CLINICAL SCIENCE

Instrument Development of the UNC Dry

Eye Management Scale
Joseph Grubbs, Jr, MD, MPH,*† Kyle Huynh, MD,*‡ Sue Tolleson-Rinehart, PhD,*†
Mark A. Weaver, PhD,* Jennifer Williamson, MD,*§ Chelsea Lefebvre, MD,§ and Richard M. Davis, MD§

Key Words: dry eye disease, quality of life measures, instrument

Purpose: Dry eye disease (DED) is a common ocular disease that development, validity and reliability testing
can have adverse effects on quality of life. Our aim was to develop
a single-item questionnaire that is reliable, patient-driven, and clinic (Cornea 2014;33:1186–1192)
friendly to assess DED symptoms and their effect on quality of life to
help support the management of patients with DED.
Methods: An initial dry eye questionnaire was created and
administered to 18 patients with DED followed by a 15-minute
D ry eye disease (DED) is a common ocular disease that
affects 5% to 17% of the US population with prevalence
increasing with age.1–3 It is a chronic disease characterized by
cognitive interviewing session. This questionnaire was then refined symptoms such as ocular pain, grittiness, burning, foreign
using feedback obtained from the cognitive interview and was body sensation, tearing, and sensitivity to light.4,5 Multiple
termed the University of North Carolina Dry Eye Management Scale studies have confirmed that DED adversely affects a person’s
(UNC DEMS). Field testing was then performed on 66 patients (46 quality of life (QOL).1,5–9 Specifically, DED symptoms can
with DED and 20 without DED) to determine the validity and test– affect a person’s ability to read comfortably, concentrate,
retest reliability of the UNC DEMS compared with the current gold operate a computer, drive, or even perform basic work tasks.1
standard, the Ocular Surface Disease Index (OSDI). Pearson corre- Moreover, the adverse effects on QOL typically become more
lation coefficients were calculated between the UNC DEMS, OSDI, pronounced with disease chronicity and symptom severity.9
and other DED measures to assess criterion-related validity. Reli- Two recent studies used utility assessments, a type of QOL
ability coefficients were estimated for test–retest reliability. measure, to quantify DED’s effect on a patient’s QOL. The
Results: Comparing the UNC DEMS with the OSDI across all studies demonstrated that patients with moderate-to-severe
study participants, the correlation coefficient was 0.80 (P , 0.001). dry eye have utility scores comparable to those who have
Comparing the UNC DEMS with the OSDI in the DED group, the chronic conditions such as kidney failure requiring dialysis,
correlation coefficient was 0.69 (P , 0.001). The test–retest reliabil- severe angina, and hip fractures.3,10 This finding is strong evi-
ity coefficient of the UNC DEMS was estimated to be 0.90. dence that QOL and symptom severity are interrelated. Both
need to be addressed when treating patients with dry eye to
Conclusions: The UNC DEMS is a valid, reliable questionnaire maximize health outcome and patient–physician satisfaction.
that can be efficiently administered in a busy clinical practice and With the increasing recognition that DED symptoms
can be used to support the management of patients with DED. diminish QOL, multiple dry eye questionnaires have been
developed to evaluate both dry eye symptoms and their effect
on QOL. Many of these questionnaires, however, either have
not undergone sufficient validity and reliability testing or are
Received for publication May 14, 2014; revision received July 6, 2014;
accepted July 11, 2014. Published online ahead of print September 25, not specific to DED.4,6 In fact, a recent review of dry eye
2014. questionnaires revealed only 2 validated and reliable disease-
From the *University of North Carolina School of Medicine, Chapel Hill, NC; specific questionnaires that accounted for both DED symptoms
†University of North Carolina Gillings School of Global Public Health, and QOL: the Ocular Surface Disease Index (OSDI)11 and the
Chapel Hill, NC; ‡School of Medicine and Health Sciences, George Wash-
ington University, Washington, DC; and §Department of Ophthalmology, Impact of Dry Eye on Everyday Life (IDEEL).12,13 The OSDI
University of North Carolina, Chapel Hill, NC. and IDEEL have both proven extremely valuable in assessing
Supported by a grant from the North Carolina Translational and Clinical dry eye symptoms and disease effect on QOL in clinical
Sciences Institute (which receives its funding from the National Institutes trials.2,4–6,8,9,14 The IDEEL, however, contains 57 items and
of Health) and by a grant from the Triangle Community Foundation.
The authors have no conflicts of interest to disclose. the OSDI, a 12-item questionnaire, involves a complex, time-
J. Grubbs and K. Huynh are co-first authors. consuming scoring algorithm.11,12,14 Therefore, both question-
Supplemental digital content is available for this article. Direct URL citations naires are time-consuming to complete and score, and may have
appear in the printed text and are provided in the HTML and PDF limitations being implemented into a busy clinical setting.11,12,14
versions of this article on the journal’s Web site (www.corneajrnl.com).
Reprints: Joseph Grubbs, Jr, MD, MPH, 229 Harbor Way, Ann Arbor, MI
In addition to the administrative and scoring burdens of
48103 (e-mail: [email protected]). the OSDI and IDEEL, clinical markers for DED, such as
Copyright © 2014 by Lippincott Williams & Wilkins fluorescein staining, tear break-up time (TBUT), and Schirmer

