英国一项全国性多中心试验（成人严重呼吸衰竭常规通气与体外膜肺氧合治疗对比试验，CESAR）中经济评估的数据收集与分析方法
Methods of data collection and analysis for the economic evaluation alongside a national, multi-centre trial in the UK: conventional ventilation or ECMO for Severe Adult Respiratory Failure (CESAR).
作者信息
Thalanany Mariamma M, Mugford Miranda, Hibbert Clare, Cooper Nicola J, Truesdale Ann, Robinson Steven, Tiruvoipati Ravindranath, Elbourne Diana R, Peek Giles J, Clemens Felicity, Hardy Polly, Wilson Andrew
机构信息
School of Medicine, Health Policy and Practice, University of East Anglia, Norwich, NR4 7TJ, UK.
出版信息
BMC Health Serv Res. 2008 Apr 30;8:94. doi: 10.1186/1472-6963-8-94.
BACKGROUND
Extracorporeal Membrane Oxygenation (ECMO) is a technology used in treatment of patients with severe but potentially reversible respiratory failure. A multi-centre randomised controlled trial (CESAR) was funded in the UK to compare care including ECMO with conventional intensive care management. The protocol and funding for the CESAR trial included plans for economic data collection and analysis. Given the high cost of treatment, ECMO is considered an expensive technology for many funding systems. However, conventional treatment for severe respiratory failure is also one of the more costly forms of care in any health system.
METHODS/DESIGN: The objectives of the economic evaluation are to compare the costs of a policy of referral for ECMO with those of conventional treatment; to assess cost-effectiveness and the cost-utility at 6 months follow-up; and to assess the cost-utility over a predicted lifetime. Resources used by patients in the trial are identified. Resource use data are collected from clinical report forms and through follow up interviews with patients. Unit costs of hospital intensive care resources are based on parallel research on cost functions in UK NHS intensive care units. Other unit costs are based on published NHS tariffs. Cost effectiveness analysis uses the outcome: survival without severe disability. Cost utility analysis is based on quality adjusted life years gained based on the Euroqol EQ-5D at 6 months. Sensitivity analysis is planned to vary assumptions about transport costs and method of costing intensive care. Uncertainty will also be expressed in analysis of individual patient data. Probabilities of cost effectiveness given different funding thresholds will be estimated.
DISCUSSION
In our view it is important to record our methods in detail and present them before publication of the results of the trial so that a record of detail not normally found in the final trial reports can be made available in the public domain.
TRIAL REGISTRATIONS
The CESAR trial registration number is ISRCTN47279827.
背景
体外膜肺氧合（ECMO）是一种用于治疗严重但可能可逆的呼吸衰竭患者的技术。英国资助了一项多中心随机对照试验（CESAR），以比较包括ECMO在内的治疗与传统重症监护管理。CESAR试验的方案和资金包括经济数据收集和分析计划。鉴于治疗成本高昂，对于许多资金系统而言，ECMO被视为一项昂贵的技术。然而，严重呼吸衰竭的传统治疗也是任何卫生系统中成本较高的护理形式之一。
方法/设计：经济评估的目标是比较ECMO转诊政策与传统治疗的成本；评估6个月随访时的成本效益和成本效用；并评估预测寿命期内的成本效用。确定试验中患者使用的资源。资源使用数据从临床报告表中收集，并通过对患者的随访访谈获取。医院重症监护资源的单位成本基于对英国国民健康服务（NHS）重症监护病房成本函数的平行研究。其他单位成本基于已公布的NHS收费标准。成本效益分析使用的结果是：存活且无严重残疾。成本效用分析基于6个月时根据欧洲五维度健康量表（Euroqol EQ - 5D）获得的质量调整生命年。计划进行敏感性分析，以改变关于运输成本和重症监护成本核算方法的假设。个体患者数据分析中也将体现不确定性。将估计不同资金阈值下成本效益的概率。
讨论
我们认为，详细记录我们的方法并在试验结果发表之前公布这些方法很重要，这样可以在公共领域提供一份最终试验报告中通常不会出现的详细记录。
试验注册
CESAR试验注册号为ISRCTN47279827。
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