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Qualitative and Quantitative Analysis of Nonneoplastic Lesions in Toxicology Studies

Experimental Pathology Laboratories, Inc, Research Triangle Park, North Carolina 27709, cshackelford{at}epl-inc.com

Gerald Long

Eli Lilly & Company Lilly Research Laboratories, Greenfi eld, Indiana, 46140

Jeffrey Wolf

Experimental Pathology Laboratories, Inc, Research Triangle Park, North Carolina 27709

Carlin Okerberg

Experimental Pathology Laboratories, Inc, Research Triangle Park, North Carolina 27709

Ronald Herbert

National Institute for Environmental Health Sciences, Research Triangle Park, North Carolina, 27709

A pathology report is written to convey information concerning the pathologic findings in a study. This type of report must be complete, accurate and communicate the relative importance of various findings in a study. The overall quality of the report is determined by three Quality Indicators: thoroughness, accuracy, and consistency. Thoroughness is the identification of every lesion present in a particular organ or tissue, including spontaneous background lesions. Experienced pathologists familiar with background lesions may disregard certain types of lesions or establish a threshold or a severity above which background lesions are diagnosed. Accuracy is the ability to make, and precisely communicate, correct diagnoses. Nomenclature of lesions is a matter of definition and experienced pathologists generally agree as to what terms are to be used. Consistency is the uniform use of a specific term to record a defined lesion and implies that the same diagnostic criteria are being followed for each type of diagnosis. The relative severity of nonneoplastic lesions can be recorded either semiquantitatively or quantitatively. Semiquantitative analysis involves the application of defined severity grades or ranges for specific lesions. Quantitative analysis (counts and measurements) can be performed manually or electronically, utilizing image analysis and stereological techniques to provide numerical values. When both qualitative and quantitative parameters are applied in preparation of a pathology report, the recorded pathology findings can be interpreted and put into perspective. The use of this approach assures a reader that the pathology report meets the highest standards.

Key Words: Thoroughness • thresholds • accuracy • consistency • semiquantitative • severity grades • image analysis • stereology.

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