Validation of the French Version of the Prediction of the Alcohol Withdrawal Severity Scale (PAWSS)
PAWSS-VF
2 other identifiers
observational
545
1 country
1
Brief Summary
The goal of this observational study is to validate the French version of the PAWSS scale in a population of patients with Alcohol Use Disorders. Prediction of Alcohol Withdrawal Severity Scale (PAWSS) has an excellent psychometric characteristics and predictive value of complicated alcohol withdrawal. The main question it aims to answer is: Are the psychometric properties of the French version of the PAWSS scale comparable to those of the English version in a population of alcohol use disorders subjects? AUDs participants are included and followed for three days during their hospitalization, They will performed several scales and surveys (DSM-5 AUD criteria, AUDIT, French version of PAWSS and CIWA-AR).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2024
Typical duration 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
September 30, 2024
CompletedFirst Posted
Study publicly available on registry
November 5, 2024
CompletedStudy Start
First participant enrolled
November 11, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2027
February 25, 2025
February 1, 2025
2.9 years
September 30, 2024
February 24, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Psychometric qualities evaluation of French PAWSS
The primary endpoint is the evaluation of the psychometric qualities of the French version of PAWSS scale (PRSAC) by measuring predictive performance through the calculation of sensitivity, specificity, and positive and negative predictive values.
3 days
Secondary Outcomes (3)
The optimal cut-off score of 4 for the French version of the Prediction of the Alcohol Withdrawal Severity Scale
3 days
Reproducibility in predicting the risk of French PAWSS
3 days
Doses and Durations of Benzodiazepine
3 days
Study Arms (1)
AUD participant
Subject evaluation included during 3 days. Day 1: Collection of consent and clinical data, DSM-5 criterion for alcohol use disorders, AUDIT, PRSAC scale (twice by two investigators), and CIWA-AR scale every 8 hours. Day 2 and Day 3: administration of CIWA-AR scale every 8 hours.
Interventions
French version of the Prediction of Alcohol Withdrawal Severity Scale
Eligibility Criteria
AUD adults subjects hospitalized
You may qualify if:
- Male or female, aged 18 to 60 years
- Subjects with DSM-5 criteria for alcohol use disorders (AUD)
- Subjects hospitalized for scheduled withdrawal or patients developing alcohol withdrawal hospitalized for another reason.
- Subjects who understand French
- Subject affiliated to the French social security system
- Subject having given their written consent to the study
You may not qualify if:
- Subjects transferred from other hospitalization services for whom a withdrawal syndrome could have already been treated.
- Subjects scheduled for discharge within 48 hours.
- Subjects with known uncontrolled epilepsy.
- Subjects unable to understand the questionnaire.
- Subjects unable to give consent or not volunteering for the study.
- Subjects under guardianship or curatorship.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Etablissement Public de Santé Barthélemy Durand
Étampes, 91150, France
Related Publications (5)
Maldonado JR, Sher Y, Das S, Hills-Evans K, Frenklach A, Lolak S, Talley R, Neri E. Prospective Validation Study of the Prediction of Alcohol Withdrawal Severity Scale (PAWSS) in Medically Ill Inpatients: A New Scale for the Prediction of Complicated Alcohol Withdrawal Syndrome. Alcohol Alcohol. 2015 Sep;50(5):509-18. doi: 10.1093/alcalc/agv043. Epub 2015 May 21.
PMID: 25999438BACKGROUNDMaldonado JR, Sher Y, Ashouri JF, Hills-Evans K, Swendsen H, Lolak S, Miller AC. The "Prediction of Alcohol Withdrawal Severity Scale" (PAWSS): systematic literature review and pilot study of a new scale for the prediction of complicated alcohol withdrawal syndrome. Alcohol. 2014 Jun;48(4):375-90. doi: 10.1016/j.alcohol.2014.01.004. Epub 2014 Feb 19.
PMID: 24657098BACKGROUNDCampos J, Roca L, Gude F, Gonzalez-Quintela A. Long-term mortality of patients admitted to the hospital with alcohol withdrawal syndrome. Alcohol Clin Exp Res. 2011 Jun;35(6):1180-6. doi: 10.1111/j.1530-0277.2011.01451.x. Epub 2011 Feb 25.
PMID: 21352245BACKGROUNDEloma AS, Tucciarone JM, Hayes EM, Bronson BD. Evaluation of the appropriate use of a CIWA-Ar alcohol withdrawal protocol in the general hospital setting. Am J Drug Alcohol Abuse. 2018;44(4):418-425. doi: 10.1080/00952990.2017.1362418. Epub 2017 Oct 5.
PMID: 28981333BACKGROUNDSullivan JT, Sykora K, Schneiderman J, Naranjo CA, Sellers EM. Assessment of alcohol withdrawal: the revised clinical institute withdrawal assessment for alcohol scale (CIWA-Ar). Br J Addict. 1989 Nov;84(11):1353-7. doi: 10.1111/j.1360-0443.1989.tb00737.x.
PMID: 2597811BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alain Dervaux
Etablissement Public de Santé Barthélemy Durand
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 30, 2024
First Posted
November 5, 2024
Study Start
November 11, 2024
Primary Completion (Estimated)
October 1, 2027
Study Completion (Estimated)
October 1, 2027
Last Updated
February 25, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will not share