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`105
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`105
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`CLINICAL SCIENCE
`
`Dry Eye Medication Use and Expenditures: Data From the
`Medical Expenditure Panel Survey 2001 to 2006
`
`Anat Galor, MD, MSPH, *7‘ D. Diane Zheng, MS,,z‘ Kristopher L. Arheart, EdD,,Z‘ Byron L. Lam, MD,7"
`Victor L. Perez, MD, 7'" Kathryn E. McCollz'ster, PhD,f Manuel Ocasio, BS,,2’“ Laura A. McClure, MSPH,,z‘
`and David J. Lee, PhD7‘,z‘
`
`Purpose: To study dry eye medication use and expenditures from
`2001 to 2006 using a nationally representative sample of US adults.
`
`Methods: This study retrospectively analyzed dry eye medication
`use and expenditures of participants of the 200] to 2006 Medical
`Expenditure Panel Survey, a nationally representative subsample of
`the National Health Interview Survey. Afizer adjusting for survey
`design and for inflation using the 2009 inflation index, data from 147
`unique participants aged 18 years or older using the prescription
`medications Restasis and Blepharnide were analyzed. The main
`outcome measures were dry eye medication use and expenditures
`from 2001 to 2006.
`
`Results: Dry eye medication use and expenditures increased between
`the years 2001 and 2006, with the mean expenditure per patient per
`year being $55 in 2001 to 2002 (n = 29), $137 in 2003 to 2004
`(n = 32), and $299 in 2005 to 2006 (n = 86). This finding was strongly
`driven by the introduction of topical cyclosporine emulsion 0.05%
`(Remasis; Allergan, Irvine, CA). In analysis pooled over all survey
`years, demographic factors associated with dry eye medication expen-
`ditures included gender (female: $244 vs. male: $122, P < 0.0001),
`ethnicity (non—Hispanic: $228 vs. Hispanic: $106, P < 0.0001), and
`education (greater than high school: $250 vs. less than high school:
`$100, P < 0.0001).
`
`Conclusions: We found a pattern of increasing dry eye medication
`use and expenditures from 2001 to 2006. Predictors of higher dry
`eye medication expenditures included female gender, non—l-lispanic
`ethnicity, and greater than a high school education.
`
`Key Words: dry eye syndrome, Medical Expenditure Panel Survey,
`MEPS, expenditures
`
`(Cornea 2012;?» 1: l403~-I407)
`
`Received for publication June 30, 20] l; revision received August 27, 2011;
`accepted August 3], 2011.
`From the ‘Diwsion of Ophthalmology, Miami Veterans Afiairs Medical Cen-
`ter, Miami, FL; 'lDep.-irtment of Ophthalmology, Bascom Palmer Eye In-
`stitute, Miami, FL; and inepamnent of Epidemiology & Public Health,
`University of Miami School of Medicine, Miami, FL.
`Supported by a grant from the National Eye Institute (lR21EY019096) and
`an unrestricted grant from the Research to Prevent Blindness.
`The authors state that they have no proprietary interest in the products named
`in this article.
`Reprints: Anat Galor, Bascom Palmer Eye Institute, 900 Northwest 17th St,
`Miami, FL 33132 (email: galor@rned.miami.edu).
`Copyright © 2012 by Lippinoott Williams & Wilkins
`
`Dry eye syndrome (DES) has recently gained recognition
`as a public health problem.'"3 In the decade between
`1970 and 1980, 670 articles were published on DES (search
`terminology dry eye syndrome, limits humans, and English);
`this increased to 1485 articles in the 1980s, 2511 articles in
`the 1990s, and 4887 articles in the last decade. Part of this
`recognition came from several US population—based and
`international population-based studies demonstrating that
`the condition was present in between 5% and 30% of the
`population aged 50 years or older.‘*2*"”” Another part of the
`recognition came fi'orn understanding that the symptoms of
`DES, which include constant irritation, foreign body sensa-
`tion, and blurred vision, interfere with the ability to work and
`carry out daily functions."‘2° A study using the Impact of
`Dry Eye Living Questionnaire found that severe dry eye
`symptoms were correlated with difficulties in physical, social,
`and mental fiinctioning.“ Such difliculties translate into a rel-
`atively lower health-related quality of life compared with the
`general population“-patients with severe dry eye symptoms
`have health—related quality of life scores in the range of con-
`ditions like class III/IV angina.”
