Skip to main content

Table 1 Revised 2010 Consolidated Standards of Reporting Trials (CONSORT) Checklist

From: CONSORT in China: past development and future direction

Section/Topic Number Description
Title and Abstract 1 Identification as a randomized trial in the title
2 Has an abstract
3 Has a structured summary
4 Summary including trial design
5 Summary including methods
6 Summary including results
7 Summary including conclusions
Introduction
Background and objectives 8 Scientific background
9 Explanation of rationale
10 Specific objectives or hypotheses
Methods
Trial design 11 Description of trial design (such as parallel, factorial)
12 Description including allocation ratio
13 Important changes to methods after trial commencement (such as eligibility criteria)
14 Reasons for changes to methods after trial commencement
Participants 15 Eligibility criteria for participants
16 Settings and locations where the data were collected
Intervention 17 States precise details of the interventions intended for each group about how to conduct the administration which could allow replication
18 States precise details of the interventions intended for each group about when to conduct the administration which could allow replication
Outcomes 19 Defined what is the primary outcome measures
20 Completely defined how the primary outcome measures were assessed
21 Completely defined when the primary outcome measures were assessed
22 Defined what is the secondary outcome measures
23 Completely defined how the secondary outcome measures were assessed
24 Completely defined when the secondary outcome measures were assessed
25 Any changes to trial outcomes after the trial commenced
26 Reasons of changes to trial outcomes after trial commenced
Sample size 27 How sample size was determined
28 When applicable, any interim analyses
29 Explanation of the interim analyses
30 When applicable, any interim stopping guidelines
31 Explanation of stopping guidelines relative with interim analyses.
Randomization
Sequence generation 32 Method to generate the random allocation sequence
33 Types of randomization
34 Details of any restriction for randomization (such as blocking and block size)
Allocation concealment mechanism 35 Mechanism used to implement the random allocation sequence (such as sequentially numbered containers)
36 Describes any steps taken to concealed the sequence until interventions were assigned
Implementation 37 States who generated the allocation sequence
38 States who enrolled participants?
39 States who assigned participants to interventions (their trail groups)
Blinding 40 States that the trial is blinded or open.
41 States how the trial is blinded
42 States who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes)
43 If relevant, description of the similarity of interventions
Statistical methods 44 Defines the statistical methods used in the trail
45 Defines statistical methods used to compare groups for primary outcomes
46 Defines statistical methods used to compare groups for secondary outcomes
47 Methods for additional analyses, such as subgroup analyses and adjusted analyses
Results
Participant flow (a diagram is strongly recommended) 48 For each group, the numbers of participants who were randomly assigned
49 For each group, the numbers of participants who received intended treatment
50 For each group, the numbers of participants who were analyzed for the primary outcome
51 For each group, losses and exclusions after randomization
52 Reasons for losses and exclusions after randomization
Recruitment 53 Define the periods of recruitment
54 Define the specific dates of recruitment
55 Define the periods of follow-up
56 Define the specific dates of follow-up
57 Why the trial ended or was stopped
Baseline data 58 A table showing the baseline demographic and clinical characteristics for each group
Numbers analyzed 59 Actual number of participants in each group
60 States whether the analysis was by original assigned groups
Outcomes and estimation 61 Summary of results for each group with primary outcomes
62 Estimates effect size for primary outcomes
63 Estimates precision of effect size (95 % confidence interval) for primary outcomes
64 Summary of results for each group with secondary outcomes
65 Estimates effect size for secondary outcomes
66 Estimates precision of effect size (95 % confidence interval) for secondary outcomes
67 For binary outcomes, presentation of both absolute and relative effect sizes is recommended
Ancillary analyses 68 Results of any other analyses performed, distinguishing prespecified from exploratory
69 Results of subgroup analyses performed, distinguishing prespecified from exploratory
70 Results of adjusted analyses performed, distinguishing prespecified from exploratory
Harms 71 All important harms or unintended effects in each group
Discussion
Limitations 72 Trial limitations
73 Addressing sources of potential bias
74 Addressing sources of imprecision
75 If relevant, addressing source of multiplicity of analyses
Generalizability 76 Generalizability (external validity or applicability) of the trial findings
Interpretation 77 Interpretation of results
78 Balancing benefits and harms
79 Considering other relevant evidence relating with the results
Other Information
Registration 80 Registration number
81 Name of trial registry
Protocol 82 Where the full trial protocol can be accessed, if available
Funding 83 Sources of funding and other support (such as supply of drugs)
84 Role of funders