Background
The CONSORT Statement
Scope of CONSORT-SPI 2018
Methods
Systematic reviews
Online Delphi process
Consensus meeting
Post-meeting activities
Results
Systematic review
Online Delphi process
Consensus meeting
Section | Item # | CONSORT 2010 | CONSORT-SPI 2018 |
---|---|---|---|
Title and abstract | |||
1a | Identification as a randomised trial in the title§ | ||
1b | Structured summary of trial design, methods, results, and conclusions (for specific guidance see CONSORT for Abstracts)§ | Refer to CONSORT extension for social and psychological intervention trial abstracts | |
Introduction | |||
Background and objectives | 2a | Scientific background and explanation of rationale§ | |
2b | Specific objectives or hypotheses§ | If pre-specified, how the intervention was hypothesised to work | |
Methods | |||
Trial design | 3a | Description of trial design (such as parallel, factorial), including allocation ratio§ | If the unit of random assignment is not the individual, please refer to CONSORT for Cluster Randomised Trials [33] |
3b | Important changes to methods after trial commencement (such as eligibility criteria), with reasons | ||
Participants | 4a | Eligibility criteria for participants§ | When applicable, eligibility criteria for settings and those delivering the interventions |
4b | Settings and locations where the data were collected | ||
Interventions | 5 | The interventions for each group with sufficient details to allow replication, including how and when they were actually administered§ | |
5a | Extent to which interventions were actually delivered by providers and taken up by participants as planned | ||
5b | Where other informational materials about delivering the intervention can be accessed | ||
5c | When applicable, how intervention providers were assigned to each group | ||
Outcomes | 6a | Completely defined pre-specified outcomes, including how and when they were assessed§ | |
6b | Any changes to trial outcomes after the trial commenced, with reasons | ||
Sample size | 7a | How sample size was determined§ | |
7b | When applicable, explanation of any interim analyses and stopping guidelines | ||
Randomisation | |||
Sequence generation | 8a | Method used to generate the random allocation sequence | |
8b | Type of randomisation; details of any restriction (such as blocking and block size)§ | ||
Allocation concealment mechanism | 9 | Mechanism used to implement the random allocation sequence, describing any steps taken to conceal the sequence until interventions were assigned§ | |
Implementation | 10 | Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions§ | |
Awareness of assignment | 11a | Who was aware of intervention assignment after allocation (for example, participants, providers, those assessing outcomes), and how any masking was done | |
11b | If relevant, description of the similarity of interventions | ||
Analytical methods | 12a | Statistical methods used to compare group outcomes§ | How missing data were handled, with details of any imputation method |
12b | Methods for additional analyses, such as subgroup analyses, adjusted analyses, and process evaluations | ||
Results | |||
Participant flow (a diagram is strongly recommended) | 13a | For each group, the numbers randomly assigned, receiving the intended intervention, and analysed for the outcomes§ | Where possible, the number approached, screened, and eligible prior to random assignment, with reasons for non-enrolment |
13b | For each group, losses and exclusions after randomisation, together with reasons§ | ||
Recruitment | 14a | Dates defining the periods of recruitment and follow-up | |
14b | Why the trial ended or was stopped | ||
Baseline data | 15 | A table showing baseline characteristics for each group§ | Include socioeconomic variables where applicable |
Numbers analysed | 16 | For each group, number included in each analysis and whether the analysis was by original assigned groups§ | |
Outcomes and estimation | 17a | For each outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval)§ | Indicate availability of trial data |
17b | For binary outcomes, the presentation of both absolute and relative effect sizes is recommended | ||
Ancillary analyses | 18 | Results of any other analyses performed, including subgroup analyses, adjusted analyses, and process evaluations, distinguishing pre-specified from exploratory | |
Harms | 19 | All important harms or unintended effects in each group (for specific guidance see CONSORT for Harms) | |
Discussion | |||
Limitations | 20 | Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses | |
Generalisability | 21 | Generalisability (external validity, applicability) of the trial findings§ | |
Interpretation | 22 | Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence | |
Important information | |||
Registration | 23 | Registration number and name of trial registry | |
Protocol | 24 | Where the full trial protocol can be accessed, if available | |
