Patient diaries can be used to collect information on number of stools and consistency on a daily basis. 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.
This example shows baseline stool information for actual daily number of bowel movements and typical stool consistency each day over a 3-day period prior to the baseline visit. Please note that it may be important for sponsors to provide additional instructions to the diary (e.g., how a subject should evaluate their consistency if they had 1 loose and 1 hard stool in a day).
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?
FATPT FATPT and LBTPT
|Record the date the subject indicated the diary was completed.||
FADAT FADTC and LBDTC
|Record the number of bowel movements that the subject had on this day.||
EPSDNUM_FAORRES FAORRES where FATESTCD = "EPSDNUM"
|Record the typical consistency of the subject's stools over this day.||
What is the typical consistency of bowel movements as reported by the subject?
CONSIST_LBORRES LBORRES where LBTESTCD = "CONSIST"
The total daily number of bowel movements for each of the 3 days of the diary is represented in the FACE domain.
|BOWEL MOVEMENT||2||/day||2||2||/day||SUBJECT||2017-01-02||END OF DIARY DAY -3||-3||-P1D|
|2||NUTR123||FA||NUTR123_001||2||D-2_1||2||EVENTFRQ||Event Frequency||BOWEL MOVEMENT||3||/day||3||3||/day||SUBJECT||2017-01-03||END OF DIARY DAY -2||-2||-P1D|
|3||NUTR123||FA||NUTR123_001||3||D-1_1||3||EVENTFRQ||Event Frequency||BOWEL MOVEMENT||2||/day||2||2||/day||SUBJECT||2017-01-04||END OF DIARY DAY -1||-1||-P1D|
|1||NUTR123||LB||NUTR123_001||1||D-3_1||1||CONSIST||Consistency||Loose||Loose||STOOL||SUBJECT||2017-01-02||END OF DIARY DAY -3||-3||-P1D||TYPICAL|
|2||NUTR123||LB||NUTR123_001||2||D-2_1||2||CONSIST||Consistency||Hard||Hard||STOOL||SUBJECT||2017-01-03||END OF DIARY DAY -3||-2||-P1D||TYPICAL|
|3||NUTR123||LB||NUTR123_001||3||D-1_1||3||CONSIST||Consistency||Loose||Loose||STOOL||SUBJECT||2017-01-04||END OF DIARY DAY -3||-1||-P1D||TYPICAL|
LB NSV Metadata
|LBCOLSRT||Collected Summary Result Type||text||Non-Standard Variable Qualifier if --ORRES||CRF|