The CONSORT Statement (CONsolidated Standards Of Reporting Trials) is the reporting guideline for writing up the results of a randomized controlled trial (RCT). It defines the minimum information a published trial report must contain so readers, peer reviewers, and systematic reviewers can judge how the trial was conducted and whether its results are trustworthy.
CONSORT is maintained by an independent international group of trialists, statisticians, and journal editors, and is one of the reporting guidelines catalogued by the EQUATOR Network, alongside PRISMA for systematic reviews and STROBE for observational studies.
CONSORT 2025 has superseded CONSORT 2010
The version most researchers still refer to by habit — CONSORT 2010 (Schulz, Altman, and Moher, published in BMJ) — is no longer the current statement. On 14 April 2025, an updated CONSORT 2025 statement was published simultaneously in five major medical journals: The BMJ, JAMA, The Lancet, Nature Medicine, and PLOS Medicine. Any trial report being prepared now should be checked against CONSORT 2025, not the 2010 checklist, unless a specific journal’s author instructions still explicitly reference the older version.
CONSORT 2025 expanded the checklist from 25 items to 30 items. The update added seven new items, revised three existing items, deleted one item (on generalizability), and folded in content that previously lived only in separate CONSORT extensions — including material on harms reporting, outcome reporting, and non-pharmacological treatments. The new items address areas the 2010 checklist did not require explicitly, including a data sharing statement, disclosure of authors’ financial and other conflicts of interest, patient and public involvement in the trial, eligibility criteria for the sites and individuals delivering an intervention, a dedicated harms-assessment item, an explicit definition of who is included in each analysis population, and further detail on how the intervention was actually delivered.
What the 30-item checklist covers
CONSORT 2025 organizes its checklist into six sections. This is a structural summary, not the verbatim checklist wording — researchers preparing a manuscript should work from the actual checklist and the accompanying explanation and elaboration document on the official CONSORT website, not from a paraphrase.
- Title and abstract (2 items) — identification of the report as a randomized trial in the title, and a structured summary of trial design, methods, results, and conclusions.
- Open science (4 items) — a new section in the 2025 revision, consolidating trial registration, where the protocol and statistical analysis plan can be accessed, data sharing arrangements, and funding and conflicts of interest into one reporting block rather than scattering them through the report.
- Introduction (2 items) — scientific background and rationale, and the trial’s specific objectives or hypotheses.
- Methods (11 items) — the largest section: trial design, eligibility criteria (now including criteria for sites and for the individuals delivering an intervention), interventions and how they were actually delivered, outcome definitions, harms assessment, sample size determination, randomization sequence generation, allocation concealment, blinding, and statistical methods, including how each analysis population is defined.
- Results (8 items) — participant flow through the trial, recruitment and trial dates, baseline demographic and clinical characteristics, numbers analyzed, outcome results with effect estimates and precision, ancillary and subgroup analyses, and harms.
- Discussion (2 items) — interpretation of the results in the context of existing evidence, and the trial’s limitations.
Several of the Methods and Results items in CONSORT 2010 — most notably randomization sequence generation and allocation concealment — are commonly conflated in practice but are reported as separate checklist items, because they address different sources of bias: sequence generation concerns whether the assignment order was genuinely unpredictable, while allocation concealment concerns whether that sequence was hidden from whoever enrolled participants until the moment of assignment.
The CONSORT flow diagram
Alongside the checklist, CONSORT requires a flow diagram documenting how participants moved through the trial: how many were assessed for eligibility, how many were excluded and why, how many were randomized to each arm, how many received the allocated intervention, how many were lost to follow-up or discontinued (and why), and how many were included in the final analysis of each arm. The diagram exists because attrition and exclusions happening unevenly across arms are a recognized source of bias that a results narrative alone can obscure; a reader can trace the diagram to see exactly how the analyzed sample was arrived at, arm by arm.
CONSORT extensions
Beyond the core statement, CONSORT maintains a family of extensions adapting the checklist to trial designs and reporting situations the core checklist does not fully address on its own — including cluster-randomized trials, non-inferiority and equivalence trials, pragmatic trials, adaptive designs, crossover trials, and factorial designs, as well as extensions focused on specific reporting elements such as harms and abstracts. CONSORT 2025 folded some previously extension-only content (harms, outcomes, non-pharmacological treatment detail) into the core checklist itself, but design-specific extensions remain relevant for trials with those specific designs and should be consulted in addition to, not instead of, the core 2025 checklist.