1186 | www.corneajrnl.com Cornea  Volume 33, Number 11, November 2014

Cornea  Volume 33, Number 11, November 2014 UNC Dry Eye Management Scale

testing, have high interobserver biases, lack standardization Validity and Reliability Testing
among ophthalmologist providers, and correlate poorly with Following the sixth and seventh PROMIS standards
subjective symptoms.4,6,7,15 Consequently, physician and (validity and reliability testing),18 we began field-testing on
patient ratings of dry eye status and its effect on QOL are a larger cohort of patients to determine the validity and test–
often discordant. It is essential that physicians take this dis- retest reliability of the UNC DEMS compared with the
cordance into account when attempting to treat a patient’s dry current gold standard, the OSDI. Using the initial validation
eye because clinical signs alone may not fully capture the pa- study of the OSDI as a guide, we determined that 50 patients
tient’s experience with DED. If a busy clinical practice does not would be an adequate sample size to estimate the intraclass
allow a clinician the necessary time to administer the OSDI or correlation to within 0.06 using a 1-sided 95% confidence
IDEEL, however, this discordance may not be detected and interval (CI) if the true correlation is 0.9 (to determine reli-
a patient’s symptoms may go untreated.1,5,7,13 Thus, there is ability of the questionnaire); in addition, we determined that
a pressing need to produce a more efficient and reliable this sample size would provide 98% power to detect a 0.50
patient-driven instrument that physicians can use to help guide correlation with the OSDI and 89% power to detect a 0.40
therapy and management of DED.3 In response to this need, our correlation with artificial tear use.11 Therefore, we aimed to
research team developed a single-item dry eye questionnaire recruit 75 patients (with the goal of at least two thirds of those
called the University of North Carolina Dry Eye Management patients fully completing the study). Ultimately, a total of 66
Scale (UNC DEMS). Following the Patient-Reported Outcome patients were recruited into the study, of which 46 had dry
Measurement Information System (PROMIS) guidelines for eye (ICD-9 code: 375.15) and 20 were controls without DED.
instrument development as outlined below, we created the To be included in the dry eye group, patients had to be 18
UNC DEMS to simultaneously assess both DED symptoms years of age or older with a known diagnosis of dry eye.
and their effect on QOL in dry eye patients. These patients must have experienced dry eye symptoms
within the last 3 months before enrolling in the study. Control
patients were healthy and without ocular surface disease or
METHODS vision correction surgery. All study participants were English
speaking as the UNC DEMS was available only in English.
PROMIS Standards
The exclusion criteria for both dry eye and control patients
The US Food and Drug Administration’s publication were: intraocular surgery within the past 90 days, history of
of guidelines for instrument development for patient-
corneal transplant or neurotrophic keratitis, dry eye secondary
reported outcomes measures (PROs) in 2006 spurred the
to Stevens–Johnson syndrome and/or cicatricial pemphigoid,
paradigm shift favoring the proper development and imple-
severe conjunctival goblet cell loss or scarring conditions,
mentation of PROs in policy and health systems.16,17 The
congenitally absent meibomian or lacrimal glands, or active
PROMIS, a National Institute of Health–funded initiative,
ocular infection such as blepharitis or lid margin inflamma-
has established a set of 9 standards for instrument devel-
tion. This study was approved by the University of North
opment, refinement, and field-testing of PROs for research
and clinical use.18 The UNC DEMS (Fig. 1), a 1-item, Carolina Institutional Review Board before enrolling patients.
graded scale (1–10), was developed using these PROMIS During a regular clinic visit, consent was obtained from
standards as a guide. qualified study patients who were then asked to complete the
DEMS (the word “UNC” was omitted from the questionnaire in
this field test to prevent bias), OSDI, and a short survey. In this
Instrument Development and Psychometric survey, patients were asked to report whether they have used
Evaluation of the UNC DEMS artificial tears, frequency of artificial tear use, and their subjective
To date, in this ongoing effort, we have followed the first rating of their DED status as either normal, mild-to-moderate, or
7 PROMIS standards for UNC DEMS instrument development. severe. The study investigators also obtained TBUT and fluores-
The first 5 PROMIS standards: (1) defining target concept and cein corneoconjunctival staining (FUL-GLO, Akorn, MD). The
conceptual model, (2) generating and design of individual average TBUT of both eyes was determined by taking 3 consec-
items, (3) constructing item pool, (4) determining item bank utive measurements of TBUT in each eye and then using the
properties, and (5) field-testing and instrument format18 are mean of these 6 measurements for our analyses. A fluorescein
detailed in a previous publication by the authors.19 In brief, corneoconjunctival staining score was determined for each eye
we used a comprehensive literature search of dry eye symptoms using the Oxford Grading Scale; the average of the OD and OS
and disease effect on QOL combined with direct consultations score for each patient was used for our statistical analyses. An
with multiple ophthalmologists and dry eye patients to create an attending ophthalmologist then performed a complete slit-lamp
initial dry eye questionnaire. This questionnaire was adminis- examination and provided his or her assessment of the patient
tered to 18 patients with DED (International Classification of DED status as being normal, mild-to-moderate, or severe. Of
Diseases, 9th Revision, code: 375.15) followed by a 15-minute note, the ophthalmologist performing this assessment was
cognitive interviewing session. The UNC DEMS was then masked to the UNC DEMS and OSDI patient-reported outcomes.
refined using feedback obtained from the cognitive interviews Using his or her clinical judgment and experience, the ophthal-
(see Appendix, Supplemental Digital Content 1 and 2, http:// mologist also recorded the presence or absence of ocular condi-
links.lww.com/ICO/A250; http://links.lww.com/ICO/A251). A tions commonly associated with DED, including chalasis,
final version of the UNC DEMS was produced (Fig. 1). meibomian gland dysfunction, superficial punctate keratitis

Ó 2014 Lippincott Williams & Wilkins www.corneajrnl.com | 1187

Grubbs et al Cornea  Volume 33, Number 11, November 2014

FIGURE 1. The UNC DEMS.

