• Research

    Choosing Wisely–At odds with Diagnostic Accuracy?

Primary Sjögren’s syndrome is a chronic autoimmune disease where your body attacks its self.  This happens because some of the white blood cells and several proteins made by these and other cells attack on normal functioning salivary glands (i.e. those in your mouth—leading to cavities, ulcers, and tooth degradation) and tear glands (i.e. your eyes).  However, the assault does not stop at just the glands; it wreaks havoc on your entire body, making you feel tired and run down. If you have Sjögren’s syndrome you also likely have painful, swollen joints that make it hard to enjoy even everyday activities. Sjögren’s can also affect the heart, lungs, brain and kidneys as well.

The diagnosis of primary Sjögren’s syndrome is not straightforward, taking an average of three years to reach a diagnosis after when symptoms started.  Patients often present with vague symptoms that could be caused by many other conditions or even side effects from common medications.

Recent, strict guidelines put forth from the American-European Consensus Group Classification Criteria are very clear on the diagnostic criteria for accurate diagnosis of primary Sjögren’s syndrome.  They include having four out of the six diagnostic criteria:

  1. Ocular symptoms - Dry eyes for more than three months, foreign-body sensation, use of tear substitutes more than three times daily
  2. Oral symptoms - Feeling of dry mouth, recurrently swollen salivary glands, frequent use of liquids to aid swallowing
  3. Ocular signs - Schirmer test performed without anesthesia (< 5 mm in 5 min), positive vital dye staining results
  4. Oral signs - Abnormal salivary scintigraphy findings, abnormal parotid sialography findings, abnormal sialometry findings (unstimulated salivary flow < 1.5 mL in 15 min)
  5. Positive minor salivary gland biopsy findings
  6. Positive anti–SSA or anti–SSB antibody results in the blood

Using data from the Rochester Epidemiology Project, Mayo Clinic researchers performed the first population based study in the United States of primary Sjögren’s syndrome to look at the prevalence of Sjögren’s syndrome in Olmsted County, Minnesota.  Out of those diagnosed with Sjögren’s, only 22 percent of patients met the diagnostic criteria put forth by the American-European Consensus Group due to the lack of certain diagnostic tests (i.e. dry eye testing, salivary gland biopsy).

In an era where we expect clinicians to be on the cutting edge of many data driven guidelines and be the protector to our limited number of resources how do clinicians come to terms with these various crusades such as Choosing Wisely™ and Diagnostic Accuracy?

Choosing Wisely refers to performing tests that provide high value at relatively low cost and eliminating expensive tests that provide low value. This could seemingly be at odds with Diagnostic Accuracy, which is the expectation for medical providers to be able to give an accurate and timely explanation for a person’s health problem.

How are clinicians meant to handle such cases?  Where does the physician’s gestalt factor in?  While guidelines help standardize care, surely physicians did not go to medical school to simply follow an algorithm.  Has the art of diagnosis been lost?

For example, one of the tests recommended for proper diagnosis of primary Sjögren’s syndrome is a lip biopsy – but physicians are not ordering this test. A lip biopsy is not without consequence and long-term implications, including the potential of a permanently numb lip.  Given this, is there a role for a physician to say, “yes, I think this is what you have—you may be sub-clinical, but I do not think it is worth the expense and complications of further testing.”

Is there harm in this assumption of diagnosis based on other less-invasive tests and observations?  Or is the harm actually performing the invasive tests?

Is there room for Choosing Wisely and Diagnostic Accuracy to meet in the middle; to allow physicians to use their clinical judgment versus ordering more tests?

Eric Matteson, M.D.

“The results of this study highlight the conceptual differences between disease diagnosis and classification criteria,” says study author Eric Matteson M.D., a rheumatologist and health sciences researcher at Mayo Clinic. “Classification criteria are tools designed specifically for clinical research. Their main objective is to guarantee that primary Sjögren’s syndrome patients included in different studies (especially clinical trials) will be similar and that a comparison of different studies will be possible.”

He cautions that classification criteria are not designed to be used as clinical tools to diagnose the disease.

“Indeed, as the results of the current study clearly show, in a real-life community setting physicians rarely use several of the tests included in classification criteria for primary Sjögren’s syndrome to diagnose the disease in individual patients, drastically decreasing the sensitivity of classification criteria,” he says.

Thus, the balance between Diagnostic Accuracy and Choosing Wisely has a tension; albeit perhaps a healthy tension.  Somewhat of a check and balance in a health care system where we try to limit low value testing, but at the same time allow physicians to apply their knowledge and experience in decision-making.  We must make progress on decreasing high cost tests and the notion of unending resources in our medical system. At the same time, we must continue to study and improve the accuracy of diagnosis, in order to more safely care for patients. But throughout this journey, carry the understanding that we live in a dynamic, colorful world; one that is not black and white (like the classification system), but full of possibilities.


Meghan Knoedler, M.S., B.S.N, R.N.

About the Author: Meghan Knoedler, M.S., B.S.N., R.N., is a Health Services Analyst for the Center for the Science of Health Care Delivery with a policy, practice, and translation focus.