{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,11]],"date-time":"2026-04-11T15:48:23Z","timestamp":1775922503931,"version":"3.50.1"},"reference-count":15,"publisher":"SAGE Publications","issue":"11","license":[{"start":{"date-parts":[[2005,11,1]],"date-time":"2005-11-01T00:00:00Z","timestamp":1130803200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Ann Pharmacother"],"published-print":{"date-parts":[[2005,11]]},"abstract":"<jats:sec><jats:title>BACKGROUND<\/jats:title><jats:p> 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. <\/jats:p><\/jats:sec><jats:sec><jats:title>OBJECTIVE<\/jats:title><jats:p> To evaluate the reliability and validity of the Naranjo criteria for ADR determination in the intensive care unit (ICU). <\/jats:p><\/jats:sec><jats:sec><jats:title>METHODS<\/jats:title><jats:p> 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\u20134 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<jats:sub>s<\/jats:sub>) coefficient. <\/jats:p><\/jats:sec><jats:sec><jats:title>RESULTS<\/jats:title><jats:p> The kappa statistic ranged from 0.14 to 0.33, reflecting poor inter-rater agreement. The weighted kappa within raters was 0.5402\u20130.9371. The Cronbach alpha ranged from 0.443 to 0.660, which is considered moderate to good. The r<jats:sub>s<\/jats:sub> coefficient range was 0.385\u20130.545; all r<jats:sub>s<\/jats:sub> coefficients were statistically significant (p &lt; 0.05). <\/jats:p><\/jats:sec><jats:sec><jats:title>CONCLUSIONS<\/jats:title><jats:p> 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. <\/jats:p><\/jats:sec>","DOI":"10.1345\/aph.1g177","type":"journal-article","created":{"date-parts":[[2005,10,5]],"date-time":"2005-10-05T03:28:16Z","timestamp":1128482896000},"page":"1823-1827","source":"Crossref","is-referenced-by-count":44,"title":["Are the Naranjo Criteria Reliable and Valid for Determination of Adverse Drug Reactions in the Intensive Care Unit?"],"prefix":"10.1177","volume":"39","author":[{"given":"Sandra L","family":"Kane-Gill","sequence":"first","affiliation":[{"name":"Sandra L Kane-Gill PharmD MSc, 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"}]},{"given":"Levent","family":"Kirisci","sequence":"additional","affiliation":[{"name":"Levent Kirisci PhD, Associate Professor, Schools of Pharmacy and Psychiatry, University of Pittsburgh"}]},{"given":"Dev S","family":"Pathak","sequence":"additional","affiliation":[{"name":"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"}]}],"member":"179","published-online":{"date-parts":[[2005,11,1]]},"reference":[{"key":"bibr1-aph.1G177","doi-asserted-by":"publisher","DOI":"10.1097\/01.ta.0000196009.42623.50"},{"key":"bibr2-aph.1G177","doi-asserted-by":"publisher","DOI":"10.1002\/cpt1976195part1489"},{"key":"bibr3-aph.1G177","doi-asserted-by":"publisher","DOI":"10.1007\/BF00562895"},{"key":"bibr4-aph.1G177","doi-asserted-by":"publisher","DOI":"10.1002\/cpt1977213247"},{"key":"bibr5-aph.1G177","doi-asserted-by":"publisher","DOI":"10.1001\/jama.1979.03300070019017"},{"key":"bibr6-aph.1G177","first-page":"14","volume":"15","author":"Jones JK","year":"1988","journal-title":"J Rheumatol"},{"key":"bibr7-aph.1G177","doi-asserted-by":"publisher","DOI":"10.1038\/clpt.1981.154"},{"key":"bibr8-aph.1G177","doi-asserted-by":"publisher","DOI":"10.1345\/aph.1D202"},{"key":"bibr9-aph.1G177","doi-asserted-by":"publisher","DOI":"10.1097\/00003246-200412001-00099"},{"key":"bibr10-aph.1G177","doi-asserted-by":"publisher","DOI":"10.1093\/ajhp\/55.2.165"},{"key":"bibr11-aph.1G177","first-page":"998","volume":"37","author":"Pathak DS","year":"1980","journal-title":"Am J Hosp Pharm"},{"key":"bibr12-aph.1G177","doi-asserted-by":"publisher","DOI":"10.1177\/002224377901600102"},{"key":"bibr13-aph.1G177","first-page":"5","volume-title":"Health measurement scales\u2014a practical guide to their development and use","author":"Streiner DL","year":"1998","edition":"2"},{"key":"bibr14-aph.1G177","doi-asserted-by":"publisher","DOI":"10.1007\/978-1-4613-8977-4_1"},{"key":"bibr15-aph.1G177","unstructured":"15. Stokes MB, Davis CS, Knoch GC. Categorical data analysis using SAS system. 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