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Dry Eye Disease
Edited by
ANAT GALOR, MD, MSPH
Associate Professor of Ophthalmology
Bascom Palmer Eye Institute
University of Miami
Miami, Florida
]
Dry Eye Disease ISBN: 978-0-323-82753-9
Copyright Ó 2023 Elsevier Inc. All rights reserved.
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Notices
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using any information, methods, compounds or experiments described herein. Because of rapid advances
in the medical sciences, in particular, independent verification of diagnoses and drug dosages should be
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material herein.
v
vi LIST OF CONTRIBUTORS
CHAPTER 1
The accepted TFOS DEWS II definition (2017)1 of dry Content validity is evidence that the instrument
eye includes symptoms as a required element of a diag- measures what it is intended to measure, i.e., it has
nosis of dry eye disease and this was also the case with been validated to differentiate different severities of a
the 2007 definition.2 However, symptoms alone cannot certain medical condition in a population of interest.
make a diagnosis of dry eye disease.3 Standardization is Other considerations include
important for a diagnosis and hence in the 2017 TFOS • Number of items/respondent burden
DEWS II diagnostic methodology report4 reviewed the • The longer the questionnaire, the more the
many available questionnaires and recommended burden on respondents and the more likely
the use of the Ocular Surface Disease Index (OSDI) or questions will be missed or due attention will not
the Dry Eye Questionnaire (DEQ-5). “The consensus be paid, affecting the responses.6,7
view of the committee was to use the OSDI due to its • Administration mode
strong establishment in the field or the DEQ-5 due to • Contact with a clinician when completing a
its short length and discriminative ability”.4 In addition, questionnaire (such as asking the questions by
they noted the continuous nature of visual analogue telephone or face to face) can artificially reduce
scales makes them attractive for clinical trials compared the symptoms/reported difficulty of a patient.8
to discrete Likert-based question rating. However, completing it independently could be
more burdensome if vision is impaired or the
DESIGN CONSIDERATIONS eyes are uncomfortable.
The Food and Drug Administration (FDA) of the United • Response options
States published a report in 20095 highlighting the • Free text is useful to collect additional informa-
critical features for the development of Patient Reported tion or for respondents to clarify their approach
Outcome (PRO) measures. Many dry eye question- in scoring a question, but this is more qualitative.
naires were developed before this report was available, • Likert/rating scales allow respondents to identify
but it still gives a useful benchmark as to how robust their intensity of feeling by selecting a number
these questionnaires are. from a range between two or more “anchor”
The conceptual framework explicitly defines the con- descriptors. They rely on the separation between
cepts measured by the instrument and how the items each number being equal, but the scale is not
(questions) interrelate to give the scores produced by continuous. A larger range allows more sensitive
a PRO instrument. The instrument may contain several increments, but may not improve the accurate
subconcepts that contribute to the overall measure- recording by respondents.9 There should be a
ment. Hence, for dry eye it is common to assess severity wide enough range and suitable “anchor” de-
and frequency of several dry eye type symptoms that scriptors to ensure that ceiling/floor effects do not
combine (usually just summed, with none attributed occur (when a normal distribution is skewed as
a greater weight than others if they are presumed to too many responses fall at the top or bottom of
independently contribute) to an overall score. the scale respectively). An even range of numbers
in the field. These individuals perform the initial assess- Item Response Theory compares individuals to an inde-
ment of clarity (cognitive interviews to check their un- pendent standard rather than each other.17 It uses a
derstanding of what the questions mean) and mathematical model that describes the relationship be-
readability. The questions should be relevant to most tween the level of a latent trait for a particular person
patients as “non-applicable” options cause problems and the probability of that person selecting a particular
for scoring.5 response to an item. Rasch Analysis is a form of Item
response Theory that is based on Poisson models and
principals of the score indicating the severity (order),
HOW SHOULD THE QUESTIONNAIRE BE the raw score of a questionnaire can be used for the
VALIDATED? measurement of an attribute (additivity), and only a
Following question selection and refinement the ques- single attribute is measured by the questionnaire
tionnaire prototype should be trialled in a target popu- (unidimensionality). Questionnaires that have been
lation with a wide range of the “condition” being tested. developed using Rasch Analysis will therefore be inde-
Additional tests should be performed which are hy- pendent of the sample used to obtain the initial re-
pothesized to assess the same relationship to stratify sponses allowing subsequent use to measure the
this population by the severity of the “condition” attribute on any population without variation of the
should be conducted to test the construct validity of psychometric properties. It should be noted a variety
the questionnaire prototype (either as an association/ of statistical information is produced in Rasch Analysis,
correlation (discriminant and convergent validity) or but it is up to the developers to select the most appro-
the ability to statistically separate the identified severity priate outputs for item reduction.
