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# 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 |