Challenges in the design and conduct of controlled clinical effectiveness trials in XXXX .

@entity1 @entity146 @entity1316 @entity161 @entity1090
BACKGROUND: The introduction of antipsychotic medication has been a major advance in the treatment of @entity161 and allows millions of @entity1 to live outside of institutions. It is generally believed that long-acting intramuscular antipsychotic medication is the most effective approach to increasing medication adherence and thereby reduce relapse in high-risk @entity1 with @entity161 , but the data are scant. PURPOSE: To report the design of a study to assess the effect of long-acting injectable @entity1090 in unstable @entity1 and under more realistic conditions than previously studied and to evaluate the effect of this medication on @entity146 inpatient hospitalization, @entity161 symptoms, quality of life, medication adherence, side effects, and health care costs. METHODS: The trial was an open randomized clinical comparative effectiveness trial in @entity1 with @entity161 or @entity1316 in which parenteral @entity1090 was compared to an oral antipsychotic regimen selected by each control @entity1 's psychiatrist. @entity1 had unstable @entity146 disease defined by recent hospitalization or exhibition of unusual need for @entity146 services. The primary endpoint was hospitalization for @entity146 indications; the secondary endpoint was @entity146 symptoms. RESULTS: Overall, 382 @entity1 were randomized. Determination of a @entity1 ' competency to understand the elements of informed consent was addressed. The use of a closed-circuit TV interview for psychosocial measures provided an economical, high quality, reliable means of collecting data. A unique method for insuring that usual care was optimal was incorporated in the follow-up of all subjects. LIMITATIONS: @entity1 with @entity161 or @entity1316 and with the common co-morbid illnesses seen in the VA are a challenging group of subjects to study in long-term trials. Some techniques unique in the VA and found useful may not be generalizable or applicable in other research or treatment settings. CONCLUSIONS: The trial tested a new antipsychotic medication early in its adoption in the Veterans Health Administration. The VA has a unique electronic medical record and database which can be used to identify the endpoint, that is, first hospitalization due to a @entity146 problem, with complete ascertainment. Several methodologic solutions addressed competency to understand elements of consent, the costs and reliability of collecting interview data gathering, and insuring usual care.
