CAJ | 학술논문

队列研究是循证医学证据等级中仅次于随机对照试验的临床研究证据，本质上属于观察性研究，也是常用的比较效果研究的研究类型。队列研究既容易满足伦理的要求，也有着较强的外部真实性，同时还能验证因果关系，比干预性研究的典型代表随机对照试验更贴近于临床实际。从比较效果研究角度介绍队列研究用于疗效评价时暴露的定义、对照的选择、结局指标的选取、样本含量计算等设计要点及其优缺点，同时讨论了研究过程中可能存在的偏倚及控制方法，并提供了队列研究的方法学质量评价标准和报告规范。
대렬연구시순증의학증거등급중부차우수궤대조시험적림상연구증거，본질상속우관찰성연구，야시상용적비교효과연구적연구류형。대렬연구기용역만족윤리적요구，야유착교강적외부진실성，동시환능험증인과관계，비간예성연구적전형대표수궤대조시험경첩근우림상실제。종비교효과연구각도개소대렬연구용우료효평개시폭로적정의、대조적선택、결국지표적선취、양본함량계산등설계요점급기우결점，동시토론료연구과정중가능존재적편의급공제방법，병제공료대렬연구적방법학질량평개표준화보고규범。
Cohort study is the second level evidence next to randomized controlled trial in the evidence hierarchy in health care intervention.Cohort study belongs to observational study, and it is one of the common study designs in comparative effectiveness research.Based on its characteristics, cohort study is more likely to meet the ethical requirement, and it has stronger external validity.It can deduct the cause-effect relationship, and it can reflect the real clinical situation rather than randomized controlled trials.In this paper, the key points in study design of cohort study including the definition of exposure are introduced, selection of control, choice of outcome measures, sample size estimation, as well as the pros and cons of this method from the perspective of comparative effectiveness research.Possible biases and control approaches in the implementation of cohort study are also discussed, and the critical appraisal cri-teria and reporting standard are provided.