Unplanned Healthcare Visits for Heart Failure 

In this example, the sponsor collected information on unscheduled healthcare visits for heart failure and whether any heart failure therapies or treatments were administered. This information was used by the sponsor to determine the study endpoint: time to worsening heart failure that required protocol-specified interventions.

In the SDTM dataset, the sponsor assigned visit numbers for each unscheduled healthcare visit for heart failure. A decimal point is used to number each unscheduled visit between the scheduled visits. These were defined in a Subject Visits (SV) dataset, which is not included; for examples of SV datasets, see the SDTMIG (https://www.cdisc.org/standards/foundational/sdtmig).

The sponsor used the CDASH variables --HONO and --HOSPID to create the appropriate --LNKID values needed for the dataset relationship shown in the RELREC dataset. The sponsor included "HEART FAILURE" in NSHO.HOINDC as the indication for these unplanned healthcare visits. 

Treatments administered during unscheduled healthcare visits are represented in the Concomitant/Prior Medications (CM) domain. The sponsor included the Anatomical Therapeutic Chemical (ATC) classes to categorize the records; this is not shown in the example.

The PR domain was used to represent information on procedures performed during the unscheduled healthcare visits. PRDECOD values are aligned with the

 codelist.

The RELREC dataset shows the relationship between the HO, CM, and PR domains.