<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/NCT04443465</url>
  </required_header>
  <id_info>
    <org_study_id>IRAS 239002</org_study_id>
    <nct_id>NCT04443465</nct_id>
  </id_info>
  <brief_title>Patient Experiences of IONM and Outcomes</brief_title>
  <acronym>IONM</acronym>
  <official_title>Physical Effects and Emotional Experiences of Intra-operative Neuro-monitoring (IONM)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>King's College Hospital NHS Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>King's College Hospital NHS Trust</source>
  <oversight_info>
    <has_dmc>No</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>
      Resection of brain tumours forms a large proportion of work in brain surgery. One important&#xD;
      aspect is to minimize damage to normal brain structures during this process. This improves&#xD;
      patient outcomes and reduces complications. To identify normal brain structures from the&#xD;
      abnormal tumours, the brain surgeons use a 'guidance' technique called intraoperative&#xD;
      neuro-monitoring (IONM).&#xD;
&#xD;
      IONM uses various electrodes to observe spontaneous electrical activity of the brain or its&#xD;
      reaction to a stimulus such as muscle contraction, light or sound. It is now becoming common&#xD;
      practice for neurosurgeons to use this tool during brain and spinal surgery to provide a&#xD;
      real-time feedback under anaesthesia to help them minimise injury to important and normal&#xD;
      brain and spine structures.&#xD;
&#xD;
      IONM interpretation needs fulfilment of multiple preconditions and major modifications to the&#xD;
      anaesthetic to reduce its inaccuracies. This invites added risks and complications such as&#xD;
      awareness, convulsions and heart problems under anaesthesia. A team approach between the&#xD;
      surgeon, anaesthetist and neurophysiologist (IONM specialist) is also crucial to obtain&#xD;
      meaningful results. Therefore, the usefulness of this technique is still not perfect.&#xD;
&#xD;
      Although, benefits of IONM are obvious, information on associated complications and patient&#xD;
      experience are not commonly found in the literature. Information on other effects such as&#xD;
      hormonal balance and tumour recurrence are also scarce. In general, these aspects have little&#xD;
      scientific exploration.&#xD;
&#xD;
      There are anecdotal reports of recurrent seizures during IONM leading to serious heart&#xD;
      problems, teeth and tongue damage due to grinding and postoperative calf muscle injury&#xD;
      necessitating further surgery to save limbs. Neither of these is in the literature including&#xD;
      unorthodox treatments such as the use of cold saline to control IONM triggered fits.&#xD;
&#xD;
      This study is designed to observe complications and outcome and explore patient experiences&#xD;
      following IONM in an observational capacity not interfering with the clinical management or&#xD;
      treatment of these patients. The investigators intend to interview the participants after&#xD;
      surgery, at a convenient time before leaving hospital to understand their views and&#xD;
      experiences during and after surgery and their general progress in the following one year.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      INTRODUCTION Intraoperative neuro-monitoring (IONM) is a 'SAT NAV' used by neurosurgeons to&#xD;
      prevent injury to normal structures during brain and spinal surgery under anaesthesia. It&#xD;
      involves the use of surface and implanted electrodes to observe spontaneous electrical&#xD;
      activity of the brain or evoked responses to an electrical stimulus (motor, visual or&#xD;
      auditory). This requires major modifications to the anaesthetic that provides lighter planes&#xD;
      of anaesthesia with no muscle relaxation inviting added risks and complications such as&#xD;
      awareness, seizures and cardiac events.&#xD;
&#xD;
      This cohort study over a period of one year will include a qualitative enquiry of patient&#xD;
      experience and a quantitative evaluation of the immediate postoperative course and&#xD;
      complications at 28 days and 1 year. It will explore the relatively unknown area of emotional&#xD;
      experiences of participants under anaesthesia who undergo various types of neuro stimulation&#xD;
      and related post-operative sequelae. The results are expected to assist improve patient&#xD;
      experiences and outcomes.&#xD;
&#xD;
      BACKGROUND AND RATIONALE Resections of brain tumours constitute a significant proportion of&#xD;
      work in neurosurgery. One important aspect is minimizing injury to normal neural structures&#xD;
      during this process to improve outcomes of such operations and reduce complications. This&#xD;
      involves intraoperative neuro-monitoring (IONM).&#xD;
&#xD;
      IONM uses surface and implanted electrodes to observe spontaneous electrical activity of the&#xD;
      brain or evoked response to a motor, visual or auditory stimulus. It is now becoming common&#xD;
      practice for neurosurgeons to use this tool during brain and spinal surgery to provide a&#xD;
      real-time feedback under anaesthesia to help them minimise injury to critical and normal&#xD;
      neural structures by 'mapping' normal from abnormal areas of the brain.&#xD;
&#xD;
      IONM interpretation needs fulfilment of multiple preconditions and major modifications to the&#xD;
      anaesthetic to reduce its inaccuracies. This invites added risks and complications such as&#xD;
      awareness, seizures and cardiac events. A team approach is also crucial to obtain meaningful&#xD;
