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8 January 2013 Annals of Internal Medicine Tip Sheet

Below is information about an article being published in the January 8 issue of Annals of Internal Medicine. The information is not intended to substitute for the full article as a source of information. Annals of Internal Medicine attribution is required for all coverage. For an embargoed copy of a study, contact Megan Hanks at or 215-351-2656 or Angela Collom at or 215-351-2653.

1. New Guidelines Aim to Improve the Completeness of Trial Protocols

A panel of experts has released a new 33-item protocol checklist focusing on clarifying the content of clinical trials. The goal of the Standard Protocol Items: Recommendations for Interventional Trials, or SPIRIT, guideline is to dictate the minimum content of a clinical trial protocol, helping to make protocols more homogeneous and transparent. Ultimately, standardized requirements for trial protocols should support the development of evidence-based guidelines. While the protocol of a clinical trial serves as the foundation for study planning, conduct, reporting, and appraisal, trial protocols and existing protocol guidelines vary greatly in content and quality. Adherence to SPIRIT would enhance the transparency and completeness of trial protocols and could help ensure that protocols contain the requisite information for critical appraisal and interpretation. High-quality protocols can provide important information about trial methods and conduct that is not available from journals or trial registries. As a transparent record of the researchersí original intent, comparisons of protocols with final trial reports can help to identify selective reporting of results and undisclosed amendments, such as changes to primary outcomes. According to the authors, pilot-testing and informal feedback of the SPIRIT guideline has shown that it is particularly valuable for trial investigators when they draft their protocols and can also serve as a training tool for new investigators, peer reviewers, and research ethics committee members or institutional review board members. There is also potential benefit for trial implementation.

Note: For an embargoed PDF, contact Megan Hanks or Angela Collom. To speak with the lead author, please contact Heather Gibson at 416-351-3732 ext 3824 or