Informed consent in randomised controlled trials: development and preliminary evaluation of a measure of Participatory and Informed Consent (PIC)

Autor: Julia Wade, Daisy Elliott, Kerry N. L. Avery, Daisy Gaunt, Grace J. Young, Rebecca Barnes, Sangeetha Paramasivan, W Bruce Campbell, Jane M. Blazeby, Alison J Birtle, Rob C. Stein, David J Beard, Alison W Halliday, Jenny L. Donovan, On behalf of the ProtecT study group, CLASS study group, Chemorad study group, POUT study group, OPTIMA prelim study group, CSAW study group and ACST-2 study group

Publikováno v: Trials, Vol 18, Iss 1, Pp 1-13 (2017)

Abstract Background Informed consent (IC) is an ethical and legal prerequisite for trial participation, yet current approaches evaluating participant understanding for IC during recruitment lack consistency. No validated measure has been identified t

Externí odkaz: https://doaj.org/article/818bfc829320400da5c2e6a4e02d5319

An observational study showed that explaining randomization using gambling-related metaphors and computer-agency descriptions impeded randomized clinical trial recruitment

Autor: Jepson, Marcus, Elliott, Daisy, Conefrey, Carmel, Wade, Julia, Rooshenas, Leila, Wilson, Caroline, Beard, David, Blazeby, Jane M, Birtle, Alison, Halliday, Alison, Stein, Rob, Donovan, Jenny L, CSAW Study Group, Chemorad Study Group, POUT Study Group, ACST-2 Study Group, OPTIMA Prelim Study Group

OBJECTIVES: To explore how the concept of randomization is described by clinicians and understood by patients in randomized controlled trials (RCTs) and how it contributes to patient understanding and recruitment. STUDY DESIGN AND SETTING: Qualitativ

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::af7b9e48e39f53738592b30f4348c3ea

Strategies to Improve Recruitment to a De-escalation Trial: A Mixed-Methods Study of the OPTIMA Prelim Trial in Early Breast Cancer.

Autor: Conefrey C; Population Health Sciences, University of Bristol, Bristol, UK. Electronic address: carmel.conefrey@bristol.ac.uk., Donovan JL; Population Health Sciences, University of Bristol, Bristol, UK., Stein RC; National Institute for Health Research, University College London Hospitals Biomedical Research Centre, London, UK., Paramasivan S; Population Health Sciences, University of Bristol, Bristol, UK., Marshall A; Warwick Medical School, University of Warwick, Coventry, UK., Bartlett J; Ontario Institute for Cancer Research, Toronto, Ontario, Canada., Cameron D; The University of Edinburgh, Cancer Research UK Edinburgh Centre, Western General Hospital, EH4 University Cancer Centre, University of Edinburgh, Edinburgh, UK., Campbell A; Warwick Medical School, University of Warwick, Coventry, UK., Dunn J; Warwick Medical School, University of Warwick, Coventry, UK., Earl H; Oncology Centre, Addenbrooke's Hospital, Cambridge, UK., Hall P; The University of Edinburgh, Cancer Research UK Edinburgh Centre, Western General Hospital, EH4 University Cancer Centre, University of Edinburgh, Edinburgh, UK., Harmer V; Imperial College Healthcare NHS Trust, Charing Cross Hospital, London, UK., Hughes-Davies L; Oncology Centre, Addenbrooke's Hospital, Cambridge, UK., Macpherson I; Beatson West of Scotland Cancer Centre, Glasgow, UK., Makris A; Mount Vernon Cancer Centre, Mount Vernon Hospital, Northwood, UK., Morgan A; Independent Cancer Patients' Voice, London, UK., Pinder S; King's College London, Comprehensive Cancer Centre at Guy's Hospital, London, UK., Poole C; Arden Cancer Centre, University Hospitals Coventry and Warwickshire, Coventry, UK., Rea D; School of Cancer Sciences, University of Birmingham, Birmingham, UK., Rooshenas L; Population Health Sciences, University of Bristol, Bristol, UK.

