Concordance Study of Case Definitions of Healthcare Associated Infections

SPONSOR

The European Centre for Disease prevention and Control (ECDC); www.ecdc.europa.eu. ECDC will be the owner of all documentation, all data and databases produced, and all methodology accumulated through the activities commissioned by ECDC for this project.

STUDY ADMINISTRATION
Prof. Dr. Petra Gastmeier
Institute of Hygiene and Environmental Health
Charité University Medicine Berlin
Hindenburgdamm 27
D-12203 Berlin
Germany

STUDY ORGANIZATION
Dr. Sonja Hansen
Institute of Hygiene and Environmental Health
Charité University Medicine Berlin
Hindenburgdamm 27
D-12203 Berlin
Germany

DATABASE ADMINISTRATION
Dr. Michael Behnke
Institute of Hygiene and Environmental Health
Charité University Medicine Berlin
D-Hindenburgdamm 27
12203 Berlin
Germany

Background

Surveillance of nosocomial infections is a valuable measure to decrease healthcare associated infection (HCAI) rates. It seems to be in particular successful when the infection rates of the own institution can be compared with reference data. Across Europe the diagnosis of HCAI varies since some countries are using Centers for Disease Control and Prevention (CDC) definitions others use Hospitals in Europe Link for Infection Control through Surveillance (HELICS) definitions. A change in surveillance definitions (indipendently of the direction of the conversion of the definitions; either from CDC definitions or to HELICS definitions or vice versa) would cause a loss of continuity to previous data in the individual surveillance system and also may lead to problems in reorganizing the surveillance system. Therefore the knowledge about the extent of concordance between both sets of HCAI definitions is of high value to interpret surveillance data from the individual countries and to compare previous surveillance data with data collected following the introduction of the other set of definitions.

Objectives

• To set up an international study team and elaborate an agreed protocol for the concordance study of HCAI case definitions (CDC and IPSE/HELICS) in collaboration with ECDC
• To perform a concordance study between EU (IPSE/HELICS) and US (CDC/NHSN) case definitions for the surveillance of HCAI - for which differences were identified - in hospitals from at least 5 EU Member States performing surveillance of HCAI
• To analyze the collected data, assess the concordance between HCAI HELICS versus CDC case definitions including the subcategories of the case definition, report on the results in a peer-reviewed scientific journal
• To suggest which data have to be collected in the EU surveillance of HCAI and in the EU point prevalence survey protocol to allow member states to use HELICS definitions while keeping retrospective comparability with CDC definitions

Methods

The study consists of three work packages (WP) and schedules including the following tasks and activities:

WP1: During a first meeting the working group with experts from at least 5 EU Member States or EEA/EFTA countries and 1 ECDC expert differences between HCAI case definitions of IPSE/HELICS and CDC/NHSN will be identified. A protocol to assess the concordance of case definitions (including their subcategories) will be developed.

WP2: A concordance study will be conducted in acute care hospitals of at least 5 EU Member States or EEA/EFTA countries. A pre-test of the study protocol will be organized in at least 2 countries. In a second meeting of the working group the protocol will be adapted according to the findings of the pretest. Final data collection tools will be defined. A standardized training material for hospital staff will be developed and practical organisation of the study will be discussed and planned.

WP3: The concordance between HCAI definitions will be analysed and reported. In a third meeting results and scientific communication strategy will be discussed. Working group members are asked to translate study document forms in their national language and distribute them to the participating hospitals. Local infection control personnel who is performing the surveillance has to be trained in diagnosing HCAI according to EU (IPSE/HELICS) and US (CDC/NHSN) definitions.