Recommendations to address respondent burden associated with patient-reported outcome assessment.

Autor: Aiyegbusi OL; Centre for Patient-Reported Outcomes Research (CPROR), Institute of Applied Health Research, University of Birmingham, Birmingham, UK. O.L.Aiyegbusi@bham.ac.uk.; National Institute for Health and Care Research (NIHR) Birmingham Biomedical Research Centre (BRC), University Hospital Birmingham and University of Birmingham, Birmingham, UK. O.L.Aiyegbusi@bham.ac.uk.; National Institute for Health and Care Research (NIHR) Applied Research Collaboration (ARC) West Midlands, University of Birmingham, Birmingham, UK. O.L.Aiyegbusi@bham.ac.uk.; NIHR Blood and Transplant Research Unit (BTRU) in Precision Transplant and Cellular Therapeutics, University of Birmingham, Birmingham, UK. O.L.Aiyegbusi@bham.ac.uk.; Birmingham Health Partners Centre for Regulatory Science and Innovation, University of Birmingham, Birmingham, UK. O.L.Aiyegbusi@bham.ac.uk., Cruz Rivera S; Centre for Patient-Reported Outcomes Research (CPROR), Institute of Applied Health Research, University of Birmingham, Birmingham, UK.; Birmingham Health Partners Centre for Regulatory Science and Innovation, University of Birmingham, Birmingham, UK., Roydhouse J; Menzies Institute for Medical Research, University of Tasmania, Hobart, Tasmania, Australia.; Department of Health Services Policy and Practice, Brown University School of Public Health, Providence, RI, USA., Kamudoni P; Merck KGaA, Darmstadt, Germany., Alder Y; Centre for Patient-Reported Outcomes Research (CPROR), Institute of Applied Health Research, University of Birmingham, Birmingham, UK., Anderson N; Centre for Patient-Reported Outcomes Research (CPROR), Institute of Applied Health Research, University of Birmingham, Birmingham, UK.; National Institute for Health and Care Research (NIHR) Birmingham Biomedical Research Centre (BRC), University Hospital Birmingham and University of Birmingham, Birmingham, UK.; National Institute for Health and Care Research (NIHR) Applied Research Collaboration (ARC) West Midlands, University of Birmingham, Birmingham, UK.; University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK., Baldwin RM; Health Canada, Ottawa, Ontario, Canada., Bhatnagar V; Oncology Center of Excellence, US Food and Drug Administration, Silver Spring, MD, USA., Black J; Health Canada, Ottawa, Ontario, Canada., Bottomley A; Bottomley Consulting Group, Belgium, Belgium., Brundage M; Queen's University, Kingston, Ontario, Canada., Cella D; Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, IL, USA., Collis P; Centre for Patient-Reported Outcomes Research (CPROR), Institute of Applied Health Research, University of Birmingham, Birmingham, UK., Davies EH; Aparito, Wrexham, UK., Denniston AK; National Institute for Health and Care Research (NIHR) Birmingham Biomedical Research Centre (BRC), University Hospital Birmingham and University of Birmingham, Birmingham, UK.; University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK., Efficace F; Italian Group for Adult Hematologic Diseases (GIMEMA), Data Center and Health Outcomes Research Unit, Rome, Italy., Gardner A; The Royal Orthopaedic Hospital NHS Foundation Trust, Birmingham, UK.; Aston University, Birmingham, UK., Gnanasakthy A; RTI Health Solutions, Durham, NC, USA., Golub RM; Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA., Hughes SE; Centre for Patient-Reported Outcomes Research (CPROR), Institute of Applied Health Research, University of Birmingham, Birmingham, UK.; National Institute for Health and Care Research (NIHR) Birmingham Biomedical Research Centre (BRC), University Hospital Birmingham and University of Birmingham, Birmingham, UK.; National Institute for Health and Care Research (NIHR) Applied Research Collaboration (ARC) West Midlands, University of Birmingham, Birmingham, UK.; NIHR Blood and Transplant Research Unit (BTRU) in Precision Transplant and Cellular Therapeutics, University of Birmingham, Birmingham, UK., Jeyes F; Centre for Patient-Reported Outcomes Research (CPROR), Institute of Applied