Melanie Calvert, Derek Kyte, Rebecca Mercieca-Bebber, Anita Slade, An-Wen Chan, Madeleine T King, Amanda Hunn, Andrew Bottomley, Antoine Regnault, An-Wen Chan, Carolyn Ells, Daniel O'Connor, Dennis Revicki, Donald Patrick, Doug Altman, Ethan Basch, Galina Velikova, Gary Price, Heather Draper, Jane Blazeby, Jane Scott, Joanna Coast, Josephine Norquist, Julia Brown, Kirstie Haywood, Laura Lee Johnson, Lisa Campbell, Lori Frank, Maria von Hildebrand, Michael Brundage, Michael Palmer, Paul Kluetz, Richard Stephens, Robert M Golub, Sandra Mitchell, Trish Groves
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: Recommendations for Interventional Trials) statement was published in 2013 and aims to improve the completeness of trial protocols by providing evidence-based recommendations for the minimum set of items to be addressed, but it does not provide PRO-specific guidance...
February 6, 2018: JAMA