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ASCO began its guidelines program in 1993. Since then, ASCO has published a total of 19 guidelines and technology assessments (see sidebar “Current Guidelines and Technology Assessments”); another 14 are in progress (see sidebar “Guidelines and Technology Assessments in Development”). The impetus for guideline development by ASCO is straightforward: Guidelines are intended to improve the quality of cancer care by helping oncologists make choices about treatment, prevention, supportive care, or follow-up in line with the best available evidence from oncology research. This article offers answers to a range of frequently asked questions about ASCO guidelines.
ASCO members choose guideline topics. Topics address important questions where there is perceived or proven practice variation, high cost, or recent advances in care. The ASCO Health Services Committee (HSC) reviews and approves topics on behalf of the ASCO Board of Directors. ASCO funds the travel and administrative costs of guideline development, and the Expert Panel meets to write and revise based on tables of evidence developed by ASCO staff.
ASCO members who nominate topics are required to submit a narrative proposal (see the American Society of Clinical Oncology Guideline Procedures Manual at www.asco.org/asco/downloads/Methodology_Manual-11.3.05.pdf) that addresses the burden or importance of the condition or intervention, the degree of uncertainty or controversy about the relative effectiveness of existing clinical options, the perceived or documented variation in practice in the management of the condition or the use of the intervention, the availability of evidence to inform practice recommendations, and the existence of high-quality guidelines or technology assessments on the topic in question.
Once a guideline topic is approved by the Board, an expert panel of content-area experts, including community oncologists, and a patient representative is convened. By the first meeting, ASCO staff usually have already performed the systematic review and assembled tables of evidence. Once the Panel reviews the tables, they compose explicit guideline statements, with discussions about each topic area written later and assembled by the Chairs into the formal document. Multiple committees—including the Board—contribute to this process, requesting changes and clarification before the document is published.
There are several potential sticking points along the way. First, systematic literature reviews take a long time to complete, depending on the number of questions being addressed by the Expert Panel and the depth of the related literature. For example, when the systematic review was performed for the Fertility Preservation Guideline, more than 1,500 potential articles were identified. Second, scheduling meetings with experts from around the country to meet in person may take months. Third, ASCO is a volunteer organization, and guideline development requires a significant commitment from already busy content experts. Finally, the ASCO guideline review process is intensive and multilayered, which also creates the potential for delays. To address these concerns, ASCO has enhanced its in-house systematic review capabilities and is developing plans to streamline the writing and review functions.
The National Comprehensive Cancer Network (NCCN) has made a major contribution to clinical practice through its guideline development program. The NCCN'S disease-management guidelines are stage specific, covering work-up through treatment and follow-up, as well as supportive care. ASCO guidelines generally focus on a single question or a group of questions around an important topic. The fundamental difference between the two groups' guidelines relates to how they are developed: NCCN relies on narrative reviews of the literature, whereas ASCO relies on systematic reviews. The major difference between a systematic review and a narrative review relates to the transparency of the processes used in each. Systematic reviews require explicit statements about literature search strategies and study selection criteria, and result in graded evidence tables. Panels that compose practice guidelines for ASCO try to confine their recommendations to the evidence gleaned from the systematic review before providing expert opinion or consensus. Narrative reviews are based on the literature, but rely heavily on consensus to derive the final product, and the methods used to identify the articles included in the review are not always clear.
Despite the exacting process of systematic literature review, ASCO Panels still are called upon to use their expertise to bridge gaps in the literature. For instance, the frequency of carcinoembryonic antigen (CEA) testing, physician visits, or the use of chest computed tomography (CT) scans has never been formally tested in colorectal cancer follow-up. Nevertheless, the Colorectal Cancer Surveillance Panel achieved consensus on these recommendations, acknowledging the importance of providing ASCO members with guidance in this area.
Yes, although a few oncologists say they are hard to find.1 An estimate of whether ASCO guidelines are used depends on the metric considered. Formal evidence is encouraging. Recent data from JCO's Web site, JCO.org, indicate that five of the top 10 and eight of the top 15 most frequently accessed JCO articles are ASCO practice guidelines. The 2003 “Unresectable NSCLC Guideline” tops the list of all JCO articles accessed. Moreover, in two Internet surveys of the ASCO membership (albeit, each representing just 14% of the total membership), ASCO guidelines were ranked third of 12 activities or services provided by ASCO, behind the JCO and the Annual Meeting, in terms of overall importance. In a survey of international members conducted in January 2005, the guidelines were a highly rated feature, with 73% of those surveyed scoring the guidelines as an 8, 9, or 10 on a 10-point scale.
Theoretically, clinicians should be aware of everything published in the field of oncology to provide the most up-to-date care of their patients. Practically speaking, it's just not possible for clinicians to see patients for 40 to 60 hours per week, take call, and digest the dozens of oncology publications in print or online monthly. A search of MEDLINE reveals that at least 1,859 articles specific to cancer therapy were published in the month of January 2005 alone. Optimally, guidelines should be like airline checklists; they serve as reminders about operations of the plane during different phases of flight, but in the end, the pilot still has ultimate responsibility. Likewise, the doctor still has to sit at the bedside of the patient and execute the treatment plan. The availability of guidelines online makes this cross check available in real time in the office.
Guidelines are not rules, and oncologists see exceptions every day. Given the scenario presented at the outset, it may not be unreasonable for an insurance company to deny monthly CEA measurements (on the basis of ASCO's recent CRC guideline). On the other hand, it would be very difficult for an insurer to deny periodic CT scanning for high-risk patients on the basis of the strength of literature and expert support furnished by the guideline. ASCO's guidelines may be used by payers, but that places the burden on ASCO to keep our guidelines available and up to date.
Payers recognize that errors and costs are caused in part by wide variations in practice. In fact, Quality Oncology Practice Initiative (QOPI) data show wide variation in oncology practice in a number of areas addressed by practice guidelines.2 National organizations such as ASCO are taking a leadership role by acknowledging shortcomings and providing tools, such as guidelines, to members to improve care.
One payer, the Centers for Medicare & Medicaid Services (CMS), has incorporated reference to ASCO guidelines in its 2006 Demonstration Project, which is on the path to pay for performance. One criterion for performance may be the use of practice guidelines in practice. In a fact sheet released in August 2005, CMS states, “In particular, clinicians armed with appropriate assessments and the best evidence-based practice guidelines can reduce some of the unpleasant and frequent side-effects that often accompany cancer and chemotherapy treatment, obtain the best possible clinical outcomes, and avoid unnecessary costs.” One of the questions currently being asked by CMS is, “Are there more effective measures related to quality of care, for example, measures related to the use of evidence-based practice guidelines?”
Scenario: You pull up the colorectal surveillance guideline on ASCO.org, and notice a new link to a guideline summary. With a patient in your office, you don't have time right now to read the full guideline (although of course you're eager to do so later), so you scroll through the two-page summary and print the table summarizing the follow-up recommendations. You also print the flow sheet of recommended patient follow-up to help you quickly and easily set up a surveillance schedule for your patient.
ASCO has launched an initiative to make the guidelines more useful in clinicians' offices and hospitals.3 In addition to examining ways of streamlining development of the guidelines themselves, ASCO is developing new tools to accompany the guidelines; these tools are intended to quickly and easily facilitate adherence to evidence-based recommendations on a day-to-day basis.