Abstract
ObjectiveTo develop and validate a comprehensive patient-reported outcomes instrument focusing on the impact of dry eye on everyday life (IDEEL).MethodsDevelopment 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.ResultsFocus 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.ConclusionThe 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.
Highlights
The Dry Eye Workshop defined dry eye as a “multifactorial disease of the tears and ocular surface that results in symptoms of discomfort, visual disturbance, and tear film instability with potential damage to the ocular surface” [1,2]
Dry eye or non-Sjögren’s keratoconjunctivitis sicca is a condition due to lacrimal and/or meibomian gland dysfunction leading to diminished production or increased evaporation of tears [1,8]
Development of the questionnaire The focus groups had 6 to 10 participants in each; the total population consisted of 45 patients: 30 with nonSS KCS and 15 with s Syndrome (SS)
Summary
The Dry Eye Workshop defined dry eye as a “multifactorial disease of the tears and ocular surface that results in symptoms of discomfort, visual disturbance, and tear film instability with potential damage to the ocular surface” [1,2]. Dry eye or non-Sjögren’s keratoconjunctivitis sicca (non-SS KCS) is a condition due to lacrimal and/or meibomian gland dysfunction leading to diminished production or increased evaporation of tears [1,8]. It may be associated with Sjögren’s Syndrome (SS), which is a systemic autoimmune disorder in which chronic inflammation of the lacrimal and salivary glands, that eventually leads to insufficient tear production, and the characteristic clinical features of dry eyes and dry mouth [1,9,10]. Dry eye is a chronic condition that is heterogeneous in aetiology, and in severity
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