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Table 2 Noteworthy changes to CONSORT 2010 items in the CONSORT-SPI 2018 checklist

From: Reporting randomised trials of social and psychological interventions: the CONSORT-SPI 2018 Extension

• 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.