ITMO public health
Last update : 01/01/2019 | Version : 1 | ID : 114
| General | |
| Identification | |
| Detailed name | Evaluation study of the DN4 questionnaire in mixed pain |
| Sign or acronym | DN4 mixte |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL N°907211 |
| General Aspects | |
| Medical area |
Neurology |
| Others (details) | neuropathic pain |
| Keywords | DN4 questionnaire, evaluation |
| Scientific investigator(s) (Contact) | |
| Name of the director | Millet |
| Surname | Véronique |
| Address | 23-25 avenue du Dr Lannelongue, 75668 paris cedex 14 |
| Phone | +33 (0)1 58 07 34 12 |
| veronique.millet@pfizer.com | |
| Unit | Pfizer |
| Organization | Pfizer |
| Collaborations | |
| Funding | |
| Funding status |
Private |
| Details | Pfizer |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Pfizer |
| Organisation status |
Private |
| 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 institutions and services |
| Database recruitment is carried out as part of an interventional study |
No |
| Additional information regarding sample selection. | Recruitment through participating doctors |
| Database objective | |
| Main objective |
Main: Compare the average scores of the DN4 questionnaire observed in 4 sub-groups of patients monitored for lumbar radiculalgia. Secondary objectives: - For each item on the DN4, compare the proportion of the positive items between each sub-group. - Compare the proportions of the subjects that have a DN4 score > 4/10 between each sub-group. - Compare the proportions of the subjects that have been considered as having neuropathic component by a 1st investigator between each sub-group. - Estimate the sensitivity, specificity, the positive and negative predictive value of the DN4 scale in relation to the opinion of the 1st investigator within each sub-group: o By taking a DN4 threshold at 4/10 o Using the ROC curve - Compare the averages of the scores of the modified Schöber index and the ""hand-to-floor distance"" according to the presence or not of a neuropathic component in the 4 sub-groups. |
| Inclusion criteria |
Patients ≥ 18 years, - First consultation in an investigating center, - Patients having a lumber pain with or without radiculalgia (patients presenting another pain of moderate to severe were excluded), - Pain present for at least 3 months, - Moderate to severe pain (intensity ≥ 4 on the 11-point Lickert scale), - Patients who have signed the written consent. |
| 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 | Metropolitan France |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 2007 |
| Date of last collection (YYYY or MM/YYYY) | 2009 |
| Size of the database | |
| Size of the database (number of individuals) |
< 500 individuals |
| Details of the number of individuals | 132 |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Clinical data Declarative data |
| Clinical data (detail) |
Direct physical measures Medical registration |
| Declarative data (detail) |
Face to face interview |
| Presence of a biobank |
No |
| Health parameters studied |
Health care consumption and services |
| Care consumption (detail) |
Medical/paramedical consultation |
| Procedures | |
| Data collection method | Paper CRF |
| Participant monitoring |
Yes |
| Details on monitoring of participants | 1 to 3 days |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | Methods for accessing the database are currently being defined |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
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