Alcohol Misuse Treatment Delivered in the Hepatology Clinic to Patients Newly Diagnosed With Alcohol-related Liver Disease: a Randomized Controlled Trial
Phase: NA
Conditions: Liver Diseases, Alcoholic, Alcohol Use Disorder, Treatment Adherence, Alcoholism, Liver Disease; Alcohol-Related
Sponsor: Zealand University Hospital

 
1 
Statistical analysis plan: Alcohol misuse treatment delivered in the hepatology clinic to patients 
newly diagnosed with alcohol-related liver disease: a randomized controlled trial 
 
 
Statistical analysis plan date: 31.10.2025 
Ethical protocol version 6 of 19.08.2025, SJ-895, EMN-2022-05916 
 
Enrollment start date: 01.11.2025 
 
Registration at clinicaltrials.gov was conducted before enrollment began: Yes, link:  
 
Sponsor-investigator 
None 
 
Investigator 
Gro Askgaard, email: gras@regsj.dk  
Emil Buch Fromberg, Emil: Ebuf@regsj.dk 
Section of Gastroenterology and Hepatology, Medical Department, Zealand University Hospital, 4600 Køge, 
DK-Denmark 
 
Clinical epidemiologist responsible 
Matilde Winter-Jensen, email: matilde.winther-jensen.01@regionh.dk 
Center for Clinical Research and Prevention, Bispebjerg and Frederiksberg Hospital, The Capital Region, 
Denmark 
 
 
 

 
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Content 
Abbreviations ................................................................................................................................................. 4 
Introduction ........................................................................................................................................................ 4 
Objective ........................................................................................................................................................ 5 
Hypotheses, endpoints, and rationale ............................................................................................................... 5 
Hypotheses and endpoints............................................................................................................................. 5 
Rationale......................................................................................................................................................... 6 
Study methods ............................................................................................................................................... 6 
Trial design ................................................................................................................................................. 6 
Randomization ........................................................................................................................................... 8 
Sample size ................................................................................................................................................. 8 
Framework, interim analysis and stopping guidance ................................................................................ 9 
Timing of final analysis ............................................................................................................................... 9 
Timing of outcome assessment.................................................................................................................. 9 
Statistical principles ...................................................................................................................................... 10 
Confidence and P-values .......................................................................................................................... 10 
Adherence and protocol deviation .......................................................................................................... 10 
Analysis populations ................................................................................................................................. 10 
Trial population ............................................................................................................................................ 10 
Screening data .......................................................................................................................................... 10 
Eligibility ................................................................................................................................................... 11 
Inclusion criteria ........................................................................................................................................... 11 
Exclusion criteria .......................................................................................................................................... 11 
Recruitment .............................................................................................................................................. 11 
Withdrawal/follow-up .............................................................................................................................. 11 
Baseline characteristics ............................................................................................................................ 12 
Analysis ......................................................................................................................................................... 12 
Outcome definitions ................................................................................................................................. 12 
Primary endpoint...................................................................................................................................... 12 
Secondary outcomes: ............................................................................................................................... 14 
Statistical analysis ..................................................................................................................................... 15 
Secondary outcomes: ............................................................................................................................... 16 
Assessment of model assumptions .......................................................................................................... 17 
Sensitivity analysis .................................................................................................................................... 18 

 
3 
Subgroup analysis ..................................................................................................................................... 18 
Assessment of missing data ..................................................................................................................... 18 
References ................................................................................................................................................ 24 
 
 
 

 
4 
Abbreviations 
RCT Randomized controlled trial 
AUD Alcohol use disorder 
ALD Alcohol-related liver disease 
REDCAP Research Electronic Data Capture 
 
Introduction 
Alcohol consumption is the main cause of advanced chronic liver disease in the European region, 
and data from 2004 suggests that alcohol is the cause of 75% of chronic liver disease in the EU (1,2).  
Cessation of alcohol intake is an important factor for survival in patients with alcohol-related liver 
disease (ALD), with an almost double 10-year survival in ALD patients with decompensated liver 
cirrhosis who were abstainers compared to active alcohol users (65% vs 35%) (3). Today, no routine 
practice supporting alcohol cessation in newly diagnosed ALD patients exists in Danish hospitals and 
similar in several other countries. Often, alcohol use disorder (AUD) treatment is anchored in local 
municipalities, away from hospital settings. Observational studies found that AUD treatment in ALD 
patients is associated with a reduced risk of decompensation and mortality (4). Still, few 
randomized controlled trials of AUD treatment of patients with ALD have been undertaken, and 
they have mainly been in the context of liver transplantation. Qualitative studies have described the 
diagnosis of ALD and hepatology care as a key “teachable moment”, as well as AUD treatment being 
heavily stigmatized and potential participants having great misconceptions about what it might 
entail (5).  
In 2021, we established an observational cohort of patients with newly diagnosed ALD (<3 months). 
Preliminary data from our cohort suggest that less than 10% of patients currently receive 

