PMID- 15291959 OWN - NLM STAT- MEDLINE DCOM- 20050214 LR - 20240411 IS - 1477-7525 (Electronic) IS - 1477-7525 (Linking) VI - 2 DP - 2004 Aug 3 TI - The ECOS-16 questionnaire for the evaluation of health related quality of life in post-menopausal women with osteoporosis. PG - 41 AB - 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. FAU - Badia, Xavier AU - Badia X AD - Health Outcomes Research (HOR) Europe, Barcelona, Spain. xbadia@hor-europe.com FAU - Diez-Perez, Adolfo AU - Diez-Perez A FAU - Lahoz, Raquel AU - Lahoz R FAU - Lizan, Luis AU - Lizan L FAU - Nogues, Xavier AU - Nogues X FAU - Iborra, Jordi AU - Iborra J LA - eng PT - Journal Article PT - Multicenter Study PT - Research Support, Non-U.S. Gov't PT - Validation Study DEP - 20040803 PL - England TA - Health Qual Life Outcomes JT - Health and quality of life outcomes JID - 101153626 SB - IM MH - Aged MH - Female MH - Fractures, Bone/etiology MH - Humans MH - Low Back Pain/etiology MH - Middle Aged MH - Observation MH - Osteoporosis/*physiopathology/psychology MH - Outpatient Clinics, Hospital MH - Pain Measurement MH - Postmenopause/physiology/*psychology MH - Primary Health Care MH - Prospective Studies MH - Psychometrics/*instrumentation MH - Quality of Life/*psychology MH - *Sickness Impact Profile MH - Social Class MH - Spain MH - *Surveys and Questionnaires/*statistics & numerical data PMC - PMC514569 EDAT- 2004/08/05 05:00 MHDA- 2005/02/16 09:00 PMCR- 2004/08/03 CRDT- 2004/08/05 05:00 PHST- 2003/12/09 00:00 [received] PHST- 2004/08/03 00:00 [accepted] PHST- 2004/08/05 05:00 [pubmed] PHST- 2005/02/16 09:00 [medline] PHST- 2004/08/05 05:00 [entrez] PHST- 2004/08/03 00:00 [pmc-release] AID - 1477-7525-2-41 [pii] AID - 10.1186/1477-7525-2-41 [doi] PST - epublish SO - Health Qual Life Outcomes. 2004 Aug 3;2:41. doi: 10.1186/1477-7525-2-41.