ARTICLE IN PRESS Resuscitation xxx (2011) xxx xxx

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1 Resuscitation xxx (2011) xxx xxx Contents lists available at ScienceDirect Resuscitation journal homepage: Clinical paper Quality management in resuscitation Towards a European Cardiac Arrest Registry (EuReCa) J.T. Gräsner a,, J. Herlitz b, R.W. Koster c, F. Rosell-Ortiz d, L. Stamatakis e, L. Bossaert f a Department of Anesthesiology and Intensive Care Medicine, University Hospital Schleswig-Holstein, Schwanenweg 21, Kiel, Germany b Division of Cardiology, Sahlgrenska University Hospital, SE Göteborg, Sweden c afd. Cardiologie, Kamer F3-239, Academisch Medisch Centrum, Meibergdreef 9, 1105 AZ Amsterdam, The Netherlands d Empresa Pública de Emergencias (Public Utility for Health Emergencies), Sanitarias, Almería, Spain e Department of Emergency Medicine CHU Tivoli, ULB, La Louvière, Belgium f University of Antwerp, Faculty of Medicine Universitetisplein 1, B2610 Antwerp, Belgium article info abstract Article history: Received 1 December 2010 Received in revised form 20 February 2011 Accepted 23 February 2011 Available online xxx Keywords: Resuscitation Cardiac arrest Registry Register Quality management ERC Background: Knowledge about the epidemiology of cardiac arrest in Europe is inadequate. Aim: To describe the first attempt to build up a Common European Registry of out-of-hospital cardiac arrest, called EuReCa. Methods: After approaching key persons in participating countries of the European Resuscitation Council, five countries or areas within countries (Belgium, Germany, Andalusia, North Holland, Sweden) agreed to participate. A standardized questionnaire including 28 items, that identified various aspects of resuscitation, was developed to explore the nature of the regional/national registries. This comprises inclusion criteria, data sources, and core data, as well as technical details of the structure of the databases. Results: The participating registers represent a population of 35 million inhabitants in Europe. During 2008, 12,446 cardiac arrests were recorded. The structure as well as the level of complexity varied markedly between the 5 regional/national registries. The incidence of attempted resuscitation ranged between registers from 17 to 53 per 100,000 inhabitants each year whilst the number of patients admitted to hospital alive ranged from 5 to 18 per 100,000 inhabitants each year. Bystander CPR varied 3-fold from 20% to 60%. Conclusion: Five countries agreed to participate in an attempt to build up a common European Registry for out-of-hospital cardiac arrest. These regional/national registries show a marked difference in terms of structure and complexity. A marked variation was found between countries in the number of reported resuscitation attempts, the number of patients brought to hospital alive, and the proportion that received bystander CPR. At present, we are unable to explain the reason for the variability but our first findings could be a wake-up-call for building up a high quality registry that could provide answers to this and other key questions in relation to the management of out-of-hospital cardiac arrest Elsevier Ireland Ltd. All rights reserved. 1. Introduction In 2008, the European Resuscitation Council (ERC) set up a working group with the objective of creating a uniform European Registry of Cardiac Arrests (EuReCa), based on the existing experiences from member countries. It must encompass variations in EMS structure, organisation, and interventions, whilst including the involvement of diverse participants including bystanders, ambulance personnel, and critical care specialists. Reports will reflect the A Spanish translated version of the summary of this article appears as Appendix in the final online version at doi: /j.resuscitation Corresponding author. Tel.: ; fax: address: graesner@anaesthesie.uni-kiel.de (J.T. Gräsner). use of international guidelines that define current resuscitation and provide recommendations for optimal emergency care. 1 7 In 1991, the Utstein Style for uniform reporting on cardiac arrest and resuscitation was developed to permit the collection of comparable data. It has been used for numerous registries, studies, and analyses of out-of-hospital cardiac arrest However, an up to date system to provide a European overview and monitoring of cardiac arrest and resuscitation is not yet available International resuscitation registries, registries of cardiac arrest, and quality management systems Large registries of out-of-hospital and in-hospital cardiac arrest already exist. In North America, at least three are in place. The Resuscitation Outcomes Consortium (ROC) Epistry Cardiac Arrest /$ see front matter 2011 Elsevier Ireland Ltd. All rights reserved. doi: /j.resuscitation

