CONSORT2010 checklist of information to include when reporting a randomised trial

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.

Title and Abstract

1a. Title 

Identification as a randomisedtrial in the title.

1b. Abstract

Structured summary of trialdesign, methods, results, and conclusions

Introduction

2a. Background

Scientific background andexplanation of rationale

2b. Objectives

Specific objectives or hypotheses

Methods

3a. Trial Design

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

3b. Changes to trial design

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

4a. Participants

Eligibility criteria forparticipants

4b. Study settings

Settings and locations where thedata were collected

5. Interventions 

The interventions for each groupwith sufficient details to allow replication, including how and when they wereactually administered

6a. Outcomes 

Completely defined pre-specifiedprimary and secondary outcome measures, including how and when they wereassessed

6b. Changes to outcomes 

Any changes to trial outcomesafter the trial commenced, with reasons

7a. Sample size 

How sample size was determined

7b. Interim analyses and stoppingguidelines

When applicable, explanation ofany interim analyses and stopping guidelines

8a. Randomisation: sequencegeneration

Method used to generate therandom allocation sequence

8b. Randomisation: type

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

9. Randomisation: allocationconcealment mechanism 

Mechanism used to implement therandom allocation sequence (such as sequentially numbered containers),describing any steps taken to conceal the sequence until interventions wereassigned

10. Randomisation: implementation

Who generated the allocationsequence, who enrolled participants, and who assigned participants tointerventions

11a. Blinding 

If done, who was blinded afterassignment to interventions (for example, participants, care providers, thoseassessing outcomes) and how

11b. Similarity ofinterventions 

If relevant, description of thesimilarity of interventions

12a. Statistical methods 

Statistical methods used tocompare groups for primary and secondary outcomes

12b. Additional analyses 

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

Results

13a. Participant Flow 

For each group, the numbers ofparticipants who were randomly assigned, received intended treatment, and wereanalysed for the primary outcome

13b. Losses and exclusions 

For each group, losses andexclusions after randomisation, together with reasons

14a. Recruitment 

Dates defining the periods ofrecruitment and follow-up

14b. Reason for stoppedtrial 

Why the trial ended or wasstopped

15. Baseline Data

A table showing baselinedemographic and clinical characteristics for each group

16. Numbers analysed 

For each group, number ofparticipants (denominator) included in each analysis and whether the analysiswas by original assigned groups

17a. Outcomes andestimation 

For each primary and secondaryoutcome, results for each group, and the estimated effect size and itsprecision (such as 95% confidence interval)

17b. Binary outcomes

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

18.  Ancillaryanalyses 

Results of any other analysesperformed, including subgroup analyses and adjusted analyses, distinguishingpre-specified from exploratory

19. Harms

All important harms or unintendedeffects in each group

Discussion

20. Limitations

Trial limitations, addressingsources of potential bias, imprecision, and, if relevant, multiplicity ofanalyses

21. Generalisability 

Generalisability (externalvalidity, applicability) of the trial findings

22. Interpretation

Interpretation consistent withresults, balancing benefits and harms, and considering other relevant evidence

Other information

23. Registration

Registration number and name oftrial registry

24. Protocol

Where the full trial protocol canbe accessed, if available

25. Funding 

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

 

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