Initiating Clinical Trials: A Case Study of a Proposed Clinical Trial for Acute Myocardial Infarction

摘要

The case study examined the process underlying the development of a proposal for a randomized clinical trial (RCT) to assess the comparative effectiveness, following uncomplicated acute myocardial infarction (AMI), of continued care in a coronary care unit (CCU) and in a monitored hospital bed after 24 hours in a CCU. The proposed study was to involve some 2,300 patients in eight hospitals having only mild AMIs and assign them randomly either to a CCU or standard hospital bed monitored by telemetry. Three hypotheses would be tested: that CCU services do not result in better outcomes, such as improved survival rates or the rate of complication occurrence (arrhythmias); that CCU patients experience more anxiety based on psychological tests and urine catecholamine levels; that the costs of providing services to hemodynamically stable AMI patients are higher in the CCU than in a monitored bed. Several design flaws led to disapproval of the RCT, including variability within comparison groups, problems with arrhythmia measurement, and the validity of specific psychometric tests and the use of catecholamines as measures of stress and anxiety. The case study was done as part of a larger project dealing with RCT decisionmaking at NIH funded by the National Center for Health Services Research and Health Care Technology Assessment.