SUMMARY
Introduction
Acute gastroenteritis (AG) is one of the most common paediatric illnesses, and it causes over a million deaths worldwide, mainly in developing countries.
In Europe, although AG is not usually a cause of mortalità, it is one of the most common causes of health care usage in paediatrics. Viral AG is one of the main nosocomial infections in the paediatric age group.
A recent study in 7 european countries has shown that 10-12% children under the age of 5 years has an episode of AG each year. The symptoms can be variable, in the most serious cases there is a high risk of dehydration, especially below the age of 2 years, with a high risk of admission to hospital.
Treatment of AG is usually symptomatic and carried out with the administration of fluids to decrease the risk of dehydration. Specific treatments are not available and antibiotics are generally
contraindicated.
Two attenuated vaccines for rotavirus (RV) are currently being registered in Europe (Rotarix, GSK; Rotateq, SP MSD). These vaccines have been shown to be efficient in preventing RV diarrhoea. However, even if their introduction successfully decreased the incidence of RV diarrhoea, it would have no impact on the other causes of diarrhoea. It is therefore of particular importance in the paediatric age group to have drugs able to treat diarrhoea in a non specific fashion so as to decrease the risk of dehydration.
An encephalinase inhibitor (RACECADOTRIL), which decreases the secretion of fluids in the gastrointestinal tract without affecting motility, has been shown to be very efficient in adults and children in decreasing the severity of diarrhoea.
To be able to define the impact of any therapy on childhood diarrhoea it is essential to have information about the illness in the paediatric population, on incidence, outcome and clinical management.
Since 2001, Italy has had a network for research into family paediatrics called PEDIANET . Paediatricians who participate send clinical information electronically in an anonymous format to a central server which analyses the data for epidemiological purposes.
Currently, 130,000 children are included in the network and data has been used for various important studies (both prospective and retrospective) published in important international journals.
The pedianet data base is an ideal tool to investigate the incidence of diseases and their clinical management.
Objectives:
- Examine the incidence of AG in Italian children by age and by sex
- Describe the clinical presentation and outcomes of AG (access to emergency departments, hospitalisations)
- Describe the management of AG (drugs, lab investigations,etc)
- Describe the workload of the family paediatrician (appointments, prescriptions) as compared to other common childhood illnesses
The study started in September 2001 and was divided into 2 parts.
First phase: collection of prescription data
Second phase: collection and validation of outcomes
A questionnaire was sent to 673 family paediatricians using the same software for at least two years to see if they met the criteria to take part in the study (prescriptions for the drugs being studied, registration of these prescriptions in the database, availability of information on the hospitalisations of interest to the study, interest in taking part in the study). By the 1st March 2002, 278 paediatricians had responded positively to the recruitment criteria and were enrolled in the study. 185 of these sent the data requested within the time frame needed for the study.
The population studied included all children between the ages of 0 and 14 years followed by the 185 participating family paediatricians. 193,727 children (48.1% females), of which 63.4% resident in North Italy were included.
Each child was followed from the 1st January 1998 (start of the study) or frokm the date they joined the family paediatrician (if after 1st January 1998) until May 2001 or until they left the family paediatrician. One patient may have contributed more than one set of data if they received more than one prescription for the drug being studied.
Methods
The evaluation will be carried out using the Pedianet database.
Pedianet is a network (currently approximately 150 family paediatrician)which electronically collects anonymous information (reason for access, diagnosis, treatment, outcome, etc) about children (aged 0-14 years) followed by the paediatricians in their practice, after having asked parents for informed consent. The data is collected by the same data management system and are periodically sent by internet to a central server , where the data is validated and analysed with CNR in Milan and the Centre for Epidemiology and biostatistics of Rotterdam University.
Population studied:
All children between 0 and 12 years of age enrolled into Pedianet by the participating paediatricians between September 2001 and September 2006 will be studied. The children will be followed until they exit follow up (exceeding age limit, changing paediatrician, death, etc).
Case definition:
Children with a diagnosis of acute gastroenteritis or diarrhoea (at least three episodes of watery stool in 24 hours) and who do not have chronic gastrointestinal pathology (malformations, Hirschsprung, celiac disease, malabsorption, etc.) will be recruited.
Cases will be identified retrospectively from the database by electronic query (ICD 8.6 and free text combinations). Single cases will then be validated by analysis of free text boxes (diaries). Paediatric appointments will be linked to an episode if they are within 30 days from diagnosis.
Outcomes:
The following information was collected for each patient and analysed by sex, age and area of residence:
- Clinical presentation
- Treatment prescribed
- Number of appointments for each episode
- Access to emergency department
- Hospitalisation
Statistical Analysis:
Incidence of AG will be calculated per age group and sex for the duration of follow-up (person time). Multivariate analysis will be used to analyse the different variable studied. Frequencies will be expressed with 95% confidence intervals.
PARTECIPANTS AND COLLABORATIONS
Coordinators
Miriam CJM Sturkenboom
Department of Epidemiology and Buiostatistics and medical informatics, Erasmus University Medical Centre, Rotterdam
Carlo Giaquinto
Dipartimento di Pediatria, Padova
Luigi Cantarutti
Coordinamento Pedianet, PLS, Padova
Partecipants
Alongi Angelo, Avarello Giovanni, Barberi Frandanisa Maria, Barone Roberto, Basoccu Pietro, Biondi Claudio, Bonfigli Emanuela, Bratto Massimo, Budassi Roberto, Cantarutti Luigi, Cera Giuseppe Egidio, Cuboni Giancarlo, Curto Salvatore, De Clara Roberto, De Marchi Annamaria, Doria Mattia, Drago Stefano, Elio Giuseppe, Ferretti Michele, Fusco Fabrizio, Galvagno Andrea, Gentili Alberta, Gentilucci Pierfrancesco, Giancola Giuseppe, Girotto Silvia, Gobbi Costantino, Grillone Giuseppe, Lietti Giuseppe, Lista Cinzia, Lorusso Giuseppe, Macropodio Nadia, Masotti Sergio, Mauri Laura, Mazzini Franco, Milani Massimo, Mirabelli M. Cristina, Mulas Anna, Muzzolini Carmen, Nicoloso Flavia, Olimpi Laura, Pasinato Angela, Passarella Andrea, Rosas Paolo, Rosignoli Rino, Ruffato Bruno, Salamone Pietro, Sambugaro Daniela, Saretta Luigi, Sciolla Nicola, Semenzato Flavio, Senesi Paolo, Spanevello Walter, Speciale Sergio ,Speranza Francesco, Storelli Francesco, Tamassia Gianni, Tambaro Paolo, Terenghi Albino, Toffol Giacomo, Trebbi Miro, Valpreda Andrea, Vannini Paola, Varni Pierfiorenzo, Vertua Guido, Volpe Concetta.
Collaborations
Antonio Scamarcia
Società Servizi Telematici, Padova
Computer-related Assistance
Alessandro Zandarin
Società Servizi Telematici, Padova
PUBLICATIONS
FINANCING
The study is financed by ABBOTT