Review Article

The STROBE guidelines

ABSTRACT
An observational study is a type of epidemiological study design, which can take the form of a cohort, a case–control,
or a cross‑sectional study. When presenting observational studies in manuscripts, an author needs to ascertain a clear
presentation of the work and provide the reader with appropriate information to enable critical appraisal of the research. The
Strengthening the Reporting of Observational studies in Epidemiology (STROBE) guidelines were created to aid the author
in ensuring high‑quality presentation of the conducted observational study. The original articles publishing the STROBE
guidelines together with their bibliographies were identified and thoroughly reviewed. These guidelines consist of 22 checklist
items that the author needs to fulfil before submitting the manuscript to a journal. The STROBE guidelines were created
to aid the authors in presenting their work and not to act as a validation tool for the conducted study or as a framework to
conduct an observational study on. The authors complying with these guidelines are more likely to succeed in publishing
their observational study work in a journal.

Key words: Data reporting; epidemiology; observational studies; publishing; research design

Introduction to aid in the presentation of the conducted observational

study to ensure adequate reporting (what was planned, done,
Different epidemiological study designs are available and found, and concluded) as well as assessment of the strengths
are adopted by a researcher depending on the research and weaknesses of the study.[1,2] Such study information is
question at hand. An observational study is one type of of vital importance in a manuscript since this will determine
epidemiological study design, which can be in the form of a whether the established results can be included in systemic
cohort, a case–control, or a cross‑sectional study. This type of reviews later on.[3,4] Furthermore, the STROBE guidelines
study design (observational) is defined as a nonexperimental enable the journal’s editor, reviewers, and the readers to
research, where the researcher observes a particular critically appraise the study.[1]
environmental behavior without artificially controlling the
environment under study. To ascertain high‑quality reporting The STROBE Guidelines
of observational studies, the Strengthening the Reporting of
Observational studies in Epidemiology (STROBE) guidelines The aim of the STROBE guidelines was to provide a readily
were developed following a collaborative initiative of available checklist to ensure a clear presentation of what
epidemiologists, methodologists, statisticians, researchers, was planned and conducted in an observational study.
and journal editors in 2004.[1] These guidelines were created These studies are set out to investigate the associations

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DOI:
10.4103/sja.SJA_543_18 How to cite this article: Cuschieri S. The STROBE guidelines. Saudi
J Anaesth 2019;13:S31-4.

Sarah Cuschieri
Department of Anatomy, Faculty of Medicine and Surgery, Biomedical Building, University of Malta, Msida, Malta

Address for correspondence: Dr. Sarah Cuschieri, Department of Anatomy, Faculty of Medicine and Surgery, Biomedical Building,
University of Malta, Msida MSD 2080, Malta. E‑mail: sarah.cuschieri@um.edu.mt

