Table 1.
The CONSORT-SPI 2018 checklist
| 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 | ||
This table lists items from the CONSORT 2010 checklist (with some modifications for social and psychological intervention trials as described in Table 2) and additional items in the CONSORT-SPI 2018 extension. Empty rows in the ‘CONSORT-SPI 2018’ column indicate that there is no extension to the CONSORT 2010 item
*We strongly recommended that the CONSORT-SPI 2018 Explanation and Elaboration (E&E) document be reviewed when using the CONSORT-SPI 2018 checklist for important clarifications on each item
§An extension item for cluster trials exists for this CONSORT 2010 item