Beruflich Dokumente
Kultur Dokumente
Section/Topic
Item
Checklist item
No
Title and abstract
1a
1b
Introduction
Background and
Objectives
Methods
Trial design
Participants
2a
2b
3a
3b
6b
7a
8a
8b
Interventions
4a
4b
5
Outcomes
6a
Sample size
Randomisation:
Sequence
Generation
Allocation
concealment mechanism
Implementation
10
Blinding
11a
Statistical methods
11b
12a
12b
Result
Participant flow (a
diagram is strongly
13a
size)
Mechanism used to implement the random allocation sequence
sequentially numbered containers), describing any steps taken
sequence until interventions were assigned
Who generated the random allocation sequence, who enrolled
and who assigned participants to interventions
If done, who was blinded after assignment to interventions (for
participants, care providers, those assessing outcomes) and ho
If relevant, description of the similarity of interventions
Statistical methods used to compare groups for primary and se
outcomes
Methods for additional analyses, such as subgroup analyses an
analyses
recommended)
13b
Recruitment
14a
Baseline data
14b
15
Numbers analysed
16
Outcomes and
Estimation
17a
17b
Ancillary analyses
18
Harms
19
Discussion
Limitations
20
Generalisability
Interpretation
21
22
Other information
Registration
Protocol
Funding
23
24
25
*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.