Study type

Study type

Non-interventional study

Scope of the study

Drug utilisation
Other

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

Analysis of adverse events leading to hospitalisation or occurring during the hospital stay. Establishing interoperable standards for analyzing routine clinical data in 13 university hospitals.
Non-interventional study

Non-interventional study design

Cohort
Case-control
Population studied

Age groups

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)

Special population of interest

Renal impaired

Estimated number of subjects

767000
Study design details

Main study objective

It is the primary objective of this project to develop, implement and evaluate IT-based tools for the assessment of medication safety that can be shared and used across different university hospitals.

Outcomes

We will identify and quantify the occurrence of major drug-related problems including potentially inappropriate medications (PIMs) and contraindicated medications, frequent adverse drug events (ADE) and ADE-associated outcomes (e.g. new diagnoses, readmission to hospital, mortality). For example, we will analyse - associations of PIMs and adverse drug events (ADEs) - prevalences of contraindicated drug use with focus on high risk populations - potentially inadequate prescribing in renal insufficiency - ADE-related hospital admissions and readmissions due to suspected ADEs In addition, we will develop risk models for predicting ADEs. See study protocol for more detail

Data analysis plan

Descriptive analysis: absolute and relative frequencies, incidence, prevalence. Association studies (drug exposure - adverse (drug) event): Raw and adjusted regression models, Odd's ratios, relative risks depending on study design. For selected AE's (e.g. falls) validation studies will be conducted (ROC-analysis).