American Association for Clinical Chemistry
Better health through laboratory medicine
February 2011 Clinical Laboratory News: Clinical Collaborations
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 February 2011: Volume 37, Number 2


Clinical Collaborations
A Pathway to Improved Patient Care?

By Bill Malone

A common refrain among laboratorians has long been that the profession does not get the respect it deserves nor the visibility it needs to fulfill its potential as an essential part of modern medicine. This long standing frustration may be coming to an end, or at least lessening as laboratorian’s clinical colleagues voice their own frustrations. Clinicians are also having an epic struggle of their own: they can’t keep up with a swelling sea of choices in drugs and diagnostics, and they need help—whether in the clinic or in crafting practice guidelines.

Not content to sit on the sidelines, many laboratorians are now reaching out to clinicians in new ways. While some have focused on grass-roots efforts, AACC leaders are finding success working with clinical professional societies that they hope will bear fruit at all levels. Whether contributing to guidelines, jointly publishing papers in other clinical journals, or bringing laboratorians and clinicians face-to-face at educational events, AACC is forging collaborations with cardiologists, endocrinologists, and other specialists who increasingly appreciate the critical contributions of the lab to their practice of medicine.

The 2011 AACC President, Ann Gronowski, PhD, has promised to make collaboration with clinical societies a major focus for the future of the association, working to ensure that laboratorians are at the table in educational programming, guidelines development, and research with colleagues in other areas of medicine. “These relationships will lead to clinicians asking for our help and advice, and partnering with laboratorians in all areas—from more outcome-oriented test ordering to biomarker discovery,” she said. “Ultimately, such collaborations will not only increase the visibility of the profession, which is important, but also increase the quality of care that we’re able to give our patients, as more thought goes into the proper methods, cutoffs, and other elements of the lab component which too often are overlooked.” Gronowski is associate professor of pathology and immunology and associate medical director of clinical chemistry at Washington University in St. Louis.

Knowledge Gap Getting Worse

Working with clinical societies on focused projects may be the best way to break down communication barriers and boost healthy exchanges of expertise among physicians and lab directors, according to laboratorians who have deep experience in the physician community. Many have noted the increasing difficulty physicians have in properly utilizing the burgeoning menu of lab tests. With information about drugs and other areas of medicine exploding too, the situation with the lab is only likely to get worse as medical schools have less time to spend on laboratory medicine.

However, this trend goes both ways, with not only fewer physicians training in lab medicine, but PhD-level laboratorians becoming more separated from patient care, said Alan Jaffe, MD, professor of medicine and laboratory medicine at the Mayo Clinic. As a cardiologist and a laboratorian, Jaffe has served as an ambassador for the lab community to the American College of Cardiology (ACC) and other physician groups. “In many areas there is tremendous confusion among physicians about the lab, often due to a kind of language gap between the clinical community—which no longer is very astute to some of the problems that occur in the lab—and the lab community which also has less and less clinical experience,” he said. “We have PhDs in the lab that are terrific, but are getting more and more distant from the clinical side. So one thing that will be increasingly important will be translators: people who understand the perspective of both clinicians and the lab.”

A member of AACC’s clinical societies collaboration committee, Jaffe has extensive experience on both sides of lab/physician collaboration, such as chairing the biochemistry group of the Global Task Force for the Definition of Myocardial Infarction which issued guidelines in 2007 supported by the European Society of Cardiology, the American Heart Association (AHA), the World Heart Foundation, and ACC.

Despite such successes, there remains a whole variety of clinical confounds where clinicians lack knowledge, especially in the cardiac biomarker area, Jaffe noted. “I think it’s terribly important for AACC, or at least laboratory-oriented individuals, to have a seat at the table when there are discussions about how to use lab tests. We need to stimulate better interactions at all levels that in the long run, increase the ability of all of us to use laboratory tests in a better way.”

With physicians overloaded with information in medical school, it’s going to take proactive steps from laboratorians, working through AACC and other professional groups, to give a voice to the lab community in the field, Jaffe emphasized. “Some have suggested more training for clinicians who have lab interests. The problem is that already the training programs are excessively long,” he said. “We’re talking about medical students whose children will be in college before they’re out of training.”

The solution, said Gronowski, is positioning laboratorians as the go-to people for clinicians, whether in one-on-one interactions or building credibility on a large scale through professional societies. “With the burgeoning of medical knowledge today, physicians should not be expected to know it all, and that’s where lab medicine can play a big role,” she said. “We can say, ‘it’s okay, you don’t have to remember all the tests and their sensitivity and specificity: that’s my job. I can help you.’ We want them to know that we are the highly specialized experts they can go to.”

Building Bridges in Education

One of the primary avenues for building rapport and gaining visibility with clinicians on a larger scale has been continuing education. AACC has developed targeted educational and networking events with ACC, AHA, the American Diabetes Association (ADA), the American Association of Clinical Endocrinologists (AACE), the College of American Pathologists (CAP), and the Society for Critical Care Medicine (SCCM).

