Clinical prediction rule to identify high-risk inpatients for adverse drug events: the JADE Study

Pharmacoepidemiol Drug Saf. 2012 Nov;21(11):1221-6. doi: 10.1002/pds.3331. Epub 2012 Aug 6.


Purpose: Adverse drug events (ADEs) are common health problems worldwide. Developing a prediction rule to identify patients at high risk for ADEs to prevent or ameliorate ADEs could be one attractive strategy.

Methods: The Japan Adverse Drug Events (JADE) study is a prospective cohort study including 3459 participants. We randomly divided the JADE study cohort into the derivation and the validation sets, using an automated random digit generator. We calculated the probabilities of ADE in each patient in the validation set after applying the prediction rule developed in the derivation set. The actual incidence and area under the receiver operating characteristic curve (AUC) in the validation set were compared with those in the derivation set to evaluate the prognostic ability of our developed prediction rule.

Results: The developed prediction rule included eight independent risk factors. Each patient in the validation set was classified into three categories of risk for the ADEs according to the probability of ADEs calculated by the developed prediction rule. Eight percent (137/1730) of patients in the validation set fell into the high-risk group, and 35% of this group (48/137) had at least one ADE. The AUC in the validation set was 0.63 (95%CI 0.60-0.66), and the performance to discriminate the probability of ADE was similar (p = 0.08) compared with that in the derivation set.

Conclusions: This prediction rule had the modest predictive ability and could help physicians and other healthcare professionals to make an estimation of patients at high risk for ADEs.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Adverse Drug Reaction Reporting Systems / statistics & numerical data*
  • Cohort Studies
  • Decision Support Techniques*
  • Drug-Related Side Effects and Adverse Reactions* / epidemiology
  • Drug-Related Side Effects and Adverse Reactions* / etiology
  • Female
  • Hospitalization / statistics & numerical data
  • Humans
  • Incidence
  • Inpatients / statistics & numerical data*
  • Japan / epidemiology
  • Male
  • Multivariate Analysis
  • Pharmacoepidemiology / methods*
  • Pharmacoepidemiology / statistics & numerical data
  • Predictive Value of Tests
  • Prospective Studies
  • Risk Factors