Clinical trial NCT05865847: Socioeconomic Differences in Alcohol Harm in Finland in a Nationwide Cohort Study
Official title: Unveiling the Alcohol Harm Paradox: Analysis of Socioeconomic Differences in Alcohol Harm in Finland in a Nationwide Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Alcohol-Related Disorders
Lead sponsor: Finnish Institute for Health and Welfare
Sponsor class: OTHER_GOV
Collaborators: name: Social Insurance Institution, Finland
First posted: 2023-05-19
Enrollment: 3950000
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All permanent residents in Finland older than 25 years old and without an alcohol-attributable hospital admission during the past three years

Brief summary: This is a nationwide cohort study of Finnish adults aged 25 and older, who are followed up for the incidence of an alcohol-attributable hospitalization or death. The primary objective is to examine the relative and absolute socioeconomic differences in cause-specific alcohol-attributable hospital admissions and deaths.

Detailed description: Background

Alcohol consumption is a leading risk factor for death and disability, resulting in substantial societal costs and social and community harm. Alcohol-related harm has been consistently shown to be higher among people of lower socioeconomic status, despite the fact they often report similar or lower levels of alcohol use. This apparent contrast has been called the alcohol harm paradox.

Understanding what explains the alcohol harm paradox is crucial for the design and implementation of population health interventions to reduce socioeconomic differences in alcohol harm. Explanations for the paradox can be broadly categorised into three groups: (i) differential exposure to alcohol, drinking patterns and trajectories and to other behavioural risk factors and joint effects among them, (ii) differential vulnerability resulting from individual factors, such as biological characteristics, psychological traits or stress, cumulative disadvantage and broader community and societal upstream factors, and (iii) differential biases in the measurement of alcohol exposure.

A crucial weakness of existing empirical studies comes from the operationalization of alcohol harm. With few exceptions, a vast majority of studies has used a composite endpoint combining several causes of alcohol-attributable deaths or hospitalizations or even merging alcohol-attributable hospital admissions with deaths in a single outcome. While this strategy increases the statistical power to analyse rare events, composite endpoints are prone to misclassification bias by masking divergent underlying patterns and associations.

Cause-specific analyses might shed light on different mechanisms driving the socioeconomic differences in overall alcohol-attributable harm, as well as opening potential avenues for policy interventions to reduce them. The study will take advantage of a recently formed dataset covering the total Finnish population to explore associations between socioeconomic status and cause-specific alcohol-attributable events. An additional contribution to the literature will be reporting both relative and absolute inequalities in alcohol-attributable harm. Absolute differences have been rarely reported even though might be as relevant as relative differences because, from a pragmatic standpoint, they are more feasible to reduce.

The study will aim to (1) examine the relative and absolute socioeconomic differences in cause-specific alcohol-attributable hospital admissions and deaths; (2) describe the geographical differences in cause-specific alcohol-attributable hospital admissions and deaths; and (3) quantify the relative contribution of each specific alcohol-attributable cause to the overall alcohol-attributable harm.

Eligibility criteria: Inclusion Criteria:

* Permanent residents (defined by Statistics Finland as those Finnish and foreign nationals who have a legal domicile in Finland and intend to stay (or have stayed) for at least one year) alive in Finland by December 31, 2015
* Age 25 years or older by January 1, 2016
* Not having an alcohol-attributable hospitalization during the past three years ((January 2013-December 2015

Exclusion Criteria:

* Temporary residents, including foreign nationals living in Finland for less than a year, asylum seekers who have not been granted a legal domicile, temporary migrant workers and Finnish nationals living temporarily abroad by December 31, 2015

Primary outcomes:
measure: Alcohol intoxication - Hospitalization
timeFrame: January 1, 2016 to February 28, 2020
measure: Alcohol intoxication - Death
timeFrame: January 1, 2016 to February 28, 2020
measure: Alcohol dependence - Hospitalization
timeFrame: January 1, 2016 to February 28, 2020
measure: Alcohol dependence - Death
timeFrame: January 1, 2016 to February 28, 2020
measure: Psycho-organic syndrome caused by alcohol - Hospitalization
timeFrame: January 1, 2016 to February 28, 2020
measure: Psycho-organic syndrome caused by alcohol - Death
timeFrame: January 1, 2016 to February 28, 2020
measure: Alcoholic liver disease - Hospitalization
timeFrame: January 1, 2016 to February 28, 2020
measure: Alcoholic liver disease - Death
timeFrame: January 1, 2016 to February 28, 2020
measure: Pancreatic diseases caused by alcohol - Hospitalization
timeFrame: January 1, 2016 to February 28, 2020
measure: Pancreatic diseases caused by alcohol - Death
timeFrame: January 1, 2016 to February 28, 2020
measure: Gastritis caused by alcohol - Hospitalization
timeFrame: January 1, 2016 to February 28, 2020
measure: Gastritis caused by alcohol - Death
timeFrame: January 1, 2016 to February 28, 2020
measure: Alcoholic cardiomyopathy - Hospitalization
timeFrame: January 1, 2016 to February 28, 2020
measure: Alcoholic cardiomyopathy - Death
timeFrame: January 1, 2016 to February 28, 2020
measure: Nervous system disorders caused by alcohol - Hospitalization
timeFrame: January 1, 2016 to February 28, 2020
measure: Nervous system disorders caused by alcohol - Death
timeFrame: January 1, 2016 to February 28, 2020
measure: Alcohol poisoning - Hospitalization
timeFrame: January 1, 2016 to February 28, 2020
measure: Alcohol poisoning - Death
timeFrame: January 1, 2016 to February 28, 2020
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Finnish Institute for Health and Welfare
name: Sebastián Peña, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Finnish Institute for Health and Welfare
name: Sonja Lumme, PhD
role: STUDY_CHAIR
affiliation: Finnish Institute for Health and Welfare
name: Päivikki Koponen, PhD
role: STUDY_CHAIR
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