levels (group validity)). This might include an overall All response scales must be scored in the same
single question about how a patient feels. If there is direction, i.e., a larger number should reflect an
an accepted gold standard for the same concept, the increasing amount of the condition, or vice versa.
extent to which this correlates with the questionnaire The statistics indicate whether items are too predict-
is the “criterion validity.” able or too random. Unused or rarely used response
The choice of population induces a level of bias as options are removed from the scale or combined
the inclusion and exclusion criteria used to choose the with adjacent response options. Once the response-
test participants will affect the apparent effectiveness scale function has been optimized, the procedure for
of the questionnaire. The questionnaire prototype is item reduction involves item fit statistics, item target-
also tested a second time in a subgroup to assess its ing, frequency of endorsement, and tests of normality
repeatability. If this is too soon after the initial testing, (skew and kurtosis) which have specific requirements
then it is likely to be influenced by patient recall. If that need to be met in order to indicate conformance
the repeat completion is too long after the initial with the Rasch model. If the questionnaire does not
testing, variation in the “condition” with factors such meet all of the criteria, the item that fails the most
as the environment can make the questionnaire seem criteria is eliminated from the questionnaire, and all
unreliable.8 of the statistics and criteria are recalculated and reas-
sessed. This is repeated in an iterative process until
all of the remaining items meet all of the criteria or un-
STATISTICAL ANALYSIS til the removal of an item causes the separation index
Item Reduction and Scale Optimization to fall below a value of 2, which indicates a loss in
One the data have been collected, statistical analysis is questionnaire precision.18
applied to assess whether the questionnaire assesses a
single trait, the items it uses are relevant to the majority
of the population, that the items discriminate between Psychometric Properties of the Final
individuals and that the items are reliable. Classical Test Questionnaire
Theory was based upon the assumption that the Once the questionnaire has been finalized through sta-
amount of an attribute is characterized by the “raw” tistical refinement of the questions and the response op-
questionnaire score. It has been shown that raw scores tions, its ability to detect change (equally sensitive to
derived from ordinal data cannot be used as an accurate gains and losses in the measurement concept and to
measurement of an attribute,16 while it also cannot be change across the entire range expected for the popula-
assumed that an attribute is normally distributed within tion of interest) should be determined. This would typi-
a population. In addition, it cannot be assumed that all cally involve use prior to and after a treatment strategy
tasks in question are of equal difficulty. The more recent known to be effective. The ability of an instrument to
4 SECTION I What is Dry Eye Disease (DED)?
detect change in a certain population demographic in- The process typically consists of a two-phased
fluences the sample size for evaluating the effectiveness approach:
of treatments in clinical trials. • Representational validity requires comparison
The psychometric properties of a questionnaire refer and correlation between the questionnaire
to its reliability and validity18: scores and other similar measures of the
• reliability is defined as the extent to which mea- attribute of interest (convergent validity) or
surements are repeatable, stable and free from error; by comparison to measures that are known
usually expressed as a ratio of the variability in not to tap the attribute of interest (divergent
observed questionnaire scores to the total variability or discriminant validity), confirming that the
including error, generating a coefficient between questionnaire doesn’t measure what it isn’t
0 (unreliable) and 1 (indicating higher reliability). supposed to measure.
