myCSG © |Area: SDTM| Concept: HO : Healthcare Encounters | Lesson: L101 : Healthcare Encounters - reason, admission and discharge dates |

 

Background
  • Most clinical trials are conducted on outpatient basis wherein the subjects visit the trial site (clinic/hospital) only at predetermined time points or on-need basis
  • Subjects in such studies may have planned or unplanned hospitalization
  • If required, such information related to hospitalization may be collected
  • Some data points related to hospitalizations include:
    • Reason for admission
    • Facility to which admission is made (ER/ICU/General ward etc)
    • Date of admission and discharge etc.
  • In SDTM standard, we have a domain called "Healthcare Encounters (HO)" to collect data for inpatient and outpatient healthcare events (e.g., hospitalization, nursing home stay, rehabilitation facility stay, ambulatory surgery) etc.
  • HO belongs to 'Events' class and has an expected record structure of 'One record per healthcare encounter per subject'.

What type of information is typically collected or presented?
  • Term described by the subject for healthcare encounter
  •  Start date/time
  • Status of the encounter- ongoing or ended?
    • If ended, end date/time
  • In cases there are prespecified encounters
    • Encounter occurred?
      • Yes
      • No
        • Reason not occurred
  • Duration of the encounter
 

In this lesson we will see

  • an example case report form (CRF) related to hospitalization
  • how to map the raw variables to SDTM variables (CRF annotation)
  • how to write/interpret SDTM specification for SDTM.HO dataset
  • how to write the program the SDTM.HO dataset 

HOSP : Hospitalizations
Question Response
Date Admitted
[HOSTDAT]
Date Discharged
[HOENDAT]
Reason for Hospitalization
[HOREAS]

Adverse Event
Normal Clinical Practice
Other
Hospital Unit
[HOUNIT]

ICU
General Ward
Emergency Room
Other



SUPPVARIABLE_NAMEVARIABLE_LABELTYPEGENERAL_COMMENTFORM_HOSP
_ STUDYID Study Identifier Char Set to 'statschoice'
_ DOMAIN Domain Abbreviation Char Set to 'HO'
_ USUBJID Unique Subject Identifier Char Concatenate hosp.PROJECT and hosp.SUBJECT with a hyphen in between.
_ HOSEQ Sequence Number Num Sort the records by USUBJID, HOTERM, HOSTDTC, HOENDTC, HOSPID and assign as 1 on the first record of each subject and increment by 1 for each subsequent record for that subject.
_ HOSPID Sponsor-Defined Identifier Char Populate using hosp.RECORDPOSITION in three digit format padding with leading 0's where applicable.
_ HOTERM Healthcare Encounter Term Char Populate using hosp.HOUNIT
_ EPOCH Epoch Char Populate using SDTM.SE.EPOCH by comparing HOSTDTC with SESTDTC and SEENDTC of each element of the subject. Populate as 'TREATMENT' when the record falls on the boundary of SCREENING and TREATMENT elements. Populate as 'TREATMENT' when the record falls on the boundary of TREATMENT and FOLLOW-UP.
_ HOSTDTC Start Date/Time of Healthcare Encounter Char Populate using hosp.HOSTDAT in ISO 8601 format.
_ HOENDTC End Date/Time of Healthcare Encounter Char Populate using hosp.HOENDAT in ISO 8601 format.
_ HOSTDY Study Day of Start of Encounter Num If the SDTM.HO.HOSTDTC is on or after reference start date then SDTM.HO.HOSTDTC-SDTM.DM.RFSTDTC +1. Else if date is before reference start date then assign as SDTM.HO.HOSTDTC-SDTM.DM.RFSTDTC.
_ HOENDY Study Day of End of Healthcare Encounter Num If the SDTM.HO.HOENDTC is on or after reference start date then SDTM.HO.HOENDTC-SDTM.DM.RFSTDTC +1. Else if date is before reference start date then assign as SDTM.HO.HOENDTC-SDTM.DM.RFSTDTC.
_ HOENRTPT End Relative to Reference Time Point Char Populate as 'ONGOING' when hosp.HOENDAT is null.
_ HOENTPT End Reference Time Point Char Populate as 'END OF STUDY' when SDTM.HO.HOENRTPT is 'ONGOING'.
Y HOREAS Reason of Healthcare Encounter Char Populate using hosp.HOREAS
Complete SAS code to generate the output is available for registered users!

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