© 2019 Saudi Journal of Anesthesia | Published by Wolters Kluwer - Medknow S31

 Cuschieri: STROBE - Guidelines for publishing observational studies

between an exposure and a health outcome. In no way were guidelines do not allow the use of the words “prospective”
these guidelines established to provide a methodological or “retrospective” or “concurrent” or “historical,” but
framework for conducting an observational study.[1] Nor rather encourage the researcher to describe the actual
were the guidelines developed as an instrument for quality methodology.[1]
evaluation of observational research.[2] Furthermore, the
guidelines were not aimed to bring forward standardization Information on the tools of measurement, setting, and
of manuscripts but rather to encourage the production locations should be reported to enhance the reader’s
of interesting and narrative articles while maintaining understanding of the study’s results. The reporting of the
transparency.[5] participants’ recruitment procedure will vary depending on
the type of observation design being conducted. Therefore,
The Strobe Checklist it is important that the researcher is knowledgeable about
the epidemiological methodological design for each
A total of 22 checklist items contribute to the STROBE different observational study (i.e., cohort, case–control, or
guidelines. Eighteen items are common to all the three cross‑sectional, respectively).
observational designs, that is, cohort, cross‑sectional, and
case–control studies. However, the remaining four checklist All the variables considered for the descriptive and
items (items number 6, 12, 14, and 15) have specific statistical analysis of the study need to be noted down
variations according to the study design. Table 1 exhibits within the methods section. This also includes the
the STROBE guidelines as published by Vandenbroucke reporting of any specific cut‑off points implemented
et al.[1] The following is an abbreviated explanation of the during the analysis. It is essential that any exposures,
checklist items. confounders, or outcomes measurements are accounted
for and reported for the reader to critically appraise the
Item 1: Title and Abstract study’s reliability and validity. The inclusion and exclusion
criteria and methods to overcome any potential bias should
The adopted study design should be part of the manuscript be noted down as well.
title to ensure correct indexing of the manuscript in
electronic databases. Indexing of the published manuscript The method used to establish the study size needs to be
is of utmost importance to ensure visibility of a researcher’s reported along with the confidence intervals considered.
work and increase the citation potential of the published This is essential for the reader to ascertain whether sufficient
manuscript. Citation of published manuscripts is imperative statistical precision has been attained in the study.[1]
for the enhancement of the researcher’s research metrics
and for increasing the prestigious acknowledgement of The reporting of statistical analysis will vary depending on the
the researcher and his or her work within the scientific study design (i.e., cohort, case–control, or cross‑sectional).
community.[6] The abstract should include a brief summary However, it is important that all statistical methods and
of the study and present only information found within the adjustments for potential confounders or missing data are
actual body of the manuscript. noted down clearly.

Items 2 and 3: Introduction Items 13–17: Results

The introduction should consist of background information The results section should give an in‑depth account of the
that will set the scene for the study and the objective of the response rate and the description of the study population
study. The objective states the researcher’s intentions for along with the main descriptive and analytical results. The
conducting the study and potential hypotheses that may information provided will depend on the type of observational
arise from such work. design (i.e., cohort, case–control, or cross‑sectional) followed
by the researcher and the corresponding statistical analysis
Items 4–12: Methods performed.

The methods section should provide a clear description Items 18–21: Discussion
of the study design at an early stage. This will enable the
reader to understand the basis of the study and be able to The discussion should address all the central issues of the
critically appraise the study’s methodology. The STROBE study including the validity of the study. The objective/s of the

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 Cuschieri: STROBE - Guidelines for publishing observational studies

Table 1: STROBE guidelines

STROBE guidelines
Section/topic Item number Recommendation
Title and abstract 1 Indicate the study’s design with a commonly used term in the title or the abstract
Provide in the abstract an informative and balanced summary of what was done and what was found
Introduction
Background/rationale 2 Explain the scientific background and rationale for the investigation being reported
Objectives 3 State specific objectives, including any prespecified hypotheses
Methods
Study design 4 Present key elements of study design early in the manuscript
Setting 5 Describe the setting, locations, and relevant dates, including periods of recruitment, exposure, follow‑up,
and data collection
Participants 6 Cohort study – give the eligibility criteria, and the sources and methods of selection of participants;
describe methods of follow‑up
Case–control study – 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
Cross‑sectional study – give the eligibility criteria, and the sources and methods of selection of
participants
Cohort study – for matched studies, give matching criteria and number of exposed and unexposed
Case–control study – for matched studies, give matching criteria and the number of controls per case
Variables 7 Clearly define all outcomes, exposures, predictors, potential confounders, and effect modifiers; give
diagnostic criteria, if applicable
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
Bias 9 Describe any efforts to address potential sources of bias
Study size 10 Explain how the study size was arrived at
Quantitative variables 11 Explain how quantitative variables were handled in the analyses; if applicable, describe which groupings
were chosen and why
Statistical methods 12 Describe all statistical methods, including those used to control for confounding
Describe any methods used to examine subgroups and interactions
Explain how missing data were addressed
Cohort study – if applicable, explain how loss to follow‑up was addressed
Case–control study – if applicable, explain how matching of cases and controls was addressed
Cross‑sectional study – if applicable, describe analytical methods taking account of sampling strategy
Describe any sensitivity analyses
Results
Participants 13* Report numbers of individuals at each stage of study – e.g., numbers potentially eligible, examined for
eligibility, confirmed eligible, included in the study, completing follow‑up, and analyzed
Give reasons for nonparticipation at each stage
Consider use of a flow diagram
Descriptive data 14* Give characteristics of study participants (e.g., demographic, clinical, social) and information on
exposures and potential confounders
Indicate number of participants with missing data for each variable of interest
Cohort study – summarize follow‑up time (e.g., average and total amount)
Outcome data 15* 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
Cross‑sectional study – report numbers of outcome events or summary measures
Main results 16 Give unadjusted estimates and, if applicable, confounder‑adjusted estimates and their precision (e.g.,
95% confidence interval); make clear which confounders were adjusted for and why they were included
Report category boundaries when continuous variables were categorized
If relevant, consider translating estimates of relative risk into absolute risk for a meaningful time period
Other analyses 17 Report other analyses done – e.g., analyses of subgroups and interactions, and sensitivity analyses
Discussion
Key results 18 Summarize key results with reference to study objectives
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
Interpretation 20 Give a cautious overall interpretation of results considering objectives, limitations, multiplicity of
analyses, results from similar studies, and other relevant evidence
Generalizability 21 Discuss the generalizability (external validity) of the study results
Contd...
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 Cuschieri: STROBE - Guidelines for publishing observational studies

