SPIRIT-PRO Extension explanation and elaboration: guidelines for inclusion of patient-reported outcomes in protocols of clinical trials

SPIRIT-PRO Extension explanation and elaboration: guidelines for inclusion of patient-reported outcomes in protocols of clinical trials

Patient-reported outcomes (PROs) are used in clinical trials to provide valuable evidence on the impact of disease and treatment on patients’ symptoms, function and quality of life. High-quality PRO data from trials can inform shared decision-making, regulatory and economic analyses and health polic...

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Main Authors: Kirstie Haywood, Ameeta Retzer, Anita Slade, Melanie Calvert, Jane Blazeby, Rebecca Mercieca-Bebber, Antonia Bennett, Carolyn Ells, Gary Price, Galina Velikova, Heather Draper, Dennis Revicki, Julia Brown, Lori Frank, Madeleine King, Jane Scott, Sandra Mitchell, Grace Turner, Michael Brundage, Andrew Bottomley, Michael Palmer, Richard Stephens, Ingolf Griebsch, Donald Patrick, Lari Wenzel, Daniel O'Connor, Robert M Golub, Olalekan Aiyegbusi, E Basch, Jill Bell, Vishal Bhatnagar, Lisa Campbell, Amylou C Dueck, Amanda Hunn, Bellinda King-Kallimanis, Thomas Morel, Linda Nelson, Josephine Norquist, Antoine Regnault, Antonia Valakas, Maria von Hildebrand, Anita Walker
Format: Article
Language:English
Published: BMJ Publishing Group 2021-06-01
Series:BMJ Open
Online Access:https://bmjopen.bmj.com/content/11/6/e045105.full

Internet

https://bmjopen.bmj.com/content/11/6/e045105.full

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