Abstract
Patient-reported outcome measures (PROMs) are now common endpoints in clinical trials. In 2009 in an effort to standardize and streamline their use in medical product labeling, the FDA published FDA Guidance for Industry Patient-Reported Outcomes Measures: Use in Medical Product Development to Support Labeling Claims. This publication drew attention to the need to ensure that PROMs are methodologically sound. Nonetheless, in this paper I discuss how many of these measures continue to fall short in terms of validity, interpretability, and responsiveness. As a reaction to these shortcomings, researchers increasingly call for the development of more scientific measures. I argue that although improving PROMs’ measurement properties is a worthy endeavor, we should not be uncritical of these attempts. Calling for improved measures in the name of science should not blind us to the way that even our best measures employ values in their development—values that may further the marketing needs of industry. When values are needed to further our scientific ends, it behooves us to examine them in terms of their social consequences. Thus I argue that we ought to consider not only the scientific advances that new PROMs may bring but also the values that are used to develop them.
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Notes
- 1.
Standard errors are a way of telling from a statistical perspective if x is significantly different from y. If standard errors overlap, this tells us that, in the case of PROMs, two items are similar enough to be indistinguishable.
- 2.
For a longer discussion of the difficulties that CTT has with distinguishing between true scores and measurement error, see McClimans 2017.
References
BIPM (Bureau International des Poids et Measures). 2006. The International System of Units (SI). Sèvres: BIPM. http://www.bipm.org/en/si/si_brochure/. Accessed 16 Apr 2015.
Cano, S.J., and J.C. Hobart. 2011. The problem with health measurement. Patient Preference and Adherence 5: 279–290.
Chauhan, C. 2007. Denouement: A Patient-Reported Observation. Value in Health 10: S146–S147.
Critical Path Institute. 2015. http://c-path.org/about/. Accessed 7 Apr 2015.
DeMuro, C., M. Clark, L. Doward, E. Evans, M. Mordin, and A. Gnanasakthy. 2013. Assessment of PRO Label Claims Granted by the FDA as Compared to the EMA (2006–2010). Value in Health 16(8): 1150–1155.
Douglas, H. 2009. Science, Policy, and the Value-Free Ideal. Pittsburgh: University of Pittsburgh Press.
Fayers, P., and D. Machin. 2007. Quality of Life: The Assessment, Analysis and Interpretation of Patient-Reported Outcomes, 2nd ed. Chichester: Wiley.
Food and Drug Administration. 2007. Drug Development Tools Qualification Programs > Clinical Outcome Assessment Qualification Program. http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugDevelopmentToolsQualificationProgram/ucm284077.htm. Accessed 7 Apr 2015.
Hobart, J.C., S.J. Cano, J.P. Zajicek, and A.J. Thompson. 2007. Rating Scales as Outcome Measures for Clinical Trials in Neurology: Problems, Solutions, and Recommendations. Lancet Neurology 6(12): 1094–1105.
Hunt, S.M. 1997. The Problem of Quality of Life. Quality of Life Research 6(3): 205–212.
Jaeschke, R., J. Singer, and G.H. Guyatt. 1989. Measurement of Health Status. Ascertaining the Minimal Clinically Important Difference. Contemporary Clinical Trials 10(4): 407–415.
McClimans, L. 2010a. Towards Self-Determination in Quality of Life Research: A Dialogic Approach. Medicine, Health Care, and Philosophy 13(1): 67–76.
———. 2010b. A Theoretical Framework for Patient-Reported Outcome Measures. Theoretical Medicine and Bioethics 31(3): 225–240.
———. 2011. Interpretability, Validity, and the Minimum Important Difference. Theoretical Medicine and Bioethics 32(6): 389–401.
———. 2017. Measurement in Medicine and Beyond: Quality of Life, Blood Pressure and Time. In Reasoning in Measurement, ed. N. Mößner and A. Nordmann. London: Routledge.
McClimans, L., and J.P. Browne. 2012. Quality of Life Is a Process Not an Outcome. Theoretical Medicine and Bioethics 33(4): 279–292.
Schwartz, C.E., and M.A. Sprangers. 1999. Methodological Approaches for Assessing Response Shift in Longitudinal Health-Related Quality-of-Life Research. Social Science & Medicine 48(11): 1531–1548.
Sismondo, S. 2007. Ghost Management: How Much of the Medical Literature Is Shaped Behind the Scenes by the Pharmaceutical Industry? PLoS Medicine 4(9): e286.
Sismondo, S., and M. Doucet. 2010. Publication Ethics and the Ghost Management of Medical Publication. Bioethics 24(6): 273–283.
Sismondo, S., and S.H. Nicholson. 2009. Publication Planning 101. Journal of Pharmacy & Pharmaceutical Sciences 12(3): 273–279.
Stenner, A.J., and M. Smith. 1982. Testing Construct Theories. Perceptual and Motor Skills 55(2): 415–426.
Streiner, D.L., and G.R. Norman. 2008. Health Measurement Scales: A Practical Guide to Their Development and Use. Oxford: Oxford University Press.
Tal, E. 2011. How Accurate Is the Standard Second? Philosophy in Science 78(5): 1082–1096.
Taminiau-Bloem, E.F., F.J. Van Zuuren, M. Visser, C. Tishelman, C.E. Schwartz, M.A. Koeneman, C. Koning, and M. Sprangers. 2011. Opening the Black Box of Cancer Patients’ Quality-of-Life Change Assessments: A Think-Aloud Study Examining the Cognitive Processes Underlying Responses to Transition Items. Psychology & Health 26(11): 1414–1428.
Terwee, C.B., F.W. Dekker, W.M. Wiersinga, M.F. Prummel, and P. Bossuyt. 2003. On Assessing Responsiveness of Health-Related Quality of Life Instruments: Guidelines for Instrument Evaluation. Quality of Life Research 12(4): 349–362.
Wyrwich, K.W., and V.M. Tardino. 2006. Understanding Global Transition Assessments. Quality of Life Research 15(6): 995–1004.
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McClimans, L. (2017). Health Measurement, Industry, and Science. In: Ho, D. (eds) Philosophical Issues in Pharmaceutics. Philosophy and Medicine, vol 122. Springer, Dordrecht. https://doi.org/10.1007/978-94-024-0979-6_6
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