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.
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
|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?
|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
|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"
|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"
- 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-141Getting 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.
|Rows 1-3:||Show 3 bowel movement episodes on the first day of the diary.|
|Rows 4-5:||Show 2 bowel movement episodes on the second day of the diary.|
|Rows 6-7:||Show 2 bowel movement episodes on the third day of the diary.|
|Row 8:||Shows an example of where there are no bowel movements episodes for the first day of the diary (although this is quite unlikely).|
|Row 9:||Shows an example of where the subject forgot to record any bowel movement episodes for the second day of the diary. In this example, there was just a line struck through the diary with a note of "Forgot to complete." As no other data was recorded by the subject, CEDTC/CESTDTC/CEOCCUR are all blank. The CESTAT and CEREASND variables are used to show that the bowel movement assessments were not done on this day.|
|1||NUTR123||CE||NUTR123_001||1||D-3_1||1||BOWEL MOVEMENT||Y||Y||2017-01-02||2017-01-02 T09:45||DIARY DAY -3||-3|
|2||NUTR123||CE||NUTR123_001||2||D-3_2||2||BOWEL MOVEMENT||Y||Y||2017-01-02||2017-01-02 T12:45||DIARY DAY -3||-3|
|3||NUTR123||CE||NUTR123_001||3||D-3_3||3||BOWEL MOVEMENT||Y||Y||2017-01-02||2017-01-02 T19:45||DIARY DAY -3||-3|
|4||NUTR123||CE||NUTR123_001||4||D-2_1||1||BOWEL MOVEMENT||Y||Y||2017-01-03||2017-01-03 T08:30||DIARY DAY -2||-2|
|5||NUTR123||CE||NUTR123_001||5||D-2_2||2||BOWEL MOVEMENT||Y||Y||2017-01-03||2017-01-03 T20:00||DIARY DAY -2||-2|
|6||NUTR123||CE||NUTR123_001||6||D-1_1||1||BOWEL MOVEMENT||Y||Y||2017-01-04||2017-01-04 T09:00||DIARY DAY -1||-1|
|7||NUTR123||CE||NUTR123_001||7||D-1_2||2||BOWEL MOVEMENT||Y||Y||2017-01-04||2017-01-04 T21:00||DIARY DAY -1||-1|
|8||NUTR123||CE||NUTR123_002||1||D-3_1||1||BOWEL MOVEMENT||Y||N||2017-02-12||DIARY DAY -3||-3|
|9||NUTR123||CE||NUTR123_002||2||D-2_1||1||BOWEL MOVEMENT||Y||NOT DONE||FORGOT TO COMPLETE||DIARY DAY -2||-2|
|1||NUTR123||LB||NUTR123_001||1||D-3_1||1||CONSIST||Consistency||Loose||Loose||STOOL||CAREGIVER||2017-01-02 T09:45||DIARY DAY -3||-3|
|2||NUTR123||LB||NUTR123_001||2||D-3_1||1||COLOR||Color||Brown||Brown||STOOL||CAREGIVER||2017-01-02 T09:45||DIARY DAY -3||-3|
|3||NUTR123||LB||NUTR123_001||3||D-3_2||2||CONSIST||Consistency||Hard||Hard||STOOL||CAREGIVER||2017-01-02 T12:45||DIARY DAY -3||-3|
|4||NUTR123||LB||NUTR123_001||4||D-3_2||2||COLOR||Color||Brown||Brown||STOOL||CAREGIVER||2017-01-02 T12:45||DIARY DAY -3||-3|
|5||NUTR123||LB||NUTR123_001||5||D-3_3||3||CONSIST||Consistency||Loose||Loose||STOOL||CAREGIVER||2017-01-02 T19:45||DIARY DAY -3||-3|
|6||NUTR123||LB||NUTR123_001||6||D-3_3||3||COLOR||Color||Brown||Brown||STOOL||CAREGIVER||2017-01-02 T19:45||DIARY DAY -3||-3|
|7||NUTR123||LB||NUTR123_001||7||D-2_1||1||CONSIST||Consistency||Hard||Hard||STOOL||CAREGIVER||2017-01-03 T08:30||DIARY DAY -2||-2|
|8||NUTR123||LB||NUTR123_001||8||D-2_1||1||COLOR||Color||Brown||Brown||STOOL||CAREGIVER||2017-01-03 T08:30||DIARY DAY -2||-2|
|9||NUTR123||LB||NUTR123_001||9||D-2_2||2||CONSIST||Consistency||Hard||Hard||STOOL||CAREGIVER||2017-01-03 T20:00||DIARY DAY -2||-2|
|10||NUTR123||LB||NUTR123_001||10||D-2_2||2||COLOR||Color||Brown||Brown||STOOL||CAREGIVER||2017-01-03 T20:00||DIARY DAY -2||-2|
|11||NUTR123||LB||NUTR123_001||11||D-1_1||1||CONSIST||Consistency||Hard||Hard||STOOL||CAREGIVER||2017-01-04 T09:00||DIARY DAY -1||-1|
|12||NUTR123||LB||NUTR123_001||12||D-1_1||1||COLOR||Color||Brown||Brown||STOOL||CAREGIVER||2017-01-04 T09:00||DIARY DAY -1||-1|
|13||NUTR123||LB||NUTR123_001||13||D-1_2||2||CONSIST||Consistency||Loose||Loose||STOOL||CAREGIVER||2017-01-04 T21:00||DIARY DAY -1||-1|
|14||NUTR123||LB||NUTR123_001||14||D-1_2||2||COLOR||Color||Brown||Brown||STOOL||CAREGIVER||2017-01-04 T21:00||DIARY DAY -1||-1|