`An additional event that helped push DES into the
`limelight was the release of the first Food and Drug
`Administration-approved prescription medication for DES,
`cyclosporine emulsion 0.05% (Restasis; Allergan,
`Irvine,
`CA). The Food and Drug Administration approved the med-
`ication in 2002, and the pharmaceutical company Allergen
`launched cyclosporine emulsion in the United States in late
`2003. As part of its sales strategy, Allergan used direct to
`consumer marketing and cormnissioned magazine and televi-
`sion advertisements to reach its target audience;
`it also
`heavily promoted cyclosporine emulsion within the eye care
`community. These activities had the effect of increasing phy-
`sician and patient awareness of the prevalence of DES, its
`morbidity, and its potential treatments.
`Although there is a sense that the economic implica-
`tions of DES are substantial, few articles have studied the
`direct costs associated with DES and other ocular surface
`disorders. These include costs associated with oflice visits,
`prescription medication, over-the—counter medication, alter-
`native or complementary medication, and nonpharmacologio
`purchases (cg, humidifiers). A retrospective claims analysis
`evaluating costs in 9065 patients who received topical
`cyclosporine for DES found a mean health care cost of
`$336 per patient with a total cost of $3.05 million.” A retro-
`spective analysis of the annual cost of DES in patients treated
`
`Cornea - Volume 31, Number 12, December 2012
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`106
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`
`
`Galor et al
`
`Cornea 0 Volume 31, Number 12, December 2012
`
`by an ophthalmologist in 6 European countries estimated
`a total annual healthcare cost between 0.27 and 1.10 million
`US dollars per country. However, this cost did not take into
`consideration patients who self—tIeated their condition or were
`treated by their primary care physician.”
`The Medical Expenditure Panel Survey (MEPS) is an
`annual survey of families and individuals,
`their medical
`providers, and employers across the United States. MEPS,
`which is designed to be representative of the US population,
`provides the most complete source of data on the cost and use
`of health care and health insurance coverage.“ Given that
`prescription cost information is available through the MEPS
`data set, we examined recent patterns in dry eye medication
`expenditures. We aimed to confirm our hypothesis that a sub-
`stantial increase in expenditures has occurred over the past
`few years, perhaps in response to the increased public and
`provider awareness of the condition along with the availabil-
`ity of a new prescription medication.
`
`MATERIALS AND METHODS
`
`Sample
`The MEPS is a nationally representative subsample of
`the National Health Interview Survey, a continuous multipur-
`pose and multistage area probability survey of the US civilian
`noninstitutionalized population living at addressed dwellings.
`To have an adequate number of persons in important
`population subgroups,
`the MEPS oversampled Blacks and
`Hispanics in all years and began oversampling of Asians in
`2002.25 The overall MEPS response rate ranged from 66% in
`2001 to 58% in 2006. Sampling weights were applied to ensure
`that the resulting sample was nationally representative of US
`households and includes adjustment for oversampling of race/
`ethnic groups and survey nonresponse.
`To obtain dry eye medication expenditures, a compre-
`hensive list of available prescription medications, including
`name brands, generics, and chemical names, for the study
`period was first generated and used to identify those MEPS
`participants who used any medication via the MEPS Pre-
`scribed Medicines
`files. The Prescribed Medicines files
`contained comprehensive information on medications used
`by MEPS participants.” From this list, 2 medications used in
`the setting of DES were identified: cyclosporine emulsion
`0.05%, used to treat aqueous tear deficiency, and sulfaceta-
`rnide sodium—prednisolone acetate ophthalmic suspension,
`USP 10%/0.2% (Blephamide), used to treat lipid tear defi-
`ciency (blepharitis), among other conditions.
