DN4 mixte - Evaluation study of the DN4 questionnaire in mixed pain ARCHIVE

Head :
Millet Véronique, Pfizer

Last update : 01/01/2019 | Version : 1 | ID : 114

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Métadonnées
Identification
General Aspects
Scientific investigator(s) (Contact)
Collaborations
Funding
Governance of the database
Additional contact
Type of database
Database objective
Population type
Dates
Size of the database
Data
Procedures
Promotion
Access
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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
Email 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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