The result has been to encourage earlier diagnosis without compromising accuracy. Gelfand, in Handbook of Clinical Neurology, 2014 Evolving diagnostic criteria for the relapsing-form of multiple sclerosisĭiagnostic criteria for MS have evolved over the past several decades, with each revision impacting the apparent prevalence and prognosis of the disorder. We revised all the diagnoses of the MS patients according to the new criteria recently formulated by McDonald.” ( 33) reported, “e enrolled 270 MS patients admitted … with definite MS, as diagnosed according to the Poser criteria. In an appropriate response to a change in standards, Grasso et al. ( 30) warned “that the new McDonald criteria lead to more than double the number of patients with a diagnosis of MS at 1 year compared with the use of the Poser criteria.” Some studies on multiple sclerosis have used both sets of criteria ( 31, 32).Ī question that arises, not just for multiple sclerosis, but for any disease, is what to do when a standard of criteria is changed after the study has been set in motion. But if the trials use different criteria, the comparison will likely result in spurious and artifactual conclusions, as cautioned by Sormani et al. If both trials used the same set of criteria, then the results from both trials can reasonably be compared. When comparing the results of two different multiple sclerosis clinical trials, investigators need to be vigilant and determine whether the first trial used the Poser criteria and the second trial used the McDonald criteria. Moreover, the McDonald criteria have been replaced by the revised 2005 McDonald criteria ( 26, 27). The Poser criteria ( 24) date from 1983, while the McDonald criteria ( 25) date from 2001. The Poser criteria for diagnosing multiple sclerosis are an older diagnostic method, which have been replaced with the newer McDonald criteria ( 22, 23). There is no single clinical feature or diagnostic test that is sufficient to diagnose multiple sclerosis, and the diagnosis is mainly a clinical one ( 21). Such is the case with multiple sclerosis. However, for many diseases, the diagnostic criteria are complex, require use of more than one type of technology, require dedicated experts, and are subject to revision from time to time. For many disorders, such as iron-deficiency anemia, the diagnostic criteria are straightforward, and can be found in standard manuals, such as Henry’s Clinical Diagnosis and Management by Laboratory Methods ( 20). People must be diagnosed with a condition or disease in order to satisfy the inclusion criteria of any clinical trial. Tom Brody Ph.D., in Clinical Trials (Second Edition), 2016 a Diagnosing Multiple Sclerosis
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