Economic Analysis of Pulmonary Artery Catheter Use

肺动脉导管（PAC）是一种常用的设备，可提供血流动力学数据，指导危重患者的护理，如急性肺损伤或急性呼吸窘迫综合征（ARDS/ALI）患者。临床医生认为使用PAC可以改善决策和患者预后，但缺乏证据，最近的数据表明PAC可能会增加死亡率，并大大增加成本。作为回应，NHLBI资助了一项大型多中心试验（液体和导管治疗试验（FACTT） （N01-HR-46054-46064））， ARDS/ALI患者将随机接受PAC或侵入性较小的中心静脉导管（CVC），并根据PAC或CVC提供的数据接受自由或保守的液体管理方案。主要终点是患者的死亡率。我们建议同时对PAC进行经济分析，以补充FACTT。我们的目标是：1.比较研究组在长期生存、生活质量和质量调整生存方面的差异；2)比较两组在急症护理和长期费用方面的差异；3)计算PAC使用的成本-效果（即FACTT试验受控环境下的成本和效果的平衡）；4)估算更多“现实世界”条件下的成本效益，并产生生命周期成本效益比率，从而促进我们的结果与其他成本效益分析的比较。为了实现目标1-3，我们将扩大FACTT数据收集，包括医院费用的详细信息，延长至少一年的生存随访，以及出院后患者访谈，以确定第一年的生活质量和资源使用情况。我们将通过构建一个微观模拟模型来实现目标4，该模型首先由FACTT的结果和发表的预期寿命和成本数据校准，然后进行调整，以反映常规临床实践中使用PAC的更广泛的患者病例组合和临床效果。我们将使用来自金县肺损伤项目流行病学研究（NHLBI HL-96-014）的患者水平数据来调整来自英国PAC使用的大型实用试验的病例组合和患者水平数据，以调整PAC使用的临床效果。我们提出的对FACTT的补充结果将大大扩大所收集数据的价值，并首次从广泛应用这一重要技术的随机数据中提供可靠的经济影响估计。

The pulmonary artery catheter (PAC) is a commonly used device that provides hemodynamic data to guide care of the critically ill, such as patients with acute lung injury or the acute respiratory distress syndrome (ARDS/ALI). Clinicians believe PAC use improves decision-making and patient outcomes but evidence is lacking and recent data suggest the PAC may increase mortality as well as considerably increasing costs. In response, the NHLBI funded a large multicenter trial (Fluid And Catheter Treatment Trial (FACTT) (N01-HR-46054-46064)) where ARDS/ALI patients will be randomized to receive a PAC or the less invasive central venous catheter (CVC) and to receive a liberal or conservative fluid management protocol in response to data provided by the PAC or CVC. The primary end-point will be in- patient mortality. We propose to complement FACTT with a concurrent economic analysis of the PAC. Our aims are to: 1.) compare differences between study arms in long-term survival, quality of life, and quality-adjusted survival; 2.) compare differences between study arms in acute care and long-term costs; 3.) calculate the cost- efficacy of PAC use (i.e., the balance of costs and effects under the controlled environment of the FACTT trial), and; 4.) estimate cost-effectiveness under more "real-world" conditions and produce life-time cost-effectiveness ratios, thereby facilitating comparison of our results to other cost-effectiveness analyses. We will achieve Aims 1-3 by augmenting FACTT data collection with detailed information on hospital costs, extended survival follow- up for a minimum of one year, and post-discharge patient interviews to determine quality of life and resource use in the first year. We will achieve Aim 4 by constructing a microsimulation model first calibrated by results from FACTT and published data on life-expectancy and costs and then adjusted to reflect the broader patient case-mix and clinical effects of PAC use in routine clinical practice. We will use patient-level data from the King County Lung Injury Project epidemiology study (NHLBI HL-96-014) to adjust case-mix and patient-level data from a large pragmatic trial of PAC use in the United Kingdom to adjust the clinical effects of PAC use. The results of our proposed adjunct to FACTT will substantially amplify the value of the data being collected and provide, for the first time, robust estimates from randomized data of the economic effects of the widespread application of this important technology.