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The need for ethical guidance for the use of patient-reported outcomes in research and clinical practice

Nature Medicine volume 27, pages 572–573 (2021)Cite this article

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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.

Despite the benefits of incorporating PROs in research and routine practice, several ethical challenges can hinder the uptake and benefit to patients of PRO data. The PRO content of trial protocols and reporting of PRO results are often suboptimal, missing data rates are high, and delay of the publication of PRO data is commonplace. A recent study evaluating 228 studies from the National Institute of Health Research Cancer Portfolio demonstrated that 50,000 patients were involved in studies that failed to publish the PRO data collected, which is considered unethical6.

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References

  1. Calvert, M., Kyte, D., Price, G., Valderas, J. M. & Hjollund, N. H. Br. Med. J. 364, k5267 (2019).

    Article  Google Scholar 

  2. Vodicka, E. et al. Contemp. Clin. Trials 43, 1–9 (2015).

    Article  CAS  Google Scholar 

  3. Calvert, M. J., O’Connor, D. J. & Basch, E. M. Nat. Rev. Drug Discov. 18, 731–732 (2019).

    Article  CAS  Google Scholar 

  4. Basch, E. et al. J. Am. Med. Assoc. 318, 197–198 (2017).

    Article  Google Scholar 

  5. Brundage, M. et al. Qual. Life Res. 12, 395–404 (2003).

    Article  CAS  Google Scholar 

  6. Kyte, D. et al. J. Natl. Cancer Inst. Monogr. 111, 1170–1178 (2019).

    Article  Google Scholar 

  7. Hagell, P., Reimer, J. & Nyberg, P. Value Health 12, 613–617 (2009).

    Article  Google Scholar 

  8. Kyte, D., Draper, H. & Calvert, M. J. Am. Med. Assoc. 310, 1229–1230 (2013).

    Article  CAS  Google Scholar 

  9. Aiyegbusi, O. L. & Calvert, M. J. Lancet 396, 531–531 (2020).

    Article  CAS  Google Scholar 

  10. Moher, D., Schulz, K. F., Simera, I. & Altman, D. G. PLoS Med. 7, e1000217 (2010).

    Article  Google Scholar 

Download references

Acknowledgements

M.J.C. receives funding from the National Institute for Health Research (NIHR) Birmingham Biomedical Research Centre, the NIHR Surgical Reconstruction and Microbiology Research Centre and NIHR ARC West Midlands at the University of Birmingham and University Hospitals Birmingham NHS Foundation Trust, Health Data Research UK, Innovate UK (part of UK Research and Innovation). The views expressed in this article are those of the author(s) and not necessarily those of the NIHR, or the Department of Health and Social Care. R.M.B. is supported by the Australian Government by a National Health and Medical Research Early career fellowship.

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Authors and Affiliations

  1. Centre for Patient Reported Outcomes Research, Institute of Applied Health Research, University of Birmingham, Birmingham, UK

    Samantha Cruz Rivera, Olalekan Lee Aiyegbusi, Gary Price & Melanie J. Calvert

  2. Birmingham Health Partners Centre for Regulatory Science and Innovation, University of Birmingham, Birmingham, UK

    Samantha Cruz Rivera, Olalekan Lee Aiyegbusi & Melanie J. Calvert

  3. Faculty of Medicine, Sydney Medical School, Central Clinical School, University of Sydney, Sydney, New South Wales, Australia

    Rebecca Mercieca-Bebber

  4. National Institute for Health Research Applied Research Centre West Midlands, Birmingham, UK

    Olalekan Lee Aiyegbusi & Melanie J. Calvert

  5. Janssen Global Services, Johnson & Johnson, High Wycombe, UK

    Jane Scott

  6. A J Hunn Associates, London, UK

    Amanda Hunn

  7. Division of Haematology-Oncology, IWK Health Care Centre, Halifax, Nova Scotia, Canada

    Conrad Fernandez

  8. Bristol Medical School, Bristol Population Health Science Institute, University of Bristol, Bristol, UK

    Jonathan Ives

  9. School of Population and Global Health, McGill University, Montreal, Quebec, Canada

    Carolyn Ells

  10. Social Science and Systems in Health, University of Warwick, Warwick, UK

    Heather Draper

  11. NIHR Birmingham Biomedical Research Centre, NIHR Surgical Reconstruction and Microbiology Research Centre, University of Birmingham, Birmingham, UK

    Melanie J. Calvert

  12. Health Data Research UK, London, UK

    Melanie J. Calvert

Authors
  1. Samantha Cruz Rivera
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  2. Rebecca Mercieca-Bebber
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  7. Jonathan Ives
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  8. Carolyn Ells
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  9. Gary Price
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  10. Heather Draper
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  11. Melanie J. Calvert
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Contributions

S.C.R. and M.J.C. conceived of the idea; S.C.R. developed the first draft; and all authors made substantial revisions and approved the final manuscript.

Corresponding author

Correspondence to Melanie J. Calvert.

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Competing interests

M.J.C. receives funding from Macmillan Cancer Support and UCB Pharma, and has received personal fees from Astellas, Takeda, Merck, Daiichi Sankyo, Glaukos, GlaxoSmithKline and the Patient-Centered Outcomes Research Institute outside the submitted work. O.L.A. declares personal fees from Gilead Sciences and GlaxoSmithKline outside the submitted work. J.S. is an employee of Janssen-Cilag UK and holds stock in Johnson & Johnson.

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Cruz Rivera, S., Mercieca-Bebber, R., Aiyegbusi, O.L. et al. The need for ethical guidance for the use of patient-reported outcomes in research and clinical practice. Nat Med 27, 572–573 (2021). https://doi.org/10.1038/s41591-021-01275-z

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