<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02252718</url>
  </required_header>
  <id_info>
    <org_study_id>1-2014</org_study_id>
    <nct_id>NCT02252718</nct_id>
  </id_info>
  <brief_title>Amsterdam Stool Scale: Usefulness in Clinical Setting</brief_title>
  <official_title>Amsterdam Stool Scale: Usefulness in Clinical Setting</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Warsaw</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of Warsaw</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to assess interobserver and intraobserver variability of the&#xD;
      Amsterdam Stool Scale in clinical practice. After passing a stool by the child participating&#xD;
      in the study it will be assessed using the Amsterdam Stool Scale independently by one of the&#xD;
      parents and the medical doctor. At the same time a parent will take 2 photos that will be&#xD;
      independently evaluated by another doctor.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      INTRODUCTION:&#xD;
&#xD;
      Description of stool appearance is important in clinical practice. Parents are often asked to&#xD;
      evaluate stool of their child. At present parents also take more frequently photos using&#xD;
      smartphone camera when they are concerned with child's stool appearance and show it to their&#xD;
      doctors. To make stool evaluation easier there have been stool form scales created. One of&#xD;
      this is Amsterdam Stool Scale that enables stool assessment of children who are not yet&#xD;
      toilet trained. This scale facilitates to describe amount, consistency and color of the&#xD;
      stool.&#xD;
&#xD;
      AIM:&#xD;
&#xD;
      To assess interobserver and intraobserver variability of the Amsterdam Stool Scale in&#xD;
      clinical practice.&#xD;
&#xD;
      METHODS:&#xD;
&#xD;
      After passing a stool by the child participating in the study, within a short-time interval&#xD;
      (&lt;5 min), the stool will be assessed independently by one of the parents and the medical&#xD;
      doctor. At the same time a parent will take 2 photos with phone camera. The photographs then&#xD;
      will be independently evaluated by another doctor who will be unaware of both the &quot;in vivo&quot;&#xD;
      stool appraisal and child condition.&#xD;
&#xD;
      STATISTICAL ANALYSIS:&#xD;
&#xD;
      Then the interobserver (between a parent, the doctor and the doctor assessing photograph)&#xD;
      variability will be evaluated by calculating the kappa (κ) statistics for nominal data for&#xD;
      the stool consistency, amount and color separately.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">March 2015</completion_date>
  <primary_completion_date type="Actual">March 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Interrater Variability (IV)</measure>
    <time_frame>&lt;5min after defecation</time_frame>
    <description>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).</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">100</enrollment>
  <condition>Stool Assessment</condition>
  <arm_group>
    <arm_group_label>Children 1-18 months of age</arm_group_label>
    <description>Children aged between 1 month and 18 months admitted to the Department of Pediatrics The Medical University of Warsaw</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Stool Assessment</intervention_name>
    <description>After passing a stool by the child participating in the study, within a short-time interval (&lt;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 &quot;in vivo&quot; stool appraisal and child condition.</description>
    <arm_group_label>Children 1-18 months of age</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The group will be selected from the children admitted to the Department of Pediatrics The&#xD;
        Medical University of Warsaw&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 0-18 months of age&#xD;
&#xD;
          -  Lack of ability to use the toilet&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Lack of parental consent to participate in the study&#xD;
&#xD;
          -  Parental inability to understand the study procedures&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Month</minimum_age>
    <maximum_age>18 Months</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Paediatrics, The Medical University of Warsaw</name>
      <address>
        <city>Warsaw</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>September 23, 2014</study_first_submitted>
  <study_first_submitted_qc>September 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 30, 2014</study_first_posted>
  <results_first_submitted>November 5, 2016</results_first_submitted>
  <results_first_submitted_qc>January 4, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">February 23, 2017</results_first_posted>
  <last_update_submitted>January 4, 2017</last_update_submitted>
  <last_update_submitted_qc>January 4, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">February 23, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of Warsaw</investigator_affiliation>
    <investigator_full_name>Katarzyna Wojtyniak</investigator_full_name>
    <investigator_title>M.D.</investigator_title>
  </responsible_party>

  <clinical_results>

    <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.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Children 2-18 Months of Age</title>
          <description>Children aged between 2 and 18 months of age, who were not toilet trained, admitted to the Department of Pediatrics The Medical University of Warsaw&#xD;
