SPIRIT 2013 Statement: Defining Standard Protocol Items for Clinical Trials
Women's College Hospital · Johns Hopkins University · +15 more institutions
Abstract
The protocol of a clinical trial serves as the foundation for study planning, conduct, reporting, and appraisal. However, trial protocols and existing protocol guidelines vary greatly in content and quality. This article describes the systematic development and scope of SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013, a guideline for the minimum content of a clinical trial protocol.The 33-item SPIRIT checklist applies to protocols for all clinical trials and focuses on content rather than format. The checklist recommends a full description of what is planned; it does not prescribe how to design or conduct a trial. By providing guidance for key content, the SPIRIT…
Citation impact
- FWCI
- 145.45
- Percentile
- 100%
- References
- 47
Authors
19- ACAn‐Wen ChanCorresponding
Women's College Hospital, Johns Hopkins University
- JTJennifer Tetzlaff
University of Ottawa, Johns Hopkins University, Women's College Hospital
- DGDouglas G. Altman
Women's College Hospital, Johns Hopkins University, University of Oxford
- ALAndreas Laupacis
Centre of Biomedical Research, Johns Hopkins University, Women's College Hospital
- PCPeter C Gøtzsche
Women's College Hospital, Johns Hopkins University, University of Copenhagen
Topics & keywords
- Medicine
- Protocol (science)
- Statement (logic)
- Clinical trial
- Medical physics
- Alternative medicine
- Internal medicine
- Pathology