July 2007: Volume 33, Number 7
New NACB Guidelines Are Built on Evidence-Based Medicine
LMPGs on Cardiovascular Risk Factors, Pharmacogenetics Scheduled for 2007 Release
By Julie McDowell
The AACC’s National Academy of Biochemistry (NACB) this year is scheduled to release a number of finalized and draft Laboratory Medicine Practice Guidelines (LMPGs), all of which are being developed using an evidence-based approach, rather than the consensus-based approach that was used in the past. “By the end of the year, we expect to release LMPGs on emerging cardiovascular risk factors, as well as finalized guidelines on pharmacogenetics and tumor markers,” said Catherine Hammett-Stabler, PhD, President of the NACB Board of Directors. In addition, a draft guideline on expanded newborn screening, scheduled to be posted in July, will be presented at this month’s AACC Annual Meeting in San Diego, Calif. “We also expect to have the updated diabetes guidelines posted in early October, and they will then be presented at the Beckman Conference in the fall,” she added. The conference will be held on Nov. 15 and 16 in Atlanta.
The NACB’s shift to a more evidence-based approach to developing guidelines has been evolving over the past 5 years. The recently updated LMPGs on acute coronary syndrome biomarkers—published in the March issues of both Clinical Chemistry and Circulation—and point-of-care testing were the initial guidelines to be developed through using this revised process. “Initially the LMPGs were designed as consensus-based guidelines, so teams of experts were put together from both the laboratory side and the clinical users side,” said Hammett-Stabler, who is with the University of North Carolina Hospital Department of Pathology and Laboratory Medicine in Chapel Hill. “Now, while there are still teams of experts developing guidelines, they delve into the literature in much greater depth. Instead of being consensus-based, they are more evidence based.”
In order for a recommendation to be included in an LMPG under this current process, the evidence is weighted depending on the literature source. For example, evidence data from case reports carry less weight than results from blinded studies, all of which is taken into consideration when formulating a recommendation. However, Hammett-Stabler points out that in the absence of strong evidence, the LMPG committees will revert to a consensus-based recommendation. “We recognize that for some analytes, there may not be strong evidence there. For example, most of the studies and information in the literature report might be method comparisons or cases,” she explained. “When the evidence isn’t there, we want to make sure that it’s clear that the recommendation we give is consensus-based. We’re trying to make this as transparent as possible.”
In addition to these changes, the forthcoming LMPGs will include conflict of interest disclosure information. The NACB Board of Directors, Education and Scientific Affairs Committee, and the Publications Committee are also looking at faster ways to produce the LMPGs. One approach is to take on more narrow topics. “Recently we’ve taken on some very large topics and tried to be as inclusive as possible, but that makes it harder to get the teams together and get everything assembled in a short period of time,” said Hammett-Stabler. The directors are also trying to assist the LMPG committees by providing them with a template to organize and structure their recommendations.
“Most of the time, the committees can do the reviews and develop their first set of guidelines fairly rapidly,” she explained. “But it’s the writing and finalizing that can be time consuming, so we’re actually trying to develop ways in which we can facilitate the writing and preparation of the final format, which would help get the guidelines out there and in use sooner.”
The LMPGs can be found on the NACB’s Web site.