Declaration of interests | 25 | Sources of funding and other support; role of funders | Declaration of any other potential interests |
Stakeholder involvement* | 26a | Any involvement of the intervention developer in the design, conduct, analysis, or reporting of the trial | |
26b | Other stakeholder involvement in trial design, conduct, or analyses | ||
26c | Incentives offered as part of the trial |
• Item 6a. The distinction between ‘primary’ versus ‘secondary’ outcomes has been removed. • Item 11. ‘Blinding’ has been changed to ‘Awareness of assignment’ and ‘masking’ in the section heading and item wording, respectively. These changes address concerns about the use of the term ‘blinding’ as well as the need to emphasise the issue of awareness of assignment by providers and participants in social and psychological intervention trials. • Item 12. The section heading ‘Statistical methods’ has been changed to ‘Analytical methods’ because some methods may be qualitative in social and psychological intervention RCTs. • Item 12a. The distinction between ‘primary’ versus ‘secondary’ outcomes has been removed. • Item 12b. Process evaluations are specifically highlighted. • Item 13a. The distinction between ‘primary’ versus ‘secondary’ outcomes has been removed. • Items 13a and 16. The wording ‘number of participants’ has been changed to ‘number’ because the term ‘participants’ is not appropriate for RCTs in which the unit of intervention is a geographic area. While social and psychological interventions may target individual participants or groups of individuals, such as families or schools, they may also involve place-based techniques that target geographic units and examine area-level effects. However, for convenience and consistency with the CONSORT 2010 guidance [72], the CONSORT-SPI 2018 checklist and E&E will refer to the unit targeted by the intervention as ‘participants’, though ‘participants’ throughout this guidance is meant to stand for ‘participating units’ or the unit being targeted by the intervention [87], which may include geographic units. • Item 15. The words ‘clinical and demographic’ have been removed because this checklist targets interventions that may not be medical in nature or have health outcomes, and thus to emphasise the need to report important baseline characteristics irrespective of their nature. • Item 16. The parenthetical ‘(denominator)’ has been removed. The term implied the use of dichotomous outcomes, whereas continuous outcomes are extremely prevalent in social and psychological intervention RCTs. • Item 17a. The distinction between ‘primary’ versus ‘secondary’ outcomes has been removed. • Items 23–25. The section ‘Other Information’ has been changed to ‘Important Information’ because consensus meeting participants had concerns that ‘Other’ makes the requested information appear to be of secondary importance to previous sections. • Item 25. The phrase ‘such as supply of drugs’ has been removed because drug trials are not in the purview of this extension by definition. • Item 26: New item. A new sub-section in ‘Important Information’ called ‘Stakeholder Involvement’ has been added because consensus meeting participants thought such a sub-section would best fit the three sub-items currently allocated to it. |
Section | CONSORT abstract item | Relevant CONSORT-SPI item |
---|---|---|
Title | Identification of the study as randomised | |
Authors | Contact details for the corresponding author | |
Trial design | Description of the trial design (e.g. parallel, cluster, noninferiority) | If the unit of random assignment is not the individual, refer to CONSORT for Cluster Randomised Trials and report the items included in its extension for abstracts [33] |
Methods | ||
Participants | Eligibility criteria for participants and the settings where the data were collected | When applicable, the eligibility criteria for the setting of the intervention delivery and the eligibility criteria for the persons who delivered the interventions |
Interventions | Interventions intended for each group | |
Objective | Specific objective or hypothesis | If pre-specified, how the intervention was hypothesised to work |
Outcomes | Clearly defined primary outcome for this report | |
Randomisation | How participants were allocated to interventions | |
Awareness of assignment | Who was aware of intervention assignment after allocation (for example, participants, providers, those assessing outcomes), and how any masking was done | |
Results | ||
Number randomly assigned | Number randomised to each group | |
Recruitment | Trial status | |
Interventions | Extent to which interventions were actually delivered by providers and taken up by participants as planned | |
Number analysed | Number analysed in each group | |
Outcomes | For the primary outcome, a result for each group and the estimated effect size and its precision | |
Harms | Important adverse events or side effects | |
Conclusions | General interpretation of the results | |
Trial registration | Registration number and name of trial register | |
