Table 2 Quantification of alcohol consumption in clinical trials

From: Designing clinical trials to address alcohol use and alcohol-associated liver disease: an expert panel Consensus Statement

Measure

Advantages

Limitations

Outcome measures

Self-report measures

AUDIT or AUDIT-C

Quick to perform

Well validated across patient populations and cultures

Can be collected online

Might be less sensitive to detect change from very high risk to moderate risk drinking

Self-report measures can be affected by poor recall, minimizing use or shame at disclosing

Discrete levels of current use along quantity, frequency, and frequency of binge use

Timeline FollowBack

Gold standard method to quantify alcohol consumption

Well validated and reliable

Can be self-administered by participant

Provides detailed data for longitudinal monitoring

Time consuming

Administration by staff can improve quality of data but requires staff time and training

Online version is not available, although online delivery has been validated

Self-report measures can be affected by recall bias, minimizing use or shame at disclosing

Provides quantitative alcohol consumption data over specific interval of time that enables creation of several drinking and/or abstinence outcomes related to quantity, frequency, pattern and duration. Can ascertain all FDA end points and WHO risk drinking levels

Daily diary, Ecological Momentary Assessments

Detailed, granular, highly accurate data

Captures patterns of alcohol use in real time and measures alcohol consumption at very high levels of accuracy

More complex data for management and analysis (particularly for sensors)

Requires high degree of compliance by participant, poor compliance causes data loss

Can be costly and resource-intensive

Provides quantitative alcohol consumption data over specific intervals of time that allows creation of several drinking and/or abstinence outcomes related to quantity, frequency, pattern and duration

  1. AUDIT, Alcohol Use Disorders Identification; AUDIT-C, Alcohol Use Disorders Identification Test-consumption.