• internal consistencyda measure of the interrela- • Elaborative validity confirms the need for the
tionship between items in a questionnaire. Op- existence of the questionnaire, by showing
tions include the item-total correlations (the that it can be used in some way, most often to
observed scores for each item to be correlated in monitor change (“discriminative validity”).
turn to the total questionnaire score excluding that • Criterion validity is similar to elaborative validity,
particular item) or “Cronbach’s alpha” (splitting all but is a demonstration that the questionnaire can
items of a questionnaire into two halves and then discriminate people between groups. This usually
determining correlation between the two). involves the use of a Receiver Operating Charac-
Acceptable values are typically considered to be teristic (ROC) curve (a plot of the sensitivity of
>0.70 (lower values suggest the PRO is not the questionnaire against 100 minus the speci-
measuring a single trait/multidimensionality) and ficity of the questionnaire; Fig. 1.2). Sensitivity is
<0.90 (greater values suggest items are redundant). the true-positive rate, i.e., the proportion of
• testeretest reliabilitydthe ability of the ques- people correctly categorized by the question-
tionnaire to produce repeatable responses, when naire, while specificity is the true-negative rate,
complete after a time interval. Intraclass Corre- i.e., the proportion of “normal” people correctly
lation Coefficient measures concordance (agree- identified as being “normal.” The area under the
ment) rather than just correlation (association) ROC curve is an index of discriminative ability,
which can be strong even if the scores are sys- where an area of 0.5 (diagonal line) indicates that
tematically raised or depressed on the retest. A a test has no discriminative ability and the closer
value of 0.8 is typically desired for good ques- the curve is to the top left corner of the plot, the
tionnaire testeretest reliability, although a value greater the area and therefore discriminative
of at least 0.6 is considered acceptable. ability (an area of 1.0 indicating perfect
• validity is a measure of how well the questionnaire is discriminative ability). This relies on there being
able to measure what it is supposed to measure, an independent gold standard for comparison
although a perfect correlation is not expected as this which is usually not the case.
would indicate the questionnaire is redundant. • factorial validity confirms the number of attri-
There are five specific areas that together encompass butes (subscales) the questionnaire measures.
the meaning of validity. Two are relevant to the Factor analysis or principal component analysis
development stage: allows the number of variables or factors in a
• face validity is whether the questionnaire seems to questionnaire to be identified, as well as
a person with the condition/disease or expert, to concurrently describing the proportion of the
be asking appropriate questions. variation that each accounts for.
• content validity requires a judgment on whether
the coverage and content of the items is appro-
priate, in terms of being applicable to all people DRY EYE QUESTIONNAIRES
within the intended target population. The development of the common dry eye question-
The other three assessments of validity are typically naires are presented in Table 1.1 along with the design
made after the questionnaire has been statistically elements and analysis applied to refine the question-
analyzed. naire. Only those questionnaires that have been well
• construct validity is an assessment of whether established with attempts at detailed psychometric
questionnaire scores are related to other variables evaluation have been summarized. For example, ques-
or attributes as would be expected to in theory. tionnaires such as the Women’s Health Study
CHAPTER 1 Questionnaire Design and Use to Assess Dry Eye Disease 5
80
60
Sensitivity
40
20
0
0 20 40 60 80 100
100-Specificity
FIG. 1.2 Receiver Operating Curve demonstrating how a questionnaire is able to distinguish those individuals
in an imagery dry eye group (sensitivity) without falsely selecting those from the nondry eye group (specificity)
for different cut-off criteria.
