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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Bibliographic Details
Published in:	BMJ open Vol. 11; no. 6; p. e045105
Main Authors:	Calvert, Melanie, King, Madeleine, Mercieca-Bebber, Rebecca, Aiyegbusi, Olalekan, Kyte, Derek, Slade, Anita, Chan, An-Wen, Basch, E, Bell, Jill, Bennett, Antonia, Bhatnagar, Vishal, Blazeby, Jane, Bottomley, Andrew, Brown, Julia, Brundage, Michael, Campbell, Lisa, Cappelleri, Joseph C, Draper, Heather, Dueck, Amylou C, Ells, Carolyn, Frank, Lori, Golub, Robert M, Griebsch, Ingolf, Haywood, Kirstie, Hunn, Amanda, King-Kallimanis, Bellinda, Martin, Laura, Mitchell, Sandra, Morel, Thomas, Nelson, Linda, Norquist, Josephine, O'Connor, Daniel, Palmer, Michael, Patrick, Donald, Price, Gary, Regnault, Antoine, Retzer, Ameeta, Revicki, Dennis, Scott, Jane, Stephens, Richard, Turner, Grace, Valakas, Antonia, Velikova, Galina, von Hildebrand, Maria, Walker, Anita, Wenzel, Lari
Format:	Journal Article
Language:	English
Published:	England British Medical Journal Publishing Group 30.06.2021 BMJ Publishing Group LTD BMJ Publishing Group
Series:	Communication
Subjects:	Checklist Clinical trials Data collection education & training (see medical education & training) Humans Hypotheses Intervention Patient Reported Outcome Measures Patient-centered care protocols & guidelines Quality of Life Research Design Research Methods Research Report Shared decision making statistics & research methods protocols & guidelines clinical trials education & training (see medical education & training) statistics & research methods
ISSN:	2044-6055, 2044-6055
Online Access:	Get full text
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