Clinical research

The STROBE Checklist for Observational Studies, Explained

What the STROBE checklist asks for in cohort, case-control and cross-sectional studies, section by section, with the items reviewers most often find missing.

STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) is the reporting guideline for the three main observational designs: cohort, case-control and cross-sectional studies. Most medical journals ask authors to submit the completed checklist, giving the page on which each item appears. It does not tell you how to do the study; it lists what the paper must say so that readers can judge it.

The structure

The 22 items follow the paper's sections. Eighteen apply to every design; four (items 6, 12, 14 and 15) have versions for cohort, case-control and cross-sectional studies.

SectionItemsWhat they ask for
Title and abstract1The design in the title or abstract, and an informative, balanced abstract
Introduction2-3Background and rationale; specific objectives and hypotheses
Methods4-12Design, setting and dates, participants and how they were selected, variables (outcomes, exposures, confounders), data sources and measurement, bias, study size, handling of quantitative variables, statistical methods
Results13-17Participants at each stage (ideally a flow diagram), descriptive data, outcome data, main results with confounder-adjusted estimates and CIs, other analyses
Discussion18-21Key results, limitations, interpretation, generalisability
Other22Funding

The items reviewers most often find missing

  • Item 9, bias: what you did to address possible sources of bias, not only a list of them in the limitations.
  • Item 10, study size: how the sample size was arrived at. See how to calculate sample size for a survey.
  • Item 12, statistical methods: how confounders were controlled, how missing data were handled, and any sensitivity analyses.
  • Item 13, participants: numbers at each stage (eligible, examined, included, analysed) and reasons for non-participation.
  • Item 14, descriptive data: participant characteristics and missing data per variable, usually as Table 1.
  • Item 16, main results: unadjusted and adjusted estimates with 95% CIs, and which confounders were adjusted for and why.

How to fill it in

  1. Download the checklist for your design from the STROBE website.
  2. For each item, write the page (and paragraph) where it is reported, not "yes".
  3. If an item does not apply, say why ("not applicable: no follow-up").
  4. Use the gaps as a to-do list before submission: an empty item is a likely reviewer comment.

Mistakes reviewers catch

  • A checklist that says "yes" everywhere with no page numbers.
  • Unadjusted results only, or adjusted results without saying for what.
  • Missing data not reported for each variable.
  • Causal language ("X causes Y") in a cross-sectional study.

Let KyroStat do the write-up for you

KyroStat produces the parts of a STROBE-compliant Results section that come from the data: participant flow numbers, Table 1 with missing data, and unadjusted and adjusted estimates with confidence intervals.

Frequently asked questions

Which guideline applies to randomized trials? CONSORT. See the CONSORT 2025 guide.

Is there a STROBE version for my field? Yes, several extensions exist (for example STROBE-MR for Mendelian randomisation and RECORD for routinely collected data). The EQUATOR Network lists them.

How should the statistics be formatted? By your journal's style; most medical journals use AMA style. See how to report statistics in AMA style.

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