Melanie Calvert|Madeleine King|Rebecca Mercieca?Bebber|Olalekan Lee Aiyegbusi|Derek Kyte|Anita Slade|An Wen Chan|Ethan Basch|Jill A. Bell|Antonia V. Bennett|Vishal Bhatnagar|Jane Blazeby|Andrew Bottomley|Julia Brown|Michael Brundage|Lisa Campbell|Joseph C. Cappelleri|Heather Draper|Amylou C. Dueck|Carolyn Ells|Lori Frank|Robert Golub|Ingolf Griebsch|Kirstie Haywood|Amanda Hunn|Bellinda King?Kallimanis|Laura Díaz Martín|Sandra A. Mitchell|Thomas Morel|Linda P. Nelson|Josephine M. Norquist|Daniel O’Connor|Michael J. Palmer|Donald L. Patrick|Gary Price|Antoine Regnault|Ameeta Retzer|Dennis A. Revicki|Jane Scott|Richard Stephens|Grace Turner|Antonia Valakas|Galina Velikova|Maria Hildebrand|Anita Walker|Lari Wenzel
SPIRIT-PRO Extension explanation and elaboration: guidelines for inclusion of patient-reported outcomes in protocols of clinical trials
University of Birmingham|NIHR Birmingham Biomedical Research Centre|NIHR Surgical Reconstruction and Microbiology Research Centre|NIHR Clinical Research Network|University of Sydney|University of Sydney|National Health and Medical Research Council|University of Birmingham|NIHR Birmingham Biomedical Research Centre|University of Birmingham|University of Birmingham|NIHR Surgical Reconstruction and Microbiology Research Centre|Women's College Hospital|University of Toronto|University of North Carolina at Chapel Hill|AstraZeneca (United States)|University of North Carolina at Chapel Hill|United States Food and Drug Administration|NIHR Bristol Biomedical Research Centre|University of Bristol|University Hospitals Bristol NHS Foundation Trust|European Organisation for Research and Treatment of Cancer|University of Leeds|Queen's University|Pfizer (United States)|University of Warwick|Mayo Clinic in Arizona|McGill University|Patient-Centered Outcomes Research Institute|Boehringer Ingelheim (Germany)|University of Warwick|United States Food and Drug Administration|Daiichi Sankyo (Germany)|National Cancer Institute|UCB Pharma (Belgium)|Patient-Centered Outcomes Research Institute|MSD (United States)|Queen's University|University of Washington|University of Birmingham|Pathophysiology, Diagnosis and Treatment of Bone Diseases|University of Birmingham|Health Outcomes Solutions (United States)|Johnson & Johnson (United Kingdom)|Janssen (United Kingdom)|National Cancer Research Institute|University of Birmingham|NIHR Surgical Reconstruction and Microbiology Research Centre|Merck (Germany)|St James's University Hospital|University of Leeds|University of Birmingham|University of Birmingham|University of California, Irvine
patientreported outcomes pros used clinical trials provide valuable evidence impact disease treatment patients symptoms function quality life highquality pro data trials inform shared decisionmaking regulatory economic analyses health policy recent evidence suggests pro content past trial protocols often incomplete unclear leading research waste address issue international consensusbased prospecific guidelines developed standard protocol items recommendations interventional trials spiritpro extension spiritpro extension 16item checklist aims improve content quality aspects clinical trial protocols relating pro data collection minimise research waste ultimately better inform patientcentred care spiritpro explanation elaboration ee paper provides information promote understanding facilitate uptake recommended checklist items including comprehensive protocol template spiritpro item provide detailed description one examples existing trial protocols supporting empirical evidence items importance recommend paper protocol template used alongside spirit 2013 spiritpro extension paper optimise transparent development review trial protocols pros