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CRITICAL CARE

Are the Naranjo Criteria Reliable and Valid for Determination of Adverse Drug Reactions in the Intensive Care Unit?

At time of completion of the project, Fellow, Ohio State University, Columbus, OH; now, Assistant Professor, School of Pharmacy, University of Pittsburgh, Center for Pharmacoinformatics and Outcomes Research, Pittsburgh, PA

Levent Kirisci, PhD

Associate Professor, Schools of Pharmacy and Psychiatry, University of Pittsburgh

Dev S Pathak, DBA

At time of completion of the project, Professor, Ohio State University; now, Dean and Professor, Robert Stempel School of Public Health, Florida International University, Miami, FL

Reprints: Dr. Kane-Gill, University of Pittsburgh, Center for Pharmacoinformatics and Outcomes Research, 904 Salk Hall, 3501 Terrace St., Pittsburgh, PA 15261-0001, fax 412/624-1850, kanesl{at}upmc.edu

BACKGROUND: The Naranjo criteria are frequently used for determination of causality for suspected adverse drug reactions (ADRs); however, the psychometric properties have not been studied in the critically ill.

OBJECTIVE: To evaluate the reliability and validity of the Naranjo criteria for ADR determination in the intensive care unit (ICU).

METHODS: All patients admitted to a surgical ICU during a 3-month period were enrolled. Four raters independently reviewed 142 suspected ADRs using the Naranjo criteria (review 1). Raters evaluated the 142 suspected ADRs 3-4 weeks later, again using the Naranjo criteria (review 2). Inter-rater reliability was tested using the kappa statistic. The weighted kappa statistic was calculated between reviews 1 and 2 for the intra-rater reliability of each rater. Cronbach alpha was computed to assess the inter-item consistency correlation. The Naranjo criteria were compared with expert opinion for criterion validity for each rater and reported as a Spearman rank (r_s) coefficient.

RESULTS: The kappa statistic ranged from 0.14 to 0.33, reflecting poor inter-rater agreement. The weighted kappa within raters was 0.5402-0.9371. The Cronbach alpha ranged from 0.443 to 0.660, which is considered moderate to good. The r_s coefficient range was 0.385-0.545; all r_s coefficients were statistically significant (p < 0.05).

CONCLUSIONS: Inter-rater reliability is marginal; however, within-rater evaluation appears to be consistent. The inter-item correlation is expected to be higher since all questions pertain to ADRs. Overall, the Naranjo criteria need modification for use in the ICU to improve reliability, validity, and clinical usefulness.

Key Words: adverse drug reactions, Naranjo probability scale; critical care unit

Published Online, October 4, 2005. www.theannals.com, DOI 10.1345/aph.1G177

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