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

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.

Study Overview

• Status: Completed
• Conditions: Unhealthy Alcohol Use
• Intervention / Treatment: Other: questionnaire

• Study Type: Observational
• Enrollment (Actual): 394

Contacts and Locations

Study Locations

• France
  • Saint-Quentin-Fallavier, France, 38070
    • Cabinet de Médecine Générale Dr Christine Maynie-François

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

General population consulting in a primary care office over 18 years old.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Primary care patients aged 18 or more; All patients consulting in a general practitioner office, aged 18 or more, who completed the questionnaire

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 28, 2020
• Primary Completion (ACTUAL): December 18, 2020
• Study Completion (ACTUAL): December 18, 2020

Study Registration Dates

• First Submitted: March 30, 2020
• First Submitted That Met QC Criteria: March 30, 2020
• First Posted (ACTUAL): April 1, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 26, 2022
• Last Update Submitted That Met QC Criteria: September 23, 2022
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Drinking Behavior; Alcohol Drinking
• Other Study ID Numbers: 69HCL19_0889

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No