Clinical inclusion criteria (ocular and oral symptoms; ≥1 positive response to the following questions):

1) Have you had daily, persistent, troublesome dry eyes for >3 months?

2) Do you have a recurrent sensation of sand or gravel in your eyes?

3) Do you use tear substitutes >3 times a day?

4) Have you had a daily feeling of dry mouth for >3 months?

5) Do you frequently drink liquids to aid in swallowing dry food?

Or suspicion of Sjögren syndrome based on ESSDAIa

Clinical exclusion criteria: History of head and neck radiation therapy, active HCV infection (confirmed by PCR), AIDS, sarcoidosis, amyloidosis, graft-versus-host disease, IgG4-related disease

Classification criteria (histopathology, autoantibodies, ocular signs)

Points

Diagnosis of focal lymphocytic sialadenitis in a labial salivary glandb with a focus score count >1 foci/4 mm2

3

Anti-Ro/SSA antibody positive

3

Ocular staining scorec ≥5 or van Bijsterveld scored ≥4 in ≥1 eye

1

Schirmer test ≤5 mm/5 minutes in ≥1 eyee

1

Unstimulated whole saliva flow rate ≤0.1 mL/minf

1

Interpretation:

Patients with a total score ≥4 points meet the criteria for primary Sjögren syndrome (sensitivity, 96%; specificity, 95%)

a RMD Open. 2015;1(1):e000022.

b Arthritis Rheum. 2011 Jul;63(7):2021-30.

c Am J Ophthalmol. 2010 Mar;149(3):405-15.

d Arch Ophthalmol. 1969 Jul;82(1):10-4.

e Patients treated with anticholinergic drugs should be evaluated after a sufficient interval during which the drugs are withheld.

f J Am Dent Assoc. 2008 May;139 Suppl:35S-40S.