(SPK), lid wiper epitheliopathy, and poor lid apposition. After at between the DEMS, the OSDI, and other DED measures.
least a week had passed since the clinic visit, the study partic- Additionally, we plotted the DEMS against the OSDI at the
ipants were asked to complete the DEMS and OSDI a second clinic visit and fit a simple linear regression with 95%
time. The post-1-week forms were sent to the patients either by prediction intervals. To assess construct validity, we com-
regular mail or by a Web-link in an e-mail. Participants were able pared the mean DEMS scores between the DED and control
to submit their responses either by mail or online, depending on patients as well as between groups based on patient and
their preferences. All participants were compensated with physician ratings of DED status. For these comparisons, we
a redeemable $25 gift card. used nonparametric Kruskal–Wallis tests. For the compari-
sons across the ratings groups, we first conducted an overall
test to compare across the 3 groups, and, only if the overall
Statistical Analysis
To assess criterion-related validity of the UNC DEMS,
we estimated the Pearson correlation coefficients and their TABLE 2. Patient and Physician Rating of Disease Severity
95% confidence intervals using Fisher z transformation, Control Patients, Dry Eye Patients, Total Patients,
N = 20, n (%) N = 46, n (%) N = 66, n (%)
TABLE 1. Patient Demographics Patient rating of
disease severity
Control Patients, Dry Eye Total Patients,
Normal 18 (90.0) 4 (8.6) 22 (33.3)
N = 20 Patients, N = 46 N = 66
Mild-to-moderate 2 (10.0) 26 (56.5) 28 (42.4)
Ethnicity, n (%) Severe 0 (0.0) 14 (30.4) 14 (21.2)
African American 2 (10.0) 10 (21.7) 12 (18.1) No rating 0 (0.0) 2 (4.3) 2 (3.0)
White 18 (90.0) 33 (71.7) 51 (77.2) provided
Other/unknown 0 (0.0) 3 (6.5) 3 (4.5) Physician rating of
Sex, n (%) disease severity
Female 15 (75.0) 37 (80.4) 52 (78.7) Normal 18 (90.0) 5 (10.8) 23 (34.8)
Male 5 (25.0) 9 (19.5) 14 (21.2) Mild-to-moderate 2 (10.0) 39 (84.7) 41 (62.1)
Age, mean (SD) 62.8 (13.1) 61.6 (13.1) 62.4 (13.0) Severe 0 (0.0) 2 (4.3) 2 (3.0)

1188 | www.corneajrnl.com Ó 2014 Lippincott Williams & Wilkins

Cornea  Volume 33, Number 11, November 2014 UNC Dry Eye Management Scale

FIGURE 2. Scatter plot of DEMS by OSDI at the clinic

visit with estimated regression line and 95% pre-
diction interval.

