xml: <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/NCT05982847</url>
    </required_header>
    <id_info>
      <org_study_id>REC 4/23/03/22</org_study_id>
      <nct_id>NCT05982847</nct_id>
    </id_info>
    <brief_title>National Blood Pressure Screening in Children to Improve Paediatric Healthcare in South Africa</brief_title>
    <official_title>National Blood Pressure Screening in Children to Optimise Clinical Management of Paediatric Hypertension in South Africa</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>North-West University, South Africa</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Medical Research Council, South Africa</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>University of Cape Town</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>University of Limpopo</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Walter Sisulu University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>University of KwaZulu</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Red Cross War Memorial Childrens Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>University of Witwatersrand, South Africa</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>University of Zurich</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Groote Schuur Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Nelson Mandela Metropolitan University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Chris Hani Baragwanath Academic Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>University of the Free State</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>North-West University, South Africa</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The Childhood Hypertension Consortium of South Africa (CHCSA) was established to foster&#xD;
        relationships between the healthcare sector and schools through community engagement and&#xD;
        outreach as well as contributing to the decolonization of normative paediatric blood pressure&#xD;
        reference values. To date, there has been no nation-wide project in South Africa to determine&#xD;
        nationally representative normal blood pressure reference values, nor to estimate the true&#xD;
        prevalence of hypertension in the paediatric population of the country. This study will&#xD;
        provide critical information on the understanding of blood pressure and hypertension in&#xD;
        children, especially of African ancestry. Not only will this effort contribute to the&#xD;
        development of the first nationally representative normal reference values of blood pressure&#xD;
        but will also benefit healthcare providers in the sector with a clear guideline on the&#xD;
        management of high blood pressure in children as developed by experts working with these&#xD;
        challenges daily.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Rationale: Currently there exist no nationally representative set of normative reference&#xD;
        values for blood pressure and anthropometry in South African children, while clinicians rely&#xD;
        on European and US reference values. The latter seems inappropriate in the South African&#xD;
        setting, especially considering the lack of data available in African ancestry normative&#xD;
        data.&#xD;
  &#xD;
        Objectives: The investigators aim to development the first nationally representative normal&#xD;
        reference values of blood pressure and anthropometry in children, to develop scientific&#xD;
        evidence-based hypertension guidelines in the paediatric population of South Africa.&#xD;
  &#xD;
        Methods: The target population for this study includes 5 to under 18 years school-aged (all&#xD;
        school quintiles) children in South Africa from all provinces in the country selected in a&#xD;
        randomized manner and to ensure generalizability.&#xD;
  &#xD;
        Population: A sample of 22 464 (81% Black African; 9% Coloured; 8% White and 2% Indian/Asian)&#xD;
        will be required to enable computation of reference values for each age and sex across urban,&#xD;
        peri-urban and rural settings in all provinces.&#xD;
  &#xD;
        Time frame: The study will recruit and collect data over a period of five years.&#xD;
  &#xD;
        Expected outcomes: The investigators expect that normative blood pressure in children (ages&#xD;
        above 5 and under 18 years) will differ from currently accepted international thresholds. The&#xD;
        investigators will engage in the communities to optimise awareness and care of high blood&#xD;
        pressure and its comorbidities. Recommendations will be made to the National Department of&#xD;
        Health regarding blood pressure measurement/screening for hypertension in children at the&#xD;
        local clinic in the Road to Health booklet. The investigators will also develop the first&#xD;
        clinical practice guidelines for the management of hypertension in children in South Africa&#xD;
        in collaboration with hypertension societies.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">February 1, 2024</start_date>
    <completion_date type="Anticipated">November 30, 2028</completion_date>
    <primary_completion_date type="Anticipated">November 30, 2028</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>To determine and compute nationally representative normative reference values for blood pressure in children</measure>
      <time_frame>Through study completion, an average of 1 year</time_frame>
      <description>To date there are no national normative blood pressure reference values for children in South Africa. Normative values used by clinicians are those extrapolated from studies on blood pressure done in the USA and Europe and these may not be truly representative of normative values of blood pressure in South Africa. This study aims to address this issue, because children can be misdiagnosed for high blood pressure based on the wrong normative values.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>To determine and compute nationally representative normative reference values for blood pressure in children</measure>
      <time_frame>Through study completion, an average of 1 year</time_frame>
