ENEIS - National survey on serious adverse events in hospitals 
Head :
Michel Philippe
Last update : 01/01/2019 | Version : 1 | ID : 73176
| General | |
| Identification | |
| Detailed name | National survey on serious adverse events in hospitals |
| Sign or acronym | ENEIS |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | Cnil : 1328615 ; CNIS : label n°2009X706SA Thématiques générales |
| General Aspects | |
| Medical area |
Study of allergies |
| Health determinants |
Iatrogenic Medicine |
| Keywords | serious adverse events, patient safety |
| Scientific investigator(s) (Contact) | |
| Name of the director | Michel |
| Surname | Philippe |
| Address |
3 Quai des Célestins 69002 Lyon |
| Phone | +33 (0)4 72 40 71 04 |
| philippe.michel@chu-lyon.fr | |
| Organization | Hospices Civils de Lyon |
| Collaborations | |
| Funding | |
| Funding status |
Public |
| Details | Ministère de la santé - DREES |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Direction de la recherche, des études, de l'évaluation et des statistiques (DREES) |
| Organisation status |
Public |
| Additional contact | |
| Main features | |
| Type of database | |
| Type of database |
Study databases |
| Study databases (details) |
Repeated cross-sectional studies (except case control studies) |
| Database recruitment is carried out by an intermediary |
A selection of health institutions and services |
| Database recruitment is carried out as part of an interventional study |
No |
| Additional information regarding sample selection. | Sampling plan: Three-tier sampling 1st tier: picking of observation dates (window of observation) 2nd tier: picking of beds 3nd tier: picking of stays or fractions of stays observed over the period of observation. |
| Database objective | |
| Main objective |
The survey's primary objective is to estimate the incidence of serious adverse events observed in hospitals and their avoidable character - for events resulting from admission in medicine and surgery units of health institutions or arising in such units during hospitalization.
The secondary objectives are: 1) estimate the severity and avoidable portion of such events; 2) describe the immediate care-related causes of such events arising. |
| Inclusion criteria | All patient stays present during the survey in shortstay medicine and surgery units |
| Population type | |
| Age |
Newborns (birth to 28 days) Infant (28 days to 2 years) Early childhood (2 to 5 years) Childhood (6 to 13 years) Adolescence (13 to 18 years) Adulthood (19 to 24 years) Adulthood (25 to 44 years) Adulthood (45 to 64 years) Elderly (65 to 79 years) Great age (80 years and more) |
| Population covered |
Sick population |
| Gender |
Male Woman |
| Geography area |
National |
| Detail of the geography area | Metropolitan France |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 2004 |
| Date of last collection (YYYY or MM/YYYY) | 2009 |
| Size of the database | |
| Size of the database (number of individuals) |
[1000-10 000[ individuals |
| Details of the number of individuals | The purpose is to compile a minimum sample of 800 stays or fractions of stays in each of the analytical areas defined below. The analysis is conducted according to two main criteria: 1) the type of care unit: surgery or medicine 2) the type of care institution: regional or university teaching hospitals (CHU/CHR), other public and private not-for-profit institutions, private profitmaking institutions. This makes six analytical strata. In total, around 8,000 stays make up the sample. The sample allows for national estimations to be made. |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Clinical data Administrative data |
| Clinical data (detail) |
Direct physical measures |
| Administrative data (detail) | admission date, discharge date, age |
| Presence of a biobank |
No |
| Health parameters studied |
Health event/morbidity Health event/mortality |
| Procedures | |
| Data collection method | External survey takers to the health institution collected the data over two stages During one week, an investigating nurse comes every two or three days to detect patients likely to present an adverse event from a grid of 17 detection criteria. This detection is carried out with the care manager and on the basis of the patient's record. One or two weeks afterwards, an investigating physician comes to the unit to confirm or invalidate the presence of an adverse event for the patients detected. Moreover, this physician assesses the avoidable character of the events that have occurred during hospitalization. To do this, s/he meets the patient's attending physician, with whom s/he also consults the patient's record. |
| Participant monitoring |
No |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Link to the document | http://www.drees.sante.gouv.fr/l-enquete-nationale-sur-les-evenements-indesirables-lies,6507.html |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) |
The anonymized database can be made available to researchers subject to a justified request (examination by a scientific committee).
The participating institutions are given feedback concerning them in December of the collection year. |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
