American Association for Clinical Chemistry
Better health through laboratory medicine
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In This Issue . . .

A LOOK AT LAB TRENDS IN 2005 AND BEYOND: VIEWS FROM FOUR CLINICAL LABORATORY PROFESSIONALS
How preventive medicine, pharmacogenomics, and genetic testing fits into the future lab.

Reimbursement 2005: What to Expect in the Coming Year
A synopsis of the changes in Medicare laboratory reimbursement.

What’s Coming in Point-of-Care Testing
Australia set to conduct nationwide POCT trial; NACB moving toward completion of POCT guidelines.


What’s Coming in Point-of-Care Testing

Advances in point-of-care testing (POCT) technology have moved many common tests out of the lab and closer to the patient. As lab directors face increasing demands for POCT from physicians, using the latest evidence-based research to make decisions about which tests to use will become increasingly important. This month, Strategies looks at two major initiatives—in the U.S. and abroad—that will increase the volume of evidence-based medicine studies regarding the use of POCT.

Australia’s Department of Health and Ageing (DHA) is conducting the first comprehensive point-of-care testing (POCT) trial in a general practice setting, and the results will determine whether the technology will be publicly funded through the country’s Medical Benefits Scheme (MBS).

With its expansive geography and dispersed population, Australia would appear to be an ideal setting for widespread use of POCT. But only a handful of these diagnostic devices—such as pregnancy tests—are currently covered by the MBS. Reimbursement for POCT is vital for providing access to laboratory testing for a majority of the Australian population, many of whom live in rural or remote areas, say many national advocates, including officials with the Rural Doctors Association of Australia (RDAA). In a policy paper published in July 2003, RDAA stated that publicly-funded POCT for hematological and biochemical specimens should become an integral part of rural general medical practices. “Without this support, the cost of the tests and of the staff to carry them out will preclude GPs [general practitioners] in small and marginally viable rural practices from providing this service,” RDAA officials stated.

The DHA will begin the randomized controlled trial—which will cover urban, rural, and remote regions—in early 2005 with an estimated 6,000 participants, according to government documents. The trial will begin with a six-month preparation phase, followed by an 18-month live phase. Patients will be eligible to participate if they have a pre-existing diagnosis for anti-coagulant disorders, hyperlipidaemia, and/or diabetes. Tests used in the trial are those for measuring International Normalized Ratio (INR), total cholesterol (TC), high density lipoprotein (HDL), triglycerides (TG), glycated hemoglobin (HbA1c), and microalbumin. In terms of evaluating the tests, the DHA is looking at the safety, efficacy, and cost-effectiveness of the POCT devices, as well as how these tests compare to those in a laboratory setting in terms of cost, convenience, and patient outcomes.

Results of the trial are scheduled to be released in mid-2007, at which time the DHA’s Medical Services Advisory Committee (MSAC) will assess the results and make a recommendation to the Minister for Health and Ageing regarding public funding for POCT. The MSAC advises the Minister on the evidence-based effectiveness of new and emerging technologies, in addition to their safety, efficacy, and cost-effectiveness. In addition, the committee makes recommendations on public funding of burgeoning areas of medical technology.

This comprehensive trial follows MSAC’s 2001 assessment of a cholesterol POCT device, the LDX System manufactured by Cholestech (Hayward, Calif.). After reviewing this device, the committee recommended that further testing was needed on the diagnostic performance of cholesterol POCT devices in community settings before a decision could be made regarding public funding.

POCT Stateside

In the United States, many clinical experts are looking to the findings from the Australian trial to supplement current POCT evidence-based literature.

“Even though they are looking at different populations, I think there are a lot of commonalities,” said James H. Nichols, PhD, FACB, medical director of Baystate Health Systems’ Clinical Chemistry Laboratories (Springfield, Mass.) and chair of the National Academy of Clinical Biochemistry (NACB)’s POCT Laboratory Medicine Practice Guidelines (LMPG) committee. “The types of diseases that the patients are showing up to their clinicians with, the needs of clinicians to manage patients faster, the throughput in the offices, and how they manage patients in the emergency department are all some common issues not just in the United States or Australia, but that can be extrapolated to other places.”

Nichols’ LMPG committee recently unveiled its draft guidelines for public comment on evidence-based practice for POCT. One common issue that all clinicians deal with in the emergency department, whether in the U.S. or abroad, is patients experiencing chest pain. Based on the NACB POCT committee’s review, it was clear that the faster you can get a cardiac marker result, the faster you can move patients through treatment, explained Nichols. “You can get the patient into the cardiac cath lab, you can get them clot-busting drugs, you can get them working into the system to help improve their outcome, rather than leaving the patient sitting there waiting for a test result. That’s as common a problem in Australia as it is here,” he added.

Because clinicians want to do the best for patient care, any technology—such as POCT—that leads to faster diagnosis and treatment is very tempting. However, even the most efficient technology requires preparation, noted Nichols.

“You need to train people [how to use the POCT device], you have to make sure that this device is really going to fit their clinical need,” he added. When laboratorians or POCT coordinators hear about a new product, their initial response is to research current literature on the device, asking where the devices have been used and what’s known in terms of patient outcomes. “We thought it would be good to do a systematic review of the literature that exists that links point-of-care testing to clinical outcomes,” said Nichols. The LMPG guideline recommendations were made based on these literature reviews.

Gaps in Published Research

The POCT LPMG guidelines feature both positive and negative recommendations for POCT testing in different clinical settings, including the use of glucose meters in various applications. But in many instances, there was not enough literature available for a proper evaluation. “Where there were holes in the literature and support did not exist, we didn’t given an opinion one way or another, but let the public know that we just didn’t have anything to support this,” said Nichols, who hopes that researchers will strive to plug these research holes. “If you are getting good outcomes and are using POCT in that fashion, then publish it. Get it into the literature.”

To continue to follow developments in POCT, here are some useful Web sites:

 

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