Research output: Contribution to Journal/Magazine › Journal article › peer-review
Research output: Contribution to Journal/Magazine › Journal article › peer-review
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TY - JOUR
T1 - A note on statistical analysis of organ weights in non-clinical toxicological studies.
AU - Wolfsegger, Martin J.
AU - Jaki, Thomas
AU - Dietrich, Barbara
AU - Kunzler, Jackie A.
AU - Barker, Kerry
PY - 2009/10
Y1 - 2009/10
N2 - Statistical comparison of organ weights between treated and untreated animals have traditionally been used to predict potential toxicity for patients. The manner of presentation of organ weight data, and the value of statistical analyses have been topics of discussion. Historically, a decision tree approach has been applied for statistical comparison of organ weights which does not control the overall error rate and can lead to different statistical tests being used by chance for identical settings causing confusion. This paper proposes a simple nonparametric approach for assessing treatment effects on organ weights in terms of ratios based on the Hodges-Lehmann estimator. This allows for simple interpretation of results and aids in the identification of potential target organs as the evaluation is based on effect sizes and not on p-values allowing a robust proof of effect as well as a robust proof of no effect. The proposed estimate and the corresponding nonparametric confidence interval applied to a rank-sum score can be used as a confirmatory test for difference and as a confirmatory test for equivalence. Exploratory analyses can be performed calculating the proposed estimates for each organ weight separately to be summarized graphically in a confidence interval plot.
AB - Statistical comparison of organ weights between treated and untreated animals have traditionally been used to predict potential toxicity for patients. The manner of presentation of organ weight data, and the value of statistical analyses have been topics of discussion. Historically, a decision tree approach has been applied for statistical comparison of organ weights which does not control the overall error rate and can lead to different statistical tests being used by chance for identical settings causing confusion. This paper proposes a simple nonparametric approach for assessing treatment effects on organ weights in terms of ratios based on the Hodges-Lehmann estimator. This allows for simple interpretation of results and aids in the identification of potential target organs as the evaluation is based on effect sizes and not on p-values allowing a robust proof of effect as well as a robust proof of no effect. The proposed estimate and the corresponding nonparametric confidence interval applied to a rank-sum score can be used as a confirmatory test for difference and as a confirmatory test for equivalence. Exploratory analyses can be performed calculating the proposed estimates for each organ weight separately to be summarized graphically in a confidence interval plot.
KW - Toxicity evaluation method
KW - Risk assessment
KW - Drug toxicity
KW - Organ weights
U2 - 10.1016/j.taap.2009.06.012
DO - 10.1016/j.taap.2009.06.012
M3 - Journal article
VL - 240
SP - 117
EP - 122
JO - Toxicology and Applied Pharmacology
JF - Toxicology and Applied Pharmacology
SN - 1096-0333
IS - 1
ER -