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To meet the needs of these diverse stakeholders, protocols should adequately address key trial elements.
However, protocols often lack information on important concepts relating to study design and dissemination plans.2 3 4 5 6 7 8 9 10 11 12 Guidelines for writing protocols can help improve their completeness, but existing guidelines vary extensively in their content and have limitations, including non-systematic methods of development, limited stakeholder involvement, and lack of citation of empirical evidence to support their recommendations.13 As a result, there is also variation in the precise definition and scope of a trial protocol, particularly in terms of its relation to other documents such as procedure manuals.14Given the importance of trial protocols, an international group of stakeholders launched the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) Initiative in 2007 with the primary aim of improving the content of trial protocols.
We searched MEDLINE, the Cochrane Methodology Register, and the Cochrane Database of Systematic Reviews (limited to reviews) up to September 2009, and EMBASE up to August 2007.
We searched reference lists, Pub Med “related articles,” and citation searches using SCOPUS to identify additional relevant studies.
This SPIRIT 2013 Explanation and Elaboration paper provides important information to promote full understanding of the checklist recommendations.
For each checklist item, we provide a rationale and detailed description; a model example from an actual protocol; and relevant references supporting its importance.
Proper names of trial personnel have been abbreviated with italicised initials, and any reference numbers cited in the original quoted text are denoted by  to distinguish them from references cited in this E&E paper.
Additional examples are also available on the SPIRIT website (A clinical trial is a prospective study in which one or more interventions are assigned to human participants in order to assess the effects on health related outcomes.