Guidelines for Inclusion of Patient-Reported Outcomes in Clinical Trial Protocols

Calvert, Melanie; Kyte, Derek; Mercieca‐Bebber, Rebecca; Slade, Anita; Chan, An‐Wen; King, Madeleine; the SPIRIT-PRO Group, and; Hunn, Amanda; Bottomley, Andrew; Regnault, Antoine; Chan, An‐Wen; Ells, Carolyn; O’Connor, Daniel; A. Revicki, Dennis; L. Patrick, Donald; Altman, Doug; Basch, Ethan; Velikova, Galina; Price, Gary; Draper, Heather; Blazeby, Jane; Scott, Jane; Coast, Joanna; M. Norquist, Josephine; Brown, Julia; Haywood, Kirstie; Lee Johnson, Laura; Campbell, Lisa; Frank, Lori; Hildebrand, Maria; Brundage, Michael; Palmer, Michael; G. Kluetz, Paul; Stephens, Richard; Golub, Robert; A. Mitchell, Sandra; Groves, Trish

doi:10.1001/jama.2017.21903

Public

Guidelines for Inclusion of Patient-Reported Outcomes in Clinical Trial Protocols

Published in JAMA • Feb 6, 2018

Authors:

Melanie Calvert

Derek Kyte

Rebecca Mercieca‐Bebber

Abstract

Importance: Patient-reported outcome (PRO) data from clinical trials can provide valuable evidence to inform shared decision making, labeling claims, clinical guidelines, and health policy; however, the PRO content of clinical trial protocols is often suboptimal. The SPIRIT (Standard Protocol Items:...

Subject

Medicine

Inclusion (mineral)

Clinical trial

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