Stool Assessment: After passing a stool by the child participating in the study, within the shortest possible time (&lt;5 min), the stool will be assessed independently and simulataneously by one of the parents and the medical doctor. They were unaware of the evaluation results made by the other. At the same time 2 photos were taken with smartphone camera. Then the photographs were subsequently evaluated by the other physician (MD2), who was unaware of the in vivo stool evaluation.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="100"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="100"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Children between 2 and 18 months of age who were not toilet trained were eligible for the study. Exclusion criteria included parental inability to understand the study procedure and lack of parental consent to participate.</population>
      <group_list>
        <group group_id="B1">
          <title>Children 2-18 Months of Age</title>
          <description>Children between 2 and 18 months of age who were not toilet trained</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="100"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>month</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5.02" spread="4.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Gender</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="42"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Interrater Variability (IV)</title>
        <description>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).</description>
        <time_frame>&lt;5min after defecation</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Children 2-18 Months of Age</title>
            <description>Children aged between 2 and 18 months of age, who were not toilet trained, admitted to the Department of Pediatrics The Medical University of Warsaw&#xD;
Stool Assessment: After passing a stool by the child participating in the study, within the shortest possible time (&lt;5 min), the stool will be assessed independently and simulataneously by one of the parents and the medical doctor. They were unaware of the evaluation results made by the other. At the same time 2 photos were taken with smartphone camera. Then the photographs were subsequently evaluated by the other physician (MD2), who was unaware of the in vivo stool evaluation.</description>
          </group>
        </group_list>
        <measure>
          <title>Interrater Variability (IV)</title>
          <description>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).</description>
          <units>kappa value</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>parent- MD1: amount</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.79" lower_limit="0.7" upper_limit="0.88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>parent- MD1: consistency</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.87" lower_limit="0.78" upper_limit="0.95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>parent- MD1: color</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.81" lower_limit="0.71" upper_limit="0.91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>parent- MD2: amount</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.44" lower_limit="0.3" upper_limit="0.59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>parent- MD2: consistency</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5" lower_limit="0.36" upper_limit="0.64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>parent- MD2: color</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.33" lower_limit="0.21" upper_limit="0.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Children 2-18 Months of Age</title>
          <description>Children aged between 2 and 18 months of age, who were not toilet trained, admitted to the Department of Pediatrics The Medical University of Warsaw&#xD;
Stool Assessment: After passing a stool by the child participating in the study, within the shortest possible time (&lt;5 min), the stool will be assessed independently and simulataneously by one of the parents and the medical doctor. They were unaware of the evaluation results made by the other. At the same time 2 photos were taken with smartphone camera. Then the photographs were subsequently evaluated by the other physician (MD2), who was unaware of the in vivo stool evaluation.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <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.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Katarzyna Wojtyniak</name_or_title>
      <organization>Medical University of Warsaw</organization>
      <phone>(+48) 223179536</phone>
      <email>wojtyniakkasia@gmail.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02252718
org study id: 1-2014
nct id: NCT02252718
lead sponsor: 
has dmc: No
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.
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.
observational model: Case-Only
time perspective: Cross-Sectional
measure: Interrater Variability (IV)
time frame: <5min after defecation
description: 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).
arm group label: Children 1-18 months of age
description: Children aged between 1 month and 18 months admitted to the Department of Pediatrics The Medical University of Warsaw
intervention type: Other
intervention name: Stool Assessment
description: 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.
arm group label: Children 1-18 months of age
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 1 Month
maximum age: 18 Months
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Poland
responsible party type: Principal Investigator
investigator affiliation: Medical University of Warsaw
investigator full name: Katarzyna Wojtyniak
investigator title: M.D.
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
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.
point of contact: 