test was significant at the 0.05 level, we then conducted all In the control group, the mean DEMS score was 1.85 6
pairwise comparisons. For test–retest reliability, we used only 1.72; whereas in the dry eye group, it was 5.73 6 2.15 (P ,
data from patients who provided follow-up measurements, 0.001). In the control group, the mean OSDI score was
and we applied linear mixed models to estimate the reliability 9.49 6 14.18 as compared with 37.18 6 23.24 in the dry
coefficient along with 95% bootstrapped confidence intervals. eye group (P , 0.001). The average DEMS and OSDI scores
Additionally, we created a limits of agreement plot20 for both varied significantly (P , 0.001 for each) across patients
repeated measurements of the DEMS, including only dry with normal, mild-to-moderate, and severe DED (Table 4).
eye patients to avoid artificially inflating the number of zero
differences. Finally, we compared the DEMS scores across
groups of patients based on the presence or absence of ocular Test–Retest Reliability
conditions using Kruskal–Wallis tests, and we fit a simple Fifty-seven of 66 patients (86.4%) completed the post-1-
linear regression to assess the association of the DEMS score week follow-up DEMS; 55 patients (83.3%) also completed the
with the total number of ocular conditions. All analyses were post-1-week follow-up OSDI. The test–retest reliability coeffi-
conducted in SAS, version 9.3 (SAS Institute, Cary, NC). cient of the UNC DEMS was estimated to be 0.90 (95% CI,
0.84–0.95). By comparison, the OSDI’s reliability coefficient
was 0.81 (95% CI, 0.70–0.91). Among dry eye patients, the
RESULTS mean difference between the post-1-week and clinic DEMS
Population Demographics score was 20.24 units, and agreement was very good with only
A total of 66 patients participated in the UNC DEMS 1 value being outside the limits of agreement (Fig. 3).
validity and reliability study; 46 were dry eye patients and 20
were control participants free of ocular disease. Patients in the Other Findings
dry eye and control groups were similar in age range and On average, patients who were noted to have SPK on
numbers of men and women (Table 1). Artificial tear use was examination had a DEMS score of 2.80 points higher than did
higher in the dry eye group than in the control (mean: 2.53 those without SPK (P , 0.001). Patients with poor lid apposi-
times per day vs. 0.15 times per day). Physicians and patients tion had an average DEMS score of 2.56 points higher than did
both rated the DED disease status as normal, mild-to- those without poor lid apposition, but this difference was not
moderate, or severe (Table 2). Physicians were less likely statistically significant (P = 0.090). There was no statistically
than patients to rate the patient’s DED status as severe. significant evidence of association between DEMS score and
the presence of chalasis, meibomian gland dysfunction, or lid
Validity Testing
Figure 2 presents a scatter plot of the DEMS against the
TABLE 3. Pearson Correlations of DEMS and OSDI With DED
OSDI at the clinic visit. The DEMS is correlated to the OSDI
Parameters (Overall Study Participants, N = 66)
across all study participants at an estimated coefficient of 0.80
(95% CI, 0.69–0.87; P , 0.001). The DEMS was correlated DEMS (P) OSDI (P)
to the OSDI in the dry eye group at an estimated coefficient of OSDI 0.80 (,0.001) 1.00
0.69 (95% CI, 0.49–0.81; P , 0.001). Table 3 presents the Frequency of artificial tear use 0.43 (,0.001) 0.39 (0.001)
correlations of the DEMS and OSDI with DED clinical meas- Average Oxford Score OU 0.39 (0.001) 0.42 (,0.001)
ures. Overall, the DEMS and OSDI have similar moderate, Average TBUT OU 20.26 (0.032) 20.38 (0.002)
but significant, correlations with artificial tear usage, fluores- OU, both eyes.
cein staining, and TBUT.

Ó 2014 Lippincott Williams & Wilkins www.corneajrnl.com | 1189

Grubbs et al Cornea  Volume 33, Number 11, November 2014

the reliability coefficient is most likely a conservative estimate.

