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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

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

 

 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 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

 

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, 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

  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