By Derek Raghavan, MD, PhD, FACP, FRACP, FASCO, and Edward S. Kim, MD, FACP
- The optimal approach to clinical medicine and oncology is achieved by a fusion of art and science.
- Several organizations have created clinical pathways, which are criticized by some as providing a cookbook approach to medicine.
- The authors believe that the production of pathways does not lead to a cookbook approach to oncology. When developed in an evidence-based, transparent way, pathways simply provide a potentially authoritative source of information that will empower the clinician.
For centuries, there has been an ongoing tacit debate between the respective proponents of the view that the art of medicine (an amalgam of learned information, clinical experience, skill, and instinct) trumps the science of our discipline versus those who advocate the converse idea. In oncology, Hippocrates’ belief that “life is short, and art is long” provides an interesting philosophical juxtaposition in the present time when cancer survival is improving and the number of therapies is expanding. We believe that the optimal approach to clinical medicine, and thus oncology, is achieved by a fusion of art and science. However, within that paradigm, it seems more likely that scientific evidence will more often lead to better outcomes in oncologic practice than sole reliance on the time-honored approach to creative medical thinking, which can blur the line between anecdotal expertise and a lack of knowledge of the available evidence. When there is no high-level evidence available (e.g., for salvage therapy or for the primary management of uncommon entities), clinical and anecdotal experience (and art) become much more crucial.
It is widely acknowledged that the burgeoning costs of medical care cannot be supported by our community,1,2 particularly as the increase in cost frequently does not result in improved outcomes. Thus, in an era when a much higher level of focus is being directed to the value proposition in clinical care and the broader consumer population is posing much more focused questions about the return on investment from medical expenditure, it seems that an increasingly structured approach to medical management is urgently required. Furthermore, the practice of medicine has changed dramatically over time. In addition to the focus on patient care, clinicians must spend more time on electronic documentation, participation in the reimbursement process, and fiscal practice management.
A practical approach to the definition of value in medicine is embedded in the equation, “value = outcome/cost.”1
For useful implementation of this equation, outcomes must be defined clearly and measured carefully, and cost also must be defined (because cost does not necessarily equate with price). In addition, the hidden costs of medical care, such as the costs of ancillary services, treatment of complications, and costs to the patient for nonmedical additions (e.g., babysitting, transport, and time lost from work) must be factored into this equation.
Several initiatives have occurred in the attempt to address the uncontrolled and (sometimes) poorly justified increasing costs of medical care. The American Board of Internal Medicine Foundation created Choosing Wisely®, which was focused on the elimination of unnecessary care that does not contribute to improved outcomes. As a result, the ASCO Value Task Force issued two encyclicals focused on common oncologic practices that were not justified by the resulting outcomes.3,4 For example, our review of the literature showed that extensive metastatic screening work-up for patients with low-risk prostate cancer (prior to definitive treatment) reveals positive results in fewer than 1% of cases,3 which is within the error range of the tests used, and, thus, this practice was discouraged. Similar recommendations were made for abstaining from interventions that are not supported by evidence, including the use of colony-stimulating factors in certain situations, the mismatched use of antiemetic regimens by emetic risk category, other pointless staging programs after definitive treatment, multiagent salvage regimens, etc.3,4 These recommendations provide guidance to clinicians and also a potential defense against spurious medicolegal attack, given that they recommend best-practice approaches based on published evidence from panels of experts, avoiding unnecessary expenditure without loss of (and perhaps a resulting gain in) quality.
Many clinicians, for a broad range of reasons, will tend to ignore such “soft” recommendations in their clinical practices. This can reflect lack of awareness of the current evidence-based literature, the tendency of clinicians to use the territorial imperative to maintain long-held patterns of practice, reluctance to have “oversight,” fiscal conflicts of interest, and pressure from well-intentioned patients and/or advocates (such as the recent societal discussion on prostate-specific antigen screening). To increase adherence to evidence-based medicine and promote higher-value care, several organizations have begun to create more defined clinical pathways, effectively providing a cookbook approach to many aspects of medicine. The Institute of Medicine published recommendations in 2011 on how to develop trustworthy guidelines, which pathways are frequently based upon.5
The principles of pathway development require a predetermined strategy, and the clinical pathways themselves have a number of benefits and drawbacks.6 When used appropriately, pathways promote evidence-based, high-value care that respects input from patients, payers, and providers. However, reports have stressed the need for transparency, inclusiveness, and disclosure. Additional concerns have been raised, such as the inconsistent pathway development process, the administration burden of adhering to multiple pathways when treating similar patients, and understanding the true impact of pathway use on patient health outcomes.6
Furthermore, there is no standard definition of “experts” across organizations or panels, and, in many cases, the available evidence has been limited, leading to the creation of consensus documents based on general agreement of the participants (rather than necessarily the production of true evidence-based pathways). Some pathways have been created as part of a menu of products and intrude into clinical workflow areas that are simply too complex to allow the creation of accurate and significant cookie-cutter care. This has become a greater problem when payers take them up as gospel and refuse to reimburse reasonable care patterns that are not congruent with these specific pathways.