TABLE 4. DEMS and OSDI Scores by DED Severity
In addition, our estimate of 0.81 for the reliability coefficient
Mean DEMS Mean OSDI for the OSDI is consistent with the estimate of 0.82 initially
Score 6 SD Score 6 SD
reported by Schiffman et al.11 Our finding of similar reliability
Patient disease severity rating coefficients in the OSDI further strengthens our confidence in
Normal (n = 22) 1.45 6 0.72 7.34 6 7.50 the test–retest reliability of the DEMS.
Mild-to-moderate (n = 28) 5.40 6 1.41 36.32 6 22.04 Our validity testing showed that the DEMS has a clear
Severe (n = 14) 7.86 6 1.32 51.41 6 17.79 ability to discriminate between normal, mild-to-moderate, and
Physician disease severity rating severe DED status as defined by the patient. In addition, the
Normal (n = 22) 2.50 6 2.03 14.60 6 19.21 DEMS was able to discriminate between normal and mild-to-
Mild-to-moderate (n = 40) 5.68 6 2.46 38.25 6 23.30 moderate disease as defined by the clinician. The ophthalmol-
Severe (n = 2) 5.50 6 2.12 23.39 6 17.01 ogists who graded disease severity in this study only labeled 2
P , 0.001 for comparing both the DEMS and OSDI across both patient- and patients as having severe disease despite the fact that 14
physician-rating groups. For patient ratings, all pairwise comparisons between the 3 patients rated their own disease status as severe. This finding is
severity rating groups for each of the DEMS and OSDI resulted in P , 0.04. For
physician ratings, comparison of mild-to-moderate to normal rating groups resulted in
in accordance with the findings of 2 studies showing that
P , 0.001 for both DEMS and OSDI; pairwise comparisons between Severe group and clinicians routinely underestimate both patient symptoms and
other 2 groups resulted in P . 0.05 for both DEMS and OSDI. disease effect on QOL.21,22 Such results further highlight the
discrepancy between patient and physician interpretation of
disease severity in the dry eye population.
wiper epitheliopathy. When all 5 of these clinical findings were In general, correlation coefficients #0.35 are consid-
taken together, there was statistically significant association ered low correlations, coefficients 0.36 to 0.67 are considered
between the DEMS score and the total number of findings moderate, and coefficients $0.68 are considered strong.23
present on examination. On average, the DEMS score increased Using these definitions, the DEMS score correlated strongly
by 0.66 points for each additional finding (P = 0.016). with the OSDI score, the current gold standard of symptom
and QOL measurement in dry eye patients. In addition, the
DEMS showed moderate correlation with frequency of artifi-
DISCUSSION cial tear use. The DEMS showed low-to-moderate correlation
Our results indicate that UNC DEMS is a valid and with clinical measures of DED status (fluorescein staining and
reliable questionnaire that can help meet the growing need for TBUT), which is consistent with the clinical correlations of
a patient-centric measure of DED that is efficiently adminis- other PROs in DED such as the OSDI and IDEEL.11,12
tered in a busy clinical setting. In this study, the DEMS It is important to note that although scores of the UNC
demonstrated excellent test–retest reliability in a moderate sam- DEMS and OSDI are highly correlated, the UNC DEMS is not
ple size of both dry eye patients and controls. Some may sug- a replacement for either the OSDI or IDEEL. Both the OSDI
gest that the test–retest reliability is subject to question because and IDEEL will likely remain valuable patient-reported meas-
patients filled out a mailed or online version of the question- ures in the clinic and especially in clinical trials.2,4–6,8,9,14
naire (rather than completing the questionnaire again in the Although both of these latter instruments have served as excel-
clinic). Completing a mailed or e-mailed version of the ques- lent measures of DED’s effects on a patient’s daily living in
tionnaire in a nonclinical setting, however, should reduce or clinical trials, both are multiitem questionnaires that have a rel-
have no effect on the test–retest reliability of the questionnaire, atively high burden of administration for patients, and consume
rather than artificially inflating it. Thus, our estimate of 0.90 for valuable clinic time for scoring.11,12,14 Alternatively, the DEMS

FIGURE 3. Limits of agreement plot for dry eye patients

with repeated DEMS measurements (N = 40).

1190 | www.corneajrnl.com Ó 2014 Lippincott Williams & Wilkins

Cornea  Volume 33, Number 11, November 2014 UNC Dry Eye Management Scale

is a single-item questionnaire and may prove especially useful use at https://www.med.unc.edu/ophth/for-patients/clinical-