 
5 
specialized AUD therapy, and 62% of patients were actively using alcohol 6 months after diagnosis 
(unpublished data). In addition, we found that 65% of patients expressed high motivation to cut 
down on alcohol consumption (unpublished data). A high rate of continuing alcohol problems and a 
low rate of AUD treatment in ALD patients have also been reported in the United States (4). With 
this background, we propose a randomized controlled trial embedded in an ongoing clinical cohort 
study to test if an offer to an alcohol misuse treatment in the hepatology clinic to newly diagnosed 
patients with ALD can increase abstinence 6 months later compared to standard care. 
Objective 
• To evaluate the efficacy of offering AUD treatment in the hepatology clinic to newly 
diagnosed ALD patients on alcohol abstinence after 6 months. We will conduct a 
randomized controlled superiority trial with parallel group design, hypothesis blinding and 
blinded outcome assessment comparing A) an offer of specialized AUD treatment in the 
hepatology clinic (intervention) and B) standard care (control).  
• The primary outcome is abstinence throughout the last 30 days assessed 6 months after 
randomization. 
Hypotheses, endpoints, and rationale 
Hypotheses and endpoints 
• Null-hypothesis: We hypothesize that among patients with newly diagnosed ALD, an offer of 
AUD treatment in the hepatology clinic will not make a clinically significant difference to the 
proportion that is abstinent throughout the last 30 days at 6 months of follow-up compared 
to standard care. 
• Alternative hypothesis: We hypothesize that among patients with newly diagnosed ALD, an 
offer of AUD treatment in the hepatology clinic will make a clinically significant increase in 
the proportion that is abstinent throughout the last 30 days at 6 months of follow-up 
compared to standard care from 38% to 60%. 
 

 
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Rationale 
Alcohol cessation in ALD patients is key to avoiding the progression of the disease, but many 
patients with ALD continue to drink alcohol. The efficacy of offering AUD treatment in the 
hepatology clinic to newly diagnosed ALD patients is nearly unstudied, with data on the efficacy of 
AUD treatment mainly coming from studies with participants without established ALD or patients 
awaiting liver transplantation (6–18). 
Study methods 
Trial design 
We have designed a randomized controlled superiority trial to investigate the effectiveness of 
systematically offering AUD treatment in the hepatology clinic to newly diagnosed ALD patients to 
increase the proportion that is abstaining from alcohol after 6 months compared to standard care. 
The study will be embedded in an existing observational cohort from which already included 
participants will be used as controls in the RCT (n = 89). Please see Figure 1 for the flow of 
participants in the study. From 1 November 2025, we will start randomization of eligible 
participants.  
Randomization will take place in connection with the first visit in the observational cohort study. 
Study participants randomized as controls will receive standard care through their treating 
physicians, which consists of individualized education on the nature of ALD as well as 
encouragement of alcohol use cessation.  
Patients in the intervention group will receive standard care and in addition an offer of AUD 
treatment for six months, which includes a meeting with a therapist from the AUD treatment center 
at the hepatology clinic from which an individualized course of treatment is developed. 
As decided by the local ethics committee, those randomized as controls will receive the same offer 
of AUD treatment in the hepatology clinic as the intervention group, but 6 months after their 
baseline visit. The historical controls will not be offered AUD treatment in the hepatology clinic. 
 
