J Formos Med Assoc
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Translational medicine has been defined as bench-to-bedside research, where a basic laboratory discovery becomes applicable to the diagnosis, treatment or prevention of a specific disease, and is brought forth by either a physician/scientist who works at the interface between the research laboratory and patient care, or by a team of basic and clinical science investigators. Statistics plays an important role in translational medicine to ensure that the translational process is accurate and reliable, with statistical assurance. ⋯ Under a well established and validated translational model, statistical tests for one-way and two-way translation are discussed. Some discussion on lost in translation is also given.
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This study focuses on strategies and statistical considerations for assessment of translation in language (e.g. translation of case report forms in multinational clinical trials), information (e.g. translation of basic discoveries to the clinic) and technology (e.g. translation of Chinese diagnostic techniques to well-established clinical study endpoints) in pharmaceutical/clinical research and development. However, most of our efforts will be directed to statistical considerations for translation in information. ⋯ Statistical inference for the applicability of an animal model to a human model is also discussed. Strategies for selection of clinical study endpoints (e.g. absolute changes, relative changes, or responder-defined, based on either absolute or relative change) are reviewed.
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Randomized Controlled Trial
Randomized study of darbepoetin alfa and recombinant human erythropoietin for treatment of renal anemia in chronic renal failure patients receiving peritoneal dialysis.
Darbepoetin alfa can be administered less frequently than recombinant human erythropoietin (r-HuEPO) for the treatment of anemia in chronic renal failure (CRF) patients. We aimed to confirm that darbepoetin alfa at a reduced dosing schedule can safely maintain a target hemoglobin level in CRF patients undergoing peritoneal dialysis. ⋯ Both darbepoetin alfa and r-HuEPO safely maintain hemoglobin levels within the target range in peritoneal dialysis patients.
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An epidemic of severe acute respiratory syndrome (SARS) occurred in Taiwan from April to July 2003. A nosocomial outbreak of SARS occurred at Kaohsiung Chang Gung Memorial Hospital (CGMH) in May 2003. The purpose of our study was to survey the prevalence of the SARS coronavirus (CoV) in a community adjacent to Kaohsiung CGMH and collect demographic data, including basic information about health status, household, and possible risk factors for SARS-CoV infection. ⋯ There was low post-epidemic seroprevalence of SARS-CoV in a community adjacent to a hospital which had a nosocomial SARS outbreak. The SARS outbreak in Taiwan was primarily limited to hospital settings.
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Taiwan saw an increase in immigration during the last decade. This retrospective study investigated whether immigrant status confers a protective effect on birth outcomes and whether this effect varies across racial/ethnic subgroups in Hsin-Chu County, Taiwan. ⋯ An epidemiologic paradox and heterogeneity of birth outcomes were observed among immigrants in this study. However, aboriginal Taiwanese constituted the subgroup with the highest risk. Further research is needed to identify the determinants of birth outcomes.