ITMO public health
Last update : 07/08/2015 | Version : 1 | ID : 9027
| General | |
| Identification | |
| Detailed name | Cross-Sectional Study on Adverse Events Linked to Ambulatory Care |
| Sign or acronym | EVISA |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | --- |
| General Aspects | |
| Medical area |
Emergency medicine |
| Keywords | iatrogenesis, treatment-related adverse event, medical accidents and incidents, outpatient care, patient safety, nosocomial, health safety, risk |
| Scientific investigator(s) (Contact) | |
| Name of the director | Michel |
| Surname | Philippe |
| philippe.michel@ccecqa.asso.fr | |
| Organization | Comité de Coordination de l’Évaluation Clinique et de la Qualité en Aquitaine |
| Name of the director | Quenon |
| Surname | Jean-Luc |
| jean-luc.quenon@ccecqa.asso.fr | |
| Organization | Comité de Coordination de l’Évaluation Clinique et de la Qualité en Aquitaine |
| Collaborations | |
| Funding | |
| Funding status |
Public |
| Details | Directorate for Research, Studies, Evaluation and Statistics (DREES). |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Directions Régionales des Affaires Sanitaires et Sociales (DRASS) Aquitaine |
| Organisation status |
Public |
| Sponsor(s) or organisation(s) responsible | OMEDIT-Agence régionale de l'hospitalisation Aquitaine |
| Organisation status |
Public |
| Additional contact | |
| Main features | |
| Type of database | |
| Type of database |
Study databases |
| Study databases (details) |
Not-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. | Patient sample was formed from random selection with two stratification levels, in order to reflect diversity within institutions and disciplines (medicine, surgery), and elements where patient recruitment differs. |
| Database objective | |
| Main objective | To estimate the frequency, severity and preventability of adverse events linked to ambulatory care, as well as investigate the context and contributing factors on the occurrence of these events and to estimate the hospital treatment costs. |
| Inclusion criteria |
- Male and female;
- Patients hospitalised in medical and surgical departments in short-stay healthcare institutions. |
| Population type | |
| Age |
Adulthood (19 to 24 years) Adulthood (25 to 44 years) Adulthood (45 to 64 years) |
| Population covered |
Sick population |
| Gender |
Male Woman |
| Geography area |
National |
| Detail of the geography area | Metropolitan France (7 hospitals). |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 2008 |
| Size of the database | |
| Size of the database (number of individuals) |
< 500 individuals |
| Details of the number of individuals | 47 |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Declarative data |
| Declarative data (detail) |
Paper self-questionnaire |
| Details of collected declarative data | Detection and confirmation questionnaires developed from British Review Forms. |
| Presence of a biobank |
No |
| Health parameters studied |
Health event/morbidity Health event/mortality |
| Procedures | |
| Data collection method | Adverse events were detected by a physician in the surveyed department from a detection questionnaire. |
| Classifications used | Data quality control was carried out in three stages: |
| Quality procedure(s) used | - The CCECQA (Coordination Committee for Clinical Evaluation and Quality in Aquitaine) carried out checks in institutions to verify proper data collection conduct, adherence to the method, as well as the completeness and quality of collected data. - Researchers and research associates coded questionnaires and checked for completeness and consistency. - All questionnaires were reviewed by CCECQA methodologists. Problematic records (unclear; inconsistent; complex clinical situation; episodes, causes or impact of an unusual event, etc.) were reviewed by a case review committee and, if required, by field experts. |
| Participant monitoring |
No |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | Contact the scientist in charge. |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
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