The study period for recruitment will proceed from November 2025, until 132 participants have 
been randomized in total, expected in autumn 2028. There is follow-up for each individual 
participant conducted by personnel blinded to the randomization and consisting of: 1) telephone 
contact with interview about alcohol consumption using the time-line follow-back method 

 
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conducted at three time points after 1, 3 and 6 months after baseline, 2) measurement of 
phosphatidyl ethanol after 6 months, and 3) electronic health records after 6 months. We plan to 
later conduct an analysis of the randomized controls who are offered AUD treatment in the 
hepatology clinic after 6 months, that is 6 months postponed compared to the intervention group. 
Furthermore, we plan to conduct long-term follow-up via healthcare registries in about 3 years 
after study recruitment is finished. Please see Figure 2 for clarification on trial structure.  
Figure 1. Expected flow of participants in the RCT (Created in BioRender. Fromberg, E. (2025) https://BioRender.com/ 
Tcacppm) 
 
 
 

 
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Figure 2. Study activities. Phosphatidylethanol = PETH, AUD = Alcohol use disorder, EPR = Electronic Patient Record 
 
 
Randomization 
Eligible participants from the existing observational cohort will be included as controls (n = 89). 
Before enrollment to the randomized study, a randomization sequence will be generated by 
Microsoft Excel 2013 and uploaded to the software program REDCap. From November 2025, 
participants will be continuously allocated to intervention or control group using REDCap with 
stratification by age (over/under 60 years), sex, and current alcohol use status (self-reported active 
alcohol consumer or abstinence less than 30 days vs. self-reported alcohol abstinence more than 30 
days). Participants are randomized 4.4:1 to an offer of referral to AUD treatment vs. standard care 
to ensure that we can compare clinical characteristics in controls before and after randomization 
began.  
 
Sample size 
We plan to include 221 individuals in the study: 102 will be offered the intervention, and 119 will be 
controls. This number is based on preliminary data based on 80 patients from the observational 
cohort, demonstrating that 38% have been abstinent the last 30 days at 6 months of follow-up, and 
we want to improve this percentage to 60%. The study is a superiority trial with a margin of 5%. A 
superiority margin of 5% was chosen due to the expectation of no adverse effects of the 
intervention and because even a small improvement in abstinence is expected to improve the 
prognosis in ALD (19). With a power of 80% and a 5% significance level, it requires 102 participants 

 
9 
in the intervention arm and 101 in the control arm. As 89 participants were already enrolled as 
controls, 12 more controls are needed, but to enhance the sub analysis of comparing the 
randomized control group to the historic cohort, it was chosen to increase the randomized control 
group to 30. Also to allow comparison for clinical characteristics in historical and randomized 
controls. Therefore, we need to randomize 132 new participants at a ratio of 4.4:1 to 
intervention:control group. We expect the loss to follow up to be 10-15%. The power calculation 
was performed in the software program of Excel (20). 
 
Framework, interim analysis and stopping guidance 
No interim analyses will be performed. 
 
Timing of final analysis 
Analyses will be performed in a blinded data set with treatment allocation labeled “A” and “B”. 
Prior to this, the statistical analysis plan will be completed, signed, and uploaded at clinicaltrials.gov, 
and the data set will be locked. Unblinding will not occur until all analyses are performed (expected 
spring 2029. This means that apart from data on long-term follow-up, all analyses will be finalized 
collectively. 
 
Timing of outcome assessment 
The primary outcome will be assessment of abstinence (see detailed description in Table 1) 6 
months after the randomization or 6 months after the baseline visit in controls who were not 
randomized because they were part of the already enrolled controls. Secondary outcomes will be 
assessed after 3, 6 and 12 months. Later, we will conduct a secondary analysis with a longer follow-
up of up to 3 years. 
 

 
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Statistical principles 
Confidence and P-values 
Level of statistical significance is set at an alpha level of 0.05 with two-sided testing and a 
confidence interval of 95%. 
 
Adherence and protocol deviation 
Protocol deviations will be presented in a table and divided into categories: Eligibility, study 
procedure, and randomization. The deviations “lost to follow-up” (in case of emigration out of 
Denmark) and “withdrawal” (when study participants withdraw their informed consent) are 
described in more detail below. 
 
Analysis populations 
The primary analysis will be performed using the intention-to-treat approach, which includes all 
patients included in the RCT. In a secondary analysis, the primary outcome will be investigated using 
the per-protocol principle, where only those participants randomized to the intervention, who 
accepted AUD treatment in the hepatology clinic and who were successfully contacted at the 6-
month follow-up will be included in the analysis in addition to the controls. This analysis will also 
exclude participants who are lost to follow-up due to emigration or withdrawal from the study. 
Follow-up will be possible for all participants who have not emigrated (follow-up procedures are 
described below). 
 
Trial population 
Screening data 
A CONSORT flow chart will present the flow of study participants.  
 

