Abstract
This manuscript suggests a new method of instrument selection in novel applications. Dimension change profile analysis was developed to ensure the credibility and validity of the observed outcomes while maximizing the probability of obtaining statistically significant results.
Ad-hoc or disease-specific instruments developed for a specific purpose, which are generally more responsive to changes in patient health status, may suffer from lack of acceptance by regulatory agencies. Dimension change profile analysis addresses this issue by providing a systematic, defensible method for selecting a previously developed, complementary instrument to provide additional validation of results.
Meta-analytical techniques are used to derive from the literature a profile of impairments in dimensions of health-related quality of life associated with the underlying disease state, and to produce a profile of likely change or effect for the intended interventions. When the two profiles are combined it produces a profile of the dimensions in which significant change is possible.
Possible change is then compared to the relevant group of available, previously validated off-the-shelf instruments. The process facilitates and systematizes the selection of a “companion” instrument in such a manner that the probability of finding significant results with the secondary instrument is optimized, while permitting the researcher to benefit from the use of an instrument whose previous use and acceptance enhances credibility and validity. A hypothetical example is presented to illustrate the technique.
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Murawski, M.M. Dimension Change Profile Analysis: A Systematic Approach to Health-Related Quality of Life Instrument Selection in Novel Applications. Ther Innov Regul Sci 37, 165–175 (2003). https://doi.org/10.1177/009286150303700206
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DOI: https://doi.org/10.1177/009286150303700206