Disagreements between central clinical events committee and site investigator assessments of myocardial infarction end-points in an international clinical trial : review of the PURSUIT study

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dc.contributor.authorCorbalán Herreros, Ramón
dc.contributor.authorMahaffey, Kenneth W.
dc.contributor.authorHarrington, Robert A.
dc.contributor.authorAkkerhuis, Martijn.
dc.contributor.authorKleiman, Neal S.
dc.contributor.authorBerdan, Lisa G.
dc.contributor.authorCrenshaw, Brian S.
dc.contributor.authorTardiff, Barbara E.
dc.contributor.authorGranger, Christopher B.
dc.contributor.authorDeJong, Ingrid.
dc.date.accessioned2019-10-17T15:43:15Z
dc.date.available2019-10-17T15:43:15Z
dc.date.issued2001
dc.date.updated2019-10-14T18:55:58Z
dc.description.abstractAbstract Background Limited information has been published regarding how specific processes for event adjudication can affect event rates in trials. We reviewed nonfatal myocardial infarctions (MIs) reported by site investigators in the international Platelet Glycoprotein IIb/IIIa in Unstable Angina: Receptor Suppression Using Integrilin (Eptifibatide) Therapy (PURSUIT) trial and those adjudicated by a central clinical events committee (CEC) to determine the reasons for differences in event rates. Methods The PURSUIT trial randomised 10,948 patients with acute coronary syndromes to receive eptifibatide or placebo. The primary end-point was death or post-enrolment MI at 30 days as assessed by the CEC; this end-point was also constructed using site-reported events. The CEC identified suspected MIs by systematic review of clinical, cardiac enzyme, and electrocardiographic data. Results The CEC identified 5005 (46%) suspected events, of which 1415 (28%) were adjudicated as MI. The site investigator and CEC assessments of whether a MI had occurred disagreed in 983 (20%) of the 5005 patients with suspected MI, mostly reflecting site misclassification of post-enrolment MIs (as enrolment MIs) or underreported periprocedural MIs. Patients for whom the CEC and site investigator agreed that no end-point MI had occurred had the lowest mortality at 30 days and between 30 days and 6 months, and those with agreement that a MI had occurred had the highest mortality. Conclusion CEC adjudication provides a standard, systematic, independent, and unbiased assessment of end-points, particularly for trials that span geographic regions and clinical practice settings. Understanding the review process and reasons for disagreement between CEC and site investigator assessments of MI is important to design future trials and interpret event rates between trials.
dc.fuente.origenBiomed Central
dc.identifier.citationTrials. 2001 Jul 17;2(4):187
dc.identifier.doi10.1186/cvm-2-4-187
dc.identifier.urihttps://repositorio.uc.cl/handle/11534/26788
dc.issue.numeroNo. 187
dc.language.isoen
dc.nota.accesoContenido completo
dc.pagina.final8
dc.pagina.inicio1
dc.revistaTrialses_ES
dc.rightsacceso abierto
dc.rights.holderMahaffey et al, licensee BioMed Central Ltd
dc.subject.ddc610
dc.subject.deweyMedicina y saludes_ES
dc.subject.otherInfarto de miocardio - diagnósticoes_ES
dc.subject.otherInfarto del miocardio - Terapiaes_ES
dc.subject.otherElectrocardiografía - Procesamiento de datoses_ES
dc.titleDisagreements between central clinical events committee and site investigator assessments of myocardial infarction end-points in an international clinical trial : review of the PURSUIT studyes_ES
dc.typeartículo
dc.volumenVol. 2
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