Study type

Study topic

Disease /health condition
Human medicinal product

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness
Disease epidemiology
Other

If ‘other’, further details on the scope of the study

Analysis of discrepancies in results between different databases

Data collection methods

Secondary use of data
Non-interventional study

Non-interventional study design

Case-control
Cohort
Other

Non-interventional study design, other

Case-crossover, Self-controlled case series, Descriptive study = description of exposure and/or outcome in the whole database during a defined period of time
Study drug and medical condition

Anatomical Therapeutic Chemical (ATC) code

(J01) ANTIBACTERIALS FOR SYSTEMIC USE
ANTIBACTERIALS FOR SYSTEMIC USE

Medical condition to be studied

Liver injury
Population studied

Short description of the study population

Patients of all ages with an active or died registration status during the study period of January 1st 2004 to December 31st 2009. Patients must have attained one year of enrolment with the GP and one year of computerized prescription history.

Age groups

Infants and toddlers (28 days – 23 months)
Children (2 to < 12 years)
Adolescents (12 to < 18 years)
Adults (18 to < 46 years)
Adults (46 to < 65 years)
Adults (65 to < 75 years)
Adults (75 to < 85 years)
Adults (85 years and over)

Estimated number of subjects

55700000
Study design details

Main study objective

To assess the association between the use antibiotics and the risk of acute liver injury with different study designs across different primary care databases and to compare the results between databases, across designs to evaluate the impact of design/database/population differences on the outcome of the studied association.

Data analysis plan

Descriptive study of the primary study population including all ages, from 1 Jan 2004 to 31 Dec 2009). Prevalence of antibiotic (AB) use stratified by age, by sex, by indication, by number of prescriptions and by AB class. Incidence of first-time liver failure by age, by sex per calendar year. Retrospective Cohort study: estimates of incidence rate ratios and 95% confidence intervals of acute liver injury associated with current AB as compared to non-use with Poisson regression adjusted by age/sex/ and calendar year categories. Case Control Study: estimates of relative risk and 95% confidence intervals using unconditional logistic regression. Age, sex, calendar year, and other variables will be introduced in the model to control for potential confounding. Case-crossover analysis estimates of the odds of having an event (liver injury while exposed to antibiotic drugs will be compared with the odds of having liver injury while unexposed.
Documents
Study publications
Udo R, Tcherny‐Lessenot S, Brauer R, Dolin P, Irvine D, Wang Y, Auclert L, Juha…
Brauer R, Ruigómez A, Klungel O, Reynolds R, Feudjo Tepie M, Smeeth L, Douglas …
Brauer R, Douglas I, Garcia Rodriguez LA, Downey G, Huerta C, de Abajo F, Bate …
Ruigomez A, Brauer R, Rodríguez LG, Huerta C, Requena G, Gil M, de Abajo F, Dow…