2 2 J.T. Gräsner et al. / Resuscitation xxx (2011) xxx xxx is designed as a prospective population-based registry of all Emergency Medical Services (EMS) in eight US and three Canadian regions The American Heart Association s National Registry of CardioPulmonary Resuscitation (NRCPR) is a multicentre registry of in-hospital cardiac arrests. 18,19 The third one is the Cardiac Arrest Registry to Enhance Survival (CARES) which was created to provide communities with a means to identify cases of out-of-hospital cardiac arrest, measure how well emergency medical services (EMS) perform key elements of emergency cardiac care, and determine outcomes through hospital discharge. 20 These three registries in selected high-quality sites benefit from a standardized EMS system and a uniform legislation that allows valid comparison between sites EMS and registries in Europe A distinction may be made between the term register (referring to the regional/national database of individual records) and the term registry (referring to the anonimised collection of regional/national registers for global analysis). In the interest of simplicity, the term registry is used to describe both. The ERC defines Europe as the European continent according to the definition by the Council of Europe, with 47 countries and 823 million inhabitants. 21 The situation in Europe is different from that in North America: individual countries have EMS systems of varying types and legislation, making a unified registry a more complex issue. 22 EMS is organised either as a single or as a two-tiered system following national customs and laws for BLS and ALS. ALS may be performed by paramedics, specialised nurses, or physicians. The registries that had previously been set up in Europe are therefore local, covering services of a similar nature Variations in outcome: real or artefactual? Systematic reviews of literature emphasised that results differ substantially between and within countries and regions In the past 2 decades, several investigators have emphasised how differences in EMS organisation may influence comparative studies They will also be affected by non-uniform definitions. However, the observation that outcome may vary by a factor of 3 requires an analysis of the individual steps in emergency care Aims of EuReCa The primary purpose of the ERC is to improve the quality and outcome of resuscitation applied to cardiac arrest victims in Europe. EuReCa can facilitate that goal because it will permit: Identification of differences in interpretation of definitions so that they may be more uniformly applied; Valid comparison of process and outcome between regions and countries; Identification of weak local, regional, or national links in the chain of survival and assistance in improvement; Evaluation of potential improvements in procedures; Evaluation of changes in guidelines; Generation of convincing evidence to encourage financial support for evaluation and improvement of organisation and process; Creation of a network for national and international scientific cooperation in the field of cardiopulmonary resuscitation. 2. Materials and methods 2.1. Study group Participants from five existing European registries agreed to be included after a call to all member councils of the ERC: Andalusia (Spain), Belgium, Germany, North-Holland (the Netherlands) and Sweden Inclusion criteria Existing and active registries collecting data on resuscitation attempts for out-of-hospital cardiac arrest, regardless of age Data collection In order to describe the participating registries, EuReCa developed a standardized questionnaire (Supplement 1) including 28 items, to explore details of the region, the dissemination and scope of the respective registry, the data sources used, the inclusion criteria, the participants, the core data, and time intervals. In addition, technical details of the structure of the databases were collected. The questionnaires were completed by the national or regional coordinators of the respective registries and were refined by interviews during site visits. Core data and time intervals were defined and recorded in accordance with to the Utstein-Style protocol. 12, Site visits In addition to submitting their questionnaires, the five participating registration centres were visited and their coordinators interviewed by the same investigator (JTG). The questionnaire was used as a framework for the interview. 3. Results 3.1. Participating registries and population represented Overall, the participating registries represent a population of 34.9 million inhabitants. Two registries (Belgium and Andalusia) record all EMS interventions or resuscitation attempts at the national or regional level and thus provide a complete coverage. Two registries (Sweden and North-Holland) cover fully a defined part/region of the country. German resuscitation registry records data on a national level, but participating centres represent only 9% of the total population Description of the registries Belgium This registry is organised by the Ministry of Health; it records resuscitation attempts by the EMS system for all the 11 million inhabitants of Belgium. Since participation is mandatory, documentation should be complete. Case record forms are completed by the EMS team; data are then transferred to a central database. Information from the admitting hospitals is also collected centrally with a delay of up to 18 months Germany The German Resuscitation Registry represents 4.5 million citizens (total population of Germany 85 million) and collects data on out- and in-hospital resuscitation attempts throughout the country. Participation is voluntary. Currently, 150 emergency centres record data on resuscitation attempts. These centres are an integral part of public EMS systems; they are staffed by physicians from

