Clinical trial NCT06158906: Validity of Web-Based OSDI-6 Questionnaire in a Chinese Adult Population
Official title: Validity of Web-Based OSDI-6 Questionnaire in a Chinese Adult Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dry Eye
Keywords: qestionnaire
Lead sponsor: He Eye Hospital
Sponsor class: OTHER
First posted: 2023-12-06
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who have been diagnosed with dry eye

Brief summary: This study aimed to evaluate the validity of the Chinese translation version of OSDI-6 (C-OSDI-6) in a theoretical set-up of two questionnaire groups for dry eye

Detailed description: Screening for dry eye symptoms and quantifying dry eye symptoms aids in assessment, diagnosis, and treatment. Patient-reported outcome (PRO) instruments such as the Ocular Surface Disease Index (OSDI-12) are utilized for assessing patients' subjective experiences and functional abilities. The OSDI-12 comprises of 12-item and is often used in conjunction with other tests in clinical settings to assess individuals with DE. Created in 1997, the original OSDI consisted of 12 items and was designed to evaluate subjective dry eye symptoms and the consequences of DED on vision-related activities of daily life over the preceding week. The 12 items are grouped into three subscales: ocular symptoms (three items), vision-related functions (six items), and environmental triggers (three items). While the original version of the OSDI-12 questionnaire was created in English and was later translated and validated into other languages, it should be used carefully since the cutoff values vary among various languages (27.2 points for the Chinese version and 36.3 points for the Japanese version) . Recent research using Rasch analysis found that separating answer items into four categories by merging "half of the time" and "most of the time" might lead to higher thresholds and better intervals in each category. The OSDI-12 total score is calculated using the formula: \[(sum of scores for all questions answered) × 100\]/ \[(total number of questions answered) × 4\]. Ocular Surface Disease Index-6 (OSDI-6) is a derivative and shortened version of the original OSDI-12 and can potentially improve efficiency in a busy clinical setting.

Eligibility criteria: Inclusion Criteria:

* Diagnosed dry eye
* Able and willing to comply with the schedule
* Able to read and understand the C-OSDI-12 questionnaire independently

Exclusion Criteria:

* The researchers judged to be not suitable

Primary outcomes:
measure: OSDI12
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Shenyang
country: China
facility: He Eye Hospital
state: None Selected
Study officials:
References:
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