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Model Documentation

Class: Operation

The Operation class is used in the operations attribute of the AnalysisMethod class to define the statistical operations to be performed for any analysis that references the analysis method.

Examples of operations include:

  • "Count of subjects by group" and "Percent of subjects by group" in a "Summary by group of a categorical variable" method.
  • "Mean", "Standard Deviation", "Minimum Value", "Maximum Value", and confidence intervals in a "Summary by group of a continuous variable" method.
  • "P-value" in a "Pearson's chi-square test group comparison for a categorical variable" method.
Each operation generates a single result for each combination of groups in "results-by-group" grouping factors referenced by an analysis that references the analysis method containing the operation (see the Analysis and OperationResult sections for more information about "results-by-group" grouping factors). Each result is generally expected to represent a single value, but sponsors may choose to define operations that generate composite results as a combination of more than 1 individual value. However, the disadvantage of composite results is that there will not be individual metadata elements to describe each component of a composite result. A better approach is to define operations that generate individual result values and then, if necessary, combine the result values from these operations to produce a composite value for display.

ER Diagram: Operation

Each operation is defined as an instance of the Operation class and, in each instance:

  • The id attribute contains the identifier value assigned for the operation.
  • The name attribute indicates the assigned name of the operation.
  • The label attribute contains a short label for the operation, such as might be shown in an output display (e.g., "n", "%", "Mean", "SD").
  • The description attribute may be used record a detailed description of the operation.
  • The referencedOperationRelationships attribute may be used to specify relationships to any other operations whose results are referenced in the calculation of the results for this operation, as described below.
  • The resultPattern attribute contains a textual representation for the default pattern or format used for the display of the results of this operation in output displays. The pattern should indicate the precision of the value to be displayed (e.g., "X.XXX") and may include parentheses or other additional characters (e.g., "(XXX.X)" or "±XX.XX"). In general, the pattern will usually be in the format that is displayed in output table shells, but sponsors may choose to use other pattern specifications.

Some operations may be defined to reuse the results of other operations in the calculation of their result values. For example, an operation that calculates a percentage may reuse the results of other "count of subjects" operations to act as the numerator and denominator in the calculation of the percentage. In such operations, the referencedOperationRelationships attribute is used to specify 1 or more relationships to the other operation(s) whose results are used, or referenced, in this operation's calculation. Each relationship is defined as an instance of the ReferencedOperationRelationship class, in which:

  • The id attribute contains the identifier value assigned for the relationship.
  • The referencedOperationRole attribute contains an indication of the role that the results of the referenced operation play in the calculation. The role is represented as an instance of 1 of the two specializations of the ExtensibleTerminologyTerm class for the OperationRoleEnum enumeration:
    • OperationRole, in which the controlledTerm attribute contains a file type from the OperationRoleEnum enumeration
    • SponsorOperationRole, in which the sponsorTermId attribute contains the identifier of a sponsor term created in the terminology extension for the OperationRoleEnum enumeration. In this case, the submissionValue attribute of the referenced sponsor term contains the name of the role. 

Refer to the TerminologyExtension and ExtensibleTerminologyTerm sections for more information about the definition and use of terminology extensions, including examples.

  • The operationId attribute contains the identifier value for the operation that is being referenced.
  • The analysisId attribute may contain the identifier of an analysis that uses the method that contains the referenced operation. The analysisId attribute is only used if the results of the referenced operation are always generated by the same analysis. If the analysis producing the required results may differ depending on which analysis uses the method containing the operation being defined, then the analysis that generates the results of the referenced operation may be specified in the referencedAnalysisOperations attribute of the analysis that uses this operation (as described below).
  • The description attribute may be used to record a details of the relationship, which may include:
    • In description of the referenced operation and how its results are used.
    • In indication of which analyses are expected to produce the required result values, which may be helpful in situations when the analysisId is not provided.

For example,

    • "The count operation whose result provides the numerator for calculation of the percentage. The referenced analysis should be the analysis that contains this percent operation."
    • "The count operation whose result provides the denominator for calculation of the percentage. The referenced analysis should have the same analysis set and subject grouping factor(s) as the analysis containing this percent operation."


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