SPIRIT PRO Extension for inclusion of patient-reported outcomes in clinical trials protocols

The SPIRIT PRO Extension provides patient reported outcome–specific guidance to complement the SPIRIT 2013 guideline (Standard Protocol Items: Recommendations for Interventional Trials) for clinical trial protocols. Patient Reported Outcomes (PROs) are reports coming directly from patients about their health status, symptoms or quality of life, without interpretation by clinicians or others, usually collected using validated questionnaires or scales. The SPIRIT-PRO Extension aims to improve the completeness and quality of PRO related content in protocols, reduce research waste and enhance the value of PRO data for patient centered care.