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Health and Quality of Life Outcomes
Published in: Health and Quality of Life Outcomes 1/2011

Open Access 01-12-2011 | Research

Development and validation of the impact of dry eye on everyday life (IDEEL) questionnaire, a patient-reported outcomes (PRO) measure for the assessment of the burden of dry eye on patients

Authors: Linda Abetz, Krithika Rajagopalan, Polyxane Mertzanis, Carolyn Begley, Rod Barnes, Robin Chalmers, the impact of dry eye on everyday life (IDEEL) Study Group

Published in: Health and Quality of Life Outcomes | Issue 1/2011

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Abstract

Objective

To develop and validate a comprehensive patient-reported outcomes instrument focusing on the impact of dry eye on everyday life (IDEEL).

Methods

Development and validation of the IDEEL occurred in four phases: 1) focus groups with 45 dry eye patients to develop a draft instrument, 2) item generation, 3) pilot study to assess content validity in 16 patients and 4) psychometric validation in 210 subjects: 130 with non-Sjögren's keratoconjunctivitis sicca, 32 with Sjögren's syndrome and 48 controls, and subsequent item reduction.

Results

Focus groups identified symptoms and the associated bother, the impact of dry eye on daily life and the patients' satisfaction with their treatment as the central concepts in patients' experience of dry eye. Qualitative analysis indicated that saturation was achieved for these concepts and yielded an initial 112-item draft instrument. Patients understood the questionnaire and found the items to be relevant indicating content validity. Patient input, item descriptive statistics and factor analysis identified 55 items that could be deleted. The final 57-item IDEEL assesses dry eye impact constituting 3 modules: dry eye symptom-bother, dry eye impact on daily life comprising impact on daily activities, emotional impact, impact on work, and dry eye treatment satisfaction comprising satisfaction with treatment effectiveness and treatment-related bother/inconvenience. The psychometric analysis results indicated that the IDEEL met the criteria for item discriminant validity, internal consistency reliability, test-retest reliability and floor/ceiling effects. As expected, the correlations between IDEEL and the Dry Eye Questionnaire (a habitual symptom questionnaire) were higher than between IDEEL and Short-Form-36 and EuroQoL-5D, indicating concurrent validity.

Conclusion

The IDEEL is a reliable, valid and comprehensive questionnaire relevant to issues that are specific to dry eye patients, and meets current FDA patient-reported outcomes guidelines. The use of this questionnaire will provide assessment of the impact of dry eye on patient dry eye-related quality of life, impact of treatment on patient outcomes in clinical trials, and may aid in treatment effectiveness evaluation.
Appendix
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Metadata
Title
Development and validation of the impact of dry eye on everyday life (IDEEL) questionnaire, a patient-reported outcomes (PRO) measure for the assessment of the burden of dry eye on patients
Authors
Linda Abetz
Krithika Rajagopalan
Polyxane Mertzanis
Carolyn Begley
Rod Barnes
Robin Chalmers
the impact of dry eye on everyday life (IDEEL) Study Group
Publication date
01-12-2011
Publisher
BioMed Central
Published in
Health and Quality of Life Outcomes / Issue 1/2011
Electronic ISSN: 1477-7525
DOI
https://doi.org/10.1186/1477-7525-9-111

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