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临床试验/NCT01209091
NCT01209091已完成不适用

Utility and Work Productivity Data for Economic Evaluation of Breast Cancer Therapies in the Netherlands and Sweden

GlaxoSmithKline0 个研究点目标入组 200 人开始时间: 2009年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
200
主要终点
Health utility: is a measure of strength of preference that people have for particular health states. A year in full health is arbitrarily assigned a value of 1: a state that is considered equivalent to death is assigned a value of zero

研究概览

简要总结

Introduction: Many reimbursement authorities use economic evaluation to help guide decisions regarding the adoption of new treatments in reimbursement systems. Survival and quality of life are often the main measure of benefit used in an economic evaluation - expressed as a quality adjusted life year (QALY). In addition though, some decision makers will also consider the impact of a treatment on a patient's ability to continue working (expressed in terms of productivity). The aim of the present study is to estimate quality of life weights (utilities) and productivity loss for women with metastatic breast cancer (Human Epidermal Growth Factor Receptor 2 positive or HER 2+).

Methods: Separate surveys will be used to assess utilities and productivity in HER2+ metastatic breast cancer (MBC). To capture utilities health state descriptions or vignettes describing progressive disease, stable disease, and seven grade 3/4 adverse events (diarrhoea, fatigue, anaemia, leukopenia, anorexia, decreases in left ventricular ejection fraction (LVEF), and skin rash) will be developed. The vignettes will be developed based on a literature review and in depth interviews with women with MBC in the Netherlands and Sweden. Clinical experts in both countries will review the health states for content validity. The health states will be translated using forward and back translation. Members of the general public will rate the states (100 men and women in NL; 100 women aged 50+ in Sweden) using the visual analogue scale and Time Trade Off method to determine utility values. In a separate survey women who are currently being treated or have recently completed their treatment for MBC will be surveyed regarding the impact of disease on their ability to work using a validated work productivity measure (Work Productivity and Activity Impairment) in women in the Netherlands and Sweden.

研究设计

研究类型
Observational
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Health utility: is a measure of strength of preference that people have for particular health states. A year in full health is arbitrarily assigned a value of 1: a state that is considered equivalent to death is assigned a value of zero

次要结局

  • Productivity loss: productive working time lost due to health related inability to work. These include the costs of lost work due to absenteeism or early retirement, impaired productivity at work, and lost or impaired leisure activity.

研究者

申办方类型
Industry
责任方
Sponsor

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