Head and Neck Cancer Care: Quality Guidelines

Carol M. Lewis

Amy C. Hessel

Stephen Y. Lai

Randal S. Weber

The quality and appropriateness of cancer care are of paramount importance and can critically impact outcome. Deviation from evidence-based care will result in higher treatment costs and may jeopardize patients’ outcomes. Providing evidence-based care should provide the patient the best opportunity for cure. Failure of initial treatment is associated with diminished tumor control and survival regardless of salvage treatment.¹^,² Quality of care has been defined as delivering efficient evidence-based care by experienced clinicians in an accessible setting or as doing the right thing, for the right patient, at the right time, and achieving the best possible result.³

The 2001 report by the Institute of Medicine (IOM) entitled “Crossing the Quality Chasm: A New Health System for the 21st Century” highlighted the gap that exists between what we know to be effective, beneficial care, and the care that is often delivered to an individual patient.⁴ In the report, the IOM stated, “Between the health care we have and the care we could have lies not just a gap, but a chasm.” The report, signifying a national initiative to improve the quality of care in the United States, articulated the following 6 aims for a new health care system: (1) enhance the safety of health care by avoiding injuries to patients; (2) provide effective services based on scientific knowledge (evidence-based care) and avoid services of no proven benefit; (3) deliver patient-centric care; (4) deliver timely care by reducing wait times and harmful delays; (5) increase efficiency and decrease waste; and (6) deliver care that is equitable regardless of gender, ethnicity, and social economic status. The IOM also recognized a need to optimize quality cancer care in the United States and recommended funding research into factors influencing care and the quality of cancer care delivered.⁵

The United States spends the most money per capita for health care delivery of any country in the world, yet our outcomes are not outstanding. It is estimated that patients receive evidence-based care only 50% of the time, leading to increased cost of care.⁵ In the United States, health care costs continue to rise but at a less rapid rate. In 2013, hospitals received an increase of 4.3% to $936.9 billion compared to 5.7% growth in 2012.⁶ Payments to physicians and clinical services provided increased 3.8% in 2013 to $586.7 billion, from 4.5% growth in 2012. Medicare outlays accounted for 20% of national health spending in 2013 and grew 3.4% to $585.7 billion, down from a growth rate of 4.0% in 2012. Cancer care costs will continue to increase for the foreseeable future due, in large part, to aging “baby boomers” who are in their cancer-prone years and the introduction of new technologies and molecularly targeted therapies.⁷ The Affordable Care Act (ACA) is an attempt by the federal government to diminish the rate of increase while at the same time improving the quality of care provided to patients.

An example of methodologies within the ACA designed to decrease the cost of care includes alternative payment strategies; principal among these is value-based reimbursement.⁸^,⁹ Value in health care is defined as the outcome achieved (quality) divided by the cost of care to achieve that outcome.¹⁰ Health care reimbursement is currently tied to the quantity and volume of care delivered rather than outcomes. Payers, the largest of which is the Centers for Medicare and Medicaid Services (CMS), are moving toward value-based reimbursement as a way of rewarding providers (hospitals and health care professionals) that achieve better outcomes. It is estimated that one-third or more of health care dollars expended caring for cancer patients are wasted on inappropriate or futile care.⁵ Examples include inappropriate or poorly performed surgical procedures, care not consistent with current cancer therapeutic guidelines, or continuing to administer chemotherapy in the terminal phase of cancer illness when end of life and supportive care is more appropriate.

One of the difficulties in improving the quality of care for patients with cancer of the head and neck is a lack of available benchmark or comparator data; capturing outcome data is difficult and costly. Current electronic health records (EHR) do not facilitate capturing important data elements related to a specific patient that can be easily retrieved for reporting and analysis. As the EHR evolves, patient information such as demographics, tumor-specific details, comorbidity, the treatment provided, and functional outcomes will be captured as discrete data elements in the workflow, thus facilitating reporting outcomes. As these databases become robust, risk-adjusted outcomes along with the cost of care will be reportable. At that point, value analysis based on high-quality data will be reportable allowing for benchmarking outcomes and the ability to compare individual providers and institutions.

