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Health and Quality of Life Outcomes

, 2:41

First Online: 03 August 2004Received: 09 December 2003Accepted: 03 August 2004


BackgroundThe aim of this study is to validate the questionnaire ECOS-16 Assessment of health related quality of life in osteoporosis for the evaluation of health related quality of life HRQoL in post-menopausal women with osteoporosis.

MethodsAn observational, prospective and multi-centre study was carried out among post-menopausal women with osteoporosis in primary care centres and hospital outpatient clinics. All patients attended 2 visits: at baseline and at 6 months. In addition, the subgroup of outpatients attended another visit a month after the baseline to assess the test-retest reliability. The psychometric properties of the questionnaire were evaluated in terms of feasibility, validity content validity and construct validity and internal consistency in baseline, and in terms of test-retest reliability and responsiveness to change in visit at month and visit at 6 months, respectively. In all visits, ECOS-16, EUROQoL-5D EQ-5D and four 7-point items about health status general health status, back pain, limitation in daily activities and emotional status were administered, whereas only outpatients were given MINI-OQLQ Mini Osteoporosis Quality of Life Questionnaire, besides all clinical variables; and sociodemographic variables at baseline.

Results316 women were consecutively included, 212 from primary care centres and 104 from hospital outpatient clinics. Feasibility: 94.3% of patients answered all items of the questionnaire. The mean administration time was 12.3 minutes. Validity: factor analysis suggested that the questionnaire was unidimensional. In the multivariate analysis, patients with vertebral fractures, co-morbidity and a lower education level showed to have worse HRQoL. Moderate to high correlations were found between the ECOS-16 score and the other health status questionnaires 0.47–0.82. Reliability: internal consistency Cronbach-s α was 0.92 and test-retest reliability ICC was 0.80. Responsiveness to change: ECOS-16 scores increased according to change perceived by the patient, as well as the effect size ranges between 1.35 to 0.43, the greater the perception of change in patients- general health status, the greater the changes in patients- scores. The Minimal Clinically Important Difference MCID suggested a change of 0.5 points in the ECOS-16 score, representing the least improvement in general health status due to their osteoporosis: -slightly better-.

ConclusionECOS-16 has been proven preliminarily to have good psychometric properties, so that it can be potentially a useful tool to evaluate HRQoL of post-menopausal women with osteoporosis in research and routine clinical practice.

Electronic supplementary materialThe online version of this article doi:10.1186-1477-7525-2-41 contains supplementary material, which is available to authorized users.

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Autor: Xavier Badia - Adolfo Díez-Pérez - Raquel Lahoz - Luis Lizán - Xavier Nogués - Jordi Iborra


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