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    CONSORT Checklist

    Uploaded by

    Katya Palafox
    This document provides a checklist for authors to complete when reporting the results of a randomized controlled trial based on the CONSORT guidelines. The checklist contains 25 items addressing key aspects of trial design, methods, results and conclusions to ensure transparent and complete reporting. Completing the checklist involves indicating the page numbers in the manuscript where readers can find details for each item. The completed checklist should be uploaded as an extra file when submitting the manuscript for publication.

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    Download as DOCX, PDF, TXT or read online from Scribd

    CONSORT Checklist

    Uploaded by

    Katya Palafox
    20 views8 pages
    This document provides a checklist for authors to complete when reporting the results of a randomized controlled trial based on the CONSORT guidelines. The checklist contains 25 items addressing key aspects of trial design, methods, results and conclusions to ensure transparent and complete reporting. Completing the checklist involves indicating the page numbers in the manuscript where readers can find details for each item. The completed checklist should be uploaded as an extra file when submitting the manuscript for publication.

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    CONSORT_checklist

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    This document provides a checklist for authors to complete when reporting the results of a randomized controlled trial based on the CONSORT guidelines. The checklist contains 25 items addressing key aspects of trial design, methods, results and conclusions to ensure transparent and complete reporting. Completing the checklist involves indicating the page numbers in the manuscript where readers can find details for each item. The completed checklist should be uploaded as an extra file when submitting the manuscript for publication.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
    20 views8 pages

    CONSORT Checklist

    Uploaded by

    Katya Palafox
    This document provides a checklist for authors to complete when reporting the results of a randomized controlled trial based on the CONSORT guidelines. The checklist contains 25 items addressing key aspects of trial design, methods, results and conclusions to ensure transparent and complete reporting. Completing the checklist involves indicating the page numbers in the manuscript where readers can find details for each item. The completed checklist should be uploaded as an extra file when submitting the manuscript for publication.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
    of 8

    Reporting checklist for randomised trial.

    Based on the CONSORT guidelines.

    Instructions to authors
    Complete this checklist by entering the page numbers from your manuscript where readers will find
    each of the items listed below.
    Your article may not currently address all the items on the checklist. Please modify your text to
    include the missing information. If you are certain that an item does not apply, please write "n/a" and
    provide a short explanation.
    Upload your completed checklist as an extra file when you submit to a journal.
    In your methods section, say that you used the CONSORTreporting guidelines, and cite them as:

    Schulz KF, Altman DG, Moher D, for the CONSORT Group. CONSORT 2010 Statement: updated
    guidelines for reporting parallel group randomised trials

    Reporting Item

    Page Number

    Title and Abstract

    Title

    #1aX

    Identification as a randomized trial in the title.


    Abstract

    #1bX

    Structured summary of trial design, methods, results, and conclusions

    Introduction

    Background and objectives

    #2aX

    Scientific background and explanation of rationale

    Background and objectives

    #2bX

    Specific objectives or hypothesis

    Methods

    Trial design

    #3aX

    Description of trial design (such as parallel, factorial) including allocation ratio.

    Trial design

    #3bX
    Important changes to methods after trial commencement (such as eligibility criteria), with reasons

    Participants

    #4aX

    Eligibility criteria for participants

    Participants

    #4bX

    Settings and locations where the data were collected

    Interventions

    #5X

    The experimental and control interventions for each group with sufficient details to allow replication,
    including how and when they were actually administered

    Outcomes

    #6aX

    Completely defined prespecified primary and secondary outcome measures, including how and when
    they were assessed

    Outcomes

    #6bX

    Any changes to trial outcomes after the trial commenced, with reasons

    Sample size

    #7aX

    How sample size was determined.


    Sample size

    #7bX

    When applicable, explanation of any interim analyses and stopping guidelines

    Randomization - Sequence generation

    #8aX

    Method used to generate the random allocation sequence.

    Randomization - Sequence generation

    #8bX

    Type of randomization; details of any restriction (such as blocking and block size)

    Randomization - Allocation concealment mechanism

    #9X

    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

    Randomization - Implementation

    #10X

    Who generated the allocation sequence, who enrolled participants, and who assigned participants to
    interventions

    Blinding

    #11aX
    If done, who was blinded after assignment to interventions (for example, participants, care providers,
    those assessing outcomes) and how.

    Blinding

    #11bX

    If relevant, description of the similarity of interventions

    Statistical methods

    #12aX

    Statistical methods used to compare groups for primary and secondary outcomes

    Statistical methods

    #12bX

    Methods for additional analyses, such as subgroup analyses and adjusted analyses

    Results

    Participant flow diagram (strongly recommended)

    #13aX

    For each group, the numbers of participants who were randomly assigned, received intended
    treatment, and were analysed for the primary outcome

    Participant flow

    #13bX

    For each group, losses and exclusions after randomization, together with reason
    Recruitment

    #14aX

    Dates defining the periods of recruitment and follow-up

    Recruitment

    #14bX

    Why the trial ended or was stopped

    Baseline data

    #15X

    A table showing baseline demographic and clinical characteristics for each group

    Numbers analysed

    #16X

    For each group, number of participants (denominator) included in each analysis and whether the
    analysis was by original assigned groups

    Outcomes and estimation

    #17aX

    For each primary and secondary outcome, results for each group, and the estimated effect size and
    its precision (such as 95% confidence interval)

    Outcomes and estimation

    #17bX

    For binary outcomes, presentation of both absolute and relative effect sizes is recommended
    Ancillary analyses

    #18X

    Results of any other analyses performed, including subgroup analyses and adjusted analyses,
    distinguishing pre-specified from exploratory

    Harms

    #19X

    All important harms or unintended effects in each group (For specific guidance see CONSORT for
    harms)

    Discussion

    Limitations

    #20X

    Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of
    analyses

    Generalisability

    #21X

    Generalisability (external validity, applicability) of the trial findings

    Interpretation

    #22X

    Interpretation consistent with results, balancing benefits and harms, and considering other relevant
    evidence
    Registration

    #23X

    Registration number and name of trial registry

    Other information

    Interpretation

    #22X

    Interpretation consistent with results, balancing benefits and harms, and considering other relevant
    evidence

    Registration

    #23X

    Registration number and name of trial registry

    Protocol

    #24X

    Where the full trial protocol can be accessed, if available

    Funding

    #25X

    Sources of funding and other support (such as supply of drugs), role of funders

    None The CONSORT checklist is distributed under the terms of the Creative Commons Attribution
    License CC-BY. This checklist can be completed online using https://www.goodreports.org/, a tool
    made by the EQUATOR Network in collaboration with Penelope.ai

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