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临床试验/NCT04329988
NCT04329988已完成不适用

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

Hospices Civils de Lyon1 个研究点 分布在 1 个国家目标入组 394 人开始时间: 2020年5月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
394
试验地点
1
主要终点
sensitivity of the single question

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Consulting in a general practitioner's office
  • •Over 18 years Old

排除标准

  • •Less than 18 years old
  • •Pregnant women or breast-feeding mothers
  • •People under legal protection

结局指标

主要结局

sensitivity of the single question

时间窗: At inclusion (Patients will answer the questionnaire only once while waiting in theirs doctor's waiting room).

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

specificity of the single question

时间窗: At inclusion (Patients will answer the questionnaire only once while waiting in theirs doctor's waiting room).

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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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