Table 5 Average reporting percentages for the CONSORT 2010 checklist items

1a

Identification as a randomized trial in the title

14(82.4)

1b

Structured summary of trial design, methods, results, and conclusions

17(100.0)

 Background and objectives

2a

Scientific background and explanation of rationale

17(100.0)

2b

Specific objectives or hypotheses

17(100.0)

 Trial design

3a

Description of trial design (such as parallel, factorial) including allocation ratio

12(70.6)

3b

Important changes to methods after trial commencement (such as eligibility criteria), with reasons

1(5.9)

 Participants

4a

Eligibility criteria for participants

16(94.1)

4b

Settings and locations where the data were collected

12(70.6)

 Interventions

5

The interventions for each group with sufficient details to allow replication, including how and when they were actually administered

17(100.0)

 Outcomes

6a

Completely defined prespecified primary and secondary outcome measures, including how and when they were assessed

17(100.0)

6b

Any changes to trial outcomes after the trial commenced, with reasons

N.A.

 Sample size

7a

How sample size was determined

11(64.7)

7b

When applicable, explanation of any interim analyses and stopping guidelines

1(5.9)

 Sequence generation

8a

Method used to generate the random allocation sequence

16(94.1)

8b

Type of randomization; details of any restriction (such as blocking and block size)

12(70.6)

 Allocation concealment mechanism

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

6(35.3)

 Implementation

10

Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions

10(58.8)

 Blinding

11a

If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how

10(58.8)

11b

If relevant, description of the similarity of interventions

N.A.

 Statistical methods

12a

Statistical methods used to compare groups for primary and secondary outcomes

17(100.0)

12b

Methods for additional analyses, such as subgroup analyses and adjusted analyses

9(52.9)

 Participant flow (a diagram is strongly recommended)

13a

For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analyzed for the primary outcome

17(100.0)

13b

For each group, losses and exclusions after randomization, together with reasons

13(76.5)

 Recruitment

14a

Dates defining the periods of recruitment and follow-up

12(70.6)

14b

Why the trial ended or was stopped

N.A.

 Baseline data

15

A table showing baseline demographic and clinical characteristics for each group

14(82.4)

 Numbers analyzed

16

For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups

17(100.0)

 Outcomes and estimation

17a

For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval)

13(76.5)

17b

For binary outcomes, presentation of both absolute and relative effect sizes is recommended

N.A.

 Ancillary analyses

18

Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing prespecified from exploratory

9(52.9)

 Harms

19

All important harms or unintended effects in each group

0(0.0)

 Limitations

20

Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses

17(100.0)

 Generalizability

21

Generalizability (external validity, applicability) of the trial findings

2(11.8)

 Interpretation

22

Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence

17(100.0)

 Registration

23

Registration number and name of trial registry

12(70.6)

 Protocol

24

Where the full trial protocol can be accessed, if available

7(41.2)

 Funding

25

Sources of funding and other support (such as supply of drugs), role of funders

15(88.2)

77.3