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Clinical Trials/NCT02252718
NCT02252718CompletedNot Applicable

Amsterdam Stool Scale: Usefulness in Clinical Setting

Medical University of Warsaw1 site in 1 country100 target enrollmentStarted: September 2014Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
100
Locations
1
Primary Endpoint
Interrater Variability (IV)

Study Overview

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:

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
1 Month to 18 Months (Child)
Sex
All
Accepts 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

Outcomes

Primary Outcomes

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).

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Medical University of Warsaw
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Katarzyna Wojtyniak

M.D.

Medical University of Warsaw

Study Sites (1)

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