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The need for ethical guidance for the use of patient-reported outcomes (PROs) in 2 research and clinical practice
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Cruz Rivera, Samantha, Merieca-Bebber, Rebecca, Lee Aiyegbusi, Olalekan, Scott, Jane, Hunn, Amanda, Fernandez, Conrad, Ives, Jonathan, Ells, Carolyn, Price, Gary, Draper, Heather and Calvert, Melanie J. (2021) The need for ethical guidance for the use of patient-reported outcomes (PROs) in 2 research and clinical practice. Nature Medicine, 27 . pp. 572-573. doi:10.1038/s41591-021-01275-z
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WRAP-need-ethical-guidance-patient-reported-0utcomes-PROs-2021.pdf - Accepted Version - Requires a PDF viewer. Download (568Kb) | Preview |
Official URL: https://doi.org/10.1038/s41591-021-01275-z
Abstract
To the Editor—Patient-reported outcomes (PROs) are increasingly being used in clinical research to provide evidence of the benefits and risk of therapy from a patient perspective. PRO data from clinical trials can inform regulatory approvals and drug labeling, clinical guideline development and health policy1. Approximately one third of clinical trials include PROs collected through the use of patient questionnaires2. Beyond trials, PRO data are also increasingly captured in observational research and routine clinical care to provide information on the burden of disease and real-world evidence of treatment safety and effectiveness3, for audit and benchmarking1, and to monitor the status of patients and provide timely care tailored to individual needs. For instance, a study demonstrated that systematic web-based collection of information on symptoms led to improved health-related quality of life, survival and quality-adjusted survival, and fewer visits to the emergency room and hospitalization, among patients receiving chemotherapy for advanced solid tumors4. Patients value PRO trial results, as they can enhance clinician–patient communication about treatment options, which helps patients to feel more empowered in shared decision-making around their care5.
Item Type: | Journal Item | ||||||||
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Divisions: | Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School | ||||||||
Journal or Publication Title: | Nature Medicine | ||||||||
Publisher: | Nature Publishing Group | ||||||||
ISSN: | 1078-8956 | ||||||||
Official Date: | April 2021 | ||||||||
Dates: |
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Volume: | 27 | ||||||||
Page Range: | pp. 572-573 | ||||||||
DOI: | 10.1038/s41591-021-01275-z | ||||||||
Status: | Peer Reviewed | ||||||||
Publication Status: | Published | ||||||||
Access rights to Published version: | Restricted or Subscription Access | ||||||||
Date of first compliant deposit: | 2 February 2021 | ||||||||
Date of first compliant Open Access: | 4 September 2021 | ||||||||
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