and procedures that constitute the best practice or state of the art for a particular situation. Such order sets collate care standards to increase efficiency of care. Clinical pathways are much more complex and sophisticated than order sets or triage protocols but the goals are similar. This column will provide an overview of clinical pathways as they exist today and attempt to demystify the language, process, and expectations surrounding their development and use.
The Impetus for Clinical Pathways in Cancer Care
The development of clinical pathways has been especially effective in treatment planning for cancer care. The treatment for many other diseases, such as diabetes, is largely drug-based but has evolved less dramatically over the last several years, or, like orthopedic care, is highly dependent on the skill of the surgeon and uses relatively few drugs. The treatment of cancer lends itself to the use of more complex protocols, ie, pathways, for several reasons:
Cancer itself is complex. With more than 50 major categories and multiple disease presentations based on disease stage, lab values, genetic variations, etc, there are hundreds of unique disease presentations in cancer.
The treatment for many types of cancer is largely drug-based, and the drug therapies are complex and can be highly toxic. Oncologists must ensure that the drug selected is the most effective against the patient’s specific disease presentation while still being tolerable to the patient.
Available therapies are expensive. With many cancer drugs costing tens or hundreds of thousands of dollars per course of treatment, it is imperative to select the most appropriate treatments in the context of the investment.
Drug therapies continue to evolve rapidly. In 1990, there were 37 drug-related chemotherapy treatment options with 60 indications.1 Today, there are well over 500 approved antineoplastic drugs.2
The literature evolves rapidly, ie, multiple new studies are published daily, with implications for best practices on an increasing number of ever-more-targeted patient subpopulations.
Without an effective tool, like clinical pathways, to help identify the most appropriate standard of care therapy for a specific disease presentation, oncologists would be left to their own research or would rely on what had worked in other similar cases. These approaches are inefficient and much less likely to result in the delivery of high-quality and high-value care with the enormous complexities of and surrounding cancer treatment.
Many oncologists practicing in a community or hospital setting see a wide range of cancers daily. The use of a tool to assist with clinical decision support, such as pathways, helps ensure that they are providing optimal treatment to every patient—even patients with less common disease presentations. Having these tools to recommend appropriate treatment options helps ensure that these doctors can effectively treat a higher percentage of their patients, allowing them to be treated in their own community rather than having to travel a longer distance to receive care at an academic center.
So, What Are Pathways?
First, what shall we call them? Various terms have been used to refer to the same concept, in general. “Clinical pathways,” “treatment pathways,” “treatment selection pathways,” and “oncology care pathways” are all different names for the same type of tool but what we will refer to here simply as “pathways.”
Pathways are a set of treatment recommendations that aim to integrate evidence regarding the clinical efficacy, toxicity, and affordability of treatments (weighed in
that order of importance) to create optimal standard-of-care recommendations for patients, while simultaneously reducing the unnecessary variation in care across similarly situated patients. Pathways may also include prompts or entry areas for patient preferences, integrating specific patient characteristics or care goals into treatment recommendations.
Another term commonly associated with pathways is “clinical decision support” (CDS). CDS systems, as used in relation to pathways, operate by querying the user for information or gathering it from underlying interfaces through integration with data sources, usually the electronic medical record. Information would include patient demographic, major tumor type, stage, genetic and lab test results, prior therapies, etc. The response to each question leads to the next related question, refining the description of the disease presentation. Once sufficient data has been captured or brought in, the recommendation is offered. The pathways tools that exist in the market today are generally designed to provide this type of decision support. An automated or visual tool will rely on a conceptual decision tree, with each decision leading to a branch with either additional considerations or one or more recommendations.
The operational definition of what an ideal pathway looks like includes adherence to the following 4 criteria: (1) a structured multidisciplinary plan of care; (2) the translation of guidelines or evidence into an algorithm; (3) detailed steps within the pathway along a timeframe in a course of treatment/care plan; and (4) standardized care for a specific population.3
An important distinction to note, pathways differ from guidelines in that pathways offer one or more specific treatment recommendations based on a hierarchy of selection criteria. Guidelines, on the other hand, offer a set of reasonable treatment options but without prioritizing specific recommendations. Think of it as the difference between “could” and “should”: guidelines tell an oncologist what they could do; pathways tell them what they should do. Neither tell the oncologist what they must do, however, which will be discussed later when off-pathway decisions are addressed.