Enhancing the QUAlity and Transparency Of health Research
Published on 8 January 2013 in both the BMJ and Annals of Internal Medicine, the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013 Statement provides guidance regarding the minimum content that should be included in a clinical trial protocol. A 33-item checklist and diagram are provided with the aim of helping to ensure that published trial protocols are of a high quality.
An explanatory paper (SPIRIT 2013 Explanation and Elaboration: Guidance for Protocols of Clinical Trials) has also been published discussing the rationale and supporting evidence for each checklist item and providing examples from actual protocols.
Chan A-W, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jerić K, Hróbjartsson A, Mann H, Dickersin K, Berlin J, Doré C, Parulekar W, Summerskill W, Groves T, Schulz K, Sox H, Rockhold FW, Rennie D, Moher D. SPIRIT 2013 Statement: Defining standard protocol items for clinical trials. Ann Intern Med 2013; Online first version. http://annals.org/article.aspx?articleid=1556168
Chan A-W, Tetzlaff JM, Gøtzsche PC, Altman DG, Mann H, Berlin J, Dickersin K, Hróbjartsson A, Schulz KF, Parulekar WR, Krleža-Jerić K, Laupacis A, Moher D. SPIRIT 2013 Explanation and Elaboration: Guidance for protocols of clinical trials. BMJ 2013;346:e7586.
A comment about SPIRIT 2013 has also been published in the Lancet: http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2812%2962160-6/fulltext?rss=yes
The SPIRIT website is available at: http://www.spirit-statement.org/
Melissa Sharp, a second-year doctoral research student in the Methods in Research on Research (MIROR) program, recently spent 3 months with the UK EQUATOR Centre. MIROR doctoral fellows earn joint doctorates from two EU universities and spend time at partner...