Burden of of Paediatric Paediatric Burden Pierre VAN DAMME Rotavirus Rotavirus University of Antwerp Gastroenteritis in in Gastroenteritis Belgium Europe Europe REVEAL Study Study REVEAL Rotavirus gastroenteritis R Epidemiology & E Viral types in V Europe E Accounting for A Losses in Public Health & Society L 1 1
Study objectives objectives Study – Annual rate of consultation due to acute Paediatric Rotavirus Annual rate of consultation due to acute Paediatric Rotavirus – Gastroenteritis (RVGE) in: Gastroenteritis (RVGE) in: - hospitals hospitals - - emergency rooms - emergency rooms - GP, FP or Paediatricians practices GP, FP or Paediatricians practices - – Age and seasonal distribution of RVGE Age and seasonal distribution of RVGE – – Comparison of clinical and management characteristics of RVGE v Comparison of clinical and management characteristics of RVGE vs. s. – characteristics of acute gastroe characteristics of acute gastro enteritis (AGE) other then RVGE nteritis (AGE) other then RVGE – Serotyping Serotyping of RV strains of RV strains – – Costs of RV disease Costs of RV disease – 2 2 REVEAL study
Study Design Study Design Prospective multicentre observational study 7 European regions Study population: Sweden - children <5 years of age - living in the defined study area - meeting the case definition of AGE - informed consent obtained U.K. Germany Belgium Study period: Oct 1, 2004 – Sept 30, 2005 France Italy 3 Settings - all Hospitals in study area (n total =12) Spain - all Emergency Room in study area (n total =16) - sample of GPs and/or Peadiatricians (n total =139) 3 3 REVEAL study
Study sites Study sites Belgium - Antwerp Spain - Gandia+Denia (Valencia) 2 Hospitals 2 Hospitals 2 Emergency rooms 3 Emergency rooms 22 GPs or Pediatricians 23 GPs or Pediatricians France - Dijon Sweden - Umea Sweden 2 Hospitals 2 Hospitals 6 Emergency rooms 3 Emergency room 22 GP or Pediatrician 13 GP or Pediatricians U.K. Belgi Germany - Rostock UK - Wirral (Liverpool) Germany um 2 Hospitals 1 Hospital 0 Emergency rooms 1 Emergency room France 34 GPs or Pediatricians 12 GPs or Pediatricians Italy Italy - Padova Spain 1 Hospital 1 Emergency room 13 GPs or Pediatricians 4 4
Study area NOT country data Study area NOT country data Belgium Belgium France France Germany Germany Italy Italy Spain Spain Sweden Sweden UK UK Cities of Wirral Cities of Wirral Great City of City of Great City of City of City of City of Rostock Rostock Gandia Gandia Peninsul Peninsul Study area Study area Antwerp Antwerp Dijon Padova Umea Dijon Padova Umea et Denia Denia a et a Number of Number of 238 309 432 740 180 000 305 000 100 000 300 000 238 309 432 740 180 000 305 000 100 000 300 000 Inhabitants in Inhabitants in 250 243 250 243 study area study area Number of Number of 15 050 15 844 16 000 14 856 15 206 17 488 15 050 15 844 16 000 14 856 15 206 17 488 14 193 14 193 children < 5 y children < 5 y % of children < % of children < 6.3 3.7 6.9 4.9 15.2 5.8 5.7 6.3 3.7 6.9 4.9 15.2 5.8 5.7 5y 5y Number of Number of 2 H 2 H 1 H 2 H 2 H 1 H 2 H 2 H 1 H 2 H 2 H 1 H hospitals (H) and 2 H hospitals (H) and 2 H emergency wards 2 EW 2 EW emergency wards 6 EW 0 EW 1 EW 3 EW 3 EW 1 EW 6 EW 0 EW 1 EW 3 EW 3 EW 1 EW (EW) (EW) Number of Number of 22 34 13 23 13 12 primary care 22 22 34 13 23 13 12 primary care 22 participant participant 5 5 m15
Slide 5 m15 Pre-defined selection criteria of investigators are as follows: - preference for a previous involvement in research studies - preference for a routine use of computerized medical records - investigators able to estimate an accurate denominator of patients followed in his/her practice - agreement to follow the quality control procedures defined in the protocol - full-time practitioners - investigators who have a refrigerator suitable for specimen storage at their office or agree to use a freezer provided by the CRO for the study duration mkulig, 11/30/2005
Study Procedures Study Procedures At Baseline - all children presenting with symptoms of AGE screened � physician diagnosed AGE - inclusion of a subset of screened children - questionnaires: by physician and by parents Follow-up procedures Swe - physician visit : only if sought by parents U.K. Bel - questionnaires: by parents after child’s recovery Ger Fra Stool sample collection Ita - at health care contact or Spa - at home, shipped to treating physician - Immunochromatographic assay (ICG) testing (VIKIA – BioMerieux) End of symptoms Visit to physician Qs: parents (+ nurse) (mean duration) Qs: parents + physician Stool sample 6 6 REVEAL study
