Clinical trial NCT03504384: Adaptation and Validation of the Arabic Version of EuroQol 5D-5L
Official title: Cross Cultural Adaptation and Validation of The Arabic Version Of EuroQol 5D-5L
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Validation Study
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-04-20
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: between 18 and 70 years old. patients operated upon for spine degenerative disease coming for follow up in the outpatient clinics.

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: A reliable and validated Arabic version of the EQ-5D-5L instrument
timeFrame: basline
Secondary outcomes:
measure: factors affecting quality of life of spine disease patients.
timeFrame: baseline
Other outcomes:
Locations:
Study officials:
References:
citation: EuroQol Group. EuroQol--a new facility for the measurement of health-related quality of life. Health Policy. 1990 Dec;16(3):199-208. doi: 10.1016/0168-8510(90)90421-9.
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. doi: 10.1016/0895-4356(93)90142-n.