SPIRIT 2013 statement: defining standard protocol items for clinical trials.

By A. Chan, J. Tetzlaff, Douglas G. Altman, A. Laupacis, P. Gøtzsche, K. Krleza-Jeric, A. Hrõbjartsson, H. Mann, K. Dickersin, Jesse Berlin and 9 more. Annals of Internal Medicine, 2013

6,010 citations recorded by the source corpus.

How researchers see this paper

The researchers whose trusted networks rank it highest, strongest advocate first. Every researcher gets a different order.

Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015 statement (2015, methodology): “The definition provided is a culmination of the terminology used by the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2013 initiative [24], the PROSPERO register, and the IOM Standards (Table 2).”
Guidelines for Inclusion of Patient-Reported Outcomes in Clinical Trial Protocols: The SPIRIT-PRO Extension (2018, methodology): “Survey participants were asked to rate the importance of including each of the 56 candidate items in the final SPIRIT-PRO Extension using a 9-point scale ranging from not important (1-3) to important but not critical (4-6) and critical (7-9).”
CONSORT 2025 statement: updated guideline for reporting randomised trials (2025, neutral): “…and transparent reporting of trial protocols led to the development of the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) statement, published in 2013, 11 and its accompanying explanation and elaboration document 12 explaining the principles underlying the statement.”