Table 1 The instrument used to extract data on CONSORT variables (items)

Title

1a

Identification as a randomised trial in the title

1 = word random appears in the title

0 = no word "random" appears

Abstract

1b

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

1 = Structured abstract

0 = No structured abstract

Trial design

3a

Description of trial design (such as parallel, factorial) including allocation ratio (ex-split-mouth)

1 = well described design

0 = not well-described design

Participants

4a

Eligibility criteria for participants

1 = specified

0 = not specified

4b

Settings (A) and locations (B) where the data were collected

2 = A and B

1 = A or B

0 = not specified

Interventions

5

The interventions for each group (A) with sufficient details to allow replication, including how and when they were actually administered (B) (i.e. "usual care" for control group not enough)]

2 = A and B

1 = A, but only one group with details

0 = only A or only one group without details

Outcomes

6a

Completely defined pre-specified primary (A) and secondary outcome (B) measures, including how and when they were assessed (C)

2 = A and B and C

1 = A or B (no distinction) + C

0 = A or B, no C

Sample size

7a

How sample size was determined

1 = specified

0 = not specified

Sequence generation

8a

The method used to generate the random allocation sequence

1 = specified

0 = not specified

Allocation concealment mechanism

9

The 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

1 = steps for concealment specified

0 = concealment not specified

Implementation

10

Who generated the random allocation sequence (A), who enrolled participants (B), and who assigned participants to interventions (C)

2 = A and B and C

1 = (A and B) or (A and C)

0 = A missing

Blinding

11a

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

2 = (A and B) OR reason why the study is open label

1 = declares who is blinded but no details as how

0 = declares the study blind but no who nor how

Statistical methods

12a

Statistical methods used to compare groups for primary and secondary outcomes

2 = states full stats method for each outcome

1 = states stats methods for primary outcome

0 = states stats methods vaguely

Participant flow (a diagram is strongly recommended)

13a

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

2 = A and B and C (narrative in text OR complete flow diagram)

1 = A or B or C missing (only one missing)

0 = only one reported or no info at all

13b

For each group, losses (A) and exclusions (B) after randomisation, together with reasons (C)

2 = A and B and C

1 = A or B or C missing (only one missing)

0 = only one reported, or no info at all

Recruitment

14a

Dates defining the periods of recruitment (A) and follow-up (B)

2 = A and B reported

1 = A or B reported

0 = none reported

Baseline data

15

A table showing baseline demographic and clinical characteristics for each group

1 = "Table 1" present

0 = "Table 1" not present

Numbers analysed

16

For each group, number of participants (denominator) included in each analysis (A) and whether the analysis was by original assigned groups (B) [ITT or Per Protocol]

2 = A and B

1 = A or B

0 = not stated

Outcomes and estimation

17a

For each primary and secondary outcome, results for each group (A), and the estimated effect size (B) and the precision (confidence interval) (C) [only for primary outcome]

2 = A and B and C

1 = A or B or C missing (only one missing)

0 = only one reported or none

Harms

19

All important harms or unintended effects in each group

1 = harms described

0 = harms not described

Registration

23

Registration number and name of trial registry

1 = present

0 = absent

Protocol

24

Where the full trial protocol can be accessed, if available

1 = present

0 = absent

Funding

25

Sources of funding and other support (such as the supply of drugs)

1 = present

0 = absent

Additional item

AIa

Total number of patients randomised

Annotate sample size

Additional item

AIb

Conflict of interest statement

1 = present

0 = absent

Additional item

AIc

Ethics review

1 = present

0 = absent

Additional item

AId

Language of article

Spanish/English/Portuguese