Case definition of AGE Case definition of AGE A child who had within a 24- -hour period: hour period: A child who had within a 24 � � - at least at least 3 loose stools or 3 loose stools or - - 3 watery stools or 3 watery stools or - - forceful vomiting with no other cause - forceful vomiting with no other cause symptoms in the last 7 days before a medical visit symptoms in the last 7 days before a medical visit � � preceded by a symptom- -free period of 14 days free period of 14 days preceded by a symptom � � Exclusion criteria: Exclusion criteria : nosocomial nosocomial RVGE, chronic gastrointestinal tract disease with symptoms simi RVGE, chronic gastrointestinal tract disease with symptoms similar to lar to GE (i.e. coeliac GE (i.e. coeliac disease, disease, Hirschsprung Hirschsprung) ) Lab test: Lab test: Immunochromatographic assay (ICG) testing (VIKIA – BioMerieux) ( by physician) (on fresh stool) ( by physician) (on fresh stool) � ELISA testing (central lab) (frozen stools sent to Cincinnati Children ELISA testing (central lab) (frozen stools sent to Cincinnati Ch ildren’ ’s Hospital) s Hospital) � � – – Genotyping (G Genotyping (G- -serotypes by RT serotypes by RT- -PCR and sequencing) (Merck Research Laboratories) PCR and sequencing) (Merck Research Laboratories) 7 7 RVGE- -case = AGE plus ELISA testing + case = AGE plus ELISA testing + RVGE REVEAL study
Rotavirus is a major cause of Paediatric Rotavirus is a major cause of Paediatric Gastroenteritis Gastroenteritis Unknown Rotavirus RV+ 40.4% RV- 59.6% Bacteria Adenovirus Astrovirus Calicivirus Proportion (%) of Rotavirus positive samples (RV+) vs. Rotavirus negative samples (RV-) Industrialised countries in the REVEAL study N RV+ = 1102, N RV- = 1610 Kapikian AZ, Jama 1996 8 8
Incidence rate calculation calculation for 3 settings for 3 settings Incidence rate � Children go to primary care or ER and may be referred: Children go to primary care or ER and may be referred: � – Primary care Primary care → → ER : incidence ER ER : incidence ER – – Primary care Primary care → → Hosp : incidence hospital Hosp : incidence hospital – – Primary care Primary care → → ER ER → → Hosp : incidence hospital Hosp : incidence hospital – � Each study area: inclusion of all hospitals, all ER & sample of Each study area: inclusion of all hospitals, all ER & sample of primary care physicians primary care physicians � – Need take into account Need take into account sample fraction sample fraction of primary care physicians of primary care physicians – � Proportion of included children in each setting is not the same: Proportion of included children in each setting is not the same: � – Take into account Take into account participation rate participation rate – � For incidence rate calculation all eligible children are needed For incidence rate calculation all eligible children are needed � (Number Number of of observed observed AGE/RVGE) + ( AGE/RVGE) + (Number Number of of estimated estimated AGE/RVGE) AGE/RVGE) ( Incidence: Number of of children children <5 y. living in the <5 y. living in the study study area area Number 9 9 REVEAL study
Example Spain: Flow of children in hospital Example Spain: Flow of children in hospital Eligible children screened at hospital 181 Not included Included in the study in the study 101 80 53.4 % 53.4 % Estimated RV+ RV+ 42 54 101 + 80 x100 = 1.22 % 101 + 80 54 + 42 x100 = 0.65 % 54 + 42 AGE Incidence: AGE Incidence: RVGE Incidence: RVGE Incidence: 14856 14856 14856 14856 95% CI (0.53-0.77) 95% CI (1.04-1.40) 10 10 REVEAL study
Incidence rate of AGE/RVGE per 1000 children children/ /year year Incidence rate of AGE/RVGE per 1000 in each each area area stratified stratified by setting by setting in Distribution of incidence rate in 3 settings is dependent on country Health Care System # children 70 Emergency room 60 AGE 50 RVGE # children 25 Hospital 40 20 30 AGE RVGE 20 15 country 10 10 0 Belgium France Germany Italy Spain Sweden UK 5 0 # children 180 Belgium France Germany Italy Spain Sweden UK AGE country 160 GP/FP RVGE 140 120 100 80 60 40 20 0 11 11 Belgium France Germany Italy Spain Sweden UK REVEAL study country
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