      <description>Overweight and obesity classification according to the World Health Organisation percentiles for childhood obesity only include a small sample size from less than five African countries, therefore the underrepresentation of children of African ancestry will be addressed by this study.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>To develop clinical practice guidelines for the management of childhood hypertension in South Africa</measure>
      <time_frame>Through study completion, an average of 1 year</time_frame>
      <description>The findings of this study will help develop clinically relevant guidelines for the management of hypertension in children between 5 and 18 years of age based on local normative values, as well as to improve cost and availability of anti-hypertensive agents for children and adolescents.</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">22464</enrollment>
    <condition>Hypertension</condition>
    <condition>Obesity, Adolescent</condition>
    <condition>Obesity, Childhood</condition>
    <arm_group>
      <arm_group_label>Boys</arm_group_label>
    </arm_group>
    <arm_group>
      <arm_group_label>Girls</arm_group_label>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Blood pressure screening</intervention_name>
      <description>Blood pressure and anthropometric measurements will be performed in children and adolescents between ages 5-18 years to develop South African nomograms that will aid in the development of clinical practice guidelines to optimise hypertension care in South Africa youth.</description>
      <arm_group_label>Boys</arm_group_label>
      <arm_group_label>Girls</arm_group_label>
      <other_name>Anthropometric measurements</other_name>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          The target population for this study includes 5 to under 18 years school-aged children in&#xD;
          South Africa from all provinces in the country selected in a randomized manner and to&#xD;
          ensure generalizability. All South African public ordinary schools are categorised into&#xD;
          five groups, called quintiles, largely for purposes of the allocation of financial&#xD;
          resources from government. Quintile one is the lowest socioeconomic quintile, while&#xD;
          quintile five is the highest. In addition, lower quintile schools are mostly rural and/or&#xD;
          peri-urban. Participants will be drawn from quintile 1-5 schools and those in more remote&#xD;
          areas will be reached via mobile fieldwork teams. A sample of 22 464 (81% Black African; 9%&#xD;
          Coloured; 8% White and 2% Indian/Asian) will be required to enable computation of reference&#xD;
          values for each age and sex across urban and rural settings in all provinces.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  All children between ages 5-&lt;18 years&#xD;
  &#xD;
            -  All children with voluntary assent/consent and parent's permission&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  circumstances interfere with the participant's ability to give informed consent&#xD;
               (diminished understanding or comprehension, or any language barriers that may pose&#xD;
               potential risk in participation under false expectations)&#xD;
  &#xD;
            -  randomly selected children who choose not to participate (lack of assent/consent),&#xD;
               even if parent's permission was received,&#xD;
  &#xD;
            -  conditions that interfere with a patient's ability to follow study guidelines, e.g.,&#xD;
               the use of drugs, alcohol or tobacco products&#xD;
  &#xD;
            -  ages &gt;18 years or under 5 years&#xD;
  &#xD;
            -  Children will be excluded from the analysis for the determination of normative&#xD;
               reference values for blood pressure and anthropometry if taking certain concomitant&#xD;
               medication(s) that may affect their blood pressure, or any underlying disease e.g.,&#xD;
               chronic kidney disease, chronic heart disease etc. that may raise blood pressure.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>5 Years</minimum_age>
      <maximum_age>18 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Ruan Kruger, PhD</last_name>
      <phone>+27182992904</phone>
      <email>ruan.kruger@nwu.ac.za</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Lebo F Gafane-Matemane, PhD</last_name>
      <phone>+27182992193</phone>
      <email>lebo.gafane@nwu.ac.za</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Walter Sisulu University</name>
        <address>
          <city>Mthatha</city>
          <state>Eastern Cape</state>
          <country>South Africa</country>
        </address>
      </facility>
      <contact>
        <last_name>Benedicta Nkeh-Chungag, PhD</last_name>
        <phone>+27475021989</phone>
        <email>bnkehchungag@wsu.ac.za</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Nelson Mandela Metropolitan University</name>
        <address>
          <city>Port Elizabeth</city>
          <state>Eastern Cape</state>
          <country>South Africa</country>
        </address>
      </facility>
      <contact>
        <last_name>Aayesha Kholvadia, PhD</last_name>
        <email>Aayesha.Kholvadia@mandela.ac.za</email>
      </contact>
      <contact_backup>
        <last_name>Cheryl Walter, PhD</last_name>
        <email>cheryl.walter@mandela.ac.za</email>
      </contact_backup>
    </location>
    <location>
      <facility>
        <name>University of the Free State</name>
        <address>
          <city>Bloemfontein</city>
          <state>Free State</state>
          <country>South Africa</country>
        </address>
      </facility>
      <contact>
        <last_name>Johannes Cronje, MD</last_name>
        <email>rigel.jcc@gmail.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>University of the Witwatersrand</name>
        <address>
          <city>Johannesburg</city>
          <state>Gauteng</state>
          <country>South Africa</country>
        </address>
      </facility>
      <contact>
        <last_name>Shane Norris, PhD</last_name>
        <email>shane.norris@wits.ac.za</email>
      </contact>
      <contact_backup>
        <last_name>Lisa J Ware, PhD</last_name>
        <email>lisa.ware@wits.ac.za</email>
      </contact_backup>
      <investigator>
        <last_name>Bhavisha Nagar, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Karen Peterson, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Innocent Maposa, PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Sanushka Naidoo, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Stephen Tollman, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Xavier Gómez-Olivé, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Nilesh Lala, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>University of KwaZulu-Natal</name>
