Skip to main content

Table 2 Frequencies of CONSORT 2010 items from customized overall quality of reporting checklist (N = 35)

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
  1. Legend: Total: Total number of trials reporting item; %: Percentage of trials reporting item