Scribd Logo
Upload

Welcome to Scribd!

  • Ecs 90139

    Uploaded by

    Anggia Bunga
    11 views7 pages

    Copyright

    © © All Rights Reserved

    Available Formats

    PDF or read online from Scribd

    Did you find this document useful?

    Is this content inappropriate?

    Report this Document

    Copyright:

    © All Rights Reserved
    Download as PDF or read online from Scribd
    Flag for inappropriate content
    11 views7 pages

    Ecs 90139

    Uploaded by

    Anggia Bunga

    Copyright:

    © All Rights Reserved
    Download as PDF or read online from Scribd
    Flag for inappropriate content
    of 7
    RRR] Reliability and Validity of the Ocular Surface Disease Index Rhett M. Schiffman, MD, MS: Murray Dale Christianson, MD, FRCSC; Gordon Jacobsen, MS; Jan D. Hirsch, PhD; Brenda L. Reis, PhD Objectives To evaluate the validity and reliability of the ‘Ocular Surface Disease Index (OSDI) questionnaire. ‘Methods: Participants (109 patients with dry eye and 30) normal controls) completed the OSDI, the National Eye Institute Visual Functioning Questionnaire (NEI VEQ- 25), the McMonnies Dry Eye Questionnaire, the Short Porm-12 (SP-12) Health Status Questionnaire, and an oph- thalmic examination including Schirmer tess, tear breakup lime, and fluorescein and lissamine green staining. Results: Factor analysis identified 3 subscales of the (OSDI: vision-related function, ocular symptoms, and en- Vironmental triggers. Reliability (measured by Cron- bach @) ranged from good to excellent for the overall in- strumentand each subscale, and test-retest reliability was good to excellent. The OSDI was valid, effectively dis criminating between normal, mild to moderate, and se- vere dry eye disease as defined by both physician's as- sessment and a composite disease severity score, The OSDI also correlated significantly with the MeMonnies ques- onnaire, the National Eye Instinute Visual Functioning, Questionnaire, the physical component summary score of the Short Form-12, patient perception of symptoms, and artificial tear usage. Conelusions: The OSDI is « valid and reliable insteu- ‘ment for measuring the severity of dry eye disease, and It possesses the necessary psychometric properties to be used as an end point in clinical trials “Arch Ophthalmol, 2000;118:615-621 RY EYE DISEASE is one of the most frequently encountered categories of ocular morbidity in the United States, with as many as 4.3 million persons older than 65 years suffering from symptoms either often of all of the time."* The National Eye Institute workshop on clinical tials In dry eye defined dry eye as ‘a disorder of the tear film due to tear deficiency oF excessive tear evaporation which causes to the interpalpebral ocular sur- face and is associated with symptoms of °This workshop noted that a dry eye condition can exist without evidence of ocular surface dam- age and that a primary goal of treatment should be to improve symptoms. More- over, the workshop participants con- cluded that all clinical trials concerning dry eye should include an assessment of subjective symptoms and functional life- style through the use of a well-designed and validated questionnaire, and that such an instrument may be the best me sure for determining the clinical efficacy of therapeutic interventions damag ocular discomfort From the Department of Eye (Gare Services, Henry Ford Health system, Detroit, Mich (rs Scifnan and ‘Christianson and Mr Jacobsen), and Allergan Ie, Irvine, Calif (rs Hirsch and Rets), (©2000 American Med To date, the MeMonnies Dry Eye Questionnaire is the only patient- perspective instrument specific for dry eye disease that has a formalized grading scheme and some published psychomet- ric properties." However, this instru- ‘ment was evaluated as a screening test to discriminate subjects with dry eye [rom a rormal population and not as an instru- ment to grade either dry eye symptom verity of its effect on vision-related fune- tion, Inaddition, formal reliability testing on this instrument has not been pub- lished. Bandeen-Roche et al° developed a 6-item symptom inventory for population- based epidemiological research. How- ever, they did not inclide a numeric grad- ing Scheme that easily summarizes a patients reported severity. Moreover, the reported Cronbach a for this symptom in- ventory (0.61) suggests that its internal consistency may not be high enough for groupwise comparisons The Ocular Surface Disease Index (OSD), developed by the Outcomes Re- search Group at Allergan Inc (Irvine, Cali," is a 12-item questionnaire de- signed to provide a rapid assessment of the Association, All rights reserved. SUBJECTS AND METHODS ‘This study was conducted in compliance with the Code of Federal Regulations for institutional review beards, spon- sors, and investigator obligations. Written informed con- sent was oblained from all patients before engollment in the study SUBJECTS Patients 18 years or older who had been diagnosed as hay- ing dry eye symptoms (Intemational Classiation of Dis cases Ninth Revision’ code 375.15) atthe Heny Ford Heath Stem inthe preceding 12 month and who had had symp toms for at eat 3 months were recruited forthe study. Any patients who had undergone temporary or permanent pun {alocclision were clighe3 months after te procedure, Con- trl subject ad to have no significa ocular dese thes than refactiveeror and no systemic disease key to bea sociated wih dry ye Control subjects weresexmatched and sgeiced 2 yustetheptentaty eye dace “Any pallet who had any uncontrolled systemic die- case or dsblty that affected his or her atv of daly living (including ocular allergy infection, or iran that twas not related ody eye dence) was excluded fom pa Uipation nthe study. Also excluded were patents who ad tindergone ocular surgery Gncuding cataract surgery) within the previous 6 months or who were known to have anal deny toany component of any of te agente sed inthe study, cg, lssamine geen, uorestin, or anesthe ‘Allstudy participants had to havea life expectancy of 1 year or more and “walling-around™ visual acuity (with {heir usual correction) of 2040 or beter in each ey. They had to be English-speaking and cognitively inact (on of =20 onthe Folin Mint-Mental state Examination). STUDY PROTOCOL Eligible participants completed a series of questionnaires in which thelr sociodemographic statu, Health status, sal functioning and ocular sympoms were assessed. AC ter completion ef the questionnare, pallens underwent 4 detailed ophthalmic examination. Questionnaies were onypleted before the examination to cnsure that the clini Galencounter would no influence the pallens responses {Fo determine test-retest reliability ofthe OSDI all pa Uents were asked o return in 2 weeks tocomplee the ques tonnaire second time MEASUREMENTS Health Status Measures Participants completed by selF-adminisration the Shor. Health survey (SF-12),a measur of general health satus the Natlonal Eye nse Vital Functioning Ques ‘ionnaine (NEI VFQ.25),squestionnat ound to be eel ble and valid across several common eye diseases the MeMonnies Dry Eye Questionnaires and the OSDI, They tere leo asked to record thelr perception ofthe severity oftheir dry ee symptoms (as measured by a level sub- Jrevebeil preston se) They aks empl ame Gal comorbidity survey. Clinical Measures Clinical measures included “walking.around™” binocular Sual acuity according tothe Eatly Treatment of Diabetic Retinopathy Study char; corneal and conjunctival surface $alning using fuoresceln and lseamine green, graded a= cording the Van Bjstervl and Oxford soring schemes, respecvely;tear production according to Schrme et ype T Goth no anesthesia), Schirmer test type 2 (with nal stimulation for thse wth no tear production on Schirmer testiypeIyand basic secrets test (ith anesthesia) and tear ually (using teat breakup time). The presence of biephiari; meibotsian gland dysfuncion, ocular mucin, Iid abnormalities, and eculat surface disorders was re corded a well (based onthe physician's judgment). The severity of dy eye disease was assessed tn the fllowing 3 ‘ways By physician assessment, bya compost diseases ery sore eel), and bythe pat een lial tear use “The composite disease severly score was created to establish s second measure of severity tha was substan tially less dependent on the physicians subjective assess tment and cally reproducible It also adheres to recom- mendations ofthe National Eye Institute Workshop by Combining tadiona clinical measure of dry eye (Scher tei anaine gren ting) haat the evaluation of dry eye: The criteria for measuring dis case severity based on thls composite score were setup 4 Pron and