Stool AssessmentNCT02252718
Amsterdam Stool Scale: Usefulness in Clinical Setting
An observational study of Stool Assessment, run by Medical University of Warsaw at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 18 monthsHealthy volunteers can take part
- Conditions the study is for
- Stool Assessment
- What is being tested?
- Stool Assessment
- How many people
- 100 participants
- Where
- 1 sitePoland
- Study dates
- Sep 2014to Mar 2015
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 18 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: The group will be selected from the children admitted to the Department of Pediatrics The Medical University of Warsaw
Who may be able to join
- Age 0-18 months of age
- Lack of ability to use the toilet
Who cannot join
- Lack of parental consent to participate in the study
- Parental inability to understand the study procedures
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Paediatrics, The Medical University of Warsaw
Warsaw
About this study
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.
Read the 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.
- Conditions
- Stool Assessment
- Being tested
- Stool Assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stool AssessmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Stool Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: <5min after defecation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Stool AssessmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katarzyna Wojtyniak, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02252718
- Sponsor's protocol ID
- 1-2014
- Status last verified
- Jan 2017
- First submitted
- 23 Sep 2014
- Last updated
- 23 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Amsterdam Stool Scale: Usefulness in Clinical Setting
- ClinicalTrials.gov ID
- NCT02252718
- Acronym / sponsor ID
- 1-2014
- Conditions
- Stool Assessment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 30 Sep 2014 (estimated)
- Results
- Posted 23 Feb 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children 1-18 months of age | – | Other: Stool AssessmentChildren aged between 1 month and 18 months admitted to the Department of Pediatrics The Medical University of Warsaw |
Who may qualify
- Ages
- 1 month to 18 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The group will be selected from the children admitted to the Department of Pediatrics The Medical University of Warsaw
Key inclusion criteria (2 listed)
- Age 0-18 months of age
- Lack of ability to use the toilet
Key exclusion criteria (2 listed)
- Lack of parental consent to participate in the study
- Parental inability to understand the study procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stool AssessmentAfter 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. | Other | Children 1-18 months of age |
Primary outcome
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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stool Assessment, run by Medical University of Warsaw at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Feb 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interrater Variability (IV) (time frame: <5min after defecation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2017.