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一项临床试验中心力衰竭患者健康认知与效用之间的关系:OVERTURE子研究结果

The relationship between health perception and utility in heart failure patients in a clinical trial: results from an OVERTURE substudy.

作者信息

Havranek Edward P, Simon Teresa A, L'Italien Gilbert, Smitten Allison, Hauber A Brett, Chen Roland, Lapuerta Pablo

机构信息

Division of Cardiology, Denver Health Medical Center, University of Colorado Health Sciences Center, Denver, Colorado 80204-4507, USA.

出版信息

J Card Fail. 2004 Aug;10(4):339-43. doi: 10.1016/j.cardfail.2003.11.002.

Abstract

BACKGROUND

Cost-effectiveness analyses should be based on incremental years of life gained adjusted with a health status measure known as a utility. Measuring utilities for all subjects in a large-scale randomized trial, however, would be prohibitively cumbersome. We therefore sought to estimate utilities for all subjects from results obtained in a subset of patients.

METHODS AND RESULTS

We studied a subset of patients enrolled in a randomized trial of omapatrilat for the treatment of heart failure. Survey instruments (a time trade-off questionnaire, a visual analog scale [VAS] score of overall health perception, and the Duke Activity Status Index [DASI]) were administered to patients by mail and by telephone interviews. There was a significant (P <.0001) relationship between VAS score and utility described by the power function u=1-(1-v)q, where q=2.17 (95% CI 1.76 to 2.58). There was a significant positive correlation (r=.17, P <.04) between the DASI and utility, and a significant negative correlation (r=-.26, P <.001) between utility and New York Heart Association functional class.

CONCLUSION

There is a significant relationship between the relatively easily obtainable health perception score by VAS with the more complex utility by time tradeoff for a subset of patients in a multicenter randomized clinical trial. This relationship may be helpful in examining the cost-effectiveness of new treatments for heart failure.

摘要

背景

成本效益分析应基于通过一种称为效用的健康状况衡量指标调整后的增量生命年。然而,在大规模随机试验中为所有受试者测量效用将极其繁琐。因此,我们试图根据一部分患者的结果来估计所有受试者的效用。

方法与结果

我们研究了参加奥美普利拉治疗心力衰竭随机试验的一部分患者。通过邮寄和电话访谈向患者发放调查问卷(时间权衡问卷、总体健康感知视觉模拟量表[VAS]评分以及杜克活动状态指数[DASI])。VAS评分与幂函数u = 1 - (1 - v)^q所描述的效用之间存在显著(P <.0001)关系,其中q = 2.17(95%CI 1.76至2.58)。DASI与效用之间存在显著正相关(r =.17,P <.04),效用与纽约心脏协会功能分级之间存在显著负相关(r = -.26,P <.001)。

结论

在一项多中心随机临床试验的一部分患者中,通过VAS相对容易获得的健康感知评分与通过时间权衡得出的更复杂的效用之间存在显著关系。这种关系可能有助于评估心力衰竭新治疗方法的成本效益。

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