questionnaire, which has a single question on dry and divided by the number of questions answered to
eye symptom frequency, along with checking whether reach the final OSDI score (on a 0e100 scale). This
the individual has ever been diagnosed with dry eye, approach is to overcome the issue of patients noting
but no psychometric design evaluation, were questions as not being applicable (such as driving at
excluded.19 night), but is not ideal. While the questionnaire was
developed based on the comments of patients from pre-
The Ocular Surface Disease Index vious clinical trials and comments from over 400 pa-
Since the introduction of the OSDI by Schiffman and tients and 2 health professionals, the refinement from
colleagues20(commissioned and copyrighted by by the initial 40 questions to the final 12 is just described
Allergan, Inc) in 2000, it has become the most widely as based on two small groups of patients with dry eye
used symptomology questionnaire in the dry eye com- and one phase II clinical trial group. Internal consis-
munity. However, it doesn’t assess the severity of the tency between the items was high, suggesting possible
symptoms, just their frequency, and as well as general redundancy, factor analysis identified 3 subscales and
ocular-related symptoms (sensitivity to light, grittiness, repeatability was good (intraclass correlation of 0.82
pain/soreness, blurred vision, and poor vision) it in- overall, but less for the subscales), but Rasch modeling
cludes quality of life questions on limitation to activ- was not conducted.20 The OSDI was able of differen-
ities (reading, driving at night, working with a tiate dry eye patients from normal based on physician
computer or bank machine, and watching television) rating (sensitivity 0.60, specificity 0.83) or a composite
and whether the discomfort has environmental triggers dry eye score (combining Schirmers I, lissamine green
(wind, humidity, and air conditioning). These re- and patient perception of ocular symptoms with no
sponses are scored on a 5 point Likert scale (between further details stated; sensitivity 0.80, specificity 0.79)
all of the time (4) and none of the time (0)) and the re- and correlated well with other eye-specific health status
sults of the 3 subsections summed, multiplied by 25 measures.
TABLE 1.1
The Development of the Common Dry Eye Questionnaires with Psychometric Evaluation with the Design Elements and Analysis Applied to Refine
the Questionnaire.
QUESTIONNAIRE DESIGN ELEMENTS REFINEMENT ANALYSIS
Saturation Robust
Recall Dry Eye Literature of Scale Psychometric Repeatability Sensitivity
Name/Authors Items Period Sufferers Review Questions Type Participants Testing Period Testing Scoring
McMonnies and 12 Not x x x Variable 68 x x Rheumatological Arbitrary
Ho 198647 stated Likerts dry eye patients weight of
question items
0e33 or 0e45
SANDE 2 2 months x x x VAS 26e52 x ICC 1e2 days None at time Multiplication
Schaumberg et al. w0.6e0.8 of VAS, rooted
200766 2 months w0.40 0e100
Ocular Comfort 12 1 week Unknown Stated but no x 7 rating 150e452 U 14 7 days OSDI n ¼ 337 Rasch scaled
Index56 number details N ¼ 100 Ocular lubricants 0e100
N ¼ 150
Subjective 3 Not x x x 5 point 97 x x x Categorization
Evaluation of stated Likert or added 0e12
Symptom of
Dryness21
Standard Patient 8 Present, x x x 4e5 point 100 x x Lid wiper presence Summed for 4
Evaluation of Eye 72 h and Likert frequency
Dryness 3 weeks (0e4) and
Questionnaire severity (0e5)
(SPEED)30 symptoms;
0e28
Dry Eye 5 Typical x x x 5 50 x x Control versus dry Added;
Questionnaire (5 day (frequency) eye 0e22
item)50 or 6 point Non-Sjögren’s
(severity) versus Sjögren’s
Likert patients
Ocular Surface 12 Last Over 400 x x 5 point 139 x 2 weeks 109 dry eye versus Added,
Disease Index week Likert Internal N ¼ 76 30 normals multiplied by
(OSDI)20 consistency 25 and divided
calculated by number of
questions
answered;
0e100
Revised Ocular 6 Past Based on x x 5 point 264 U 1 day 264 dry eye versus Added
Surface Disease month original Likert N ¼ 50 normals 0e24
Index (OSDI-6)28
Texas Eye 28 Past “Extensive Stated but no x 5 point 89 X 8e12 weeks 37 dry eye versus Scored
Research and week focus details rating Internal N ¼ 13 52 normals 0e94
Technology Center and past groups” consistency
Dry Eye month calculated
Questionnaire
(TERTC-DEQ)59
University of North 1 Past Stated, but Stated, but not x 10 point 66 x 1 week 46 dry eye versus Measured
Carolina Dry Eye week not accessible Likert N ¼ 56 20 normals 0e100
Management accessible
Scale (UNC
DEMS)60
Impact of Dry Eye 57 Past 6 focus x U Mainly 4 or 210 U 2 weeks 162 dry eye versus 0e100 for each
in Everyday Life 2 weeks groups 5 point N ¼ 210 48 normals of three
(IDEEL)62 N ¼ 45 Likert dimensions
Dry Eye-Related 15 Past 20 From 3 x 5 point 142 U Although only 2 weeks 203 dry eye Added,
Quality-of-Life week previous (frequency) on 24 of original versus 21 multiplied by
Score (DEQS)65 questionnaires or 4 point 45 items normals þ punctal 25 and divided
(severity) plug treatment by number of
Likert N ¼ 10 questions
answered;
