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Guidelines have evolving role in modern cancer care
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Although many call the current era of cancer care the personalized care era, the oncology community is practicing in an evidence-based era that began about 15 to 20 years ago with the introduction of clinical practice guidelines.
As cancer treatments grow more complex, evidence-based guidelines are expected to assert more influence on clinical practice.
Cancer associations such as the American Society of Clinical Oncology (ASCO) and the National Comprehensive Cancer Network (NCCN) devote a substantial amount of time and effort to compiling evidence and making expert recommendations based on this evidence to provide the highest level of treatment available to patients, according to Gary H. Lyman, MD, MPH, professor of medicine and director of comparative effectiveness and outcomes research at Duke University School of Medicine and the Duke Cancer Institute.
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Photo courtesy of Peter Bach, MD |
Clinical practice guidelines not only address specific clinical situations and cancer types, but they also provide recommendations on medical products and drugs, procedures and tests.
“Oncologists are very busy, and guidelines provide evidence and expert recommendations that they can turn to, to quickly make a treatment decision,” Lyman said. “The science behind oncology and the complexity in treatment and testing has increased so dramatically over the last decade that it is too much information to stay attuned with all the new advances. Treating cancer patients is extremely difficult, and guidelines can boil all the information down in a systematic way for oncologists.”
HemOnc Today talked to several experts in the design, distribution and use of clinical practice guidelines to examine their use and role in current oncology care.
Meeting a need
Studies being done in the late 1980s showed a great variance in care among major medical centers, even those in proximity to each other, according to William T. McGivney, PhD, CEO of the NCCN.
“Additional studies indicated that patients were undergoing a lot of unnecessary medical procedures,” McGivney said.
According to Lyman, many interpreted this variation in practice and use of unnecessary treatments as a general uncertainty among the medical community as to the best way to treat certain conditions.
“This is when people began to say that medicine needed to be more guideline-based and that these guidelines needed to be based on evidence, so that there is a foundation to serve as a template,” McGivney said.
The NCCN, an alliance of 21 leading cancer centers, was formed in the mid-1990s to help improve the quality and efficacy of care for cancer patients. Part of this mission, according to McGivney, was developing guidelines that would help to communicate appropriate care to oncologists. About the same time, the American Society of Clinical Oncology (ASCO), published its first clinical guideline on the use of hematopoietic colony-stimulating factors.
Today, ASCO has compiled and published more than 20 guidelines, and the NCCN more than 100, that are available to help guide patient treatment. In addition, oncology-based guidelines are also being published by the European Society for Medical Oncology, the US Preventive Services Task Force and more.
“Since their inception, guidelines have become a mainstream resource,” Lyman said. “I don’t see that changing.”
Current role of guidelines
As cancer research increases and new technologies and drugs become available for use, the landscape of oncology becomes only more complex. It is this complexity that highlights the role of clinical practice guidelines.
“Doctors are less expected to have memorized everything they need to know and are becoming more skilled at using well-designed tools that contain accurate information to help them practice,” said Peter B. Bach, MD, director of the Center for Health Policy and Outcomes at Memorial Sloan-Kettering Cancer Center. “The sequence of decisions that have to be made can’t be memorized, and guidelines are the only good way to communicate, in a concise way, what the sequence of decisions that should be made is.”
A study conducted by the Association of Community Cancer Centers (ACCC) found that more than 90% of the oncologists surveyed regularly referred to clinical practice guidelines.
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“Most physicians wanted to provide the best treatment possible,” Alan S. Weinstein, MD, chair of the guidelines committee for the ACCC, told HemOnc Today. “Our study found that you are actually an outlier if you do not use them.”
The study was conducted in 2010 to address the use of clinical practice guidelines in the community oncology setting. The researchers identified 50 programs that used guidelines to be surveyed. The results indicated that not only did nearly all of the physicians refer to clinical practice guidelines, but also they adhere to them nearly 80% of the time.
However, they also reported some barriers to use, such as guidelines being too rigid or not appropriate to unique clinical settings, or that following the guidelines would require a significant change of practice. Both Weinstein and Lyman said guidelines are simply that, guidelines, and that they are meant to be a flexible tool.
“We recognize that guidelines have limitations and are based on evidence from studies of highly selected patients who are typically younger and have fewer comorbidities,” Lyman said. “But that does not mean that the guidelines are not valid, only that they have to be put into context of the individual patient.”
Search for best practices
The study also found that most physicians turned first to the NCCN guidelines and then to ASCO. The NCCN guidelines are considered to be the most comprehensive and widely used by clinicians and are also used by private insurance companies and the CMS to make determinations about treatment coverage, according to McGivney.
“NCCN guidelines are the bread and butter, so to speak, of oncology today,” Weinstein said. “They encompass about 95% to 98% of cancers that are seen in clinical practice.”
