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Purpose. To report on a subjective dry eye assessment method for use in large-scale research,
to evaluate its application in a population-based study of dry eye among elderly persons
in the United States, and to apply novel techniques to improve simple questionnaire item
summaries.
Methods. A dry eye questionnaire was administered to a population-based sample of 2520
volunteers ages 65 to 84 years in Salisbury, Maryland. Individual symptoms and signs, counts
of symptoms and signs, and latent class model summary of item responses were evaluated for
validity and internal consistency.
Results. Approximately 15% of participants reported experiencing one or more of six dry eye
symptoms often or all the time; 20% reported experiencing three or more symptoms sometimes, often or all the time. Four groups were derived on the basis of symptomatology, using
latent class analysis. The groups exhibited face validity, revealed symptom patterns that added
specificity to simple symptom counts, and were qualitatively similar when derived separately
within population subgroups. Internal consistency was moderate (Cronbach's alpha = 0.61),
indicating some variability in reporting.
Conclusions. Dry eye symptoms are commonly reported in a representative elderly population.
Symptom data were moderately consistent, suggesting their usefulness for dry eye assessment
if properly summarized. A latent class summary revealed biologically meaningful summary
patterns of symptoms reported in this population and holds promise for use in risk factor
investigations and in clinical trials. Invest Ophthalmol Vis Sci. 1997; 38:2469-2475.
U r y eye conditions comprise a syndrome the pathogenesis of which is increasingly well understood, but
for which substantial problems of measurement and
classification remain.1 Difficulties include nonspecific
diagnostic profiles, uncertain biologic significance
and interpretation of standard objective test results,2"4
and the frequent lack of concordance between objective test results and self-reported symptoms and of
symptomatology among patients who appear clinically
similar.5'6 Most of the assessment tools that exist have
been developed using clinic-based populations, leaving uncertain their utility in population-based settings.
Symptom assessment is a key component of clinical dry eye diagnosis. However, the literature reports
on few standardized symptom questionnaires designed for formal research purposes.7'8 Supporting the
potential usefulness of this approach, one clinic-based
study found that a screen based on symptoms alone
was better able to discriminate cases from noncases
than one based on symptoms plus diagnosed signs.9
For screening and in large-scale research, methods for
assessing dry eye must be brief and noninvasive. Here,
where symptom questionnaires may be particularly appropriate, the development of effective self-report assessment methods is especially needed.
The two principal challenges in developing a
questionnaire for dry eye are that symptom profiles
vary substantially among clinically similar people and
that dry eye diagnosis is typically individualized and
dependent on clinical judgment that is not systematic.5 These challenges raise two methodologic issues
Investigative Ophthalmology & Visual Science, November 1997, Vol. 38, No. 12
Copyright Association for Research in Vision and Ophthalmology
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Investigative Ophthalmology & Visual Science, November 1997, Vol. 38, No. 12
in applying a standardized instrument in populationbased research: the need for effective scoring or other
method for summarizing symptoms to filter out incidental fluctuations in reporting and appropriate instrument validation. Internal validation in populationbased research is not feasible in the absence of a
broadly applicable gold standard diagnositic approach, and the opportunity for external validation is
also limited because of the acknowledged disparity
between objective and subjective dry eye tests. This
leaves, as feasible alternatives, the determination of
whether symptom patterns are consistent with biologic
mechanisms that give rise to dry eye (face validity)
and whether comparable populations report symptoms similarly (cross-validation).
The criteria for determining an effective method
for summarizing symptoms will vary according to the
scientific purpose. For the purpose of detecting clinically significant dry eye in a person, one reasonable
approach might be to identify whether a symptom
is experienced persistently (a yes/no summary). In
contrast, in a population-based study in which the object is to identify risk factors for dry eye, the investigator must define dry eye status and severity in participants as precisely as possible. To assess study participants' status, the most common strategy is to create a
symptom scorefor example, the number of symptoms reported with at least a given severity or frequency. To assess disease status, this works well when
items reflect severity for a single cause. Dry eye does
not fit this paradigm but rather includes a heterogeneous collection of disorders with diverse pathogenesis involving at least two separate causes: insufficient
tear flow and abnormal tear content.1'10 This suggests
the potential importance of accounting not only for
severity (persistence or number) of symptoms, but also
for patterns of symptoms. We propose that grouping
persons who report symptoms in similar patterns may
serve as a more useful construct for summarizing dry
eye symptoms than does simply calculating severity
scores.
In this report, we will use the statistical method
of latent class analysis11"13 to formalize the idea of
grouping people with similar symptom patterns. This
and related methods have served to clarify a symptombased definition of health status in other substantive
areasfor example, gerontology.14 Latent class analysis views an overall study population as comprised of
several "diagnostic" groups, possibly including "no
disease," each of whose members report symptoms
similarly. Key quantities described by the analysis are
the prevalence of each group and, within groups, the
proportions of people who report each symptom. These
latter quantities identify the qualitative composition
of the derived groups. For instance, only a small proportion of disease-free people should report dry eye
complaints, whereas most people with conditions
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l. Demographic Characteristics of
Sample (n = 2520)
TABLE
65-69
70-74
75-79
80-86
Sex
Male
Female
Race
White
Black
Education
<7 years
7-12 years
>12 years
Mini-Mental State Examination Score
<20
20-24
25-29
>29
31.0
33.1
22.0
13.9
42.1
57.9
73.6
26.4
8.4
63.7
28.1
1.2
15.0
65.4
18.4
tive when reported to occur rarely or never. For definition 2, a response was defined as positive when the
subject reported a symptom to occur often or all the
time and as negative when reported to occur sometimes,
rarely, or never. Next, we derived two symptom summaries: counts (number of symptoms), and diagnostic
group profiles (symptom reporting patterns) resulting
from latent class analysis. Derived diagnostic groups
were examined for face validity and cross-tabulated
with clinical dry eye outcomes as a measure of external
validity. To assess internal consistency of symptom reporting, we used odds ratios to measure associations
between individual symptoms, Cronbach's alpha10 to
assess variability of counts, and latent class reporting
probabilities to assess variability in symptom patterns.
