Validation and Repeatability of the Epidermolysis Bullosa Eye Disease Index in Dystrophic Epidermolysis Bullosa.
Journal
Cornea
ISSN: 1536-4798
Titre abrégé: Cornea
Pays: United States
ID NLM: 8216186
Informations de publication
Date de publication:
01 Jan 2023
01 Jan 2023
Historique:
received:
15
10
2021
accepted:
29
01
2022
pubmed:
6
10
2022
medline:
7
12
2022
entrez:
5
10
2022
Statut:
ppublish
Résumé
Dystrophic epidermolysis bullosa (DEB) is a devastating condition that causes painful corneal abrasions and vision loss. Epidermolysis Bullosa Eye Disease Index (EB-EDI) for the first time captures and quantifies EB-specific assessment of ocular symptoms and activities of daily living scales. This survey will become critical in developing new interventions on patients' quality of life. Three-part set of the EB-EDI baseline, EB-EDI interval, and Ocular Surface Disease Index (OSDI) survey was distributed to 92 patients with DEB who previously reported eye symptoms on previous surveys. It was then posted online through several EB patient organizations. We compared the EB-EDI with the gold standard OSDI and examined the repeatability of the EB-EDI over a 7- to 15-day interval. Of the 45 individuals who initially responded, 30 of 45 (67%) completed the surveys sent 7 to 15 days later. The age of participants ranged from 6 to 51 years (mean 21 ± 15 years), and 60% (18 of 30) of participants were younger than 18 years. The overall Cronbach alpha values for the subscales of EB-EDI baseline and interval tools presented a good internal consistency (≥0.7). From 2 visits, the domain scores of EB-EDI baseline (0.94) and interval tools (0.83) were shown to have excellent test-retest reliability (intraclass correlation coefficient >0.8). By comparison, OSDI had the intraclass correlation coefficient score of 0.72 ± 0.11. The convergent validation analysis showed that correlations between the domain scores of EB-EDI baseline and interval tools and the subscales of the OSDI reached the hypothesized strength. Based on a 30-person repeated-measures study, we found that the EB-EDI has excellent reliability and validity specifically in patients with DEB.
Identifiants
pubmed: 36197337
doi: 10.1097/ICO.0000000000003017
pii: 00003226-202301000-00011
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
74-79Informations de copyright
Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.
Déclaration de conflit d'intérêts
V. M. Chen is a consultant for Phoenix Tissue Repair, Inc. The remaining authors have no conflicts of interest to disclose.
Références
Fine JD, Mellerio JE. Extracutaneous manifestations and complications of inherited epidermolysis bullosa: part II. Other organs. J Am Acad Dermatol. 2009;61:387–402; quiz 403–404.
Fine JD, Mellerio JE. Extracutaneous manifestations and complications of inherited epidermolysis bullosa: part I. Epithelial associated tissues. J Am Acad Dermatol. 2009;61:367–384; quiz 385–386.
Smith KA, Jones SM, Nischal KK. Refractive and ocular motility findings in children with epidermolysis bullosa. Am Orthopt J. 2009;59:76–83.
Fine J-D. Epidemiology of inherited epidermolysis bullosa based on incidence and prevalence estimates from the National Epidermolysis Bullosa Registry. JAMA Dermatol. 2016;152:1231–1238.
Adachi E, Hopkinson I, Hayashi T. Basement-membrane stromal relationships: interactions between collagen fibrils and the lamina densa. Int Rev Cytol. 1997;173:73–156.
Chen VM, Shelke R, Nystrom A, et al. Collagen VII deficient mice show morphologic and histologic corneal changes that phenotypically mimic human dystrophic epidermolysis bullosa of the eye. Exp Eye Res. 2018;175:133–141.
Fine JD, Johnson LB, Weiner M, et al. Eye involvement in inherited epidermolysis bullosa: experience of the National Epidermolysis Bullosa Registry. Am J Ophthalmol. 2004;138:254–262.
Rashad R, Weed MC, Quinn N, et al. Extended wear bandage contact lenses decrease pain and preserve vision in patients with epidermolysis bullosa: case series and review of literature. Ocul Immunol Inflamm. 2019;28:379–383.
Tanaka AC, Robbins CC, Wiss K, et al. Frequent corneal abrasions precede scarring and vision loss in epidermolysis bullosa: an international patient survey. J Am Acad Dermatol. 2020;83:917–919.
Dystrophic Epidermolysis Bullosa Research Association. Available at: www.debra.org . Accessed June 2, 2020.
