Validation of the Turkish Version of QUALEFFO-31

Study Overview
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Brief Summary
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The aim of this study is to investigate the adaptation and validity of the Quality of Life Questionnaire of the European Foundation for Osteoporosis-31 in patients with osteoporosis. Thus, to present a scale that will help us analyze the psychometric properties of patients with osteoporosis to the use of the Turkish people .

Detailed Description
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Osteoporosis has become an important public health problem due to low bone mass, decreased bone strength and increased risk of fractures. Today, the measurement of quality of life plays an important role in the approach to diseases. Quality of Life Questionnaire of the European Foundation for Osteoporosis-41 (QUALEFFO-41) has been used for many years as a well-established and fully self-administered questionnaire. In the following years, a shorter and more practical version was needed because the QUALEFFO-41 contains many questions and takes a long time. For this reason, the questionnaire was updated in 2006 and the version of QUALEFFO-31 was made and the validity of the current questionnaire was shown. The aim of this study is to conduct the reliability and validity study of Turkish version of QUALEFFO-31 and to evaluate the power of the questionnaire to distinguish patients with osteoporosis.

Official Title
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Validation of the Turkish Version of Quality of Life Questionnaire of the European Foundation for Osteoporosis-31 (QUALEFFO-31)

Conditions
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Osteoporosis

Intervention / Treatment
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* Other: Testing the Quality of Life Questionnaire of the European Foundation for Osteoporosis-31(QUALEFFO-31)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: To have Dual-energy X-ray absorptiometry (DXA) results and thoracolumbar lateral spine X-Rays taken for any reason in the last 6 months. To have calcium, phosphorus, parathormone (PTH) and 25-hydroxyvitamin D level in the last 3 months. To be independently ambulatory. To have a cognitive capacity to understand and complete the questionnaires. Exclusion Criteria: To have malignancy. To have inflammatory diseases. To have a metabolic bone disease other than osteoporosis. To have neuromuscular diseases.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| QUALITY OF LIFE QUESTIONNAIRES<br>The group is anticipated to consist of 150 female and male with osteoporosis, osteopenia or normal bone mineral density. | Other: Testing the Quality of Life Questionnaire of the European Foundation for Osteoporosis-31(QUALEFFO-31)<br>* Administer the questionnaires to 150 participants to classify their status of quality of life.<br>* Other names: Testing the Short Form-36 (SF-36);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reliability and validity of the Quality of Life Questionnaire of the European Foundation for Osteoporosis-31 | Internal consistency will be tested with Cronbach Alpha coefficient. Intergroup reliability and consistency will be evaluated by T-Test. | Through study completion, an average of 6 months | 
| Correlation between Quality of Life Questionnaire of the European Foundation for Osteoporosis-31 and Short Form-36. | The Spearman Correlation Analysis will be used for the correlation between QUALEFFO-31 and SF-36. | Through study completion, an average of 6 months | 
| Testing Short Form-36 | SF-36 is a self-assessment instrument. It consists of eight domains: bodily pain, physical functioning, social functioning, general health, mental health, vitality, and role restrictions due to physical and emotional problems.SF-36 is scored from 0 to 100. 0 indicated poor health status and 100 indicated good health status. | Through study completion, an average of 6 months | 
| Testing Quality of Life Questionnaire of the European Foundation for Osteoporosis-31 | QUALEFFO-31 is a self-assessment instrument. It consists of three domains: pain,physical function and a mental function. QUALEFFO-31 is scored from 0 to 100. Domain scores were calculated by summing the scores of questions included in the domain and submitting the sum to a linear transformation to a scale of 100. Zero indicated good health status and 100 indicated poor health status. | Through study completion, an average of 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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osteoporosis, Questionnaire, Quality of Life, QUALEFFO