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In some cases patient diaries can also be used to collect information on individual stool episodes and consistency within each day. In this case, the calculation of average number of stools or the typical consistency over the 3-day period may be calculated in an ADaM dataset from this source data.
Example
This example shows baseline stool information for each bowel movement and the corresponding stool consistency for each stool episode over a 3-day period prior to the baseline visit. The sponsor chose to use a paper diary that was given to subject prior to the visit and then handed back at the visit where this was entered into the EDC system.
| Select the diary day being entered |
What is the diary day?
CETPT CETPT and LBTPT
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|---|---|---|---|
| Record the date the subject indicated the diary was completed |
CESTDAT CEDTC and CESTDTC and LBDTC
|
_________________ | |
| Indicate if any bowel movements occurred, checking Yes or No. |
Did the subject have any bowel movements for this day?
CEOCCUR
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|
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| Record the bowel movement episode number. For each diary day, start the count at 1. |
What is the clinical event identifier?
CESPID CESPID and LBSPID
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||
| Record the start time the subject indicated the bowel movement started |
CESTTIM CESTDTC LBDTC
|
_________________ | |
| Record the consistency of the subject's stool |
What is the consistency of bowel movement reported by the subject?
CONSIST_LBORRES LBORRES where LBTESTCD = "CONSIST"
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|
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| Record the color of the subject's stool |
What is the color of bowel movement reported by the subject?
COLOR_LBORRES LBORRES where FATESTCD = "COLOR"
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|
- Because these data are based on a diary, the sponsor chose to leave the variables VISITNUM blank as these assessments are not completed at a specified protocol visit.
- Because data were collected on individual bowel movement episodes, these were considered clinical events and therefore data for the occurrence of each episode were represented in the CE domain.
- The consistency and color of each episode were represented in the Laboratory Findings (LB) domain.
- Because the sponsor instructed the subject to record the time equivalent to the start of the bowel movement, CESTDTC was used to represent the start date and time of the bowel movement.
- CEREFID was populated by the sponsor to represent the diary day number and the individual bowel movement (e,g,. D-3_1 represents bowel movement 1 on diary Day -3). The same format was used for LBREFID showing the consistency and color of the stool nut NUT-141 - Getting issue details... STATUS . The CE and LB datasets can therefore be linked based on --REFID variables.
- The rows are color coded to help identify each day of the diary.
The following example shows the consistency and color of each stool episode from the CE data above. Note that there is no LB consistency/color data for the last 2 rows of the CE dataset above, because they represent (1) a day when there were no bowel movement episodes and (2) a day when the subject forgot to complete the diary. The consistency of the stool was assessed by the infant's caregiver and therefore LBEVAL was used to represent this. If a subject was assessing their own stool sample then LBEVAL would be "SUBJECT."
The relrec.xpt example is represented below.