0e100
8 SECTION I What is Dry Eye Disease (DED)?
Subsequent Rasch analysis has suggested unidimen- point Likert scale (never, sometimes, often and con-
sionality and discriminative ability,21 but unidimen- stant) and severity on a 5 point Likert scale (no prob-
sionality was equivocal,22,23 it did not confirm to the lems, tolerable, uncomfortable, bothersome, and
Rasch model,22 categories of “half of the time” and intolerable). The psychometric properties of the ques-
“most of the time” should be collapsed into one tionnaire were not assessed until 2013 when using
response option and the subscales were not valid.23 Rasch analysis on the results of 50 patients (30 with
Comparison of its predictive ability of dry eye patients dry eye disease) it was found to have unidimensions
compared to other questionnaires has been with 3 subscales (dryness, burning, and fatigue/sore-
mixed.24,25 Clinicians and participants consider a mini- ness) be unidimensional, sensitive to dry eye patients
mally clinically important change for mild to moderate as “diagnosed” by the OSDI, and repeatable (over
dry eye symptoms to be 4.5e7.3 units and 7.3e13.4 1 week),31 although the concordant correlation coeffi-
units for severe dry eye.26 cient of 0.923 suggests some question redundancy. A
Pult and Wolffsohn have since used item response further analysis with 127 patients showed that while
theory to create a short form of the OSDI known as the questionnaire was largely robust, there was substan-
the OSDI-6 (Fig. 1.3), with better psychometric proper- tial mis-targeting of the items, with the author suggest-
ties and discriminative ability.28 It contains two items ing the questionnaire was improved if a fatigue item
from each of the three OSDI categories (with no was removed (which was not part of the original ques-
“non-applicable” options) and is simply scored by add- tionnaire, but seems to have been introduced by 201232
ing the values of each response (0e24 range, with >4 and used in subsequent studies) and dryness seems to
the cut-off for dry eye). The OSDI has been accepted have been combined with grittiness and scratchiness,
in the United States for use in FDA clinical trials and to make a six question version.24 The SPEED psycho-
translated into other languages such as Japanese.29 metric properties were also tested in 150 contact lens
wearers and 134 noncontact lens wearers. This identi-
Standardized Patient Evaluation of Eye fied that the initial question on timescales caused multi-
Dryness dimensions, while the eight questions on frequency and
The Standardized Patient Evaluation of Eye Dryness severity had acceptable response category functioning,
(SPEED) questionnaire was introduced by Korb and fitted well to the Rasch model and measurement preci-
colleagues in 2005 while differentiating the prevalence sion. Analysis of these eight items still showed evidence
of lid wiper epitheliopathy in patients who had dry of slight multidimensionality.33 Cut-offs have been
eye symptoms.30 No design considerations or psycho- proposed with no symptoms (SPEED ¼ 0), mild to
metric testing was reported. The symptoms investigated moderate symptoms (SPEED ¼ 1e9), and severe symp-
are dryness, grittiness or scratchiness, soreness or irrita- toms (SPEED 10).34
tion, and burning or watering. The initial question (not
scored) asks whether the symptoms are present at the Symptom Assessment in Dry Eye
present time, in the past 72 h or the past 3 months. The SANDE, developed by Deborah Schaumberg and
The frequency or the symptoms are assessed on a 4 colleagues in 2007, consists of two visual analogue scale
Have problems with your eyes limited you in performing any of the following during a typical day of the
last month?
