Background Major differences have been reported in the management strategies and outcome for cardiovascular diseases among different geographic regions in Europe. Since the causes of these differences are poorly understood, indeed, there is a need to collect quantitative information on the prevalence and incidence of cardiovascular diseases and on methods for patient management in clinical practice. Such data is obtained by the Euro Heart Survey through systematic surveys in hospitals throughout Europe. Until 2006, each survey was designed to collect detailed representative cross-sectional and prospective information on large samples of patients (4,500 - 13,000 per survey), within given time frames in selected hospitals throughout Europe. University hospitals as well as large general hospitals and smaller practices were invited to participate to account for differences in management strategies and profiles of care.
As of 2006 all Cardiologists in hospitals or private practices are invited to participate in the Euro Heart Survey. The EHS programme is now moving from its former cyclic survey structure to continuous data collection in ongoing registries.
Procedure For the Euro Heart Survey programme, groups of patients with different forms of cardiovascular disease or undergoing specific procedures are studied. The survey topics are selected by the Euro Heart Survey Committee in cooperation with experts from the European Society of Cardiology Working Groups (see paragraph 5 below). The surveys focus on : - Clinical practice in relation to existing guidelines in cardiology.
It is assessed whether existing guidelines (European, National including those from the American Heart Association and American College of Cardiology) are being followed in clinical practice. The reasons for deviation from guidelines will be registered, which may lead to either modification of the guidelines, or to further education of practitioners about existing guidelines.
- Applicability of results of major trials.
Such clinical trials are a major framework for evidence based medicine. However, most trials address selected groups of patients. Therefore, it is interesting to investigate which patients encountered in clinical practice meet the selection criteria of recently completed trials. Patient groups which are under- or not represented in trials are identified.
- Outcome of different strategies for patient management.
This includes collection of base line data at the time of presentation of patients either in hospital or at the outpatient clinic, as well as follow up data, for example after one year and again after 3-5 years.
For each survey a Scientific Expert Committee is convened in consultation with the Committee for Practice Guidelines (CPG) of the European Society of Cardiology, and with the appropriate Working Groups. The Scientific Expert committee develops the aims and the content of survey (protocol), and the questionnaires based on published guidelines, previous clinical trials and follow up cohort studies. For each survey the responsible project expert committee follows similar procedures : - The existing Guidelines prepared by the ESC, by European National Organisations, and by others (e.g. the American Heart Association and American College of Cardiology) are analysed, and the key elements identified,
- An overview is prepared of the enrolment and exclusion criteria of major clinical trials in the domain under study,
- An overview is prepared of follow-up studies to identify all relevant factors which determine patient outcome.
The questionnaires for each specific survey are based on these overviews. The Scientific Expert committees analyse the data and report the results of the survey. Consequently, the Scientific Expert committees will guide the appropriate actions by the European Society of Cardiology aimed at improvement of cardiovascular patient management.
The procedures developed are based on those currently used in large clinical trials, following good clinical practice (GCP) guidelines. QuestionnairesThe questionnaires consist of general (demographic) and issue-specific (topic oriented) data elements. Each questionnaire contains 100 to 400 items (5 - 20 pages per questionnaire), and will be tested in two to ten hospitals. Questionnaires will be modified if necessary according to observations made during the pilot study.
The Euro Heart Survey Programme Information Technology The Euro Heart Survey programme uses Internet technology for survey communication. Each centre has personalized access to the Euro Heart Survey website where data could be entered directly. Centres may view their own progress as well as global survey progress and a benchmark report of their data. A range of survey-related options are also accessible. The system is user-friendly and has proved to be reliable, easy and efficient.
Confidentiality Requests and Access to Survey Data All data is encrypted for transfer. Patient personal data will be protected and encoded according to the rules in each participating country. The data to be collected by the Euro Heart Survey may be of interest to cardiologists, but also to hospital management and other providers of health care. In addition to the investigators, others will have access to the data upon approval by the Euro Heart Survey Committee. The Committee for Methodology and Data Management has developed rules for the use of parts of the data by interested parties and to ensure that all ethical and legal requirements related to confidentiality of the data will be maintained. The identity of the patients is only recorded through code numbers in the participating hospitals and is not transferred to the central database within the European Heart House.
Structure & participation procedureCurrently a total of 47 West-European, East European and Mediterranean countries participate in the European Society of Cardiology (ESC). It is the intention to extend the Euro Heart Survey to all or most of these countries. Up to date 43 countries from the European Community and neighbouring countries have participated in the surveys.
Cardiologists of ESC member countries could participate in the Euro Heart Survey programme. They could either contcat their National Coordinator or cvointcat directly the Euro Heart Survey team at ehs@escardio.org
Quality Assurance This aims to ensure compliance to the protocol and ethics committee requirements, to ensure consecutive patient enrolment and to obtain complete, accurate and reliable data.
In each country the survey is reported to, and if necessary, approved by an ethics committee and other national or local regulatory bodies (in this case, the appropriate regulatory requirements are implemented which may include the patient's written consent).
Clear definition of the methodology, of screening and enrolment procedures are the first steps to ensure consecutive patient enrolment. These are reinforced by appropriate training of the Data Collection Officers and monitoring or auditing of the centres.
Compliance to the protocol begins by checking that patients meet inclusion criteria. The questionnaire is designed to follow the protocol and limit deviation. Any inconsistencies are subject to verification.
The data is checked on-site before transfer to the central database. The transfer process itself is then verified for its precision, the data is transferred and a check is made for discrepancies. These are reported to the Data Collection Officer for correction or confirmation, and to the Scientific Committee if needed. A final verification is made on the entire database and inconsistent data is removed before the database is locked and transferred to the statistical software.
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