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STUDY PROTOCOL
Year : 2016  |  Volume : 1  |  Issue : 3  |  Page : 121-126

Benefit of carbohydrate deficient transferrin in detecting chronic alcohol abuse in the elderly: study protocol for a multicentre, non-randomized, open-label study


Geriatrics Department, Groupe Hospitalier Regional Mulhouse Sud Alsace, Mulhouse, France

Correspondence Address:
Cécile Schnell
Geriatrics Department, Groupe Hospitalier Regional Mulhouse Sud Alsace, Mulhouse
France
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/2468-5658.191354

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Background: Alcohol misuse affects about five million people in France. Self-reported alcohol consumption, questionnaires, biological markers like gamma-glutamyltranspeptidase (GGT), mean corpuscular volume (MCV) and carbohydrate deficient transferrin (CDT) are usually used to detect alcohol abuse. As a biological marker of alcohol misuse, the specificity of the CDT is known to be superior to GGT and MCV as well. The elderly may suffer from this pathology, but its clinical and biological detection and management are often difficult, due to a frequent denial of the alcoholism and multiple chronic diseases. Methods/Design: A prospective, multicentre, non-randomized, open-label will be performed in the Geriatrics Department of the Hospital of Mulhouse, Alsace and in an Alsatian health care network. Inclusion criteria are: age ≥ 60 years, patients hospitalized for 1 day or 1 week in the Geriatrics department or new patients of the health care network, presence of a suitable relative or helper. A total of 200 enrolled patients are expected. Alcohol consumption will be detected by the Alcohol Use Disorder Identification Test - Consumption questionnaire. This questionnaire will be submitted to the patient and to a relative. If one of the two scores ≥ 1, a CDT analysis may be performed. Primary outcome is the benefit of CDT in the detection of chronic alcohol abuse in the elderly as compared with usual clinical detection tools. Secondary outcomes are sensitivity and specificity of disturbance of GGT and MCV in case of alcohol consumption and identification of socio-economic characteristics of alcohol abusers (socio-professional category, education level, way of life and environment). Discussion: Findings of this trial will probably show low sensitivity and specificity of CDT to detect chronic alcohol misuse in the elderly. Those results suggest that biological markers are not more effective than questionnaires and medical interview to detect alcohol abuse, even if the consumption is initially denied. If confirmed, the results should improve medical screening, diagnosis and care in case of alcohol abuse in the elderly and reduce costs of biological analysis. Trial registration: ClinicalTrials.gov identifier: NCT02822911, registered on 30 June 2016. Ethics: The Committee for the Protection of Persons located in Strasbourg, France, delivered a favourable opinion on the study project. Informed consent: The physician or the health network's care coordinator informs the patient about the study protocol and obtains the patient's assent. The investigator completes a non-opposition file and a copy is given to the patient and to his/her relative or helper.


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