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 | |