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serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyTOBA-170
Respiratory assessments may be measured in studies on tobacco products to evaluate impact on respiratory function. Spirometry is a test that measures how an individual inhales or exhales volumes of air as a function of time, and is a test of general respiratory health.

The Respiratory System Findings (RE) domain is a body system-based morphology/physiology domain. This Findings domain is used to represent physiological and morphological findings related to the respiratory system, including the organs that are involved in breathing such as the nose, throat, larynx, trachea, bronchi, and lungs.  

Example

Include Page
SDTM Example.Respiratory Findings
SDTM Example.Respiratory Findings

Pagenav

This example shows results from a study in smoking cessation. In all participants we measured exhaled CO using an instantaneous reading CO monitor. The measured exhaled CO  are recorded in the RE Finding domain.  In cases were it is important to track the device used for the testing, the Device information can be reported using the CDISC Medical  Device Guide ( need to decide whether to include at this time) in can be  The Device Identifiers (DI) domain contains the total set of characteristics necessary for device identification, and the Device In-Use (DU) domain contains information about the use of the device.

Because the original and standardized units of measure are identical in this example, RESTRESC, RESTRESN, RESTRESU, and RESTREFN are not shown. Instead, an ellipsis marks their place in the dataset.

The DI domain establishes identifiers for devices used in the study.  In this example, the only parameter needed to establish identifiers is the device type.

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Namere

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Rows 1-2:

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Show the measurement of Exhaled CO at Visit 2, and 3  start of the smoking cessation study.  

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Rows 4-5:

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Show the measurement of Exhaled CO for three daily visit after all smoking was to have been stopped. 

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