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

Abstract

BackgroundVertebral 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.MethodsNine 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.ResultsDuring 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).ConclusionsThe 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.

Health-related quality of life in older people with osteoporotic vertebral fractures: a systematic review and meta-analysis

“…Sixteen studies that met all inclusion criteria were included in the final analysis [13][14][15][16][17][18][19][20][21][22][23][24][25][26][27][28] with a total of 3131 men and women (1698 with vertebral fracture, and 1433 without vertebral fracture). Fourteen of these studies were cross-sectional [13-17, 19, 20, 22-28], one case-control [21], and one baseline data from an RCT [18].…”

“…Fourteen of these studies were cross-sectional [13-17, 19, 20, 22-28], one case-control [21], and one baseline data from an RCT [18]. The characteristics of the included studies are shown in Table 1.…”

“…To measure bone density, DXA was used in all the included studies. Osteoporosis was defined as T score ≤ 2.5 SD, and lumbar BMD was measured in five studies [19][20][21][22]24], eight studies reported lumbar or/and hip BMD [13, 16-18, 23, 25, 27, 28], and in three studies the site of DXA scan was not mentioned [14,15,26]. Vertebral fractures were identified using Semi-quantitative (SQ) method in 11 studies [13, 16, 17, 21-25, 27, 28], quantitative morphometric (QM) method in two studies [14,19], the SQ, the binary semi quantitative (BSQ), and the QM in one study, the Japanese diagnostic criteria in one study [26], and in one study the method is not mentioned [15].…”

“…Six papers reported HRQoL by using the (QUALEFFO) questionnaire [17,19,20,22,23,25], three used the (SF-36) questionnaire [14,15,28], one used the generic SF-12 [16], one used both QUALEFFO and SF-36 [27], one used SF-36, mini-osteoporosis quality of life questionnaire (OQLQ) and the generic (EQ-5D) [13], one used QUALEFFO and EQ-5D [21], one used QUALEFFO and the World Health Organization Quality of Life questionnaire (WHOQOL-100) [24], one used the generic Nottingham health profile questionnaire (NHP), EQ-5D and QUALEFFO [18], and one used SF-36, the Japanese Osteoporosis Quality of Life Questionnaire (JOQOL), and EQ-5D [26]. The effect size between groups was reported as mean (SD) in all studies apart from Lombardi study [14] which reported effect in median (range).…”

“…In 13 studies patients were recruited from secondary care [14,15,[17][18][19][21][22][23][24][25][26][27][28], one study recruited patients from primary care [20], one study from both secondary and primary care [13], and one was a population-based study [16]. In 11 studies the age for those with and without vertebral fractures were reported [13, 14, 16-18, 21-23, 25, 27, 28].…”