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Using healthcare systems data for outcomes in clinical trials: issues to consider at the design stage.

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Title: Using healthcare systems data for outcomes in clinical trials: issues to consider at the design stage.
Authors: Toader AM; MRC-NIHR Trials Methodology Research Partnership, Department of Health Data Science, University of Liverpool, Liverpool, UK. Sgatoade@liverpool.ac.uk., Campbell MK; Health Services Research Unit, University of Aberdeen, Aberdeen, AB25 2ZD, UK., Quint JK; School of Public Health &, National Heart and Lung Institute, Imperial College London, London, UK., Robling M; Centre for Trials Research, Cardiff University, Cardiff, CF14 4YS, UK., Sydes MR; MRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, UCL, London, UK.; BHF Data Science Centre, Health Data Research UK, London, UK., Thorn J; Health Economics Bristol, Population Health Sciences, University of Bristol, Bristol, UK., Wright-Hughes A; Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research,, University of Leeds, Leeds, LS2 9JT, UK., Yu LM; Oxford Primary Care CTU, Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK., Abbott TEF; William Harvey Research Institute, Queen Mary University of London, London, EC1M 6BQ, UK., Bond S; Cambridge Clinical Trials Unit, Cambridge, UK., Caskey FJ; BHF Data Science Centre, Health Data Research UK, London, UK., Clout M; Bristol Trials Centre, Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, BS8 2PS, UK., Collinson M; Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research,, University of Leeds, Leeds, LS2 9JT, UK., Copsey B; Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research,, University of Leeds, Leeds, LS2 9JT, UK., Davies G; UCL Great Ormond Street Institute of Child Health, London, WC1N 1EH, UK., Driscoll T; Swansea Trials Unit, Swansea University, Swansea, SA2 8PP, UK., Gamble C; Liverpool Clinical Trials Centre, University of Liverpool, Liverpool, UK., Griffin XL; Barts Bone and Joint Health, Blizard Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK., Hamborg T; Pragmatic Clinical Trials Unit, Wolfson Institute of Population Health, Queen Mary University of London, London, E1 2AB, UK., Harris J; Bristol Trials Centre, Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, BS8 2PS, UK., Harrison DA; Intensive Care National Audit & Research Centre, London, UK., Harji D; Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research,, University of Leeds, Leeds, LS2 9JT, UK.; Manchester University NHS Foundation Trust, Manchester, UK., Henderson EJ; Ageing and Movement Research Group, Bristol Medical School, University of Bristol, Bristol, UK.; Older People's Unit, Royal United Hospitals NHS Foundation Trust, Bath, UK., Logan P; School of Medicine, University of Nottingham and Nottingham City Care Partnership, Nottingham, UK., Love SB; MRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, UCL, London, UK., Magee LA; Department of Women and Children's Health, King's College London, London, UK., O'Brien A; Division of Medicine, UCL Institute for Liver and Digestive Health, Royal Free Campus, Upper 3Rd FloorRowland Hill Street, London, NW3 2PF, UK., Pufulete M; Bristol Medical School, University of Bristol, Bristol, BS8 2PS, UK., Ramnarayan P; Department of Surgery and Cancer, Imperial College London, London, W21PB, UK., Saratzis A; Department of Cardiovascular Sciences, University of Leicester, Leicester, UK., Smith J; Keele Clinical Trials Unit, Faculty of Medicine and Health Sciences, Keele University, Staffordshire, UK., Solis-Trapala I; Keele Clinical Trials Unit, Faculty of Medicine and Health Sciences, Keele University, Staffordshire, UK., Stubbs C; Birmingham Clinical Trials Unit (BCTU), Institute of Applied Health Research College of Medical and Dental Sciences, The University of Birmingham, Edgbaston, Birmingham, B15 2TT, UK., Farrin A; Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research,, University of Leeds, Leeds, LS2 9JT, UK., Williamson P; MRC-NIHR Trials Methodology Research Partnership, Department of Health Data Science, University of Liverpool, Liverpool, UK.
Source: Trials [Trials] 2024 Jan 29; Vol. 25 (1), pp. 94. Date of Electronic Publication: 2024 Jan 29.
