课件：谭姣《流行病学》6实验流行病-临床.ppt

* 系统随机分组：身份证号码、病例号、学号… 样本量小的时候，有时难以达到平衡 样本量大的时候，较容易达到平衡 * 1.适用于已知有肯定防治效应的疾病 2.在所研究疾病尚无有效的防治药物或使用安慰剂后对研究对象的病情无影响时才使用 * 即使是药物也很难完全做到盲法 很难准备出与实验药物完全一样的安慰剂 药物的气味、味觉、感觉上都可能不太一样 药物可能有副作用 检验结果可能不能盲不了 研究对象可能会对药物进行化验 结局测量采用“硬指标” 死亡 测量 实验室指标 HgA1C vs. 糖尿病严重性得分 UA vs. 排尿困难与频次 检测结果 MVO2 vs. 自己报告锻炼能力 多普勒超声 vs. 深静脉血栓时腿肿胀 得分与日记 vs. 调查者判断 老年抑郁得分 vs. “改善” 7日排尿记录 vs. “口渴” 测量未盲的程度： 在部分盲的实验中 让研究对象猜猜所接受的治疗是什么 让研究工作人员猜猜实施的治疗是什么 如果基本上没有盲，则应该在文章的讨论中评价未盲的影响 * 结局事件：发病、死亡、某些中间变量 * 结局事件：发病、死亡、某些中间变量 治疗有效例数应包括治愈人数和好转人数 * * 结局事件：发病、死亡、某些中间变量 * 结局事件：发病、死亡、某些中间变量 * In health care research, however, bias is defined as any factor or process that tends to deviate the results or conclusions of a trial systematically away from the truth.3-6 This deviation from the truth can result in underestimation or exaggeration of the effects of an intervention. biases that can occur at any point during the course of a trial, from the allocation of participants to study groups, through the delivery of interventions and the measurement of outcomes, to the interpretation and reporting of results. Other types of bias that tend to receive less attention can also, however, have a profound influence on the way in which the results of RCTs are interpreted and used. These biases can occur during the dissemination of a trial from the investigators to potential users, or during the uptake of trial information by potential users of the trial. * A perfectly randomised method to allocate participants to the study groups does not, however, protect an RCT from selection bias. Selection bias can be introduced if some potentially eligible individuals are selectively excluded from the study because of prior knowledge of the group to which they would be allocated if they participated in the study. Imagine that the investigator in charge of recruiting patients for the multiple sclerosis trial thinks that depressed patients are less likely to respond to the new drug. The trial is not designed to detect depression in the partic