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Developing Protocols [Spirit-Pro]

Patient-reported outcome (PRO) data from clinical trials can provide valuable evidence to inform shared decision making, labeling claims, clinical guidelines, and health policy.

The paper Guidelines for Inclusion of Patient-Reported Outcomes in Clinical Trial Protocols: The SPIRIT-PRO Extension recommends best practices for writing the PRO aspects of randomized controlled trial protocols by specifying the items that are critical to address when PROs are primary or key secondary outcomes.

The SPIRIT-PRO Extension builds on the general 2013 SPIRIT clinical trial protocols guidance by addressing the minimum elements related to PROs that should be included.


Using SPIRIT-PRO guidance provides benefits to stakeholders by:

Helping protocol writers improve PRO trial design by encouraging and facilitating careful planning of PRO components.
Helping protocol reviewers, research ethics committees, and patient partners assess PRO elements.
Helping trial staff and patient participants understand the rationale for PRO assessment and improve PRO data completeness and quality.
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