The Italian Registry Of Cystic Echinococcosis: Preliminary results Francesca Tamarozzi1 5, Patrizia Rossi2, Fabio Galati3, Mara Mariconti 1 5, Jacopo Nicoletti 1 5 Francesca Rinaldi 1 5 , Adriano Casulli 2, Edoardo Pozio2, Enrico Brunetti 1 4 5 1Department of Clinical, Surgical, Diagnostic and Paediatric Sciences, University of Pavia, Italy; 2 Department of Infectious, Parasitic and Immunomediated Diseases, Istituto Superiore di Sanita’, Rome, Italy; 3 SIDBAE, Information Technology, Istituto Superiore di Sanita’, Rome, Italy; 4 Division of Infectious and Tropical Diseases, San Matteo Hospital Foundation, Pavia, Italy; 4 WHO Collaborating Centre on Clinical Management of Cystic Echinococcosis Innovation for the Management of Echinococcosis Besançon 27-29 March 2014

NEW CE CASES PER YEAR Data from Dr F. Cattaneo, MD thesis, 2013 Total CE Foreigners Eastern Europe Africa Western Europe South America Asia CE is endemic in Southern and Eastern Europe, Italy included. For example data from our recent review of 30 years of activity of the outpatient clinic for CE in Pavia show that number of new cases are steadily increasing over time, and that patients come both from Italy and foreign countries, especially Easter Europe and North Africa Data from Dr F. Cattaneo, MD thesis, 2013

2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 Total Italy 2400 2100 1993 1987 1865 1714 1554 1499 1338 1136 963 18445 Italians (%) 91.8 91.5 89.7 88.3 83.4 85.1 80.7 78.6 82.3 78.7 74.2 85.8 * Italian region with highest prevalence of human cases according to HDR Italian hospital discharge records show that CE cases in Italy exist but notwithstanding the European and Italian law, no cases arrive to European health agencies  the reporting system is not efficient and is not appropriate for a disease like CE where most cases are diagnosed, treated and followed on an outpatient basis.

Chronic Complex Neglected Underreporting and/or misreporting  cascade of drawbacks. In a vicious circle, underreporting  perception that CE is not an important health problem  measurement of disease burden even more difficult + hampering of collection of good quality data to inform control programmes and evidence-based diagnostic and therapeutic strategies  at least suboptimal clinical management of single cases and allocation of public resource for treatment. Limitations of current reporting system: inaccurate number of cases, absence of discrimination between new and re-admitted cases, lack of collection of important epidemiological data such as occupation and other risks. chronicity and frequent relapses of CE  patients often access different health centres over time = duplication of data = inaccurate statistics. complex natural history and clinical presentation of CE  profound impact on clinical management and public health resource allocation BUT cyst stage, therapy and outcome are not collected in the notification forms

The Italian Registry of Cystic Echinococcosis (RIEC) is a prospective multicenter registry of CE patients visited from January 2012 in Italian health centres which adhered to RIEC. RIEC was published in the website of the Istituto Superiore di Sanità (Rome) in October 2012 with the aims of: indicating the burden of CE in Italy; bringing to the attention of health authorities the importance of this neglected infection; encouraging public health policies toward its control; stimulating research on CE. The implementation of RIEC responded to a long standing need of a CE national registry with online data entry, similar to the European Registry of Alveolar Echinococcosis. Its design, with unequivocal patient-based prospective data entry, allows the collection of both basic epidemiology data and longitudinal clinical data in a simple way.

Since its outset, 346 CE patients were enrolled in 11 centres, while 5 centred did not entered any data yet. Data taken from Pavia centre show that 2/3 of patients are Italian and 1/3 are foreigners, Morocco and Romania being the most common geographical origin of these patients. The incidence of CE in our centre was 14 new cases in 2012 (12.3% of all visits in 2012) and 21 new cases in 2013 (21.2% of all visits in 2013). Jan 2012-Feb 2014

Critical issues Voluntary adhesion of health care centres Time required to fill/update the records Patient’s recall and previous records May be useful an automatic patient recall to minimize loss to follow-up? Regular monitoring and evaluation of the registry itself Only compulsory notification of CE through an easy accessible data entry system would be fully effective for surveilling the disease in humans. A centralized registry would eliminate the need to merge regional data, avoid data duplication, capture both inpatient and outpatient data, and make both clinical and epidemiological data accessible to clinicians, epidemiologists, and health authorities.

European Registry of Cystic Echinococcosis Difficulties in correctly reporting of CE do not apply to Italy alone. Examples Pardo data published in Spain and unpublished data from Cretu (Romania). In December 2013, the HERACLES project was launched, funded by the European Union, Seventh Framework Programme (grant to Adriano Casulli, ISS). HERACLES encompasses, among its main objectives, the creation of the European Registry of Cystic Echinococcosis (ERCE), with the initial inclusion, within the project’s 4-years lifespan, of data from Romania, Bulgaria and Turkey, among the most endemic countries in Europe. The translation of Registry documents and web-pages in English and National languages, and the implementation of the required amendments are ongoing. This would provide and efficient and disease-tailored template suitable for further application in other European countries, in the perspective of a better harmonization of European health practices.

Acknowledgements And Thank you! Dr Giovanna Masala IZS Sardegna, Sassari, Italy Funding : Progetto di Ricerca Corrente IZS SA 07/10 RC Dr Adriano Casulli ISS, Rome, Italy Funding European Union Seventh Framework Programme (FP7/2007-2013) project HERACLES, grant agreement n°[602051] And Thank you!