The Levine Cancer Institute, Carolinas HealthCare System, is an agglomeration of 25 oncology units gathered under a single leadership structure, a common institutional review board, one cancer trials unit, a data safety monitoring system, and ASCO’s Quality Oncology Practice Initiative (QOPI®) and Commission on Cancer certification. We have developed a series of electronically linked evidence-based pathways (EAPathways) that can be used on iPads, smartphones, and desktop computers to facilitate symmetrical oncology management at each regional site in the system. The pathways, which focus on initial and second-line care, have been developed as consensus documents by our multidisciplinary oncology teams, leveraging level 1 to 2 data and available published pathways. Because EAPathways is an electronically based program, the pathways can be easily modified when the underpinning data change and with the assent of the relevant tumor-specific team meetings. They incorporate diagnostic and treatment algorithms, open clinical trials and their status, and blood or tissue collection protocols that leverage our system-wide biorepository. Our physicians are encouraged to treat patients according to these pathways, which are also linked to the functioning of our Oncology and Pharmacy Therapeutics Committee. Of critical importance, each pathway has a default option that allows the use of judgment or identification of a contraindication to lead to a deviation of pathway management for individual cases. Providers’ use of pathways is recorded, and the data can be used to assess compliance and practice patterns. The intent is to improve system-wide symmetry of care, with a focus on evidence-based practice, emphasis on value, and avoidance of unnecessary expenditure that is not linked to better outcomes.
The question that arises is whether this approach will generate an automaton who no longer uses judgment, experience, or skill to provide superior medical care. We, the authors, firmly believe that the production of pathways does not lead to a cookbook approach to oncology. For decades, house staff and faculty have used a variety of aids to their practice, such as UpToDate, textbooks, PubMed, and a more recent plethora of online sources of information. Further, the range of available information is increasing exponentially, as is the gratuitous online targeting of oncologists by some pharmaceutical and diagnostic companies, providing their view of utility and benefit of their wares. The provision of evidence-based guidelines or pathways simply provides a potentially authoritative source of information that will empower the clinician, particularly those who do not routinely have access to a comprehensive tumor board or equivalent.
However, there is a risk: pathways that intrude into overly complex areas (e.g., salvage management) or domains for which there is little published level 1 to 2 evidence may cause inaccuracy of interpretation or confusion, where a cookbook approach yields false confidence for the isolated or inexperienced practitioner. In addition, the over-interpretation of the intent of published guidelines by payers or regulatory authorities—particularly when the pathways reflect expert consensus opinions rather than level 1 data—will cause a decline in quality and outcomes in the community at large and will negate the ability of experienced clinicians to respond to the variations of natural history that frequently appear in clinical medicine.
As the treatment of patients continues to rapidly evolve, navigating the complex world of delivering treatment that is high quality, consistent, and valuable is becoming increasingly challenging. Prior guidelines developed in a static structure have difficulty in keeping up with fast-moving molecular data. Guidelines, in principle, are rooted in assisting clinical teams in decision-making processes that give confidence to physicians. However, the approach of integrating tools to guide the decision-making process is also becoming increasingly complex, and, thus, providing a tool that is evidence based, not disruptive to workflow, and that delivers information and updates in a timely manner will be important considerations in guideline tool development.6 Yet to be proven is whether the implementation of such pathways in clinical workflow will improve community-based accrual to cancer trials beyond the disappointing national figure of 5%.7 By offering sensible pathways based on Institute of Medicine guidelines, and by integrating these resources to empower clinical teams to deliver comprehensive treatment, our clinicians of the present and future will avoid the cookbook, spending less time in the kitchen and more time with patients.
About the Authors: Dr. Raghavan is president of Levine Cancer Institute at Carolinas HealthCare System.Dr. Kim is chair of the department of solid tumor oncology at Levine Cancer Institute at Carolinas HealthCare System.