Primary Care Validation in French of a Single-question Screening Test for Unhealthy Alcohol Use.

Unhealthy Alcohol Use Clinical Trial

— DECORA  

Official title:

Primary Care Validation in French of a Single-question Screening Test for Unhealthy Alcohol Use.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04329988
• Other study ID #: 69HCL19_0889
• Status: Completed
• Start date: May 28, 2020
• Est. completion date: December 18, 2020

Study information

• Verified date: January 2021
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 394
• Est. completion date: December 18, 2020
• Est. primary completion date: December 18, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Consulting in a general practitioner's office

• Over 18 years Old

Exclusion Criteria:

• Less than 18 years old

• Pregnant women or breast-feeding mothers

• People under legal protection

Related Conditions & MeSH terms

• Alcohol Drinking
• Unhealthy Alcohol Use

Intervention

Other:
• questionnaire
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.

Locations

Country	Name	City	State
France	Cabinet de Médecine Générale Dr Christine Maynie-François	Saint-Quentin-Fallavier

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).
Primary	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).