Summary
Objectives:
To apply an institutional clinical data warehouse (CDW) to the assessment of adverse
drug reactions (ADRs) and demonstrate its utility through a specific example.
Methods:
We modeled the process for assessing ADRs through retrospective cohort design by
using CDW at the Osaka University Hospital as follows: 1) We defined a drug X, an
adverse drug reaction (ADR) Y, and a laboratory measurement Z to assess Y during a
given study period; 2) we excluded those whose Z value exceeded the defined criteria
or were not available at the inception of the cohort; 3) we divided the patients into
two groups based on exposure or non-exposure to X; 4) we matched the patient characteristics
between the two groups through stratification and randomization; and 5) we compared
the frequency of patients who presented Y during the study period between the two
groups. Aminoglycoside and Cephalosporin associated nephrotoxicity in pediatric inpatients
was used as an example to demonstrate the usefulness of this approach.
Results:
Our evaluation indicates that there is an increased risk of nephrotoxicity for pediatric
inpatients who were prescribed cephalosporin either alone or in combination with aminoglycoside;
further, aminoglycoside tends to increase the cephalosporin-associated nephrotoxicity.
Conclusions:
Our findings are consistent with those drawn from other studies, indicating thatthe
method of a pplying an institutional CDW is useful for assessing ADRs.
Keywords
Clinical data warehouse - relational database - retrospective cohort study - adverse
drug reactions
