Study Finds Excessive Testing Prescribed for Monoclonal Gammopathy Patients

A retrospective analysis has determined that the tests for M-protein that physicians routinely order to help diagnose and monitor patients with the age-related immune disorder monoclonal gammopathy (MG), often do not benefit the patient. Pathologists who performed the study have proposed an optimizing algorithm for more effective decision-making based on the evidence for clinical value.

Instead of ordering individual tests, physicians request an initial workup for MG, said study leader Dr. Gurmukh Singh, chief of Clinical Pathology, Medical College of Georgia, Augusta University (Augusta, GA, USA). Once pathologists examine a patient’s medical record and interpret results of a screening test for M-protein using serum protein electrophoresis (SPEP) – they can use the new algorithm to decide in a stepwise fashion what, if any, additional tests are warranted.

The cause of monoclonal gammopathy is unclear, but the risk tends to increase with age. Usually not detectable from routine lab tests, some physicians specifically screen for the condition in patients over age 50.

A review of experience at a medium-sized teaching hospital in Georgia, as well an earlier study in Missouri, found that ~50% of the time physicians order tests that ultimately don’t benefit their patients. The study reviewed the history of 237 patients age 19-87 who had a total of 1,503 episodes of testing. In addition to SPEP, many patients also had the more expensive serum immunofixation electrophoresis (SIFEP) and/or serum-free light-chain (SFLC) assays for M-Protein. A patient’s physician may order this series of tests dozens of times over several months.

From the examined data, only 46% of SIFEPs and 42% of SFLC assays were warranted. The two tests were ordered multiple times in patients in whom M-Protein was easily detected with SPEP. Indeed, for most patients with measurable levels of M-protein, SPEP can be used alone to monitor course of disease and treatment. Similar test-use patterns are also at play in hospitals across the country.

“About 40-50% of the second tests are not needed or adding value,” said Dr. Singh. The team proposed an algorithm that would put more of the decision-making in the hands of pathologists interpreting the tests. “These are stepwise things. If it’s a new patient, do this; if it’s a known patient, do that. Results drive it. That will reduce the number of tests that are done without in any way being of detriment to the patient or the quality of care,” he added.

A protocol similar to that proposed in the new study has safely enabled up to 60% reduction, over ~8 years, in volume of the additional tests at the Missouri hospital.

Testing should be algorithmically driven based on evidence. Electronic medical records enable these more rigorous approaches by pathologists. Similar approaches could be used for numerous other diseases (e.g. celiac disease) where a battery of tests also is routinely ordered and a stepwise approach might be more prudent.

The study, by Heaton C et al, was published online April 22, 2016, in the American Journal of Clinical Pathology.

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