An interview with Clinical Practice Guidelines Methodology Subcommittee Chair Gary H. Lyman, MD, MPH

ASCO's clinical practice guidelines provide recommendations on challenging clinical scenarios and offer tools for decision-making. Gary H. Lyman, MD, MPH, of Duke University, who serves as Chair of the Clinical Practice Guidelines Methodology Subcommittee, discusses the ways in which ASCO is working to broaden its portfolio of guidelines while ensuring that the recommendations meet high standards of reliability.

AC: How does an ASCO guideline come together?

Dr. Lyman: ASCO follows a very rigorous process. A thorough review of the literature on that topic is done, and the evidence is assimilated and summarized. This summary is put before an expert panel that reviews the totality of evidence and makes recommendations. ASCO guidelines are highly regarded and appreciated for the strong scientific basis of their recommendations, both in the United States and internationally.

While this evidence-based approach is the gold standard, it has its challenges, the biggest being that the process is very labor- and time-intensive. Most ASCO guidelines take at least a year to develop, so we aren't able to address every question that could come up in the practice of clinical oncology. A consensus-based approach, which is used by other organizations, can address questions and provide updates faster, but does not have the same scientific rigor as the evidence-based approach.

Many of us have the view that these approaches are complementary, not competitive. The consensus-based guidelines can cover a lot of issues and can be updated frequently. Evidence-based guidelines, ASCO's niche, can address particularly challenging questions where there may be a lot of uncertainty or widespread variation in practice.

AC: How will ASCO guidelines fit into CancerLinQ^TM?

Dr. Lyman: We're developing strategies to adapt our guidelines process to the needs of the rapid-learning approach. Guidelines in CancerLinQ must reflect real-time, up-to-date recommendations, and they must be in a form that can quickly and easily be used by a clinician at the point of care. We're trying to develop recommendations that stem from the guidelines but are fluid and easily adapted into an electronic system like CancerLinQ.

AC: How is ASCO working to stay nimble and create or update guidelines in a timely way?

Dr. Lyman: We offer Provisional Clinical Opinions for important issues when we want to get information out to the membership quickly; the opinion is "provisional" because the conclusions might change if and when that issue is addressed in a rigorous evidence-based guideline.

We're interested in doing more expedited endorsements, which help us avoid duplicating efforts with other organizations. This involves finding a guideline created by another organization, particularly one that uses a rigorous process similar to ours, and putting it before a panel of ASCO members for review. If the panel agrees that the recommendations are sound, we would have the opportunity to endorse the guideline. We've tested this in a few instances, but we'd like to develop more formal partnerships with other organizations around the world for the endorsement of high-quality guidelines.

Another approach is "modified consensus," which falls between a true evidence-based and a true consensus-based guideline, using what's called the modified Delphi technique. This minimizes the risk of bias creeping into the recommendations and prevents the loudest (or most prestigious or most senior) voice in the room from having the most say.

ASCO's Clinical Practice Guidelines Committee is working hard to institute more streamlined approaches to developing systematic review-based guidelines.

Dr. Lyman is a Professor of Medicine and Director in Comparative Effectiveness and Outcomes Research Program at Duke University School of Medicine and the Duke Cancer Institute and a Senior Fellow at Duke Center for Clinical Health Policy Research. He serves on the ASCO Board of Directors and has been a Fellow of ASCO since 2010.