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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If you are interested in developing a new SPIRIT or CONSORT extension please review our extension policy. You can register your interest by completing this short registration form .

The following extensions have been published based on the SPIRIT 2013 and CONSORT 2010 checklists:

Extensions to SPIRIT 2013

Design

• Early-phase dose-finding trials: Checklist (Word) / Statement

• Factorial trials: Statement

• N-of-1 trials: Checklist (Word) / Explanation and elaboration

Data

• Outcomes: Statement

• Pathology: Statement

• Patient-reported outcomes: Statement

• Surrogate outcomes: Statement

Interventions

• Artificial intelligence: Checklist (Word) / Statement

Extensions to CONSORT 2010

Design

• Adaptive designs: Abstract checklist (Word) / Main checklist (Word) / Statement

• Cluster trials: Checklist (Word) / Statement

• Cluster crossover trials: Statement

• Crossover trials: Statement

• Early-phase dose-finding trials: Checklist (Word) / Statement

• Factorial trials: Statement

• Multi-arm trials: Statement

• Non-inferiority/equivalence trials: Checklist (Word) / Statement

• N-of-1 trials: Checklist (Word) / Statement / Explanation and elaboration

• Pilot and feasibility trials: Abstract checklist (Word) / Main checklist (Word) / Flow diagram (Word) / Statement

• Pragmatic trials: Checklist (Word) / Statement

• Stepped-wedge cluster trials: Checklist (.pdf) / Statement

• Trials using cohort/routine data: Checklist (.pdf) / Statement

• Within-person trials: Checklist (Word) / Flow diagram (Word) / Statement

Data

• Abstracts: Checklist (Word) / Statement / Explanation and elaboration

• Equity: Checklist (Word) / Flow diagram (Word) / Statement

• Harms: Statement

• Outcomes: Statement

• Patient-reported outcomes: Statement

• Surrogate outcomes: Statement

Interventions

• Non-pharmacological interventions: Abstract checklist (Word) / Main checklist (Word) / Flow diagram (Word) / Statement / Explanation and elaboration

• Social and psychological interventions: Statement