pp 1–17 | Cite as

First person epidemiological measures: vehicles for patient centered care

  • Leah M. McClimansEmail author
S.I.: Philosophy of Epidemiology


Since the 1970’s epidemiological measures focusing on “health-related quality of life” or simply “quality of life” have figured increasingly as endpoints in clinical trials. Before the 1970’s these measures were known, generically, as performance measures or health status measures. Relabeled as “quality of life measures” they were first used in cancer trials. In the early 2000’s they were relabeled again as “patient-reported outcome measures” or PROMs, in their service to the FDA to support drug labeling claims. To the limited degree that the philosophical literature addresses these measures, it tends to associate them with two major theories of well-being: subjective well-being and the capabilities approach. In this paper, I argue that philosophers ought to treat quality of life measures/PROMs as a distinct from these theories. I argue that quality of life/PROMs serve healthcare as vehicles for patient-centered care and this has important consequences for how we theorize these measures. To this end, two requirements set them apart from measures of subjective well-being and the capabilities approach: quality of life/PROMs need to be patient-directed and inclusive.


Epidemiology Measurement Quality of life Patient centered care Subjective well being Capabilities approach to quality of life 



I’d like to thank the anonymous reviewers who helped to make this paper sharper and more intelligible. Also thank you to the editors of this special issue, Sean Valles and Jonathan Kaplan for being so helpful and patient. All errors or infelicities are my own.


