Table 5.
Average reporting percentages for the CONSORT 2010 checklist items
| Section/Topic | Item No | Checklist Item | Yes N (%) |
|---|---|---|---|
| Title and abstract | |||
| 1a | Identification as a randomized trial in the title | 14(82.4) | |
| 1b | Structured summary of trial design, methods, results, and conclusions | 17(100.0) | |
| Introduction | |||
| Background and objectives | 2a | Scientific background and explanation of rationale | 17(100.0) |
| 2b | Specific objectives or hypotheses | 17(100.0) | |
| Methods | |||
| Trial design | 3a | Description of trial design (such as parallel, factorial) including allocation ratio | 12(70.6) |
| 3b | Important changes to methods after trial commencement (such as eligibility criteria), with reasons | 1(5.9) | |
| Participants | 4a | Eligibility criteria for participants | 16(94.1) |
| 4b | Settings and locations where the data were collected | 12(70.6) | |
| Interventions | 5 | The interventions for each group with sufficient details to allow replication, including how and when they were actually administered | 17(100.0) |
| Outcomes | 6a | Completely defined prespecified primary and secondary outcome measures, including how and when they were assessed | 17(100.0) |
| 6b | Any changes to trial outcomes after the trial commenced, with reasons | N.A. | |
| Sample size | 7a | How sample size was determined | 11(64.7) |
| 7b | When applicable, explanation of any interim analyses and stopping guidelines | 1(5.9) | |
| Randomization: | |||
| Sequence generation | 8a | Method used to generate the random allocation sequence | 16(94.1) |
| 8b | Type of randomization; details of any restriction (such as blocking and block size) | 12(70.6) | |
| Allocation concealment mechanism | 9 | Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned | 6(35.3) |
| Implementation | 10 | Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions | 10(58.8) |
| Blinding | 11a | If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how | 10(58.8) |
| 11b | If relevant, description of the similarity of interventions | N.A. | |
| Statistical methods | 12a | Statistical methods used to compare groups for primary and secondary outcomes | 17(100.0) |
| 12b | Methods for additional analyses, such as subgroup analyses and adjusted analyses | 9(52.9) | |
| Results | |||
| Participant flow (a diagram is strongly recommended) | 13a | For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analyzed for the primary outcome | 17(100.0) |
| 13b | For each group, losses and exclusions after randomization, together with reasons | 13(76.5) | |
| Recruitment | 14a | Dates defining the periods of recruitment and follow-up | 12(70.6) |
| 14b | Why the trial ended or was stopped | N.A. | |
| Baseline data | 15 | A table showing baseline demographic and clinical characteristics for each group | 14(82.4) |
| Numbers analyzed | 16 | For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups | 17(100.0) |
| Outcomes and estimation | 17a | For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval) | 13(76.5) |
| 17b | For binary outcomes, presentation of both absolute and relative effect sizes is recommended | N.A. | |
| Ancillary analyses | 18 | Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing prespecified from exploratory | 9(52.9) |
| Harms | 19 | All important harms or unintended effects in each group | 0(0.0) |
| Discussion | |||
| Limitations | 20 | Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses | 17(100.0) |
| Generalizability | 21 | Generalizability (external validity, applicability) of the trial findings | 2(11.8) |
| Interpretation | 22 | Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence | 17(100.0) |
| Other information | |||
| Registration | 23 | Registration number and name of trial registry | 12(70.6) |
| Protocol | 24 | Where the full trial protocol can be accessed, if available | 7(41.2) |
| Funding | 25 | Sources of funding and other support (such as supply of drugs), role of funders | 15(88.2) |
| Average percentage | 77.3 | ||