The title must identify the study as a randomized trial. The abstract must be structured (background, methods, results, conclusions) and must report the design, participants, interventions, primary outcome, results with effect estimates and uncertainty, harms, and trial registration number. Reviewers look here first — an abstract that hides the design or omits the primary outcome and its effect estimate is an immediate red flag.
02Introduction — background and objectives
State the scientific rationale and the specific objectives, including pre-specified primary and secondary hypotheses. Reviewers check that the objectives stated here match the protocol, the registry record, and the primary outcome reported in Results. Misalignment across these three sources is one of the clearest signals of post-hoc outcome switching.
Describe the design (parallel, factorial, crossover, cluster), the allocation ratio, and any changes to methods after the trial began (with reasons). For non-inferiority and equivalence trials, the margin and its justification must be reported. This is where reviewers verify that the design described actually supports the conclusions later in the manuscript.
Eligibility criteria for participants and settings, plus the locations where the data were collected, must be described in enough detail that another team could replicate enrollment. Vague age ranges, undefined disease states, or unstated recruitment settings make it impossible to assess generalizability.
05Methods — interventions
Each intervention must be described with sufficient detail to allow replication — dose, route, duration, schedule, who delivered it, and what the comparator received. Drug names alone are not enough. For complex interventions (behavioral therapy, surgical procedures, devices), the level of detail required is higher, not lower.
Completely defined pre-specified primary and secondary outcomes, including how and when they were assessed. Any changes to trial outcomes after the trial began, with reasons. This is the item most often violated — outcomes added after data are seen, primary outcomes demoted to secondary, or definitions tightened to capture the desired signal. Reviewers will compare what you report here to your registered protocol.
How sample size was determined: anticipated effect size, variance estimate, significance level, power, and the rationale for any interim analyses or stopping rules. "We enrolled 100 patients per arm" is not a sample size justification. Reviewers expect the full calculation with the values used and where the inputs came from.
08Methods — randomization (sequence, allocation, implementation)
Three distinct items: the method used to generate the random allocation sequence (including any restriction such as blocking and block size); the mechanism used to implement the sequence (e.g., sequentially numbered opaque containers, central web-based allocation), describing whether the sequence was concealed until interventions were assigned; and who generated the sequence, who enrolled participants, and who assigned participants to interventions. Vague randomization ("randomized by computer") is a major issue.
If done, who was blinded after assignment to interventions (e.g., participants, care providers, those assessing outcomes) and how. If relevant, a description of the similarity of interventions. Open-label trials are not penalized — but they must be declared and justified, and the implications for outcomes susceptible to ascertainment bias must be acknowledged.
10Methods — statistical methods
Statistical methods used to compare groups for primary and secondary outcomes, methods for additional analyses (subgroup, adjusted, sensitivity), and how missing data were handled. Pre-specification is critical — analyses described here but not pre-registered carry less weight, and analyses not described here but appearing in Results are an automatic flag.
11Results — participant flow
A CONSORT flow diagram is effectively required: for each group, the numbers of participants randomly assigned, receiving intended treatment, completing the study protocol, and analyzed for the primary outcome, with reasons for losses and exclusions. Counts must reconcile. "450 randomized, 200 analyzed" with no explanation of the 250 missing is one of the most common — and most fixable — reasons for rejection.
12Results — recruitment, baseline data, numbers analyzed
Dates defining the periods of recruitment and follow-up. A baseline characteristics table by group. The numbers analyzed for each outcome, with whether the analysis was by original assigned groups (intention-to-treat). Per-protocol or completers-only analyses presented as primary instead of ITT is a major issue and is flagged immediately.
13Results — outcomes and estimation
For each primary and secondary outcome: results for each group, the estimated effect size, and its precision (such as 95% confidence interval). Binary outcomes require both absolute and relative effect sizes. Effect sizes and confidence intervals — not p-values alone — are what reviewers expect.
14Results — ancillary analyses
Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-specified from exploratory. Subgroup findings presented without explicit interaction tests, or framed as confirmatory when they were exploratory, are common overreaches.
All important harms or unintended effects in each group, with a clear severity and causality framework. CONSORT 2025 places greater weight on harms reporting — "the drug was well tolerated" without counts, grading, or comparison is no longer adequate.
16Discussion — limitations, generalizability, interpretation
Trial limitations addressing sources of potential bias, imprecision, and (if relevant) multiplicity of analyses. The generalizability (external validity, applicability) of the findings. An interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence. Discussions that overreach beyond what the data support — or fail to acknowledge limitations the reviewer can see — undermine the manuscript's credibility.
17Other information — registration, protocol, funding
Registration number and registry name (e.g., ClinicalTrials.gov, ISRCTN); where the full trial protocol can be accessed; sources of funding and other support (such as drug supply), role of funders. CONSORT 2025 expands this with open-science expectations around protocol, data, and code availability. Unregistered trials and trials registered after enrollment are flagged.