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April 1997

Use of Quality-of-Life Instruments in Randomized Clinical Trials

Author Affiliations

Baltimore, Md

Arch Ophthalmol. 1997;115(4):564-565. doi:10.1001/archopht.1997.01100150566031

I read with interest the insightful editorial by Carl Kupfer, MD, in the July 1996 issue of the Archives1 stressing the importance of obtaining "cost outcomes along with the clinical and quality-of-life outcomes" as integral components of randomized clinical trials. Recent studies more than justify Dr Kupfer's focus on the need for identifying clinical outcomes that actually affect the everyday functioning of individuals we seek to help.

It was interesting to note that the National Eye Institute, Bethesda, Md, is developing "a vision function assessment-quality-of-life instrument to be used in all RCTs." At least 2 types of quality-of-life measures have generally been employed. One measures an individual's sense of well-being, such as the instrument indicating that patients with myopia who are undergoing refractive surgery are more concerned with improved vision than with ridding themselves of glasses.2 The second measures changes in an individual's perceived ability to function, like

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