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letter
. 2022 Apr 27;23:359. doi: 10.1186/s13063-022-06316-7

Table 1.

Extensions to the SPIRIT Checklist

• SPENT 2019 – SPIRIT extension and elaboration for n-of-1 trials [4]
• SPIRIT-PRO – extension explanation and elaboration: guidelines for inclusion of patient-reported outcomes in protocols of clinical trials [5]
• SPIRIT-AI – guidelines for clinical trial protocols for interventions involving artificial intelligence [6]
• SPIRIT-TCM – Standard Protocol Items for Clinical Trials with Traditional Chinese Medicine 2018: recommendations, explanation, and elaboration [7]
• SPIRIT-Path – guidelines for cellular and molecular pathology content in clinical trial protocols [8]
• SPIRIT-ROUTINE – a study protocol for the development of a SPIRIT extension for trials conducted using cohorts and routinely collected data (under development) [9]