From: Quality of reporting of randomised controlled trials in chiropractic using the CONSORT checklist
Item | Criterion | CONSORT Description | Total | % |
---|---|---|---|---|
1a | Title | Identification as a randomised trial in the title | 26 | 74 |
1b | Abstract | Structured summary of trial design, methods, results, and conclusions | 35 | 100 |
2a | Background | Scientific background and explanation of rationale | 35 | 100 |
2b | Specific objectives or hypotheses | 34 | 97 | |
3a | Trial Design | Description of trial design (such as parallel, factorial) | 18 | 51 |
4a | Participants | Eligibility criteria for participants | 34 | 97 |
4b | settings and locations where the data were collected | 17 | 49 | |
5 | Interventions | The interventions for each group with sufficient details to allow replication, including how they were administered | 32 | 91 |
6a | Outcomes | Completely defined pre-specified primary and secondary outcome measures | 32 | 91 |
7a | Sample size | How sample size was determined | 25 | 71 |
8a | Sequence generation | Method used to generate the random allocation sequence | 29 | 83 |
9 | Allocation concealment | 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 | 31 | 87 |
10 | Implementation | Was implementation discussed. Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions | 26 | 74 |
11ai | Blinding | Whether or not participants, were blinded to group assignment | 16 | 46 |
11aii | Whether those assessing the outcomes were blinded to group assignment | 25 | 71 | |
12a | Statistical methods | Statistical methods used to compare groups for outcome(s) | 35 | 100 |
13a | Participant flow | For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analysed for the primary outcome | 29 | 83 |
13b | For each group, losses and exclusions after randomization, together with reasons | 20 | 57 | |
14a | Recruitment | Dates defining the periods of recruitment and follow-up | 23 | 66 |
15 | Baseline data | A table showing baseline demographic | 32 | 91 |
16i | Numbers Analysed | Number of participants (denominator) in each group included in each analysis; state the results in absolute numbers when feasible (e.g., 10/20, not 50 %) | 16 | 46 |
16ii | “Intention-to-treat” analysis | 21 | 60 | |
17ai | Outcomes and estimation | Primary outcome: a summary of results for each group and the estimated effect size and its precision (e.g., 95 % confidence interval) | 26 | 74 |
17aii | Secondary outcome: a summary of results for each group and the estimated effect size and its precision (e.g., 95 % confidence interval) | 25 | 71 | |
17b | For binary outcomes, presentation of both absolute and relative effect sizes is recommended | 4 | 11 | |
18 | Ancillary Analyses | Results of other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-specified | 7 | 20 |
19 | Adverse events | All adverse events or side effects in each intervention group | 22 | 63 |
20 | Limitations | Trial limitations | 31 | 89 |
23 | Registration | Registration number | 19 | 54 |
25 | Funding | Sources of funding and other support | 32 | 91 |