ITMO public health
Last update : 03/07/2016 | Version : 2 | ID : 9015
| General | |
| Identification | |
| Detailed name | Cross-Sectional Study on Primary Care for Adverse Events |
| Sign or acronym | ESPRIT |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL |
| General Aspects | |
| Medical area |
General practice |
| Health determinants |
Healthcare system and access to health care services |
| Keywords | risk management, frequency, adverse events |
| Scientific investigator(s) (Contact) | |
| Name of the director | Michel |
| Surname | Philippe |
| philippe.michel@chu-lyon.fr | |
| Organization | Comité de Coordination de l’Évaluation Clinique et de la Qualité en Aquitaine |
| Collaborations | |
| Participation in projects, networks and consortia |
Yes |
| Details | Partnership with Open Rome http://esprit.openrome.org/documents/Rapport_ESPRIT_final.pdf |
| Funding | |
| Funding status |
Public |
| Details | Ministry of Health. |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Comité de Coordination de l’Évaluation Clinique et de la Qualité en Aquitaine (CCECQA) |
| 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 care professionals |
| Database recruitment is carried out as part of an interventional study |
No |
| Additional information regarding sample selection. | All patients seen or contacted by 127 voluntary general practitioners from the Network of Regional Influenza Surveillance Groups (GROG). |
| Database objective | |
| Main objective | To estimate the incidence of avoidable treatment-related adverse effects in general medicine and to describe the typology. |
| Inclusion criteria |
- Male and female;
- Patients seen or contacted by voluntary general practitioners from the study. |
| Population type | |
| Age |
Adulthood (19 to 24 years) Adulthood (25 to 44 years) Adulthood (45 to 64 years) |
| Population covered |
General population |
| Gender |
Male Woman |
| Geography area |
National |
| Detail of the geography area | 19 regions throughout metropolitan France. |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 01/2012 |
| Date of last collection (YYYY or MM/YYYY) | 12/2013 |
| Size of the database | |
| Size of the database (number of individuals) |
< 500 individuals |
| Details of the number of individuals | 475 |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Declarative data |
| Declarative data (detail) |
Paper self-questionnaire |
| Details of collected declarative data | General practitioner profile questionnaire; procedure registry for the collection of completed procedures during the collection period; questionnaire on treatment-related adverse effects, consequences and causes. |
| Presence of a biobank |
No |
| Health parameters studied |
Health event/morbidity Quality of life/health perception |
| Procedures | |
| Data collection method | Collection will be carried out over a randomly selected week during the data collection period that is scheduled beforehand with all general practitioners, according to availability. All data is collected on a secure website hosted by Open Rome, except for general practitioners who choose to send questionnaires in paper format to Open Rome, who are in charge of recording. |
| Quality procedure(s) used | Data completeness will be monitored: ‐ in real time, - when files arrive to Open Rome by post. If required, the organisation will contact to the physician again to adjust or supplement data collection. The quality of data recording and consistency will be checked by those in charge of the database in accordance with regular procedures |
| Participant monitoring |
No |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Link to the document | http://www.invs.sante.fr/beh/2014/24-25/2014_24-25_1.html |
| Link to the document | http://www.ccecqa.asso.fr/sites/ccecqa.aquisante.priv/files/fiches-projets/Projets-PJ-ESPRIT-rapport-final.pdf |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/?term=ESPRIT+AND+Michel+P+[Author] |
| 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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