Skip to main content

Advertisement

SpringerLink
Log in

A theoretical framework for patient-reported outcome measures

  • Published:
Theoretical Medicine and Bioethics Aims and scope Submit manuscript

Abstract

Patient-reported outcome measures (PROMs) are increasingly used to assess multiple facets of healthcare, including effectiveness, side effects of treatment, symptoms, health care needs, quality of care, and the evaluation of health care options. There are thousands of these measures and yet there is very little discussion of their theoretical underpinnings. In her 2008 Presidential address to the Society for Quality of Life Research (ISOQoL), Professor Donna Lamping challenged researchers to grapple with the theoretical issues that arise from these measures. In this paper, I attempt to do so by arguing for an analogy between PROMs and Hans-Georg Gadamer’s logic of question and answer. While researchers readily admit that the constructs involved in PROMs are imperfectly understood and lack a gold standard, they often ignore the consequences of this fact. Gadamer’s work on questions and their importance to philosophical hermeneutics helps to show that the questions researchers ask about such constructs are also imperfectly understood. I argue that these questions should not be standardized, and I instead propose a theoretical framework that understands PROMs as posing genuine questions to respondents—questions that are open to reinterpretation.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Similar content being viewed by others

Notes

  1. Although ISOQoL refers explicitly to ‘quality of life research’, in practice, the interests of the society extend beyond these specific measures. In this paper, I use the term ‘patient-reported outcome measures’ to cover these more general interests.

  2. It is important to note that some philosophers have explored the theoretical basis of the constructs that these measures are meant to assess. These discussions tend to focus on questions about the nature of quality of life or welfare, e.g., are these constructs ‘subjective’ or ‘objective’, or are these constructs best characterized in terms of happiness or capabilities or preferences. For examples, see [1–4]. These discussions, however, often fail to engage with the practical grounding of PROMs as questionnaires or psychometric instruments. Thus in many ways they fail to meet the theoretical needs of researchers in this field. Antaki and Rapley make a similar point; see [5].

  3. Professor Lamping’s Presidential Address was made at the 2008 ISOQoL annual conference in Montevideo, Uruguay on 25 October 2009.

  4. Following Gadamer, I will use the terms ‘interpretation’ and ‘understanding’ synonymously.

  5. To be sure, we may have misunderstood the subject matter and then our questions may still be wrong.

  6. Collingwood [7] makes a similar point.

  7. To be sure, some have argued that there are ‘objective’ indicators for measuring quality of life, and thus we need not ask respondents questions. But there is now a strong consensus amongst PROMs researchers that quality of life and perceived health status are ‘subjective’ constructs, i.e., we need to ask patients questions; see [8].

  8. Although I am suggesting here that the FDA and ISPOR’s conceptualization of quality of life and perceived health status is inadequate, it is important to note that these new guidelines represent a significant step forward. Most existing measures have been developed with little if any patient input or qualitative research; see [10].

  9. This program is used to monitor and prioritize patients waiting for cataract surgery using the VF-14. This program makes it particularly easy to identify and follow-up on patients with high VF-14 scores; see [17].

  10. These findings compare favorably with a study in the UK in which the mean VF-14 score was 82.7. In this study 93% of patients described the results of their operation as good or better; 82% found their visual problems much better; 3.4% felt that the surgery was of no benefit or worse [19].

  11. Indeed in the UK, Black et al. found similar results in their 2009 study. In this study between 30 and 50% of patients had pre-operative VH-14 scores that indicated they could achieve little to no improvement. Yet after surgery 93.5% of these patients reported that their problem was better and 93.1% reported their outcome as good to excellent. Black et al. have suggested that a new, improved instrument for assessing the impact of cataract surgery on perceived visual functioning and quality of life is needed; see [19].

  12. This is not to say that every interpretation is legitimate, see [13].

  13. In terms of overcoming, see [25, 26]; in terms of taming, see [27].

References

  1. Griffin, James. 1986. Well-being. Oxford: Clarendon Press.

    Google Scholar 

  2. Sen, Amartya. 1993. Capability and well being. In The quality of life, ed. Martha C. Nussbaum, and Amartya Sen, 30–53. Oxford: Clarendon Press.

    Chapter  Google Scholar 

  3. Nordenfelt, Lennart. 1993. Quality of life, health and happiness. Aldershot: Ashgate Publishing.

    Google Scholar 

  4. Sumner, Leonard W. 1996. Welfare, happiness and ethics. Oxford: Clarendon Press.

    Google Scholar 

  5. Antaki, Charles, and Mark Rapley. 1996. Quality of life talk: The liberal paradox of psychological testing. Discourse and Society 7: 293–316.

    Article  Google Scholar 

  6. Gadamer, Hans-Georg. 2003. Truth and method, 2nd ed. Trans. Joel Weinsheimer and Donald G. Marshall. New York: Continuum Press.

  7. Collingwood, Robin G. 1939. An autobiography. London: Oxford University Press.

    Google Scholar 

  8. Stenner, P. H., D. Cooper, and S.M. Skevington. 2003. Putting the Q into quality of life; the identification of subjective constructions of health-related quality of life using Q methodology. Social Science and Medicine 57: 2161–2173.

    Google Scholar 

  9. Food and Drug Administration. 2009. Guidance for industry on patient-reported outcome measures: Use in medicinal product development to support labeling claims. Federal Register 74: 1–43.

    Google Scholar 

  10. Rotherman, M., L. Burke, P. Erickson, N.K. Leidy, D.L. Patrick, and C.D. Petrie. 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.

    Article  Google Scholar 

  11. Hickey, A., C.A. O’Boyle, H.M. McGee, and C.R.B. Joyce. 1999. The schedule for the evaluation of individual quality of life. In Individual quality of life: Approaches to conceptualisation and assessment, ed. C.R.B. Joyce, C.A. O’Boyle, and H. McGee, 119–134. Australia: Harwood Academic Publishers.