`Data from MEPS 2007 were available but were not
`included in this analysis because the methodology in editing the
`pharmacy data was changed. Comparison of prescription drug
`spending before and after 2007 was therefore not recommended
`by the Agency for Healthcare Research and Quality.“ MEPS
`initially had an over-the-counter medication section that col-
`lected details about nonprescription medication purchases; how-
`ever, this section was omitted fi'om the questionnaire beginning
`in 2002." Because we were interested in dry eye medication
`costs in the years since the launch of cyclosporine emulsion,
`we were unable to include over-the-counter medications in our
`
`analysis. For the study period, 147 unique participants aged
`18 years or older were found to have used sulfacetaniide
`sodium-prednisolone acetate ophthalmic suspension and/or
`cyclosporine emulsion and were included in the analysis.
`Expenditure of these medications for each participant over
`2-year intervals was analyzed. The data were adjusted for sur-
`vey design, and the expenditure was adjusted for inflation using
`2009 inflation index.
`
`Demographic Data
`Demographic and insurance information of the qualified
`participants was obtained from the MEPS Full-Year Consoli-
`dated Data Files. Demographic data collected included gender,
`age, race (white, black, other/multiple), ethnicity (Hispanic,
`non-Hispanic), health insurance status (private, public only, and
`uninsured), and education level (less than high school, high
`school, greater than high school). Family income, measured as
`a percentage, was calculated by dividing total family income by
`the applicable poverty line (based on family size and compo-
`sition). The resulting percentages were gmuped into 3 catego-
`ries:
`low income/poverty (less than 200%), middle income
`(200% to less than 400%), and high income (400% or more).
`
`Statistical Analyses
`All statistical analyses were performed using SAS 9.2
`(SAS Institute, Inc., Cary, NC) and SUDAAN l0 (RTI
`International, Triangle, NC) statistical packages. To account
`for complex survey design of the MEPS data, analyses were
`completed with adjustments for sample weights and design
`efl’ects. We conducted descriptive analyses
`to evaluate
`patterns in dry eye medication expenses per person over
`a 2-year interval. T tests were performed to compare average
`medication expenditure across different demographic groups.
`A multivariate linear regression was performed to study dc-
`mographic variables that predict high dry eye medication
`expense. The University of Miami Institutional Review Board
`reviewed and approved this study, which was conducted in
`accordance with the principles of the Declaration of Helsinki.
`
`RESULTS
`More patients used prescription dry eye medications in
`2005 to 2006 (n = 86) compared with the previous 4 years
`(n = 29 and 32 for 2001-2002 and 2003-2004, respectively),
`and the total number of prescriptions filled increased with
`each year (Fig. 1). The cost associated with dry eye prescrip-
`tion medications also increased between 2001 and 2006, with
`a mean expenditure per patient of $55 in 2001 to 2002, $137
`in 2003 to 2004, and $299 in 2005 to 2006 (Fig. 2). The
`introduction of topical cyclosporine significantly affected
`both the number of prescriptions filled and the dry eye expen-
`ditures because after its introduction, 68% of prescriptions
`and 80% of expenditures were related to cyclosporine emul-
`sion in 2003 to 2004 and 84% of prescriptions and 92% of
`expenditures were related to cyclosporine emulsion in 2005 to
`2006. The mean cost of sulfacetamide sodium-prednisolone
`acetate ophthalmic suspension increased from $36.27 in 2001
`
`1404 l www.comea;'ml.com
`
`© 2012 Lippincott Williams & Wilkins
`
`107
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`Comea - Volume 31, Number 12, December 2012
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`159 .-------------------------»--m--»-»
`
`......,............t,i.»..-._,.ux xxx \l\\\\ . .
