- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05865847
Socioeconomic Differences in Alcohol Harm in Finland in a Nationwide Cohort Study
Unveiling the Alcohol Harm Paradox: Analysis of Socioeconomic Differences in Alcohol Harm in Finland in a Nationwide Cohort Study
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Lowest income groups
Deciles of equivalized net household income.
The method compares the whole socioeconomic distribution.
|
Not applicable, this is an observational study
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Alcohol intoxication - Hospitalization
Time Frame: January 1, 2016 to February 28, 2020
|
Incidence of alcohol intoxication hospitalization (ICD-10 F10.0-1)
|
January 1, 2016 to February 28, 2020
|
Alcohol intoxication - Death
Time Frame: January 1, 2016 to February 28, 2020
|
Death due to alcohol intoxication (ICD-10 F10.0-1)
|
January 1, 2016 to February 28, 2020
|
Alcohol dependence - Hospitalization
Time Frame: January 1, 2016 to February 28, 2020
|
Incidence of hospitalization due to alcohol dependence (F10.2)
|
January 1, 2016 to February 28, 2020
|
Alcohol dependence - Death
Time Frame: January 1, 2016 to February 28, 2020
|
Death due to alcohol dependence (F10.2)
|
January 1, 2016 to February 28, 2020
|
Psycho-organic syndrome caused by alcohol - Hospitalization
Time Frame: January 1, 2016 to February 28, 2020
|
Incidence of hospitalization due to psycho-organic syndrome caused by alcohol (F10.3-9)
|
January 1, 2016 to February 28, 2020
|
Psycho-organic syndrome caused by alcohol - Death
Time Frame: January 1, 2016 to February 28, 2020
|
Death due to psycho-organic syndrome caused by alcohol (F10.3-9)
|
January 1, 2016 to February 28, 2020
|
Alcoholic liver disease - Hospitalization
Time Frame: January 1, 2016 to February 28, 2020
|
Incidence of hospitalization due to alcoholic liver disease(K70)
|
January 1, 2016 to February 28, 2020
|
Alcoholic liver disease - Death
Time Frame: January 1, 2016 to February 28, 2020
|
Death due to alcoholic liver disease(K70)
|
January 1, 2016 to February 28, 2020
|
Pancreatic diseases caused by alcohol - Hospitalization
Time Frame: January 1, 2016 to February 28, 2020
|
Incidence of hospitalization due to pancreatic diseases caused by alcohol (K85.2,
K86.0)
|
January 1, 2016 to February 28, 2020
|
Pancreatic diseases caused by alcohol - Death
Time Frame: January 1, 2016 to February 28, 2020
|
Death due to pancreatic diseases caused by alcohol (K85.2,
K86.0)
|
January 1, 2016 to February 28, 2020
|
Gastritis caused by alcohol - Hospitalization
Time Frame: January 1, 2016 to February 28, 2020
|
Incidence of hospitalization due to gastritis caused by alcohol (K29.2)
|
January 1, 2016 to February 28, 2020
|
Gastritis caused by alcohol - Death
Time Frame: January 1, 2016 to February 28, 2020
|
Death due to gastritis caused by alcohol (K29.2)
|
January 1, 2016 to February 28, 2020
|
Alcoholic cardiomyopathy - Hospitalization
Time Frame: January 1, 2016 to February 28, 2020
|
Incidence of hospitalization due to alcoholic cardiomyopathy (I42.6)
|
January 1, 2016 to February 28, 2020
|
Alcoholic cardiomyopathy - Death
Time Frame: January 1, 2016 to February 28, 2020
|
Death due to alcoholic cardiomyopathy (I42.6)
|
January 1, 2016 to February 28, 2020
|
Nervous system disorders caused by alcohol - Hospitalization
Time Frame: January 1, 2016 to February 28, 2020
|
Incidence of hospitalization due to degeneration of the nervous system due to alcohol, epileptic seizures related to alcohol, alcoholic polyneuropathy, alcoholic myopathy (G312, G4051, G621, G721)
|
January 1, 2016 to February 28, 2020
|
Nervous system disorders caused by alcohol - Death
Time Frame: January 1, 2016 to February 28, 2020
|
Death due to degeneration of the nervous system due to alcohol, epileptic seizures related to alcohol, alcoholic polyneuropathy, alcoholic myopathy (G312, G4051, G621, G721)
|
January 1, 2016 to February 28, 2020
|
Alcohol poisoning - Hospitalization
Time Frame: January 1, 2016 to February 28, 2020
|
Incidence of hospitalization due to alcohol poisoning (T51, X45)
|
January 1, 2016 to February 28, 2020
|
Alcohol poisoning - Death
Time Frame: January 1, 2016 to February 28, 2020
|
Death due to alcohol poisoning (T51, X45)
|
January 1, 2016 to February 28, 2020
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Sebastián Peña, MD, PhD, Finnish Institute for Health and Welfare
- Study Chair: Sonja Lumme, PhD, Finnish Institute for Health and Welfare
- Study Chair: Päivikki Koponen, PhD, Finnish Institute for Health and Welfare
Publications and helpful links
General Publications
- GBD 2016 Alcohol Collaborators. Alcohol use and burden for 195 countries and territories, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet. 2018 Sep 22;392(10152):1015-1035. doi: 10.1016/S0140-6736(18)31310-2. Epub 2018 Aug 23. Erratum In: Lancet. 2018 Sep 29;392(10153):1116. Lancet. 2019 Jun 22;393(10190):e44.
