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

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

*Corresponding author for this work

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Medicine & Life Sciences