CONSORT 2010

Question 1

What should be included in the title of a randomised trial?

Answer 1

Identification as a randomised trial in the title

Question 2

What is required in the structured summary of a trial?

Answer 2

Trial design, methods, results, and conclusions

Question 3

What should be explained in the background and objectives section?

Answer 3

Scientific background and explanation of rationale

Question 4

What specific information should be stated regarding objectives or hypotheses?

Answer 4

Specific objectives or hypotheses

Question 5

Which aspect of trial design must be described?

Answer 5

Description of trial design including allocation ratio

Question 6

What must be reported if there are important changes to methods after trial commencement?

Answer 6

Important changes with reasons

Question 7

What criteria must be defined for participants?

Answer 7

Eligibility criteria for participants

Question 8

What information is needed about settings in the methods section?

Answer 8

Settings and locations where the data were collected

Question 9

What details about interventions must be included?

Answer 9

Sufficient details to allow replication, including how and when they were administered

Question 10

What must be completely defined regarding outcome measures?

Answer 10

Pre-specified primary and secondary outcome measures

Question 11

What should be reported about changes to trial outcomes after commencement?

Answer 11

Any changes with reasons

Question 12

How should sample size determination be reported?

Answer 12

How sample size was determined

Question 13

What should be explained if interim analyses and stopping guidelines are applicable?

Answer 13

Explanation of any interim analyses and stopping guidelines

Question 14

What method should be used to generate the random allocation sequence?

Answer 14

Method used to generate the random allocation sequence

Question 15

What type of randomisation details must be reported?

Answer 15

Type of randomisation, including any restrictions

Question 16

What mechanism must be described regarding allocation concealment?

Answer 16

Mechanism used to implement the random allocation sequence

Question 17

Who should be identified in the implementation of random allocation?

Answer 17

Who generated the sequence, enrolled participants, assigned interventions

Question 18

In blinding, who should be identified as blinded after assignment?

Answer 18

Participants, care providers, those assessing outcomes

Question 19

What statistical methods must be reported?

Answer 19

Statistical methods used to compare groups for primary and secondary outcomes

Question 20

What should be included in the participant flow section?

Answer 20

Numbers of participants assigned, received treatment, and analysed for outcomes

Question 21

What information should be provided about losses and exclusions?

Answer 21

Losses and exclusions after randomisation, with reasons

Question 22

What dates should be defined in the recruitment section?

Answer 22

Dates defining the periods of recruitment and follow-up

Question 23

What should be reported if the trial ended or was stopped?

Answer 23

Reasons why the trial ended or was stopped

Question 24

What table should be presented for baseline data?

Answer 24

A table showing baseline demographic and clinical characteristics for each group

Question 25

What must be reported about the numbers analysed?

Answer 25

Number of participants included in each analysis and analysis by assigned groups

Question 26

What results must be provided for primary and secondary outcomes?

Answer 26

Results for each group, estimated effect size and its precision

Question 27

What is recommended for binary outcomes?

Answer 27

Presentation of both absolute and relative effect sizes

Question 28

What should be included in ancillary analyses?

Answer 28

Results of any other analyses performed, distinguishing pre-specified from exploratory

Question 29

What harms must be reported for each group?

Answer 29

All important harms or unintended effects

Question 30

What limitations should be addressed in the discussion?

Answer 30

Trial limitations, sources of potential bias, and imprecision

Question 31

What must be discussed regarding generalisability?

Answer 31

Generalisability (external validity, applicability) of the trial findings

Question 32

What should interpretation of results consider?

Answer 32

Balancing benefits and harms, and other relevant evidence

Question 33

What registration information should be included?

Answer 33

Registration number and name of trial registry

Question 34

Where can the full trial protocol be accessed?

Answer 34

Where the full trial protocol can be accessed, if available

Question 35

What sources of funding should be reported?

Answer 35

Sources of funding and role of funders