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Medical Reporting Guidelines

Making Descriptive Science Robust Science: STROBE Guidelines

 

Jeffrey Isenberg, M.D., M.P.H., LetPub Editor

June 2021

Basic and translational research traditionally tests hypotheses with experiments that are repeatable over time and by multiple individuals. In general, any scientist using the same materials and methods should obtain the same or similar results as any other scientist. However, clinical research, by its nature, is subject to many more variables, which can confound results and conclusions. To improve the clarity and presentation of clinical observational studies, the Strengthening the Reporting of Observational studies in Epidemiology (STROBE) guidelines were promulgated. (1) These guidelines consist of 22 items researchers are encouraged to address before submitting their manuscript to a journal. (2)

What are the STROBE guidelines?

The table below best summarizes the specific STROBE guidelines. Researchers are recommended to consult the references below for additional details.

Item
Recommendation
1. Title and abstract Indicate the study’s design with a commonly used term in the title or the abstract. Provide an informative and balanced summary of what was done and what was found in the abstract.
2. Introduction/background Explain the scientific background and rationale for the investigation being reported.
3. Objectives State objectives and hypothesis.
4. Methods – study design Summarize study design, study dates, location, and follow-up. For cohorts, give eligibility details, selection methods, any matching, etc. Define outcomes and confounders.
5. Setting Give setting, locations, and relevant dates (recruitment, treatment, follow-up).
6. Participants Eligibility; case, control and rationale; and methods used to select study subjects.
7. Variables Define outcomes, exposures, predictors, modifiers, and diagnostic groups.
8. Data For any variable, give source and how it was assessed.
9. Bias Point out sources of bias.
10. Study size Indicate how study size was determined.
11. Quantitative How were these variables analyzed?
12. Statistics State which type of statistics with details, controls, interactions, lost data handling, matching, and sensitivity.
13. Cohort numbers Include possible and final numbers enrolled; and explain loss of study participants, if any.
14. Cohort description Demographics, social, cultural information, confounders and absent data.
15. Outcome data Include as appropriate for type of study.
16. Main results/td> Unadjusted, confounder adjusted with precision; note boundaries; absolute vs relative.
17. Other analysis Subgroup and/or sensitivity analyses can be included.
18. Discussion - key results Summary of key findings.
19. Discussion - limitations Limitations of study should be addressed.
20. Discussion – interpretation Cautious evaluation of study findings.
21. Discussion – conclusions Short summary of primary findings.
22. Funding Who supported the work financially?


Goals of the STROBE guidelines

When one takes a closer look at the guidelines, it is clear that their aims are multiple and include:

(1) to provide authors a road map during the process of proposing a hypothesis and designing their study to capture as much relevant data in a controlled fashion as possible;
(2) to provide a template to adhere to generate a manuscript with a clear rationale and logical structure;
(3) to standardize the presentation of the study’s details and results; and
(4) to encourage greater transparency in science.

This latter practice was widely adapted by basic science researchers and journals. Indeed, most top-flight science journals have a “best practices approach” to publication. The STROBE guidelines represent a movement in this direction for observational science.

What do the STROBE guidelines mean for researchers? Authors of observational studies are tasked with adherence to the STROBE guidelines by a continually expanding list of translationally and clinically focused journals. Detailed understanding and application of the guidelines will soon to be de rigueur for observational type research. The end result will be quality research that is sound in design and execution and that can be clearly interpreted by the science community.

References

1. Vandenbroucke JP, von Elm E, Altman DG, Gøtzsche PC, Mulrow CD, Pocock SJ, et al. Strengthening the reporting of observational studies in epidemiology (STROBE): Explanation and elaboration. PLoS Med. 2007 Oct 16;4(10): e297. PMID: 17941715

2. Cuschieri S. The STROBE guidelines. Saudi J Anaesth. 2019;13(Suppl 1): S31-S34. PMID: 30930717

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