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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05865847
Other study ID # KKO-Inv 4-Johto-VPT-Terveysind
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date January 1, 2015
Est. completion date September 30, 2023

Study information

Verified date May 2023
Source Finnish Institute for Health and Welfare
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 3950000
Est. completion date September 30, 2023
Est. primary completion date February 28, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 25 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Not applicable, this is an observational study
Not applicable, this is an observational study

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Finnish Institute for Health and Welfare Social Insurance Institution, Finland

References & Publications (14)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 14 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Alcohol intoxication - Hospitalization Incidence of alcohol intoxication hospitalization (ICD-10 F10.0-1) January 1, 2016 to February 28, 2020
Primary Alcohol intoxication - Death Death due to alcohol intoxication (ICD-10 F10.0-1) January 1, 2016 to February 28, 2020
Primary Alcohol dependence - Hospitalization Incidence of hospitalization due to alcohol dependence (F10.2) January 1, 2016 to February 28, 2020
Primary Alcohol dependence - Death Death due to alcohol dependence (F10.2) January 1, 2016 to February 28, 2020
Primary Psycho-organic syndrome caused by alcohol - Hospitalization Incidence of hospitalization due to psycho-organic syndrome caused by alcohol (F10.3-9) January 1, 2016 to February 28, 2020
Primary Psycho-organic syndrome caused by alcohol - Death Death due to psycho-organic syndrome caused by alcohol (F10.3-9) January 1, 2016 to February 28, 2020
Primary Alcoholic liver disease - Hospitalization Incidence of hospitalization due to alcoholic liver disease(K70) January 1, 2016 to February 28, 2020
Primary Alcoholic liver disease - Death Death due to alcoholic liver disease(K70) January 1, 2016 to February 28, 2020
Primary Pancreatic diseases caused by alcohol - Hospitalization Incidence of hospitalization due to pancreatic diseases caused by alcohol (K85.2, K86.0) January 1, 2016 to February 28, 2020
Primary Pancreatic diseases caused by alcohol - Death Death due to pancreatic diseases caused by alcohol (K85.2, K86.0) January 1, 2016 to February 28, 2020
Primary Gastritis caused by alcohol - Hospitalization Incidence of hospitalization due to gastritis caused by alcohol (K29.2) January 1, 2016 to February 28, 2020
Primary Gastritis caused by alcohol - Death Death due to gastritis caused by alcohol (K29.2) January 1, 2016 to February 28, 2020
Primary Alcoholic cardiomyopathy - Hospitalization Incidence of hospitalization due to alcoholic cardiomyopathy (I42.6) January 1, 2016 to February 28, 2020
Primary Alcoholic cardiomyopathy - Death Death due to alcoholic cardiomyopathy (I42.6) January 1, 2016 to February 28, 2020
Primary Nervous system disorders caused by alcohol - Hospitalization 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
Primary Nervous system disorders caused by alcohol - Death 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
Primary Alcohol poisoning - Hospitalization Incidence of hospitalization due to alcohol poisoning (T51, X45) January 1, 2016 to February 28, 2020
Primary Alcohol poisoning - Death Death due to alcohol poisoning (T51, X45) January 1, 2016 to February 28, 2020
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