Adaptation and Validation of the Arabic Version of EuroQol 5D-5L

Validation Study Clinical Trial

Official title:

Cross Cultural Adaptation and Validation of The Arabic Version Of EuroQol 5D-5L

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03504384
• Other study ID #: validation of EuroQol 5D-5L
• Status: Not yet recruiting
• First received: April 12, 2018
• Last updated: April 12, 2018
• Start date: May 1, 2018
• Est. completion date: June 1, 2019

Study information

• Verified date: April 2018
• Source: Assiut University
• Contact: Ahmed Mahmoud Ahmed
• Phone: +201024608017
• Email: drahmed.mahmoud[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of the work is to provide a validated Arabic version of EuroQol 5D-5L ,so that it would be used as a quality of life assessment tool for Egyptian patients

Specific objectives:

1. Cross cultural adaptation of the translated Arabic version of EuroQol 5D-5L.

2. Assessment of the reliability of the translated Arabic version of EuroQol 5D-5L.

3. Testing the validity of the translated version of EuroQol 5D-5L.

Description:

Chronic back pain is one of the most important disabling illnesses. It has a high incidence, high prevalence and high cost to society. One of the most common causes of back pain are degenerative spine diseases which affect all aspects of quality of life (QoL) of the patients. They could affect job opportunities, social activities and hinder the patients from performing common daily activities.It was found that many factors could affect quality of life of spine degenerative diseases patients such as sex, age, body mass index (BMI), employment status , living with other family members, smoking, orthopedic disorder in another part of the body (other than spinal disease), history of spinal surgery, and bladder function. Comprehensive assessment of these patients should include health related quality of life (HRQoL) measures in addition to the objective clinical measures of the diseases. Europeans Quality of life questionnaire 5 dimensions ,5 levels (EQ-5D-5L) is a standardized measure of health status developed by the EuroQol Group which provides a simple, generic measure of health for clinical and economic appraisal (2).Despite being translated and validated in many languages, there is no validated Arabic version of EQ-5D-5L to measure the quality of life. The objective of this study is to evaluate the reliability and validity of the Arabic version of the questionnaire for Egyptian patients diagnosed to have Spine degenerative diseases.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 160
• Est. completion date: June 1, 2019
• Est. primary completion date: May 1, 2019
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• patients operated upon for spine degenerative disease coming for follow up in the outpatient clinics.

Exclusion Criteria:

• preoperative patients and immediate postoperative patients.

Related Conditions & MeSH terms

• Validation Study

Intervention

Other:
• questionnaire
All patients will be interviewed using a semi-structured questionnaire detailing patients' demographic characteristics (age, sex, education, occupation, residence), and the factors that could affect their quality of life such as pain and neurological symptoms, orthopedic disorder in another part of the body and history of spinal surgery.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (2)

EuroQol Group. EuroQol--a new facility for the measurement of health-related quality of life. Health Policy. 1990 Dec;16(3):199-208. — View Citation

Guillemin F, Bombardier C, Beaton D. Cross-cultural adaptation of health-related quality of life measures: literature review and proposed guidelines. J Clin Epidemiol. 1993 Dec;46(12):1417-32. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A reliable and validated Arabic version of the EQ-5D-5L instrument	Cross cultural adaptation and validation of the Arabic version of the EQ-5D-5L.	basline
Secondary	factors affecting quality of life of spine disease patients.	to study factors affecting quality of life of spine disease patients.	baseline