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Reporting Guidance for Trial Protocols

Given deficiencies in the quality of trial protocols, the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) Statement was developed to provide an evidence-based set of items to address in protocols of clinical trials on biomedical interventions. However, such reporting guidance does not exist for trial protocols on social science interventions. Tailored guidance for these trial protocols is needed due to the complexity of social science interventions and trial designs, such as covariates to consider for analysis. Such guidance could improve research and publishing norms on a large scale.
In this project, Sean Grant proposed to introduce items in the SPIRIT Statement to a social science audience, explaining their application to protocols of social intervention trials. A modified online Delphi process is used to prioritize protocol checklist items and provide insight regarding future implementation of guidelines across disciplines.

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