3.3 Analysis of Shift Tables

The previous section discussed statistical methods for constructing reference limits for quantitative diagnostic and safety data. Once the limits have been established, quantitative results are converted into categorical outcomes. For example, laboratory test results are commonly labeled as “low”, “high” or “normal” depending on whether the observed value is below the lower reference limit, above the upper reference limit or between the limits. This section reviews methods for handling the obtained categorical outcomes that are commonly summarized using shift tables (square contingency tables). To simplify the discussion, we will focus on the case of paired categorical variables. Safety and diagnostic assessments ...

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