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临床试验/CTRI/2025/03/082138
CTRI/2025/03/082138尚未招募不适用

Cross cultural adaptation, translation, and psychometric analysis of Diabetes quality of life questionnaire(Diabetes QoL-Q) in Tamil language, India

Prof.T.S.Veeragoudhaman1 个研究点 分布在 1 个国家目标入组 322 人开始时间: 2025年1月5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
322
试验地点
1
主要终点
Self reported quality of life using Diabetes quality of life questionnaire

研究概览

简要总结

1. Introduction

The purpose of this protocol is to outline the steps involved in the cross-cultural adaptation, translation, and psychometric analysis of the Diabetes Quality of life questionnaire (Diabetes QoL-Q) in Tamil language. The Diabetes QoL-Q (46 items) is a health related quality of life questionnaire widely used among diabetes population, which has been translated into different languages. Adapting and translating the Diabetes QoL- Q into Tamil language will enable its use in Tamil -speaking populations, ensuring cultural appropriateness and validity. The researchers hope to capture the distinctive experiences and opinions of individuals with diabetes in India using culturally relevant healthcare assessments.

2. Cross-Cultural Adaptation Process

The cross-cultural adaptation process involves the following steps:

Step 1: Permission and Collaboration

Obtain permission from the original developers of the Diabetes QoL-Q to proceed with the adaptation process. Seek collaboration from experts in diabetes related research and Tamil language specialists.

Step 2: Translation

Engage bilingual translators proficient in English and Tamil to independently translate the original Diabetes QoL-Q into Tamil language. Aim for two or more independent translations to ensure multiple perspectives.

Step 3: Synthesis

Form a committee consisting of translators, experts, and a methodologist. Review the independent translations and compare them to identify discrepancies and areas of disagreement. Develop a consensus version of the translated Diabetes QoL-Q through discussion and consensus among the committee members.

Step 4: Back-Translation

Engage bilingual translators who are native English speakers and are fluent in Tamil. Provide them with the consensus version of the translated QoL-Q Diabetes and instruct them to independently back-translate it into English.

Step 5: Expert Committee Review

Convene the expert committee to review the back-translated English version in comparison to the original QoL- Q Diabetes. Identify any discrepancies and discuss potential cultural and linguistic differences.

Step 6: Pretesting

Administer the pre-final version of the translated Diabetes QoL-Q to a sample of the target population (Tamil-speaking individuals). Collect feedback on comprehension, cultural relevance, and clarity of the items. Modify the translated Diabetes QoL-Q based on the feedback received.

3. Psychometric Analysis

Once the adapted and translated Diabetes QoL- Q is finalized, it is important to assess its psychometric properties to ensure validity and reliability. This involves the following steps:

Step 1: Sampling

Determine the desired sample size based on statistical considerations. Aim for a representative sample of Tamil-speaking individuals across different age groups, genders, and both type I and type II diabetes patients.

Step 2: Data Collection

Administer the finalized Tamil version of the Diabetes QoL-Q to the selected sample. Collect demographic information and ensure standardized procedures for data collection to minimize bias.

Step 3: Reliability Analysis

Assess the internal consistency reliability of the Tamil Diabetes QoL-Q using statistical methods such as Cronbach’s alpha. This analysis measures the extent to which items in the Diabetes QoL-Q are interrelated.

Step 4: Construct Validity Analysis

Evaluate the construct validity of the Tamil Diabetes QoL-Q by assessing its correlation with other established diabetes related measures or clinical assessments. Use appropriate statistical techniques such as correlation coefficients or factor analysis.

Step 5: Test-Retest Reliability

Assess the test-retest reliability of the Tamil Diabetes QoL-Q by re-administering the questionnaire to a subsample of participants after a specified interval. Calculate the intra class correlation coefficient (ICC) to determine the degree of agreement between the two administrations.

Step 6: Cultural Adaptation Report

Prepare a comprehensive report summarizing the cross-cultural adaptation process, translation procedure, and psychometric analysis results. Include recommendations for the use of the Tamil Diabetes QoL-Q in research and clinical practice.

4. Conclusion

This protocol outlines the steps involved in the cross-cultural adaptation, translation, and psychometric analysis of the Diabetes Quality of life questionnaire (Diabetes QoL- Q) in Tamil. Adapting and validating the Diabetes QoL-Q in Tamil will enable its accurate assessment of quality of life and related to their treatment among Tamil-speaking individuals, contributing to more culturally sensitive research and healthcare practices.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • Participants should be native Tamil speakers or individuals fluent in Tamil, adults aged 18 years and above, both type I and Type II diabetes, those who is willing to participate in the study.

排除标准

  • Individuals with cognitive impairment, hearing impairment, visual impairment, physically challenged individuals and pregnant mothers.

结局指标

主要结局

Self reported quality of life using Diabetes quality of life questionnaire

时间窗: Baseline and 2 weeks test retest reliability

次要结局

  • Self reported general health measured by SF 36questionnaire(Baseline & 2 weeks test retest reliability)

研究者

发起方
Prof.T.S.Veeragoudhaman
申办方类型
Other [Self funded]

研究点 (1)

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