        <address>
          <city>Durban</city>
          <state>KwaZulu-Natal</state>
          <country>South Africa</country>
        </address>
      </facility>
      <contact>
        <last_name>Rajendra Bhimma, MD</last_name>
        <email>bhimma@ukzn.ac.za</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>University of Limpopo</name>
        <address>
          <city>Polokwane</city>
          <state>Limpopo</state>
          <country>South Africa</country>
        </address>
      </facility>
      <contact>
        <last_name>Kotsedi D Monyeki, PhD</last_name>
        <email>kotsedi.monyeki@ul.ac.za</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Hypertension in Africa Research Team (HART), North-West University</name>
        <address>
          <city>Potchefstroom</city>
          <state>North West</state>
          <zip>2531</zip>
          <country>South Africa</country>
        </address>
      </facility>
      <contact>
        <last_name>Ruan Kruger, PhD</last_name>
        <phone>+27824902342</phone>
        <phone_ext>992904</phone_ext>
        <email>Ruan.Kruger@nwu.ac.za</email>
      </contact>
      <investigator>
        <last_name>Lebo F Gafane-Matemane, PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Red Cross War Memorial Children Hospital</name>
        <address>
          <city>Cape Town</city>
          <state>Western Cape</state>
          <country>South Africa</country>
        </address>
      </facility>
      <contact>
        <last_name>Peter Nourse, MD</last_name>
        <email>peter.nourse@uct.ac.za</email>
      </contact>
      <contact_backup>
        <last_name>Mignon McCulloch, MD</last_name>
        <email>mignon.mcculloch@uct.ac.za</email>
      </contact_backup>
    </location>
    <location>
      <facility>
        <name>South African Medical Research Council</name>
        <address>
          <city>Cape Town</city>
          <state>Western Cape</state>
          <country>South Africa</country>
        </address>
      </facility>
      <contact>
        <last_name>Liesl Zuhlke, MD</last_name>
        <email>liesl.zuhlke@mrc.ac.za</email>
      </contact>
      <contact_backup>
        <last_name>Rabia Johnson, PhD</last_name>
        <email>rabia.johnson@mrc.ac.za</email>
      </contact_backup>
      <investigator>
        <last_name>Jyoti Sharma, PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>University of Cape Town</name>
        <address>
          <city>Cape Town</city>
          <state>Western Cape</state>
          <country>South Africa</country>
        </address>
      </facility>
      <contact>
        <last_name>Sandra Mukasa, PhD</last_name>
        <email>sandra.mukasa@uct.ac.za</email>
      </contact>
      <contact_backup>
        <last_name>Erika Jones, MD</last_name>
        <email>erika.jones@uct.ac.za</email>
      </contact_backup>
      <investigator>
        <last_name>Friedrich Thienemann, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Landon Myer, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Patrick Katoto, PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>University of Zurich</name>
        <address>
          <city>Zürich</city>
          <country>Switzerland</country>
        </address>
      </facility>
      <contact>
        <last_name>Friedrich Thienemann, MD</last_name>
        <email>friedrich.thienemann@uct.ac.za</email>
      </contact>
      <investigator>
        <last_name>Friedrich Thienemann, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>South Africa</country>
      <country>Switzerland</country>
    </location_countries>
    <link>
      <url>https://www.chc-sa.org/home</url>
      <description>CHCSA website</description>
    </link>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 1, 2023</study_first_submitted>
    <study_first_submitted_qc>August 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 9, 2023</study_first_posted>
    <last_update_submitted>August 31, 2023</last_update_submitted>
    <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>North-West University, South Africa</investigator_affiliation>
      <investigator_full_name>Ruan Kruger</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <keyword>Adiposity</keyword>
    <keyword>Blood Pressure</keyword>
    <keyword>Cardiovascular Diseases</keyword>
    <keyword>Health Knowledge, Attitudes, Practice</keyword>
    <keyword>Lifestyle Factors</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hypertension</mesh_term>
      <mesh_term>Obesity</mesh_term>
      <mesh_term>Pediatric Obesity</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
      <ipd_description>The national data will be first collated to develop the nomograms for blood pressure and anthropometric measurements. The data will be made available upon reasonable request from the principal investigator(s) after publication of the nomograms findings.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05982847
  org study id: REC 4/23/03/22
  nct id: NCT05982847
  lead sponsor: 
  collaborator: 
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  collaborator: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The Childhood Hypertension Consortium of South Africa (CHCSA) was established to foster
        relationships between the healthcare sector and schools through community engagement and
        outreach as well as contributing to the decolonization of normative paediatric blood pressure
        reference values. To date, there has been no nation-wide project in South Africa to determine
        nationally representative normal blood pressure reference values, nor to estimate the true
        prevalence of hypertension in the paediatric population of the country. This study will
        provide critical information on the understanding of blood pressure and hypertension in
        children, especially of African ancestry. Not only will this effort contribute to the
        development of the first nationally representative normal reference values of blood pressure
        but will also benefit healthcare providers in the sector with a clear guideline on the
        management of high blood pressure in children as developed by experts working with these
        challenges daily.
