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临床试验中成本效益解读的问题。实验成本与实施成本。

Problems in interpreting cost effectiveness in clinical trials. Experimental versus implementation costs.

作者信息

De Nino L A, Mulrow C D, Gerety M B, Averyt E C

机构信息

Geriatric Research, Education and Clinical Center, Audie L. Murphy Memorial Veterans Hospital, San Antonio, TX 78284.

出版信息

Online J Curr Clin Trials. 1993 Apr 10;Doc No 44:[4864 words; 42 paragraphs].

PMID:8306003
Abstract

OBJECTIVE

To demonstrate the difficulty of estimating cost effectiveness of alternative implementation strategies using clinical trial data.

DESIGN

Two examples drawn from a hearing-aid intervention trial and a physical-therapy trial for frail elderly are used to demonstrate how alternative implementation strategies may affect cost effectiveness. Sensitivity analysis is used to document a range of possible economic outcomes for each example and show how assumptions based on trials may bias implementation decisions.

MAIN OUTCOME MEASURES

Costs and cost-effectiveness ratios are estimated for alternative implementation strategies and compared with trial results.

MAIN RESULTS

Staffing and equipment substitutions, reconfigurations, and economies of scale can reduce the cost of trial interventions substantially. Such resource alterations as well as protocol and target group modifications may also have an impact on effectiveness. In both examples effectiveness can be reduced by as much as 50% and under certain conditions alternative implementation strategies will still be cost effective.

CONCLUSIONS

Cost effectiveness of implementations can differ substantially from a trial when different resources or target populations are incorporated. Institutions must conduct preimplementation studies which consider alternative resource configurations before adopting an intervention based on trial results.

摘要

目的

证明利用临床试验数据评估替代实施策略的成本效益存在困难。

设计

从一项针对体弱老年人的助听器干预试验和一项物理治疗试验中选取两个例子,以说明替代实施策略可能如何影响成本效益。敏感性分析用于记录每个例子一系列可能的经济结果,并展示基于试验的假设可能如何使实施决策产生偏差。

主要结局指标

对替代实施策略的成本和成本效益比率进行估算,并与试验结果进行比较。

主要结果

人员配置和设备替代、重新配置以及规模经济可大幅降低试验干预的成本。此类资源变更以及方案和目标群体的修改也可能对效果产生影响。在两个例子中,效果最多可降低50%,并且在某些情况下,替代实施策略仍具有成本效益。

结论

当纳入不同资源或目标人群时,实施的成本效益可能与试验有很大差异。机构在基于试验结果采用干预措施之前,必须进行考虑替代资源配置的实施前研究。

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