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.
- 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 using - NUT-125Getting issue details... STATUS the CE domain.
- The consistency and color of each episode were represented using the Laboratory Test Results - NUT-125Getting issue details... STATUS (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.
- Bowel movements were assessed by the infant's caregiver and therefore CEEVAL was used to represent this. If a subject was assessing their own stool sample then CEEVAL would be "SUBJECT". - NUT-136Getting issue details... STATUS
- The rows are color coded to help identify each day of the diary.