  Rationale: Currently there exist no nationally representative set of normative reference
        values for blood pressure and anthropometry in South African children, while clinicians rely
        on European and US reference values. The latter seems inappropriate in the South African
        setting, especially considering the lack of data available in African ancestry normative
        data.
  
        Objectives: The investigators aim to development the first nationally representative normal
        reference values of blood pressure and anthropometry in children, to develop scientific
        evidence-based hypertension guidelines in the paediatric population of South Africa.
  
        Methods: The target population for this study includes 5 to under 18 years school-aged (all
        school quintiles) children in South Africa from all provinces in the country selected in a
        randomized manner and to ensure generalizability.
  
        Population: A sample of 22 464 (81% Black African; 9% Coloured; 8% White and 2% Indian/Asian)
        will be required to enable computation of reference values for each age and sex across urban,
        peri-urban and rural settings in all provinces.
  
        Time frame: The study will recruit and collect data over a period of five years.
  
        Expected outcomes: The investigators expect that normative blood pressure in children (ages
        above 5 and under 18 years) will differ from currently accepted international thresholds. The
        investigators will engage in the communities to optimise awareness and care of high blood
        pressure and its comorbidities. Recommendations will be made to the National Department of
        Health regarding blood pressure measurement/screening for hypertension in children at the
        local clinic in the Road to Health booklet. The investigators will also develop the first
        clinical practice guidelines for the management of hypertension in children in South Africa
        in collaboration with hypertension societies.
  observational model: Cohort
  time perspective: Prospective
  measure: To determine and compute nationally representative normative reference values for blood pressure in children
  time frame: Through study completion, an average of 1 year
  description: To date there are no national normative blood pressure reference values for children in South Africa. Normative values used by clinicians are those extrapolated from studies on blood pressure done in the USA and Europe and these may not be truly representative of normative values of blood pressure in South Africa. This study aims to address this issue, because children can be misdiagnosed for high blood pressure based on the wrong normative values.
  measure: To determine and compute nationally representative normative reference values for blood pressure in children
  time frame: Through study completion, an average of 1 year
  description: Overweight and obesity classification according to the World Health Organisation percentiles for childhood obesity only include a small sample size from less than five African countries, therefore the underrepresentation of children of African ancestry will be addressed by this study.
  measure: To develop clinical practice guidelines for the management of childhood hypertension in South Africa
  time frame: Through study completion, an average of 1 year
  description: The findings of this study will help develop clinically relevant guidelines for the management of hypertension in children between 5 and 18 years of age based on local normative values, as well as to improve cost and availability of anti-hypertensive agents for children and adolescents.
  arm group label: Boys
  arm group label: Girls
  intervention type: Diagnostic Test
  intervention name: Blood pressure screening
  description: Blood pressure and anthropometric measurements will be performed in children and adolescents between ages 5-18 years to develop South African nomograms that will aid in the development of clinical practice guidelines to optimise hypertension care in South Africa youth.
  arm group label: Boys
  arm group label: Girls
  other name: Anthropometric measurements
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 5 Years
  maximum age: 18 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Ruan Kruger, PhD
  phone: +27182992904
  email: ruan.kruger@nwu.ac.za
  last name: Lebo F Gafane-Matemane, PhD
  phone: +27182992193
  email: lebo.gafane@nwu.ac.za
  facility: 
  contact: 
  facility: 
  contact: 
  contact backup: 
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  investigator: 
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  country: South Africa
  country: Switzerland
  url: https://www.chc-sa.org/home
  description: CHCSA website
  responsible party type: Principal Investigator
  investigator affiliation: North-West University, South Africa
  investigator full name: Ruan Kruger
  investigator title: Professor
  mesh term: Hypertension
  mesh term: Obesity
  mesh term: Pediatric Obesity
  sharing ipd: Undecided
  ipd description: The national data will be first collated to develop the nomograms for blood pressure and anthropometric measurements. The data will be made available upon reasonable request from the principal investigator(s) after publication of the nomograms findings.