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Evidence-Based Oncology April 2016
ASCO Policy Statement on Clinical Pathways in Oncology: Why Now?
Robin Zon, MD, FACP, FASCO
The Oncology Medical Home - Beyond Clinical Pathways
Daniel P. McKellar, MD, FACS; Charles Bane, MD; M. Asa Carter, MBA, CTR; Allison Knutson, CCRP; Vicki Chiappetta, RHIA, CTR; Bo Gamble
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Recommendations for the Role of Clinical Pathways in an Era of Personalized Medicine
Alan J. Balch, PhD; Charles M. Balch, MD; Al Benson III, MD; Deborah Morosini, MD; Robert M. Rifkin, MD; Loretta A. Williams, PhD
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Surabhi Dangi-Garimella, PhD
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Surabhi Dangi-Garimella, PhD
Conference Coverage: ACCC
Surabhi Dangi-Garimella, PhD

Recommendations for the Role of Clinical Pathways in an Era of Personalized Medicine

Alan J. Balch, PhD; Charles M. Balch, MD; Al Benson III, MD; Deborah Morosini, MD; Robert M. Rifkin, MD; Loretta A. Williams, PhD
We offer recommendations for the development and design of clinical pathways in an effort to establish a set of normative criteria that creates trust and transparency.
Clinical care pathways have been used for more than 30 years in hospitals and physician practices as tools to link care decisions with evidence-based practice in ways that reduce variation, improve patient outcomes, and maximize clinical efficiency.1,2 Healthcare professionals have been the leaders in pathway development for decades, just as they have been in the creation of the clinical guidelines on which they are typically based.

However, some health insurance companies are now developing their own pathways in ways that may limit physician decision making and restrict patients’ access to new state-of-the-art treatments for cancer and other chronic diseases. Of special concern to providers and patient advocates are programs that pay physicians a monthly fee to prescribe preselected therapies that are “on-pathway.” Coverage is likely to be denied or delayed when the physician opts for an “off-pathway” treatment based on clinical judgment of the patient’s unique circumstances, even one that is considered standard-of-care, according to well-established guidelines. Penalizing “off-pathway” prescribing, either directly or indirectly, when supported by evidence, may cause harm to patients and impose unnecessary costs on the health system. Compounding the problem, the process, by which some clinical pathways are developed, is not transparent—providers and patients may not know why certain treatments are covered, what evidence was considered when creating pathway protocols, and whether their physician has a financial incentive to prescribe specific drugs.

We offer recommendations, in the following areas, in an effort to establish a set of normative criteria for the development and design of pathways that creates trust and transparency: the fundamental elements of a clinical pathway, the necessary transparency standards for their development, and the steps needed to ensure patients receive the best care in a shared-decision making context that reflects their physician’s clinical judgment.  
 
What Are the Common Characteristics of a Pathway?

Ideally, clinical pathways should consist of a structured, multidisciplinary plan that details essential steps to improve continuity and coordination in the care of specific patients, and should span areas like diagnostics, surgery, nutrition, medications, and discharge planning.3 However, pathway programs in medical oncology often place a greater emphasis or focus on drug selection.
In 2010, a team of Cochrane Review authors identified at least 5 characteristics (Table) that define a clinical pathway from the literature that has subsequently been recognized as “a standardized, internationally accepted definition of a clinical pathway.”3 Clinical pathways are often developed and defined at the local or institutional level by the providers who are expected to implement them.4 This approach takes into account variations in the ways providers practice medicine within their local ecosystem to ensure that the needs of their patients are met.4 Some clinical pathways, however, are intended to standardize treatment protocols at a national, state, or regional scale to further reduce variations in the delivery of evidence-based care across sites, particularly in the absence of scientific merit for local variability in treatment regimens.5  





 
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