However, a 2010 study published in the Journal of Clinical Oncology found that of the 1,023 recommendations given in the 10 most common cancer-type guidelines, only 6% of guidelines were category I, or “high level evidence with uniform consensus.” Eighty-three percent of the recommendations were category IIA, or “lower level evidence with uniform consensus,” which McGivney said is evidence of an overall lack of quality data.
“The NCCN guidelines are definitely more consensus-based, and not as much based on extensive literature reviews,” Lyman said. “However, they are updated much more frequently.”
The NCCN has expert panels that are able to modify and update guidelines two or three times a year, using the most recent evidence available.
In contrast, ASCO has developed more “boutique” guidelines around specific questions in which there seems to be considerable variability or contention about treatment, according to Lyman.
“In reality, they are complementary to each other,” he said. “Not every question has an ASCO guideline. NCCN tends to be more global and addresses most major cancers and clinical situations based on expert consensus. They are not one-size-fits-all.”
Influence on outcomes
Regardless of which guidelines are used, the bigger question among the oncology community is whether the publication of guidelines, ultimately, has any effect on patient outcomes.
“So many things are happening at once in oncology that it is hard to measure if it is the effect of the guidelines,” Bach said.
In addition to the guidelines, earlier detection, better technology and gene therapy have all emerged during the past 10 to 20 years.
“We are curing more patients with cancer than we have before,” Weinstein said. “We have better survival rates in a wide variety of cancers, but to prove that the guidelines and, therefore, the treatments that people applied are the only factors would be impossible, because it is not.”
For many years, the only measure of the effect of guidelines was how often they were downloaded from the NCCN or ASCO websites. There was no way to measure whether the use of these guidelines was having a direct effect on patient care.
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Slowly, the oncology community has developed methods to measure these outcomes. For example, physicians may participate in a quality measurement practice such as ASCO’s Quality Oncology Practice Initiative (QOPI). QOPI was created because many oncologists did not have a tool to measure their practice’s performance. Physicians who participate in QOPI can measure their own performance, and can compare it against that of colleagues and peers.
In the future, it is possible that researchers could take certain QOPI measures before and after a release of a new clinical practice guideline to measure the effect. However, Lyman said quality measures are a great area of need in oncology.
“It would take a huge amount of money, time and energy to prove that guidelines have made an impact in the past,” Weinstein added. “Quality has been the mantra of the last decade. What defines quality? How can we prove that we give quality treatment? We will eventually get there, but it will be slow.”
Future role
The continuing development of clinical practice guidelines has short- and long-term challenges.
“As we improve our ability to create [guidelines], we must also be able to keep them up to date, and possibly make that systematic and automated,” Lyman said. In addition, the oncology community must make sure that it is better at measuring guidelines’ effect on clinical decision-making, whether treatment choices are better or more consistent with the recommendations, and whether patients are faring better or living with an improved quality of life.
“Guidelines are a real learning source and educational tool, especially for younger physicians and trainees getting started in the field who have not yet had time to develop their own clinical experience,” Lyman said.
“There is definitely a difference between book knowledge and clinical practice knowledge, and you need to have a combination of both to develop best practice,” Weinstein said. “I do not think younger doctors are too dependent on these guidelines.”
Instead, Weinstein, who himself just recently retired from active clinical practice, was more concerned with older physicians or physicians who are unwilling to adapt or update their knowledge base.
“To ignore guidelines and evidence from well-done scientific studies and instead do what you have always done, or what you think of off the top of your head, is fraught with danger and can result in disaster in some cases,” Lyman said.
All of the experts said following guidelines will help to make a physician more efficient and operate under better quality standards, thus decreasing treatments errors and resulting in better outcomes for patients.
“Better outcomes for patients is why guidelines are the wave of the present and will most likely be the tsunami of the future,” Weinstein said. – by Leah Lawrence
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Two things seem certain: (1) Guidelines have yet to be proven to improve outcomes in most, if any, cancer patients. (2) Malpractice lawyers love guidelines and will continue to confuse (purposely) ‘guidelines’ with ‘mandates’ in suing physicians for untoward events.
– Harry S. Jacob, MD
HemOnc Today Chief Medical Editor
Disclosures: Dr. Jacob reported no relevant financial disclosures.
For more information:
- Association of Community Cancer Centers. Use of clinical practice guidelines in community cancer centers. accc-cancer.org/education/education-guidelines.asp. Accessed July 18, 2011.
- Lyman GH. J Onc Prac. 2008;4:236-237.
- Poonacha TK. J Clin Oncol. 2011;29:186-191.
- Siegel RD. J Onc Prac. 2009;5:276-281.
- Somerfield MR. J Clin Oncol. 2008;26:4022-4026.
Disclosures: Drs. Bach, Lyman, McGivney and Weinstein reported no relevant financial disclosures.
Should the cost and relative value of treatments be included in clinical practice guidelines?