The relationship with ADA has blossomed over the years to include collaboration on practice guidelines from the National Academy of Clinical Biochemistry (NACB), as well as symposia at AHA and AACC annual meetings. For the past 6 years, AACC members have presented a symposium at ADA’s annual meeting that has been well attended, noted David Bruns, MD, professor of pathology, director of clinical chemistry and toxicology, and associate director of the molecular diagnostics laboratory at the University of Virginia School of Medicine in Charlottesville. These symposia have even been presented throughout India, part of an ADA program that takes the talks from the best symposia on a special tour of the country. “People are recognizing what we’re doing here. I think that there is definitely more of a tendency for these physicians to pay attention to the laboratory testing components of what they do given how important laboratory testing is in diabetes,” Bruns said. “They really search out our input now.”

AACC struck up a similar relationship with ACC, and in April will offer a joint session on the use of troponin in ischemic heart disease at ACC’s 60th annual meeting. In addition, under a special arrangement with ACC’s CardioSource website, select Clinical Chemistry articles of interest to cardiologists are now available free to ACC members via the site’s Journal Scan feature ( Journal Scan editors take must-read journal articles and summarize them with commentary.

Also in April, AACC’s Arnold O. Beckman Conference will take place in conjunction with the AACE annual meeting and will focus on glycemic control in the hospital setting. Supporters of the conference also include ADA, CLSI, CAP, and SCCM (See Box, below). The subject matter, location, and supporting societies involved in the event are all aimed at bringing together laboratorians and physicians around common concerns. SCCM also joined with AACC to support a December 8, 2010 webinar on acute kidney injury titled, “Acute Kidney Injury: Improving Patient Outcomes through Early Detection.”

2011 Beckman Conference Brings Lab, Physicians Together

Highlighting the important role of the lab in endocrinology, the 29th Arnold O. Beckman Conference will be held in conjunction with the annual meeting of the American Association of Clinical Endocrinologists on April 12 and 13 in San Diego, Calif. The conference will cover topics of interest to both laboratorians and physicians.

Titled “Glycemic Control in the Hospital: Evidence, Issues, and Future Directions,” the conference was developed in collaboration with the American Diabetes Association, the College of American Pathologists, the Clinical and Laboratory Standards Institute, and the Society for Critical Care Medicine. AACC’s Critical and Point of Care Division is also participating.

Speakers include Greet Van den Berghe, MD, PhD, who will discuss the landmark Belgian study on the effects of intensive insulin treatment on critically ill patients. Van den Berghe is chair of the department of intensive care medicine of the University Hospital Gasthuisberg, University of Leuven, Belgium.

Additional presentations will cover various perspectives on tight, moderate, and intensive glycemic control, as well as several talks on important clinical and analytical issues, including glucose meters. The conference will conclude with recommendations from the experts on future strategies for glycemic control.

Registration is available online.

Guidelines and Other Projects

Beyond education, another critical area where laboratorians have made inroads is in practice guidelines, most notably through AACC’s relationship with ADA. An extensive update to the 2002 NACB Laboratory Medicine Practice Guidelines (LMPG) for diabetes testing is currently in press, spearheaded by David Sacks, MD, senior investigator and chief of the clinical chemistry service at the National Institutes of Health, and Bruns. Both the new, and the previous 2002 LMPG, were reviewed by the Professional Practice Committee of the ADA. The guidelines will be published in Clinical Chemistry as well as ADA’s Diabetes Care. The March issue of CLN will cover major updates in the new guidelines.

“Publishing these guidelines in both journals is really important because this means that the clinicians who see diabetes patients and really need these guidelines will see them,” said Gronowski. “It’s one thing to publish guidelines, but it’s not useful if they’re not seen by the right people.”

Going forward, Gronowski and AACC’s clinical societies collaboration committee hope to have an impact on the guidelines of other societies in the same way ADA participated in the NACB LMPG. Many laboratorians have noted that even though most guidelines reference lab testing, this element of the guideline is often misleading, incomplete, or ambiguous. Gronowski noted a recent guideline that stated only that a certain analyte should be measured using a ‘reliable method’. “This kind of guidance isn’t useful at all,” she said. “What, in fact, would that mean—mass spec or immunoassay? And in this case the assay is not well standardized either, making the recommendation basically useless. The materials and methods of papers are often ignored and it’s often ignored in guidelines as well: how are you going to measure that analyte?”