`
`zoo
`
`l
`
`i:
`
`Restasis
`I Biephamide
`
`----~w----mm--
`
`
`
`
`
`TotalNumberofPrescriptionsFilled
`
`Z001-2¢X)2
`
`20034004
`Year
`
`2&5-2W6
`
`FIGURE 1. Graphic representation of the total number of dry
`eye prescriptions filled using the MEPS database, 2001 to
`2006.
`
`to 2002 to $54.56 in 2003 to 2004 to $64.43 in 2005 to 2006.
`Likewise, the mean cost of cyclosporine emulsion increased
`from $98.98 in 2003 to 2004 to $113.06 in 2005 to 2006. The
`increase in mean dry eye expenditures over the period, there-
`fore, can be explained by both increased medication usage
`and cost.
`Several demographic factors were associated with med-
`ication expenditures in the treatment of dry eye. Gender had
`a significant effect, with mean spending for women being
`double that for men ($244 vs. $122, P < 0.0001) (Table 1,
`Fig. 2). Similarly, spending for non~I-Iispanics was double that
`for the Hispanic population (S228 vs. $106, P < 0.0001).
`
`Dry Eve Medication Expenditure Overall and by Gender,
`MEPS 2001-2006
`
`
`Mean
`
`
`
`ExpenditurePerPersonUsingDryEyeMeditation
`
`2001-02
`
`2003-04
`Year
`
`2005-06
`
`FIGURE 2. Graphic representation of mean dry eye medication
`expenditures per patient (overall and by gender) using the
`MEPS database, 2001 to 2006.
`
`Dry Eye Medication Use and Expenditures
`
`Level of education was also an important factor, with individ-
`uals with more than a high school education spending more
`than those with less than a high school education ($250 vs.
`$100, I’ < 0.0001). Race, age, and income status were not
`found to significantly aifect dry eye medication expenditures
`in our analysis.
`In a rnultivariable linear regression analysis considering
`all demographic factors, gender and education remained
`significant predictors of dry eye medication expenditures.
`Female gender was associated with a $159 higher mean
`expenditure compared with male gender (P = 0.0004). Greater
`than high school education was associated with a $145 higher
`mean expenditure compared with less than a high school edu-
`cation (P = 0.0016). Although not significant in our univariable
`analysis, with adjustment for all other covariates, those in the
`65 and older age group spent $107 more on dry eye medica-
`tions than those in the 45- to 64-year-old group (P = 0.04).
`
`DISCUSSION
`
`In this nationally representative study of patterns in
`prescription dry eye medication expenditures from 2001 to
`2006, we found that the number of patients treated with
`prescription dry eye medications and their associated expen-
`ditures increased between these years. This finding was
`strongly driven by the introduction of cyclosporinc emulsion
`in 2003. Considering demographic factors, female gender,
`non—Hispanic ethnicity, and a greater
`than high school
`education were factors significantly associated with a higher
`mean yearly expenditure for DES in our univariate models.
`Although studies have suggested that
`the economic
`implications of DES are substantial," limited data are available
`to support this statement. Fiscella et 3122' analyzed claims data
`fioru a proprietary research database containing pharmacy
`claims data on over 13 million individuals. They identified
`9065 subjects that had one or more prescriptions filled for
`topical cyclosporine emulsion between January 1, 2004, and
`December 31, 2005. The mean yearly prescription cost by the
`health insurance plans was $336, and the mean out-of-pocket
`prescription cost for the patient was $98. This compares favor-
`ably with our findings because the cost analysis above includes
`both patient and insurance expenditures combined.
`Putting these numbers in the context of other chronic
`ocular and nonocular diseases, a recent MEPS study found that
`patients with glaucoma spent a mean of $556 per year on me»
`scription glaucoma medications in 2006 (adjusted for inflation
`using 2009 inflation index)?” Similarly, another article using
`the MEPS database found that people with spine problems
`spent a mean of $397 per year on prescription medications in
`2006.” The findings in this study suggest that although DES is
`not a blinding condition, individuals are willing to spend a non-
`trivial amount of money per year to alleviate the discomfort
`associated with this disorder. It is also important to note that
`the expenditures presented in this study do not incorporate the
`costs of nonprescription medications and doctor’s visits and
`therefore the total amount of money spent on the disease is
`likely to be significantly higher.
