CONSORT 2010 checklist of information Report 2022

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 20
1b Structured summary of trial design, methods, results, and conclusions (for specific guidance see CONSORT for abstracts) 21
Introduction
Background and
objectives
2a Scientific background and explanation of rationale 22
2b Specific objectives or hypotheses 23
Methods
Trial design 3a Description of trial design (such as parallel, factorial) including allocation ratio 23
3b Important changes to methods after trial commencement (such as eligibility criteria), with reasons 22
Participants 4a Eligibility criteria for participants 21
4b Settings and locations where the data were collected 22
Interventions 5 The interventions for each group with sufficient details to allow replication, including how and when they were
actually administered
23
Outcomes 6a Completely defined pre-specified primary and secondary outcome measures, including how and when they
were assessed
23
6b Any changes to trial outcomes after the trial commenced, with reasons NA
Sample size 7a How sample size was determined 23
7b When applicable, explanation of any interim analyses and stopping guidelines 23
Randomisation:
Sequence
generation
8a Method used to generate the random allocation sequence 24
8b Type of randomisation; details of any restriction (such as blocking and block size) 24
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
23
Implementation 10 Who generated the random allocation sequence, who enrolled participants, and who assigned participants to
interventions
23
Blinding 11a If done, who was blinded after assignment to interventions (for example, participants, care providers, those 24
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assessing outcomes) and how
11b If relevant, description of the similarity of interventions NA
Statistical methods 12a Statistical methods used to compare groups for primary and secondary outcomes 24
12b Methods for additional analyses, such as subgroup analyses and adjusted analyses 25
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
25
13b For each group, losses and exclusions after randomisation, together with reasons 25
Recruitment 14a Dates defining the periods of recruitment and follow-up 25
14b Why the trial ended or was stopped
Baseline data 15 A table showing baseline demographic and clinical characteristics for each group 26
Numbers analysed 16 For each group, number of participants (denominator) included in each analysis and whether the analysis was
by original assigned groups
33
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)
27
17b For binary outcomes, presentation of both absolute and relative effect sizes is recommended 24
Ancillary analyses 18 Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing
pre-specified from exploratory
27
Harms 19 All important harms or unintended effects in each group (for specific guidance see CONSORT for harms) 28
Discussion
Limitations 20 Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses 33
Generalisability 21 Generalisability (external validity, applicability) of the trial findings 33
Interpretation 22 Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence NA
NA
Other information
Registration 23 Registration number and name of trial registry NA
Protocol 24 Where the full trial protocol can be accessed, if available 20
Funding 25 Sources of funding and other support (such as supply of drugs), role of funders
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*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.
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