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The Analysis class is used in the reporting event's analyses attribute to define the analyses for the reporting event. Each analysis is defined as a set of operations (defined in a referenced analysis method) performed on a specified analysis variable for any specified subset of data records (defined in a referenced data subset) for a given subject population (defined in a referenced analysis set) which may be subdivided by one 1 or more factors (defined in any referenced grouping factor). The results of each analysis are represented as a property of the analysis and each result is associated with references to all analysis components needed to give the result context (i.e., the operation used to calculate the result and a specific value for each of the grouping factors used for the analysis , such as treatment, sex, age group, etc.).
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An instance of the Analysis class is created for each analysis and, in each instance:,
- The id attribute contains the identifier value assigned for the analysis.
- The version attribute contains the version number of the analysis.
- The name attribute indicates the assigned name of the analysis.
- The description attribute may be used to record a detailed description of the analysis.
- The reason attribute is used to record the rationale for the analysis, and is equivalent to the arm:AnalysisReason attribute described in the ARM for Define-XML specification. The reason attribute contains an instance of 1 of the two 2 specializations of the ExtensibleTerminologyTerm class for the AnalysisReasonEnum enumeration:
- AnalysisReason, in which the controlledTerm attribute contains a value from the AnalysisReasonEnum enumeration.
- SponsorAnalysisReason, in which the sponsorTermId attribute contains the identifier of a sponsor term created in the terminology extension for the AnalysisReasonEnum enumeration. In this case, the submissionValue attribute of the referenced sponsor term contains the value that would be shown as the rationale for the analysis.
- The purpose attribute is used to record the purpose of the analysis, and is equivalent to the arm:AnalysisPurpose attribute described in the ARM for Define-XML specification. The purpose attribute contains an instance of 1 of the 2 specializations of the ExtensibleTerminologyTerm class for the AnalysisPurposeEnum enumeration:
- AnalysisPurpose, in which the controlledTerm attribute contains a value from the AnalysisPurposeEnum enumeration.
- SponsorAnalysisPurpose, in which the sponsorTermId attribute contains the identifier of a sponsor term created in the terminology extension for the AnalysisPurposeEnum enumeration. In this case, the submissionValue attribute of the referenced sponsor term contains the value that would be shown as the purpose of the analysis.
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- The order attribute contains an integer value that is used to order the referenced grouping factor with respect to other referenced grouping factors (i.e., "1" for the first grouping factor, "2" for the second, and so on).
- The groupingId attribute contains the identifier value of the referenced grouping factor.
- The resultsByGroup attribute contains either "true" or "false" to indicate whether each operation in the analysis method referenced in the methodId attribute of the analysis is (resultsByGroup = "true") or is not (resultsByGroup = "false") expected to produce a separate result value for each of the groups in the referenced grouping factor. In this guide, referenced grouping factors are referred to as "results-by-group" grouping factors when resultsByGroup is "true"; i.e.that is, an operation result value is expected for each group in the grouping factor. In analyses that generate summary statistics, all referenced grouping factors are usually results-by-group grouping factors. However, in analyses that generate comparative statistics across groups, some or all of the referenced grouping factors will not be results-by-group grouping factors. Refer to the OperationResult section for more information about the generation of operation result values for groups in grouping factors.
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