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We present a pilot validation study performed on 10 European Union (EU) Member States, of a point prevalence survey (PPS) of healthcare-associated infections (HAIs) and antimicrobial use in Europe in 2011 involving 29 EU/European Economic Area (EEA) countries and Croatia. A total of 20 acute hospitals and 1,950 patient records were included in the pilot study, which consisted of validation and inter-rater reliability (IRR) testing using an in-hospital observation approach. In the validation, a sensitivity of 83% (95% confidence interval (CI): 79-87%) and a specificity of 98% (95% CI: 98-99%) were found for HAIs. The level of agreement between the primary PPS and validation results were very good for HAIs overall (Cohen's ?appa (?): 0.81) and across all the types of HAIs (range: 0.83 for bloodstream infections to 1.00 for lower respiratory tract infections). Antimicrobial use had a sensitivity of 94% (95% CI: 93-95%) and specificity of 97% (95% CI: 96-98%) with a very good level of agreement (?: 0.91). Agreement on other demographic items ranged from moderate to very good (?: 0.57-0.95): age (?: 0.95), sex (?: 0.93), specialty of physician (?: 0.87) and McCabe score (?: 0.57). IRR showed a very good level of agreement (?: 0.92) for both the presence of HAIs and antimicrobial use. This pilot study suggested valid and reliable reporting of HAIs and antimicrobial use in the PPS dataset. The lower level of sensitivity with respect to reporting of HAIs reinforces the importance of training data collectors and including validation studies as part of a PPS in order for the burden of HAIs to be better estimated. .


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