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临床试验/CTRI/2021/07/035054
CTRI/2021/07/035054尚未招募不适用

Development and Validation of Paediatric Ocular Dryness Symptom (PODS) questionnaire

Rinu Thomas1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2021年7月24日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
120
试验地点
1
主要终点
Development and Validation of PODS Questionnaire

研究概览

简要总结

DEVELOPMENT AND VALIDATION OF PAEDIATRIC OCULAR DRYNESS SYMPTOM (PODS) QUESTIONNAIRE

 Dry eye is a multifactorial disease of both the tears and ocular surface.  It results in symptoms of discomfort, visual disturbance, and tear film instability with some potential damage to the ocular surface. The use of digital devices and technology has increased exponentially during the 20th century and with the advent of the COVID-19 pandemic. Most schools and institutions have resorted to online and digital modes of classes and learning with 36.9% of children using digital devices for more than 5 hours compared to 1.8% of children who were using before the COVID era. Due to this extensive time, which is being spent on digital devices, children are prone to experiencing the symptoms of dry eye that need to be assessed. The purpose of this study was to develop and validate the Paediatric Ocular Dryness Symptom (PODS) questionnaire specific to the paediatric population.

Methodology:

A five phased process will be adopted to develop and validate the PODS questionnaire.

  1. Item Development and Instrument Design: This involves the identification of various content dimensions which needs to be added in the questionnaire and sampling of items under each dimension leading to the development of the first version of PODS questionnaire.2. Content validation: The questions assimilated through the process of instrument construction will be distributed to the experts in the field of Optometry and Ophthalmology and they will be asked to grade the questions based on the relevance, clarity, and essentiality of the questions with respect to the study objective. Following the process of expert opinion, empirical methods will be used to calculate and quantify Content Validity Index (CVI) – Item Level and Scale Level (I-CVI and S-CVI) and Content Validity Ratio (CVR).

  2. Face validation: Qualitative face validity will be carried out using the first version of the questionnaire through a direct online cognitive interview with the target population. The target population will include children studying in an English medium school within the age group of 6-18 years corresponding to Ist to XIIth standard of education. Snowball sampling will be used for identifying more children for this phase of validation and Microsoft teams will be used for the online interview process. The quantitative method of face validation will involve allowing the participants to grade the questions in the first version of the questionnaire based on its importance to calculate the item impact score (IIS).

  3. Criterion Validity: Criterion validity will be done using two methods – Concurrent and Predictive validity methods. Concurrent validation would involve grouping children based on their diagnosis of dry eye and allowing them to complete the PODS questionnaire. Correlation between the diagnosis of dry eye and PODS questionnaire score will be used to establish the concurrent validity of the questionnaire.

A separate questionnaire to assess the screen time in children would also be done following which PODS will be given to the children. Correlation between the screen time as a predictor of dry eye symptoms would be the method used for the predictive validation process.

  1. Reliability and repeatability assessment for the questionnaire.

Outcome:

  1. Development and Validation of PODS questionnaire

  2. Correlation between screen time and dry eye symptoms in children

研究设计

研究类型
Observational

入排标准

年龄范围
6.00 Year(s) 至 18.00 Year(s)(—)
性别
All

入选标准

  • Children studying in English Medium Schools from 1st standard to 12th standard will be included in the study.

排除标准

  • Excluded all schools which are not english medium.

结局指标

主要结局

Development and Validation of PODS Questionnaire

时间窗: 6 months

次要结局

  • Correlation between screen time usage and dry eye symptoms in pediatric population(2 years)

研究者

发起方
Rinu Thomas
申办方类型
Other [self]

研究点 (1)

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