were not modified at any point during the stu Fist th patient's findings were designated as normal, ld tomoderate,orsevere foreach individual measure, Thecit off points forthe normal and severe groupe were based on ‘alles suggested by review of the medial and sclentie ‘symptoms of ocular irritation consistent with dry eye dis- ‘ease and their impact on vision-related functioning. The initial OSDI items were generated [rom patient com- ments from several years of clinical studies conducted by Allergan Inc, several quality-of-life instruments, and stiggestions from clinical investigators, This item list was then distributed to more than 400 patients with dry eye disease, who were asked to indicate whether they expe- rienced any of the symptoms or problems on the list and, if so, how often, This information was combined with responses from 44 patients with dry eye disease and 2 health professionals who were asked to list aspects of thelr (©2000 American Med jamanetvrork.com/ on 10/16/2020 dry eye condition that affected their daily activites. lem responses were then categorized, and categories men- tioned more than once were formatted into an initial ques onnaire. This initial questionnaire included 40 items, which were later reduced to the final 12 questions on the basis of validity and reliability data from 3 groups (2 small groups of patients with dry eye and one phase Il clinical trial group). The objective of the present study was to evaluate the validity and reliability of the OSDI and to determine lis usefulness as an end point in clinical trials testing the ellicacy of new treatments for dry eye disease. Association, All rights reserved. Ierature°™ However, there was no consensts consis tent tend inthe erature indicating appropriate thesh- os or disinguishingbstween patients with mild and mod crate values Therefore, ll patents wih disease severly del as grenterthan normal nt es than severe were com- bined into a single mild to moderate group. The seve designations sed forthe Schirmer test ype 1 Were a ok dows greater than 10mm, normal 6to 10mm, mild to mod erateand Oo Stn, severe The seven designations used for lisamine green staining were as follows: Oto 1, nor- inal, 2106 ld to moderate and 7 to 9, severe. The se werlty designations used forthe subjective facial expres Hon sale were as follows: Ito 3, normal +10, mild to tmoderte, nd 8 to, severe. A value of 1 was assigned to "normal grade for cach measur, 2 for alld io moderate rade, and’ for severe. The values for the 3 measures were then summed to generate a final severity score: ess than 5 normal; to7-mild to moderate; and 1 9, severe (SDI Scoring Algorithm ‘The 12 items of the OSDI questionnaire were graded on a scale of 0 to 4, where 0 indicates none of the time; 1, some ofthe time; 2, half ofthe ume; 3, st ofthe time; and 4, all of the time, The total OSDI score was then calculated fon the basso the following forma: OSDI = [(sum of cores forall questions answered) X 100}/[(otal number of ues- tions answered) * 4] “Thus, the OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability. Subscae scores are computed similasly with only the questions from each, subscale used to generate its own score. STATISTICAL ANALYSIS, ‘The distribution of age, race, sex, income, and educa tional level between patients with dry eye disease and con- trol patients was compared by (test, x" test, oF Fisher ex act test, where appropriate. AP value of.05 was considered, Significant, Mean functional status scores were compiited forall disease severity categories and the control group. The proportion of patients whose data were atthe ceiling and. floor in each category was also computed. Factor Analysis Factor analysis with varimax rotation"? was used to deter- mine whether items within the OSDI tended to clster to- gether to create subscales (eg, visual functioning and focularsymptoms). Scores were computed for identified sub- Sales, and these subscales underwent formal reliability and validity assessment slong with the total instrument. Reliability ‘The reliability of the OSDI questionnaire overall, and for the identified subscales within this stady, was computed with Cronbach a, a measure of internal consistency. The test-retest reliability ofthe instrument was evaluated by com- pling # randomelfects intraclass correlation among, pa