Physical education training for adult retardates in a sheltered workshop setting.
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We are entering an era in which the success of biomedical science and the increasing understanding of the value of evidence for practice are in a state of tension. This tension is especially notable in the device arena, in which the short life cycles and iterative nature of development are at odds with current design constructs of the types of clinical trials that provide evidence for medical decision making. The financial pressure arising from strained budgets and expanding costs from the aging of the population and the continued development of new technology heightens the need for a focus on new approaches. Given this background, a group of experts representing constituencies with different perspectives were convened for a day and a half to discuss key issues and their potential solutions. Because of the complex and heterogeneous nature of the environments in which devices are used, the meeting focused on 3 broad, general uses of devices: imaging, risk stratification, and therapeutics. The goal of the meeting was to develop a preliminary list of ideas that could be framed as researchable questions or constructs for consideration by policy makers that ultimately might lead to improvements in the current system. Across diagnostic imaging, risk stratification devices, and therapeutic devices, the crosscutting issues can be identified: We need better methods of collaborative funding and priority setting, improved and more flexible methods, and new approaches to the integration of federal agencies in overseeing the system.
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OBJECTIVES: To review the results of published randomised controlled trials in the treatment of brain metastases and, from the knowledge gained from these trials, to identify potential study questions. MATERIALS AND METHODS: The literature was searched for randomised controlled trials that dealt with the management of brain metastases. Potential research questions were identified on the basis of the results of the literature review. RESULTS: A number of research questions were identified. In the context of the NCIC Symptom Control Group, a trial of supportive care alone vs supportive care and whole-brain radiotherapy (WBRT) in a subset of patients with the diagnosis of brain metastases was deemed to be of highest priority. We discussed a number of issues relating to the feasibility of such a trial. CONCLUSIONS: The optimal management of brain metastases remains elusive. Despite the results of numerous randomised controlled trials, many questions remain unanswered. The magnitude of benefit using WBRT above supportive care alone is uncertain. A trial of supportive care alone vs supportive care and WBRT may be successful once target population, feasibility and methodological issues are thoroughly solved.
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