  1. Alexandrova, A. (2017). A philosophy for the science of well-being. Oxford: Oxford University Press.CrossRefGoogle Scholar
  2. Angner, E. (2011). The evolution of eupathics: The historical roots of subjective measures of wellbeing. International Journal of Wellbeing, 1, 4–41.CrossRefGoogle Scholar
  3. Barclay-Goddard, R., Epstein, J. D., & Mayo, N. E. (2009). Response shift: A brief overview and proposed research priorities. Quality of Life Research, 18, 335–346.CrossRefGoogle Scholar
  4. Black, N. (2013). Patient reported outcome measures could transform healthcare. British Medical Journal, 346, f167.CrossRefGoogle Scholar
  5. Brock, D. (1993). Quality of life measures in health care and medical ethics. In M. C. Nussbaum & A. Sen (Eds.), The quality of life (pp. 95–132). Oxford: Clarendon Press.CrossRefGoogle Scholar
  6. Browne, J. P., McGee, H. M., & O’Boyle, C. A. (1997). Conceptual approaches to the assessment of quality of life. Psychology & Health, 12, 737–751.CrossRefGoogle Scholar
  7. Carr, A. J., & Higginson, I. J. (2001). Are quality of life measures patient centred? British Medical Journal, 322, 1357–1360.CrossRefGoogle Scholar
  8. Crocker, T. F., Smith, J. K., & Skevington, S. M. (2015). Family and professionals underestimate quality of life across diverse cultures and health conditions: Systematic review. Journal of Clinical Epidemiology, 68, 584–595.CrossRefGoogle Scholar
  9. Darzi, L. (2008). High quality care for all: NHS next stage review, final report. London: The Stationary Office.Google Scholar
  10. Deiner, E., Suh, E. M., Lucas, R. E., & Smith, H. L. (1999). Subjective well-being: Three decades of progress. Psychological Bulletin, 125, 276–302.CrossRefGoogle Scholar
  11. Devlin, N., & Appleby, J. (2010). Getting the most out of PROMs: Putting health outcomes at the heart of NHS decision-making. London: The King’s Fund.Google Scholar
  12. Druss, B. G., & Marcus, B. C. (2005). Growth and decentralization of the medical literature: Implications for evidence-based medicine. Journal of the Medical Library Association, 93, 499–501.Google Scholar
  13. Faden, R. R., & Beauchamp, T. L. (1986). A history and theory of informed consent (pp. 53–100). Oxford: Oxford University Press.Google Scholar
  14. Fayers, P. M., & Machin, D. (2002). Quality of life: Assessment, analysis and interpretation. New Jersey: Wiley.Google Scholar
  15. Fayers P, Bottomley A on behalf of the EORTC Qualty of Life Group and the Quality of Life Unit. (2002). Quality of life research within the EORTC—EORTC QLQ-C30. European Journal of Cancer, 38, 125–133.CrossRefGoogle Scholar
  16. Guyatt, G. H., Feeny, D. H., & Patrick, D. L. (1993). Measuring health-related quality of life. Annals of Internal Medicine, 118, 622–629.CrossRefGoogle Scholar
  17. Health Services and Research Outcomes (HSRO) Subcommittee of the Radiation Therapy Oncology Group (RTOG), Spitzer Quality of Life Index. Accessed 14 April 2018.
  18. Institute of Medicine. (2001). Crossing the quality chasm: A new health system for the 21st Century. Washington, DC: National Academy Press.Google Scholar
  19. Karnofsky, D. A., & Burchenal, J. H. (1949). The clinical evaluation of chemotherapeutic agents in cancer. In C. M. MacLeod (Ed.), Evaluation of chemotherapeutic agents (p. 196). New York: Columbia Press.Google Scholar
  20. Leplège, A., & Hunt, S. (1997). The problem of quality of life in medicine. Journal of the American Medical Association, 278, 47–50.CrossRefGoogle Scholar
  21. Loscalzo, M. J. (2008). Palliative care: An historical perspective. Hematology, 1, 465.CrossRefGoogle Scholar
  22. McClimans, L. (2010a). Towards self-determination in quality of life research. Medicine, Health Care and Philosophy, 13, 67–76.CrossRefGoogle Scholar
  23. McClimans, L. (2010b). A theoretical framework for patient-reported outcome measures. Theoretical Medicine and Bioethics, 31, 225–240.CrossRefGoogle Scholar
  24. McClimans, L. (2011). Interpretability, validity and the minimum important difference. Theoretical Medicine and Bioethics, 32, 389–401.CrossRefGoogle Scholar
  25. McClimans, L. (2017). Measurement in medicine and beyond: Quality of life, blood pressure and time. In A. Nordmann & N. Mößner (Eds.), Reasoning in measurement (pp. 133–146). New York: Routledge.Google Scholar
  26. McClimans, L., & Browne, J. (2012). Quality of life is a process not an outcome. Theoretical Medicine and Bioethics, 33, 279–292.CrossRefGoogle Scholar
  27. McClimans, L., Browne, J., & Cano, S. (2017). Clinical outcome measurement: Models, theory, psychometrics and practice. Studies in the History and Philosophy of Science, 65, 67–73.CrossRefGoogle Scholar
  28. McClimans, L., Westerman, M., Bickenbach, J., Carlson, L., Wasserman, D., & Schwartz, C. (2012). Philosophical perspectives on response shift. Quality of Life Research, 22, 1871–1878.CrossRefGoogle Scholar
  29. McHorney, C. A., & Tarlov, A. R. (1995). Individual-patient monitoring in clinical practice: Are available health status surveys adequate? Quality of Life Research, 4, 293–307.CrossRefGoogle Scholar