Although the promise of the EHR to support these goals remains in the future, there are tools available now to improve the quality head and neck cancer care and to potentially diminish costs of care. Diminishing variability through the use of cancer care pathways is one readily available resource. The National Cancer Center Network (NCCN) has developed and refined treatment guidelines for patients with cancer of the head and neck based on the highest level of evidence available with input from a panel of cancer care specialists who are leaders in their respective fields of surgical, radiation, and medical oncology.¹¹ The American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS) and the American Head and Neck Society (AHNS) continue to develop clinical practice guidelines (CPGs)
and quality measures to aid in the treatment of diseases of the head and neck and also provide tools for assessing the quality of care delivered. Currently, payers use cancer care guidelines as a resource for approving diagnostic studies and proposed therapy. Treatment falling outside of these guidelines may be denied reimbursement. In the future, it is anticipated that payers will direct patients with complex diseases to providers and institutions that can demonstrate value-based care.¹²

This chapter reviews current methodologies for capturing treatment outcomes and systems-based approaches for improving cancer treatment that include organization and structure of the multidisciplinary team, the use of evidencebased guidelines, coordination of care among the disciplines, process metrics supporting efficiency, and quality improvement tools.

Evidence-Based Clinical Practice Guidelines

As medical science and technology advance at a rapid pace, it has been a challenge for hospitals and medical providers to consistently provide high-quality care to all patients. Difficulties in achieving this goal stem from our inability to clearly define quality metrics. To improve the quality of care patients receive, the IOM has challenged the health care community to incorporate evidence-based treatment guidelines as a way of consistently providing the best care possible for patients with complex or chronic disease. Patient care should be based on a continuous healing relationship customized to the patient’s needs and values and oriented toward a common goal. The patient should have access to all relevant medical information in order to make informed decisions. All medical decision making should be evidence based, cooperative, and transparent. In addition, the health system should be safe, continually trying both to decrease variation and waste and to anticipate the needs of the patients.⁴

Meeting these goals is a great challenge, for all providers at all levels of the health care system. One way of improving the consistency and reducing the variation of health care delivered is through the development of structured treatment pathways that provide evidence-based evaluations and interventions to optimize the use of resources and deliver the best outcome.⁴ CPGs are an important and powerful tool for assisting individual practitioners in using the most current evidence and consistent methodology available.¹³ As many organizations attempt to incorporate guidelines as a strategy to reach the goals articulated by the IOM, an important tool has been the development of CPGs that are specific to a patient and disease population. This section will define the role of CPGs as a means to improve current quality standards of medical care. In addition, it will discuss the necessary rigor critical to creating clinically relevant evidence-based guidelines and how they contribute to improved cancer care.

Definition of Clinical Practice Guidelines

The IOM has defined CPGs as statements that include recommendations intended to optimize patient care that are informed by a systematic review of the evidence and assessment of the benefits and harms of alternative care options.¹⁴ It has defined best practice standards for the CPG development. These include the following:

Establishing transparency: The funding for and process of development should be publicly detailed.
Management of conflict of interest: Conflicts of interest should be limited, and avoided, with group members divesting themselves of such conflicts when possible. When not possible, these conflicts should be fully disclosed.
Guideline development group composition: The group should be multidisciplinary with public and patient involvement.
Clinical practice guideline-systematic review intersection: Those performing systematic reviews and those in the guideline group should agree on the scope, method, and anticipated output of each group’s work.
Establishing evidence foundations for and rating strength of recommendations: Each recommendation should be accompanied by an explanation with summary of the evidence, a confidence rating, and a strength rating.
Articulation of recommendations: Recommendations should be clear, provide direction, and be worded appropriately.
External review: External reviewers should comprehensively represent relevant stakeholders, and all reviews should be kept confidential.
Updating: CPGs should be regularly reviewed and updated.

Once developed, a CPG is rigorously evaluated for inclusion in the National Guideline Clearinghouse (NGC) database.¹⁵ The NGC is an initiative of the Agency for Healthcare Research and Quality (AHRQ), an organization within the U.S. Department of Health and Human Services. Its mission is to provide physicians and other health professionals, health care providers, health plans, integrated delivery systems, and purchasers an accessible mechanism for obtaining objective, detailed information on CPGs and to further their dissemination, implementation, and use.¹⁵ The NCG is an extensive collection of CPGs for a broad variety of medical conditions.

