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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 www.consort-statement.org