in these time-limited clinical settings. In addition, because the specialties/unc-dry-eye-management-scale. It is our aim that
DEMS is a validated, reliable questionnaire, it may also serve this tool will assist physicians and their patients in the mon-
a valuable role as an end-point in clinical trials alongside the itoring and management of DED in clinical practice.
OSDI and IDEEL, especially if either time or funding of such
trials is limited.
One additional advantage of the UNC DEMS is that it ACKNOWLEDGMENTS
includes a time frame (1-week) for patient reporting. Many
The authors thank the physicians of UNC Ophthalmol-
current dry eye surveys neglect to include any type of time
ogy for letting the study team recruit patients in their clinics,
frame, which in turn could lead to wide variation in patient
Dr. Kathleen Gordon and Dr. David A. Chesnutt not only for
responses depending on whether they are trying to report
allowing them to recruit in their clinics but also for providing
current symptoms, average symptoms, or most severe symp-
guidance and insight into the development of the UNC DEMS,
toms.4 For example, when a time frame is not included in
their contributing experts for helping conceptualize this
a questionnaire, some patients may choose to report their
questionnaire, all of the patients who contributed to the
worst symptoms since their last clinical visit, whereas other
development of the UNC DEMS through their participation
patients may only report what their specific symptoms are that
in this research, and the Triangle Community Foundation and
day. The 1-week time frame in the UNC DEMS provides
the North Carolina Translational and Clinical Sciences
a reference point that allows patients to account for the fluc-
Institute for their generous donations to fund this research.
tuations in their symptom severity over the past week while
Use of the UNC DEMS: The UNC DEMS is available
also covering a small enough period that patients can easily
for nonprofit clinical and research use at the following
recall their symptoms and the overall effect on their QOL.
link: https://www.med.unc.edu/ophth/for-patients/clinical-
Our study is not without limitations. First, our sample size
specialties/unc-dry-eye-management-scale.
consisted of 66 patients at the UNC Ophthalmology Clinic.
Although the recruited patient population was very diverse, our
REFERENCES
institution-specific research and moderate sample size may limit
1. Miljanović B, Dana R, Sullivan DA, et al. Impact of dry eye
the generalizability of our questionnaire. Therefore, we encour- syndrome on vision-related quality of life. Am J Ophthalmol. 2007;
age other researchers to perform trials at their respective 143:409–415.
institutions to test for broader generalizability of this tool. 2. Rajagopalan K, Abetz L, Mertzanis P, et al. Comparing the discriminative
Second, the DEMS showed discriminative capability between validity of two generic and one disease-specific health-related quality of life
measures in a sample of patients with dry eye. Value Health. 2005;8:168–174.
normal, mild-to-moderate, and severe disease status as reported 3. Schiffman RM, Walt JG, Jacobsen G, et al. Utility assessment among
by the patients in this study as well as between normal and mild- patients with dry eye disease. Ophthalmology. 2003;110:1412–1419.
to-moderate physician-reported disease severity. Its ability to 4. Nichols KK. Patient-reported symptoms in dry dye disease. Ocul Surf.
discriminate severe disease status (as determined by physicians), 2006;4:137–145.