CPGs should contain systematically developed statements that include recommendations, strategies, or information that assists health care professionals to make decisions about health care in specific circumstances. All of these guidelines are evidence based, providing corroborating documentation from a systematic literature review.¹⁶ It is important to recognize that guidelines are not to be used for reimbursement, health care rationing, legal precedents, and measures for licensing or certification or for cookbook medicine.

Within oncology, the NCCN establishes CPGs for cancer management. NCCN guidelines are compiled by an expert panel of radiation, medical, and surgical oncologists who review current literature and make management recommendations based upon the best available evidence. Where evidence is lacking, expert consensus, with multidisciplinary representation from leaders in each field, is rendered.

Why Use Clinical Practice Guidelines?

There is currently a strong initiative to identify metrics that demonstrate quality care; more efficient care will reduce health care costs. The CMS has defined health care efficiency as the absence of waste, overuse, misuse, and errors through the limitation of unexplainable practice utilization variation.¹⁷ CPGs are tools that can be used to improve patient care and clinical outcomes with the goal of providing safe, consistent health care that can be tailored to each patient’s clinical and personal situation.

Opponents to CPGs express concerns that these remove the individual decision making of the medical professional. However, CPGs are not intended to dictate care but are
created to serve providers; in the setting of an ever-increasing body of literature, CPGs outline best practices based upon the best available evidence. Put another way, CPGs are systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific individual circumstances.¹⁷ They are not intended to supersede professional judgment and should allow for treatment options based on the variation in patients’ specific needs and interests.¹⁸ The primary goals for CPGs are to minimize harm, reduce inappropriate provider variations in clinical care, and optimize health outcomes. Although the use of CPGs may result in reduction of costs, the financial benefit is not the main objective of an evidence-based guideline but merely a reflection of more efficient care.¹⁶

Process for Developing Clinical Practice Guidelines

CPG development has been refined over the years to be more standardized, thereby producing more reliable CPGs. When created with high methodologic rigor, a well-designed CPG can demonstrate the capacity of an organization or society to influence both patient health and public policy.¹⁶ In general, the overall process needs to involve a systematic method of identifying evidence and ranking the relative strengths and quality of the literature, which is then critically evaluated by a panel of experts to reach an agreement on the strength of a recommendation.

Because not every clinical question can be effectively answered by strong published evidence, there are three different approaches to constructing a CPG. The first is an informal consensus in which a panel of experts convenes to consider clinical questions and render a statement on best practices; this is done when strong evidence is lacking. The second is a formal consensus guideline for which a panel of experts considers clinical questions and renders a statement on best practices; this type does include a full formal review of the literature. However, due to gaps in the evidence, it may not be possible to link each individual recommendation to the evidence. In this situation, it may be necessary to produce a summary statement globally supported by the literature. The third method includes evidence-linked construction in which a comprehensive and systematic evidence search is performed. There is a formal ranking of the strength of the evidence through grade assignment. Each clinical recommendation is then linked to the supporting evidence and the strength for which the recommendation is supported by the evidence is defined. The latter is the most rigorous approach to developing CPGs, which represent the most complete evidence-based best practices; however, the process is often complex, time-consuming, and even inefficient.¹⁶

Within the surgical specialties, the AAO-HNS has been at the forefront of CPG development. This association has been interested in identifying high utilization and multidisciplinary clinical situations for which there needs to be clarification and standardization in otolaryngology practice. With the desire to produce high-quality CPGs, the AAO-HNS created a manual for guideline development¹⁶ and assigned a task force to oversee the processes. This Guideline Development Task Force (GDTF) is made up of representatives from each sister society (e.g., AHNS) and receives input from all areas within otolaryngology. Through the GDTF and AAO-HNS leadership, otolaryngology has produced 13 CPGs and has more than 10 under development.

