Bezin Julien, Duong Mai, Lassalle Régis, Droz Cécile, Pariente Antoine, Blin Patrick, Moore Nicholas
Department of Medical Pharmacology, CHU de Bordeaux, Université de Bordeaux, 33076, Bordeaux, France.
INSERM U1219, 33076, Bordeaux, France.
Pharmacoepidemiol Drug Saf. 2017 Aug;26(8):954-962. doi: 10.1002/pds.4233. Epub 2017 May 24.
The French health care system is based on universal coverage by one of several health care insurance plans. The SNIIRAM database merges anonymous information of reimbursed claims from all these plans, linked to the national hospital-discharge summaries database system (PMSI) and the national death registry. It now covers 98.8% of the French population, over 66 million persons, from birth (or immigration) to death (or emigration), making it possibly the world's largest continuous homogeneous claims database. The database includes demographic data; health care encounters such as physician or paramedical visits, medicines, medical devices, and lab tests (without results); chronic medical conditions (ICD10 codes); hospitalisations with ICD10 codes for primary, linked and associated diagnoses, date and duration, procedures, diagnostic-related groups, and cost coding; date but currently not cause of death. The power of the database is correlatively great, and its representativeness is near perfect, since it essentially includes the whole country's population. The main difficulty in using the database, beyond its sheer size and complexity, is the administrative process necessary to access it. Recent legislative advances are making this easier. EGB (Echantillon Généraliste de Bénéficiaires) is the 1/97th random permanent representative sample of SNIIRAM, with planned 20-year longitudinal data (10 years at this time). Access time is 1 to 3 months, but its power is less (780 000 subjects). This is enough to study common issues with older drugs but may be limited for new products or rare events.
法国医疗保健系统基于几种医疗保险计划之一的全民覆盖。SNIIRAM数据库合并了所有这些计划中报销申请的匿名信息,并与国家医院出院摘要数据库系统(PMSI)和国家死亡登记处相链接。它现在覆盖了98.8%的法国人口,超过6600万人,从出生(或移民)到死亡(或移民),这可能使其成为世界上最大的连续同类索赔数据库。该数据库包括人口统计数据;医疗保健接触信息,如医生或辅助医疗人员的就诊、药品、医疗设备和实验室检查(无结果);慢性疾病(ICD10编码);具有ICD10编码的住院信息,包括主要、相关和关联诊断、日期和时长、程序、诊断相关分组和费用编码;日期但目前不包括死亡原因。该数据库的影响力相应地很大,其代表性近乎完美,因为它基本上涵盖了全国人口。使用该数据库的主要困难,除了其规模巨大和复杂性之外,是访问它所需的行政程序。最近的立法进展使这变得更容易。EGB(Echantillon Généraliste de Bénéficiaires)是SNIIRAM的1/97随机永久代表性样本,计划有20年的纵向数据(目前为10年)。获取时间为1至3个月,但其影响力较小(780000名受试者)。这足以研究旧药的常见问题,但对于新产品或罕见事件可能有限。