观察性研究报告规范

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方法中各类观察性研究的共同规范 Study size: Explain how the study size was arrived at Quantitative variables: Explain how quantitative variables
were handled in the analyses. If applicable, describe which
,暴露时间)
报告规范--方法
方法中各类观察性研究的共同规范 Variables : clearly define all outcomes, exposures, predictors, potential confounders, and effect modifiers. Give
diagnostic criteria, if applicable
的数目或者某个指标(连续变量)的总的测量结果(平均数)
报告规范—结果
主要研究结果 (a) Give unadjusted estimates and, if applicable, confounder-
adjusted estimates and their precision (eg, 95% confidence
报告规范--方法
方法中各类观察性研究的不同规范---数据来源和测量 For each variable of interest, give sources of data and details of methods of assessment (measurement). Describe
eligible, included in the study, completing follow-up, and
analyzed (b) Give reasons for non-participation at each stage
(c) Consider use of a flow diagram
观察性研究报告规范
STROBE:www.strobe-statement.org
www.microsci.com
定义以及分类
观察性研究:是非随机化的研究,在自然状态下对研究对象的特
征进行观查、记录,并对结果进行描述和对比分析。
分类: 队列研究:将人群按是否暴露于某种可疑因素及其暴露程度分为不同
confounders (b) Indicate number of participants with missing data for each
variable of interest
队列研究和横断面研究:分别给出暴露和非暴露组的信息 病例对照研究:分别给出病例组和对照组的信息 (c) 此外,对于队列研究: Summarize follow-up time (eg, average and total amount)
报告规范--方法
方法中各类观察性研究的共同规范 Study design: Present key elements of study design early in the paper
Setting: Describe the setting, locations, and relevant dates,
“case-control study”等词语。
(b) 摘要中表达清楚 “study’s design” “what was done and what was found”。
报告规范—前言
前言: (a) Background/rationale: explain the scientific background and
Cross-sectional study—Report numbers of outcome events or
summary measures 对于队列或者横断面研究: 发生某个结局的数目(分类变量)
,或者每个暴露组的某指标(连续变量)总的测量结果(平均数)。
对于病例对照组: 病例和对照组中暴露于某个因素(分类变量)
的亚组,追踪其各自的结局,比较不同亚组之间结局频率的差异,从而 判定暴露因子与结局之间有无因果关联及关联大小的一种观察性研究方 法。
病例对照研究:比较患某病者与未患该病的对照者既往暴露于某个
(或某些)可能危险因素的百分比差异,以判断这(些)因素与该病有无 关 联及关联程度大小的观察性研究方法。
横断面研究:横断面研究(cross-sectional study)是在某一特定时间
interval). Make clear which confounders were adjusted for and why they were included
(b) Report category boundaries when continuous variables were
categorized (c) If relevant, consider translating estimates of relative risk (RR) into absolute risk (AR)for a meaningful time period
队列研究和横断面研究:分别给出暴露和非暴露组的信息 病例对照研究:分别给出病例组和对照组的信息
报告规范—结果
数据描述 (a) Give characteristics of study participants (eg demographic,
clinical, social) and information on exposures and potential
including periods of recruitment, exposure, follow-up, and data collection
总结:
Study design: 研究对象, 分组情况,干预情况,检测指标及方法。 Setting: 研究地点,相关时间(招募时间,随访时间,数据采集时间
Bias: describe any efforts to address potential sources of bias 总结: (a) 定义 (某个要检测指标或者随访的结果),诊断标准 (b) 防止偏倚的努力(病例纳入和排除标准;盲法;根据混
杂因素进行分层分析或者是配对设计)
报告规范--方法
对某一定范围内的人群,以个人为单位收集和描述人群的特征以及疾病 或健康状况。
报告规范—题目和摘要
题目和摘要: (a) Indicate the study’s design with a commonly used term in
the title or the abstract
(b) Provide in the abstract an informative and balanced summary of what was done and what was found 总结: (a) 题目中应包含 “cohort study”, “cross-sectional study” and
comparability of assessment methods if there is more than one
group 队列研究和横断面研究:分别给出暴露和非暴露组的信息
病例对照研究:分别给出病例组和对照组的信息
报告规范—结果
研究对象 (a) Report numbers of individuals at each stage of study—eg numbers potentially eligible, examined for eligibility, confirmed
报告规范—结果
其他 (a)报告任何其他分析,包括亚组分析和敏感性分析
报告规范—讨论
总结: (a) 根据研究目的讨论关键关键结果 (b) 局限性(偏倚,样本量,研究对象)
(c) 谨慎的解释和总ຫໍສະໝຸດ Baidu我们的结果
(d) 意义
报告规范—其他
Funding Give the source of funding and the role of the funders for the present study and, if applicable, for the original study on which the present article is based
报告规范—结果
结果描述 Cohort study—Report numbers of outcome events or summary
measures over time
Case-control study—Report numbers in each exposure category, or summary measures of exposure
rationale for the investigation being reported.
(b) Objectives: state specific objectives, including any prespecified hypotheses. 总结:前言应该包括背景介绍,研究的理由,研究的目的
groupings were chosen and why 总结: (a) 样本量: 病例收集过程 (b) 定量指标的定量;如何根据定量指标分组,这样分组的
依据是什么?
报告规范--方法
方法中各类观察性研究的不同规范---研究对象
报告规范--方法
方法中各类观察性研究的不同规范---统计方法
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