The ACR-EULAR criteria are more likely to correctly diagnose cases of primary Sjögren’s syndrome, compared with other currently available criteria, but it may also record false positives.
Sjögren’s syndrome (pronounced show-grans) is an immune disorder that affects the glands in the body that produce mucous fluids, such as saliva or tears. The main symptoms are dry eyes or a dry mouth, but it can also cause other problems such as severe tiredness and muscle or joint pain. Sjögren’s affects more women than men,
and usually starts in middle age. People with Sjögren’s often also have a rheumatic disease such as rheumatoid arthritis or Lupus. This is called secondary Sjögren’s syndrome. Primary Sjögren’s syndrome means that there is no other underlying rheumatic disease.
Different societies and medical bodies interested in Sjögren’s have come up with criteria that put people into certain categories for entry into clinical studies. These are called classification criteria, and they assess symptoms and findings that may also help to make a diagnosis or do scientific research.
WHAT DID THE AUTHORS HOPE TO FIND?
The authors wanted to find out whether the 2016 ACR-EULAR classification criteria for primary Sjögren’s syndrome would be useful in Japanese people. ACR stands for the American College of Rheumatology, and EULAR stands for the European League Against Rheumatism. These societies have worked together to come up
with classification criteria for primary Sjögren’s syndrome.
WHO WAS STUDIED?
The study looked at 499 people with primary Sjögren’s syndrome or suspected of having primary Sjögren’s syndrome who were seen in June 2012 at 10 hospitals in Japan. Everyone included had been assessed for all four criteria of 1999 revised Japanese Ministry of Health criteria (called JPN for short) for diagnosis of
HOW WAS THE STUDY CONDUCTED?
This was an observational study. There was no medicine being tested. A questionnaire was used to collect information,
and medical records were used to check each person’s clinical findings, and the results of blood and saliva samples. Using this information, the authors then compared four different ways of diagnosing Sjögren’s syndrome to see if they all picked up the same people. The four methods were the joint ACR-EULAR, the JPN,
the AECG, and the ACR criteria. AECG is the American-European Consensus Group classification criteria, developed in 2002.
WHAT WERE THE MAIN FINDINGS OF THE STUDY?
The authors found that the ACR-EULAR criteria had significantly higher sensitivity and lower specificity in the diagnosis of primary Sjögren’s syndrome, compared with the other three sets of criteria. This means that the ACR-EULAR criteria were more likely than other measures to detect people with Sjögren’s as having the
condition. However, the ACR-EULAR criteria had a higher rate of false positives – meaning that it was not as good at finding out people who did not have primary Sjögren’s syndrome.
ARE THESE FINDINGS NEW?
Yes, this is the first study to examine the sensitivity and specificity of the ACR-EULAR criteria in Japanese people with primary Sjögren’s syndrome.
WHAT ARE THE LIMITATIONS OF THE STUDY?
The present study has certain limitations. The first is that the authors used the diagnosis by the doctor in charge as the “gold standard”. Secondly, the methods used for some tests of eye dryness and saliva volume varied among the different clinics. This could have affected the results being compared.
WHAT DO THE AUTHORS PLAN ON DOING WITH THIS INFORMATION?
The authors believe there is a need for a more sophisticated study to confirm the results, using expert clinical judgment and a set method for testing that fits completely with the items in the criteria.
WHAT DOES THIS MEAN FOR ME?
If your doctor thinks you have primary Sjögren’s syndrome, they may use the ACR-EULAR criteria to help make a diagnosis.
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Date prepared: December 2017
Summary based on research article published on: 13th November 2017
From: Tsuboi, H. et al. Comparison of performance of the 2016 ACR-EULAR classification criteria for primary Sjögren’s syndrome with other sets of criteria in Japanese patients. Ann Rheum Dis 2017;76:1980–1985.
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