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Completed

NCT Number: NCT02252718

Amsterdam Stool Scale: Usefulness in Clinical Setting

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.

Completed

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Key information

Conditions

Age range

1 month–18 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Paediatrics, The Medical University of Warsaw

Warsaw, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stool Assessment

Other

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.

Primary outcomes

  1. Interrater Variability (IV)

    Time frame: <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).

Sponsors and collaborators

Lead sponsor

Medical University of Warsaw

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Sep 30, 2014
Registry last updated
Feb 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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