余运贤实验性研究方法设计及实例.ppt

内容 研究案例（方法学部分） 临床试验（理论部分） 研究案例（结果部分） 临床试验案例相关问题 该研究采用的是那种临床试验设计类型？ 该研究满足了那几项科研设计的原则？ 该研究采用了什么随机分组方式？ 该研究用的是哪种对照方法？ 该研究是否采用盲法？如果是，哪一种？ Introduction Hyperglycemia is common in acutely ill patients, including those treated in intensive care units (ICUs). The occurrence of hyperglycemia, in particular severe hyperglycemia, is associated with increased morbidity and mortality in a variety of groups of patients Trials examining the effects of tighter glucose control have had conflicting results Systematic reviews and meta-analyses have also led to differing conclusions. Nevertheless, many professional organizations recommend tight glucose control for patients treated in ICUs. Barriers to widespread adoption of tight glucose control include the increased risk of severe hypoglycemia, the difficulty in achieving normoglycemia in critically ill patients, and the increased resources that would be required. Methods Adult medical and surgical patients admitted to the ICUs of 42 hospitals: 38 academic tertiary care hospitals and 4 community hospitals. Eligible patients were those expected to require treatment in the ICU on 3 or more consecutive days. Study participants were randomly assigned to glucose control with one of two target ranges: the intensive (i.e., tight) control target of 4.5 - 6.0 mmol/L or a conventional control target of 10.0 mmol or less /L in Australia, New Zealand, and Canada. Randomization Randomization was stratified according to type of admission (operative or nonoperative) and region (Australia and New Zealand or North America). The treatment assignments were concealed before randomization, but subsequently, clinical staff were aware of them. Control of blood glucose Control of blood glucose was achieved with the use of an intravenous infusion of insulin in saline. In the group of patients assigned to undergo conventional glucose control, insulin was administered if the blood glucose level exceeded 10mmol/L; insulin administration was reduced and then