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An Algorithm for the Operational Assessment of Adverse Drug Reactions: I. Background, Description, and Instructions for Use
Abstract
Despite widespread clinical and epidemiologic attention to adverse drug reactions (ADRs), their clinical identification has been a nonreproducible act of unspecified subjective judgment; adequate operational criteria have not been available for diagnostic decisions about the cause of an observed untoward clinical manifestation. To improve scientific precision in the diagnosis of ADRs, we have developed an algorithm that provides detailed operational criteria for ranking the probability of causation when ADR is suspected between a drug and a clinical manifestation. The algorithm provides a scoring system for six axes of decision strategy: previous general experience with the drug, alternative etiologic candidates, timing of events, drug levels and evidence of overdose, dechallenge, and rechallenge. The sum of the scores is ordinally partitioned to rate the candidate ADR as definite, probable, possible, or unlikely. (JAMA242:623-632, 1979)
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Cited by
Danan, G., & Benichou, C. (1993) · Journal of Clinical Epidemiology · doi:10.1016/0895-4356(93)90101-6 · Cited by 1,481
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Hanlon, J. T., Schmader, K. E., Samsa, G. P., Weinberger, M., Uttech, K. M., Lewis, I. K., Cohen, H. J., & Feussner, J. R. (1992) · Journal of Clinical Epidemiology · doi:10.1016/0895-4356(92)90144-c · Cited by 960
Clarifying Adverse Drug Events: A Clinician's Guide to Terminology, Documentation, and Reporting
Nebeker, J. R., Barach, P., & Samore, M. H. (2004) · Annals of Internal Medicine · doi:10.7326/0003-4819-140-10-200405180-00009 · Cited by 803
Bormate, A. B., Leboit, P. E., & McCalmont, T. H. (2008) · Archives of Dermatology · doi:10.1001/archderm.144.8.1020 · Cited by 731
Proposal for a New Tool to Evaluate Drug Interaction Cases
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Metadata
- Authors
- Kramer, M. S.
- Venue
- JAMA
- Publisher
- American Medical Association (AMA)
- Published
- 1979-08-17
- Volume
- 242
- Issue
- 7
- Pages
- 623
- ISSN
- 0002-9955 (ISSN-L)
- 0098-7484
- OpenAlex
- W4293202440
- Cited by
- 346
- References
- 0
- FWCI
- 12.33
- Type
- journal article
- Language
- en
- Open access
- closed
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- Kramer, M. S. (1979). An Algorithm for the Operational Assessment of Adverse Drug Reactions: I. Background, Description, and Instructions for Use. JAMA. https://doi.org/10.1001/jama.1979.03300070019017
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