This resource, in support of “Developing Protocols (Trials),” aims to promote implementation and use of the SPIRIT- PRO Extension for trials where PROs are a primary or key secondary outcome. The template is also recommended for use where PROs are…
The “Developing Protocols (Trials): Handbook Chapter” is an excerpt of the PROTEUS-Trials Handbook that describes the SPIRIT-PRO guidance for addressing the minimum elements related to PROs that should be included in clinical trial protocols. View the entire Handbook here (US version) or here (UK…
This powerpoint, a resource supporting “Developing Protocols (Trials),” recommends items to include in clinical trial protocols where PROs are primary or key secondary outcomes to ensure that critical aspects of the PRO study are addressed. Presented by: Melanie Calvert, PhD;…
This article, in support of “Developing Protocols (Trials),” aims to improve the completeness of trial protocols by providing recommendations for the PRO-specific information that should be addressed.” Citation Information Calvert M, Kyte D, Mercieca-Bebber R, et al. Guidelines for Inclusion…
This video, in support of “Developing Protocols (Trials),” provides researchers and clinicians with an in-depth discussion of writing protocols with PRO endpoints. Presented by: Melanie Calvert, PhD; Madeline King, PhD
This video, in support of “Developing Protocols (Trials),” provides researchers and clinicians with an overview of recommendations for writing protocols with PRO endpoints. Presented by: Melanie Calvert, PhD; Madeleine King, PhD
This checklist, in support of “Developing Protocols (Trials),” provides step-by-step instructions for developing and implementing SPIRIT-PRO best practices.
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