Trial Outcomes & Findings for Amsterdam Stool Scale: Usefulness in Clinical Setting (NCT NCT02252718)
NCT ID: NCT02252718
Last Updated: 2017-02-23
Results Overview
The outcome measures were interrater variability in the stool assessment by the parent and MD1 made in vivo and in the assessment by the parent in vivo and by MD2 based on the photograph(s). The IV was evaluated by calculating the proportion of exact agreement and the κ statistics for nominal data (colour) and weighted κ values for items in which there is a natural ordering of categories (consistency and amount). Correlation, based on the value of kappa (κ), was categorized as poor (κ ≤ 0.2), fair (0.21 ≤ κ ≤ 0.40), moderate (0.41 ≤ κ ≤ 0.60), good (0.61 ≤ κ ≤ 0.80) or excellent (0.81 ≤ κ ≤ 1.00).
COMPLETED
100 participants
<5min after defecation
2017-02-23
Participant Flow
This study was conducted at the Department of Paediatrics of the Medical University of Warsaw between September 2014 and February 2015.
Participant milestones
| Measure |
Children 2-18 Months of Age
Children aged between 2 and 18 months of age, who were not toilet trained, admitted to the Department of Pediatrics The Medical University of Warsaw
Stool Assessment: After passing a stool by the child participating in the study, within the shortest possible time (\<5 min), the stool will be assessed independently and simulataneously by one of the parents and the medical doctor. They were unaware of the evaluation results made by the other. At the same time 2 photos were taken with smartphone camera. Then the photographs were subsequently evaluated by the other physician (MD2), who was unaware of the in vivo stool evaluation.
|
|---|---|
|
Overall Study
STARTED
|
100
|
|
Overall Study
COMPLETED
|
100
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Amsterdam Stool Scale: Usefulness in Clinical Setting
Baseline characteristics by cohort
| Measure |
Children 2-18 Months of Age
n=100 Participants
Children between 2 and 18 months of age who were not toilet trained
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|---|---|
|
Age, Continuous
|
5.02 month
STANDARD_DEVIATION 4.4 • n=99 Participants
|
|
Gender
Female
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42 Participants
n=99 Participants
|
|
Gender
Male
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58 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: <5min after defecationThe outcome measures were interrater variability in the stool assessment by the parent and MD1 made in vivo and in the assessment by the parent in vivo and by MD2 based on the photograph(s). The IV was evaluated by calculating the proportion of exact agreement and the κ statistics for nominal data (colour) and weighted κ values for items in which there is a natural ordering of categories (consistency and amount). Correlation, based on the value of kappa (κ), was categorized as poor (κ ≤ 0.2), fair (0.21 ≤ κ ≤ 0.40), moderate (0.41 ≤ κ ≤ 0.60), good (0.61 ≤ κ ≤ 0.80) or excellent (0.81 ≤ κ ≤ 1.00).
Outcome measures
| Measure |
Children 2-18 Months of Age
n=100 Participants
Children aged between 2 and 18 months of age, who were not toilet trained, admitted to the Department of Pediatrics The Medical University of Warsaw
Stool Assessment: After passing a stool by the child participating in the study, within the shortest possible time (\<5 min), the stool will be assessed independently and simulataneously by one of the parents and the medical doctor. They were unaware of the evaluation results made by the other. At the same time 2 photos were taken with smartphone camera. Then the photographs were subsequently evaluated by the other physician (MD2), who was unaware of the in vivo stool evaluation.
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|---|---|
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Interrater Variability (IV)
parent- MD1: amount
|
0.79 kappa value
Interval 0.7 to 0.88
|
|
Interrater Variability (IV)
parent- MD1: consistency
|
0.87 kappa value
Interval 0.78 to 0.95
|
|
Interrater Variability (IV)
parent- MD1: color
|
0.81 kappa value
Interval 0.71 to 0.91
|
|
Interrater Variability (IV)
parent- MD2: amount
|
0.44 kappa value
Interval 0.3 to 0.59
|
|
Interrater Variability (IV)
parent- MD2: consistency
|
0.5 kappa value
Interval 0.36 to 0.64
|
|
Interrater Variability (IV)
parent- MD2: color
|
0.33 kappa value
Interval 0.21 to 0.45
|
Adverse Events
Children 2-18 Months of Age
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place