however, is unclear, because the ophthalmologists in this study 5. Friedman NJ. Impact of dry eye disease and treatment on quality of life.
Curr Opin Ophthalmol. 2010;21:310–316.
labeled only 2 patients as having severe disease. More research 6. García-Catalán MR, Jerez-Olivera E, Benítez-Del-Castillo-Sánchez JM.
should be performed to further validate this questionnaire’s Dry eye and quality of life. Arch Soc Esp Oftalmol. 2009;84:451–458.
discriminative capability. Finally, if the DEMS is to be used 7. Mizuno Y, Yamada M, Miyake Y, et al. Association between clinical
as a disease-monitoring tool, physicians need to know what diagnostic tests and health-related quality of life surveys in patients with
dry eye syndrome. Jpn J Ophthalmol. 2010;54:259–265.
score change on the scale would constitute a minimal clinically 8. Li M, Gong L, Chapin WJ, et al. Assessment of vision-related quality of
important difference (MCID). The results of this study do not life in dry eye patients. Invest Ophthalmol Vis Sci. 2012;53:5722–5727.
clearly demonstrate the MCID of the DEMS; a study at UNC, 9. Mertzanis P, Abetz L, Rajagopalan K, et al. The relative burden of dry
however, is currently underway to determine the MCID. eye in patients’ lives: comparisons to a U.S. normative sample. Invest
The UNC DEMS is currently undergoing further research. Ophthalmol Vis Sci. 2005;46:46–50.
10. Buchholz P, Steeds CS, Stern LS, et al. Utility assessment to measure the
In addition to the UNC study mentioned above, we have also impact of dry eye disease. Ocul Surf. 2006;4:155–161.
commenced a study of a culturally appropriate DEMS ques- 11. Schiffman RM, Christianson MD, Jacobsen G, et al. Reliability and validity
tionnaire in Spanish. These 2 studies together will help fulfill the of the ocular surface disease Index. Arch Ophthalmol. 2000;118:615–621.
final 2 PROMIS guidelines for PRO development of Interpret- 12. Abetz L, Rajagopalan K, Mertzanis P, et al. Development and validation
of the impact of dry eye on everyday life (IDEEL) questionnaire,
ability and Language Translation/Cultural Adaption.18 a patient-reported outcomes (PRO) measure for the assessment of the
In conclusion, the UNC DEMS is a unique, single- burden of dry eye on patients. Health Qual Life Outcomes. 2011;9:111.
item questionnaire that provides a snapshot of a patient’s 13. Grubbs JR Jr, Tolleson-Rinehart S, Huynh K, et al. A review of quality
overall experience—symptoms and QOL—with dry eye in of life measures in dry eye questionnaires. Cornea. 2014;33:215–218.
the past week. It has excellent test–retest reliability and 14. McDonald M, D’Aversa G, Perry HD, et al. Correlating patient-reported
response to hydroxypropyl cellulose ophthalmic insert (LACRISERTÒ )
strong validity. Unlike more complicated, time-consuming therapy with clinical outcomes: tools for predicting response. Curr Eye
questionnaires, the DEMS is easily understood and requires Res. 2010;35:880–887.
little time to administer in the clinic.19 As dry eye is a chronic 15. Nichols KK, Nichols JJ, Mitchell GL. The lack of association between signs
condition requiring both self-management and physician- and symptoms in patients with dry eye disease. Cornea. 2004;23:762–770.
16. Bottomley A, Jones D, Claassens L. Patient-reported outcomes: assess-
management, the UNC DEMS offers a bridge between patient ment and current perspectives of the guidelines of the Food and Drug
and provider in working together to manage this challenging Administration and the reflection paper of the European Medicines
disease. Our questionnaire is available with instructions for Agency. Eur J Cancer. 2009;45:347–353.

