he primary value of outcomes assessment is its potential to produce the data necessary to develop medical practice guidelines that will improve the practice of medicine and, consequently, patient health outcomes.(4)
Theoretically, outcomes assessment can offer a data base for deciding what works and how and when to use it. This potential has not yet been realized fully, however. First, the study of effective medical care is still in its infancy. Only a small proportion of medical services have been subjected to rigorous testing to determine their actual effectiveness or relative merit compared with alternatives.(5) Although new drugs and some medical devices must generally be shown to be both safe and effective to be approved by the Food and Drug Administration before being distributed in interstate commerce,(6) medical procedures and services are largely unregulated.
Second, appropriate methodologies have not been developed for assessing the many different types of med
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