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描述性临床研究的设计和实施要点

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开展临床研究离不开流行病学的方法学支撑.流行病学以医学为主的多学科知识为依据,利用观察和询问的方式调查社会人群的疾病和健康状况,描述疾病频率和分布,通过归纳、综合和分析提出病因假说,进而应用分析性研究对建立的病因假说进行验证,最后再通过试验研究来进一步证实.描述性临床研究也称为描述性流行病学研究,是指利用专门的调查资料或已有的资料,按照不同地区、时间或人群特征分组,把疾病或健康状况的分布情况真实地描绘、叙述处理.描述性临床研究是揭示疾病因果关系的最基础步骤,通过分析比较导致疾病或健康状况分布差异的可能原因,提出进一步研究的方向或防控策略设想,为后续开展分析性研究或试验研究奠定基础.本文从描述性临床研究的分类入手,介绍病例报告、病例系列研究、现况研究、纵向研究、生态学研究和筛检的概念,重点阐述现况研究的设计和实施要点,以期为研究人员开展描述性临床研究提供参考.
Key points in the design and conduct of descriptive clinical studies
Clinical studies can only be conducted with the methodological support of epidemiology.Epidemiology is based on multidisciplinary medical knowledge,using observation and questioning to investigate the disease and health status of social populations,describing the frequency and distribution of diseases,proposing etiological hypotheses through generalization,synthesis and analysis,and then applying analytical studies to verify the established etiological hypotheses,and finally confirming them further through experimental studies.Descriptive study,also known as descriptive epidemiological research,refers to a realistic portrayal and narrative treatment of the distribution of a disease or health condition using specialized survey data or existing information grouped according to different regions and time or population characteristics.Descriptive study is the most basic step in revealing the causal relationship of diseases.By analyzing and comparing the possible causes leading to the differences in the distribution of diseases or health conditions,it can propose the direction of further research or the conception of preventive and control strategies,and lay the foundation for the subsequent development of analytical research or experimental research.This article begins with the categorization of descriptive clinical studies,introduces the concepts of case reports,case series studies,current studies,longitudinal studies,ecological studies,and screening tests,and focuses on the key points of the design and implementation of prevalence studies,so as to provide researchers with reference for conducting descriptive clinical studies.

descriptive studyresearch designcurrent researchlongitudinal researchsample size calculation

王瑞平、李斌、肇晖

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上海市皮肤病医院临床研究与创新转化中心 上海 200443

上海医药行业协会 上海 200003

描述性研究 研究设计 现况研究 纵向研究 样本量计算

上海市卫生健康委员会卫生行业临床研究专项上海申康医院发展中心第二轮促进市级医院临床技能与临床创新三年行动计划上海市皮肤病医院引进人才科研基金项目上海人才发展基金资助项目上海市医院协会医院管理研究基金项目&&

202240371SHDC2022CRS0532021KYQD012021SHRCFZ01X2022117LCIIT-2023-14

2024

上海医药
上海医药行业协会

上海医药

影响因子：0.781
ISSN：1006-1533
年,卷(期)：2024.45(1)
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