- Manthey J, Hassan SA, Carr S, Kilian C, Kuitunen-Paul S, Rehm J. What are the Economic Costs to Society Attributable to Alcohol Use? A Systematic Review and Modelling Study. Pharmacoeconomics. 2021 Jul;39(7):809-822. doi: 10.1007/s40273-021-01031-8. Epub 2021 May 10.
- Room R, Ferris J, Laslett AM, Livingston M, Mugavin J, Wilkinson C. The drinker's effect on the social environment: a conceptual framework for studying alcohol's harm to others. Int J Environ Res Public Health. 2010 Apr;7(4):1855-71. doi: 10.3390/ijerph7041855. Epub 2010 Apr 21.
- Probst C, Lange S, Kilian C, Saul C, Rehm J. The dose-response relationship between socioeconomic deprivation and alcohol-attributable mortality risk-a systematic review and meta-analysis. BMC Med. 2021 Nov 5;19(1):268. doi: 10.1186/s12916-021-02132-z.
- Probst C, Kilian C, Sanchez S, Lange S, Rehm J. The role of alcohol use and drinking patterns in socioeconomic inequalities in mortality: a systematic review. Lancet Public Health. 2020 Jun;5(6):e324-e332. doi: 10.1016/S2468-2667(20)30052-9.
- Syden L, Sidorchuk A, Makela P, Landberg J. The contribution of alcohol use and other behavioural, material and social factors to socio-economic differences in alcohol-related disorders in a Swedish cohort. Addiction. 2017 Nov;112(11):1920-1930. doi: 10.1111/add.13889. Epub 2017 Jul 17.
- Makela P, Paljarvi T. Do consequences of a given pattern of drinking vary by socioeconomic status? A mortality and hospitalisation follow-up for alcohol-related causes of the Finnish Drinking Habits Surveys. J Epidemiol Community Health. 2008 Aug;62(8):728-33. doi: 10.1136/jech.2007.065672.
- Pena S, Makela P, Laatikainen T, Harkanen T, Mannisto S, Heliovaara M, Koskinen S. Joint effects of alcohol use, smoking and body mass index as an explanation for the alcohol harm paradox: causal mediation analysis of eight cohort studies. Addiction. 2021 Aug;116(8):2220-2230. doi: 10.1111/add.15395. Epub 2021 Jan 28.
- Katikireddi SV, Whitley E, Lewsey J, Gray L, Leyland AH. Socioeconomic status as an effect modifier of alcohol consumption and harm: analysis of linked cohort data. Lancet Public Health. 2017 May 10;2(6):e267-e276. doi: 10.1016/S2468-2667(17)30078-6. eCollection 2017 Jun.
- Makela P. Alcohol-related mortality as a function of socio-economic status. Addiction. 1999 Jun;94(6):867-86. doi: 10.1046/j.1360-0443.1999.94686710.x.
- Pena S, Makela P, Harkanen T, Heliovaara M, Gunnar T, Mannisto S, Laatikainen T, Vartiainen E, Koskinen S. Measurement error as an explanation for the alcohol harm paradox: analysis of eight cohort studies. Int J Epidemiol. 2021 Jan 23;49(6):1836-1846. doi: 10.1093/ije/dyaa113.
- Sadler S, Angus C, Gavens L, Gillespie D, Holmes J, Hamilton J, Brennan A, Meier P. Understanding the alcohol harm paradox: an analysis of sex- and condition-specific hospital admissions by socio-economic group for alcohol-associated conditions in England. Addiction. 2017 May;112(5):808-817. doi: 10.1111/add.13726. Epub 2017 Feb 6.
- Mackenbach JP, Kulhanova I, Bopp M, Borrell C, Deboosere P, Kovacs K, Looman CW, Leinsalu M, Makela P, Martikainen P, Menvielle G, Rodriguez-Sanz M, Rychtarikova J, de Gelder R. Inequalities in Alcohol-Related Mortality in 17 European Countries: A Retrospective Analysis of Mortality Registers. PLoS Med. 2015 Dec 1;12(12):e1001909. doi: 10.1371/journal.pmed.1001909. eCollection 2015 Dec.
- Mackenbach JP. Should we aim to reduce relative or absolute inequalities in mortality? Eur J Public Health. 2015 Apr;25(2):185. doi: 10.1093/eurpub/cku217. No abstract available.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KKO-Inv 4-Johto-VPT-Terveysind
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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