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STROBE-MR checklist of recommended items to address in reports of Mendelian randomization studies1 2
STROBE-MR 孟德尔随机化研究报告中推荐解决的项目清单12
 

Item No.
商品编号

Section
部分

Checklist item
核对表项目

Page No.
页码

Relevant text from manuscript
手稿中的相关文本

1

TITLE and ABSTRACT
标题和摘要

Indicate Mendelian randomization (MR) as the study’s design in the title and/or the abstract if that is a main purpose of the study
如果这是研究的主要目的,请在标题和/或摘要中注明孟德尔随机化 (MR) 作为研究的设计

1-2

Title and Abstract
标题和摘要

INTRODUCTION

2

Background
背景

Explain the scientific background and rationale for the reported study. What is the exposure? Is a potential causal relationship between exposure and outcome plausible? Justify why MR is a helpful method to address the study question
解释所报告研究的科学背景和基本原理。什么是风险敞口?暴露和结果之间的潜在因果关系是否合理?证明为什么 MR 是解决研究问题的有用方法

2

Introduction paragraphs 1-3
引言第 1-3 段

essentialhaemorrhagicthrombocythaemia is often asymptomatic at clinical diagnosis, or only presents with microvascular symptoms such as erythromelalgia, headache, or may be accompanied by mild splenomegalgia (less than 5 cm)
原发性(出血性血小板增多症在临床诊断时通常无症状,或仅表现为微血管症状,如红斑性肢痛症、头痛,或可能伴有轻度脾肿大(小于 5 cm)

......

Ezetimibe directly reduce platelet activation and significantly influence atherosclerotic markers mediated by endothelial cells.
依折麦布直接降低血小板活化并显着影响内皮细胞介导的动脉粥样硬化标志物。

3

Objectives
目标

State specific objectives clearly, including pre-specified causal hypotheses (if any). State that MR is a method that, under specific assumptions, intends to estimate causal effects
明确说明具体目标,包括预先指定的因果假设(如果有)。说明 MR 是一种在特定假设下旨在估计因果效应的方法

Introduction paragraphs 3-5
引言第 3-5 段

METHODS

4

Study design and data sources
研究设计和数据源

Present key elements of the study design early in the article. Consider including a table listing sources of data for all phases of the study. For each data source contributing to the analysis, describe the following: 
在文章的开头介绍研究设计的关键要素。考虑包括一个表格,列出研究所有阶段的数据源。对于参与分析的每个数据源,请描述以下内容:

a)

Setting: Describe the study design and the underlying population, if possible. Describe the setting, locations, and relevant dates, including periods of recruitment, exposure, follow-up, and data collection, when available.
设置:如果可能,请描述研究设计和基础人群。 描述地点、地点和相关日期,包括招募、暴露、随访和数据收集(如有)。

b)

Participants: Give the eligibility criteria, and the sources and methods of selection of participants. Report the sample size, and whether any power or sample size calculations were carried out prior to the main analysis
参与者:给出资格标准,以及选择参与者的来源和方法。报告样本量,以及在主分析之前是否进行了任何功效或样本量计算
 

c)

Describe measurement, quality control and selection of genetic variants
描述遗传变异的测量、质量控制和选择

d)

For each exposure, outcome, and other relevant variables, describe methods of assessment and diagnostic criteria for diseases
对于每种暴露、结果和其他相关变量,描述疾病的评估方法和诊断标准

e)

Provide details of ethics committee approval and participant informed consent, if relevant
提供伦理委员会批准和参与者知情同意书的详细信息(如果相关)

5

Assumptions
假设

Explicitly state the three core IV assumptions for the main analysis (relevance, independence and exclusion restriction) as well assumptions for any additional or sensitivity analysis
明确说明主要分析的三个核心 IV 假设(相关性、独立性和排除限制)以及任何附加分析或敏感性分析的假设

6

Statistical methods: main analysis
统计方法:主要分析

Describe statistical methods and statistics used
描述使用的统计方法和统计数据

a)

Describe how quantitative variables were handled in the analyses (i.e., scale, units, model)
描述在分析中如何处理定量变量(即比例、单位、模型)

b)

Describe how genetic variants were handled in the analyses and, if applicable, how their weights were selected
描述在分析中如何处理遗传变异,以及如果适用,如何选择它们的权重

c)