`We found that several demographic factors affected the
`expenditures of dry eye medications, including gender, ethnicity,
`
`© 2012 Lippincott Williams & Wilkins
`
`www.corneajrnl.com I 1405
`
`108
`
`
`
`TALE 1. Mean and Standard Error Cost (in Dollars) Per Prescription of Dry Eye Medications by Demographic Factors, 2001 to
`2006 MEPS Data
`Characteristics
`
`Mean
`217.31
`
`SE
`23.41
`
`122.24
`244.30
`
`6.87
`24.35
`
`1’
`-
`
`<0.0001
`
`White vs. Black = 0.07
`White vs. Other = 0.95
`Black vs. Other
`0.47
`
`-
`<0.0001
`
`18-44 vs. 45-64 = 0.78
`18-44 vs. 65+ = 0.38
`45-64 vs. 65+ = 0.51
`
`Private vs. public = 0.57
`Private vs. uninsured = 0.02‘
`Public vs. uninsured = 0.56‘
`
`<HS vs, HS = 0.05
`<HS vs. >HS = <0.000]
`HS vs. >HS = 0.36
`
`Low vs. middle = 0.14
`Low vs. high = 0.64
`Middle vs. high -1 0.06
`
`White
`Black
`Other
`Ethnicity
`Hispanic
`Non-1-lispanic
`Age group, yr
`1844
`45-64
`65+
`Insurance type
`Private insurance
`Public insurance only
`Uninsured
`Education
`Less than HS
`HS
`Greater than HS
`Poverty
`33
`Low income/poverty
`40
`Middle income
`74
`High income
`Bold values represent factors significantly associated with increased dry eye expenditures.
`‘Statistical analyses for the uninsured group are reported but are considered unstable due to small sample size.
`1-IS, high school; SE, standard error.
`
`220.51
`141.94
`214.18
`
`106.23
`227.99
`
`192.51
`206.44
`235.88
`
`225.06
`194.26
`166.56
`
`100.18
`204.54
`250.52
`
`219.62
`168.49
`240.57
`
`20.63
`27.39
`95.84
`
`18.89
`20.78
`
`34.40
`27.06
`34.50
`
`23.01
`45.82
`7.84
`
`15.82
`46.43
`21.78
`
`37.10
`25.46
`38.41
`
`27
`43
`77
`
`and education. The presence of gender and ethnic disparities in
`medical expenditures has been described in other conditions,
`including mental health” and hypertension managerncnt.” An
`association between higher expenditures and higher education
`levels has been reported in systemic lupus erythcmarosus.”
`Although the etiologies behind these discrepancies are not clear,
`it is important to recognize the role of demographic factors when
`considering the myriad determinants of health.
`As with all retrospective studies,
`the study findings
`must be considered hearing in mind its limitations. One
`limitation is that information on nonprescription medications
`was not available in the MEPS database, and we could
`therefore only estimate costs associated with prescription dry
`eye medications. As many more patients use over-the-counter
`medications to treat DES, we failed to include patients with
`less severe forms of the disease in our analysis. Furthermore,
`because of changes within MEPS that started in 2007,25 med-
`ication information for this year was not included in the anal-
`ysis. Another limitation is that the sample size in the present
`analysis was relatively small, limiting our ability to examine
`trends in dry eye medication expenditures and in our compar-
`isons in subgroups of interest (eg, the uninsured). Because of
`the relatively small sample size, it should not be assumed that
`
`our analytic sample of dry eye medication users are nationally
`representative despite the fact that they were obtained from
`a population-based survey. However, if present patterns con-
`tinue, there will be a growing number ofpersons in the IVHEPS
`who will use these medications, facilitating future subgroup
`analyses. Furthermore, both cyclosporine emulsion and sulfa-
`cctamide sodium—prednisolone acetate ophthalmic suspen-
`sion can be used to treat ocular surface disorders other than
`DES. Because we did not have diagnosis information linked
`to medication use, it is possible that we included patients
`treated for ocular surface conditions other than DES in our
`analysis. Finally, we acknowledge that other medications are
`used to treat subtypes of DES, including corticosteroids and
`tetracycline derivates; we chose not to include these in our
`analysis, given their multiple indications for use. Despite
`these limitations, there is no other ongoing population-based
`studies that look specifically at drug medication cost patterns;
`therefore,
`the analysis of the MEPS provides us with the
`best expenditure estimates
`for newly introduced ocular
`medications.
