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The recommendations are not intended to prescribe how a trial should be designed or conducted.Rather, we call for a transparent and complete description of what is intended, regardless of the characteristics or quality of the plans.The SPIRIT 2013 Statement addresses the minimum content for interventional trials; additional concepts may be important to describe in protocols for trials of specific designs (eg, crossover trials) or in protocols intended for submission to specific groups (eg, funders, research ethics committees/institutional review boards).If information for a recommended item is not yet available when the protocol is being finalised (eg, funding sources), this should be explicitly stated and the protocol updated as new information is obtained.Model examples were selected to reflect how key elements could be appropriately described in a trial protocol.Some examples illustrate a specific component of a checklist item, while others encompass all key recommendations for an item.For each checklist item, we provide a rationale and detailed description; a model example from an actual protocol; and relevant references supporting its importance.

To help improve the content and quality of protocols, an international group of stakeholders developed the SPIRIT 2013 Statement (Standard Protocol Items: Recommendations for Interventional Trials).The SPIRIT recommendations are intended as a guide for those preparing the full protocol for a clinical trial.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.Details of the scope and methods have been published elsewhere.13 14 15 Briefly, three complementary methods were specified beforehandin line with current recommendations for development of reporting guidelines16: 1) a Delphi consensus survey15; 2) two systematic reviews to identify existing protocol guidelines and empirical evidence supporting the importance of specific checklist items; and 3) two face-to-face consensus meetings to finalise the SPIRIT 2013 checklist.Furthermore, the checklist was pilot tested by graduate course students, and an implementation strategy was developed at a stakeholder meeting.

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