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Table 1 The CONSORT-SPI 2018 checklist

From: CONSORT-SPI 2018 Explanation and Elaboration: guidance for reporting social and psychological intervention trials

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
 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
 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  
 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  
 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  
 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  
 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, 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)  
 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
  1. 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
  2. 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 of each item
  3. §An extension item for cluster trials exists for this CONSORT 2010 item