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Reporting of Cohort and Routinely Collected Data in Randomised Controlled Trial Protocols (SPIRIT-ROUTINE): extension checklist with explanation and elaboration.

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Title: Reporting of Cohort and Routinely Collected Data in Randomised Controlled Trial Protocols (SPIRIT-ROUTINE): extension checklist with explanation and elaboration.
Authors: Kearney PM; School of Public Health, University College Cork, Cork T12 XF62, Ireland., McCarthy M; School of Public Health, University College Cork, Cork T12 XF62, Ireland., Rengarajan S; School of Public Health, University College Cork, Cork T12 XF62, Ireland srengarajan@ucc.ie., O'Keeffe LM; School of Public Health, University College Cork, Cork T12 XF62, Ireland., Avery K; NIHR Bristol Biomedical Research Centre, University Hospitals Bristol and Weston NHS Foundation Trust and University of Bristol, Bristol UK., Chan AW; Department of Medicine, Women's College Research Institute, University of Toronto, Toronto, ON, Canada., Devane D; School of Nursing and Midwifery, University of Galway, Galway, Ireland.; Health Research Board-Trials Methodology Research Network, University of Galway, Galway, Ireland., Davies G; UCL Great Ormond Street Institute of Child Health, University College London, London, UK.; Great Ormond Street Hospital for Children NHS Foundation Trust, London, UK., Gale C; Neonatal Medicine, School of Public Health, Imperial College London, Chelsea and Westminster Hospital campus, London, UK.; Imperial Clinical Trials Unit, School of Public Health, Imperial College London, London.; Centre for Paediatrics and Child Health, Imperial College London, London., Hemkens LG; Department of Clinical Research, University of Bern, Bern, Switzerland.; Research Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB), University Hospital Basel and University of Basel, Basel, Switzerland.; Meta-Research Innovation Center at Stanford (METRICS), Stanford University, Stanford, California, USA., Juszczak E; Nottingham Clinical Trials Unit, Applied Health Research Building, School of Medicine, University of Nottingham, University Park, Nottingham, UK., Kwakkenbos L; Behavioural Science Institute, Clinical Psychology, Radboud University, Nijmegen, Netherlands., Langan SM; Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK.; Guy's and St Thomas' NHS Foundation Trust, London, UK.; Health Data Research, London, UK., Lugg-Widger F; Centre for Trials Research, Cardiff University, Cardiff, UK., Moher D; Centre for Journalology, Clinical Epidemiology Programme, Ottawa Hospital Research Institute, Ottawa, ON, Canada., Schmidt M; Department of Cardiology, Gødstrup Regional Hospital, Denmark.; Department of Clinical Medicine, Aarhus University, Aarhus, Denmark., Thabane L; Department of Health Research Methods Evidence and Impact, McMaster University, Hamilton, ON, Canada.; St Joseph's Healthcare Hamilton, Hamilton, ON, Canada., Thombs BD; Lady Davis Institute for Medical Research of the Jewish General Hospital, Montréal, Québec, Canada.; Department of Psychiatry, McGill University, Montréal, Québec, Canada., Toader AM; MRC-NIHR Trials Methodology Research Partnership, University of Liverpool, Liverpool, UK., Watkins A; Faculty of Medicine, Health & Life Sciences, Swansea University, Swansea, UK., Farrin AJ; Edinburgh Clinical Trials Unit, Usher Institute, University of Edinburgh, Edinburgh, UK., Zwarenstein M; Centre for Studies in Family Medicine, Departments of Family Medicine and of Epidemiology/Biostatistics, Schulich School of Medicine and Dentistry, London, ON, Canada.; ICES, Toronto, ON, Canada., Sydes MR; MRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, UCL, London, UK.; Data for R&D, Transformation Directorate, NHS England, London, UK., Williamson PR; MRC-NIHR Trials Methodology Research Partnership, University of Liverpool, Liverpool, UK., Markham S; Department of Biostatistics & Health Informatics, Institute of Psychiatry, Psychology & Neuroscience (IoPPN), King's College London, London, UK.
Source: BMJ (Clinical research ed.) [BMJ] 2026 Jun 12; Vol. 393, pp. e087095. Date of Electronic Publication: 2026 Jun 12.
Publication Type: Journal Article
Journal Info: Publisher: British Medical Association Country of Publication: England NLM ID: 8900488 Publication Model: Electronic Cited Medium: Internet ISSN: 1756-1833 (Electronic) Linking ISSN: 09598138 NLM ISO Abbreviation: BMJ Subsets: MEDLINE; In Process
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  Data: Reporting of Cohort and Routinely Collected Data in Randomised Controlled Trial Protocols (SPIRIT-ROUTINE): extension checklist with explanation and elaboration.