3. Driving or being driven at night? 4 3 2 1 0
4. Watching TV, or a similar task? 4 3 2 1 0
Have your eyes felt uncomfortable in any of the following situations during a typical day of the last
month?
5. Windy conditions? 4 3 2 1 0
6. Places or areas with low humidity? 4 3 2 1 0
FIG. 1.3 Ocular Surface Disease Indexdsix item.27 (Reprinted with permission from Elsevier.)
CHAPTER 1 Questionnaire Design and Use to Assess Dry Eye Disease 9
questions on frequency (between “rarely” and “all of of the DEQ was used by the authors in 2003.52Rasch
the time”) and severity (between “very mild” and analysis was retrospectively applied and it met the
“very severe”) of dry eye and/or ocular irritation symp- Rasch analysis criterion of unidimensionality, was
toms. The mark placed on the visual analogue scale is able to differentiate symptomatic and asymptomatic
measured and scaled on a 0 to 100 scale with 100 being groups and correlated well to other dry eye
the worst; a global score is obtained by multiplying the questionnaires.21
result from both questions and then taking the square A subset of the Dry Eye Questionnaire were selected
root of their product. SANDE scores have been shown by correlation with a self-reported question on the
in a number of subsequent studies to correlate with severity of dry eye (from “I don’t have dry eye” (0) to
the OSDI r ¼ 0.58e0.67,35e37 but this only accounts “Extremely Severe” (5)) in 2010. These questions on
for 34%e45% of the variance. This is probably as the the frequency and severity of dryness and discomfort
OSDI is a frequency only questionnaire and more about and the frequency of eye watering were able to differen-
environments than specific symptoms in general. Sensi- tiate control versus dry eye (cut-off 6 out of 22) and
tivity of the SANDE has been shown in intraductal non-Sjögren’s versus Sjögren’s patients (cut-off 12).50
probing,38 intense-pulsed light therapy,39 Cyclo- The initial CLDEQ consisted of 36 questions (9 sub-
sporine,40 Manuka honey,41 human nerve growth fac- scales: discomfort, dryness, visual changes, soreness and
tor,42 autologous serum,43 graft versus host disease,44 irritation, grittiness and scratchiness, foreign body
eye cleaning treatment for blepharitis,45 and artificial sensation, burning, photophobia, and itching) and
tear use.46 was derived from the literature and clinical knowledge
A score of 30 in combination with a noninvasive of dry eye symptoms among contact lens wearer and pa-
breakup time <10s25 has been shown to be diagnostic tients with dry eye. Each subscale assessed the symptom
of dry eye disease as defined by TFOS DEWS II with a frequency and intensity of the symptom over the first
86% sensitivity and 94% specificity.4 2 h after contact lens insertion, midday and at the end
of the day, to examine diurnal fluctuations in symp-
McMonnies Dry Eye Questionnaire toms. This version was able to discriminate clinician
McMonnies Dry Eye Questionnaire47 consists of 12 diagnosed contact lens dry eye.53 Similarly to the
questions, together with the respondents demographics DEQ-5, the eight questions of the shorter form were
(age and sex). A weighted assignment of points were selected as those most strongly correlated with a self-
arbitrarily attributed to risk factors such as ocular sensi- reported opinion on ocular comfort when wearing con-
tivity to irritants/environment/alcohol drinking, taking tact lenses (Poor, Fair, Good, Very Good, and Excellent)
certain medications, arthritis, dryness of other tissues, and was able to reflect changes in opinion after lens
and other thyroid abnormalities, together with having refitting.54 The CLDEQ-8 has the same eye discomfort
had dry eye treatment and the frequency of symptoms. and dryness (frequency over a typical day and severity
Retrospective Rasch analysis has been applied, with at the end of your wearing time) questions, together
some studies suggesting the questionnaire is unidimen- with changeable, blurry vision (on the same scales)
sional and able to distinguish dry eye patients,21 while and closing your eyes (rated as never (0), rarely (1) or
other found it to not conform with the requirements for sometimes (2)) giving a summed score from 0 to
a valid questionnaire.22,48 However, it remains well 37.54 It did not fit the Rasch model unless it was
