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01.12.2012 | Research | Ausgabe 1/2012 Open Access

Health and Quality of Life Outcomes 1/2012

Validation of the osteoporosis quality of life questionnaire QUALEFFO-41 for the Serbian population

Health and Quality of Life Outcomes > Ausgabe 1/2012
Ivana Tadic, Nada Vujasinovic Stupar, Ljiljana Tasic, Dejan Stevanovic, Aleksandar Dimic, Bojana Stamenkovic, Sonja Stojanovic, Sasa Milenkovic
Wichtige Hinweise

Electronic supplementary material

The online version of this article (doi:10.​1186/​1477-7525-10-74) contains supplementary material, which is available to authorized users.

Competing interests

The authors declare that they have no competing interest.

Authors’ contributions

TI, NVS and LJT has organized the study, has collected, analysed and interpreted the data; TI has written the first version of manuscript; SD has analysed and interpreted the data and helped draft the paper; DA, SB, SS and MS have collected the data and edited the paper. All authors have read and approved the final manuscript.



Vertebral fractures could lead to reduced physical, social and mental functioning, and loss of personal independence. Therefore, during the treatment of osteoporosis, it has become necessary to examine the changes in everyday functioning, well-being and health related quality of life (HRQOL). To that effect, this study aims to translate, culturally adapt, and validate the Serbian version of Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO-41) for patients with vertebral fractures.


Nine female patients with osteoporosis participated in the pre-validation study. A validation, case–control study included two groups of female patients: one that consisted of 50 female patients with osteoporosis, and with at least one vertebral fracture, and another one that consisted of 50 control patients with osteoporosis but without fractures. They completed the QUALEFFO-41 and the EuroQol group questionnaire with five dimensions (EQ-5D) twice within a month. The validation study examined internal consistency, concurrent validity, test-retest reliability, sensitivity and specificity.


During the pre-validation study, three of the items in the QUALEFFO-41 were slightly changed. Afterwards, during the validation study, the statistically significant differences (adjusted for: age, duration of menopause, current employment and marital status) in the mean values of all domains and total scores between the groups were noted. For the case group, the internal consistency of the QUALEFFO-41 domains and of total questionnaire was above 0.70. The test-retest reliability was tested by the intraclass correlation coefficients (ICC) that were in range 0.87 – 0.96 for the case, and 0.15 – 0.83 for the control group. Correlations between the total scores of the QUALEFFO-41 and the EQ-5D health state value, for both groups were negative and statistically significant (r = -0.78, p<0.001 and r = -0.73, p<0.001, respectively). The QUALEFFO-41 had a better prediction of the value of HRQOL of cases compared to the generic questionnaire EQ-5D (the AUC difference was 0.099, p = 0.013).


The Serbian QUALEFFO-41 version is reliable, valid, sensitive and predictive for examinations of HRQOL in patients with prevalent vertebral fractures and can be used in further studies.
Additional file 1: Number of patients according to the number of vertebral fractures. (PDF 10 KB)
Additional file 2: Distribution of patients according to fracture site. (PDF 12 KB)
Authors’ original file for figure 1
Authors’ original file for figure 2
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