Table 1

CONSORT 2010 Checklist and percentage of articles that adequately report each CONSORT 2010 checklist item

Title and abstract
 1aIdentification as a randomised trial in the title30.3% (23/33)
 1bStructured summary of trial design, methods, results and conclusions (for specific guidance, see CONSORT for abstracts)9.1% (3/33)
Background and objectives
 2aScientific background and explanation of rationale93.9% (31/33)
 2bSpecific objectives or hypotheses87.9% (29/33)
Trial design
 3aDescription of trial design (such as parallel, factorial) including allocation ratio42.4% (14/33)
 3bImportant changes to methods after trial commencement (such as eligibility criteria), with reasons100% (6/6)
 4aEligibility criteria for participants97% (32/33)
 4bSettings and locations where the data were collected21.2% (7/33)
 5The interventions for each group with sufficient details to allow replication, including how and when they were actually administered78.8% (26/33)
 6aCompletely defined prespecified primary and secondary outcome measures, including how and when they were assessed66.7% (22/33)
 6bAny changes to trial outcomes after the trial commenced, with reasonsNA (0/0)*
Sample size
 7aHow sample size was determined69.7% (23/33)
 7bWhen applicable, explanation of any interim analyses and stopping guidelines100% (4/4)
Sequence generation
 8aMethod used to generate the random allocation sequence33.3% (11/33)
 8bType of randomisation; details of any restriction (such as blocking and block size)33.3% (11/33)
Allocation concealment mechanism
 9Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned12.1% (4/33)
 10Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions21.2% (7/33)
 11aIf done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how32.3% (10/31)
 11bIf relevant, description of the similarity of interventions34.5% (10/29)
Statistical methods
 12aStatistical methods used to compare groups for primary and secondary outcomes97.0% (32/33)
 12bMethods for additional analyses, such as subgroup analyses and adjusted analyses77.8% (14/18)
Participant flow
 13aFor each group, the numbers of participants who were randomly assigned, received intended treatment, and were analysed for the primary outcome66.7% (22/33)
 13bFor each group, losses and exclusions after randomisation, together with reasons65.6% (21/32)
 14aDates defining the periods of recruitment and follow-up45.5% (15/33)
 14bWhy the trial ended or was stopped12.1% (4/33)
Baseline data
 15A table showing baseline demographic and clinical characteristics for each group90.9% (30/33)
Numbers analysed
 16For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups54.5% (18/33)
Outcomes and estimation
 17aFor each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval)39.4% (13/33)
 17bFor binary outcomes, presentation of both absolute and relative effect sizes is recommended0.0% (0/7)
Ancillary analyses
 18Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing prespecified from exploratory68.8% (11/16)
 19All important harms or unintended effects in each group (for specific guidance, see CONSORT for harms)53.1% (17/32)
 20Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses78.8% (26/33)
 21Generalisability (external validity, applicability) of the trial findings87.9% (29/33)
 22Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence97.0% (32/33)
Other information
 23Registration number and name of trial registry48.5% (16/33)
 24Where the full trial protocol can be accessed, if available100.0% (13/13)
 25Sources of funding and other support (such as supply of drugs), role of funders36.4% (12/33)