used. reduced to a 4-item scale on eye discomfort and dryness
frequency (5 point: “never” to “constantly” Likert scale)
Dry Eye Questionnaire-5 and intensity (6 point: “never have it” to “very intense”
Begley and colleagues developed a questionnaire in rating scale).33
1999 using visual analogue scales examining the fre-
quency, severity and impact of dryness, soreness, Subjective Evaluation of Symptom of
burning, blur, light sensitivity, and itch49 and another Dryness
to assess contact lens wearers examining the presence, Authors from the University of Waterloo, Canada, uti-
frequency, severity, and intrusiveness of common lized a 3 question screening tool to differentiate “dry”
ocular symptoms, including dryness, scratchiness and from “nondry eye” patients. The questions were fre-
irritation, soreness, light sensitivity, and blurry, change- quency of symptoms, presence of discomfort and inter-
able vision (Fig. 1.4).51 However, no psychometric pro- ference with activity on 5 option Likert scales.21 While it
cess was used to refine these questionnaires and the differentiated patients in a similar manner to McMon-
source of the items was not identified. A revised version nies questionnaire, Dry Eye Questionnaire and OSDI,
10 SECTION I What is Dry Eye Disease (DED)?
DEQ 5
0 Never
1 Rarely
2 Sometimes
3 Frequently
4 Constantly
b. When your eyes felt discomfort, how intense was this feeling of discomfort at the end of the day,
within two hours of going to bed?
0 Never
1 Rarely
2 Sometimes
3 Frequently
4 Constantly
b. When your eyes felt dry, how intense was this feeling of dryness at the end of the day, within
two hours of going to bed?
0 Never
1 Rarely
2 Sometimes
3 Frequently
4 Constantly
Score: 1a + 1b + 2a + 2b + 3 = Total
___+___+___+___+___= _____
FIG. 1.4 Dry Eye Questionnaire 5-item.50 (Reprinted with permission of the authors.)
assess the frequency (“never” to “always”) and intensity but the link is not accessible and not published. Hence,
(“never had it” to “severe”) of dryness, grittiness, sting- the robustness of the item reduction is not possible to
ing, tiredness, pain, and itch. The initial items were assess, but the single item was shown to be correlated
developed by patients and a literature review (although to the OSDI (r ¼ 0.80), repeatable (ICC ¼ 0.90), and
the details are not given) and questions on comfort, able to discriminate dry eye patients.60 The minimal
clarity/bothersomeness of vision changes were excluded clinical important difference is 1 point.61
by Rasch analysis. The initial study included assessing
the sensitivity to detect the treatment effect of an ocular Impact of Dry Eye in Everyday Life
lubricant in 100 dry eye patients (5.5 to 8.0 units) The Impact of Dry Eye in Everyday Life (IDEEL) ques-
and correlation with the OSDI (r ¼ 0.73). McMonnies tionnaire developed in 200362 is a well-designed ques-
questionnaire was found to better identify contact tionnaire with robust psychometric testing. The initial
lens induced dry eye than the ocular comfort index, 116 items were refined to a 57-item instrument, orga-
but the latter was not designed to diagnose.57 The valid- nized into 3 different modules; the Dry Eye Symptom-
ity of the Rasch conformity has been confirmed, Bother (20 items on 1 dimension); the Dry Eye Impact
although the analysis suggested that more than one trait on Daily Life (27 items covering 3 dimensions); and the
might be contributing to the final score.22 One of the Dry Eye Treatment Satisfaction (10 items covering two
initial authors published an abstract in 2011 suggesting dimensions). The items are mainly scored on 4 or 5
that patient interviews had identified that the original point Likert scales although some questions require a
questionnaire did not capture the scope of dry eye dis- dichotomous “Yes” or “No” response, with each mod-
ease symptoms and hence a modified version would ule scored on a 0e100 scale. The Minimal Clinically
be validated,58 but this has never been published. Important Difference is 12 points.63 A Chinese version
Instead the original version has been used in multiple has now been validated.64 While the IDEEL question-
treatment studies. naire has good psychometric properties, it takes about
30 min to complete, is not unidimensional, and needs
Texas Eye Research and Technology Center users to purchase it.
