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O.L.A. declares personal fees from Gilead Sciences, Merck and GSK outside the submitted work. S.C.R. receives funding from UK SPINE and 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 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, LifeArc, UK SPINE, European Regional Development Fund\u2014Demand 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 and Vertex outside the submitted work. In addition, a family member owns shares in GSK. N.A. is an NIHR Senior Research Leader and receives funding from the NIHR, NIHR ARC West Midlands and NIHR Birmingham BRC. 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. S.E.H. declares personal fees from Cochlear, Pfizer, Rinri Therapeutics, Astra Zeneca, Aparito and CIS Oncology outside the submitted work. K.K. has acted as a consultant, speaker or received grants for investigator-initiated studies for Astra Zeneca, Bayer, Novo Nordisk, Sanofi-Aventis, Servier, Lilly and Merck Sharp & Dohme, Boehringer Ingelheim, Oramed Pharmaceuticals, Pfizer, Roche, Daiichi Sankyo, Applied Therapeutics, Embecta and Nestle Health Science. K.K. is supported by the NIHR Applied Research Collaboration East Midlands (ARC EM), the NIHR Leicester BRC and the British Heart Foundation (BHF) Centre of Excellence. D.K. reports grants from the NIHR (CDF-2015-08-074 RATE-AF, NIHR130280 DaRe2THINK, NIHR132974 D2T-NeuroVascular, NIHR203326 Biomedical Research Centre), the BHF (PG\/17\/55\/33087, AA\/18\/2\/34218 and FS\/CDRF\/21\/21032), the EU\/EFPIA Innovative Medicines Initiative (BigData@Heart 116074), EU Horizon and UKRI (HYPERMARKER 101095480), UK National Health Service\u2014Data for R&D-Subnational Secure Data Environment programme, UK Department for Business, Energy & Industrial Strategy Regulators Pioneer Fund, the Cook & Wolstenholme Charitable Trust and the European Society of Cardiology supported by educational grants from Boehringer Ingelheim\/BMS-Pfizer Alliance\/Bayer\/Daiichi Sankyo\/Boston Scientific, the NIHR\/University of Oxford Biomedical Research Centre and BHF\/University of Birmingham Accelerator Award (STEEER-AF); in addition, D.K. has received research grants and advisory board fees from Bayer, Amomed and Protherics Medicines Development; all are 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. A.D. is deputy director of the Birmingham Health Partners Centre for Regulatory Science and Innovation and is an NIHR Senior Investigator. A.D. receives funding from the NIHR, UKRI and NIHR Birmingham BRC. J.M. is chief editor at <i>Nature Medicine<\/i> and has excused himself from the peer review and editorial process of this article. P.M. is director of the Clinical Practice Research Datalink, a UK government real-world data research service that also provides clinical trial recruitment services. R.H. receives funding from the Leverhulme Trust.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}]}}