Table 1.
CONSORT 2010 checklist of information to include when reporting a randomized trial
| Section/topic | Item number | Checklist item |
|---|---|---|
| Title and abstract | 1a | Identification as a randomized trial in the title |
| 1b | Structured summary of trial design, methods, results, and conclusions | |
| Introduction | 2a | Scientific background and rationale |
| 2b | Specific objectives or hypothesis | |
| Methods | ||
| Trial design | 3a | Description of trial design (eg, parallel, factorial) including allocation ratio |
| 3b | Important changes to methods after trial commencement including reasons (eg, eligibility criteria) | |
| Participants | 4a | Eligibility criteria |
| 4b | Settings and locations where the data were collected | |
| Interventions | 5 | Description of interventions with sufficient details to allow repetition (eg, dosage, timing, etc) |
| Outcomes | 6a | Definition of prespecified primary and secondary outcome measures including their assessment |
| 6b | Any changes to trial outcomes after the trial commenced with reasons | |
| Sample size | 7a | How sample size was determined |
| 7b | Explanation of interims analysis or stopping guidelines when applicable | |
| Randomization | ||
| Sequence generation | 8a | Method used to generate the random allocation sequence |
| 8b | Type of randomization, details on restrictions (eg, blocking and block sizes) | |
| Allocation concealment mechanism | 9 | Mechanism used to implement the random allocation sequence (eg, sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned |
| Allocation concealment implementation | 10 | Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions |
| Blinding | 11a | If done, who was blinded after assignment to interventions (eg, participants, care providers, outcome assessors) and how |
| 11b | If relevant, description of the similarity of interventions | |
| Statistical methods | 12a | Statistical methods used to compare groups for primary and secondary outcomes |
| 12b | Methods for additional analyses, such as subgroup or adjusted analyses | |
| Results | ||
| Participants flow | 13a | For each group, the number of participants who were randomly assigned received intended treatment and were analyzed for the primary outcome |
| 13b | For each group, losses and exclusions after randomization with respective reasons | |
| Recruitment | 14a | Dates defining the periods of recruitment and follow-up |
| 14b | Why the trial was ended or stopped | |
| Baseline data | 15 | A table showing baseline demographic and clinical characteristics for each group |
| Numbers analyzed | 16 | For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned group |
| Outcomes and estimation | 17a | For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (eg, 95% confidence intervals) |
| 17b | For binary outcomes, presentation of both absolute and relative effect sizes is recommended | |
| Ancillary analysis | 18 | Results of any other analysis performed, including subgroup and adjusted analyses, distinguishing prespecified from explanatory |
| Harms | 19 | All important harms or unintended effects in each group |
| Discussion | ||
| Limitations | 20 | Trial limitations, addressing sources of potential bias, imprecision, and, if applicable, multiplicity of analyses |
| Generalizability | 21 | Generalizability (external validity, applicability) of the trial findings |
| 22 | Interpretation consistent with results, balancing harms and benefits, and considered other relevant evidence | |
| Other information | ||
| Registration | 23 | Registration number and name of trial registry |
| Protocol | 24 | Where the full trial protocol can be accessed, if available |
| Funding | 25 | Sources of funding and other support (eg, supply of drugs), role of funders |
Notes: Reproduced from Schulz KF, Altman DG, Moher D, et al. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. Trials. 2010;11:32,13 with permission of BioMed Central. It may be instrumental in critically assess manuscripts of randomized controlled trials and support designing a study protocol.
Abbreviation: CONSORT, Consolidated Standards of Reporting Trials.