Original article
Validation and Repeatability of a Short Questionnaire for Dry Eye Syndrome

https://doi.org/10.1016/j.ajo.2006.02.038Get rights and content

Purpose

To clinically validate and ascertain the repeatability of a short questionnaire for dry eye syndrome (DES), consisting of two questions pertaining to symptoms (dryness and irritation) and one question regarding previous history of clinically diagnosed DES.

Design

Clinical validation study with repeated assessments.

Methods

A short questionnaire for DES was administered to participants of two large cohort studies, the Women’s Health Study (WHS) and the Physicians’ Health Study (PHS). A supplementary questionnaire comprising 16 questions pertaining to symptoms was mailed to a subset of 450 WHS and 240 PHS participants, selected so that a third of these subjects had DES based on their response to the short questionnaire. Repeatability of the dryness and irritation symptom questions was ascertained using intraclass correlation coefficient (ICC). Standardized ophthalmologic examination was performed on 53 subjects. Sensitivity and specificity of the short questionnaire was determined using a combination of clinical tests to define clinical DES.

Results

An ICC of 0.75 for dryness and 0.65 for irritation was found between subsequent measurements. Participants’ responses to the dryness and irritation questions were highly correlated (r = 0.75) with a score derived from responses to the longer 16-symptom questionnaire. The short questionnaire for DES had a sensitivity of 77% and specificity of 83% when cutoff point for clinical DES was Schirmer 1 value ≤10 mm or tear breakup time <10 seconds.

Conclusion

The short questionnaire for DES is a sensitive and repeatable tool that is easy to administer in large epidemiologic research studies as well as clinical research.

Section snippets

Methods

The study was conducted in compliance with the Good Clinical Practice Program, Institutional Review Board regulations, informed consent regulations, the tenets of the Declaration of Helsinki, and Health Insurance Portability and Accountability Act regulations (HIPAA). All subjects enrolled in the study were adults above 18 years of age who were able to give informed consent.

The WHS was a randomized, double masked, placebo-controlled trial conducted among 39,876 female health professionals in

Results

Among the subset of WHS and PHS participants who were mailed the supplementary questionnaire, 408 WHS (91%) and 219 PHS (91%) participants completed the questionnaire. Comparing responses from the original and the supplementary questionnaires, we observed an ICC of 0.75 for reported frequency of symptoms of dryness and 0.65 for irritation. In addition, we observed that participants’ responses to the dryness and irritation questions were highly correlated with a total symptom score calculated by

Discussion

DES is a common ocular surface disorder of diverse etiology. DES represents a significant public health problem and an important area requiring further study. For large-scale patient-oriented research studies, there is need for a tool that is brief, easy, and noninvasive. The goal of the current study was to validate a short questionnaire composed of three questions that could be used as a simple tool to assess dry eye status in large-scale epidemiologic research studies as well as in the

Abha Gulati, MD, is a Senior Scientific Associate at the Schepens Eye Research Institute, Boston, Massachusetts. Dr Gulati principal research interests include the study of signaling pathways involved in tear secretion and their relation to the ocular surface immuno-inflammatory responses in dry eye syndrome.

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    • Cited by (0)

    Abha Gulati, MD, is a Senior Scientific Associate at the Schepens Eye Research Institute, Boston, Massachusetts. Dr Gulati principal research interests include the study of signaling pathways involved in tear secretion and their relation to the ocular surface immuno-inflammatory responses in dry eye syndrome.

    Debra A. Schaumberg, ScD, OD, MPH, is an Assistant Professor of Medicine and Ophthalmology at Harvard Medical School, Clinical Associate Scientist at the Schepens Eye Research Institute, and the Director of Ophthalmic Epidemiology, Division of Preventive Medicine, Brigham and Women’s Hospital, Boston, Massachusetts. Dr Schaumberg principal research interests regard the roles of both environmental and genetic risk factors, and their interactions, in common eye diseases including dry eye syndrome, cataract, macular degeneration, and diabetic retinopathy.

    This study was supported primarily by an unrestricted grant from Pfizer Consumer Healthcare Inc, Morris Plains, New Jersey (R.D., D.A. Schaumberg). Follow-up of the Physicians’ Health Study cohort is supported by grant CA40360 from the National Institutes of Health, and the Women’s Health Study by grants CA47988 and HL43851 from the National Institutes of Health. The study also received funding from the Joint Clinical Research Center, Massachusetts Eye and Ear Infirmary, Schepens Eye Research Institute, Department of Ophthalmology, Boston, Massachusetts.

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