Stool Assessment
Conditions
Brief summary
The aim of this study is to assess interobserver and intraobserver variability of the Amsterdam Stool Scale in clinical practice. After passing a stool by the child participating in the study it will be assessed using the Amsterdam Stool Scale independently by one of the parents and the medical doctor. At the same time a parent will take 2 photos that will be independently evaluated by another doctor.
Detailed description
INTRODUCTION: Description of stool appearance is important in clinical practice. Parents are often asked to evaluate stool of their child. At present parents also take more frequently photos using smartphone camera when they are concerned with child's stool appearance and show it to their doctors. To make stool evaluation easier there have been stool form scales created. One of this is Amsterdam Stool Scale that enables stool assessment of children who are not yet toilet trained. This scale facilitates to describe amount, consistency and color of the stool. AIM: To assess interobserver and intraobserver variability of the Amsterdam Stool Scale in clinical practice. METHODS: After passing a stool by the child participating in the study, within a short-time interval (\<5 min), the stool will be assessed independently by one of the parents and the medical doctor. At the same time a parent will take 2 photos with phone camera. The photographs then will be independently evaluated by another doctor who will be unaware of both the in vivo stool appraisal and child condition. STATISTICAL ANALYSIS: Then the interobserver (between a parent, the doctor and the doctor assessing photograph) variability will be evaluated by calculating the kappa (κ) statistics for nominal data for the stool consistency, amount and color separately.
Interventions
OTHERStool Assessment
After passing a stool by the child participating in the study, within a short-time interval (\<5 min), the stool will be assessed independently by one of the parents and the medical doctor. At the same time a parent will take 2 photos with phone photographic camera. Then the photographs will be independently evaluated by another doctor who will be unaware of both the in vivo stool appraisal and child condition.
Sponsors
Medical University of Warsaw
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
1 Months to 18 Months
Healthy volunteers
Yes
Inclusion criteria
* Age 0-18 months of age * Lack of ability to use the toilet
Exclusion criteria
* Lack of parental consent to participate in the study * Parental inability to understand the study procedures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Interrater Variability (IV) | <5min after defecation | 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). |
Countries
Poland
Participant flow
Recruitment details
This study was conducted at the Department of Paediatrics of the Medical University of Warsaw between September 2014 and February 2015.
Participants by arm
| Arm | Count |
|---|---|
| Children 2-18 Months of Age Children between 2 and 18 months of age who were not toilet trained | 100 |
| Total | 100 |
Baseline characteristics
| Characteristic | Children 2-18 Months of Age |
|---|---|
| Age, Continuous | 5.02 month STANDARD_DEVIATION 4.4 |
| Gender Female | 42 Participants |
| Gender Male | 58 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 100 |
| serious Total, serious adverse events | 0 / 100 |
Outcome results
Primary
Interrater Variability (IV)
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).
Time frame: <5min after defecation
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Children 2-18 Months of Age | Interrater Variability (IV) | parent- MD1: amount | 0.79 kappa value |
| Children 2-18 Months of Age | Interrater Variability (IV) | parent- MD1: consistency | 0.87 kappa value |
| Children 2-18 Months of Age | Interrater Variability (IV) | parent- MD1: color | 0.81 kappa value |
| Children 2-18 Months of Age | Interrater Variability (IV) | parent- MD2: amount | 0.44 kappa value |
| Children 2-18 Months of Age | Interrater Variability (IV) | parent- MD2: consistency | 0.5 kappa value |
| Children 2-18 Months of Age | Interrater Variability (IV) | parent- MD2: color | 0.33 kappa value |