To assess stability of latent class model findings, symptom pattern summaries were derived separately and
examined for similarity (cross-validated) across randomly selected halves of the sample as well as age-,
race-, and sex-specific subgroups.
RESULTS
Demographic characteristics of the sample are listed
in Table 1, including age at the time of clinical examination, sex, race, Mini-Mental Status Examination
(MMSE)17 score, and years of education.
gritty burning
red
crust
shut
Investigative Ophthalmology & Visual Science, November 1997, Vol. 38, No. 12
2472
TABLE
Dry
Age (years)
65-69
70-74
75-79
80+
N/R
774
824
540
344
80.0
76.2
78.2
77.6
15.6
18.3
17.2
18.6
O/A N/R
4.4
5.5
4.6
3.8
68.2
67.7
69.3
65.7
Red
Burn
O/A N/R
26.4 5.4
26.3 6.0
25.6 5.2
23.8 10.5
73.9
75.4
79.3
76.2
S
23.8
22.1
17.4
19.5
O/A N/R
2.3
2.6
3.3
4.4
76.4
76.6
79.4
82.9
S
18.7
19.6
17.2
14.5
Crust
O/A N/R
4.9
3.9
3.3
2.6
84.9
82.8
85.2
81.1
S
12.3
13.1
10.9
14.2
Shut
O/A N/R
2.8
4.1
3.9
4.7
(2> = 17.5;
P< 0.001
Race
White
Balck
0/A
X (6) = 12.8;
P = 0.05
Sex
Male
Female
5.6 77.0 20.8 2.2 76.8 18.2 4.4 87.1 10.3 2.7 92.2
6.7 75.0 21.5 3.4 78.9 17.6 3.6 81.3 14.2 4.6 93.8
6.8
5.6
1.0
0.6
X2(2) = 15.7;
P< 0.001
X2(2) = 19.5;
P < 0.001
1,832 77.7 16.9 5.4 72.0 22.3 5.7 77.2 19.4 3.2
650 78.8 18.3 2.9 56.3 35.9 7.8 72.0 26.0 2.0
X2(2) = 55.4;
v = 6.6;
(2> = 13.6;
P< 0.001
P = 0.001
P = 0.04
4.9 0.7
9.4 0.9
r<2> = 17.2;
P = 0.001
N/R = never or rarely experiences; S = sometimes experienced; O/A = experienced often or all the time.
2473
OVERALL
g
LJJ
C
OVERALL
0.34
0.70
0.08
0.21
0.15
0.05
0.46
0.68
0.98
0.50
0.01
0.10
0.55
0.67
0.63
0.57
Crust
Shut
0.07
0.04
0.08
0.11
0.07
0.02
Prevalence
0.57
0.21
0.13
0.09
Symptom
Dry
Grit
Burn
Red
1.0
0.37
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Investigative Ophthalmology & Visual Science, November 1997, Vol. 38, No. 12
TABLE 4. Association Between Derived Dry Eye Groups and Clinical Findings
Dry Eye Group
1 (n = 1499)
Clinical Finding
88
5.9
48
0.032
Number
Blepharitis evidence?
2(n = 428)
Number
55
12.9
11
0.026
3 (n = 343)
4 (n = 209)
70
20.4
11
0.032
46
22.0
18
0.087
df
Value
102.4
<0.001
17.7
<0.001
subsamples are consistent with our finding of systematic differences in reporting individual symptoms (Table 2). This should be considered in age-, sex-, or racespecific analyses.
In summary, dry eye symptoms were common and
were reported throughout a range of severity in our
population-based setting. Some heterogeneity in reporting among clinically similar people and across demographic subgroups was indicated. However, two distinct and qualitatively stable symptom patterns were
observed at substantial severity. Thus, our methodology added more information than does simple counts
and provided symptom summaries that are promising
for use in further research. Derived patterns had good
biologic and clinical validity, suggesting that our instrument is useful for assessing dry eye.
DISCUSSION
For screening and in large population-based studies,
simple approaches for assessing disease are often mandatory. Because treatment of dry eye is primarily designed to relieve patient symptoms, it is essential to
incorporate self-reported symptoms as outcomes in
dry eye epidemiologic research and randomized trials
in a clinically usable way. We report on results of a
self-reported assessment of dry eye and describe the
development and application of methods to summarize dry eye symptoms using latent class analysis. The
questionnaire used detected substantial dry eye symptomatology in a population-based setting. Moreover,
dry eye profiles derived from latent class analysis were
Dry
Grit
Burn
Red
Crust
Shut
Dry
Grit
Burn
Red
Crust
Shut
4.4
3.3
4.1
2.5
2.8
4.4
7.5
5.2
2.8
2.8
2.2
2.5
2.6
3.3
2.6
2.8
7.5
16.8
19.4
15.8
7.1
7.2
6.3
6.7
6.7
8.6
11.9
12.7
2.5
22.3
2475
APPENDIX 1
Dry Eye Questionnaire*
1. Do your eyes ever feel dry?
2. Do you ever feel a gritty or sandy sensation in
your eye?
3. Do your eyes ever have a burning sensation?
4. Are your eyes ever red?
5. Do you notice much crusting on your lashes?
6. Do your eyes ever get stuck shut in the morning?
* Allowable responses: never, rarely, sometimes,
often or all the time