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Felicitometric hermeneutics: interpreting quality of life measurements

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Abstract

The use of quality of life (QOL) outcomes in clinical trials is increasing as a number of practical, ethical, methodological, and regulatory reasons for their use have become apparent. It is important, then, that QOL measurements and differences between QOL scores be readily interpretable. We study interpretation in two contexts: when determining QOL and when basing decisions on QOL differences. We consider both clinical situations involving individual patients and research contexts, e.g., randomized clinical trials, involving groups of patients. We note the ethical importance of such understanding: proper interpretation and communication facilitate health care decision making. Communication that facilitates interpretation is of moral significance since better communication can attenuate ethical problems and inform choices. Much of what is communication worthy about QOL assessments is determined by the particular QOL instrument used in the assessment and how it is administered. In practice, these choices will be driven by the purpose of the assessment, but, it is argued, to maximize understanding, we should combine the information garnered from traditional standardized QOL instruments, from individualized QOL assessments, and from a recently proposed dialogic paradigm, where QOL is determined by shared conversation regarding the interpretation of texts. And, while some studies can surely succeed using abbreviated methods of administration (e.g., postal surveys may suffice for certain purposes), we will focus on methods of administration involving interviewer–respondent interaction. We suggest that during the QOL elicitation process, interviewer and respondent should engage in a two-way conversation in order to achieve a shared understanding of the “answers” to QOL “questions” and, finally, to reach a shared interpretation of the individual’s QOL.

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Notes

  1. See [1] for a look at the growth curve over the 1980s and 1990s as well as what qualifies as a quality of life outcome. A current PubMed search for “quality of life” in either the title or among the keywords produced 156,828 hits. A simple Google search on “quality of life” found 76,000,000 items.

  2. From whence springs the title “Felicitometric Hermeneutics”? Felicitometrics is the measurement of the “quality” in quality of life. This term was coined by Bernheim [3]. He meant for it to be used in Happiness and general QOL research. Here our focus is on health related QOL and clinical trial outcomes, but the term maintains its usefulness in this more restricted context. Hermeneutics is the study of interpretation.

  3. The FDA has reviewed a number of products for approval to communicate QOL outcomes in labeling and promotion. The importance of “getting this right”—especially the part about advertising—is apparent.

  4. They used the terminology Patient Reported Outcomes (PROs), which include, but are not limited to, QOL outcomes.

  5. Examples of explicit attempts to enhance the usefulness and interpretability of QOL scores are the minimal clinically important difference [8], the sufficiently important difference [9], the binomial effect size display [10], and the number needed to treat [11].

  6. Lydick and Epstein give the example of a clinical trial for a new therapy for benign prostatic hyperplasia that used urine flow as an outcome measure [12]. At the end of one year, the urine flow of individuals receiving active treatment improved, on average, by 3 cc/s over those who received placebo. Would you consider that the new therapy, on average, improves QOL?

  7. Several individualized instruments ask for 5 dimensions, but this is arbitrary. In general, k dimensions can be used. In our discussion, we take k = 5.

  8. While instruments of this kind can be self-administered in certain situations, generally speaking, trained interviewers will be used in soliciting the required information. Some respondents have difficulty in specifying dimensions and may require some prompting to get to the number 5. As a result of this interaction, interviewers will identify a number of issues as defining a dimension. For example, the dimension comprised of issues relating to health may contain particular issues like to be cured, to not be so tired, to feel better, etc. Issues relating to autonomy might include being independent, being able to drive, being able to shop, etc.

  9. Response shift refers to a change in the meaning of the self-evaluation of QOL resulting from changes in internal standards, values, or conceptualization. When, at different times of measurement, respondents indicate different dimensions, this could represent a reconceptualization and a change in the assigned weights a change in values.

  10. If we have pre- and post-measures on a subject, we ask at the time of the post-measure for the subject to rate (or weight) the dimension at the time of the pre-measure, not as they recall it, but as they now see it, the so-called then-measure. The difference between the pre- and then-measure is due to response shift and the difference between the post- and then-measure is a more accurate estimate (as compared to the usual post- minus pre-measure) of treatment effect since it controls for response shift.

  11. For example, Joyce et al. said “The SEIQoL score is probably no more culture-bound than systolic blood pressure or body temperature” [27, p. 278].

  12. Former Surgeon General Koop has said, “Nothing in medicine—and nothing anywhere else in our Western Judeo-Christian tradition—enables one person to make a judgment about another person’s ‘quality of life.’”

  13. In the language of survey methodology literature, this would be called a cognitive interview; a request to think-aloud.

  14. QOL measures can be used in various ways, e.g., they can be used to define inclusion/exclusion criteria for a clinical trial, to judge treatment effectiveness (in an individual patient or in groups of patients), or for monitoring adverse events. One might imagine that the best instrument to use will be the one easiest to administer that can answer the question posed. This choice might even be easy on occasion. Contrasting SF-36 scores in a particular group 10 years ago with current scores can be done in only one way.

  15. Even if further research might suggest additional dimensions will have value, it is best to learn to walk before running.

  16. She does suggest that we might “use qualitative studies to survey a sub-section of respondents at different periods throughout the duration of a study … to help provide insight and raise questions regarding the meaning of our constructs and questions” [24, p. 238]. We think that the size of the subsample and the frequency of periods will be determined by study aims. Every study will not require that we survey everyone at each time of measurement, but some might, and those involving repeated administration of the SEIQoL will.

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Authors and Affiliations

  1. Institutional Review Board, Health Sciences/Behavioral Sciences, University of Michigan, 540 East Liberty, Ste 202, Ann Arbor, MI, 48104, USA

    Charles J. Kowalski

  2. Vrije Universiteit Brussel, Brussels, Belgium

    Jan L. Bernheim & Peter Theuns

  3. University of Michigan, Ann Arbor, MI, USA

    Nancy Adair Birk

Authors
  1. Charles J. Kowalski
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  2. Jan L. Bernheim
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  3. Nancy Adair Birk
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  4. Peter Theuns
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Correspondence to Charles J. Kowalski.

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Kowalski, C.J., Bernheim, J.L., Birk, N.A. et al. Felicitometric hermeneutics: interpreting quality of life measurements. Theor Med Bioeth 33, 207–220 (2012). https://doi.org/10.1007/s11017-012-9215-3

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