`
`In summary, we found a pattern of increased dry eye
`medication use and expenditure fi'om 2001 to 2006. Women,
`non-Hispanics, and those with greater than a. high school
`
`1406 1 www.comeajm|.com
`
`© 2012 Lippincott Williams & Wilkins
`
`109
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`
`
`education had higher expenditures compared with their
`counterparts. Additional research is necessary to understand
`the underlying reasons for the difierence in dry eye medica-
`tion expenditures by patient characteristics.
`
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`expenditures attributable to hypertension in the United States. Womens
`Health Issues. 20lil;20: l l4—l 25.
`. Sutcliffe N, Clarke AB, Taylor R, et al. Total costs and predictors ofcosts
`in patients with systemic lupus erythematosus. Rlteumarology (Oxford).
`200l;4El:37—47.
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`Sysiunctlorsal Tear Syndrome
`A Delphi Approach to Treatment Recommendations
`
`Ashley Belirens, MD, * John .1 Doyle, MPH, 7‘ Lee Stern, MS, 7‘ Roy S. Chuck, MD, PhD, *
`Peter .12 McDonnell, MD’* and the Dysfunctional Tear Syndrome Study Group: Dimitri 1? Azar; MD,
`Harminder S. Due, MD, PhD, Milton Ham, OD, Paul ML Karpecki, OD, Peter R. Laibson, MD,
`Michael A. Lemp, MD, David M. Meisler; MD, Juan Mumbe dc! Castillo, MD, PhD,
`Terrence .P 0’Brien, MD, Stephen C. Rflugfeiden MD, Maurizio Rolando, MD,
`Oliver D. Schein, MD, MPH, Berthold Seitz, MD, Schefler C. Tseng, MD, PhD,
`Gysbert van Setten, MD, PhD, Steven E. Wilson, MD, and Samuel C. Wu, MD, PhD
`
`Purpose: To develop current treatment recommendations for dry
`eye disease from consensus of expert advice.
`
`Methods: Of 25 preselected international specialists on dry eye, 17
`agreed to participate in a modified, 2-round Delphi panel approach.
`Based on available literature and standards of case, a survey was
`presented to each panelist. A two-thirds majority was used for
`consensus building from responses obtained. Treatment algorithms
`were created. Treatment recommendations for dilfcrent types and
`severity levels of dry eye disease were the main outcome.
`
`Results: A new term for dry eye disease was proposed: dysfunctional
`tour syndrome (DTS). Treatment
`recommendations were based
`primarily on patient symptoms and signs. Available diagnostic tests
`were considered of secondary importance in guiding therapy.
`Development of algorithms was based on the presence or absence
`of lid margin disease and disturbances of tear distribution and
`clearance. Disease severity was considered the most important factor
`for treatrnent decision-making and was categorized into 4 levels.
`Severity was assessed on the basis of tear substitute requirements,
`symptoms of ocular dismmfort, and visual disturbance. Clinical signs
`present in lids, twr film, conjunctiva, and cornea were also used for
`categorization of severity. Consensus was reached on trwtrnent al-
`gorithms for DTS with and without concurrent lid disease.
`
`Conclusion: Panelist opinion relied on symptoms we signs (not
`tests) for selection oftreatment strategies. Therapy is chosen to match
`disease severity and presence versus absence of lid margin disease or
`tear distribution and clearance disturbances.