Funding | Source of funding |
Section | CONSORT Abstract item | Relevant CONSORT Cluster extension item |
---|---|---|
Title | Identification of the study as randomised | Identification of study as cluster randomised |
Authors | Contact details for the corresponding author | |
Trial design | Description of the trial design (e.g. parallel, cluster, noninferiority) | |
Methods | ||
Participants | Eligibility criteria for participants and the settings where the data were collected | Eligibility criteria for clusters |
Interventions | Interventions intended for each group | |
Objective | Specific objective or hypothesis | Whether objective or hypothesis pertains to the cluster level, the individual participant level, or both |
Outcomes | Clearly defined primary outcome for this report | Whether the primary outcome pertains to the cluster level, the individual participant level, or both |
Randomisation | How participants were allocated to interventions | How clusters were allocated to interventions |
Awareness of assignment | Who was aware of intervention assignment after allocation (for example, participants, providers, those assessing outcomes), and how any masking was done | |
Results | ||
Number randomly assigned | Number of participants randomised to each group | Number of clusters randomised to each group |
Recruitment | Trial status | |
Number analysed | Number of participants analysed in each group | Number of clusters analysed in each group |
Outcomes | For the primary outcome, a result for each group and the estimated effect size and its precision | Results at the cluster or individual level as applicable for each primary outcome |
Harms | Important adverse events or side effects | |
Conclusions | General interpretation of the results | |
Trial registration | Registration number and name of trial register | |
Funding | Source of funding |
Section | Item # | Cluster extension item |
---|---|---|
Title | 1a | Identification as a cluster randomised trial in the title |
Abstract | 1b | See Table 4 |
Introduction | ||
Background and objectives | 2a | Rationale for using a cluster design |
2b | Whether objectives pertain to the cluster level, the individual participant level, or both | |
Methods | ||
Trial design | 3a | Definition of cluster and description of how the design features apply to the clusters |
Participants | 4a | Eligibility criteria for clusters |
Interventions | 5 | Whether interventions pertain to the cluster level, the individual participant level, or both |
Outcomes | 6a | Whether outcome measures pertain to the cluster level, the individual participant level, or both |
Sample size | 7a | Method of calculation, number of clusters(s) (and whether equal or unequal cluster sizes are assumed), cluster size, a coefficient of intracluster correlation (ICC or k), and an indication of its uncertainty |
Randomisation | ||
Sequence generation | 8b | Details of stratification or matching if used |
Allocation concealment mechanism | 9 | Specification that allocation was based on clusters rather than individuals and whether allocation concealment (if any) was at the cluster level, the individual participant level, or both |
Implementation | 10a | Who generated the random allocation sequence, who enrolled clusters, and who assigned clusters to interventions |
10b | Mechanism by which individual participants were included in clusters for the purposes of the trial (such as complete enumeration, random sampling) | |
10c | From whom consent was sought (representatives of the cluster, individual cluster members, or both) and whether consent was sought before or after randomisation | |
Analytical methods | 12a | How clustering was taken into account |
Results | ||
Participant flow (a diagram is strongly recommended) | 13a | For each group, the numbers of clusters that were randomly assigned, received the intended treatment, and were analysed for the primary outcome |
13b | For each group, losses and exclusions for both clusters and individual cluster members | |
Baseline data | 15 | Baseline characteristics for the individual and cluster levels as applicable for each group |
Numbers analysed | 16 | For each group, the number of clusters included in each analysis |
Outcomes and estimation | 17a | Results at the individual or cluster level as applicable and a coefficient of intracluster correlation (ICC or k) for each primary outcome |
Generalisability | 21 | Generalisability to clusters or individual participants (as relevant) |
Discussion
Strengths and limitations
Endorsement
JOURNAL NAME requires a completed CONSORT-SPI 2018 checklist as a condition for submitting manuscripts about randomised trials of social and psychological interventions. We recommend that your submission addresses each item in the CONSORT-SPI 2018 checklist. Taking the time to ensure your manuscript meets these basic reporting requirements will greatly improve your manuscript, and may potentially enhance its chances for eventual publication.