ASSESSMENT OF COUNTRY-LEVEL HEALTH-RELATED QUALITY OF LIFE (HRQL) OUTCOMES AND TREATMENT EFFECT OF LEVONORGESTREL-RELEASING INTRAUTERINE SYSTEM (LNG-IUS) IN WOMEN WITH IDIOPATHIC MENORRHAGIA

Author(s)

Stull DE1, Vanness D2, Lambrelli D3, Filonenko A4, Franke E4, Wittrup-Jensen K41United BioSource Corporation (formerly), London, United Kingdom, 2University of Wisconsin, Madison, WI, USA, 3United BioSource Corporation, London, United Kingdom, 4Bayer Sche

OBJECTIVES: Calculate the country-level scores for the SF-36v2 subscales and components for women with idiopathic menorrhagia treated with LNG-IUS; explore between-country variability in HRQL experience of this condition; and evaluate the treatment effect in different geographical settings. METHODS: Baseline and 12-month data from a prospective, observational study of women with idiopathic menorrhagia from 9 countries (Bulgaria, Croatia, India, Jordan, Romania, Russia, Saudi Arabia, Serbia and Montenegro, and Turkey) were analyzed. Scores were calculated for each of the eight domains and Physical and Mental component summaries (PCS and MCS) of the SF-36v2. Hierarchical modeling was applied to account for nested nature of observations within the countries. Frequentist mixed effects regressions in STATA and Bayesian Markov Chain Monte Carlo simulation in WinBUGS were used to calculate country-level estimates, controlling for covariates. RESULTS: Idiopathic menorrhagia negatively affects HRQL in different geographic settings; in most countries baseline mean MCS scores are more than one standard deviation (10 units) below the normative UK mean. Between-country variability was confirmed in Bayesian and Frequentists analysis for baseline subscales (range: 36-86) and MCS and PCS (range: 35-51), indicating variation in experience with menorrhagia. In general, 12-month estimates were much higher than those at baseline, indicating substantial improvement in HRQL while on treatment, regardless of country. In addition, there was a consistent, positive relationship of haemoglobin with the SF-36v2 subscales and the MCS. CONCLUSIONS: Women in 9 countries in the study are negatively affected by menorrhagia, though country-level variation was seen.  Improvement in HRQL while on treatment was consistent across geographic settings. Exploration of potential country- or patient-level effects is recommended in future research.

Conference/Value in Health Info

2011-11, ISPOR Europe 2011, Madrid, Spain

Value in Health, Vol. 14, No. 7 (November 2011)

Code

PIH48

Topic

Patient-Centered Research

Topic Subcategory

Patient-reported Outcomes & Quality of Life Outcomes

Disease

Reproductive and Sexual Health

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