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Quality pp 121–158Cite as

The Role of Signs or Symptoms

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Abstract

The focus of this chapter is on the complex relationship between signs and symptoms, as an analog and therefore continuation of my discussion of the relationship between objective and subjective indicators. I discuss the figurative language used to express signs and symptoms, and a history of the development of the concept of objectivity. A final major topic covers the role of subjectivity in clinical medicine, and includes a discussion of the difference between clinimetric and psychometric assessments.

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Notes

  1. 1.

    Of course, a person’s heart rate, blood pressure, or blood chemistries could become part of a quality assessment, these symptoms are qualified (i.e., a person indicates the importance these indicators have for them). Evidence that this occurs naturally can be confirmed when respondents claim that various signs are impeding their ­quality-of-life.

  2. 2.

    I will limit my discussion in this chapter to the assessment of a sign or symptom, and discuss how sign or symptom domains are formed in Chaps. 6 and 7.

  3. 3.

    The term “objectification” has another use different from how I am using it. In the alternative usage, objectification refers to the phenomenon that a person views his or her body as an object; something outside themselves (Fredrickson and Roberts 1997). This has been associated with the presence or eating disorders, particularly for women.

  4. 4.

    As will be discussed, “Grounded Field Theory” as an example of a qualitative assessment method, can reliably extract information from available data (e.g., interviews) and generate statements that have some of the properties of an invariant statement. This is so even though invariant statements generated from qualitative data may differ from those generated from quantitative data.

  5. 5.

    In Chap. 10, I provide another example of a neurological (dementia) deterioration and what it does to artistic expression.

  6. 6.

    This same question can be asked when establishing the relationship between symptoms and HRQOL. Is it the similarity, prototypicality, or exemplariness of features of a symptom that determines its relationship to HRQOL?

  7. 7.

    Mensuration refers to assessment, but the part of assessment or geometry concerned with ascertaining lengths, areas, and volumes. It originates from the Latin, “from mensurare” or “to measure.”

  8. 8.

    The Kaplan et al. (2000) paper was published prior to the Sullivan paper, but both are responding to a general debate that pervades medical science, to which Feinstein has made significant contributions.

  9. 9.

    Defining and monitoring adverse events is a fairly complicated field involving several alternative definitions of what is adverse; application sites (e.g., clinical trials, postmarketing surveillance); settings (e.g., research or clinical); and type of intervention (e.g., drugs, biological agents, various device, so on). There are also different agencies involved in this type of activity, such as the World Health Organization, the Food and Drug Administration, the European Union, etc. The WHO organization definition of adverse events is “An injury related to medical management, in contrast to complications of disease. Medical management includes all aspects of care, including diagnosis and treatment, failure to diagnose or treat, and the systems and equipment used to deliver care. Adverse events may be preventable or nonpreventable.” (WHO 2005; p. 8).

  10. 10.

    The issue of explicit and implicit valuations is a topic I will continue to discuss in this book. There are many more instances of implicit valuations, as opposed to formal explicit valuations, and the extent of this should reinforce the cognitive model of quality assessment being promoted in this book.

  11. 11.

    A typical dose-escalation protocol would have three subjects being exposed to a particular dose, until at least one person experiences a toxic response. Then three more people are exposed to the dose, and if none of the participants respond to this dose, they are exposed to the next higher dose, but if one of the three did respond, then the MTD would be said to have been reached. Dose-finding, however, is not unique to Phase I trials, since it is also found in Phase II and III, as well as in clinical practice.

  12. 12.

    At the time of presentation of this paper (October 1990), there were only two papers published that supported my argument: Berkel et al. (1988), which I was not aware of and did not cite; and an abstract by Melink et al. (1985), which I cited, and which was eventually published as a full paper in 1992.

  13. 13.

    The “line of equality” is a 45-degree angle with the origin at 0,0.

Abbreviations

AE:

Adverse events

BFI:

Brief fatigue inventory (Mendoza et al. 1999)

BPI:

Brief pain inventory (Cleeland 1989)

CES-D:

Center for epidemiology scale – depression (Radloff 1977)

CTCAE:

Common terminology criteria for adverse events

FACT-G:

Functional assessment of cancer treatment – general (Cella et al. 1993)

FACT-P:

Functional assessment of cancer treatment – prostate (Esper et al. 1997)

HRQOL:

Health-related quality-of-life

HUI:

Health Utility Index (Torrance et al. 1995)

IES:

Impact of Event Scale (Horowitz et al. 1979)

LC:

Local control

LCSS:

Lung Cancer Symptom Scale (Hollen et al. 1993)

QLQ-30C:

Quality-of-life questionnaire for cancer (Aaronson et al. 1991)

Q-TwiST:

Quality-adjusted time without symptoms and toxicity

QWB:

Quality of Well-being Scale (Kaplan and Anderson 1990)

REL:

Relapse

SF-36:

Short Form-36 (Ware et al. 1993)

TOI:

Summary measure of physical well-being, functional well-being, and disease-specific overall score from disease-specific FACT assessments

TOX:

Toxicity

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    Ivan Barofsky

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Barofsky, I. (2012). The Role of Signs or Symptoms. In: Quality. Springer, New York, NY. https://doi.org/10.1007/978-1-4419-9819-4_5

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