Ó 2014 Lippincott Williams & Wilkins www.corneajrnl.com | 1191

Grubbs et al Cornea  Volume 33, Number 11, November 2014

17. Reeve BB, Burke LB, Chiang YP, et al. Enhancing measurement in 20. Bland JM, Altman DG. Measuring agreement in method comparison
health outcomes research supported by Agencies within the US Depart- studies. Stat Methods Med Res. 1999;8:135–160.
ment of Health and Human Services. Qual Life Res. 2007;16(suppl 1): 21. Chalmers RL, Begley CG, Edrington T, et al. The agreement between
175–186. self-assessment and clinician assessment of dry eye severity. Cornea.
18. PROMIS: Instrument Development and Validation Scientific Standards: 2005;24:804–810.
Version 2.0. May, 2013. Available at: http://www.nihpromis.org/ 22. Guillemin I, Begley C, Chalmers R, et al. Appraisal of patient-reported
Documents/PROMISStandards_Vers2.0_Final.pdf. Accessed April 25, 2014. outcome instruments available for randomized clinical trials in dry eye:
19. Grubbs J. Instrument Development of the UNC Dry Eye Management Scale. revisiting the standards. Ocul Surf. 2012;10:84–99.
Chapel Hill, NC, UNC University Libraries; 2013:1–34. Available at: http:// 23. Taylor R. Interpretation of the correlation coefficient: a basic review.
dc.lib.unc.edu/cdm/ref/collection/s_papers/id/2652. Accessed May 1, 2014. J Diagn Med Sonogr. 1990;1:35–39.

1192 | www.corneajrnl.com Ó 2014 Lippincott Williams & Wilkins