Primary Care Validation in French of a Single-question Screening Test for Unhealthy Alcohol Use.
DECORA
1 other identifier
observational
394
1 country
1
Brief Summary
Unhealthy alcohol use (UAU) is a very important public health concern. In France UAU is the second cause of avoidable death after tobacco smoking. In 2014, 31% of the French adult population presented with unhealthy alcohol use. Primary care practitioners have access to validated questionnaires in French such as the Alcohol Use Disorder Identification Test (AUDIT) and the Fast Alcohol Consumption Evaluation (FACE). These tests are not often used because of their length. In 2009 a study by Smith et al in the USA compared a single question with the AUDIT-c (a short version of the AUDIT). The single question was "How many times in the past year have you had X or more drinks in a day?" Where X is 7 for men and 6 for women. This study found that the single question had a comparable sensitivity and a specificity, respectively 81,8% and 79,3%. The aim of the study is to validate this question in French. First the question has been translated from English to French following the WHO method. The aim of the present study is to validate the French translation by comparing it with the AUDIT and the FACE. A questionnaire will be given to patients with inclusion criteria in general practitioners waiting rooms (15 different locations). This questionnaire will be composed of the single question, followed by the AUDIT and FACE, and three socio-demographic questions. The questionnaire will be anonymous.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2020
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 30, 2020
CompletedFirst Posted
Study publicly available on registry
April 1, 2020
CompletedStudy Start
First participant enrolled
May 28, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 18, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 18, 2020
CompletedSeptember 26, 2022
January 1, 2021
7 months
March 30, 2020
September 23, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
sensitivity of the single question
sensitivity of the single question as measured versus the AUDIT (Alcohol use disorder identification test) Sensitivity = TP/(TP+FN) TP : true positives : people answering 1 or more at the single question and having a score of 8 or more with the AUDIT questionnaire FN : False Negatives : people answering 0 at the single question and having a score of 8 or more with the AUDIT questionnaire TN : True negatives : people answering 0 at the single question and having a score of 7 or less with the AUDIT questionnaire
At inclusion (Patients will answer the questionnaire only once while waiting in theirs doctor's waiting room).
specificity of the single question
specificity of the single question as measured versus the AUDIT (Alcohol use disorder identification test). Specificity = TN/(TN+FP) TP : true positives : people answering 1 or more at the single question and having a score of 8 or more with the AUDIT questionnaire TN : True negatives : people answering 0 at the single question and having a score of 7 or less with the AUDIT questionnaire FP : False positives : people answering 1 or more at the single question and having a score of 7 or less with the AUDIT questionnaire
At inclusion (Patients will answer the questionnaire only once while waiting in theirs doctor's waiting room).
Study Arms (1)
Primary care patients aged 18 or more
All patients consulting in a general practitioner office, aged 18 or more, who completed the questionnaire
Interventions
A questionnaire will be made available to all eligible patients in general practitioners waiting rooms. This questionnaire will be composed by the single question, followed by the AUDIT and FACE questionnaires, and three socio-demographic questions. This questionnaire will be anonymous. Patients who agree to fill out a questionnaire will place it in a sealed box once completed.
Eligibility Criteria
General population consulting in a primary care office over 18 years old.
You may qualify if:
- Consulting in a general practitioner's office
- Over 18 years Old
You may not qualify if:
- Less than 18 years old
- Pregnant women or breast-feeding mothers
- People under legal protection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cabinet de Médecine Générale Dr Christine Maynie-François
Saint-Quentin-Fallavier, 38070, France
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 30, 2020
First Posted
April 1, 2020
Study Start
May 28, 2020
Primary Completion
December 18, 2020
Study Completion
December 18, 2020
Last Updated
September 26, 2022
Record last verified: 2021-01
Data Sharing
- IPD Sharing
- Will not share