3 J.T. Gräsner et al. / Resuscitation xxx (2011) xxx xxx 3 Table 1 Data sources. Data sources Belgium Germany Andalusia North-Holland Sweden Dispatch centre Yes Yes Yes Yes Yes Ambulance defib No Sometimes No Yes Yes AED No Sometimes Yes Yes Yes Run sheet EMS Yes Yes Yes Yes Yes Emergency department No Sometimes Yes Yes Yes Hospital departments No Sometimes Yes Yes Yes Discharge information No Sometimes Yes Yes Yes Vital status at discharge No Sometimes Yes Yes Yes Vital status after 3 months No Sometimes Yes Yes No Vital status after 6 months No Sometimes Yes Yes No Vital status after 12 months No Sometimes Yes Yes No several medical disciplines (predominantly anaesthesia, surgery, internal medicine) with additional training in emergency medicine. The inclusion rate was reported to be %. The registry is organised and financed by the national Society of Anaesthesiology (Deutsche Gesellschaft für Anästhesiologie und Intensivmedizin DGAI). 27,28, Andalusia This registry is a quality management system in a defined part of the country with 8 million inhabitants (total population of Spain 46.9 million). All EMS responses for out-of-hospital cardiac arrest are recorded. The registry is organised by the public health organisation. Financing forms part of the general reimbursement of EMS costs. Data for the registry are collected online electronically by the dispatching centre and linked appropriately. Information from the admitting hospitals is also collected centrally and recorded in the database. Quality control is under the supervision of a dedicated working group North Holland This regional cardiac arrest registry is part of a scientific project to study resuscitation care and outcome in a defined part of the country with 2.4 million inhabitants (total population of the Netherlands 16.5 million). The inclusion rate is >90%. The registry is organised from an academic centre and is financed by industrial sponsors and scientific organisations. Data from suspected cardiac arrest are telephoned by the paramedic to the coordinating centre that records the response details, emergency protocols, and follow-up information to hospital discharge, as well as data stored electronically from the AED/defibrillator including ECG rhythms, timestamps, number of shocks, etc. There is a rigid quality control Sweden This national resuscitation registry covers the population of Sweden (9 million). Participation is voluntary. Based on the experience over more than 20 years, the register recorded % of all resuscitation attempts throughout the country in Organisation is in the hands of the National Resuscitation Council. Data are recorded online. In addition, the coordination centre receives information from the admitting hospital including discharge status enabling completion of those variables needed for analysing outcome data. 14,30, Initial results The five selected registries recorded 12,446 attempted resuscitations in one year. The incidence varied among the registries from 17 to 53/100,000 inhabitants/year; the numbers achieving ROSC from 5 to 18/100,000 inhabitants/year; and the rate of admission to hospital also from 5 to 18/100,000 inhabitants/year (Table 3). The number with arrests of presumed cardiac cause varied from 13 to 44/100,000 inhabitants/year with ROSC in this group ranging from 3 to 14/100,000 inhabitants/year. All five registries have defined the inclusion criteria required for opening a data set. None has age limits. Belgium and Andalusia record all emergency cases attended by the EMS. The cause of the arrest is recorded in all registries. Andalusia and North-Holland require a reason for do not attempt resuscitation. Andalusia, North-Holland and Sweden use set criteria for termination of resuscitation (TOR) Data collection and data sources (Table 1) Data relating to resuscitation attempts are available from obtaining timestamps (dispatch centre), treatment information (run sheets, reports from emergency departments and hospitals, discharge information), real-time records of clinical variables (AED/defibrillator), or information about outcome at discharge at three, six or 12 months after resuscitation. Admission to hospital is recorded in all registries, whereas only Andalusia, North-Holland and Sweden record hospital discharge data. Andalusia and North-Holland also report survival to one year. The registry in Belgium has access to information from run sheets only but a link to outcome data is planned. Table 2 EMS process and time points. EMS process Belgium Germany Andalusia North-Holland Sweden Witnessed collapse recorded? No Yes Yes Yes Yes Bystander CPR recorded? No Yes Yes Yes Yes Therapeutic hypothermia recorded No Yes Yes Yes Yes Time points Moment of alert Yes Yes Yes Yes Yes Moment of dispatch Yes Yes Yes Yes Yes Vehicle arrives at site Yes Yes Yes Yes Yes Arrival at the patient s side No Yes Sometimes Yes Yes Defibrilator connection No No Sometimes Yes Yes First shock No Yes Sometimes Yes Yes ROSC No Yes Sometimes No Unknown

