ASH Clinical News | Page 41

feature Interview The Road to the New Sickle Cell Disease Guidelines: Interview with Co-Chair George R. Buchanan, MD On September 9, 2014, the National Heart, Lung, and Blood Institute (NHLBI) released an evidence-based expert panel report on the management of sickle cell disease (SCD) — the first-ever comprehensive guidelines providing guidance for all clinicians who care for patients with SCD, from primary-care physicians to specialists. To get the behind-the-scenes look at how the guidelines went from plan to conception to reality, ASH Clinical News spoke with George R. Buchanan, MD, professor of pediatrics and internal medicine at University of Texas Southwestern Medical Center in Dallas, and co-chair of the Expert Panel. Based on its overall merits and potential to improve care — while still recognizing the limitations of currently available evidence and need for more research — ASH decided to endorse the new NHLBI report. Accordingly, the Society is working to ensure that clinicians understand how to implement these new recommendations. Read more about the Society’s efforts in ASH Directions, including new pocket guides and a stakeholders meeting planned to take place at ASH Headquarters early next year, on page 13. ASHClinicalNews.org ASH Clinical News: Let’s first talk about the need for this type of guideline — was there anything like this before now? NHLBI had previously published some recommendations over the years, often referred to as “The Black Book” or “The Red Book,” which contained expertwritten chapters regarding various aspects of SCD and disease management, but these were not evidence-based. There had also been comprehensive systematic literature reviews of hydroxyurea — one of the two disease-modifying treatments for SCD — published in 2008, but, to my knowledge, no systematic, comprehensive, evidence-based reviews regarding other treatments and management issues regarding SCD have existed prior to the document we developed. Who is the target audience for this report? These new guidelines are mainly designed for the frontline primary-care physicians, general practitioners, family physicians, pediatricians, general internists, and other specialists or subspecialists who deal with sickle cell patients — rather than hematologists who have historically been more involved with managing SCD. Hematologists who frequently encounter SCD may not really “need” these guidelines, at least not as much as the other physicians who are less involved with the disease. However, hematologists and oncologists who may be less directly involved with SCD may also be called upon to help with managing SCD, so, hopefully, all ASH members will derive some benefit from the publication of these guidelines. And, there is no question that hematologists are very keen on having these comprehensive evidence-based recommendations compiled in one document. How long did it take to develop the report? This process began in 2009, when Susan Shurin, MD, then the deputy director of NHLBI, asked me to co-chair this report. Our first face-to-face meeting occurred in early 2009, with the initial thinking that the report would be complete in a couple of years. There were a couple of major reasons behind the delay. First, there was initially some turnover in the membership of the committee, and then a change in the methodology group who assisted the writing panel with literature review and grading of the evidence. Second, this set of guidelines was fundamentally different from any others that NHLBI has developed. Typically, NHLBI guidelines deal with the management of one aspect of a disease, but our task here was to develop the recommendations for an entire disease — meaning every organ, every part of the patient’s body, and managing all of the unique complications from SCD. During the process, we also stopped temporarily to allow for public comments and input from ASH and other professional societies, which offered many helpful recommendations. We did make a fair number of modifications as a result of those comments. How did the expert panel begin the process of making recommendations and grading supporting evidence? In the early meetings, we developed our major strategy and the overarching questions we needed to answer in five major topic areas: • Ongoing health maintenance (i.e., necessary monitoring and laboratory testing) • Managing acute complications • Managing chronic complications • Hydroxyurea therapy • Blood transfusion “ ur task was O to develop recommendations for an entire disease — meaning managing all of the unique complications from SCD.” After identifying those areas and specific questions we wished to answer, we got involved with the methodologists who actually performed the systematic review of the literature. Around 12,000 publications were reviewed, dating back from 1970 to April 2014, to make sure we didn’t miss any pertinent information. Then, the promising data from each paper or manuscript were assessed according to the GRADE system and entered into “evidence tables.” The GRADE system had to be modified because it only allowed for two Continued on page 44 ASH Clinical News 39