对照前瞻干预随机.ppt

* 保护率=[对照组发病(或死亡)率－实验组发病(或死亡)率]/对照组发病(或死亡率)*100% * 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 participants and he is the only person with access to the allocation sequence (which has been generated by computer and is locked in his desk). This investigator could introduce bias into the trial, knowingly or unknowingly, just by making it more difficult for depressive patients to receive the new drug. He can achieve this in at least two ways: first, he can make depressive patients allocated to receive the new drug fit exclusion criteria more easily and more frequently than if they had been al