Amsterdam Stool Scale: Usefulness in Clinical Setting

NCT02252718 | Completed Results

• 1 other identifier: 1-2014
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Stool Assessment

Outcome Measures

Primary Outcomes (1)

• 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).

  <5min after defecation

Study Arms (1)

Children 1-18 months of age

Children aged between 1 month and 18 months admitted to the Department of Pediatrics The Medical University of Warsaw

Other: Stool Assessment

Interventions

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.

Children 1-18 months of age

Eligibility Criteria

• Age: 1 Month - 18 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The group will be selected from the children admitted to the Department of Pediatrics The Medical University of Warsaw

You may qualify if:

• Age 0-18 months of age
• Lack of ability to use the toilet

You may not qualify if:

• Lack of parental consent to participate in the study
• Parental inability to understand the study procedures

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (1)

Department of Paediatrics, The Medical University of Warsaw

Warsaw, Poland

Location

Limitations and Caveats

Limitations of our study included the lack of external validity. Children were recruited in only one paediatric department. Only one physician conducted stool assessment in vivo and only one physician evaluated photographs.

Results Point of Contact

• Title: Katarzyna Wojtyniak
• Organization: Medical University of Warsaw

wojtyniakkasia@gmail.com

(+48) 223179536

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: September 23, 2014
• First Posted: September 30, 2014
• Study Start: September 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: February 23, 2017
• Results First Posted: February 23, 2017

Record last verified: 2017-01

Locations

PL (1)