 
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Eligibility 
Inclusion criteria 
• Age > 18 years 
• Newly diagnosed alcohol-related liver disease, defined as within six months from baseline 
visit. 
• A liver stiffness ≥8.0 kPa with 10 successful measurements and an interquartile range of less 
than 30% as assessed with transient elastography. 
• Excessive alcohol consumption defined as >7 units/week for women and >14 units/week for 
men within the previous year.  
• The patient is able to understand the purpose of the study and give informed oral and 
written consent to participate. 
Exclusion criteria 
• Not enough proficiency in Danish to participate in interviews and questionnaires. 
• Pregnancy 
• Ongoing specialized AUD treatment. Self-help groups and AUD counselling at general 
practitioners are not counting as specialized AUD treatment in this study. 
Recruitment 
November 2025 until complete recruitment of 221 study participants. 
Patients will be recruited from the Department of Internal Medicine, ZUH Køge, Denmark, with a 
satellite outpatient facility at Holbæk Hospital, Denmark. 
 
Withdrawal/follow-up 
See Table 1 for the description of follow-up. Four follow-up methods will be applied: Telephone 
interview, measurement of phosphatidylethanol in blood, review of medical chart records, and 
records from the alcohol treatment center. If participants are not approachable by telephone, 
follow-up data will be based on information from records from the hospital and alcohol treatment 
center alone. Withdrawal is when a study participant withdraws their informed consent for study 
participation. 

 
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Loss to follow-up is only in the case if the patient emigrates or if the participant withdraws consent 
to be followed through the health registries. 
 
Baseline characteristics 
The following characteristics will be summarized according to intervention allocation: 
- 
Sex 
- 
Age, median and 25-75% percentiles 
- 
Months since last alcohol consumption, median 
- 
Abstinence throughout the last month (yes/no) 
- 
Years exceeding 10 units/week, groups (<5, 5-10, 10-15, 15-20, >20) 
- 
Audit-C 
- 
Motivation to cut down on 10 point scale, percentage answering “10”, median and IQR 
- 
Belief in capability to cut down on alcohol, 10 point scale, percentage answering “10”, 
median and IQR 
- 
Current smoking (yes/no) 
 
Analysis 
Outcome definitions 
Primary endpoint 
Primary outcome: Alcohol abstinence throughout the last 30 days assessed after 6 months after the 
randomization (randomized participants) or baseline visit (only for controls enrolled before 
randomization began).  
 
 

 
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Table 1. Evaluation of primary outcome of alcohol abstinence throughout the last 30 days 
 
Interpreted as not fulfilling 
alcohol abstinence if 
indicated by one or more of 
the outcome measures below 
Interpreted as fulfilling 
alcohol abstinence the last 
month if indicated by all 
three of the outcome 
measures below 
1) Telephone interview with 
timeline follow-back method 
Interview reveals any alcohol 
intake the last 30 days 
Interview reveals alcohol 
abstinence the last 30 days 
2) Phosphatidylethanol 
Phosphatidylethanol value 
was  0.05 μmol/L 
Phosphatidylethanol value 
was < 0.05 μmol/L 
3) Electronic health record 
Hospital contact the last 30 
days with history that 
indicates current drinking: 
alcohol intoxication, ethanol 
measurement, self-reported 
by the patient, or death with 
obvious alcohol involvement 
recorded in patient charts. If it 
has not been possible to 
establish contact with the 
Hospital contact without 
mentioning of alcohol 
consumption last 30 days. 
Death with no obvious alcohol 
involvement as reported in 
patient charts. 

 
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Secondary outcomes:  
1. Alcohol abstinence throughout the last 30 days assessed after 3 months. 
2. Any treatment for alcohol use disorder after 6 months. 
3. Number of received sessions of treatment for alcohol use disorder after 6 months. 
  
Assessed as the difference between baseline visit and 3 or 6 months of follow-up:  
4. Reduction in drinks per week after 3 and 6 months compared to baseline (yes or no).  
5. Reduction in phosphatidylethanol value at 6 months compared to baseline (yes or no).  
Analysis of the randomized control group accepting referral to AUD treatment, as part of the cohort 
study the participants will meet for a 1-year follow-up, performing the same tests as for the 6 
months follow up. 
1. Alcohol abstinence throughout the last 30 days assessed 1 year after the randomization. 
2. Reduction in drinks per week after 12 months compared to 6 months (yes or no). 
3. Reduction in phosphatidylethanol value at 12 months compared to 6 month follow up (yes 
or no). 
patient using methods 1), 2), 
or 3) no hospital contacts. 
4) Report of alcohol 
consumption via specialized 
AUD treatment from Novavi 
AUD treatment provider 
reports patients have ongoing 
alcohol consumption. 
AUD treatment provider 
reports patients are alcohol 
abstinent. 