4 4 J.T. Gräsner et al. / Resuscitation xxx (2011) xxx xxx Table 3 Incidence and results. Belgium Germany Andalusia North-Holland Sweden Reported year Total population in the reported Region (Millions) OHCA for which EMS is called 10, Incidence of EMS called for OHCA/100, OHCA considered for resuscitation Incidence of OHCA considered for resuscitation/100, Resuscitation started Incidence of started resuscitation/100, Cardiac causes Incidence of started resuscitation in cardiac causes/100, non cardiac causes Incidence of started resuscitation in non cardiac causes/100, Any ROSC (all causes) Incidence any ROSC (all causes)/100, ROSC CC Incidence of ROSC CC/100, ROSC ncc Incidence of ROSC ncc/100, Admitted to hospital (all causes) Incidence of admitted to hospital (all causes)/100, Admitted to hospital CC Incidence admitted to hospital CC/100, Admitted to hospital ncc Incidence admitted to hospital ncc/100, Discharged from hospital (all causes) Incidence from discharged from hospital (all causes)/100, Discharged from hospital CC In addition to the raw number of cases, results are also expressed per 100,000 inhabitants/year for the purpose of comparison. *No data = no information about this aspect. Core data of the process and time points are shown in Table 2. Core data on incidence and outcome after OHCA is shown in Table Discussion The five registries selected for this study represent nearly 35 million European citizens out of the 830 million. They describe different areas of care in varying detail, ranging from limited information about the resuscitation process to registries including comprehensive physiological parameters and access to further databases residents registers, registers of death, health insurance registers, and hospital information. This initial survey reveals the potential for a Europe-wide comparison, but it also identifies the limitations. Several reasons could explain the reluctance of other countries to cooperate at present with EuReCa. We assume that many have not yet started to build up a cardiac arrest register. Some countries have started but may feel that their register is not representative enough for submission to a European survey. Some colleagues may feel uncertain that it is appropriate to send their data outside their own country. Some countries might withhold their data for protective reasons. Finally, some colleagues might feel that they are unable to find time for this type of collaboration. All European resuscitation organisations and councils should assume responsibility to report the massive burden of cardiac arrest, the resuscitation process, and outcome within their areas. This is possible only with registration of key variables and using a uniform style of reporting that can permit identification and consequences of differences in the systems of care within Europe Cardiac arrest registry vs. resuscitation registry The information submitted to date has come from dedicated resuscitation registries (Germany and Sweden), cardiac arrest registries (North-Holland) and components of general EMS registries (Belgium and Andalusia). Thus, a direct comparison of data is difficult, since dedicated resuscitation registries may not provide information on cardiac arrests for which resuscitation is not attempted, thus potentially concealing an unintended selection bias. The number of cases per 100,000 inhabitants/year was calculated as a surrogate to support the validity of direct comparisons; this is not completely reliable because in most systems some patients are also treated by other medical facilities that may not liaise with the EMS. A complete record of resuscitations that are managed by the EMS should be available with reliable methods to avoid inclusion bias. If resuscitation or cardiac arrest data are collected on an EMS documentation system, a complete record is guaranteed, as occurs in Belgium and Andalusia. The EuReCa registry will initially focus on resuscitation attempts by the EMS, provided it can be related to the size of the population of the registry. The data basis for a European registry should, however, not be established on the lowest common denominator. On the other hand a comprehensive system with a wealth of detailed information (North-Holland) must not be taken as the benchmark for the minimum standard. Publications reporting the resuscitation process and the Utstein definitions clearly describe the minimum number of variables necessary 12,13,32 36 that includes the initial rhythm, whether the event was witnessed or not, 1- month survival (ideally with neurological status), and time from call to EMS intervention and to the first defibrillator shock; the group of patients with witnessed collapse and initial VF provide a comparator group. 