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

Calvert, Melanie; King, Madeleine; Mercieca‐Bebber, Rebecca; Lee Aiyegbusi, Olalekan; Kyte, Derek; Slade, Anita; Chan, An‐Wen; Basch, Ethan; A. Bell, Jill; V. Bennett, Antonia; Bhatnagar, Vishal; Blazeby, Jane; Bottomley, Andrew; Brown, Julia; Brundage, Michael; Campbell, Lisa; C. Cappelleri, Joseph; Draper, Heather; C. Dueck, Amylou; Ells, Carolyn; Frank, Lori; Golub, Robert; Griebsch, Ingolf; Haywood, Kirstie; Hunn, Amanda; L. King‐Kallimanis, Bellinda; Díaz‐Martín, Laura; A. Mitchell, Sandra; Morel, Thomas; Nelson, Linda; M. Norquist, Josephine; O’Connor, Daniel; Palmer, Michael; L. Patrick, Donald; Price, Gary; Regnault, Antoine; Retzer, Ameeta; A. Revicki, Dennis; Scott, Jane; Stephens, Richard; Turner, Grace; Valakas, Antonia; Velikova, Galina; Hildebrand, Maria; Walker, Anita; Wenzel, Lari

doi:10.1136/bmjopen-2020-045105

Public

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

Published in BMJ Open • Jun 1, 2021

Authors:

Melanie Calvert

Madeleine King

Rebecca Mercieca‐Bebber

Abstract

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...

Subject

Protocol (science)

Medicine

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