 
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Longer follow-up (3 years) is planned utilizing electronic medical records to investigate if the 
intervention improves liver outcomes and survival. 
These outcomes are: 
1. Time to first decompensation event, which is defined as variceal haemorrhage, ascites grade 
2 or worse, or hepatic encephalopathy West-Haven grade 2 or worse, assessed as a 
competing risk analysis, taking death as a competing risk into account. 
2. All-cause mortality. 
3. Progression in liver fibrosis grade assessed by transient elastography (21) or progression to a 
worse Child-Pugh class (A to B or C and B to C), taking death as a competing risk into 
account. 
 
Statistical analysis 
Continuous outcomes will be assessed for normality and reported as mean (sd) or median (25th-
75th percentile) and analyzed with t-test or Wilcoxon test, as appropriate. Further, outcomes will 
be analyzed using logistic regression, adjusted for confounders. Categorical outcomes will be 
reported as n (%) and analyzed using chi-square test. Linear or logistic regression will be used to 
adjust for confounders.  
The primary outcome will be assessed using logistic regression.  
The primary outcome will be assessed in the intention-to-treat population, and further, in the per-
protocol population. Participants who accepted referral to alcohol abuse treatment will be 
regarded as fulfilling the protocol. In the latter, inverse probability of treatment weighting will be 
used to account for measured confounding of age and sex. Weighting will be based on accepting 
referral to treatment.  
 

 
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Secondary outcomes:  
1. Alcohol abstinence throughout the last 30 days evaluated after 3 months (yes/no), 
assessed by logistic regression 
2. Reduction in drinks per week after 3 and 6 months (yes or no), assessed by logistic 
regression.  
3. Change in number of drinks per week after 3 and 6 months – assessed by linear regression 
4. Reduction in phosphatidylethanol value by 0.05 or more at 6 months (yes or no), assessed 
by logistic regression. 
5. Change in phosphatidylethanol value after 6 months – assessed by linear regression 
6. Any treatment for AUD (yes or no), assessed by logistic regression. 
7. Number of received sessions of treatment for AUD (median and IQR).  
Follow-up after 1 year 
1. Reduction in drinks per week after 6 and 12 months (yes or no), assessed by logistic 
regression.  
2. Change in number of drinks per week after 6 and 12 months – assessed by linear regression 
3. Reduction in phosphatidylethanol value by 0.05 or more at 12 months (yes or no), assessed 
by logistic regression. 
4. Change in phosphatidylethanol value after 12 months – assessed by linear regression 
5. Any treatment for AUD (yes or no), assessed by logistic regression. 
6. Number of received sessions of treatment for AUD (median and IQR).  

 
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Longer follow-up (3 years) is planned utilizing electronic medical records to investigate if the 
intervention improves liver outcomes and death. Death will be taken into account as a competing 
risk in analyses of non-mortality outcomes.  
These outcomes are: 
1. Time to first decompensation event, which is defined as variceal haemorrhage, ascites 
grade 2 or worse, or hepatic encephalopathy West-Haven grade 2 or worse assessed by 
competing risk analysis, taking death as competing risk into account.  
2. All-cause mortality, assessed in Cox regression 
3. Progression in liver fibrosis grade assessed by transient elastography (21) or progression to 
a worse Child-Pugh class (A to B or C and B to C), assessed by competing risk analysis, 
taking death as competing risk into account.  
 
Assessment of model assumptions 
Logistic regression: 
The assumption of linearity between log odds of outcome and the predictor is less relevant when 
the predictor is dichotomous, as in this study.  
Linear regression: 
Linear relationship between intervention and number of drinking days will be assessed by plotting 
the fitted values(x) vs. the residuals(y). 
Normality of residuals is checked by the QQ-plot, residuals should follow the straight line.  
Homoscedascity is assessed plotting standardized residuals vs. fitted values.  
Influential values are not as likely, since the intervention is dichotomous, and all numbers of heavy 
drinking days pr. 30 days are likely.  

 
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The assumption of proportional hazards in Cox regression will be tested by cloglog-plots and/or 
Schoenfeld residuals.  
Sensitivity analysis 
Only including those who had the intervention by excluding those in the intervention group who 
never had any AUD treatment (per protocol analysis). Participants who are lost to follow up due to 
emigration will also be excluded in this analysis. 
 
