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Clinical trials that use subjective measures as endpoints usually evaluate outcomes such as symptom scores, the need for rescue medication, and quality-of-life measures.
Such studies led to the increased inclusion of volumetric measures as endpoints in clinical trials.
The Food and Drug Administration FDAA) recently presented its draft guidance and view on the use of PRO measures as endpoints in clinical trials.
The Food and Drug Administration FDAA) presents its draft guidance and its view on the use of patient-reported outcome (PRO) measures as endpoints in clinical trials in this issue of Health and Quality of Life Outcomes [ 1].
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Since THA, in most cases, aims explicitly to improve HRQOL, using HRQOL measures as endpoint in orthopaedic research on evaluation of treatment outcome is now seen as a necessity to fully understand the effects of this intervention [ 26].
Behavioral alterations can be measured as endpoints for sublethal toxicity, and serve as a tool for environmental risk assessment and analysis of toxicological impact.
The parameters measured as endpoints of clinical studies, like prolongation of survival, improvement in quality of life, lowering of high blood pressure, changes that can be identified in imaging procedures, undesired side effects of drugs, and increased compliance, are considered "effects".
Information about primary study endpoints, other outcome measures, as well as follow-up visits (e.g. symptoms, clinical assessment, anthropometric measurements) are extracted from these records.
After 24 h, IL-2 production was measured as endpoint.
The semi-quantitative US endpoints demonstrated in this study, whether used alone or together with clinical measures as composite endpoints, could be used in centers not possessing quantitative analysis tools.
It can be due to insufficient power, since most economic evaluations alongside trials have clinical measures as primary endpoints.
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