Abstract | OBJECTIVE: To evaluate the performance of a multicenter, prospective surveillance program in identifying adverse events, and to seek explanations for misclassification bias. DESIGN: The design was a prospective observational study of patients with documented or suspected bacterial pneumonia. SETTING: Data were collected in 74 acute care hospitals across the US. PATIENTS: INTERVENTIONS: Clinical pharmacists documented patient demographics, concurrent illnesses and medications, antibiotic administration, relevant laboratory data, and the occurrence of nephrotoxicity and neutropenia. MAIN OUTCOME MEASURES: Validity of investigators' identification of neutropenia and nephrotoxicity as compared with objective laboratory data was assessed by using sensitivity, specificity, and positive and negative predictive value measures. RESULTS: Among the 1502 patients with sufficient data to evaluate neutropenia, there was agreement in 1270 patients (84.6%); likewise, among 1291 patients with sufficient data to evaluate nephrotoxicity there was agreement in 1186 patients (91.9%). Sensitivity of the researchers' assessments was 50.9% and 71.0% for neutropenia and nephrotoxicity, respectively. The negative predictive value was > 95% for both events. CONCLUSIONS: Overall, this evaluation demonstrated that the Drug Surveillance Network can successfully identify targeted adverse events. Moreover, this study highlights the importance of validation for all types of outcomes-oriented research studies.
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Authors | E G Timm, L S Welage, C A Walawander, J F Sayers, E L Karpiuk, T D Davis, T H Grasela Jr |
Journal | The Annals of pharmacotherapy
(Ann Pharmacother)
Vol. 29
Issue 3
Pg. 240-5
(Mar 1995)
ISSN: 1060-0280 [Print] United States |
PMID | 7606067
(Publication Type: Clinical Trial, Journal Article)
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Chemical References |
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Topics |
- Adolescent
- Adult
- Adverse Drug Reaction Reporting Systems
(standards)
- Aged
- Anti-Bacterial Agents
(adverse effects)
- Female
- Humans
- Kidney Diseases
(chemically induced)
- Male
- Middle Aged
- Multicenter Studies as Topic
- Neutropenia
(chemically induced)
- Pharmacy Service, Hospital
- Pneumonia, Bacterial
(drug therapy)
- Population Surveillance
- Program Evaluation
- Prospective Studies
- United States
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