Fowler Robert A, Mittmann Nicole, Geerts William H, Heels-Ansdell Diane, Gould Michael K, Guyatt Gordon, Krahn Murray, Finfer Simon, Pinto Ruxandra, Chan Brian, Ormanidhi Orges, Arabi Yaseen, Qushmaq Ismael, Rocha Marcelo G, Dodek Peter, McIntyre Lauralyn, Hall Richard, Ferguson Niall D, Mehta Sangeeta, Marshall John C, Doig Christopher James, Muscedere John, Jacka Michael J, Klinger James R, Vlahakis Nicholas, Orford Neil, Seppelt Ian, Skrobik Yoanna K, Sud Sachin, Cade John F, Cooper Jamie, Cook Deborah
Sunnybrook Health Sciences Centre, University of Toronto, 2075 Bayview Avenue, Room D478, Toronto, ON, M4N 3M5, Canada.
Health Outcomes and PharmacoEconomic (HOPE) Research Centre, Sunnybrook Health Sciences Centre, Department of Pharmacology, University of Toronto, 2075 Bayview Avenue, E240, Toronto, ON, M4N 3M5, Canada.
Trials. 2014 Dec 20;15:502. doi: 10.1186/1745-6215-15-502.
Venous thromboembolism (VTE) is a common complication of critical illness with important clinical consequences. The Prophylaxis for ThromboEmbolism in Critical Care Trial (PROTECT) is a multicenter, blinded, randomized controlled trial comparing the effectiveness of the two most common pharmocoprevention strategies, unfractionated heparin (UFH) and low molecular weight heparin (LMWH) dalteparin, in medical-surgical patients in the intensive care unit (ICU). E-PROTECT is a prospective and concurrent economic evaluation of the PROTECT trial.
METHODS/DESIGN: The primary objective of E-PROTECT is to identify and quantify the total (direct and indirect, variable and fixed) costs associated with the management of critically ill patients participating in the PROTECT trial, and, to combine costs and outcome results to determine the incremental cost-effectiveness of LMWH versus UFH, from the acute healthcare system perspective, over a data-rich time horizon of ICU admission and hospital admission. We derive baseline characteristics and probabilities of in-ICU and in-hospital events from all enrolled patients. Total costs are derived from centers, proportional to the numbers of patients enrolled in each country. Direct costs include medication, physician and other personnel costs, diagnostic radiology and laboratory testing, operative and non-operative procedures, costs associated with bleeding, transfusions and treatment-related complications. Indirect costs include ICU and hospital ward overhead costs. Outcomes are the ratio of incremental costs per incremental effects of LMWH versus UFH during hospitalization; incremental cost to prevent a thrombosis at any site (primary outcome); incremental cost to prevent a pulmonary embolism, deep vein thrombosis, major bleeding event or episode of heparin-induced thrombocytopenia (secondary outcomes) and incremental cost per life-year gained (tertiary outcome). Pre-specified subgroups and sensitivity analyses will be performed and confidence intervals for the estimates of incremental cost-effectiveness will be obtained using bootstrapping.
This economic evaluation employs a prospective costing methodology concurrent with a randomized controlled blinded clinical trial, with a pre-specified analytic plan, outcome measures, subgroup and sensitivity analyses. This economic evaluation has received only peer-reviewed funding and funders will not play a role in the generation, analysis or decision to submit the manuscripts for publication.
Clinicaltrials.gov Identifier: NCT00182143 . Date of registration: 10 September 2005.
静脉血栓栓塞症（VTE）是危重症常见的并发症，具有重要的临床影响。重症监护中血栓栓塞预防试验（PROTECT）是一项多中心、双盲、随机对照试验，比较了两种最常用的药物预防策略，即普通肝素（UFH）和低分子肝素（LMWH）达肝素，在重症监护病房（ICU）内科及外科患者中的有效性。E-PROTECT是对PROTECT试验进行的一项前瞻性同步经济评估。
方法/设计：E-PROTECT的主要目标是识别并量化与参与PROTECT试验的危重症患者管理相关的总（直接和间接、可变和固定）成本，并结合成本和结局结果，从急性医疗系统的角度，在一个数据丰富的ICU入院和医院入院时间范围内，确定低分子肝素相对于普通肝素的增量成本效益。我们从所有入组患者中得出基线特征以及ICU内和住院期间事件的概率。总成本来自各个中心，与每个国家入组的患者数量成比例。直接成本包括药物、医生及其他人员成本、诊断性放射学和实验室检查、手术及非手术操作、与出血、输血及治疗相关并发症有关的成本。间接成本包括ICU和医院病房的间接费用。结局指标为住院期间低分子肝素相对于普通肝素每增加一个效果的增量成本之比；预防任何部位血栓形成的增量成本（主要结局）；预防肺栓塞、深静脉血栓形成、大出血事件或肝素诱导的血小板减少症发作的增量成本（次要结局）以及每获得一个生命年的增量成本（三级结局）。将进行预先指定的亚组分析和敏感性分析，并使用自抽样法获得增量成本效益估计值的置信区间。
这项经济评估采用了一种前瞻性成本核算方法，与一项随机对照双盲临床试验同步进行，具有预先指定的分析计划、结局指标、亚组分析和敏感性分析。这项经济评估仅获得了同行评审资金，资助者不会参与稿件的撰写、分析或决定投稿发表。
Clinicaltrials.gov标识符：NCT00182143。注册日期：2005年9月10日。