tients who completed the OSDI second time. Validity Discriminant validity ofthe OSDI was assessed by testing forsigniicant dferencesin OSDI score by dseave sever: ity (based on both the physician's assessment of severity iid the compost disease feverity score) by at analyis of ‘ariance and the Tukey tet for multiple comparisons, which Ihaintains an overall Pvalue of 05, Maltplelinear regres Hon was also used io test for an asociation between dis ase severity and OSDI scores while adjusting for factors Considered likely to influence funciona status measures, including sociodemographic factors (age, race, sex, cd Cation, income, and employment sais) and numberof medical comorbidities, Concurrent validly was computed by corelating OSD1 scores with the other measures of health stats (MeMon- dies questionnaire, NELVEQ.25, and SF-12). nado, Conclations with the traditional objective measure of dry ce disease (including isamine geen at fluorescein sai ing, tar breakup ume, Schirmer scores, and aril tar ‘tigen the more severely lected (worse) eye were com- puted with he Spearman cclfiien, a nonparsmetie sta Use, ar some ofthe messures were ondna inalyrcever operating characteristic (ROC) curves were genersed to desenibe the sensitivity and specifiy ofthe OSD! forthe diagnosis of dry eye teach OSD score withthe use ofboth the physicians ssessmen of severity zd the composte disease Severity score” ‘Atarget enrollment of 150 pallens was selected to de- tecta conan coeficent of 23, detectable witha power of 080 at ana level of 05. For estimating test-retest ei sbiliy, sample sizeof 50 patents was deemed suficint to providea lsded 95% confidence interval of 04 (lower bound) foran intraclass correlation of 0.90." However, to increase the power ofthe estimate of test-retest ellabty, all patients were asked to return fora second tt. Es} PATIENT CHARACTERISTICS There were 109 patients with dry eye disease and 30 con- trol subjects. There were no statistically significant dif- ferences between the patient and control groups in the following demographic variables: age, sex, race, eduica- tion level, employment, and income. The mean ages for subjects in the control and dry eye groups were approxi mately 55 and 58 years, respectively, with the majority being female and white. As expected, patients with dry (©2000 American Med jamanetvrork.com/ on 10/16/2020 eye had more associated medical and concomitant oct- lar disorders than the control patients (able 1), AIL 139 subjects who were enrolled in the study com- pleted the first vist; 76 subjects returned fora retest visit. Some patients recruited as control subjects were found to have signs and symptoms of dry eye disease on the ba- sis of either the physician’s assessment of severity or the composite disease severity score and were analyzed ac- cordingly. Two patients recruited as control subjects re- ported a history of rheumatoid arthritis atthe time of the examination but were analyzed as controls on the basis of the physician’s assessment and the computed com- Association, All rights reserved. es, mean 80, B7S2139 S452134 30 Sox No (3) F (789) 78833) 50 ace, Mo.) white W5(607) 201667) 75, Associated media erations, No.) tone Tors) 51083) 02 ‘Sjaten dsase 373) 2 Roum artis 1758) 267) 37 Systemic pus erythematous 3(28) D> Progessiesystomicsceross (09) D> 00 Potymyosiis 490 90 Dermatomyositis 0 nS concn tat tidings, Mo.) one 61 (600) 23,767) ot Blphartis M101) 13) 46 Maboman gland dstuncion 24 (220) 5(162) 52 (cular mucin abnormally 0 0 ne isordrs fe aperture 109 1@3) a0 ‘cular sua dearer 2g) 0 > 00 Ober 1002) 0 12 Hor apliabe ‘Table 2. Relablly of the Ocular Surface Disease index Tet Retest IntrnalConststency:inaiass (romachar_Coralaton (92%. cantidonce (99% canine nterat) nterat) ‘ular SuraceDsese Index 092(080-008) 082 (075-088) ‘otal sere Visoraltad function 088 (084-092) 070(056-080) cular symptoms 92 (oaa004) 074 (052089) Eniconmental tigger 078 (074-084) 081 (074-087) posite score. Ifthese subjects actually had unrecognized dry eye, the resulting bias would have been a conserva live one and reduced the observed differences between the diseased and control groups. FACTOR ANALYSIS ‘OF THE OSDL Factor analysts disclosed that there were 3 subscales, in- terpreted as vision-related function (6 questions), ocu- lar symptoms (3 questions), and environmental triggers G questions) RELIABILITY OF THE OSDI The Cronbach a for the overall instrument and each of the subscales ranged from good to excellent (Table 2), and all exceeded the 0.7 that is recommended for group analyses.’ The intraclass correlation between the test and retest scores was also good to excellent for both the 1o- (©2000 American Med tal OSDI score and the subscales (Table 2) and once again met of exceeded 0.7. VALIDITY OF OSDI When patients were grouped according to the physi- cian’s assessment of severity, the mean OSDI total score was 36 in the severe group, 21 in the mild to moderate group, and 10 in the control group (Figure, left; Table 3). The proportion of patients with scores at the ceiling and floor in each category can also he seen in Table 3. All between-group differences were statistically sig- nificant (P05; Tukey test for multiple comparisons) with the exception of the comparison between the nor- smal and mild to moderate groups for the viston-related function subscale, and the mild to moderate and severe groups for the environmental triggers subscale ‘When patients were grouped according to compos- ite disease severity scores, the mean OSDI scores were 3o in the severe group, 18 in the mild to moderate group, and 5 in the control group (Figure, right; Table 3). The proportion of patients with scores atthe ceiling and floor in each category ean also be seen in Table 3. All group- wise comparisons (between the scores for the normal, mild to moderate, and severe groups) for the total OSDI score and each subscale of the OSDI were statistically signi cant (P=.05; Tukey test for multiple comparisons) The OSDI tolal score and each ofthe subscale scores were also significantly associated with disease severity (as measured by either the physician's assessment or the composite score) in multivariate analyses adjusting for sociodemographic factors (age, race, sex, education, in- come, and employment status) and number of medical comorbidities (P=.005). In comparing disease severity based on the phys cian’s assessment with that determined by the compos- ltescore, i was found that 130 of 139 patients were graded within 1 level of each other. The weighted x, which is a measure of agreement between 2 rating scales,” was 0.61 reflecting good agreement, However, patients’ symp- toms tended to be designated as slighily less severe ac- cording to the physician's assessment than they were on the basis of the composite disease severity score. COMPARISON OF OSDI SCORES WITH INDIVIDUAL OBJECTIVE CLINICAL MEASURES The correlation coelficients between the OSDI and tear breakup time, Schirmer test type 1, fluorescein staining, and lissamine green staining were very low when all sub- jects were analyzed together (Rable 4). However, when the analysis focused on only patients with Schirmer test type L scores less than 10 mm, low to moderate statisti cally significant correlations were detected for all sub- scales except vision-related function (Table 4) In contrast, there was a stronger correlation be- ‘oveen OSDI scores and patient-reported variables. All SDI scores showed moderate correlations with the P- tient Perception of Ocular Symptoms that were highly statistically significant (P<001) (Table 8). There was also a moderate and statistically significant correlation sported artificial tear usage and both between patient Association, All rights reserved. cara ‘aaa =a Bitte 6) ioe 8) so) [Sennett Sevres . E ». ». : d f a. L Oo "eal \WowFeusd tela” rota Teal WipeReaeé tela” got een symtans i ct ‘yen ‘ao ‘Mean Ocular Surace Diese Index (OSD) sores (tal score and sores forthe 3 ebscales) by ease evry based onthe pyle assesment (et and the compost score (aght Lisanne green scoring was unevalade or pale pevening he computation ofa compose soe the total OSDI score and all of the OSDI subscales (P<.001) (Table 5). The mean frequency with which pa- lent used artificial ears ranged from 0 to 9 times a day There were also moderate correlations between each. ‘of the OSDI scores and the MeMonnies Dry Eye Ques tionnaire; all correlations were highly statistically sig- nificant (P<.001) (Table 5). Both the total OSDI score and the scores for the 3 subscales were significantly correlated with the NEL VFQ-25 score (P<001) (Table 5). The negative corre: lations obtained