Table 2

Adherence to each CONSORT item

1a. Identification as a randomised trial in the title?222/39456.3%
1b. Structured summary of trial design, methods, results and conclusions? (See CONSORT for Abstracts)312/39479.2%
2a. Scientific background and explanation of rationale?392/39499.5%
2b. Specific objectives or hypotheses?389/39498.7%
3a. Description of trial design (such as parallel, factorial) including allocation ratio?110/39427.9%
4a. Eligibility criteria for participants?391/39499.2%
4b. Settings and locations where the data were collected?346/39487.8%
5. The interventions for each group with sufficient details to allow replication, including how and when they were actually administered?392/39499.5%
6a. Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed?212/39453.8%
7a. How sample size was determined?154/39439.1%
8a. Method used to generate the random allocation sequence?249/39463.2%
8b. Type of randomisation; details of any restriction (such as blocking and block size)?212/39453.8%
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?126/39432.0%
10. Who generated the random allocation sequence, who enrolled participants and who assigned participants to interventions?89/39422.6%
11a. If done, who was blinded after assignment to interventions (eg, participants, care providers, those CONSORT 2010 checklist Page 2 assessing outcomes) and how?128/39432.5%
12a. Statistical methods used to compare groups for primary and secondary outcomes?226/39457.4%
12b. Methods for additional analyses, such as subgroup analyses and adjusted analyses?158/39440.1%
13a. For each group, the numbers of participants who were randomly assigned, received intended treatment and were analysed for the primary outcome?303/39476.9%
13b. For each group, losses and exclusions after randomisation, together with reasons?282/39471.6%
14a. Dates defining the periods of recruitment and follow-up?171/39443.4%
15. A table showing baseline demographic and clinical characteristics for each group?342/39486.8%
16. For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups?302/39476.6%
17a. For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% CI)?192/39448.7%
18. Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-specified from exploratory?152/39438.6%
19. All important harms or unintended effects in each group? (See CONSORT for Harms)133/39433.8%
20. Trial limitations, addressing sources of potential bias, imprecision and, if relevant, multiplicity of analyses?361/39491.6%
21. Generalisability (external validity, applicability) of the trial findings?237/39460.2%
22. Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence?393/39499.7%
23. Registration number and name of trial registry?176/39444.7%
24. Where the full trial protocol can be accessed, if available?35/3948.9%
25. Sources of funding and other support (such as supply of drugs), role of funders?386/39498.0%