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Table 2 Frequency and Percentage of Adherence to Individual Criterion of the CONSORT 2010 Checklist

From: Reporting quality of randomized controlled trials in otolaryngology: review of adherence to the CONSORT statement

Criterion CONSORT item Frequency %
1a Identification as a randomized trial in the title 80 44.0%
1b Structured summary of trial design, methods, results, and conclusions 5 2.7%
2a Scientific background and explanation of rationale 182 100%
2b Specific objectives or hypotheses 182 100%
3a Description of trial design (such as parallel, factorial) including allocation ratio 182 100%
3b Important changes to methods after trial commencement (such as eligibility criteria), with reasons 3 100%
4a Eligibility criteria for participants 168 92.3%
4b Settings and locations where the data were collected 140 76.9
5 The interventions for each group with sufficient details to allow replication, including how and when they were actually administered 181 99.5%
6a Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed 77 42.3%
6b Any changes to trial outcomes after the trial commenced, with reasons 1 100%
7a How sample size was determined 74 40.6%
7b When applicable, explanation of any interim analyses and stopping guidelines 2 100%
8a Method used to generate the random allocation sequence 106 58.6%
8b Type of randomization; details of any restriction (such as blocking and block size) 45 24.7%
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 113 62.1%
10 Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions 12 6.6%
11a If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how 108 59.7%
11b If relevant, description of the similarity of interventions 54 32.3%
12a Statistical methods used to compare groups for primary and secondary outcomes 176 96.7%
12b Methods for additional analyses, such as subgroup analyses and adjusted analyses 23 88.5%
13a For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analyzed for the primary outcome 171 94.0%
13b For each group, losses and exclusions after randomization, together with reasons 146 80.2%
14a Dates defining the periods of recruitment and follow-up 96 52.7%
14b Why the trial ended or was stopped 1 100%
15 A table showing baseline demographic and clinical characteristics for each group 132 72.5%
16 For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups 164 90.1%
17a For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval) 59 32.4%
17b For binary outcomes, presentation of both absolute and relative effect sizes is recommended 13 41.9%
18 Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-specified from exploratory 7 6.5%
19 All important harms or unintended effects in each group (for specific guidance see CONSORT for harms) 138 78.0%
20 Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses 109 59.9%
21 Generalizability (external validity, applicability) of the trial findings 59 32.4%
22 Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence 175 96.2%
23 Registration number and name of trial registry 19 10.4%
24 Where the full trial protocol can be accessed, if available 7 3.8%
25 Sources of funding and other support (such as supply of drugs), role of funders 156 85.7%
  1. Adapted from