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


METHODS
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.


RESULTS
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).


CONCLUSIONS
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.
Department of Social Pharmacy and Pharmaceutical Legislation, University of Belgrade, Faculty of Pharmacy, Vojvode Stepe 450, 11000 Belgrade, Serbia. ivana.tadic@pharmacy.bg.ac.rs
Ivana
I
Tadic
Nada
N
Vujasinovic Stupar
Ljiljana
L
Tasic
Dejan
D
Stevanovic
Aleksandar
A
Dimic
Bojana
B
Stamenkovic
Sonja
S
Stojanovic
Sasa
S
Milenkovic
D015502:Absorptiometry, Photon; D000368:Aged; D000369:Aged, 80 and over; D019540:Area Under Curve; D016022:Case-Control Studies; D004651:Employment / Q000523:psychology; D005260:Female; D006801:Humans; D008593:Menopause / Q000502:physiology / Q000523:psychology; D008875:Middle Aged; D010024:Osteoporosis / Q000000981:diagnostic imaging / Q000523:psychology* / Q000534:rehabilitation; D010147:Pain Measurement; D011788:Quality of Life / Q000523:psychology*; D020127:Recovery of Function; D015203:Reproducibility of Results; D055771:Serbia; D012923:Social Class; D016103:Spinal Fractures / Q000000981:diagnostic imaging; D011795:Surveys and Questionnaires / Q000592:standards*