30,32 Not all of the five participating registries could provide full data because legal constraints limit the sharing of information between pre-hospital and in-hospital care systems especially with regard to discharge statistics. Therefore, the integrated ID-sensitive information of pre-hospital, in-hospital, and discharge data should be collected by the local registry in an anonymous form for inclusion in the EuReCa database. For describing processes, certain additional time points in the chain of care are of the utmost importance. The 1991 Utstein style version concentrated on comprehensive epidemiological aspects, whereas later updates put forward pro-

5 J.T. Gräsner et al. / Resuscitation xxx (2011) xxx xxx 5 cess flows and individual results. The specified American registries show, exactly as the European ones, deviations with regard to the recommendations on the complexity of the Utstein protocol. For epidemiological questions other data are needed than for detailed descriptions of medical care. Where required, a re-definition of the Utstein protocol might be useful, taking into account these different questions. At this stage, however, the Utstein protocols already permit flexible use. Maybe that interpretations of Utstein definitions are based on uncertainties concerning handling the protocols. Currently, due to its complexity Utstein may cover nearly any problem, however, on the other hand the complexity may demand too much of interested centres. Selecting data fields according to the focus of own analyses may help, but if fields from the Utstein portfolio are selected for the own database they have to be consistent with the specified Utstein definitions. New definitions of one s own, deviating from Utstein, would hamper or even make impossible the comparability with other registries. The time of arrival at the patient side, important for assessing the no-flow time, cannot be recorded reliably. In case of bystander CPR the no-flow-time would also be difficult to describe due to time information that is difficult to obtain. 37 The time of the first defibrillator shock, however, is a core variable. When an AED is used by a lay rescuer, the interval between the alert and the arrival of the EMS is also relevant Treatment procedures and description of process The resuscitation record provides a common basis for analysing causes of OHCA, ECG rhythms, bystander interventions, and treatment measures including post-resuscitation management. Four of the five registries provide the required data sets. For subsequent investigations, however, more detailed analyses of data definitions are needed. The fact that the rate of bystander CPR differs among the participating registries by more than a factor of three (15% in Andalusia compared with 60% in North-Holland and Sweden) may be artefactual because of underreporting or reflect real differences in education and implementation. Artefactual discrepancies must be excluded through the use of unambiguous definitions and complete reporting The future of EuReCa EuReCa may develop into a central tool for quality management in resuscitation and may eventually include countries and regions that up to now have not set up registries of their own. Thus, apart from its role as a European registry, EuReCa could serve as a tool for a national registry for new participants. All registries included in EuReCa must be checked in detail and if necessary modified in order to ensure comparability of data. One of the greatest challenges is the application of unambiguous definitions. This can be met by close co-operation of those responsible for the national registries within the EuReCa consortium, to ensure that throughout Europe the data can be truly comparable. This necessitates both careful quality control with the use of uniform definitions and valid data sources in all contributing countries and groups. Experience has shown that combining pre-hospital and inhospital data may be problematical. Local structures have to be taken into account and legal requirements observed. Since legal regulations are not uniform throughout Europe, EuReCa will include only anonymous data approved by national or regional registries in accordance with respective national data protection regulations. The collection of long-term survival data also requires local or regional solutions to achieve linkage between care providers. 5. Summary Five countries or areas within countries accepted an invitation to contribute to an attempt to build up a common European Registry for out of hospital cardiac arrest. These registries show marked differences in terms of structure and complexity. Considerable variation was found between countries in the number of registered CPR attempts, number of patients brought to hospital alive, and the proportion of bystander attempts. 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