Use of Quality of Life Measures in Clinical Trials
Section snippets
REQUIREMENTS OF A MEASURE OF QOL FOR CLINICAL-TRIALS WORK
We shall discuss four considerations relevant to clinical-trial design: whether the measure probes a specific disease, what are the psychometric properties of the measure, how long it is, and who responds to the queries it poses.
DISEASE-SPECIFIC MEASURES
Having reviewed many QOL measures for children, Eiser and Morse4 found that a greater number were available for cancer patients than for children with other conditions. To facilitate the choices of trial developers, we shall now devote some attention to these cancer-specific measures.
BARRIERS TO INCLUDING QOL MEASURES
Although trials involving adult patients with cancer routinely include measures of QOL, trials involving pediatric cancer patients do not. One may attribute such omissions in part to clinician prejudice against measures whose quality is suspect.19 Researchers have, however, advanced arguments for exclusion on other bases, including economics, maturation, and response shift.
USE OF QOL MEASURES IN CLINICAL TRIALS
Although there seems to be more interest in developing QOL measures now, their application to clinical-trials research during the years has been anything but extensive. Indeed, only 3% of trials in pediatric oncology include a QOL measure.23 The way to ensure an increase in this percentage is to design QOL considerations into the study at its outset.
For example, trials conducted to compare standard treatment with a new treatment or standard dosage with an altered dosage may seek primarily to
CONCLUSIONS
The preceding text has indicated some of the difficulties researchers encounter in measuring children's QOL. We have argued nevertheless that inclusion of QOL measures in clinical trials should be de rigueur—otherwise, a number of pressing issues concerning the effects of treatments can scarcely be discussed. Against this argument is the common retort that current QOL measures lack the versatility or specialized content necessary to probe children's issues credibly. Unfortunately, this
ACKNOWLEDGMENT
Christine Eiser was funded by Cancer Research-UK.
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