

Extensions of the SPIRIT and CONSORT Statements
The main SPIRIT and CONSORT Statements are based on the "standard" two-group parallel design. However, there are many variations to the standard trial methodology, including different design aspects (e.g., cluster), interventions (e.g., non-pharmacological) and data (e.g., harms).
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To help improve the reporting of these trials the main SPIRIT and CONSORT Statements have been extended and modified for application in these various areas. The resulting SPIRIT and CONSORT extensions are presented in this section. This list is by no means exhaustive.
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Please note that modifications to the SPIRIT or CONSORT checklists, figure or flow diagram that are not developed with the involvement of the SPIRIT–CONSORT Group do not have permission to name their work “SPIRIT” or "CONSORT".
The following extensions have been published based on the SPIRIT 2013 and CONSORT 2010 checklists:
Extensions to SPIRIT 2013
Design
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Early-phase dose-finding trials: Checklist (Word) / Statement
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Factorial trials: Statement
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N-of-1 trials: Checklist (Word) / Explanation and elaboration
Data
Interventions
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Artificial intelligence: Checklist (Word) / Statement
Extensions to CONSORT 2010
Design
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Adaptive designs: Abstract checklist (Word) / Main checklist (Word) / Statement
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Cluster trials: Checklist (Word) / Statement
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Crossover trials: Statement
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Early-phase dose-finding trials: Checklist (Word) / Statement
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Factorial trials: Statement
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Multi-arm trials: Statement
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Non-inferiority/equivalence trials: Checklist (Word) / Statement
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N-of-1 trials: Checklist (Word) / Statement / Explanation and elaboration
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Pilot and feasibility trials: Abstract checklist (Word) / Main checklist (Word) / Flow diagram (Word) / Statement
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Pragmatic trials: Checklist (Word) / Statement
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Stepped-wedge cluster trials: Checklist (.pdf) / Statement
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Trials using cohort/routine data: Checklist (.pdf) / Statement
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Within-person trials: Checklist (Word) / Flow diagram (Word) / Statement
Data
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Abstracts: Checklist (Word) / Statement / Explanation and elaboration
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Equity: Checklist (Word) / Flow diagram (Word) / Statement
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Harms: Statement
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Outcomes: Statement
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Patient-reported outcomes: Statement
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Surrogate outcomes: Statement
Interventions
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Non-pharmacological interventions: Abstract checklist (Word) / Main checklist (Word) / Flow diagram (Word) / Statement / Explanation and elaboration