One core laboratory at two international sites, is that feasible? An inter-core laboratory and intra-observer variability study

Autor: Joan C, Tuinenburg, Gerhard, Koning, Ellen, Hekking, Colette, Desjardins, François, Harel, Luc, Bilodeau, Anton W M, van Weert, Jacques, Lespérance, Johan H C, Reiber
Rok vydání: 2002
Předmět:
Zdroj: Catheterization and cardiovascular interventions : official journal of the Society for Cardiac AngiographyInterventions. 56(3)
ISSN: 1522-1946
Popis: To assess the magnitude of differences in QCA outcomes between two cooperating core laboratories in a single trial, we have carried out an inter-core laboratory variability study. Two QCA experts at the Montreal Heart Institute and Heart Core Leiden both analyzed 32 lesions (pre- and post-intervention) in accordance with previously agreed upon standard operating procedures. One of the experts analyzed the whole image set twice to determine the intraobserver variability. The inter-core laboratory differences in the acute gain (n = 31 pairs) are non-significant. The systematic errors of the individual measurements (n = 63 analyses) show an excellent intraclass correlation coefficient of reliability (75%), except for the stent length (67.7%). The corresponding random errors are small. In general, the intra-observer systematic and random errors are both slightly smaller than those for the inter-core laboratory study. QCA analyses in clinical trials can be carried out in core laboratories at two different locations if and only if highly standardized conditions are maintained.
Databáze: OpenAIRE