Functional status and quality of life as main outcome measures of therapeutic efficacy in the elderly.

Methods of research and clinical practice have been developed in young subjects and are now inadequate to solve the health problems of the older population. This is also the case for pharmacological research, which has routinely excluded elderly people, although they are major consumers of drugs. Reasons contributing to this exclusion are greater susceptibility to drug effects, difficulties in recruitment and higher drop-out rates. The necessity to make a separate evaluation of drugs in the elderly has been clearly demonstrated by recent studies. In this regard, the Food and Drug Administration published a guideline concerning the study of drugs likely to be used in aged patients. Since preservation and improvement of quality of life and functional autonomy are often more appropriate goals than reduction of mortality, evaluation of therapeutic benefits requires suitable instruments. Questionnaires for the assessment of quality of life are available, but few of them have been designed specifically for older people.