观察性临床研究(病例对照研究)遵循STROBE规范

分享到:40无标题文档 条目Recommendation 建议Title and abstract 题目与摘要1(a) Indicate the study’s design with a commonly used term in the title or

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分享到:40

无标题文档

条目

Recommendation 建议

Title and abstract 题目与摘要

1

(a) Indicate the study’s design with a commonly used term in the title or the abstract 在题目或摘要中用常用术语表明研究所采用的设计

(b) Provide in the abstract an informative and balanced summary of what was done and what was found 在摘要中对所做工作和获得的结果做一个简要的总结

Introduction 前言部分

Background/rationale

2

Explain the scientific background and rationale for the investigation being reported 解释研究的科学背景,以及研究动因

Objectives

3

State specific objectives, including any prespecified hypotheses 阐明具体研究的目的 ,包括任何预先设定的假设

Methods 方法部分

Study design

4

Present key elements of study design early in the paper 尽早陈述研究设计的关键内容

Setting

5

Describe the setting, locations, and relevant dates, including periods of recruitment, exposure, follow-up, and data collection 描述研究机构,即研究地点及相关资料,包括招募患者的时间范围(起止时间),暴露,随访和数据收集等

Participants

6

(a) Give the eligibility criteria, and the sources and methods of case ascertainment and control selection. Give the rationale for the choice of cases and controls 给出纳入标准,病例和对照的来源及确认病例和选择对照的方法,病例和对照选择原理

(b) For matched studies, give matching criteria and the number of controls per case 如果是配对设计,应说明配对标准和每个病例配对的对照数。

Variables

7

Clearly define all outcomes, exposures, predictors, potential confounders, and effect modifiers. Give diagnostic criteria, if applicable 明确定义结局、暴露、预测因子、可能的混杂因素及效应修饰因素,如果相关,给出诊断标准

Data sources/ measurement

8*

For each variable of interest, give sources of data and details of methods of assessment (measurement). Describe comparability of assessment methods if there is more than one group 对每个有意义的变量,给出数据来源和详细的测量方法,如果有一个以上的组,描述各组之间测量方法的可比性

Bias

9

Describe any efforts to address potential sources of bias 描述解决潜在偏倚的方法

Study size

10

Explain how the study size was arrived at 描述样本量确定的方法

Quantitative variables

11

Explain how quantitative variables were handled in the analyses. If applicable, describe which groupings were chosen and why 解释定量变量是如何分析的,如果相关,描述分组的方法和原因

Statistical methods

12

(a) Describe all statistical methods, including those used to control for confounding 描述所用的所有统计方法,包括减少混杂因素的方法

(b) Describe any methods used to examine subgroups and interactions 描述所有分析亚组和交互作用的方法

(c) Explain how missing data were addressed解释如何解决数据缺失

(d) If applicable, explain how matching of cases and controls was addressed 如果相关,描述如何对病例和对照进行配对

(e) Describe any sensitivity analyses 描述所有的敏感性分析方法

Results 结果部分

Participants

13*

(a) Report numbers of individuals at each stage of study—eg numbers potentially eligible, examined for eligibility, confirmed eligible, included in the study, completing follow-up, and analysed 报告研究各阶段参与的人数,如可能合格的人数,参与合各性检查的人数,证实各格的人数,纳入研究的人数,完成随访的人数及完成分析的人数。

(b) Give reasons for non-participation at each stage 解释在各阶段参与者退出研究的原因

(c) Consider use of a flow diagram 建议使用流程图

Descriptive data

14*

(a) Give characteristics of study participants (eg demographic, clinical, social) and information on exposures and potential confounders 描述参与者的特征(人口学特征,临床与社会特征)以及暴露和潜在混杂因素的相关信息

(b) Indicate number of participants with missing data for each variable of interest 描述每一个待测变量而言,缺失的数据的参与者人数

Outcome data

15*

Report numbers in each exposure category, or summary measures of exposure 报告各种暴露类别的人数或暴露综合指标

Main results

16

(a) Give unadjusted estimates and, if applicable, confounder-adjusted estimates and their precision (eg, 95% confidence interval). Make clear which confounders were adjusted for and why they were included 报告未校正的估计值。如果相关,给出混杂因素校正后的估计值及其精确度(如95%CI),指明按照哪些混杂因素进行了校正以及选择这些因素进行校正的原因

(b) Report category boundaries when continuous variables were categorized

如对连续变量进行分组,要报告每组观察值的范围

(c) If relevant, consider translating estimates of relative risk into absolute risk for a meaningful time period 对有意义的危险因素,最好把相对危险转化成针对有意义的时间范围和绝对危险度

Other analyses

17

Report other analyses done—eg analyses of subgroups and interactions, and sensitivity analyses 报告进行过的其他分析,如亚组分析,交互作用分析和灵敏性分析

Discussion

Key results

18

Summarise key results with reference to study objectives 根据研究目标概括关键结果

Limitations

19

Discuss limitations of the study, taking into account sources of potential bias or imprecision. Discuss both direction and magnitude of any potential bias 讨论研究的局限性,包括潜在的偏倚或不准确的来源、讨论任何潜在的偏倚的方向和大小

Interpretation

20

Give a cautious overall interpretation of results considering objectives, limitations, multiplicity of analyses, results from similar studies, and other relevant evidence 结合研究目标,研究局限性,多重分析,相似研究的结果和其他相关证据,谨慎给出一个总体的结果解释。

Generalisability

21

Discuss the generalisability (external validity) of the study results 讨论研究结果的普适性(外部真实性)

Other information

Funding

22

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 提供研究资金的来源和资助机构在研究中的作用,如果相关,提供资助机构在本文基于的初始研究中的作用。

*Give information separately for cases and controls.

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