Describe the MR estimator (e.g. two-stage least squares, Wald ratio) and related statistics. Detail the included covariates and, in case of two-sample MR, whether the same covariate set was used for adjustment in the two samples
描述 MR 估计器(例如两阶段最小二乘法、Wald 比率)和相关统计数据。详细说明包含的协变量,如果是双样本 MR,则详细说明是否使用相同的协变量集在两个样本中进行调整

d)

Explain how missing data were addressed
说明如何解决缺失数据

e)

If applicable, indicate how multiple testing was addressed
如果适用,请说明如何解决多重检测

7

Assessment of assumptions
假设评估

Describe any methods or prior knowledge used to assess the assumptions or justify their validity
描述用于评估假设或证明其有效性的任何方法或先验知识

8

Sensitivity analyses and additional analyses
敏感性分析和附加分析

Describe any sensitivity analyses or additional analyses performed (e.g. comparison of effect estimates from different approaches, independent replication, bias analytic techniques, validation of instruments, simulations)
描述执行的任何敏感性分析或其他分析(例如,不同方法的效果估计比较、独立复制、偏差分析技术、仪器验证、模拟)

9

Software and pre-registration
软件和预注册

a)

Name statistical software and package(s), including version and settings used 
名称统计软件和软件包,包括使用的版本和设置

b)

State whether the study protocol and details were pre-registered (as well as when and where)
说明研究方案和详细信息是否已预先注册(以及何时何地)

RESULTS

10

Descriptive data
描述性数据

a)

Report the numbers of individuals at each stage of included studies and reasons for exclusion. Consider use of a flow diagram
报告纳入研究每个阶段的个体数量和排除原因。考虑使用流程图

b)

Report summary statistics for phenotypic exposure(s), outcome(s), and other relevant variables (e.g. means, SDs, proportions)
报告表型暴露、结果和其他相关变量(例如 平均值、标准差、比例)

c)

If the data sources include meta-analyses of previous studies, provide the assessments of heterogeneity across these studies
如果数据来源包括以前研究的荟萃分析,请提供这些研究的异质性评估

d)

For two-sample MR:
对于双样品 MR:

i.  Provide justification of the similarity of the genetic variant-exposure associations between the exposure and outcome samples
i. 提供暴露和结果样本之间遗传变异-暴露关联相似性的理由

ii.  Provide information on the number of individuals who overlap between the exposure and outcome studies
ii. 提供有关暴露研究和结果研究之间重叠的个体数量的信息

11

Main results
主要结果

a)

Report the associations between genetic variant and exposure, and between genetic variant and outcome, preferably on an interpretable scale
报告遗传变异与暴露之间的关联,以及遗传变异与结局之间的关联,最好采用可解释的量表

b)

Report MR estimates of the relationship between exposure and outcome, and the measures of uncertainty from the MR analysis, on an interpretable scale, such as odds ratio or relative risk per SD difference
在可解释的量表上报告 MR 对暴露和结果之间关系的估计,以及 MR 分析的不确定性测量,例如每个 SD 差异的比值比或相对风险

c)

If relevant, consider translating estimates of relative risk into absolute risk for a meaningful time period
如果相关,请考虑将相对风险的估计值转换为有意义时间段内的绝对风险

d)

Consider plots to visualize results (e.g. forest plot, scatterplot of associations between genetic variants and outcome versus between genetic variants and exposure)
考虑使用图来可视化结果(例如,森林图、遗传变异与结果之间关联的散点图与遗传变异与暴露之间的散点图)

12

Assessment of assumptions
假设评估

a)

Report the assessment of the validity of the assumptions
报告对假设有效性的评估

b)

Report any additional statistics (e.g., assessments of heterogeneity across genetic variants, such as I2, Q statistic or E-value)
报告任何其他统计数据(例如,跨遗传变异异质性的评估,例如 2、Q 统计量或 E 值)

13

Sensitivity analyses and additional analyses
敏感性分析和附加分析

a)

Report any sensitivity analyses to assess the robustness of the main results to violations of the assumptions
报告任何敏感性分析,以评估主要结果对违反假设的稳健性

b)

Report results from other sensitivity analyses or additional analyses
报告其他敏感性分析或其他分析的结果

c)

Report any assessment of direction of causal relationship (e.g., bidirectional MR)
报告对因果关系方向的任何评估(例如,双向 MR)

d)

