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He declares personal fees from Gilead Sciences Ltd, Merck and GSK outside the submitted work. S.C.R. receives funding from UK SPINE, Merck and declares personal fees from Merck. M.J.C. is Director of the Birmingham Health Partners Centre for Regulatory Science and Innovation, Director of the Centre for the Centre for Patient-Reported Outcomes Research and is an NIHR Senior Investigator. M.J.C. receives funding from the NIHR, UKRI, NIHR Birmingham BRC, the NIHR Surgical Reconstruction and Microbiology Research Centre, NIHR ARC West Midlands, UK SPINE, European Regional Development Fund \u2013 Demand Hub and Health Data Research UK at the University of Birmingham and University Hospitals Birmingham NHS Foundation Trust, Innovate UK (part of UKRI), Macmillan Cancer Support, UCB Pharma, Janssen, GSK and Gilead. M.C. has received personal fees from Astellas, Aparito, CIS Oncology, Takeda, Merck, Daiichi Sankyo, Glaukos, GSK, Pfizer, the Patient-Centered Outcomes Research Institute (PCORI) and Vertex outside the submitted work. In addition, a family member owns shares in GSK. J.R., through her institution, has received consultancy fees from the University of Birmingham Enterprise. Through her institution, she is supported by an unrelated Select Foundation Fellowship and has received unrelated research funding from Pfizer, the EuroQol Foundation, PCORI, the Royal Hobart Hospital Research Foundation and the US FDA. In addition, she is Chair of the ISPOR Patient-Centered Special Interest Group and the ISOQOL Australia and New Zealand Special Interest Group and Associate Editor for the Journal of Patient-Reported Outcomes. N.A. receives funding from NIHR ARC West Midlands. S.E.H. receives funding from the NIHR, NIHR BTRU in Precision Transplant and Cellular Therapeutics, NIHR Birmingham BRC, NIHR (ARC) West Midlands, UKRI and UK SPINE. She declares personal fees from Cochlear, Pfizer, Rinri Therapeutics, AstraZeneca, Aparito and CIS Oncology outside the submitted work. J.D.P. has received unrelated research funding from the National Cancer Institute, the National Institutes of Health, the Food and Drug Administration, the ECOG-ACRIN Medical Research Foundation, the Peter G. Peterson Foundation, Veloxis Pharmaceuticals, Pfizer and the Northwestern University George M. O\u2019Brien Kidney Core Center. He has received unrelated personal fees from AstraZeneca, IMPAQ International and FACIT.org. In addition, he is part of the ISOQOL, Psychometric Special Interest Group Chair. F.E. received personal fees from AbbVie, Incyte, Syros and Novartis, outside the submitted work. C.M. receives funding from NIHR Surgical Reconstruction and Microbiology Research Centre, UKRI, NIHR, NIHR BTRU in Precision Transplant and Cellular Therapeutics and declares personal fees from Aparito outside the submitted work. E.H.D. owns an ePRO software platform called Atom5 through Aparito. A.B. is the founder of Bottomley Consulting Group. He has received fees, payments from Sevier, Pfizer, Ferring, Bayer, GSK, Merck, BMS, EMD Serano, Mirati, Boehringer Ingelheim, Vertex, FWA, European Commission and MD Anderson and is a Board member of the PROTEUS consortium and receives bursary from John Hopkins University. He is a member of ISOQOL and ISPOR. B.K.K. received unrelated research funding from grants from AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Jazz Pharma, Genentech, Eli Lilly, Janssen, Takeda, Dachii Sankyo, Blueprint Medicines, Janssen, Amgen and Seagen. She also served as a paid consultant to Eli Lilly, AbbVie, Bristol Myers Squibb, Gilead outside of the submitted work. A.M. is partner of QC Medica, a health economics and outcomes research consultancy company. C.S. receives research funding from Pfizer (current) and Genentech (previous) through her institution and personal fees from Janssen (previous) and Shionogi (current). A.M.S. receives unrelated research funding through her institution from the National Institutes of Health, PCORI, AHRQ, Pfizer, UroGen Pharma and the American Society of Clinical Oncology. She has received past funding from Sivan Innovation, Bladder Cancer Advocacy Network, Hematology\/Oncology Pharmacy Association and the Cancer and Aging Research Group. She also served as a paid consultant to Navigating Cancer (personal fees). M.B. receives research funding from Pfizer through another institution. A.D. is Deputy Director of the Birmingham Health Partners Centre for Regulatory Science and Innovation and is an NIHR Senior Investigator. He receives funding from the NIHR, UKRI and NIHR Birmingham BRC. No other disclosures are reported. J.M. is chief editor at <i>Nature Medicine<\/i> and has not taken part in the peer review and editorial process of this consensus statement. This work was funded by Merck Healthcare and along with the study sponsor, the University of Birmingham, had no role in the design and conduct of the study; collection, management, analysis and interpretation of the data; preparation, review or approval of the manuscript; or decision to submit the manuscript for publication. Several authors are employees of this organization; however, beyond the declared author contributions, the sponsor had no additional role. The views expressed in this article are those of the authors and not necessarily those of the NIHR, US FDA, Medicines and Healthcare products Regulatory Agency, European Medicines Agency and Health Canada.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}},{"value":"This content has been made available to all.","name":"free","label":"Free to read"}]}}