Dataset Information

The ECOS-16 questionnaire for the evaluation of health related quality of life in post-menopausal women with osteoporosis.

ABSTRACT:

Background

The 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.

Methods

An 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.

Results

316 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 alpha) 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".

Conclusion

ECOS-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.

SUBMITTER: Badia X

PROVIDER: S-EPMC514569 | biostudies-literature | 2004 Aug

REPOSITORIES: biostudies-literature

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Publications

The ECOS-16 questionnaire for the evaluation of health related quality of life in post-menopausal women with osteoporosis.

Badia Xavier X Díez-Pérez Adolfo A Lahoz Raquel R Lizán Luis L Nogués Xavier X Nogués Xavier X Iborra Jordi J

Health and quality of life outcomes 20040803

<h4>Background</h4>The 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.<h4>Methods</h4>An 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 ...[more]

PMID: 15291959

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Project description:BackgroundAdherence to anti-osteoporosis treatments is poor, exposing treated women to increased fracture risk. Determinants of poor adherence are poorly understood. The study aims to determine physician- and patient- rated treatment compliance with osteoporosis treatments and to evaluate factors influencing compliance.MethodsThis was an observational, cross-sectional pharmacoepidemiological study with a randomly-selected sample of 420 GPs, 154 rheumatologists and 110 gynaecologists practicing in France. Investigators included post-menopausal women with a diagnosis of osteoporosis and a treatment initiated in the previous six months. Investigators completed a questionnaire on clinical features, treatments and medical history, and on patient compliance. Patients completed a questionnaire on sociodemographic features, lifestyle, attitudes and knowledge about osteoporosis, treatment compliance, treatment satisfaction and quality of life. Treatment compliance was evaluated with the Morisky Medication-taking Adherence Scale. Variables collected in the questionnaires were evaluated for association with compliance using multivariate logistic regression analysis.Results785 women were evaluated. Physicians considered 95.4% of the sample to be compliant, but only 65.5% of women considered themselves compliant. The correlation between patient and physician perceptions of compliance was low (?: 0.11 [95% CI: 0.06 to 0.16]). Patient-rated compliance was highest for monthly bisphosphonates (79.7%) and lowest for hormone substitution therapy (50.0%). Six variables were associated with compliance: treatment administration frequency, perceptions of long-term treatment acceptability, perceptions of health consequences of osteoporosis, perceptions of knowledge about osteoporosis, exercise and mental quality of life.ConclusionCompliance to anti-osteoporosis treatments is poor. Reduction of dosing regimen frequency and patient education may be useful ways of improving compliance.

Project description:Studies examining real-world effectiveness of osteoporosis therapies are beset by limitations due to confounding by indication. By evaluating longitudinal changes in fracture incidence, we demonstrated that osteoporosis therapies are effective in reducing fracture risk in real-world practice settings. INTRODUCTION:Osteoporosis therapies have been shown to reduce incidence of vertebral and non-vertebral fractures in placebo-controlled randomized clinical trials. However, information on the real-world effectiveness of these therapies is limited. METHODS:We examined fracture risk reduction in older, post-menopausal women treated with osteoporosis therapies. Using Medicare claims, we identified 1,278,296 women age ≥ 65 years treated with zoledronic acid, oral bisphosphonates, denosumab, teriparatide, or raloxifene. Fracture incidence rates before and after treatment initiation were described to understand patients' fracture risk profile, and fracture reduction effectiveness of each therapy was evaluated as a longitudinal change in incidence rates. RESULTS:Fracture incidence rates increased during the period leading up to treatment initiation and were highest in the 3-month period most proximal to treatment initiation. Fracture incidence rates following treatment initiation were significantly lower than before treatment initiation. Compared with the 12-month pre-index period, there were reductions in clinical vertebral fractures for denosumab (45%; 95% confidence interval [CI] 39-51%), zoledronic acid (50%; 95% CI 47-52%), oral bisphosphonates (24%; 95% CI 22-26%), and teriparatide (72%; 95% CI 69-75%) during the subsequent 12 months. Relative to the first 3 months after initiation, clinical vertebral fractures were reduced for denosumab (51%; 95% CI 42-59%), zoledronic acid (25%; 95% CI 17-32%), oral bisphosphonates (23%; 95% CI 20-26%), and teriparatide (64%; 95% CI 58-69%) during the subsequent 12 months. CONCLUSION:In summary, reductions in fracture incidence over time were observed in cohorts of patients treated with osteoporosis therapies.

Project description: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.

Project description:We aimed to investigate the association between cadmium levels and the risk of osteopenia and osteoporosis in Korean post-menopausal women. There was a significant positive association between cadmium levels and the risk of osteopenia and osteoporosis, but further studies for dose response are required.PurposeCadmium exposure can exert detrimental effects on bone health, particularly in post-menopausal women. However, previous studies have failed to report an association in Korean post-menopausal women. We aimed to investigate the association between cadmium levels and the risk of osteopenia and osteoporosis in Korean post-menopausal women.MethodsIn total, 5432 participants from the 4th and 5th Korean National Health and Nutrition Examination Survey (KNHANES) were randomly sampled for measurements of heavy metal concentrations in the blood, bone mass density (BMD), and nutrient intake. We analyzed data for 1031 post-menopausal women ≥50 years of age. Blood cadmium levels were categorized into quartiles, and a multinomial logistic regression model was used for analysis.ResultsThere was a significant positive association between cadmium levels and the risk of osteopenia and osteoporosis, but the odds ratio (OR) at the 4th level was lower than that at the 3rd level (OR and 95% confidence interval (CI) for osteopenia: 2nd quartile: 1.24, 0.88-1.74; 3rd quartile: 3.22, 2.24-4.64; 4th quartile: 1.27, 0.87-1.85; P for trend <0.001; OR and 95% CI for osteoporosis: 2nd quartile: 1.54, 1.05-2.25; 3rd quartile: 3.63, 2.31-5.69; 4th quartile: 1.70, 1.03-2.81; P for trend <0.001). This trend was consistent in the sensitivity analysis.ConclusionOur findings suggest that there is an association between blood cadmium levels and the risk of osteopenia and osteoporosis in Korean post-menopausal women. However, further prospective studies are required to determine whether there is a dose-response relationship and address potential selection bias, especially in patients with femoral neck osteoporosis.

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Dataset Information

The ECOS-16 questionnaire for the evaluation of health related quality of life in post-menopausal women with osteoporosis.

Background

Methods

Results

Validity

Conclusion

Publications

The ECOS-16 questionnaire for the evaluation of health related quality of life in post-menopausal women with osteoporosis.

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