Publication Type: Journal Article
Journal Info: Publisher: BioMed Central Country of Publication: England NLM ID: 101263253 Publication Model: Electronic Cited Medium: Internet ISSN: 1745-6215 (Electronic) Linking ISSN: 17456215 NLM ISO Abbreviation: Trials Subsets: MEDLINE
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Sgatoade@liverpool.ac.uk.<br /><searchLink fieldCode="AU" term="%22Campbell+MK%22">Campbell MK</searchLink>; Health Services Research Unit, University of Aberdeen, Aberdeen, AB25 2ZD, UK.<br /><searchLink fieldCode="AU" term="%22Quint+JK%22">Quint JK</searchLink>; School of Public Health &, National Heart and Lung Institute, Imperial College London, London, UK.<br /><searchLink fieldCode="AU" term="%22Robling+M%22">Robling M</searchLink>; Centre for Trials Research, Cardiff University, Cardiff, CF14 4YS, UK.<br /><searchLink fieldCode="AU" term="%22Sydes+MR%22">Sydes MR</searchLink>; MRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, UCL, London, UK.; BHF Data Science Centre, Health Data Research UK, London, UK.<br /><searchLink fieldCode="AU" term="%22Thorn+J%22">Thorn J</searchLink>; Health Economics Bristol, Population Health Sciences, University of Bristol, Bristol, UK.<br /><searchLink fieldCode="AU" term="%22Wright-Hughes+A%22">Wright-Hughes A</searchLink>; Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research,, University of Leeds, Leeds, LS2 9JT, UK.<br /><searchLink fieldCode="AU" term="%22Yu+LM%22">Yu LM</searchLink>; Oxford Primary Care CTU, Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.<br /><searchLink fieldCode="AU" term="%22Abbott+TEF%22">Abbott TEF</searchLink>; William Harvey Research Institute, Queen Mary University of London, London, EC1M 6BQ, UK.<br /><searchLink fieldCode="AU" term="%22Bond+S%22">Bond S</searchLink>; Cambridge Clinical Trials Unit, Cambridge, UK.<br /><searchLink fieldCode="AU" term="%22Caskey+FJ%22">Caskey FJ</searchLink>; BHF Data Science Centre, Health Data Research UK, London, UK.<br /><searchLink fieldCode="AU" term="%22Clout+M%22">Clout M</searchLink>; Bristol Trials Centre, Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, BS8 2PS, UK.<br /><searchLink fieldCode="AU" term="%22Collinson+M%22">Collinson M</searchLink>; Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research,, University of Leeds, Leeds, LS2 9JT, UK.<br /><searchLink fieldCode="AU" term="%22Copsey+B%22">Copsey B</searchLink>; Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research,, University of Leeds, Leeds, LS2 9JT, UK.<br /><searchLink fieldCode="AU" term="%22Davies+G%22">Davies G</searchLink>; UCL Great Ormond Street Institute of Child Health, London, WC1N 1EH, UK.<br /><searchLink fieldCode="AU" term="%22Driscoll+T%22">Driscoll T</searchLink>; Swansea Trials Unit, Swansea University, Swansea, SA2 8PP, UK.<br /><searchLink fieldCode="AU" term="%22Gamble+C%22">Gamble C</searchLink>; Liverpool Clinical Trials Centre, University of Liverpool, Liverpool, UK.<br /><searchLink fieldCode="AU" term="%22Griffin+XL%22">Griffin XL</searchLink>; Barts Bone and Joint Health, Blizard Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.<br /><searchLink fieldCode="AU" term="%22Hamborg+T%22">Hamborg T</searchLink>; Pragmatic Clinical Trials Unit, Wolfson Institute of Population Health, Queen Mary University of London, London, E1 2AB, UK.<br /><searchLink fieldCode="AU" term="%22Harris+J%22">Harris J</searchLink>; Bristol Trials Centre, Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, BS8 2PS, UK.<br /><searchLink fieldCode="AU" term="%22Harrison+DA%22">Harrison DA</searchLink>; Intensive Care National Audit & Research Centre, London, UK.<br /><searchLink fieldCode="AU" term="%22Harji+D%22">Harji D</searchLink>; Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research,, University of Leeds, Leeds, LS2 9JT, UK.; Manchester University NHS Foundation Trust, Manchester, UK.<br /><searchLink fieldCode="AU" term="%22Henderson+EJ%22">Henderson EJ</searchLink>; Ageing and Movement Research Group, Bristol Medical School, University of Bristol, Bristol, UK.; Older People's Unit, Royal United Hospitals NHS Foundation Trust, Bath, UK.<br /><searchLink fieldCode="AU" term="%22Logan+P%22">Logan P</searchLink>; School of Medicine, University of Nottingham and Nottingham City Care Partnership, Nottingham, UK.<br /><searchLink fieldCode="AU" term="%22Love+SB%22">Love SB</searchLink>; MRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, UCL, London, UK.<br /><searchLink fieldCode="AU" term="%22Magee+LA%22">Magee LA</searchLink>; Department of Women and Children's Health, King's College London, London, UK.<br /><searchLink fieldCode="AU" term="%22O'Brien+A%22">O'Brien A</searchLink>; Division of Medicine, UCL Institute for Liver and Digestive Health, Royal Free Campus, Upper 3Rd FloorRowland Hill Street, London, NW3 2PF, UK.<br /><searchLink fieldCode="AU" term="%22Pufulete+M%22">Pufulete M</searchLink>; Bristol Medical School, University of Bristol, Bristol, BS8 2PS, UK.<br /><searchLink fieldCode="AU" term="%22Ramnarayan+P%22">Ramnarayan P</searchLink>; Department of Surgery and Cancer, Imperial College London, London, W21PB, UK.<br /><searchLink fieldCode="AU" term="%22Saratzis+A%22">Saratzis A</searchLink>; Department of Cardiovascular Sciences, University of Leicester, Leicester, UK.<br /><searchLink fieldCode="AU" term="%22Smith+J%22">Smith J</searchLink>; Keele Clinical Trials Unit, Faculty of Medicine and Health Sciences, Keele University, Staffordshire, UK.<br /><searchLink fieldCode="AU" term="%22Solis-Trapala+I%22">Solis-Trapala I</searchLink>; Keele Clinical Trials Unit, Faculty of Medicine and Health Sciences, Keele University, Staffordshire, UK.<br /><searchLink fieldCode="AU" term="%22Stubbs+C%22">Stubbs C</searchLink>; Birmingham Clinical Trials Unit (BCTU), Institute of Applied Health Research College of Medical and Dental Sciences, The University of Birmingham, Edgbaston, Birmingham, B15 2TT, UK.<br /><searchLink fieldCode="AU" term="%22Farrin+A%22">Farrin A</searchLink>; Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research,, University of Leeds, Leeds, LS2 9JT, UK.<br /><searchLink fieldCode="AU" term="%22Williamson+P%22">Williamson P</searchLink>; MRC-NIHR Trials Methodology Research Partnership, Department of Health Data Science, University of Liverpool, Liverpool, UK.
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