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 [8] |
3b | Important changes to methods after trial commencement (such as eligibility criteria), with reasons | Â | |
 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 | Â | |
 Interventions | 5 | The interventions for each group with sufficient details to allow replication, including how and when they were actually administered§ |  |
5a | Â | Extent to which interventions were actually delivered by providers and taken up by participants as planned | |
5b | Â | Where other informational materials about delivering the intervention can be accessed | |
5c | Â | 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 | Â | |
 Sample size | 7a | How sample size was determined§ |  |
7b | When applicable, explanation of any interim analyses and stopping guidelines | Â | |
Randomisation | |||
 Sequence generation | 8a | Method used to generate the random allocation sequence |  |
8b | Type of randomisation and 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 | Â | |
 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 | Â | |
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 | Â | |
 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, presentation of both absolute and relative effect sizes is recommended | Â | |
 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 | Â | Any involvement of the intervention developer in the design, conduct, analysis, or reporting of the trial |
26b | Â | Other stakeholder involvement in trial design, conduct, or analyses | |
26c | Â | Incentives offered as part of the trial |