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  Data: <searchLink fieldCode="AU" term="%22Kearney+PM%22">Kearney PM</searchLink>; School of Public Health, University College Cork, Cork T12 XF62, Ireland.<br /><searchLink fieldCode="AU" term="%22McCarthy+M%22">McCarthy M</searchLink>; School of Public Health, University College Cork, Cork T12 XF62, Ireland.<br /><searchLink fieldCode="AU" term="%22Rengarajan+S%22">Rengarajan S</searchLink>; School of Public Health, University College Cork, Cork T12 XF62, Ireland srengarajan@ucc.ie.<br /><searchLink fieldCode="AU" term="%22O'Keeffe+LM%22">O'Keeffe LM</searchLink>; School of Public Health, University College Cork, Cork T12 XF62, Ireland.<br /><searchLink fieldCode="AU" term="%22Avery+K%22">Avery K</searchLink>; NIHR Bristol Biomedical Research Centre, University Hospitals Bristol and Weston NHS Foundation Trust and University of Bristol, Bristol UK.<br /><searchLink fieldCode="AU" term="%22Chan+AW%22">Chan AW</searchLink>; Department of Medicine, Women's College Research Institute, University of Toronto, Toronto, ON, Canada.<br /><searchLink fieldCode="AU" term="%22Devane+D%22">Devane D</searchLink>; School of Nursing and Midwifery, University of Galway, Galway, Ireland.; Health Research Board-Trials Methodology Research Network, University of Galway, Galway, Ireland.<br /><searchLink fieldCode="AU" term="%22Davies+G%22">Davies G</searchLink>; UCL Great Ormond Street Institute of Child Health, University College London, London, UK.; Great Ormond Street Hospital for Children NHS Foundation Trust, London, UK.<br /><searchLink fieldCode="AU" term="%22Gale+C%22">Gale C</searchLink>; Neonatal Medicine, School of Public Health, Imperial College London, Chelsea and Westminster Hospital campus, London, UK.; Imperial Clinical Trials Unit, School of Public Health, Imperial College London, London.; Centre for Paediatrics and Child Health, Imperial College London, London.<br /><searchLink fieldCode="AU" term="%22Hemkens+LG%22">Hemkens LG</searchLink>; Department of Clinical Research, University of Bern, Bern, Switzerland.; Research Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB), University Hospital Basel and University of Basel, Basel, Switzerland.; Meta-Research Innovation Center at Stanford (METRICS), Stanford University, Stanford, California, USA.<br /><searchLink fieldCode="AU" term="%22Juszczak+E%22">Juszczak E</searchLink>; Nottingham Clinical Trials Unit, Applied Health Research Building, School of Medicine, University of Nottingham, University Park, Nottingham, UK.<br /><searchLink fieldCode="AU" term="%22Kwakkenbos+L%22">Kwakkenbos L</searchLink>; Behavioural Science Institute, Clinical Psychology, Radboud University, Nijmegen, Netherlands.<br /><searchLink fieldCode="AU" term="%22Langan+SM%22">Langan SM</searchLink>; Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK.; Guy's and St Thomas' NHS Foundation Trust, London, UK.; Health Data Research, London, UK.<br /><searchLink fieldCode="AU" term="%22Lugg-Widger+F%22">Lugg-Widger F</searchLink>; Centre for Trials Research, Cardiff University, Cardiff, UK.<br /><searchLink fieldCode="AU" term="%22Moher+D%22">Moher D</searchLink>; Centre for Journalology, Clinical Epidemiology Programme, Ottawa Hospital Research Institute, Ottawa, ON, Canada.<br /><searchLink fieldCode="AU" term="%22Schmidt+M%22">Schmidt M</searchLink>; Department of Cardiology, Gødstrup Regional Hospital, Denmark.; Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.<br /><searchLink fieldCode="AU" term="%22Thabane+L%22">Thabane L</searchLink>; Department of Health Research Methods Evidence and Impact, McMaster University, Hamilton, ON, Canada.; St Joseph's Healthcare Hamilton, Hamilton, ON, Canada.<br /><searchLink fieldCode="AU" term="%22Thombs+BD%22">Thombs BD</searchLink>; Lady Davis Institute for Medical Research of the Jewish General Hospital, Montréal, Québec, Canada.; Department of Psychiatry, McGill University, Montréal, Québec, Canada.<br /><searchLink fieldCode="AU" term="%22Toader+AM%22">Toader AM</searchLink>; MRC-NIHR Trials Methodology Research Partnership, University of Liverpool, Liverpool, UK.<br /><searchLink fieldCode="AU" term="%22Watkins+A%22">Watkins A</searchLink>; Faculty of Medicine, Health & Life Sciences, Swansea University, Swansea, UK.<br /><searchLink fieldCode="AU" term="%22Farrin+AJ%22">Farrin AJ</searchLink>; Edinburgh Clinical Trials Unit, Usher Institute, University of Edinburgh, Edinburgh, UK.<br /><searchLink fieldCode="AU" term="%22Zwarenstein+M%22">Zwarenstein M</searchLink>; Centre for Studies in Family Medicine, Departments of Family Medicine and of Epidemiology/Biostatistics, Schulich School of Medicine and Dentistry, London, ON, Canada.; ICES, Toronto, ON, Canada.<br /><searchLink fieldCode="AU" term="%22Sydes+MR%22">Sydes MR</searchLink>; MRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, UCL, London, UK.; Data for R&D, Transformation Directorate, NHS England, London, UK.<br /><searchLink fieldCode="AU" term="%22Williamson+PR%22">Williamson PR</searchLink>; MRC-NIHR Trials Methodology Research Partnership, University of Liverpool, Liverpool, UK.<br /><searchLink fieldCode="AU" term="%22Markham+S%22">Markham S</searchLink>; Department of Biostatistics & Health Informatics, Institute of Psychiatry, Psychology & Neuroscience (IoPPN), King's College London, London, UK.
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