Randomized trial reporting (lite) — v1.0.0
Released: 2026-01-31 · Hash: sha256:2d3b8e39f41efcf0858f22f35a73d29d946fd7e79b3b1abbfe2505d51cbdec52
Title & Abstract
| Criterion | Text |
|---|---|
| must TRIAL-01 | Make it explicit in the title/abstract that this is a randomized trial and summarize the design. |
| should TRIAL-02 | Abstract includes key elements: participants, interventions, primary outcomes, main results, and important harms. |
Methods
| Criterion | Text |
|---|---|
| must TRIAL-10 | Define eligibility criteria and the setting where participants were recruited and assessed. |
| must TRIAL-11 | Describe interventions in enough detail to allow replication (what, how, when, by whom). |
| must TRIAL-12 | Pre-specify primary and secondary outcomes and how/when they were measured. |
| should TRIAL-13 | Explain sample size reasoning (power, effect size assumptions, or practical constraints). |
| must TRIAL-14 | Describe how random allocation was generated and how allocation was concealed. |
| should TRIAL-15 | State who was blinded (if anyone) and how blinding was maintained or why it was not possible. |
Results
| Criterion | Text |
|---|---|
| must TRIAL-20 | Report participant flow: enrolled, allocated, followed up, and analyzed; explain losses/exclusions. |
| must TRIAL-21 | Provide baseline characteristics for each group. |
| must TRIAL-22 | Report effect estimates for primary outcomes with uncertainty (e.g., confidence intervals). |
Registration & Other
| Criterion | Text |
|---|---|
| should TRIAL-30 | Provide registration information and where the protocol can be accessed (if applicable). |
| should TRIAL-31 | Disclose funding/support and the role of funders. |