There are five basic steps for successfully creating a valid evidence-based guideline. First, the subject area must be identified and refined. Then, the guideline development group convenes and a systematic literature review is performed to assess the available evidence. The evidence is then translated into recommendations. Lastly, the guidelines should be sent for external review.¹⁹ The following steps outline the AAO-HNS process for producing a high-quality CPG.

Planning

The first step in guideline development is to define a topic that is timely for all of the stakeholders, including health care providers, patients and their families, society organizations, and even payers. The topic should be important and feasible. There should be multidisciplinary appeal, high utilization, or substantial burden of illness or cost due to the variation in care. A good topic also will have high-quality evidence available in the literature. It is also important to know if there are already existing published guidelines on a similar topic. During this phase of development, the guideline development group, including both the leaders and the outside stakeholders, should be identified. All conflicts of interest should be disclosed and addressed.

Evidence Collection

The initial topic may start out being very broad, but after an appropriate search of the literature, it may be refined to answer more specific questions. The target audience should be defined, as well as the types of practice settings in which the CPG would be applied. The group should discuss the clinical interventions as well as the outcomes that should be considered, including new technology and medications. With that information, it is possible to begin a literature search using identified keywords from such common sources as MEDLINE, Cochrane Community, etc.

Key Statements

Once the evidence has been defined, the key statements can be developed. These boldface statements are different from the global topics in that the latter often reflect controversy, practice variation, and areas for quality improvement. The key statements are more focused and describe when, who, what, and to whom each recommendation applies (i.e., under what conditions a provider would do a certain action to which patients). These statements use an action-type verb requesting the provider to perform a measureable action. Examples would be “prescribe,” “perform,” “educate,” “test,” “dispose,” and “refer.” A key statement should avoid passive verbs such as “consider” when making a recommendation. There are times when a recommendation is vague, but the rationale for this, such as insufficient evidence, inability to reach a consensus, legal standard of care, economic prohibitions, and ethical constraints, must be included. After the key statements have been identified, each must be supported by text that summarizes the evidence. This text should describe the risks, harms, benefits, costs, and alternatives for the recommendation.

At this point, the evidence is reviewed to identify the strength of the recommendation. Using the evidence grading system described in GRADE,¹⁹ the evidence can be ranked from A to D. A statement receiving Grade A evidence is strong
enough that further research is very unlikely to change the confidence in the estimate of effect. The evidence supporting a Grade A is usually randomized controlled trials or diagnostic studies on specific or relevant populations. Grade B evidence indicates that further research is likely to have an important impact on the confidence in the estimate of effect and may even change the estimate. This type of evidence often comes from randomized controlled trials or diagnostic studies with minor limitations. A Grade C evidence recommendation is supported by evidence in which further research is very likely to have an important impact on the confidence in the estimate of effect; more studies are likely to change the recommendations. This is seen with statements based largely on observational studies. Lastly, a Grade D recommendation is one that is not supported by the evidence. In this setting, any estimate of effect is very uncertain and is usually based on expert opinion and case reports.¹⁹

The key statements, once completed, should contain a recommendation supported by graded evidence. In general, when a strong treatment recommendation can be made with Grade A evidence, it is also important to clearly state that the benefits of the recommended therapy exceed the potential harms. On the other end of the spectrum, providing an option within a Grade D recommendation indicates that the evidence did not describe a clear advantage to use one treatment over another, so other factors, such as patient preference and cost, must be considered. It is important to clarify that there is no evidence demonstrating that the benefits outweigh the harms when choosing one treatment over the others. When there is no recommendation stated, there is a lack of evidence to guide a decision and to define the risk/benefit ratio. According to AAO-HNS guidelines, the recommendation is followed by supporting text, which discussed the level of evidence, benefits, harms, costs, values, and policies surrounding it.¹⁶

External Review

After the guideline is created, it must undergo an external review. This includes peer reviewers and relevant stakeholders. The reviewers scrutinize the CPG, focusing on the validity, the reliability, and the feasibility of the statements. In addition, the guideline should be reviewed by the board of any sponsoring organizations. Once the comments have been addressed and the guideline is edited, it can be submitted for publication. It is common that the guidelines are published in the journal of the organization or society. CPGs can also be made available on the society Web sites and submitted into clearinghouses such as NGC.¹⁵

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