  30. Mukherjee, S. (2010). The emperor of all Maladies. New York: Scribner.Google Scholar
  31. O’Boyle, C. A., McGee, H. M., Hickey, A., Joyce, C. R. B., Browne, J., O’Malley, K., et al. (1993). The schedule for the evaluation of individual quality of life (SEIQoL). Administrative manual. Dublin: Royal College of Surgeons in Ireland.Google Scholar
  32. Patel, K. K., Veestra, D. L., & Patrick, D. L. (2003). A review of selected patient-generated outcome measures and their application in clinical trials. Value in Health, 6, 595–603.CrossRefGoogle Scholar
  33. Paul, L. A. (2014). Transformative experience. Oxford: Oxford University Press.CrossRefGoogle Scholar
  34. Porter, T. (1996). Trust in numbers. Princeton: Princeton University Press.CrossRefGoogle Scholar
  35. Pusic, A. L., Klassen, A. F., Scott, A. M., Klok, J. A., Cordeiro, P. G., & Cano, S. J. (2009). Development of a new patient-reported outcome measure for breast surgery: The BREAST-Q. Plastic Reconstructive Surgery, 124, 345–353.CrossRefGoogle Scholar
  36. Rapkin, B. D., Garcia, I., Michael, W., Zhang, J., & Schwartz, C. E. (2017). Distinguishing appraisal and personality influences on quality of life in chronic illness: Introducing the quality-of-life Appraisal Profile version 2. Quality of Life Research, 26, 2815–2829.CrossRefGoogle Scholar
  37. Rapkin, B. D., & Schwartz, C. E. (2004). Toward a theoretical model of quality of life appraisal: Implications of findings from studies of response shift. Health and Quality of Life Outcomes, 15, 14.CrossRefGoogle Scholar
  38. Rothman, D. J. (1992). Strangers at the bedside a history of how law and bioethics transformed medical decision making. New York: Basic Books.Google Scholar
  39. Rothman, M., Burke, L., Erickson, P., Leidy, N. K., Patrick, D. L., & Petrie, C. D. (2009). Use of existing patient-reported outcome (PRO) instruments and their modification: The ISPOR Good Research Practices for evaluating and documenting content validity for the use of existing instruments and their modification PRO Task Force Report. Value in Health, 12, 1075–1083.CrossRefGoogle Scholar
  40. Ruta, D. A., Garratt, A. M., Leng, M., Russell, I. T., & MacDonald, L. M. (1994). A new approach to the measurement of quality of life. The Patient-Generated Index. Medical Care, 32, 1109–1126.CrossRefGoogle Scholar
  41. Schwartz, C. E., & Rapkin, B. D. (2004). Reconsidering the psychometrics of quality of life assessment in light of response shift and appraisal. Health and Quality of Life Outcomes, 15, 16.CrossRefGoogle Scholar
  42. Sen, A. (1993). Capability and well-being. In M. C. Nussbaum & A. Sen (Eds.), The quality of life (pp. 30–53). Oxford: Clarendon Press.CrossRefGoogle Scholar
  43. Sprangers, M., & Schwartz, C. (1999). Integrating response shift into health-related quality of life research: A theoretical model. Social Science and Medicine, 48, 1507–1515.CrossRefGoogle Scholar
  44. Tang, J. A., Oh, T., Scheer, J. K., & Parsa, A. T. (2014). The current trend of administering a patient-generated oncological setting: A systematic review. Oncology Reviews, 8, 245.CrossRefGoogle Scholar
  45. Timmerman, C. (2012). Just give me the best quality of life questionnaire: The Karnofsky scale and the history of quality of life measurements in cancer trials. Chronic Illness, 9, 179–190.CrossRefGoogle Scholar
  46. Timmermans, S., & Berg, M. (2003). The gold standard: The challenge of evidence-based medicine and standardization in health care. Philadelphia: Temple University Press.Google Scholar
  47. Trujols, J., & Portella, M. (2013). Not all PROMs reflect patients’ perspectives. British Medical Journal, 346, f1552.CrossRefGoogle Scholar
  48. US Food and Drug Administration. (2009). Guidance for industry on patient-reported outcomes measures: Use in medicinal product development to support labeling claims. Federal Register, 74, 1–43.Google Scholar
  49. van Loon, M. S., van Leeuwen, K. M., Ostelo, R. W. J. G., Bosmans, J. E., & Widdershover, G. A. M. (2018). Quality of life in a broader perspective: Does ASCOT reflect the capability approach? Quality of Life Research, 27, 1181–1189.CrossRefGoogle Scholar
  50. Verkerk, M. A., Busschbach, J. J. V., & Karssing, E. D. (2001). Health-related quality of life research and the capability approach of Amartya Sen. Quality of Life Research, 10, 49–55.CrossRefGoogle Scholar
  51. Wiering, B., de Boer, D., & Delnoij, D. (2017). Patient involvement in the development of patient-reported outcome measures: The developers’ perspective. BMC Health Services Research, 17, 635.CrossRefGoogle Scholar
  52. Wu, A. W., Snyder, C., Clancy, C. M., & Steinwachs, D. M. (2010). Adding the patient perspetive to comparative effectiveness research. Health Affairs, 29, 1863–1871.CrossRefGoogle Scholar

Copyright information

© Springer Nature B.V. 2019

Authors and Affiliations

  1. 1.School of NursingUniversity College CorkCorkIreland
  2. 2.Department of PhilosophyUniversity of South CarolinaColumbiaUSA

Personalised recommendations