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The main outputs are the SPIRIT 2013 Statement,14 consisting of a 33 item checklist of minimum recommended protocol items (table 1The SPIRIT 2013 Statement and E&E paper reflect the collaboration and input of 115 contributors, including trial investigators, healthcare professionals, methodologists, statisticians, trial coordinators, journal editors, as well as representatives from research ethics committees, industry and non-industry funders, and regulatory agencies.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.A summary of the relevant methodological articles was provided to each E&E author for use in preparing the initial draft text for up to six checklist items; each draft was also reviewed and revised by a second author.When citing empirical evidence in the E&E, we aimed to reference a systematic review when available.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.
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).Furthermore, the checklist was pilot tested by graduate course students, and an implementation strategy was developed at a stakeholder meeting.The SPIRIT recommendations are intended as a guide for those preparing the full protocol for a clinical trial.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.
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When no review was identified, we either cited all relevant individual studies, or if too numerous, a representative sample of the literature.