Bardhan A, Bruckner-Tuderman L, Chapple ILC, et al. Epidermolysis bullosa. Nat Rev Dis Primers. 2020;6:78.
Chen VM, Mehta N, Robbins CC, et al. Anterior-segment spectral domain optical coherence tomography in epidermolysis bullosa. Ocul Surf. 2020;18:912–919.
Midorikawa-Inomata A, Inomata T, Nojiri S, et al. Reliability and validity of the Japanese version of the Ocular Surface Disease Index for dry eye disease. BMJ Open. 2019;9:e033940.
Ozcura F, Aydin S, Helvaci MR. Ocular surface disease index for the diagnosis of dry eye syndrome. Ocul Immunol Inflamm. 2007;15:389–393.
Schiffman RM, Christianson MD, Jacobsen G, et al. Reliability and validity of the Ocular Surface Disease Index. Arch Ophthalmol. 2000;118:615–621.
Vitale S, Goodman LA, Reed GF, et al. Comparison of the NEI-VFQ and OSDI questionnaires in patients with Sjogren's syndrome-related dry eye. Health Qual Life Outcomes. 2004;2:44.
U.S. Department of Health and Human Services. Patient-reported outcome measures: use in medical product development to support labeling claims. Guidance for industry Web site. Available at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM193282.pdf . Published 2009. Accessed March 2021.
Lee BWH, Tan JCK, Radjenovic M, et al. A review of scoring systems for ocular involvement in chronic cutaneous bullous diseases. Orphanet J Rare Dis. 2018;13:83.
Frew JW, Martin LK, Nijsten T, et al. Quality of life evaluation in epidermolysis bullosa (EB) through the development of the QOLEB questionnaire: an EB-specific quality of life instrument. Br J Dermatol. 2009;161:1323–1330.
Moss C, Wong A, Davies P. The Birmingham Epidermolysis Bullosa Severity score: development and validation. Br J Dermatol. 2009;160:1057–1065.
Schwieger-Briel A, Chakkittakandiyil A, Lara-Corrales I, et al. Instrument for scoring clinical outcome of research for epidermolysis bullosa: a consensus-generated clinical research tool. Pediatr Dermatol. 2015;32:41–52.
Cronbach LJ. Coefficient alpha and the internal structure of tests. Psychometrika. 1951;16:297–334.
Nunnally JC. New York NY: MgGraw-Hill; 1978.
Cristobal E, Flavián C, Guinalíu M. Perceived e-service quality (PeSQ): measurement validation and effects on consumer satisfaction and web site loyalty. Manag Serv Qual. 2007;17:317–340.
Pult H, Wolffsohn JS. The development and evaluation of the new Ocular Surface Disease Index-6. Ocul Surf. 2019;17:817–821.
Grubbs JR Jr, Tolleson-Rinehart S, Huynh K, et al. A review of quality of life measures in dry eye questionnaires. Cornea. 2014;33:215–218.
Ngo W, Situ P, Keir N, et al. Psychometric properties and validation of the Standard Patient Evaluation of Eye Dryness questionnaire. Cornea. 2013;32:1204–1210.
Lu F, Tao A, Hu Y, et al. Evaluation of reliability and validity of three common dry eye questionnaires in Chinese. J Ophthalmol. 2018;2018:2401213.
Traipe L, Gauro F, Goya MC, et al. Validation of the Ocular Surface Disease Index Questionnaire for Chilean patients [in Spanish]. Rev Med Chil. 2020;148:187–195.
Hirosawa K, Inomata T, Sung J, et al. Diagnostic ability of maximum blink interval together with Japanese version of Ocular Surface Disease Index score for dry eye disease. Sci Rep. 2020;10:18106.
Gabbriellini G, Baldini C, Varanini V, et al. Ocular Surface Disease Index (OSDI): a potential useful instrument for the assessment of vision-targeted health-related quality of life (VT-HRQ) in primary Sjogren's syndrome (pSS) clinical trials? Clin Exp Rheumatol. 2012;30:812–813.
Olenik A, Jimenez-Alfaro I, Alejandre-Alba N, et al. A randomized, double-masked study to evaluate the effect of omega-3 fatty acids supplementation in meibomian gland dysfunction. Clin Interv Aging. 2013;8:1133–1138.
Evans JD. Linear Correlation . Pacific Grove, CA: Brooks/Cole Publishing Company; 1996.
Dougherty BE, Nichols JJ, Nichols KK. Rasch analysis of the Ocular Surface Disease Index (OSDI). Invest Ophthalmol Vis Sci. 2011;52:8630–8635.