Determination of the Minimal Clinically Important Difference of the University of North Carolina Dry Eye Management Scale

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Abstract

Purpose:

To establish an initial estimation of the MCID of the University of North Carolina Dry Eye Management Scale (UNC DEMS) and assess its association with patient perceptions of symptom change.

Methods:

Thirty-three patients (33.3% men, 67.7% women, mean age 60.5 yrs) with previous DEMS scores were recruited from a UNC ophthalmology clinic in spring 2014. We used anchor-based methods, categorizing important symptom change, to compare the change in the DEMS scores across visits to patient assessments of change; linear regression coefficients estimated the MCID. We correlated clinical assessments, patient perceptions, and DEMS scores.

Results:

DEMS score changes correlated with global anchors [−0.4229 (P = 0.014)]. Unadjusted linear regression yielded a beta coefficient of −0.54 (confidence interval, −0.97 to −0.12, R2 = 0.18, P = 0.014), which estimated the DEMS MCID. Adjusting the regression model for days since the last visit and DEMS score improved the association (beta = −0.56; confidence interval, −0.99 to −0.13; R2 = 0.43; P = 0.013). Descriptive statistics produced an MCID of 1 point. Patients said that 2 points would represent a significant change. The DEMS modestly correlated with the Schirmer test (−0.4045, P = 0.0266), Oxford Grading Scheme (+0.3713, P = 0.0364), and tear breakup time (−0.3559, P = 0.0456).

Conclusions:

The UNC DEMS is a valid, responsive patient-reported outcome measure instrument, which is easy to use in the clinic and capable of showing an MCID of 1 point.

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