    Google Scholar 

  12. Schwartz, Carolyn E., and Bruce D. Rapkin. 2004. Reconsidering the psychometrics of quality of life assessment in light of response shift and appraisal. Health and Quality of Life Outcomes 2: 14.

    Article  Google Scholar 

  13. McClimans, Leah. 2010. Towards self-determination in quality of life research: A dialogic approach. Medicine, Health Care and Philosophy 13: 612.

    Article  Google Scholar 

  14. Wright, C.J., and Y. Robens-Paradise. 2001. Evaluation of indications and outcomes in elective surgery: A feasibility study in the acute care hospitals of the Vancouver/Richmond health region. Results from the Regional Evaluation of Surgical Indications and Outcomes (RESIO) project. http://www.chspr.ubc.ca/files/publications/2001/hpru01-06R.pdf. Accessed 4 February 2010.

  15. Desai, P., A. Reidy, D.C. Minassian, G. Vafidis, and J. Bolger. 1996. Gains from cataract surgery: Visual function and quality of life. British Journal of Ophthalmology 80: 868–873.

    Article  Google Scholar 

  16. Schein, O.D., E.P. Steinberg, S.D. Cassard, J.M. Tielsch, J.C. Javitt, and A. Sommer. 1995. Predictors of outcomes in patients who underwent cataract surgery. Ophthalmology 102: 817–823.

    Google Scholar 

  17. Bellan, Lorne. 2005. Why are patients with no visual symptoms on cataract waiting lists? Canadian Journal of Ophthalmology 40: 433–438.

    Google Scholar 

  18. Wright, C.J., G.K. Chambers, and Y. Robens-Paradise. 2002. Evaluation of indications for outcomes of elective surgery. Canadian Medical Association Journal 167: 461–466.

    Google Scholar 

  19. Black, N., J. Browne, J. van der Meulen, L. Jamieson, L. Copely, and J. Lewsey. 2009. Is there overutilization of cataract surgery in England? British Journal of Ophthalmology 93: 13–17.

    Article  Google Scholar 

  20. Steinberg, E.P., J.M. Tielsch, O.D. Schein, J.C. Javitt, P. Sharkey, S.D. Cassard, M.W. Legro, et al. 1994. The VF-14. An index of functional impairment in patients with cataracts. Archives of Ophthalmology 112: 630–638.

    Google Scholar 

  21. Clark, Herbert H., and Michael F. Schober. 1992. Asking questions and influencing answers. In Questions about questions: Inquiries into the cognitive bases of surveys, ed. Judith M. Tanur, 15–48. New York: Sage Foundation.

    Google Scholar 

  22. Wright, L. 2001. Critical thinking: An introduction to analytical reading and reasoning. Oxford: Oxford University Press.

    Google Scholar 

  23. Donovan, Jennifer L., S.J. Frankel, and J.D. Eyles. 1993. Assessing the need for health status measures. Journal of Epidemiology and Community Health 47: 158–162.

    Article  Google Scholar 

  24. Mallinson, Sarah. 2002. Listening to respondents: A qualitative assessment of the short-form 36 health status questionnaire. Social Science and Medicine 54: 11–21.

    Article  Google Scholar 

  25. Krabbe, Paul F.M. 2008. Thurstone scaling as a measurement method to quantify subjective health outcomes. Medical Care 46: 357–365.

    Article  Google Scholar 

  26. Krabbe, Paul, F.M., Noor Tromp, Theo J.M. Ruers, and Piet van Riel. 2008. Better measurement methods may notably reduce response-shifts. 2008 International Society for Quality of Life Research meeting abstracts. QLR Journal: A-22, Abstract #1214. http://isoqol.org/pdfs/AbstractsForBooklet_2008v3.pdf. Accessed 4 April 2010.

  27. Rapkin, Bruce D., and Carolyn E. Schwartz. 2004. Toward a theoretical model of quality-of-life appraisal: Implications of findings from studies of response shift. Health and Quality of Life Outcomes 2: 16.

    Article  Google Scholar 

  28. Westerman, Marjan J., Tony Hak, Mirjam A. Sprangers, Harry J.M. Groen, Gerrit van der Wal, and Anne-Mei The. 2008. Listen to their answers! Response behaviour in the measurement of physical and role functioning. Quality of Life Research 17: 549–558.

    Article  Google Scholar 

  29. Goddard, Ruth-Barclay, Joshua D. Epstein, and Nancy E. Mayo. 2009. Response shift: A brief overview and proposed research priorities. Quality of Life Research 18: 335–346.

    Article  Google Scholar 

  30. Pool, Jan J.M., Sharon R. Hiralal, Raymond W.J.G. Ostelo, Kees van der Veer, and Henrica C.W. de Vet. 2010. Added value of qualitative studies in the development of health related patient reported outcomes such as the pain coping and cognition list in patients with sub-acute neck pain. Manual Therapy 15: 43–47.

    Article  Google Scholar 

  31. Grondin, Jean. 1994. Introduction to philosophical hermeneutics. Trans. Joel Weinsheimer. New Haven: Yale University Press.

Download references

Author information

Authors and Affiliations

  1. Department of Philosophy, University of South Carolina, Columbia, SC, USA

    Leah McClimans

Authors
  1. Leah McClimans
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Leah McClimans.

Rights and permissions

Reprints and permissions

About this article

Cite this article

McClimans, L. A theoretical framework for patient-reported outcome measures. Theor Med Bioeth 31, 225–240 (2010). https://doi.org/10.1007/s11017-010-9142-0

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s11017-010-9142-0

Keywords

Search

Navigation