You have prepared your manuscript and you are about to submit it to a journal. While reading the Instructions for Authors, you came across a statement such as "a CONSORT checklist is required" or "be STROBE compliant." What are these guidelines, what are the differences between them, and which one should you use, and when?
Why Do Reporting Guidelines Exist?
Reporting guidelines were developed to ensure that research is published in a transparent, complete, and reproducible way. They standardize which pieces of information should be included in a manuscript.
The great majority of high-impact journals require compliance with these guidelines. The EQUATOR Network (equator-network.org) is the central platform that provides access to all of the guidelines.
CONSORT: Randomized Controlled Trials
Use: For all randomized controlled trials (RCT).
CONSORT (Consolidated Standards of Reporting Trials) includes a 25-item checklist and a flowchart that specifically shows participant flow. The flowchart shows four stages: enrollment, allocation, follow-up, and analysis.
The most frequently omitted items: randomization method, allocation concealment, blinding details, and reasons for loss to follow-up.
Do not submit an RCT manuscript without a CONSORT flow diagram; it is the most common reason for desk rejection.
STROBE: Observational Studies
Use: For cohort, case-control, and cross-sectional studies.
STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) includes a separate 22-item checklist for each study type.
The most frequently omitted items in observational studies: the rationale for sample size determination, handling of missing data, and sensitivity analysis.
PRISMA: Systematic Reviews and Meta-Analyses
Use: For all systematic reviews and meta-analyses.
The PRISMA 2020 update includes 27 items. The most critical requirement: the PRISMA flow diagram. It shows every screening step in the literature search process and the reason for it.
PROSPERO registration became mandatory in PRISMA 2020. A systematic review without a registration is rejected by many journals.
TRIPOD: Predictive Model Studies
Use: For studies developing and validating predictive models for diagnosis or prognosis. It also applies to AI and machine learning studies.
TRIPOD (Transparent Reporting of a Multivariable Prediction Model for Individual Prognosis or Diagnosis) includes 22 items.
The TRIPOD-AI update for AI studies was published in 2024. Model performance metrics, external validation, and bias assessment are additional requirements.
STARD: Diagnostic Accuracy Studies
Use: For studies comparing a new diagnostic test or biomarker against a gold standard.
STARD (Standards for Reporting of Diagnostic Accuracy Studies) includes 30 items and a participant flow diagram. Sensitivity, specificity, the ROC curve, and the method for determining the threshold value are among the standard reporting requirements.
Which Study, Which Guideline?
| Study Type | Guideline |
|---|---|
| Randomized controlled trial | CONSORT |
| Cohort, cross-sectional, case-control | STROBE |
| Systematic review, meta-analysis | PRISMA 2020 |
| Predictive model, AI/ML | TRIPOD / TRIPOD-AI |
| Diagnostic accuracy | STARD |
| Case report | CARE |
| Quality improvement | SQUIRE |
| Animal study | ARRIVE |
If more than one guideline applies, comply with both. For example, a predictive model study based on a systematic review: both PRISMA and TRIPOD.
How Is a Checklist Used?
The checklist for each guideline can be downloaded from EQUATOR. For each item, you mark "Yes / No / Not Applicable" and indicate which page or paragraph provides that information.
The journal requests this completed checklist as supplementary material. An incompletely filled checklist leads to reviewer rejection.
For reporting guideline compliance and manuscript submission preparation, request a free consultation.
Where Do People Get Stuck Most in This Analysis?
- Your study is observational, but you do not know which STROBE items are applicable to your study.
- The journal says "include a reporting guideline checklist," but it is unclear how to complete many of the items on the form.
- Your study design does not fit into a standard category, and you cannot decide which guideline to use.