Dry Eye Questionnaire
The Texas Eye Research and Technology Center Dry Eye Dry EyeeRelated Quality-of-Life Score
Questionnaire (TERTC-DEQ) questionnaire has 28 The DEQS is a Japanese questionnaire developed in
items examining the frequency, and intensity in the 2013 with two subscales65: bothersome ocular symp-
morning and late evening of comfort, soreness/irrita- toms (foreign body sensation, dry sensation in eyes,
tion/grittiness/scratchiness/burning/stinging, dryness, painful or sore eyes, ocular fatigue, heavy sensation in
and itch, together with how bothersome symptoms eyelids, redness in eyes); and impact on daily life (diffi-
are and the contribution of discomfort, dryness, sore- culty opening eyes, blurred vision when watching
ness/grittiness/burning, the taking of certain medica- something), sensitivity to bright lights, problems with
tions, dryness of mucosal tissues, the effectiveness of eyes when reading, problems with eyes when watching
certain dry eye treatments (if used), and the frequency television or looking at a computer or cell phone,
of use of artificial tears.59 It mainly uses 5 point rating feeling distracted because of eye symptoms, eye symp-
and Likert scales, with symptoms assessed during a toms affect work, not feeling like going out because of
typical day over the last week and treatments over the eye symptoms, and feeling depressed because of eye
past month. It can differentiate dry eye patients symptoms. The 15 items each has a frequency compo-
(cut-off 32.3 points), was correlated with McMonnies nent (5 point Likert scale) and severity component (4
questionnaire (r ¼ 0.51), but the high internal consis- point Likert scale) so up to 30 responses are required.
tency (Cronbach’s alpha ¼ 0.95)59 suggests question The average of the severity responses (discounting those
redundancy. not applicable) is multiplied by 25 to create a 0e100
scale.
University of North Carolina Dry Eye There were 45 items in the initial pool which were
Management Scale refined down to 24 for testing from the opinion of 20
This single item severity of symptoms that “may patients with dry eye. Only these items were part of
include: pain, burning, tearing, grittiness, feeling like the larger psychometric testing which identified good
something is in your eye” is scored on a 10 point Likert testeretest reliability (ICC ¼ 0.81 to 0.93) and high
scale. The paper suggests it was developed through liter- internal consistency (Cronbach’s alpha ¼ 0.83e0.93)
ature search and dry eye patient/expert consultation, between questions in each subscale (suggesting
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nevezetesen azok a tömegosztályok, melyek a kasztokat alkotják.
Már utaltam a tömegek konzervativ gondolkodására és kimutattam,
hogy a legerőszakosabb forradalmak is csak azért törnek ki, hogy a
szavakon változtassanak. A XVIII. század végén, mikor az egyházat
lerombolták, a papokat kiűzték vagy leguillotinozták, a katolikus
kultuszt egyetemleg üldözték, azt lehetett volna hinni, hogy a régi
vallásos eszmék elvesztették minden hatalmukat. Mégis, alig néhány
évre, általános kivánságra vissza kellett állítani az eltörölt kultuszt.10)
Egy pillanatra kialudtak a régi hagyományok, s ismét visszavették
uralmukat.
Egy példa sem bizonyítja jobban a hagyományoknak a tömegek
lelkére gyakorolt hatalmát. Nem templomban vannak a
legborzasztóbb bálványok és nem palotákban vannak a
legkorlátlanabb zsarnokok. Ezeket meg lehet semmisíteni egy időre;
de a láthatatlan hatalmak, melyek lelkünkben laknak, kikerülnek
minden forradalmat, csak századok tudják őket lassan
megmorzsolni.
3. §. Az idő.
5. §. A tanítás és nevelés.
MÁSODIK FEJEZET.
A tömeg nézeteinek közvetlen tényezői.
2. §. Az illúziók.
3. §. A tapasztalat.
4. §. Az ész.