Health Research, University of Birmingham, Birmingham, UK., Kern S; Critical Path Institute, Tucson, AZ, USA., King-Kallimanis BL; LUNGevity Foundation, Bethesda, MD, USA., Martin A; QC Medica, Liverpool, UK., McMullan C; Centre for Patient-Reported Outcomes Research (CPROR), Institute of Applied Health Research, University of Birmingham, Birmingham, UK.; NIHR Blood and Transplant Research Unit (BTRU) in Precision Transplant and Cellular Therapeutics, University of Birmingham, Birmingham, UK., Mercieca-Bebber R; The NHMRC Clinical Trials Centre, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia., Monteiro J; Nature Medicine, New York, NY, USA., Peipert JD; Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, IL, USA., Quijano-Campos JC; William Harvey Research Institute, Queen Mary University of London, London, UK.; St Bartholomew's Hospital, Barts Health NHS Trust, London, UK.; Royal Papworth Hospital NHS Foundation Trust, Cambridge, UK., Quinten C; European Medicines Agency, Amsterdam, Netherlands., Rantell KR; Medicines and Healthcare products Regulatory Agency, London, UK., Regnault A; Modus Outcomes, Lyon, France., Sasseville M; Health Canada, Ottawa, Ontario, Canada., Schougaard LMV; AmbuFlex, Centre for Patient-reported Outcomes, Gødstrup Hospital, Herning, Denmark., Sherafat-Kazemzadeh R; Mapi Research Trust, Lyon, France., Snyder C; Johns Hopkins Schools of Medicine and Public Health, Baltimore, MD, USA., Stover AM; University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.; Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC, USA., Verdi R; Centre for Patient-Reported Outcomes Research (CPROR), Institute of Applied Health Research, University of Birmingham, Birmingham, UK., Wilson R; Centre for Patient-Reported Outcomes Research (CPROR), Institute of Applied Health Research, University of Birmingham, Birmingham, UK.; Cancer Research Advocacy Forum, London, UK., Calvert MJ; Centre for Patient-Reported Outcomes Research (CPROR), Institute of Applied Health Research, University of Birmingham, Birmingham, UK.; National Institute for Health and Care Research (NIHR) Birmingham Biomedical Research Centre (BRC), University Hospital Birmingham and University of Birmingham, Birmingham, UK.; National Institute for Health and Care Research (NIHR) Applied Research Collaboration (ARC) West Midlands, University of Birmingham, Birmingham, UK.; NIHR Blood and Transplant Research Unit (BTRU) in Precision Transplant and Cellular Therapeutics, University of Birmingham, Birmingham, UK.; Birmingham Health Partners Centre for Regulatory Science and Innovation, University of Birmingham, Birmingham, UK.
Jazyk: angličtina
Zdroj: Nature medicine [Nat Med] 2024 Mar; Vol. 30 (3), pp. 650-659. Date of Electronic Publication: 2024 Feb 29.
DOI: 10.1038/s41591-024-02827-9
Abstrakt: Patient-reported outcomes (PROs) are increasingly used in healthcare research to provide evidence of the benefits and risks of interventions from the patient perspective and to inform regulatory decisions and health policy. The use of PROs in clinical practice can facilitate symptom monitoring, tailor care to individual needs, aid clinical decision-making and inform value-based healthcare initiatives. Despite their benefits, there are concerns that the potential burden on respondents may reduce their willingness to complete PROs, with potential impact on the completeness and quality of the data for decision-making. We therefore conducted an initial literature review to generate a list of candidate recommendations aimed at reducing respondent burden. This was followed by a two-stage Delphi survey by an international multi-stakeholder group. A consensus meeting was held to finalize the recommendations. The final consensus statement includes 19 recommendations to address PRO respondent burden in healthcare research and clinical practice. If implemented, these recommendations may reduce PRO respondent burden.
(© 2024. The Author(s), under exclusive licence to Springer Nature America, Inc.)
Databáze: MEDLINE
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