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To investigate the ability of the EQ-5D to discriminate between levels of alcohol risk in a large sample of hazardous and harmful drinkers, and to explore the relationship between transitions between alcohol risk levels and changes in EQ-5D up to 12 months. METHODS: This is a web-based randomised controlled trial evaluating a novel intervention for hazardous and harmful alcohol consumption. EQ-5D scores were compared among groups of drinkers at baseline (low/medium/high risk according to self-reported past week alcohol consumption), and changes in EQ-5D scores were estimated as a function of changes in alcohol consumption level. RESULTS: Baseline EQ-5D scores were dominated by problems with anxiety/depression, which increased with alcohol risk level, whilst high-risk drinkers also experienced more problems with physical HRQoL dimensions. However, the tool demonstrated a considerable ceiling effect. At follow-up, despite considerable reductions in alcohol consumption across the sample, significant changes in aggregated EQ-5D index scores were only observed for high-risk drinkers at baseline who reduced their drinking, with small improvements (0.04-0.06) compared to those who did not reduce. CONCLUSIONS: Our results suggest that the three-option EQ-5D may not be an optimal primary end point for measuring clinical and cost-effectiveness in randomised controlled trials of interventions among hazardous and harmful alcohol users, although further testing of the sensitivity of the tool in these populations is needed.

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