CONSORT 2010 Flashcards
What should be included in the title of a randomised trial?
Identification as a randomised trial in the title
What is required in the structured summary of a trial?
Trial design, methods, results, and conclusions
What should be explained in the background and objectives section?
Scientific background and explanation of rationale
What specific information should be stated regarding objectives or hypotheses?
Specific objectives or hypotheses
Which aspect of trial design must be described?
Description of trial design including allocation ratio
What must be reported if there are important changes to methods after trial commencement?
Important changes with reasons
What criteria must be defined for participants?
Eligibility criteria for participants
What information is needed about settings in the methods section?
Settings and locations where the data were collected
What details about interventions must be included?
Sufficient details to allow replication, including how and when they were administered
What must be completely defined regarding outcome measures?
Pre-specified primary and secondary outcome measures
What should be reported about changes to trial outcomes after commencement?
Any changes with reasons
How should sample size determination be reported?
How sample size was determined
What should be explained if interim analyses and stopping guidelines are applicable?
Explanation of any interim analyses and stopping guidelines
What method should be used to generate the random allocation sequence?
Method used to generate the random allocation sequence
What type of randomisation details must be reported?
Type of randomisation, including any restrictions
What mechanism must be described regarding allocation concealment?
Mechanism used to implement the random allocation sequence
Who should be identified in the implementation of random allocation?
Who generated the sequence, enrolled participants, assigned interventions
In blinding, who should be identified as blinded after assignment?
Participants, care providers, those assessing outcomes
What statistical methods must be reported?
Statistical methods used to compare groups for primary and secondary outcomes
What should be included in the participant flow section?
Numbers of participants assigned, received treatment, and analysed for outcomes
What information should be provided about losses and exclusions?
Losses and exclusions after randomisation, with reasons
What dates should be defined in the recruitment section?
Dates defining the periods of recruitment and follow-up
What should be reported if the trial ended or was stopped?
Reasons why the trial ended or was stopped
What table should be presented for baseline data?
A table showing baseline demographic and clinical characteristics for each group
What must be reported about the numbers analysed?
Number of participants included in each analysis and analysis by assigned groups
What results must be provided for primary and secondary outcomes?
Results for each group, estimated effect size and its precision
What is recommended for binary outcomes?
Presentation of both absolute and relative effect sizes
What should be included in ancillary analyses?
Results of any other analyses performed, distinguishing pre-specified from exploratory
What harms must be reported for each group?
All important harms or unintended effects
What limitations should be addressed in the discussion?
Trial limitations, sources of potential bias, and imprecision
What must be discussed regarding generalisability?
Generalisability (external validity, applicability) of the trial findings
What should interpretation of results consider?
Balancing benefits and harms, and other relevant evidence
What registration information should be included?
Registration number and name of trial registry
Where can the full trial protocol be accessed?
Where the full trial protocol can be accessed, if available
What sources of funding should be reported?
Sources of funding and role of funders