reflect the fact that higher scores on the (SDI represent greater disease impact, while higher scores fon the NEI VFQ-25 reflect less disability. Correlations between each of the OSDI scores and the NEI VEQ-25 ‘questionnaire were stronger than those between the OSDI ‘and either the MeMonnies Dry Eye Questionnaire or the patient perception of ocular symptoms. The OSDI was also compared with the SF-12, a gen- ‘eral measure of health status (Table 5). There were low t0 moderate correlations between OSDI scores and the physi- ‘eal component summary score of the SF-12 (p= -0.39; P<.001); however, the correlations between OSDI scores ‘and the mental component summary score were poor. OPERATING CHARACTERISTICS OF THE OSDI The sensitivity and specificity of the OSDI are shown in Table 6. The sensitivity value expresses the proportion, of patients above the given threshold who have dry eye, while the specificity value expresses the proportion of pa tients below the given threshold who do not have dry eye. For the computations presented in Table 6, a threshold was selected that maximized the sum ofthe sensitivity and specificity values, Alternative thresholds could be chosen that would selectively maximize either the sensitivity the specificity, depending on how the instrument is to be used. As expected, the performance of the OSDI im- proved as it was used to discriminate more severe dis- ‘ease, The ROC curves can also be used to describe the per- formance of a test by plotting the sensitivity vs (= speeifcity) for each possible test result, The area un- der the ROC curve can be thought of as a summary mea- sure for these curves, with 0.5 indicating that the testis no better than chance at predicting dry eye disease and (©2000 American Med ‘able 3. Ocular Surface Disease Index Scores by Disease Severity Wo. (3) NO. C3) Moan 280 at cel “ola eore Phyl rang gral (n= 30) osaue2 71033, 0 Miemederate(n=06) 2083204 10(104) (10) Sowre(n=13) 3844167 0 0 Composit scora* ermal (n= 28) 45166 71292) 0 Mid-moderate(n=83) 1814171 10/120, 0 Sowre(n=31) 38442310 192) =Lissarine green scorn was unable campaion ofa conposte score for patent preventing te 1.0 indicating a perfect the ROC curve for the OSDI demonstrate good to excel- lent discrimination with the instrument (Table 6), a In the present study, the OSDI demonstrated both high internal consistency (the Cronbach a for the overall in- strument and each of the subscales ranged from good to excellent) and good to excellent test-retest reliability im a large sample of patients with dry eye disease and normal controls. The OSDI also demonstrated excellent validity elfectively discriminating between normal, mild to mod- erate, and severe dry eye disease as defined by both the physician's assessment of severity and a composite di case severity score. Moreover, the OSDI demonstrated good sensitivity and specificity in distinguishing between nor- ‘mal subjects and patients with dry eye disease. One of the assumptions of test-retest reliability assessments is that the subjects condition has remained st for dry eye. The areas under stable between the time of the first test and the time of the the symptoms of patients with dry eye disease typically fluctuate, thus violating this assumption of stability. This may explain the modest decrease in the test-retest reliabili Cronbach a and may be unavoidable with this popula- on, Despite this, the test-retest correlation still meets 1. Howevel compared with Association, All rights reserved. ‘Table 4, Correlation Between Ocular Surtace Di Index (OSDI) Scores and individual Clinical Measures inthe Worse Eye Tear eakap Time sehrmer Type 1 Test issamine areen Fiorecaln ’ ? ° ° ° D “Ai Fails sbi tot score a4 0 021 1 ats 4 on se Vision fnetin “a0 26 “aia 10 000 Ey 013 a Daa symptoms 05 0 221 i a 16 02 2 Enieonmental ggee a9 a a8 a on 2 air 6 ‘atants with ry Eye and Sonne Test Result 10 mm (0sbl tot score 029 05 0 = O0t a2 05 031 na Visions nein “020 05 “036, an 7 02 3 Daa symptoms “027 ot 235 oz 00 022 oot Enieonmental pao “a4 01 038 02 05 02 0d ‘Table , Correlation Between OSD! Score and Other Variables Palen Rporedvartates ter auestonatet pen | ——$ _, ear Usage | Melonnies ———‘NEWFO-29——SF-12:Pnyseal—_SF-12: Manat eo Pile a ee ‘sbreaeeoe 045 <0n ae? _=007 “030 “az 008 Visions fnction 038

    You might also like