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    CONSORT Checklist

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    ziana alawiyah
    This document is a checklist of information to include when reporting randomized trials based on the CONSORT 2010 guidelines. It includes 25 items across several sections: title and abstract (2 items), introduction (2 items), methods (13 items including trial design, participants, interventions, outcomes), results (7 items including participant flow, recruitment, numbers analyzed, outcomes), and other information (1 item). The checklist aims to improve transparency in trial reporting.

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    CONSORT Checklist

    Uploaded by

    ziana alawiyah
    567 views2 pages
    This document is a checklist of information to include when reporting randomized trials based on the CONSORT 2010 guidelines. It includes 25 items across several sections: title and abstract (2 items), introduction (2 items), methods (13 items including trial design, participants, interventions, outcomes), results (7 items including participant flow, recruitment, numbers analyzed, outcomes), and other information (1 item). The checklist aims to improve transparency in trial reporting.

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    CONSORT Checklist

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    This document is a checklist of information to include when reporting randomized trials based on the CONSORT 2010 guidelines. It includes 25 items across several sections: title and abstract (2 items), introduction (2 items), methods (13 items including trial design, participants, interventions, outcomes), results (7 items including participant flow, recruitment, numbers analyzed, outcomes), and other information (1 item). The checklist aims to improve transparency in trial reporting.

    Copyright:

    © All Rights Reserved
    Download as DOC, PDF, TXT or read online from Scribd
    Download as doc, pdf, or txt
    567 views2 pages

    CONSORT Checklist

    Uploaded by

    ziana alawiyah
    This document is a checklist of information to include when reporting randomized trials based on the CONSORT 2010 guidelines. It includes 25 items across several sections: title and abstract (2 items), introduction (2 items), methods (13 items including trial design, participants, interventions, outcomes), results (7 items including participant flow, recruitment, numbers analyzed, outcomes), and other information (1 item). The checklist aims to improve transparency in trial reporting.

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    © All Rights Reserved
    Download as DOC, PDF, TXT or read online from Scribd
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    of 2

    CONSORT 2010 checklist of information to include when reporting a randomised trial*

    Item Reported
    Section/Topic Checklist Item
    No on page No
    Title and abstract
    1a Identification as a randomised trial in the title
    Structured summary of trial design, methods, results, and conclusions (for specific guidance see CONSORT for
    1b
    abstracts)

    Introduction
    Background and 2a Scientific background and explanation of rationale
    objectives 2b Specific objectives or hypotheses
    Methods
    3a Description of trial design (such as parallel, factorial) including allocation ratio
    Trial design
    3b Important changes to methods after trial commencement (such as eligibility criteria), with reasons
    4a Eligibility criteria for participants
    Participants
    4b Settings and locations where the data were collected
    The interventions for each group with sufficient details to allow replication, including how and when
    Interventions 5
    they were actually administered
    Completely defined pre-specified primary and secondary outcome measures, including how and when
    6a
    Outcomes they were assessed
    6b Any changes to trial outcomes after the trial commenced, with reasons
    7a How sample size was determined
    Sample size
    7b When applicable, explanation of any interim analyses and stopping guidelines
    Randomisation:
    Sequence 8a Method used to generate the random allocation sequence
    generation 8b Type of randomisation; details of any restriction (such as blocking and block size)
    Allocation Mechanism used to implement the random allocation sequence (such as sequentially numbered
    concealment 9 containers), describing any steps taken to conceal the sequence until interventions were assigned
    mechanism
    Who generated the random allocation sequence, who enrolled participants, and who assigned
    Implementation 10
    participants to interventions

    CONSORT 2010 checklist Page 1


    If done, who was blinded after assignment to interventions (for example, participants, care providers,
    Blinding 11a
    those assessing outcomes) and how
    11b If relevant, description of the similarity of interventions
    Statistical 12a Statistical methods used to compare groups for primary and secondary outcomes
    methods 12b Methods for additional analyses, such as subgroup analyses and adjusted analyses
    Results
    Participant flow (a For each group, the numbers of participants who were randomly assigned, received intended
    13a
    diagram is strongly treatment, and were analysed for the primary outcome
    recommended) 13b For each group, losses and exclusions after randomisation, together with reasons
    14a Dates defining the periods of recruitment and follow-up
    Recruitment
    14b Why the trial ended or was stopped
    Baseline data 15 A table showing baseline demographic and clinical characteristics for each group
    Numbers For each group, number of participants (denominator) included in each analysis and whether the
    16
    analysed analysis was by original assigned groups
    For each primary and secondary outcome, results for each group, and the estimated effect size and its
    Outcomes and 17a
    precision (such as 95% confidence interval)
    estimation
    17b For binary outcomes, presentation of both absolute and relative effect sizes is recommended
    Results of any other analyses performed, including subgroup analyses and adjusted analyses,
    Ancillary analyses 18
    distinguishing pre-specified from exploratory
    Harms 19 All important harms or unintended effects in each group (for specific guidance see CONSORT for harms)
    Discussion
    Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of
    Limitations 20
    analyses
    Generalisability 21 Generalisability (external validity, applicability) of the trial findings
    Interpretation consistent with results, balancing benefits and harms, and considering other relevant
    Interpretation 22
    evidence
    Other information
    Registration 23 Registration number and name of trial registry
    Protocol 24 Where the full trial protocol can be accessed, if available
    Funding 25 Sources of funding and other support (such as supply of drugs), role of funders

    *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.

    CONSORT 2010 checklist Page 2

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