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

Journal

Nature medicine
ISSN: 1546-170X
Titre abrégé: Nat Med
Pays: United States
ID NLM: 9502015

Informations de publication

Date de publication:
29 Feb 2024
Historique:
received: 05 12 2023
accepted: 23 01 2024
medline: 1 3 2024
pubmed: 1 3 2024
entrez: 29 2 2024
Statut: aheadofprint

Résumé

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.

Identifiants

DOI: 10.1038/s41591-024-02827-9 PMID: 38424214
pubmed: 38424214
doi: 10.1038/s41591-024-02827-9
pii: 10.1038/s41591-024-02827-9
doi:

Types de publication

Journal Article Review

Langues

eng

Sous-ensembles de citation

IM

Informations de copyright

© 2024. The Author(s), under exclusive licence to Springer Nature America, Inc.

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Auteurs

Olalekan Lee 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.
ORCID: 0000-0001-9122-8251

Samantha 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.

Jessica 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.

Paul Kamudoni (P)

Merck KGaA, Darmstadt, Germany.

Yvonne Alder (Y)

Centre for Patient-Reported Outcomes Research (CPROR), Institute of Applied Health Research, University of Birmingham, Birmingham, UK.

Nicola 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.

Robert Mitchell Baldwin (RM)

Health Canada, Ottawa, Ontario, Canada.

Vishal Bhatnagar (V)

Oncology Center of Excellence, US Food and Drug Administration, Silver Spring, MD, USA.

Jennifer Black (J)

Health Canada, Ottawa, Ontario, Canada.

Andrew Bottomley (A)

Bottomley Consulting Group, Belgium, Belgium.

Michael Brundage (M)

Queen's University, Kingston, Ontario, Canada.

David Cella (D)

Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.

Philip Collis (P)

Centre for Patient-Reported Outcomes Research (CPROR), Institute of Applied Health Research, University of Birmingham, Birmingham, UK.

Elin-Haf Davies (EH)

Aparito, Wrexham, UK.

Alastair K 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.
ORCID: 0000-0001-7849-0087

Fabio Efficace (F)

Italian Group for Adult Hematologic Diseases (GIMEMA), Data Center and Health Outcomes Research Unit, Rome, Italy.

Adrian Gardner (A)

The Royal Orthopaedic Hospital NHS Foundation Trust, Birmingham, UK.
Aston University, Birmingham, UK.

Ari Gnanasakthy (A)

RTI Health Solutions, Durham, NC, USA.
ORCID: 0000-0001-9176-3983

Robert M Golub (RM)

Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.

Sarah E 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.
ORCID: 0000-0001-5656-1198

Flic Jeyes (F)

Centre for Patient-Reported Outcomes Research (CPROR), Institute of Applied Health Research, University of Birmingham, Birmingham, UK.

Scottie Kern (S)

Critical Path Institute, Tucson, AZ, USA.

Bellinda L King-Kallimanis (BL)

LUNGevity Foundation, Bethesda, MD, USA.

Antony Martin (A)

QC Medica, Liverpool, UK.

Christel 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.

Rebecca Mercieca-Bebber (R)

The NHMRC Clinical Trials Centre, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.

Joao Monteiro (J)

Nature Medicine, New York, NY, USA.

John Devin Peipert (JD)

Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.

Juan Carlos 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.
ORCID: 0000-0001-9892-5084

Chantal Quinten (C)

European Medicines Agency, Amsterdam, Netherlands.

Khadija Rerhou Rantell (KR)

Medicines and Healthcare products Regulatory Agency, London, UK.

Antoine Regnault (A)

Modus Outcomes, Lyon, France.

Maxime Sasseville (M)

Health Canada, Ottawa, Ontario, Canada.

Liv Marit Valen Schougaard (LMV)

AmbuFlex, Centre for Patient-reported Outcomes, Gødstrup Hospital, Herning, Denmark.

Roya Sherafat-Kazemzadeh (R)

Mapi Research Trust, Lyon, France.
ORCID: 0000-0002-1909-5527

Claire Snyder (C)

Johns Hopkins Schools of Medicine and Public Health, Baltimore, MD, USA.

Angela M 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.

Rav Verdi (R)

Centre for Patient-Reported Outcomes Research (CPROR), Institute of Applied Health Research, University of Birmingham, Birmingham, UK.

Roger 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.

Melanie J 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.
ORCID: 0000-0002-1856-837X

Classifications MeSH