SPIRIT Extension for N-of-1 Trials
(SPENT 2019)

​Overview

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The SPIRIT Extension for N-of-1 Trials (SPENT) 2019 provides evidence-based recommendations for reporting protocols of N-of-1 trials. Developed through an international consensus process, SPENT extends the SPIRIT 2013 Statement by addressing protocol items that are unique to N-of-1 trial designs, improving the transparency, quality and reproducibility of planned studies.​

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What is it for?​

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SPENT provides a structured framework for developing comprehensive N-of-1 trial protocols. It helps researchers clearly describe study objectives, design, interventions, outcomes, randomisation, blinding, statistical methods and other methodological features before a trial begins.​

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Who should use it?​

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Researchers, clinicians, trial methodologists, students, ethics committees, funding bodies, journal editors and peer reviewers involved in the planning, design and evaluation of N-of-1 trials.​

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Key resources​

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The SPENT guideline includes a 14-item extension to the SPIRIT 2013 Statement together with detailed explanations and examples for each reporting item within the guideline.​

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