ECONOMICS AND QUALITY OF LIFE IN THE OCCLUDED ARTERY TRI

动脉闭塞症的经济和生活质量

• 批准号: 6641155
• 负责人: Daniel B Mark
• 金额: $ 45.71万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-09-30 至 2006-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6641155
• 关键词: ACE inhibitors; acute disease /disorder; angina pectoris; behavioral /social science research tag; beta antiadrenergic agent; chemoprevention; clinical research; clinical trials; congestive heart failure; diagnostic catheterization; disease /disorder proneness /risk; functional ability; health care cost /financing; health services research tag; heart disorder chemotherapy; heart revascularization; hospital utilization; human subject; human therapy evaluation; longitudinal human study; myocardial infarction; outcomes research; quality of life; telecommunications

This revised application proposes to establish an Economics and Quality of Life Coordinating Center for the Occluded Artery Trial, (OAT), a multi-center, randomized trial of late (3-28 days) percutaneous revascularization versus standard medical therapy in 3200 asymptomatic high-risk acute myocardial infarction (MI) survivors and who are found at diagnostic catheterization to have an occluded infarct-related artery. All patients will receive standard medical therapy (including aspirin, beta blockers, ACE inhibitors). Qualifying patient will be randomized in equal proportions to either percutaneous revascularization of the occluded infarct related artery or medical therapy alone. Patients will be recruited into the trial over a 2 year period, with a subsequent minimum follow-up period of 2.25 years. The primary endpoint of the trial is a composite of all cause mortality, non-fatal MI and hospitalization for class IV heart failure. Cost, cost effectiveness and health-related quality of life are secondary endpoints. In collaboration with the Clinical Coordinating Center and the Statistical and Data Coordinating Center, the Economics and Quality of Life Coordinating Center will perform the following major functions: 1) obtain baseline economic status and quality of life data from all patients enrolled at each participating study site at the time of randomization; 2) collect detailed health resource consumption data from the index hospitalization; 3) assess detailed economic, functional status and quality of life outcomes during follow-up telephone contacts by study site coordinators at 4 months, 1 year and 2.25 years after enrollment; 4) assess angina- and heart failure-related functional status by telephone contacts every 4 months during study follow-up; 5) identify all major medical encounters that occur during follow-up and collect detailed health care resource consumption data and cost data for each; 5) compare cost and quality of life outcomes for the two treatment arms according to intention-to-treat; 7) estimate the incremental cost effectiveness ratio for the experimental arm and perform extensive sensitivity analyses. If efficacy is demonstrated for the primary study endpoint, then the economic and quality of life data collected as part of this proposal will clearly be pivotal in determining how the results of this study are viewed and whether the findings of the trial receive widespread implementation. We propose to use state-of-the-art methods for measuring cost and quality of life and for estimating cost effectiveness.

该修订后的申请提议建立一个闭塞动脉试验（OAT）的经济和生活质量协调中心，这是一项多中心、随机试验，对 3200 名无症状高危人群进行晚期（3-28 天）经皮血运重建术与标准药物治疗的比较。急性心肌梗塞 (MI) 幸存者以及在诊断导管插入术中发现梗塞相关动脉闭塞的人群。 所有患者都将接受标准药物治疗（包括阿司匹林、β受体阻滞剂、ACE抑制剂）。 符合资格的患者将按相同比例随机分配，接受闭塞梗塞相关动脉的经皮血运重建或单独药物治疗。患者将被招募参加为期 2 年的试验，随后的最短随访期为 2.25 年。 该试验的主要终点是全因死亡率、非致命性心梗和 IV 级心力衰竭住院的综合终点。 成本、成本效益和健康相关的生活质量是次要终点。经济和生活质量协调中心与临床协调中心和统计和数据协调中心合作，将履行以下主要职能：1）从每个参与研究中心入组的所有患者获取基线经济状况和生活质量数据在随机化时； 2）收集住院指标详细的卫生资源消耗数据； 3）在入组后4个月、1年和2.25年由研究中心协调员进行后续电话联系期间评估详细的经济、功能状态和生活质量结果； 4) 在研究随访期间每 4 个月通过电话联系评估心绞痛和心力衰竭相关的功能状态； 5) 识别随访期间发生的所有重大医疗事件，并收集每次的详细医疗保健资源消耗数据和成本数据； 5) 根据意向治疗比较两个治疗组的成本和生活质量结果； 7) 估计实验组的增量成本效益比并进行广泛的敏感性分析。如果主要研究终点的有效性得到证实，那么作为该提案一部分收集的经济和生活质量数据显然将在决定如何看待本研究结果以及试验结果是否得到广泛实施方面发挥关键作用。 我们建议使用最先进的方法来衡量成本和生活质量以及估计成本效益。