Table 1: Contd...
STROBE guidelines
Section/topic Item number Recommendation
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
*Give information separately for cases and controls in case–control studies and, if applicable, for exposed and unexposed groups in cohort and cross‑sectional studies

study should be kept in mind while discussing the findings. observational‑study‑inspired manuscript. Having a thorough
Comparisons to already published literature are essential. It understanding of the STROBE guidelines is therefore
may be appropriate for the discussion section to be subdivided becoming a requisite for authors who wish to conduct and
into different sections to enable better interpretation of the publish an observational study. These guidelines have been
study findings. The researcher should provide an objective formulated as an aid to authors to enable them to construct
assessment of the findings and avoid overinterpretations. an adequately presented manuscript that allows the reader
Potential confounder effects that might have had an effect on to fully comprehend and critically appraise the manuscript.
the results and associations obtained in the study should be
considered. Therefore, it is imperative to note down potential Financial support and sponsorship
limitations faced by the study, while noting any bias that might Nil.
have been present. Furthermore, researchers have to keep in
mind that causality of a particular outcome cannot be established Conflicts of interest
in most study designs, unless a longitudinal cohort study has There are no conflicts of interest.
been conducted. Therefore, this fact needs to be acknowledged
during the discussion and may act as a study limitation for
References
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in epidemiology (STROBE): Explanation and elaboration. PLoS Med
Item 22: Funding and Sponsorship 2007;4:e297.
2. von Elm E, Altman DG, Egger M, Pocock SJ, Gøtzsche PC,
Vandenbroucke JP, et al. Strengthening the reporting of observational
The source of funding and the role of the funders in the study studies in epidemiology (STROBE) statement: Guidelines for reporting
are essential pieces of information that are required at the observational studies. BMJ 2007;335:806‑8.
end of the article. This is accompanied with any conflict of 3. Jüni P, Altman DG, Egger M. Systematic reviews in health care:
interest of both the author/s and the funders. Assessing the quality of controlled clinical trials. BMJ 2001;323:42‑6.
4. Egger M, Schneider M, Davey Smith G. Spurious precision?
Meta‑analysis of observational studies. BMJ 1998;316:140‑4.
Conclusion
5. Schriger DL. Suggestions for improving the reporting of clinical
research: The role of narrative. Ann Emerg Med 2005;45:437‑43.
A substantial number of journals are requesting authors 6. Cuschieri S. WASP (Write a scientific paper): Understanding research
to follow the STROBE guidelines before submitting their metrics. Early Hum Dev 2018;118:67‑71.

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