SUMMARY
Rationale
The aim of this study i sto evacuate the impact of rotavirus gastroeneteritis (RVGE) in children less than 5 years of age by means of surveillance of activities of family paediatricians. Data will also be collected to determine the seasonal distribution, severity of infection, age distribution of the children, prevalent genotypes, family transmission and impact on the costs of public health.
The data collected in this study can therefore be useful for those responsabile for public health politics to evaluate the need to vaccinate against rotavirus and to define the benefits of universal vaccination against rotavirus in europe.
Study population
This study only involves children under the age of 5 belonging to a well defined population. The number of children “observed” will be all children under the age of 5 years who are seen by the paediatricians participating in the study for an episodi of acute gastroenteritis, with a postitive stool test for roatvirus and who present in the 12 month period of the study. Thepopulation being studied will be defined bifore the study starts and must be between 5,000 and 10,000 children less than 5 years of age for each participating country.
Objectives
Primary
-Estimate the incidente of rotavirus gastroenteritis which require a paediatric consultation in children below the age of 5 years in a well defined population.
Secondary
-Establish the age of these children, the severity of the illness and the seasonal distribution of RVGE in children less than 5 years of age.
-Identify the prevalent virus genotypes in children below the age of 5 years
-Evacuate the transmission patterns of RVGE in children below the age of 5 years who live in the same household as the child recruited to the study (defined as children who spend at least 50% nights sleeping in the same house)
-Evacuate costs related to episodes of RVGE
Study Design
-Prospective, multi-centre, observational study carried out at a regional level in a network of family paediatricians which follows a well defined population of children whithin a circumscribed geographical area.
-The study will be carried out in different european centres with a coordinating centre for each country.
-The study consisté of 3 parts:
-The impact of RVGE and economic and health implications
-Description of familial transmission
-Evaluation of the impact on public health costs
-All children less than 5 years of age included in the defined population who visit one of the centres part-taking in the study with gastroenteritis (defined as diarrhoea of less than 14 days duration) will be registered in a logbook. The child’s parents will be told about the study and asked to participate, allowing the initial data collection and stool analysis to start once the informed consent form has been signed (Section 1 on consent form).
-The stool sample is analysed by the paeditarician durino the consultation by a rapitest (rotastrip® test) to determine the presence of rotavirus.
-The children who will be eligible for the following parts of the study will include all children under the age of 5 years whose stool sample are positive for rotavirus and whose parents have agrred top art-take in the study having signed the consent form (Section 2 on consent form)
-Participating in the study also involves an interview to the parents/guardians of the child to be carried out during the consultation. The stool samples which are positive for rotavirus by rapitest, will be stored and sent to a central laboratory to establish the viral genotype.
-The consultation will be followed 14 days later by a telephone call (follow-up).
-The part of the study relative to family transmission will involve all parents/guardiano of children recruited whio haver one or more children under the age of 5 years living, or spending more than 50% of nights, in the same house. Informed consent will again be obtained (Section 3 on consent form). The parents/guardiano will be asked to contact the doctor if any of the children develop diarrhoea in the 14 days after the recruitment of the first child. The doctor can then either consult the child at home or at work.
-A stool collection kit will be given to all parents/guardiano of children recruited who consent to take part in this part of the study, to be used if any of the other children develop diarrhoea. A sample will be taken in any children meeting the age requirement (less than 5 years) who develop symptoms of gastroeneteritits.
-All participating doctors will be asked to complete a form with data relative to the general costs linked to the consultations and treatment of gastroenteritis. The doctors will also be asked before the study starts to give details on the population they cover, divided by age group, which will then serve as a denominator for the calculations of incidente.
-The study will last for 12 months during which the following will be evaluated: incidence of the disease, distribution by age, severity of the illness, seasonal variation, family transmission of the virus, cost and impact of the illness on public health costs
-Each child will be seen just once for the study (followed by telephone follow-up), unless there is repeated infection or more consultations are necesary for illness itself.
-The data will be recorded and collected on paper.
Sample size
The population size which needs to be surveilled for the study is between 5,000 and 10,000 children under the age of 5 years followed by the paediatricians included in the study. This size will allow an adeguate number of cases of RVGE amongst the children observed. Based on an expected incidence of 2 cases per 100 childyears, we expect 100-200 cases of rotavirus gastroenteritis in the population.
Data Analysis
The following analysis will be carried out both at a global level as well as at a country level: -Incidente of RVGE that require a paediatric consultation in children less than 5 years of age, by age group with a 95% confidente interval. The denominator for the calculation of incidente will be the average population under surveillance under the age of 5 between the begining and the end of the study. This analysis will be conducted for all cases of RVGE which have a positive rapitest (rotastrip®) stool sample and will be subsequently repeated on all cases which are confirmed at the external laboratory. -Percentage RVGE amongst cases of gastroeneteritis observed, in total and by age group (CI 95%). -Distribution of demographic characteristics, symptoms, severità of infection, treatment taken, duration of acute episodes of RVGE and outcome (all data calculated for whole sample and per age group) -Distribution of viral genotype amongst all samples isolated from stool samples analysed. -Severity of infection by age group and by viral serotype -Percentage children under the age of 5 years in the same household as a case who developed diarrhoea in the 14 days after recruitment into the study of the first child (total number and by age group)
PARTECIPANTS AND COLLABORATIONS
Coordinators
The study was coordinated directly by GSK. SoSeTe helped in the training and data validation of the paediatricians and the collection of information on the number of children in each paediatrician’s catchment area.
Partecipants
Partecipants (ASL 8 of Montebelluna)
F. Bonaiuto, M Callegari, S. Carnazza, F. Dell’ Atonia, P.Ghiotti, P.Gobbi, G. Matteoli. C. Montini, F.Pietrobon, F.Pompato, G. Toffol, A. Zini.
Collaborations
Data Monitor (in collaboration with GSK)
Antonio Scamarcia
Società Servizi Telematici, Padova
PUBLICATIONS
Diez-Domingo J, Baldo JM, Patrzalek M, Pazdiora P, Forster J, Cantarutti L, Pirçon JY, Soriano-Gabarró M, Meyer N; SPRIK Rotavirus Study Group. Primary care-based surveillance to estimate the burden of rotavirus gastroenteritis among children aged less than 5 years in six European countries. Eur J Pediatr. 2011 Feb;170(2):213-22. doi: 10.1007/s00431-010-1289-1. Epub 2010 Sep 15. PMID: 20842379.
Diez Domingo J, Patrzalek M, Cantarutti L, Arnould B, Meunier J, Soriano-Gabarro M, Meyer N, Pirçon JY, Holl K. The impact of childhood acute rotavirus gastroenteritis on the parents' quality of life: prospective observational study in European primary care medical practices. BMC Pediatr. 2012 May 31;12:58. doi: 10.1186/1471-2431-12-58.PMID: 22650611.
FINANCING
The study was funded by GSK Biologicals, Rixensart, Belgium