Yes, but it is less clear how this information should be used when making recommendations
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Clinical practice guidelines developed by specialty societies, like ASCO, are intended to assist clinicians, patients, payers, regulators and researchers in making informed decisions about treatment and health care processes. The cost and relative value of interventions should be reported in guidelines.
There are several reasons that specialty society guideline developers are in a good position to consider cost and relative value, and several reasons they are not.
Reasons they are in a good position: Specialty societies can assemble multidisciplinary panels of experts with balanced viewpoints to evaluate systematically collected data. Participation of patient advocates and clinicians can bring a real-world perspective, whereas researchers and government representatives (eg, from the NCI) can provide technical expertise. Systematic processes for collecting and weighing evidence, considering benefits vs. risks, and for expressing the strength of supporting evidence and strength of a recommendation can be employed (in keeping with standards published recently by the Institute of Medicine).
When adequate information about cost or cost-effectiveness is available, these panels can use such information to assess the cost of a specific benefit (eg, the incremental cost of an additional life-year saved, or the incremental cost of an additional one person out of 100 experiencing relief from nausea/vomiting by selecting one regimen over another).
Reasons they are not in a good position: Although it seems like a good idea to include cost information in guidelines to help end-users make informed decisions, a major challenge to guideline developers is that true costs of interventions are notoriously difficult to pin down in the US market. The cost of a particular drug or health care service will often vary widely across settings in the US. Costs also change over time, sometimes dramatically. Moreover, limited cost-effectiveness information is available to guideline developers about most treatment options, and data are often not up to date.
Given these limitations, what is the path forward? To include this important information in guidelines in the future, the following steps are essential:
Guideline programs should develop standard operating procedures for systematically considering cost information, cost-effectiveness analyses, and for calculating the incremental costs of various types of benefits (using best estimates of true cost) when generating guideline recommendations. Consistent methods for integrating this information into guidelines using standard verbiage are appropriate. Transparent explanations of how calculations are done and how value might vary across contexts are warranted.
Guideline programs should develop tools that users can employ to enter the true costs of interventions at their sites toward evaluating actual cost-per-unit benefits of comparative treatments in their own setting (similar to mortgage rate calculators many real estate websites provide, into which users can enter variables specific to their situation). Guidelines must take into consideration that cost-effectiveness and availability may vary based on context-specific characteristics, and therefore, treatment options should be allowed when appropriate.
Information about the cost-effectiveness of interventions must become more widely available, using similar methods across studies. Funding to conduct such work and make it publicly available — and regularly updated — is vital.
Ethan Basch, MD, is immediate past chair of the ASCO Clinical Practice Guidelines Committee, and a member of ASCO’s Comparative Effectiveness Task Force. He is also an associate attending physician and outcomes research scientist at Memorial Sloan-Kettering Cancer Center. Disclosure: Dr. Basch reported no relevant financial disclosures.
They do not have to include issues of cost
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As I understand it, the purpose of clinical practice guidelines is to demonstrate the appropriate bar, or standard, for high-level practice in a given area. We basically attempt to look at available evidence in the oncology field from mostly prospective, randomized trials. That will ultimately provide guidance as to how to manage different disease situations, or different cancer situations, stage-by-stage or clinical circumstance by clinical circumstance based upon available evidence in the published literature.
You can look at clinical practice guidelines in a purely scientific way and clinical practice sense as being limited to that. However, there is a growing opinion that cost to our patients and to society needs to be brought into the decision-making regarding the determination of the highest quality clinical care. That is to say that if there are two, three or four alternative treatments, and for many diseases there are that many alternative treatment approaches, those four treatments may have widely different financial impacts on a given patient or family constellation, let alone society.
So if treatment regimens have similar efficacy profiles and similar side effect profiles, it is imminently reasonable to me. I am advocating for the inclusion of cost as an important parameter.
Despite this increasing effort, there are immense barriers. In the very complicated health care system that we have, it is difficult to know what, for example, an individual patient or family’s situation is going to be, as far as the financial consequences of a decision made by a treating physician. Physicians often do not know specifics of their insurance arrangements. The complexity of dealing with that on a large-scale basis, like across the nation or socioeconomic demographics and regions, is very large.
What we have started to do is take a few very specific disease situations, like metastatic NSCLC presenting for the first time for treatment, and we have gone through a detailed array of the evidence that supports using one of maybe eight different regimens involving two or three chemotherapy drugs. The drugs differ in the order of sometimes hundreds, if not thousands of dollars, but in other respects, they may not differ at all. What we have decided to do, because we can’t know each patient’s individual exposure, is to provide oncologists with a depiction of what the cost base is for drugs being prescribed and the cost that the office must bear or hospital must bear in delivering those medicines to patients.
Lowell E. Schnipper, MD, is chief of hematology/oncology at the Beth Israel Deaconess Medical Center and chairman of ASCO’s Cost on Cancer Care Task Force and its Cancer Research Committee. Disclosure: Dr. Schnipper reported no relevant financial disclosures.