`
`Resolved for publication June 21, 2905; revision received January 3, 2006;
`acceplxxl January 10, 2006.
`From the ‘Wilmer Ophthalmological Ininitute, Johns Hoplcins University
`School of Medicine, Baltimore, MD; and the ‘(Analytics Group,
`New York, NY.
`Supported by unrestricted educational grants from Allergen Inc. (Irvine, CA)
`and Research to Prevent Blindness, Inc. (New York, NY).
`Disclaimer. Some authors have commercial or proprietary interests in
`products described in this study (please refer to individual disclosure).
`Reprints: Ashley Behrens, MD, The Wilmer Ophthaluiological Institute, 255
`Woods Building. 600 North Wolfe Street, Baltimore, MD 21287-9278
`(e-mail: abehrens@jl1rni.e<lu),
`Copyright @ 2006 by Lippincoii Williams & Wilkins
`
`900
`
`Key Words: Delphi panel. dry eye, dysfunctional tear syndrome, eye
`lubricants, cyclosporine A, puncual plugs, steroids, dry eye therapy,
`concensus, algorithm
`
`(Cornea 2006;25:9(lO—907)
`
`he syndrome known as “dry eye” is highly prevalent,
`affecting 14% to 33% of the population worldwide,“
`depending on the study iuul definition used. Syrnptcrns related
`to dry eye are among the leading causes of patient visits to
`ophthalmologists and optonrenists in the United Sl'.ates.5
`However, a stepwise approach to diagnosis and treatment is
`not well established.
`
`Treetrnent algoritluns are often complicated, especially
`when multiple therapeutic agents and strategies are available
`for one single disease and for (lilfercnt stages of the same
`disease. Dry eye syndrome is particularly challenging, because
`the diagiostic criteria used Vary among studies, there is poor
`correlation between signs and symptoms, and efficacy criteria
`are ofien not uniform. As a result, there is no clear current
`approach to assign therapeutic recommendations as “first,”
`“secon ” or “thir ” line.
`
`Clinical research is usually orienterl to assess the efficaey
`of medications in the treatment of dry eye
`Reports are
`based on either comparisons of one medication relative to
`untreated placebo controls or comparisons between different
`therapies.“ Categorization of treatment alternatives is usually
`not implicit in these studies. Strategies combining medications
`or medications and surgery are usually not clearly discussed in
`the literature. A panel of experts may be a good method to
`develop such strategies based on current knowledge, because
`publication of research may not precede practice. Frmermore,
`clinical
`trials are typically performed on highly selected
`populations wiux specific interventions that may not refiect
`the spectrum of disease encountered in usual practice.
`Where unanimity of opinion noes not exist because of a
`paucity of scientific evidence and where there is contradictory
`evidence, consensus methods can be useful. Such methods
`have been used in developing therapeutic algorithms in other
`ophthalmic (glaucoma) and nonophthalmic disease states.”
`
`Cornea - Volume 25, Number 8, September 2006
`
`Copyright © Lippineott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.
`cornea 2006;25(8l =9oo—so7
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`Cornea - Volume 25, Number 8, September 2006
`
`Dysfunctional Tear Syndrome
`
`The Delphi panel technique was first proposed in 1946
`by the RAND Corporation as a resource to collect information
`from different experts and to prepare a forecast of future
`technological capabilities. This tool has been expanded to
`technological,” health,“ and social sciences research.” De-
`spite some reasonable criticisms ofthis technique,” the Delphi
`approach has been used to provide reproducible consensus to
`create algorithms of treatment.‘‘‘-‘5
`In this study, we proposed to establish expert consensus
`by using the Delphi approach with an international panel to
`obtain current treatment recommendations for dry eye syndrome.
`
`MATERIALS AND METHODS
`
`Panelist Selection
`The ideal number of panelists expected with this
`technique is not well defined, with reported ranges from 10
`to 1685.“ No specific inclusion criteria are established, other
`than the qualification