Validation of the French Version of the Prediction of the Alcohol Withdrawal Severity Scale (PAWSS) (PAWSS-VF)

February 24, 2025 updated by: Etablissement Public de Santé Barthélemy Durand

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Context Alcohol use disorders (AUDs) are reported in 10-32% of hospitalized medical patients [Nielsen et al. 1994; Smothers et al. 2004; Dolman and Hawkes 2005; Doering-Silveira et al. 2014], in 23 % of hospitalized medical patients and in 25-50% of hospitalized psychiatric patients in France [Paille & Reynaud 2015]. A hospital admission may result in an abrupt cessation of alcohol consumption for individuals with AUD and thus provide a risk period for alcohol withdrawal syndrome. Even though the majority of patients at risk of AWS will develop only minor or uncomplicated withdrawal symptoms, up to 20% of patients develop symptoms associated with complicated alcohol withdrawal, including withdrawal seizures and delirium tremens [Maldonado et al., 2010]. Complicated alcohol withdrawal syndrome is associated with increased in-hospital morbidity and mortality, increased lengths of stay, inflated costs of care, and worsened cognitive functioning.

Due to lack of any similar previously existing tools, Maldonado et al. developed the Prediction of Alcohol Withdrawal Severity Scale (PAWSS) [Maldonado et al. 2014, 2015]. The PAWSS scale has excellent psychometric characteristics and predictive value of complicated alcohol withdrawal among medically ill hospitalized patients using a PAWSS cutoff of 4, the tool's sensitivity was 93.1% and specificity was 99.5%. The PAWSS scale is recommended by the American Society of Addiction Medicine for alcohol withdrawal management, (ASAM 2020, www.asam.org).

There is no scale available to identify the patients at risk of complicated withdrawal In France. The PAWSS is not a withdrawal severity scale such as the CIWA-AR or Cushman scale, which are scored during withdrawal, but a scale designed to screen beforehand, prior to withdrawal, patients at high risk for the most severe complications (Delirium tremens and seizures), and thus to take appropriate therapeutic measures. It also has the advantage of being able to guide patients towards the most suitable scheduled withdrawal modalities for their condition.

The PAWSS can therefore greatly assist clinicians in directing patients to either outpatient or hospital withdrawal in more or less intensive care, with a minimum of risk. Its use would allow earlier management to limit the sequelae, especially cognitive and those related to seizures.

The PAWSS scale includes an initial screener question and can be used with patients who are not currently exhibiting signs of withdrawal. If a patient does indeed endorse recent intake of alcohol, this must be followed by 10 questions contained in the second part of PAWSS, assessing known risk factors for withdrawal and current clinical status. The PAWSS is heavily based on self-report of alcohol intake and history provided by patients, as the literature suggests that interviews by clinicians can provide the most accurate information on alcohol abuse and relapse, as compared to collateral information or selected laboratory data.

Objectives The primary objective is to validate the French version of the PAWSS scale (PRSAC) in a population of patients with AUD.

The secondary objectives are 1) to confirm the optimal cut-off score of 4 for the PRSAC scale, 2) to evaluate PRSAC scale reproducibility in predicting the risk of complicated alcohol withdrawal syndrome and 3) to identify an optimal strategy for benzodiazepine use following the application of PRSAC scale.

Hypothesis Are the psychometric properties of the French version of the PAWSS scale (PRSAC) comparable to those of the English version in a population of alcohol use disorders subjects?

Methods This study is a multicentric non-interventional prospective cohort study. 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.

Inclusion criteria Male or female, aged 18 to 60 years Subjects with DSM-5 criteria for moderate to severe alcohol use disorders (AUD) Subjects hospitalized for AUD or another condition with AUD. Subjects who understand French and affiliated to the social security system

Non-inclusion criteria Subject with a neurological disorder, impairing cognition (epilepsy, dementia,…) Subjects unable to understand the questionnaire and to give consent or not volunteering for the study Subject under guardianship or curatorship

Study location

Academic substance abuse treatment and Psychiatry departments of:

Barthélemy Durand Hospital at Etampes, France Paul Brousse hospital in Villejuif, France Rouen university hospital, France Caen university hospital, France Martinique university hospital, France

Results & Outcome Confirmation of the psychometric qualities of the French version of the PAWSS scale.

Study Type

Observational

Enrollment (Estimated)

545

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Étampes, France, 91150
        • Recruiting
        • Etablissement Public de Santé Barthélemy Durand
        • Contact:
        • Contact:
        • Contact:
          • Amine BENYAMINA
        • Contact:
          • Alain Dervaux
        • Contact:
          • Nicolas Cabe
        • Contact:
          • Alexandre Baguet
        • Contact:
          • Jerome Lacoste
        • Contact:
          • Bernard Angerville

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

AUD adults subjects hospitalized

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Diagnostic test: French version PAWSS
French version of the Prediction of Alcohol Withdrawal Severity Scale

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Psychometric qualities evaluation of French PAWSS
Time Frame: 3 days
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
The optimal cut-off score of 4 for the French version of the Prediction of the Alcohol Withdrawal Severity Scale
Time Frame: 3 days
The optimal cut-off score of 4 will be determined by ROC curve analysis to confirm the cut-off for the French version of the Prediction of Alcohol Withdrawal Severity Scale. A French version of the Prediction of the Alcohol Withdrawal Severity Scale score of 4 or higher indicates a high risk of developing a complicated withdrawal syndrome.
3 days
Reproducibility in predicting the risk of French PAWSS
Time Frame: 3 days
Evaluate the reproducibility of the French version of the Prediction of the Alcohol Withdrawal Severity Scale in predicting the risk of complicated alcohol withdrawal syndrome by measuring inter-rater reliability through the calculation of Cohen's Kappa and Lin's concordance coefficients.
3 days
Doses and Durations of Benzodiazepine
Time Frame: 3 days
The doses and durations of benzodiazepine use during the study are collected during each participant's involvement in the study. These doses and durations will be compared between a group with a score below 4 and a group with a score of 4 or higher on the French version of the Prediction of Alcohol Withdrawal Severity Scale
3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Etablissement Public de Santé Barthélemy Durand

Investigators

  • Principal Investigator: Alain DERVAUX, Etablissement Public de Santé Barthélemy Durand

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 11, 2024

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 1, 2027

Study Registration Dates

First Submitted

September 30, 2024

First Submitted That Met QC Criteria

November 4, 2024

First Posted (Actual)

November 5, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 24, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24P04
  • 2022-A01364-39 (Registry Identifier: ANSM)

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

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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