Subgroup analysis 
Severity of liver disease at baseline (non-cirrhotic, compensated, decompensated) 
By hospital diagnosis of ALD (inpatient admission with ALD/not admitted) 
By alcohol abstinence last month at baseline 
Severity of AUD, measured by AUDIT-C (over/under median) 
By Liver frailty index at baseline 
By sex (men/women) 
By age at baseline 
By motivation to cut down at baseline 
By evidence of minimal hepatic encephalopathy assessed by continues reaction time 
 
Assessment of missing data 
Missing data will be investigated by producing tables that characterize patients with missing data 
vs. patients with information for each missing variable, as in table 2 below. There may be missing 
data in many variables, so variables of interest will be assessed.  
Table 2: Example of assessment of missingness  
 
Missing (n=xx) 
Not missing (n=YY) 

 
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Intervention 
2% 
10% 
Primary outcome 
12% 
5% 
  
Missingness is not expected in intervention assignment or outcome but may be present in 
confounders. Missingness is likely unrelated to intervention, but patterns of missingness will be 
assessed, if found meaningful this will be presented with a missingness directed acyclic graph, 
which is visual model of the causal relationships between variables and the reasons they may be 
missing. If patients with missing data differ from patients without missing data, it is assumed that 
data is missing not at random and multiple imputation may be redundant. Otherwise, multiple 
imputation may be used as a sensitivity analysis. Whether imputation can be used will be based on 
a judgment of the extent of patterns in missingness as well as degree of missingness. Imputation 
will not be used if missingness should be skewed or if missingness is present in less than 10% of the 
total dataset including the confounders to be used. All secondary outcomes will be assessed as 
cross tables with intervention, primary outcome, age, sex, marital status, and occupation. As a rule 
of thumb, differences should be less than 5% between patients with and without missing data, but 
the total pattern will be considered.  
 
 

 
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Tables  
Table 3. Baseline demographic and clinical characteristics according to randomization outcome, 
values are number (%) unless otherwise stated 
 
Randomized to 
intervention (referral 
to AUD treatment) 
Controls randomized 
to standard care 
Controls from 
before 
implementation of 
RCT (received 
standard care) 
Sex, % men 
 
 
 
Age, median 
 
 
 
Self-reported alcohol 
abstinence 
 
 
 
AUDIT-C 
 
 
 
Days since last alcohol 
consumption, median 
 
 
 
Years with exceeding 10 
units/week, median SD 
 
 
 
Phosphatidylethanol 
 
 
 
Duration of AUD 
treatment in months, 
median 
 
 
 
Number of AUD treatment 
sessions, median. 
 
 
 
Smoking, % yes 
 
 
 
 
 
 
 

 
21
Table 4. Assessment of primary outcome N (%) at 6 months after randomization according to the 
four follow-up methods 
 
Intervention 
Control 
Alcohol abstinence 
throughout the last 30 days 
Yes 
No 
Yes 
No 
At Inclusion 
 
 
 
 
By Telephone interview 
 
 
 
 
By phosphatidylethanol 
 
 
 
 
By Electronic health record 
 
 
 
 
In total 
 
 
 
 
 
 
 
 
 

 
22
Table 5.  Comparison of endpoints at 3- and 6-months follow-up according to randomization group 
 
Referral to AUD 
treatment 
(intervention) 
Standard care 
(controls) 
p-value 
Alcohol abstinence last 30 
days at 6 months (yes or 
no) 
 
 
 
Alcohol abstinence last 30 
days at 3 months (yes or 
no) 
 
 
 
Reduction in drinks per 
week last 30 days in 
drinkers at 6 months 
(yes/no) 
 
 
 
Reduction in drinks per 
week last 30 days in 
drinkers at 3 months 
(yes/no) 
 
 
 
Change in drinks per week 
in drinkers since baseline 
(drinks) at 6 months 
 
 
 
Change in drinks per week 
in drinkers since baseline 
(drinks) at 3 months 
 
 
 

 
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Phosphatidylethanol value 
at follow-up 
 
 
 
Change in 
phosphatidylethanol value 
since baseline at 6 months 
 
 
 
Received alcohol 
treatment for AUD 
yes/no), number of 
sessions,  
 
 
 
Median number of 
treatment sessions for 
AUD, total 
 
 
 
- 
Individual sessions, 
median 
 
 
 
- 
Group sessions, 
Median 
 
 
 
 
 

 
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