ITMO public health
Last update : 09/05/2017 | Version : 2 | ID : 2841
| General | |
| Identification | |
| Detailed name | Observational study of the therapeutic strategy in the management of acute sinusitis in primary care |
| Sign or acronym | ABSINTHE |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CCTI-RS 04.342, CNIL 904410 |
| General Aspects | |
| Medical area |
Otolaryngology or ENT |
| Health determinants |
Iatrogenic |
| Keywords | telithromycin, antibiotic, ENT, Ketek, management, effectiveness, therapeutic strategies, recommendations, pharmacoepidemiology, cohort, Department of Pharmacology, Bordeaux |
| Scientific investigator(s) (Contact) | |
| Name of the director | Moore |
| Surname | Nicholas |
| Address | Bât du Tondu - Case 41 - 146, Rue Léo Saignat - 33076 BORDEAUX Cedex |
| Phone | + 33 (0)5 57 57 46 75 |
| nicholas.moore@pharmaco.u-bordeaux2.fr | |
| Unit | Service de Pharmacologie, CIC-P 0005-INSERM U657- Université Bordeaux Segalen |
| Organization | Université Bordeaux |
| Collaborations | |
| Funding | |
| Funding status |
Mixed |
| Details | Laboratoire Sanofi-Aventis (soutien inconditionnel) - Sanofi-Aventis (unconditional support) |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | INSERM |
| Organisation status |
Public |
| Additional contact | |
| Main features | |
| Type of database | |
| Type of database |
Study databases |
| Study databases (details) |
Longitudinal study (except cohorts) |
| 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. | A database of general practitioners and non-hospital ENT specialists provided by Wanadoo was used for selection of physicians. General practitioners and ENT specialists were to include prospectively over a period of 4 weeks patients with an episode of acute sinusitis diagnosed according to criteria of the physician. To avoid conducting the study over a period with marked ecological features such as a period of epidemic influenza or respiratory syncytial virus that can interfere with diagnosis and / or treatment of acute sinusitis, the study was conducted over two four-week periods: March / April and September / October. Each physician was to include the first patients meeting the study inclusion criteria (5 during the first wave of inclusion and 6 in the second). |
| Database objective | |
| Main objective | The study objectives were to describe the management of acute sinusitis in real-life conditions of prescription and to evaluate the effectiveness of the initial therapeutic strategy. |
| Inclusion criteria | Patient consulting for acute sinusitis diagnosed according to criteria of the practitioner; Patient without a previous episode of acute sinusitis during the two months preceding diagnosis; Patient aged 18 years and over; Patient agreeing to participate in the study; Patient not included in a clinical trial (Huriet-Sérusclat); Patient who may be followed for two months; Patient showing no severe active disease (life-threatening in the next three months). |
| Population type | |
| Age |
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 | General practitioners and ENT specialists in metropolitan France |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 2005 |
| Date of last collection (YYYY or MM/YYYY) | 2005 |
| Size of the database | |
| Size of the database (number of individuals) |
[1000-10 000[ individuals |
| Details of the number of individuals | 5693 |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Clinical data Declarative data |
| Clinical data (detail) |
Direct physical measures |
| Declarative data (detail) |
Paper self-questionnaire |
| Presence of a biobank |
No |
| Health parameters studied |
Health event/morbidity Health event/mortality Health care consumption and services |
| Care consumption (detail) |
Medicines consumption |
| Procedures | |
| Data collection method | Patients included were the subject of collection of indirectly personal medical data (medical questionnaire completed by the physician at inclusion and 10 days and 2 months after inclusion) and they also had to complete a self-administered within 10 days following inclusion. Participating physicians were also asked to identify and register all patients with an episode of acute sinusitis (with a maximum of 20 patients). |
| Participant monitoring |
Yes |
| Details on monitoring of participants | Patients were followed for 2 months with an evaluation point at 10 days and 2 months after diagnosis. These assessment points concerned the evolution of sinusitis and associated care (antibiotics, drainage, other). |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Link to the document | http://tinyurl.com/Pubmed-ABSINTHE |
| Description | List of publications in Pubmed |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | A final study report was submitted to the funder. The final study report and scientific communications (posters, papers, ...) are validated by the study Scientific Committee. Ownership of study data is the subject of an agreement between the University of Bordeaux Segalen and the funder. Terms for third-party access to the database are to be defined. |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
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