| 1 | Result Variables (--ORRES, --ORRESU, --STRESC, --STRESU, --STRESN) | The following is applicable to results that are not collected via QRS instruments. Please refer to QS domain assumptions assumptions for expected variable population.  Image Added
- --ORRES will be populated with the result of the measurement or finding as originally collected or received, using controlled terminology where when applicable.
- When applicable, the unit associated the value of --ORRES will be populated in --ORRESU, using controlled terminology where applicable.
- Values in will be populated in --STRESC when --ORRES is populated. --STRESC is populated by:
- Deriving numeric values in --ORRES to numeric values in standard units in --STRESC.
Assigning the The value of --ORRES as the value of STRESC - Values will be populated in ---STRESN when --STRESC is populated with a numeric value. If the value of STRESC is not a numeric value, then the value of STRESN will be null.
When --ORRES is populated, --STRESC must also be populated, regardless of whether the data values are character or numeric. The variable --STRESC is populated either - will be:
- Derived by the conversion of numeric values in --ORRES to numeric values with standard
units, or by the assignment of the value of --ORRES, as in the Physical Examination (PE) domain, where --STRESC could contain a dictionary-derived term. A further step is necessary when --STRESC contains numeric values. These are converted to numeric type and written to --STRESN. Because --STRESC may contain a mixture of numeric and character values, --STRESN may contain null values, as shown in the following figure.Image Removed Occasionally data that are intended to be numeric are collected with characters attached that cause the character-to-numeric conversion to fail. For example, numeric cell counts in the source data may be specified with Figure. Original to Standardized Results When the original measurement or finding is a selection from a defined codelist, in general, the --ORRES and --STRESC variables contain results in decoded format (i.e., the textual interpretation of whichever code was selected from the codelist). In some cases where the code values in the codelist are statistically meaningful standardized values or scores, which are defined by sponsors or by valid methodologies such as SF36 questionnaires, the --ORRES variables will contain the decoded format, whereas the --STRESC variables as well as the --STRESN variables will contain the standardized values or scores. Occasionally data that are intended to be numeric are collected with characters attached that cause the character-to-numeric conversion to fail. For example, numeric cell counts in the source data may be specified with a greater than (>) or less than (<) sign attached - units. Standard units will be represented in --STRESU using controlled terminology.
- Numeric --ORRES values with characters attached (e.g., a greater than (>) or less than (<) sign) will be converted to standard units and the value of --STRESC will maintain the attached character (e.g., >10,000, <1).
In these cases, the value with the greater than (>) or less than (<) sign attached should be moved to the --STRESC variable, and --STRESN should be null. The rules for modifying the value for analysis purposes should be defined in the analysis plan and a numeric value should only be imputed in the ADaM datasets. If the value in --STRESC has different units, the greater than (>) or less than (<) sign should be maintained. See Example 1, Rows 11 and 12-
- Assignment of the value of --ORRES.
- Numeric values represented in --STRESC will be assigned to --STRESN. If --STRESC is a character value, then, --STRESN will be null.
- Numeric values with attached characters
. In these cases, the value with the greater than (>) or less than (<) sign attached should be moved to the --STRESC variable, and --STRESN should be null. The rules for modifying the value for analysis purposes should be defined in the analysis plan and a numeric value should only be imputed in the ADaM datasets. If the value in --STRESC has different units, the greater than (>) or less than (<) sign should be maintained. See Example 1, Rows 11 and 12- are considered to be character results and will not be populated in --STRESN.
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