CHECKLIST ITEMS
Extension Combination : Consort
Cluster trials
Pragmatic trials
Item_1 : TITLE & ABSTRACT
Reported
on Page
N°
1a : Identification as a randomised trial in the title
1b : Structured summary of trial design, methods, results, and conclusions
Consort
Cluster trials
1a : Identification as a cluster randomised trial
1b. Structured summary of trial design, methods, results, and conclusions
1
2
1
2
Item_2 : INTRODUCTION Background and objectives
Reported
on Page
N°
Consort
Cluster trials
Pragmatic trials
2a : Scientific background and explanation of rationale
2b : Specific objectives or hypotheses
2a : Rationale for using a cluster design.
2b : Whether objectives pertain to the individual level or the cluster level or both.
3
3
4
4
Describe the health or health service problem that the intervention is intended to address and
3
other interventions that may commonly be aimed at this problem
Item_3 : METHODS Trial design
Reported
on Page
N°
Consort
3a : Description of trial design (such as parallel, factorial) including allocation ratio
3b : Important changes to methods after trial commencement (such as eligibility
criteria), with reasons
Cluster trials
3a : Definition of cluster and description of how the design features apply to the clusters
Item_4 : METHODS Participants
4
8
4
Reported
on Page
N°
Consort
Cluster trials
Pragmatic trials
4a : Eligibility criteria for participants
4b : Settings and locations where the data were collected
4
8
4a : Eligibility criteria for clusters
4
Eligibility criteria should be explicitly framed to show the degree to which they include
typical participants and/or, where applicable, typical providers (e.g., nurses), institutions (e.g.,
4
hospitals), communities (or localities e.g., towns) and settings of care (e.g., different
healthcare financing systems)
Item_5 : METHODS Interventions
Reported
on Page
N°
Consort
Cluster trials
Pragmatic trials
5 : The interventions for each group with sufficient details to allow replication, including
4-6
how and when they were actually administered
5 : Whether interventions pertain to the individual level or the cluster level or both
4
5a : Describe extra resources added to (or resources removed from) usual settings in order to
implement intervention. Indicate if efforts were made to standardise the intervention or if the
intervention and its delivery were allowed to vary between participants, practitioners, or other 4-6
study sites
5b : Describe the comparator in similar detail to the intervention
Item_6 : METHODS Outcomes
Reported
on Page
N°
Consort
Cluster trials
Pragmatic trials
6a : Completely defined pre-specified primary and secondary outcome measures,
including how and when they were assessed
6
6b : Any changes to trial outcomes after the trial commenced, with reasons
6a : Whether outcome measures pertain to the individual level or the cluster level or both
6
Explain why the chosen outcomes and, when relevant, the length of follow-up are considered
6
important to those who will use the results of the trial
Item_7 : METHODS Sample size
Reported
on Page
N°
Consort
Cluster trials
7a : How sample size was determined
7b : When applicable, explanation of any interim analyses and stopping guidelines
7a : Method of calculation, number of cluster(s) (and whether equal or unequal cluster sizes
6-7
6-7
Pragmatic trials
are assumed), cluster size, a coefficient of intracluster correlation (ICC or k) and an indication
of its uncertainty
If calculated using the smallest difference considered important by the target decision maker
7
audience (the minimally important difference) then report where this difference was obtained
Item_8 : METHODS Randomisation : Sequence generation
Reported
on Page
N°
Consort
Cluster trials
8a : Method used to generate the random allocation sequence
8b : Type of randomisation; details of any restriction (such as blocking and block size)
8b : Details of stratification or matching if used
4-5
n/a
Item_9 : METHODS Randomisation : Allocation concealment mechanism
Reported
on Page
N°
Consort
Cluster trials
9 : Mechanism used to implement the random allocation sequence (such as sequentially
numbered containers), describing any steps taken to conceal the sequence until
n/a
interventions were assigned
9 : Specification that allocation was based on clusters rather than individuals
4
Item_10 : METHODS Implementation
Reported
on Page
N°
Consort
Cluster trials
10 : Who generated the random allocation sequence, who enrolled participants, and who
See below
assigned participants to interventions
5, 4,5
Replace by 10a, 10b and 10c
