A systematic review assessing the quality of patient reported outcomes measures in dry eye diseases

Abstract

Background Patient-reported outcome measures (PROMs) can provide valuable insights on the impact of a disease or treatment on a patient’s health-related quality of life. In ophthalmology, particularly in dry eye disease (DED) and ocular surface disease (OSD), it is unclear whether the available PROMs were developed using comprehensive guidelines. To address this, we evaluated the methodological quality of studies assessing the psychometric properties of PROMs in DED and OSD [PROSPERO registration number CRD42019142328]. Methods Four databases were searched; reference list and citation searching of included studies was also conducted. The COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist was used to appraise the quality of the studies evaluating the psychometric properties of PROMs used in DED and OSD. Results The search strategy (S3 Table) retrieved 5,761 records, 573 duplicates were removed, 5,188 abstracts were screened and 127 full-text articles were retrieved for further review. Of these, 118 full-text articles did not meet the eligibility criteria and were excluded. Reference list and citation searching, identified an additional 8 articles bringing the total numbers of papers reviewed to 17. In general, psychometric properties such as content validity, measurement error and structural validity were not assessed by the studies included in this review. Studies reviewing The Impact of Dry Eye on Everyday Life (IDEEL) presented with the highest quality scores together with the Ocular Surface Disease Index (OSDI) questionnaire. Conclusions The quality of studies evaluating PROMs in DED and OSD was considered using the COSMIN standards. The majority of the studies evaluating PROMs included in this review did not meet the recommended COSMIN criteria and the quality of the PROMs evaluated is not assured. Further evaluation of their psychometric properties is required if these are going to be used in clinical practice or research.

Comparison of the Ocular Surface Disease Index and the Symptom Assessment in Dry Eye Questionnaires for Dry Eye Symptom Assessment

“…Such questionnaires include the Impact of Dry Eye in Everyday Life questionnaire [ 7 ], the University of North Carolina Dry Eye Management Scale [ 8 ], the Dry Eye-Related Quality-of-Life Score questionnaire [ 9 ], the Ocular Comfort Index questionnaire [ 10 ], the Standard Patient Evaluation of Eye Dryness questionnaire [ 11 ], the McMonnies Questionnaire [ 12 , 13 ], the dry eye questionnaire DEQ-5 [ 14 ], and others. The Ocular Surface Disease Index (OSDI) and Symptom Assessment in Dry Eye (SANDE) have been widely used for decades [ 15 , 16 , 17 , 18 , 19 , 20 , 21 , 22 ] because they provide reliable and valid measurements of dry eye symptoms (DES) [ 15 , 17 ]. The OSDI questionnaire was developed by Allergan Inc. (Irvine, CA, USA) in 2000 [ 15 ], and the current version includes a 12-item self-administered questionnaire that evaluates the frequency of symptoms over the preceding week in approximately 5 min.…”

“…The Ocular Surface Disease Index (OSDI) and Symptom Assessment in Dry Eye (SANDE) have been widely used for decades [ 15 , 16 , 17 , 18 , 19 , 20 , 21 , 22 ] because they provide reliable and valid measurements of dry eye symptoms (DES) [ 15 , 17 ]. The OSDI questionnaire was developed by Allergan Inc. (Irvine, CA, USA) in 2000 [ 15 ], and the current version includes a 12-item self-administered questionnaire that evaluates the frequency of symptoms over the preceding week in approximately 5 min. The OSDI score ranges between 0 and 100, where higher scores represent greater severity of symptoms, as follows: no symptoms (score ≤ 12), mild symptoms (score between 13 and 22), moderate symptoms (score between 23 and 32), and severe symptoms (score between 33 and 100) [ 15 , 23 ].…”

Ocular Surface Evaluation after Switch from Latanoprost 0.005% to Latanoprostene Bunod 0.024%

“… 14 , 16 The scientific value of the OSDI test has already been validated, where the total score obtained is positively correlated with the severity of dry eye disease and the impact on daily activities. 5 , 6 It asks questions aimed at detecting and grading ocular surface involvement in the context of a person's daily life, using 12 items that assess ocular pain due to problems related to dry eye syndromes and their relationship with visual function. 17 Considering the relationship between glaucoma and ocular surface, this test has also been widely used in clinical trials to evaluate pharmacological treatments and surgical procedures in glaucoma.…”

“… 3 , 4 To assess tolerance and ocular surface disease, in addition to the clinical observations that the physician can make, it is relevant to know the patient's opinion, for which, among the different tests that have been developed, the ocular surface disease index (OSDI) is a robust, reliable and widely validated measurement tool, based on questions aimed at detecting and grading the ocular surface involvement, in the context of a person's quality of life. 5 , 6 …”

HIV-Specific Reported Outcome Measures: Systematic Review of Psychometric Properties

“…However, no guidance has been provided in the COSMIN guidelines with regard to relying on only Rasch analysis without classical test theory statistics to assess the structural validity of PROMs. Therefore, Recchioni [193] suggested that it is necessary to provide additional guidance for the study that only uses Rasch analysis, especially in the development of new PROMs.…”