Publikováno v: Clinical oncology (Royal College of Radiologists (Great Britain)) [Clin Oncol (R Coll Radiol)] 2020 Jun; Vol. 32 (6), pp. 382-389. Date of Electronic Publication: 2020 Feb 20.

The QuinteT Recruitment Intervention supported five randomized trials to recruit to target: a mixed-methods evaluation.

Autor: Rooshenas L; Population Health Sciences, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol BS8 2PS, Bristol, United Kingdom. Electronic address: leila.rooshenas@bristol.ac.uk., Scott LJ; NIHR Collaboration for Leadership in Applied Health Research and Care at University Hospitals Bristol NHS Foundation Trust, Bristol, United Kingdom., Blazeby JM; Population Health Sciences, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol BS8 2PS, Bristol, United Kingdom., Rogers CA; Population Health Sciences, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol BS8 2PS, Bristol, United Kingdom; Clinical Trials and Evaluation Unit, Bristol Royal Infirmary, School of Clinical Sciences, University of Bristol, Bristol, United Kingdom., Tilling KM; Population Health Sciences, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol BS8 2PS, Bristol, United Kingdom., Husbands S; Population Health Sciences, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol BS8 2PS, Bristol, United Kingdom., Conefrey C; Population Health Sciences, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol BS8 2PS, Bristol, United Kingdom., Mills N; Population Health Sciences, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol BS8 2PS, Bristol, United Kingdom., Stein RC; University College London Hospitals (UCLH), Biomedical Research Centre (BMC), University College London Hospitals, 1st Floor Central, 250 Euston Road, London NW1 2PG, UK., Metcalfe C; Population Health Sciences, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol BS8 2PS, Bristol, United Kingdom., Carr AJ; Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom., Beard DJ; Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom; Royal College of Surgeons Surgical Intervention Trials Unit (SITU), University of Oxford, Oxford, United Kingdom., Davis T; Queen's Medical Centre, Nottingham University Hospitals NHS Trust, Derby Road, Nottingham NG7 2UH, UK., Paramasivan S; Population Health Sciences, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol BS8 2PS, Bristol, United Kingdom., Jepson M; Population Health Sciences, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol BS8 2PS, Bristol, United Kingdom., Avery K; Population Health Sciences, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol BS8 2PS, Bristol, United Kingdom., Elliott D; Population Health Sciences, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol BS8 2PS, Bristol, United Kingdom., Wilson C; Population Health Sciences, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol BS8 2PS, Bristol, United Kingdom., Donovan JL; Population Health Sciences, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol BS8 2PS, Bristol, United Kingdom; NIHR Collaboration for Leadership in Applied Health Research and Care at University Hospitals Bristol NHS Foundation Trust, Bristol, United Kingdom.

Publikováno v: Journal of clinical epidemiology [J Clin Epidemiol] 2019 Feb; Vol. 106, pp. 108-120. Date of Electronic Publication: 2018 Oct 16.

The challenge of equipoise: qualitative interviews exploring the views of health professionals and women with multiple ipsilateral breast cancer on recruitment to a surgical randomised controlled feasibility trial.

Autor: Ingram, Jenny¹ (AUTHOR) Jenny.Ingram@bristol.ac.uk, Beasant, Lucy¹ (AUTHOR), Benson, John² (AUTHOR), Brunt, Adrian Murray³ (AUTHOR), Maxwell, Anthony^4,5 (AUTHOR), Harvey, James Richard^4,6 (AUTHOR), Greenwood, Rosemary⁷ (AUTHOR), Roberts, Nicholas⁸ (AUTHOR), Williams, Norman⁸ (AUTHOR), Johnson, Debbie¹ (AUTHOR), Winters, Zoe⁸ (AUTHOR)

Publikováno v: Pilot & Feasibility Studies. 2/28/2022, Vol. 8 Issue 1, p1-10. 10p.