Population-based analysis of non-steroidal anti-inflammatory drug use among children in four European countries in the SOS project: what size of data platforms and which study designs do we need to assess safety issues?

Table 1 Study population and database characteristics

						Pediatric source population
						(Age 0 to 18 years)
Database	Country	Type of database	Diagnoses captured with:	Drugs captured with:	Study period	Number of persons	Person-years of observation	Number of NSAID users
GePaRD	Germany	Claims database	ICD-10-GM	ATC	2005 - 2008	2,992,087	7,056,919	925,667
THIN	United Kingdom	General practice database	READ	BNF/Multilex/ATC	1999 – 2008	1,261,668	5,198,351	227,927
IPCI	Netherlands	General practice database	ICPC and free text	ATC	1999 – 2011	250,296	618,479	12,002
PHARMO	Netherlands	Record linkage system	ICD-9-CM	ATC	1999 – 2008	594,800	2,914,576	82,233
OSSIFF	Italy	National Health Services registry (claims)	ICD-9-CM	ATC	2000 – 2008	675,197	3,671,014	22,760
SISR	Italy	National Health Services registry (claims)	ICD-9-CM	ATC	2002 – 2009	1,744,525	9,111,635	34,308
Pedianet*	Italy	General practice pediatric database	ICD-9-CM and free text	ATC	2000 – 2010	221,115	1,064,867	34,575
Total						7,739,688	29,635,841	1,339,472

*Pedianet only includes children up to the age of 14 years.
ICD-10-GM: International Classification of Diseases, 10th Revision German Modified; ICD-9-CM: International Classification of Diseases, 9th Revision Clinically Modified; ICPC: International Classification for Primary Care; ATC: Anatomical Therapeutic Chemical classification; BNF: British National Formulary.

ISSN: 1471-2431