Why journals require it
CONSORT’s practical authority comes from journal adoption rather than any regulatory mandate. It is endorsed by a large number of biomedical journals worldwide, and the International Committee of Medical Journal Editors (ICMJE) recommends that journals require authors to follow the relevant EQUATOR Network reporting guideline for their study type — CONSORT for randomized trials, PRISMA for systematic reviews, STROBE for observational studies. In practice this usually means a submitting author is asked to supply a completed CONSORT checklist, keyed to manuscript page and line numbers, plus a flow diagram, at submission. Research comparing reporting quality before and after journal endorsement consistently finds an association with more complete reporting, though a causal effect is difficult to establish cleanly since journals that endorse CONSORT may also differ from non-endorsing journals in other ways.
How this fits into a trial’s workflow
For a research administrator or trial coordinator, CONSORT is best treated as a manuscript-preparation and quality-assurance tool that should be anticipated well before the results-writing stage, not addressed retroactively:
- Trial registration (a separate requirement from CONSORT itself — see clinical trial registration and results-reporting compliance) and the statistical analysis plan should be finalized and accessible before results reporting, since CONSORT 2025’s Open Science section expects the report to state where both can be found.
- Participant-flow data (screened, randomized, allocated, followed up, analyzed, and the reasons for any loss at each stage) is far easier to compile accurately if it is tracked as the trial runs, rather than reconstructed afterward from site records.
- Harms and adverse-event data, now an explicit checklist item rather than an optional add-on, needs the same rigor in collection and adjudication as the trial’s primary efficacy outcomes if it is to be reported to CONSORT’s standard.
- If the trial uses a design covered by a CONSORT extension (cluster randomization, non-inferiority, a pragmatic design, and so on), identify the applicable extension early so protocol-level decisions capture what that extension will require to be reported later.
CONSORT, PRISMA, and STROBE: which guideline applies
These three EQUATOR-catalogued guidelines are often mentioned together because they cover adjacent stages of the same evidence base, but each applies to a different kind of report and they are not interchangeable:
- CONSORT applies to reports of individual randomized controlled trials.
- PRISMA applies to systematic reviews and meta-analyses that synthesize evidence across multiple studies, which may themselves include CONSORT-reported trials. See CASRAI’s PRISMA and systematic review methodology guide for the full treatment.
- STROBE applies to observational studies (cohort, case-control, and cross-sectional designs) that do not involve random allocation to an intervention.
A trial team should not need to choose between these — the guideline is determined by the study design being reported, not by preference. For the broader category these all belong to, see CASRAI’s reporting guidelines overview, and for CASRAI’s wider clinical-research coverage, see the clinical research pillar.
Frequently asked questions
What does CONSORT stand for?
CONsolidated Standards Of Reporting Trials.
Is CONSORT 2010 still valid, or has it been replaced?
CONSORT 2025, published 14 April 2025 in The BMJ, JAMA, The Lancet, Nature Medicine, and PLOS Medicine, is the current statement and expands the checklist from 25 to 30 items. CONSORT 2010 is superseded; check the specific target journal’s current author instructions if there is any doubt about which version it expects.
Does CONSORT apply to every clinical trial?
The core statement applies specifically to two-group, parallel-design randomized controlled trials. Trials with other designs — cluster-randomized, non-inferiority or equivalence, pragmatic, adaptive, crossover, or factorial — should also consult the relevant CONSORT extension for that design.
Do all journals require a completed CONSORT checklist at submission?
Not universally, but it is a common requirement among biomedical journals that publish trial results, particularly ICMJE-affiliated titles, and is typically requested as a checklist keyed to manuscript page/line numbers alongside the flow diagram.
What is the difference between the CONSORT checklist and the CONSORT flow diagram?
The checklist is a list of items the manuscript text itself must address (design, methods, results, and so on); the flow diagram is a separate visual accounting of how many participants entered, moved through, and were ultimately analyzed in each arm of the trial.
