Reporting guideline defining standard protocol items for clinical trials. The evidence-based SPIRIT recommendations were developed using systematic, transparent methodology and broad consultation with 115 experts representing diverse stakeholders involved in the design, funding, conduct, review, and publication of trial protocols.
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Extension to the SPIRIT (standard protocol items: recommendations for interventional trials) guideline, SPENT (SPIRIT extension for n-of-1 trials), to improve the completeness and transparency of n-of-1 trial protocols.
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