Table 2 The reporting number and percentage for each item of the CONSORT checklist of the included 70 studies

 Title and abstract

1a

Identification as a randomized trial in the title

12

17

[9 to 28]

1b

Structured summary of trial design, methods, results, and conclusions (for specific guidance see CONSORT for abstracts)

54

77

[66 to 86]

  Background and objectives

2a

Scientific background and explanation of rationale

63

90

[80 to 96]

2b

Specific objectives or hypotheses

65

93

[84 to 98]

  Trial design

3a

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

58

83

[72 to 91]

3b

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

0

0

[0 to 5]

  Participants

4a

Eligibility criteria for participants

70

100

[95 to 100]

4b

Settings and locations where the data were collected

58

83

[72 to 91]

  Interventions

5

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

70

100

[95 to 100]

  Outcomes

6a

Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed

68

97

[90 to 100]

6b

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

1

1

[0 to 8]

  Sample size

7a

How sample size was determined

4

6

[2 to 14]

7b

When applicable, explanation of any interim analyses and stopping guidelines

7

10

[4 to 20]

  Randomisation

  Sequence generation

8a

Method used to generate the random allocation sequence

26

37

[26 to 50]

8b

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

20

29

[18 to 41]

  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

10

14

[7 to 25]

  Implementation

10

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

7

10

[4 to 20]

  Blinding

11a

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

11

16

[8 to 27]

11b

If relevant, description of the similarity of interventions

6

9

[3 to 18]

  Statistical methods

12a

Statistical methods used to compare groups for primary and secondary outcomes

68

97

[90 to 100]

12b

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

0

0

[0 to 5]

  Participant flow (a diagram is strongly recommended)

13a

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

5

7

[2 to 16]

13b

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

15

21

[13 to 33]

  Recruitment

14a

Dates defining the periods of recruitment and follow-up

44

63

[50 to 74]

14b

Why the trial ended or was stopped

2

3

[0 to 10]

  Baseline data

15

A table showing baseline demographic and clinical characteristics for each group

23

33

[22 to 45]

  Baseline data

16

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

57

81

[70 to 90]

  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)

2

3

[0 to 10]

17b

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

0

0

[0 to 5]

  Ancillary analyses

18

Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-specified from exploratory

1

1

[0 to 8]

  Harms

19

All important harms or unintended effects in each group (for specific guidance see CONSORT for harms)

21

30

[20 to 42]

  Limitations

20

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

10

14

[7 to 25]

21

Generalisability (external validity, applicability) of the trial findings

13

19

[10 to 30]

  Interpretation

22

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

22

31

[21 to 44]

  Registration

23

Registration number and name of trial registry

0

0

[0 to 5]

  Protocol

24

Where the full trial protocol can be accessed, if available

1

1

[0 to 8]

  Funding

25

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

14

20

[11 to 31]

  Total mean score^a