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Italian translation and validation of the Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8)
Fabrizio Zeri1, Silvia Tavazzi2, Shehzad A Naroo3
1Department of Materials Science, University of Milano-Bicocca, Milan, Italy; Research Centre in Optics and Optometry (COMiB), University of Milano-Bicocca, Milan, Italy; College of Health and Life Sciences, Aston University, Birmingham, UK.
Purpose:
To translate and validate an Italian version of the CLDEQ-8 (CLDEQ-8_IT).
Methods:
The study was carried out in two phases. In the first phase, a cross-cultural adaptation of CLDEQ-8 to Italian was performed by forward and backward translation in sequence. In the second phase, a multi-centre study was conducted for the validation of the questionnaire. Validity CLDEQ-8_IT was evaluated against three gestalt questions: overall opinion of soft contact lenses (CLs), global self-assessments of eye sensitivity and eye dryness. Reliability was evaluated by test-retest assessment in a subgroup of subjects. Finally, the psychometric properties of CLDEQ-8_IT were explored by Rasch analysis.
Results:
Two hundred and forty soft CL wearers, fluent Italian speakers (73 males and 167 females), between 18 and 70 years of age were enrolled. A significant correlation was found between CLDEQ-8_IT and each of the three Gestalt questions. The cutoff score of 12 points demonstrated the best balance between sensitivity and specificity in differentiating wearers grading their CLs as "Excellent/Very good" from those reporting their overall opinion as "Good/Fair/Poor". The Intraclass Correlation Coefficient between test and retest was 0.88 (95% CI: 0.81-0.92). Finally, infit and outfit statistics using Rasch analysis for the 8 items were in a good range, however Principal Components Analysis revealed a certain degree of multi-dimensionality of the instrument. Also, item 8 analysis could be computed after merging the last two response categories.
Conclusion:
The CLDEQ-8_IT showed very good validity and reliability in measuring symptoms of CL wearers, comparable to the original English language version. A cut-off of 12 was confirmed as yielding the best balance between sensitivity and specificity in detecting CL wearers who could benefit from clinical management of their CL-related symptoms. Collapsing of the response options 5 and 6 in the last item of questionnaire could optimise its functioning.
