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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