10a : Who generated the random allocation sequence, who enrolled clusters, and who assigned
clusters to interventions
10b : Mechanism by which individuals were included in clusters for the purposes of the trial 4
(such as complete enumeration, random sampling)
10c : From whom consent was sought (representatives of the cluster, or individual cluster
members, or both), and whether consent was sought before or after randomisation
4
Item_11 : METHODS Blinding
Reported
on Page
N°
Consort
Pragmatic trials
11a : If done, who was blinded after assignment to interventions (for example,
participants, care providers, those assessing outcomes) and how
11b : If relevant, description of the similarity of interventions
If blinding was not done, or was not possible,explain why
5
Item_12 : METHODS Statistical methods
Reported
on Page
N°
Consort
Cluster trials
12a : Statistical methods used to compare groups for primary and secondary outcomes
6-7
12b : Methods for additional analyses, such as subgroup analyses and adjusted analyses
12a : How clustering was taken into account
7
Item_13 : RESULTS Participant flow (a diagram is strongly
recommended)
Reported
on Page
N°
Consort
Cluster trials
Pragmatic trials
13a : For each group, the numbers of participants who were randomly assigned,
received intended treatment, and were analysed for the primary outcome
8-10
13b : For each group, losses and exclusions after randomisation, together with reasons
13a : The numbers of clusters that were randomly assigned, received intended treatment, and
were analysed for the primary outcome
8-10
13b : Losses and exclusions for both clusters and individual cluster members
The number of participants or units approached to take part in the trial, the number which
9-10
were eligible, and the reasons for non-participation should be reported
Item_14 : RESULTS Recruitment
Reported
on Page
N°
Consort
14a : Dates defining the periods of recruitment and follow-up
14b : Why the trial ended or was stopped
Item_15 : RESULTS Baseline data
9
Reported
on Page
N°
Consort
Cluster trials
15 : A table showing baseline demographic and clinical characteristics for each group
15 : Baseline characteristics for the individual and cluster members as applicable
9
Item_16 : RESULTS Numbers analysed
Reported
on Page
N°
Consort
Cluster trials
16 : For each group, number of participants (denominator) included in each analysis
and whether the analysis was by original assigned groups
16 : Number of clusters included in each analysis
9
9
Item_17 : RESULTS Outcomes and estimation
Reported
on Page
N°
Consort
Cluster trials
17a : For each primary and secondary outcome, results for each group, and the
estimated effect size and its precision (such as 95% confidence interval)
17b : For binary outcomes, presentation of both absolute and relative effect sizes is
recommended
17a : Results at the individual or cluster levels as applicable
17b : and a coefficient of intracluster correlation (ICC or k) for each primary outcome
9-12
10
Item_18 : RESULTS Ancillary analyses
Reported
on Page
N°
Consort
18 : Results of any other analyses performed, including subgroup analyses and adjusted
10
analyses, distinguishing pre-specified from exploratory
Item_19 : RESULTS Harms
Reported
on Page
N°
Consort
19 : All important harms or unintended effects in each group
Item_20 : DISCUSSION Limitations
Reported
on Page
N°
Consort
20 : Trial limitations; addressing sources of potential bias, imprecision, and, if relevant,
12-13
multiplicity of analyses
Item_21 : DISCUSSION Generalisability
Reported
on Page
N°
Consort
Cluster trials
Pragmatic trials
21 : Generalisability (external validity, applicability) of the trial findings
12-13
21 : Generalisability to individuals and/or clusters (as relevant)
12-13
Describe key aspects of the setting which determined the trial results. Discuss possible
differences in other settings where clinical traditions, health service organisations, staffing, or 12-13
resources may vary from those of the trial
Item_22 : DISCUSSION Interpretation
Reported
on Page
N°
Consort
22 : Interpretation consistent with results, balancing benefits and harms, and
considering other relevant evidence
13-14
Item_23 : OTHER INFORMATION Registration
Reported
on Page
N°
Consort
23 : Registration number and name of trial registry
3
Item_24 : OTHER INFORMATION Protocol
Reported
on Page
N°
Consort
24 : Where the full trial protocol can be accessed, if available
Item_25 : OTHER INFORMATION Funding
Reported
on Page
N°
Consort
25 : Sources of funding and other support (such as supply of drugs), role of funders
3,15