Modern Methods of Clinical Investigation (1990) / Chapter Skim
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3. Advances in Health Status Measurement: The Potential to Improve Experimental and Non-Experimental Data Collection
3. Advances in Health Status Measurement: The Potential to Improve Experimental and Non-Experimental Data Collection
Pages 23-32
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From page 23... ...
Since the health professionals participating in the trial are those providing clinical care, they usually are principally expert in clinical medicine rather than evaluative research. The design of trials and data collection forms is done by the coordinating center—usually a department of the firm running the study.
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From page 24... ...
A review of the literature shows that quality of life may include any one or a combination of the following factors: physical activity, social and leisure activity, work, symptoms, loss of income, cognition, emotional adaptation, self-esteem, lThe word dimension refers to an area of interest or concern that is measured by several interrelated variables. For example, cardiovascular function is a dimension of health measured by blood pressure, treadmill performance, EKG, etc.; mental status is a dimension of health that may be measured by cognitive level, mood, effect, etc.
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From page 25... ...
In some cases they were used to determine patient eligibility for participation in a trial. The Karnofsky Performance Status Index, the New York Heart Association Classification, and the Specific Activity Scale are examples.
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From page 26... ...
Medical Care 1985;23:696 development and testing. Thus, their reliability tends to be poor, which precludes their use for monitoring patient progress or assessing outcome of therapy.
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From page 27... ...
All of them include physical functioning, but they also include other aspects of health, these may be symptoms, emotional status, cognition, or perceptions of health. The developers of health status measures expected their results to be valuable for formulating health policy, since they provide information about the health status of populations and about the benefits of new therapies or systems of health services delivery, such as increased use of home health services.
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From page 29... ...
Because such consequences of treatment and treatment-related side effects can affect all aspects of a patient's life, a quality of life assessment is deemed necessary. This assessment must meet certain criteria, however: it must fit into the planned data collection scheme; it must be short so as not to burden the patient; it must take no more than 15 minutes of the data collector's time; and it must be immediately acceptable and understandable to all the clinical members of the research team.
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From page 30... ...
Only now that some work has been done by independent investigators does there seem to be interest by those directly involved in the development of new AIDS drugs in examining these effects. FOUR PROBLEMS REGARDING THE MEASUREMENT OF HEALTH STATUS IN CLINICAL TRIALS My review of clinical research that assesses health status identified four broad issues: conceptualization of a construct, the value of a gold standard, the clinical significance and sensitivity of the measures, and practical administrative problems.
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From page 31... ...
When individuals differ, there is confidence that the test will pick up the difference. The clinical importance of score differences and health status is still unclear, and the meaning of any particular score on a health status measure produces no mental pictures that represents real people or real patients.
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From page 32... ...
Testa MA, Brown B Elulpitt CJ, Jenkins CD, Klerman GL, Williams GH.
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