000			03379na a2200661 4500
999			_c14106 _d14106
003			PC14106
005			20180705130728.0
008			130622s2013 xxx||||| |||| 00| 0 eng d
040			_cH12O
041			_aeng
100			_aRuilope Urioste, Luis Miguel _9539 _eNefrología
245	0	0	_aClinical outcome endpoints in heart failure trials: a European Society of Cardiology Heart Failure Association consensus document. _h[artículo]
260			_bEuropean Journal of Heart Failure, _c2013
300			_a15(10):1082-94.
500			_aFormato Vancouver: Zannad F, García AA, Anker SD, Armstrong PW, Calvo G, Cleland JG et al. Clinical outcome endpoints in heart failure trials: a European Society of Cardiology Heart Failure Association consensus document. Eur J Heart Fail. 2013 Oct;15(10):1082-94.
501			_aPMID: 23787718
504			_aContiene 112 referencias
520			_aEndpoint selection is a critically important step in clinical trial design. It poses major challenges for investigators, regulators, and study sponsors, and it also has important clinical and practical implications for physicians and patients. Clinical outcomes of interest in heart failure trials include all-cause mortality, cause-specific mortality, relevant non-fatal morbidity (e.g. all-cause and cause-specific hospitalization), composites capturing both morbidity and mortality, safety, symptoms, functional capacity, and patient-reported outcomes. Each of these endpoints has strengths and weaknesses that create controversies regarding which is most appropriate in terms of clinical importance, sensitivity, reliability, and consistency. Not surprisingly, a lack of consensus exists within the scientific community regarding the optimal endpoint(s) for both acute and chronic heart failure trials. In an effort to address these issues, the Heart Failure Association of the European Society of Cardiology (HFA-ESC) convened a group of expert heart failure clinical investigators, biostatisticians, regulators, and pharmaceutical industry scientists (Nice, France, 1213 February 2012) to evaluate the challenges of defining heart failure endpoints in clinical trials and to develop a consensus framework. This report summarizes the groups recommendations for achieving common views on heart failure endpoints in clinical trials.
710			_986 _aServicio de Nefrología
856			_uhttp://pc-h12o-es.m-hdoct.a17.csinet.es/pdf/pc/1/pc14106.pdf _ySolicitar documento
942			_n0 _2ddc _cART