Purpose: Dry eye disease (DED) is a frequent chronic ophthalmic condition. Its diagnosis includes tests and patient reported outcomes (PRO) questionnaires. Although many PRO dry eye questionnaires (PRO-DEQs) are available, they differ greatly from each other and not all have been validated. The purpose of this study was to retrieve the PRO-DEQs present in the scientific literature by performing a descriptive analysis of them and identifying those with known validity and reliability characteristics and to perform a descriptive analysis of the geographic area, year of publication, and characteristics of the target population of the clinical studies that have used validated PRO-DEQs.
Design: Scoping review of the literature.
Methods: Searches were conducted in PubMed to retrieve PRO-DEQs published up to July 2018 and written in English, French, Italian or Spanish.
Results: One thousand six hundred two records were identified and 973 were included in the final analysis. Of these, 56 provided information on the design and validation of PRO-DEQs and 49 PRO-DEQs were identified. Twenty-two PRO-DEQs were validated (17 original and 5 modified) and 27 had no associated design, validity, and reliability studies. Most of the validated PRO-DEQs were designed in English, the number of items varies from 1 to 57, the dimensions are generally not specified, and they are self-administered. The greatest use of validated PRO-DEQs in clinical studies has been in Asia since 2010, with the Ocular Surface Disease Index being the most used. These questionnaires have been used mostly in adults, retired professionals, and people with visual diseases to diagnose DED.
Conclusions: This study aims to encourage the use of validated PRO-DEQs to guarantee the quality of the results obtained and the comparability and replicability among studies.
Keywords: Dry eye disease; patient-reported outcome; psychometric properties; questionnaires; scoping review; symptoms.
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