Consort 2010 checklist of information to include when reporting a randomised trial




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CONSORT 2010 checklist of information to include when reporting a randomised trial*


Section/Topic

Item No

Checklist item

Reported on page No

Title and abstract




1a

Identification as a randomised trial in the title




1b

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




Introduction

Background and objectives

2a

Scientific background and explanation of rationale




2b

Specific objectives or hypotheses




Methods

Trial design

3a

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




3b

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




Participants

4a

Eligibility criteria for participants




4b

Settings and locations where the data were collected




Interventions

5

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




Outcomes

6a

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




6b

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




Sample size

7a

How sample size was determined




7b

When applicable, explanation of any interim analyses and stopping guidelines




Randomisation:










 Sequence generation

8a

Method used to generate the random allocation sequence




8b

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




 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




 Implementation

10

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




Blinding

11a

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




11b

If relevant, description of the similarity of interventions




Statistical methods

12a

Statistical methods used to compare groups for primary and secondary outcomes




12b

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




Results

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




13b

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




Recruitment

14a

Dates defining the periods of recruitment and follow-up




14b

Why the trial ended or was stopped




Baseline data

15

A table showing baseline demographic and clinical characteristics for each group




Numbers analysed

16

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




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)




17b

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




Ancillary analyses

18

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




Harms

19

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




Discussion

Limitations

20

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




Generalisability

21

Generalisability (external validity, applicability) of the trial findings




Interpretation

22

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




Other information




Registration

23

Registration number and name of trial registry




Protocol

24

Where the full trial protocol can be accessed, if available




Funding

25

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



*We strongly recommend reading this statement in conjunction with the CONSORT 2010 Explanation and Elaboration for important clarifications on all the items. If relevant, we also recommend reading CONSORT extensions for cluster randomised trials, non-inferiority and equivalence trials, non-pharmacological treatments, herbal interventions, and pragmatic trials. Additional extensions are forthcoming: for those and for up to date references relevant to this checklist, see www.consort-statement.org.



CONSORT 2010 checklist Page


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