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SPIRIT-PRO Extension explanation and elaboration: guidelines for inclusion of patient-reported outcomes in protocols of clinical trials.
Calvert, Melanie; King, Madeleine; Mercieca-Bebber, Rebecca; Aiyegbusi, Olalekan; Kyte, Derek; Slade, Anita; Chan, An-Wen; Basch, E; Bell, Jill; Bennett, Antonia; Bhatnagar, Vishal; Blazeby, Jane; Bottomley, Andrew; Brown, Julia; Brundage, Michael; Campbell, Lisa; Cappelleri, Joseph C; Draper, Heather; Dueck, Amylou C; Ells, Carolyn; Frank, Lori; Golub, Robert M; Griebsch, Ingolf; Haywood, Kirstie; Hunn, Amanda; King-Kallimanis, Bellinda; Martin, Laura; Mitchell, Sandra; Morel, Thomas; Nelson, Linda; Norquist, Josephine; O'Connor, Daniel; Palmer, Michael; Patrick, Donald; Price, Gary; Regnault, Antoine; Retzer, Ameeta; Revicki, Dennis; Scott, Jane; Stephens, Richard; Turner, Grace; Valakas, Antonia; Velikova, Galina; von Hildebrand, Maria; Walker, Anita; Wenzel, Lari.
Afiliação
  • Calvert M; Centre for Patient Reported Outcome Research, Institute of Applied Health Research, University of Birmingham, Birmingham, UK M.Calvert@bham.ac.uk.
  • King M; Birmingham Health Partners Centre for Regulatory Science and Innovation, University of Birmingham, Birmingham, UK.
  • Mercieca-Bebber R; NIHR Biomedical Research Centre, Institute of Translational Medicine, Birmingham, UK.
  • Aiyegbusi O; NIHR Surgical Reconstruction and Microbiology Research Centre, Birmingham, UK.
  • Kyte D; NIHR Applied Research Collaboration West Midlands, University of Birmingham, Birmingham, UK.
  • Slade A; Faculty of Science, School of Psychology, University of Sydney, Sydney, New South Wales, Australia.
  • Chan AW; Faculty of Medicine and Health, NHMRC Clinical Trials Centre, University of Sydney, Sydney, New South Wales, Australia.
  • Basch E; Centre for Patient Reported Outcome Research, Institute of Applied Health Research, University of Birmingham, Birmingham, UK.
  • Bell J; NIHR Biomedical Research Centre, Institute of Translational Medicine, Birmingham, UK.
  • Bennett A; Centre for Patient Reported Outcome Research, Institute of Applied Health Research, University of Birmingham, Birmingham, UK.
  • Bhatnagar V; Centre for Patient Reported Outcome Research, Institute of Applied Health Research, University of Birmingham, Birmingham, UK.
  • Blazeby J; NIHR Surgical Reconstruction and Microbiology Research Centre, Birmingham, UK.
  • Bottomley A; Women's College Research Institute, Department of Medicine, University of Toronto, Toronto, Ontario, Canada.
  • Brown J; University of North Carolina, Chapel Hill, North Carolina, USA.
  • Brundage M; Oncology Digital Health, AstraZeneca, Gaithersburg, Maryland, USA.
  • Campbell L; Cancer Outcomes Research Program, University of North Carolina, Chapel Hill, North Carolina, USA.
  • Cappelleri JC; US Food and Drug Administration, Silver Spring, Maryland, USA.
  • Draper H; NIHR Bristol Biomedical Research Centre, University of Bristol, Bristol, UK.
  • Dueck AC; Division of Surgery, Head and Neck, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.
  • Ells C; Department of Quality of Life, European Organisation for Research and Treatment of Cancer, Brussels, Belgium.
  • Frank L; Clinical Trials Research Unit, University of Leeds, Leeds, UK.
  • Golub RM; Department of Oncology, Queen's University Cancer Research Institute, Kingston, Ontario, Canada.
  • Griebsch I; Medicines and Healthcare Products Regulatory Agency, London, UK.
  • Haywood K; Global Biometrics & Data Management-Statistics, Pfizer Inc, New York City, New York, USA.
  • Hunn A; University of Warwick, Coventry, UK.
  • King-Kallimanis B; Department of Health Sciences Research, Mayo Clinic, Scottsdale, Arizona, USA.
  • Martin L; School of Population and Global Health, McGill University, Montreal, Quebec, Canada.
  • Mitchell S; Patient-Centered Outcomes Research Institute, Washington, DC, USA.
  • Morel T; JAMA, Chicago, Illinois, USA.
  • Nelson L; Boehringer Ingelheim International GmbH, Ingelheim, Germany.
  • Norquist J; Warwick Research in Nursing, University of Warwick, Warwick Medical School, Coventry, UK.
  • O'Connor D; Independent Advisor, Manchester, UK.
  • Palmer M; US Food and Drug Administration, Silver Spring, Maryland, USA.
  • Patrick D; Daiichi Sankyo Europe GmbH, Munchen, Germany.
  • Price G; National Cancer Institute, Rockville, Maryland, USA.
  • Regnault A; Patient-Centered Outcomes Research, UCB Pharma, Brussels, Belgium.
  • Retzer A; Value Evidence and Outcomes-Patient Centered Outcomes, GSK, Collegeville, Pennsylvania, USA.
  • Revicki D; Center for Observational Real-world Evidence (CORE), Patient-Centered Endpoints & Strategy, Merck & Co Inc, Kenilworth, New Jersey, USA.
  • Scott J; Medicines and Healthcare Products Regulatory Agency, London, UK.
  • Stephens R; Cancer Research Institute, Queen's University, Kingston, Ontario, Canada.
  • Turner G; Department of Health Services, University of Washington, Seattle, Washington, USA.
  • Valakas A; Centre for Patient Reported Outcome Research, Institute of Applied Health Research, University of Birmingham, Birmingham, UK.
  • Velikova G; Modus Outcomes, Lyon, France.
  • von Hildebrand M; Centre for Patient Reported Outcome Research, Institute of Applied Health Research, University of Birmingham, Birmingham, UK.
  • Walker A; Outcomes Research Consulting, Sarasota, Florida, USA.
  • Wenzel L; Johnson and Johnson, Janssen Global Services LLC, High Wycombe, UK.
BMJ Open ; 11(6): e045105, 2021 06 30.
Article em En | MEDLINE | ID: mdl-34193486
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Qualidade de Vida / Projetos de Pesquisa Idioma: En Ano de publicação: 2021 Tipo de documento: Article
Texto completo
Imprimir
XML
PubMed Links
Buscar no Google

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Qualidade de Vida / Projetos de Pesquisa Idioma: En Ano de publicação: 2021 Tipo de documento: Article