When relevant, report and compare with estimates from non-MR analyses
如果相关,则报告并与非 MR 分析的估计值进行比较

e)

Consider additional plots to visualize results (e.g., leave-one-out analyses)
考虑使用其他图来可视化结果(例如,留一法分析)

DISCUSSION

14

Key results 
主要结果

Summarize key results with reference to study objectives
参考研究目标总结关键结果

15

Limitations
局限性

Discuss limitations of the study, taking into account the validity of the IV assumptions, other sources of potential bias, and imprecision. Discuss both direction and magnitude of any potential bias and any efforts to address them
讨论研究的局限性,同时考虑到 IV 假设的有效性、其他潜在偏倚来源和不精确性。讨论任何潜在偏见的方向和程度,以及为解决这些偏见所做的任何努力
 

16

Interpretation
解释

a)

Meaning: Give a cautious overall interpretation of results in the context of their limitations and in comparison with other studies
含义:根据结果的局限性并与其他研究进行比较,对结果进行谨慎的整体解释

b)

Mechanism: Discuss underlying biological mechanisms that could drive a potential causal relationship between the investigated exposure and the outcome, and whether the gene-environment equivalence assumption is reasonable. Use causal language carefully, clarifying that IV estimates may provide causal effects only under certain assumptions
机制:讨论可能驱动所调查的暴露与结果之间潜在因果关系的潜在生物学机制,以及基因-环境等效假设是否合理。谨慎使用因果语言,阐明 IV 估计可能仅在某些假设下提供因果效应

c)

Clinical relevance: Discuss whether the results have clinical or public policy relevance, and to what extent they inform effect sizes of possible interventions
临床相关性:讨论结果是否具有临床或公共政策相关性,以及它们在多大程度上影响可能干预措施的效应大小

17

Generalizability 
概 化
 

Discuss the generalizability of the study results (a) to other populations, (b) across other exposure periods/timings, and (c) across other levels of exposure
讨论研究结果 (a) 对其他人群的普遍性,(b) 跨其他暴露期/时间,以及 (c) 跨其他暴露水平

OTHER INFORMATION
其他信息

18

Funding
资金

Describe sources of funding and the role of funders in the present study and, if applicable, sources of funding for the databases and original study or studies on which the present study is based
描述资金来源和资助者在本研究中的作用,以及(如果适用)本研究所依据的数据库和原始研究的资金来源

19

Data and data sharing 
数据和数据共享

Provide the data used to perform all analyses or report where and how the data can be accessed, and reference these sources in the article. Provide the statistical code needed to reproduce the results in the article, or report whether the code is publicly accessible and if so, where
提供用于执行所有分析的数据,或报告可以访问数据的位置和方式,并在文章中引用这些来源。提供在文章中重现结果所需的统计代码,或报告代码是否可公开访问,如果是,在哪里

20

Conflicts of Interest  
利益冲突

All authors should declare all potential conflicts of interest
所有作者都应声明所有潜在的利益冲突

This checklist is copyrighted by the Equator Network under the Creative Commons Attribution 3.0 Unported (CC BY 3.0) license.
本清单的版权归 Equator Network 所有,采用知识共享署名 3.0 未本地化版本(CC BY 3.0)许可。

1. Skrivankova VW, Richmond RC, Woolf BAR, Yarmolinsky J, Davies NM, Swanson SA, et al. Strengthening the Reporting of Observational Studies in Epidemiology using Mendelian Randomization (STROBE-MR) Statement. JAMA. 2021;under review.
1. Skrivankova VW, Richmond RC, Woolf BAR, Yarmolinsky J, Davies NM, Swanson SA, et al. 使用孟德尔随机化 (STROBE-MR) 声明加强流行病学观察性研究的报告。美国医学会。2021;正在审核中。

2. Skrivankova VW, Richmond RC, Woolf BAR, Davies NM, Swanson SA, VanderWeele TJ, et al. Strengthening the Reporting of Observational Studies in Epidemiology using Mendelian Randomisation (STROBE-MR): Explanation and Elaboration. BMJ. 2021;375:n2233.
2. Skrivankova VW, Richmond RC, Woolf BAR, Davies NM, Swanson SA, VanderWeele TJ, et al. 使用孟德尔随机化 (STROBE-MR) 加强流行病学观察性研究的报告:解释和阐述。英国医学杂志。2021;375:n2233 的。

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