The lack of awareness among clinicians about standardization issues with lab tests is a major issue in guidelines, noted Mitchell Scott, PhD, who launched the clinical societies collaboration committee as president of AACC in 2005. “For instance, guidelines from the Kidney Disease Outcomes Quality Initiative for managing dialysis patients are based upon parathyroid hormone or ferritin assays, which we know are not well standardized, so it doesn’t make sense to have just one cutoff number,” he said. “When you look at guidelines like these, you wish there had been some lab input, and there are many examples like that where lab values and specific cutoffs are given because people outside the lab community don’t understand that different assays can give different numbers.” Scott is professor of pathology and immunology and co-medical director of the clinical chemistry laboratory at Washington University School of Medicine in St. Louis.

Participating in guideline development with other societies will be critical in winning esteem and visibility for the profession, according to Scott. “This is about getting the lab out in front of the clinicians in these societies, whom I believe are our customers.”

Bruns echoed Scott’s comments. “The evolution of practice guidelines is an opening for us, as all of these societies put out more and more guidelines, and they’re all using lab tests and need to get that right,” he said.

Bruns played a lead role in another upcoming Clinical Chemistry publication that grew out of his involvement with a consortium of endocrine groups. The Pituitary Society and other endocrine organizations convened a consensus conference out of which recommendations for harmonizing human growth hormone (GH) and insulin-like growth factor 1 (IGF-1) assays will be published this year. “Inviting clinical chemists like myself to this major conference was a relatively novel idea for these endocrinologists, because most have been confident they know everything about how to measure GH and IGF-1,” said Bruns. “As it turned out, the clinical chemists brought important information relevant to harmonization, such as concepts of commutability of calibrators and harmonization of results. These topics generally are not covered in detail in endocrinology residencies.”

The endocrinologists at the conference even specifically requested that the paper be submitted to Clinical Chemistry rather than an endocrinology journal. “That would have been unheard of a few years ago,” Bruns noted. “But now they’ve come to recognize that they need laboratorians’ expertise. Again, a lack of standardization for these two assays can create serious problems which endocrinologists recognize they can’t solve on their own, he said. “This is another sign that these collaborative projects that we’re doing have paid off, with physicians in endocrinology beginning to talk to us more.”

Two other projects focused on standardization have brought physicians and laboratorians together. In October, AACC convened a conference and invited laboratorians, clinicians, metrologists, manufacturers, and regulatory officials from around the world with expertise in harmonization to step up the pace of progress (CLN, Dec. 2010). The conference organizers charged participants with identifying those analytes most in need of assay harmonization and creating new processes to deal with them. “With this harmonization meeting, AACC is going to own harmonization in this country,” said Bruns. “We will be the group that societies come to talk to when they’re developing guidelines that use lab results, and nowadays that’s almost all of them.” In a separate effort, AACC along with 10 other professional societies and the Centers for Disease Control and Prevention (CDC) recently endorsed a consensus statement on standardizing testosterone measurements amid growing test volumes for the hormone (CLN, Dec. 2010).

Promoting the Profession

All these efforts have a dual aim that can improve the quality of patient care: make meaningful contributions to the work of clinical colleagues, while at the same time enhance visibility of lab medicine so that the lab can be better utilized.

This visibility is important because, even when clinical groups recognize their need of lab expertise, they’re not always sure where to turn, Jaffe noted. “Because clinicians live in a different world with unique constraints, vocabulary, and colleagues, the more that laboratorians can cross-pollinate, the more these efforts at collaboration will evolve,” he said. “As AACC becomes more known among clinicians, those who are very motivated to work with laboratorians will know how to get things started.”

Gronowski emphasized that laboratorians have made strides in visibility in the research community as well. The National Cancer Institute (NCI) has taken a major step in advancing collaboration with laboratorians by requiring that applicants for its recent Request for Applications for the Clinical Proteomic Technologies for Cancer initiative provide evidence for expertise in laboratory clinical chemistry.

So what will it take for these collaborative efforts to continue? The answer from laboratorians who’ve led such projects so far is the same: a champion. While laboratorians continue to work through professional associations like AACC, it still takes an individual with personal connections to a clinical society to initiate something new, Gronowski said. “The key is having really passionate people about a particular clinical area who are willing to do some extra work and make connections between AACC and that organization.”

With years of work put in by pioneers of these collaborations now bearing fruit, the hope is that more opportunities will arise for the next generation of laboratorians willing to put in the extra effort to build these relationships. “I think every time you get your foot in the door it makes it easier for the next issue that comes up with that specialty group of physicians,” Bruns said. “But you have to work with the leaders in the field to get them to understand it, and it’s not easy.”

As AACC is able to nurture those relationships with ADA, ACC, and others and expand into other areas like oncology, Gronowski hopes that these inroads to clinical societies will also have a broader effect on clinician’s day-to-day interactions with the lab. “When clinicians see their professional society going to AACC and vice versa, communicating back and forth for advice or studies, or to set policy, then I think physicians at a grass roots level will be more inclined to consult with laboratorians when they have questions. Long term, our goal is for laboratorians to be a more integral part of teams where they’re really needed in the hospital setting.”