Development and evaluation of a measure of patient-reported symptoms of Blepharitis

Kamran Hosseini, Linda B Bourque, Ron D Hays, Kamran Hosseini, Linda B Bourque, Ron D Hays

Abstract

Background: Blepharitis is an ocular surface disease and chronic ophthalmic condition. This paper reports on the development of psychometric evaluation of a patient-reported measure of blepharitis symptoms.

Methods: Self-reports of 13 blepharitis symptoms collected in a Phase 3 multi-site, randomized, double-masked, 4-arm parallel group, clinical trial of 907 individuals with blepharitis (mean age = 62, range: 19-93; 57% female) were analyzed. Symptoms asked about were: eyes that itch; eyes that burn; eyelids feel heavy or puffy; feel like something is in your eye; dry eyes; gritty eyes; irritated eyes; eyes that tear or water; crusty eyes; flaking from your eyelids; eyelids that are stuck together; red eyes or eyelids; and debris like pieces of skin or dandruff in your eyes.

Results: Categorical factor analyses provided support for two multi-item symptom scales: Irritation (9 items, alpha = 0.88) and Debris (4 items, alpha = 0.85). Spearman-rank order correlations of the Irritation and Debris scales with the Ocular Surface Disease total score were 0.63 and 0.41, respectively (p's < 0.001). Rank-order correlations between ratings of clinicians and self-reports of puffy eyes (r = 0.07, p < .05), red eyes (r = 0.12, p < .001), debris (r = 0.03, p > 0.05), and irritation (r = 0.47, p < .001).

Conclusions: This study provides support for the psychometric properties and construct validity of the Irritation and Debris scales for assessing symptoms of blepharitis. The associations between the self-reports and clinician ratings of 4 symptoms indicate substantial unique information in the new self-reported symptom items.

Trial registration: The trial was registered at ClinicalTrials.gov under the registry number NCT01408082 .

Keywords: Blepharitis; Reliability; Symptoms; Validity.

Conflict of interest statement

Authors’ information

RDH serves on the special methodology panel of the Journal of General Internal Medicine and on the editorial board of Quality of Life Research and Applied Research in Quality of Life.

Ethics approval and consent to participate

The study was conducted in compliance with all applicable governmental rules, ethical principles, Good Clinical Practice regulations, International Conference on Harmonisation guidelines, and in accordance with the Declaration of Helsinki. The study protocol for all sites was reviewed and approved by Copernicus IRB (Durham, NC, USA).

Written informed consent was obtained from all subjects. At each study site, subjects were randomized sequentially by assigning the number corresponding to the lowest-numbered drug kit available at the site. All investigators were masked to the randomization code. All study medications were administered from identical multidose containers, so that neither the participant nor the investigator knew which medication the subject was receiving. All medications were identical in color (colorless) and viscosity, so the appearance of the drug was the same to all the subjects.

Consent for publication

Not applicable.

Competing interests

LBB and RDH are consultants to InSite Vision. KH is an employee (chief medical officer and vice president, clinical and regulatory affairs) of InSite Vision. InSite Vision is now a subsidiary of Sun Pharmaceutical Industries. All aspects of this study were undertaken by InSite Vision prior to its acquisition. The authors report no other competing interest in this work.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

References

    1. Hahn EA, Cella D, Chassany O, Fairclough DL, Wong GY, Hays RD, the Clinical Significance Consensus Meeting Group Precision of health-related quality-of-life data compared with other clinical measures. Mayo Clin Proc. 2007;82(10):1244–1254. doi: 10.4065/82.10.1244.
    1. McMonnies C, Ho A. Marginal dry eye diagnosis. In: Holly F, editor. The preocular tear film in health, disease and contact lens wear. Lubbock: Dry Eye Insititute Inc; 1986. pp. 32–38.
    1. Nichols KK, Nichols JJ, Mitchell GL. The lack of association between signs and symptoms in patients with dry eye disease. Cornea. 2004;23(8):762–770. doi: 10.1097/01.ico.0000133997.07144.9e.
    1. Schiffman RM, Christianson MD, Jacobsen G, Hirsch JE, Reis BL. Reliability and validity of the ocular surface disease index. Arch Ophthalmol. 2000;118:615–621. doi: 10.1001/archopht.118.5.615.
    1. Begley CG, Chalmers RL, Mitchell GL, et al. Characterization of ocular surface symptoms from optometric practices in North America. Cornea. 2001;20(6):610–612. doi: 10.1097/00003226-200108000-00011.
    1. Rajagopalan K, Abetz L, Mertzanis P, et al. Comparing the discriminative validity of two generic and one disease-specific health-related quality of life measures in a sample of patients with dry eye. Value Health. 2005;8(2):168–174. doi: 10.1111/j.1524-4733.2005.03074.x.
    1. Simpson TL, Situ P, Jones LW, Fonn D. Dry eye symptoms assessed by four questionnaires. Optom Vis Sci. 2008;85(8):692–699. doi: 10.1097/OPX.0b013e318181ae36.
    1. Hossini K, Lindstrom RL, Foulks G, Nichols KK. A randomized, double-masked, parallel-group, comparative study to evaluate the clinical efficacy and safety of 1% azithromycin-0.1% dexamethasone combination compared to 1% azithromycin alone, 0.1% dexamethasone alone, and vehicle in the treatment of subjects with blepharitis. Clin Ophthalmol. 2016;10:1495–1503. doi: 10.2147/OPTH.S110739.
    1. Institute of Medicine . The National Academies of health. 2008. State of the USA health indicators, letter report.
    1. Janine AS. The epidemiology of dry eye disease: report of the epidemiology Subcommittee of the International dry eye Workshop. Ocul Surf. 2007;5:93-107.

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