This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The purpose of this pilot study is to test the hypothesis that clinical research subjects who receive additional education regarding potential side effects of medications will be more likely to report these side effects. Providers have suggested that patients who are made aware of possible medication side effects are then more likely to report them. Studies investigating this hypothesis, however, are scarce and have yielded conflicting results. In three separate studies, Myers and Calvert (1973, 1976) and Morris and Kanouse (1982) reported that giving patients information regarding potential side effects did not increase their reporting of such side effects. Myers, Cairns and Singer (l987) reported that inclusion of possible side effects in the consent form may have increased the likelihood of patients attributing symptoms to drug therapy, leading to subsequent withdrawal from the study. The issue of providing subjects with additional information, beyond what is included in the informed consent, has not been evaluated in the clinical research setting, where side effect profiles may influence medication descriptions in the Physicians' Desk Reference guide. Healthy men between the ages of 20 and 45 were admitted to the General Clinical Research Center for an endocrine study, including informed consent and information on drug side effects. They were then asked if they would like to enroll in a substudy that would consist of two types of education on the study medication. Standard education consisted of a verbal explanation of the action and potential side effects of the study medication. Intensive education consisted of standard education along with an additional education sheet written in large font listing the action and potential side effects for the subject to take home. Additionally, a short quiz was given to assess subjects' understanding of the information. At baseline and subsequent visits, the Study Staff obtained information regarding side effects. The Study Staff, Principal Investigator and all staff nurses who cared for subjects at subsequent visits were blinded as to subject randomization.
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