课程大纲

COURSE SYLLABUS

课程代码/名称

Course Code/Title

流行病学研究设计及应用

Research Design and Applications of Epidemiology

课程性质

Compulsory/Elective

选修 Elective

开课单位

Offering Dept.

医学院 School of Medicine

课程学分/学时

Course Credit/Hours

2/32

授课语言

Teaching Language

中文 Chinese

授课教师

Instructor(s)

赵文静 Zhao Wenjing

开课学期

Semester

秋季 Autumn

是否面向本科生开放

Open to undergraduates

or not

否 No

先修要求

Pre-requisites

（如面向本科生开放，请注明区分内容。 If the course is open to

undergraduates, please indicate the difference.）

无 None

10.

教学目标

Course Objectives

（如面向本科生开放，请注明区分内容。 If the course is open to undergraduates, please indicate the

difference.）

本课程设计面向全校各个年级的研究生，讲授横断面研究、队列研究、病例对照研究、实验流行病学

设计（临床试验、社区干预等）的理论框架，以及国内外经典或常见研究的实际应用。理论和实际相结

合，帮助学生理解和掌握流行病学研究设计方法，拓宽学生视野，提高学生的科研素质。

This course is designed for graduate students in all grades of the university. It teaches learners the theoretical

framework of a cross-sectional study, cohort study, case-control study and experimental epidemiology study

design, and examples of the classic or common study design at home or abroad. This course aims to help the

learners understand and master the main epidemiological study design, broaden their horizons and improve

their scientific research quality by combining theory with practice.

11.

教学方法

Teaching Methods

（如面向本科生开放，请注明区分内容。 If the course is open to undergraduates, please indicate the

difference.）

本课程拟运用理论与实际相结合的方式向学生讲授常见流行病学研究设计。结合平时作业、课堂提问，学

生实际演练，圆满完成授课任务。

This course aims to introduce learners to the common epidemiological research design by integrating theory

with practice. It is expected to successfully complete the teaching task by assigning homework, classroom

questions, and practical exercises.

12.

教学内容

Course Contents

（如面向本科生开放，请注明区分内容。 If the course is open to undergraduates, please indicate the

difference.）

课程内容分为讲授和专题讨论两个部分。

讲授内容主要包括流行病学研究设计的定义、特点、用途、优缺点、实施步骤以及国内外经典或著名的研

究实例分析。在专题讨论部分，学生以小组讨论形式提出并展示自己感兴趣的研究问题和研究计划，实施

步骤等。

The course includes two parts: lectures and student group presentations.

The main content of the lectures includes the definition, characteristics, purpose, implementation steps of

epidemiological studies designs, and the classic or famous practical examples.

Student group presentations include developing research questions and a research plan based on the group’s

interest, how to implement the target research, and making a final presentation.

Section 1

流行病学研究设计概论-Introduction to epidemiological research design

1.1 流行病学研究类型- Epidemiological Research Type

1.2 流行病学研究设计的框架- Epidemiological Research Structure

1.3 流行病学研究用处- Epidemiological Research Purpose

Section 2

流行病学研究要素 I- Basic ingredients I

2.1 研究问题的提出- Conceiving the research question

2.2 研究计划的制定-Developing Research Plan

2.3 研究人群的选择-Choosing the Study Subjects

Section 3

流行病学研究要素 II-Basic ingredients II

3.1 研究问题的测量- Planning the Measurement

3.2 样本量估计以及样本量估计的效能-Estimating Sample Size and the Power

Section 4

横断面研究设计及应用- Cross-sectional study design and the application

4.1 横断面研究的定义、特点、用途、实施步骤、优缺点-The Definition,

Characteristics, Purpose, Implementation Steps, Advantages, and

Disadvantages

4.2 研究实例介绍-The Practical Example

Section 5

队列研究设计及应用 I- Cohort study design and the application I

5.1 队列研究的定义、特点、用途、实施步骤、优缺点 --The Definition,

Characteristics, Purpose, Implementation Steps, Advantages, and

Disadvantages

5.2 研究实例：出生队列- The Practical Example: Birth Cohort Study

Section 6

队列研究设计及应用 II- Cohort study design and the application II

6.1 队列研究实例：慢性病队列-The Practical Example: Cohort Study on

Chronic Diseases

6.2 队列研究实例：老年队列-The Practical Example: Cohort Study on Old

Population

Section 7

病例对照研究设计及应用- Case-control study design and the application

7.1 病例队列研究的定义、特点、用途、实施步骤、优缺点- The Definition,

Characteristics, Purpose, Implementation Steps, Advantages, and

Disadvantages

7.2 研究实例：食管癌发病的病例对照研究- The Practical Example: Case-

Control study Related to Esophagus Cancer

Section 8

观察性研究中的因果推断- Causal inference in observational studies

8.1 加强观察性研究因果推断中的注意事项：偶然、偏移- Chance, and Bias,

8.2 加强观察性研究因果推断中的注意事项：因果倒置和混杂因子-effect-

cause and confounding factors

Section 9

小组讨论&答辩 Group discussion and presentations

Section 10

随机化盲法试验设计及应用 I- A randomized blinded trial design and the

application I

10.1 随机化盲法试验中干预组与对照组的选择、结局的定义、研究对象的选

择 -Selecting Intervention and Control Conditions, Choosing Outcome

Measurements, Selecting the Participants

10.2 基线变量的测量以及随机、盲法的方法-Measuring Baseline Variables,

and Randomizing and Blinding

10.3 研究实例- The Practical Example

Section 11

随机化盲法试验设计及应用 II-A randomized blinded trial design and the

application II

10.1 随机化盲法试验建立的步骤-Implementation Steps

10.2 研究实例（以社区病人为例）- The Practical Example (Patients Living

in the Community)

Section 12

其他临床试验设计- Alternative trial design

12.1 非随机化试验- Other Randomized Designs

12.2 组内随机-Group Randomization,

12.3 非随机化组间设计等- Nonrandomized Between-Group Designs

Section 13

医学检验的研究设计- Medical tests study design

13.1 怎样衡量医学检验的有用性、再现性-Determining Whether a Test is

Useful, Studies of Test Reproducibility

13.2 医学检验的准确性、可行性-Studies of the Accuracy of Tests, Studies of

the Feasibility of Tests

Section 14

使用既有数据库开展研究- Utilizing existing databases

14.1 二手数据的分析- Secondary Data Analysis,

14.2 系统综述的开展- Systematic Review

Section 15

研究实施事项- Study implementation issues

15.1 研究实施过程中的伦理问题、问卷设计、访谈- Addressing Ethical

Issues, Designing Questionnaires and Interviews

15.2 研究实施过程中的数据管理、质量控制-Data Management, and Quality

Control

Section 16

小组讨论&答辩 Group discussion and presentations

13.

课程考核

Course Assessment

（

○

1 考核形式 Form of examination；

○

2 .分数构成 grading policy；

○

3 如面向本科生开放，请注明区分内容。

If the course is open to undergraduates, please indicate the difference.）

本课程考核方式为考查，期末考核满分 100 分。主要从出勤（Attendance）：20%；课堂表现（Class Performance）：

20%；平时作业（Assignments）：20%；期末报告（Final Presentation and report）：20%等几个方面对学生进行考查。

14.

教材及其它参考资料

Textbook and Supplementary Readings

1. 临床研究设计（第四版）【Designing Clinical Research】Stephen B. Hulley 等著，彭晓霞，唐迅译

2. Designing Clinical Research Third Edition by Stephen B. Hulley et al.

3. 流行病学（第八版）詹思延主编