Yes/No questions on CONSORT for RCTs
1
Use the word “randomised” in the title
2
Specific objectives mentioned in the summary
3
Trial design (e.g., parallel group, cluster) and framework (e.g., superiority, equivalence,
non- inferiority, exploratory) mentioned in the summary
4
Eligibility criteria for participants and settings where the trial was conducted mentioned in summary
5
Intervention(s) and comparator(s) intended for each group mentioned in the summary
6
Primary outcome(s) mentioned in the summary
7
How participants were allocated to interventions (e.g., centralized computer-generated randomization) mentioned in the summary
8
Who was blinded after assignment to interventions (e.g., participants, care
providers, outcome assessors) mentioned in the summary
9
Number of participants randomized to each group mentioned in the summary
10
For the primary outcome, the number of participants analysed in each group, a result for each group and the estimated effect size and its precision is mentioned in the summary
11
General interpretation of the results mentioned ion the summary
12
Name of registry, Trial registry identifying number, URL to registry record, Date of registration mentioned
13
Where the protocol and full statistical analysis plan can be accessed with URL to its location mentioned
14
Sources of funding and other support, role of funders in the design, conduct, analysis and reporting of the trial mentioned
15
Financial and other conflicts of interest of the manuscript authors mentioned
16
Scientific background and rationale mentioned in the introduction
17
Specific objectives related to benefits and harms mentioned in the introduction
18
Description of trial design including type of trial (e.g., parallel group, crossover), allocation ratio, and framework (e.g., superiority, equivalence, non-inferiority etc.) mentioned in methodology
19
Important changes to the trial after it commenced including any outcomes or analyses that were not prespecified, with reason mentioned in methodoly
20
Settings (e.g., community, hospital) and locations (e.g., countries, sites) where the trial was conducted mentioned in methodology
21
Eligibility criteria for participants including method of recruitment of participants (eg. referral, self selection or advertisements) mentioned in methodology
22
Details of each intervention and comparator to allow replication eg. Components of the intervention and comparator, How, when and for how long they were administered etc. mentioned in methodology
23
Any physical or informational materials used as part of the intervention/comparator (e.g., instruction manual) and where the materials can be accessed mentioned in methodology
24
When the comparator group is “usual care”, Description of usual care and Whether the intervention group(s) also received usual care mentioned in methodology
25
Which outcomes are primary and secondary as prespecified in the protocol, Rationale for the choice of trial outcomes mentioned in the methodology and whether they are part of a core outcome set
26
How sample size was determined, including all assumptions (eg. statistical level of significance, statistical power etc.)supporting the sample size calculation mentioned in methodology
27
Explanation of any interim analyses and stopping guidelines mentioned in methodology
28
Who generated the random allocation sequence and the method used mentioned in methodology
29
Type of randomisation and details of any restriction mentioned in methodology(e.g., stratification, blocking and block size) mentioned in the methodology
30
Mechanism used to implement the random allocation sequence (e.g., central computer/telephone; sequentially numbered, sealed containers) mentioned in the menthodology
31
Who enrolled the participants and those who assigned participants to the interventions mentioned in methodology
32
Who was blinded after assignment to interventions (e.g., participants, care providers, outcome assessors, data
analysts)
33
Statistical methods used to compare groups for primary and secondary outcomes, including harms
34
The number of participants evaluated for potential enrolment, no. of participants excluded before randomisation with reasons like Declined to participate etc. mentioned in the flow diagram
35
No. of participants Randomly assigned to each group, Who received intervention as allocated in both the groups
36
Intervention and comparator as they were actually administered (e.g.who delivered the intervention/comparator, whether participants adhered, whether they were delivered as intended) mentioned
37
A table showing baseline demographic and clinical characteristics for each group
38
the no. of participants included in the analysis, result for each group, and the estimated effect size and its precision (such as 95% confidence interval) mentioned
39
All harms or unintended events in each group mentioned.
40
Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence mentioned
41
Trial limitations, addressing sources of potential bias, imprecision, generalisability, and, if relevant, multiplicity of analyses mentioned
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