Strengthening the Reporting of Observational Studies in Epidemiology Using Mendelian Randomization: The STROBE-MR Statement.

Skrivankova, Veronika W; Richmond, Rebecca C; Woolf, Benjamin A R; Yarmolinsky, James; Davies, Neil M; Swanson, Sonja A; VanderWeele, Tyler J; Higgins, Julian P T; Timpson, Nicholas J; Dimou, Niki; Langenberg, Claudia; Golub, Robert M; Loder, Elizabeth W; Gallo, Valentina; Tybjaerg-Hansen, Anne; Davey Smith, George; Egger, Matthias; Richards, J Brent (2021). Strengthening the Reporting of Observational Studies in Epidemiology Using Mendelian Randomization: The STROBE-MR Statement. JAMA - the journal of the American Medical Association, 326(16), pp. 1614-1621. American Medical Association 10.1001/jama.2021.18236

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Importance

Mendelian randomization (MR) studies use genetic variation associated with modifiable exposures to assess their possible causal relationship with outcomes and aim to reduce potential bias from confounding and reverse causation.

Objective

To develop the STROBE-MR Statement as a stand-alone extension to the STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) guideline for the reporting of MR studies.

Design, Setting, and Participants

The development of the STROBE-MR Statement followed the Enhancing the Quality and Transparency of Health Research (EQUATOR) framework guidance and used the STROBE Statement as a starting point to draft a checklist tailored to MR studies. The project was initiated in 2018 by reviewing the literature on the reporting of instrumental variable and MR studies. A group of 17 experts, including MR methodologists, MR study design users, developers of previous reporting guidelines, and journal editors, participated in a workshop in May 2019 to define the scope of the Statement and draft the checklist. The draft checklist was published as a preprint in July 2019 and discussed on the preprint platform, in social media, and at the 4th Mendelian Randomization Conference. The checklist was then revised based on comments, further refined through 2020, and finalized in July 2021.

Findings

The STROBE-MR checklist is organized into 6 sections (Title and Abstract, Introduction, Methods, Results, Discussion, and Other Information) and includes 20 main items and 30 subitems. It covers both 1-sample and 2-sample MR studies that assess 1 or multiple exposures and outcomes, and addresses MR studies that follow a genome-wide association study and are reported in the same article. The checklist asks authors to justify why MR is a helpful method to address the study question and state prespecified causal hypotheses. The measurement, quality, and selection of genetic variants must be described and attempts to assess validity of MR-specific assumptions should be well reported. An item on data sharing includes reporting when the data and statistical code required to replicate the analyses can be accessed.

Conclusions and Relevance

STROBE-MR provides guidelines for reporting MR studies. Improved reporting of these studies could facilitate their evaluation by editors, peer reviewers, researchers, clinicians, and other readers, and enhance the interpretation of their results.

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Pre-clinic Human Medicine > Institute of Social and Preventive Medicine (ISPM)

UniBE Contributor:

Whitesell, Veronika, Egger, Matthias

Subjects:

600 Technology > 610 Medicine & health
300 Social sciences, sociology & anthropology > 360 Social problems & social services

ISSN:

0098-7484

Publisher:

American Medical Association

Funders:

[4] Swiss National Science Foundation

Language:

English

Submitter:

Andrea Flükiger-Flückiger

Date Deposited:

05 Nov 2021 19:12

Last Modified:

03 Jan 2023 12:11

Publisher DOI:

10.1001/jama.2021.18236

PubMed ID:

34698778

Additional Information:

Davey Smith, Egger and Richards contributed equally to this work.

BORIS DOI:

10.48350/160665

URI:

https://boris.unibe.ch/id/eprint/160665

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