      results. Therefore, the utility of this technique is still evolving based on personal&#xD;
      experiences and perceptions and the understanding between the surgeons, anaesthetists and&#xD;
      neurophysiologists.&#xD;
&#xD;
      Although, benefits of IONM are obvious, data on associated post-operative morbidity and&#xD;
      patient experience and complications are scarce. The data is also scarce on tumour recurrence&#xD;
      or tumour behaviour following IONM guided neurosurgery. More precise excision may reduce&#xD;
      tumour recurrence. On the other hand IONM related electrical stimulation may impose humoral&#xD;
      effects on tumour behaviour. These aspects have little scientific exploration.&#xD;
&#xD;
      There are anecdotal reports of recurrent seizures during IONM leading to cardiac events such&#xD;
      as asystole, teeth grinding and damage and tongue injury in the absence of a 'bite block' and&#xD;
      postoperative calf muscle necrosis necessitating fasciotomies. Neither of these is in the&#xD;
      literature including the unorthodox effective treatments used such as pouring 'cold' saline&#xD;
      on the surface of the brain to control seizures.&#xD;
&#xD;
      The study will take place in a major neurosurgical centre in the UK that uses IONM.&#xD;
      Therefore, the study population is vast for appropriate sampling and recruitment.&#xD;
&#xD;
      STUDY DESIGN This is an observational cohort study based on data retrieved from clinical&#xD;
      notes and direct patient interview in hospital. The qualitative enquiry will address&#xD;
      emotional aspects and the process experience. The quantitative survey will investigate&#xD;
      morbidity (post-operative recovery, complications) and outcomes including mortality at 28&#xD;
      days and 1-year follow-up.&#xD;
&#xD;
      The eligible patients will be identified by the published elective neurosurgery lists and&#xD;
      approached for informed consent before surgery at the time of preoperative assessment.&#xD;
&#xD;
      The anaesthetist or the surgeon directly involved with his/her clinical care will first&#xD;
      approach the patient and subsequently introduced to the medical student for post-operative&#xD;
      data collection. Their demographic data, disease data, and neurological assessment scores&#xD;
      will be obtained from medical records. Direct patient interviews will be carried out by the&#xD;
      investigators postoperatively, using a structured open questionnaire format. This activity&#xD;
      will merge with the postoperative clinical rounds where possible.&#xD;
&#xD;
      All patients undergoing elective neurosurgery guided by IONM will be eligible for the study&#xD;
      and recruited with informed consent. The exclusion criteria shall be aged less than 10 years,&#xD;
      lack of informed consent and who are unable to communicate verbally.&#xD;
&#xD;
      A convenient sample of 50 is a realistic number of patients who can be recruited within a&#xD;
      3-month period at this centre. However, the qualitative enquiry may be stopped at an earlier&#xD;
      time if the data collected is felt to be at the saturation point by the investigators. The&#xD;
      participants shall be followed up at 28 days and 1-year post surgery.&#xD;
&#xD;
      Continuous data will be described and analysed based on their distribution, be it parametric&#xD;
      or non-parametric. Dichotomous data will be described as number of patients/episodes and&#xD;
      percentage.The patient experiences reported will be subjected to a thematic analysis&#xD;
      following the principles of qualitative research grounded theory.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">October 10, 2018</start_date>
  <completion_date type="Anticipated">March 10, 2021</completion_date>
  <primary_completion_date type="Actual">March 10, 2020</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>Experiences of participants who undergo intra-operative neurophysiological monitoring under anaesthesia</measure>
    <time_frame>2 years</time_frame>
    <description>A qualitative study of patient experiences by thematic analysis</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>IONM related postoperative sequel during post surgical recovery in hospital</measure>
    <time_frame>2 years</time_frame>
    <description>Perioperative adverse events description</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality at 28 day and 1 year follow up</measure>
    <time_frame>2 years</time_frame>
    <description>Mortality rates at 28 days and 1 year</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Morbidity at 28 days and 1 year follow up</measure>
    <time_frame>2 years</time_frame>
    <description>Residual weaknesses and disability</description>
  </secondary_outcome>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Intraoperative Neurophysiological Monitoring</condition>
  <condition>Complication</condition>
  <condition>Intraoperative Complications</condition>
  <condition>Postoperative Complications</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Adults and children aged 10 and above undergoing brain or spinal surgery with intra&#xD;
        operative neurophysiological monitoring with intravenous anaesthesia&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients aged 10 and above undergoing elective neurosurgery guided by IONM will be&#xD;
             recruited with informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Lack of informed consent and who are unable to communicate verbally.-&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Chulananda Goonasekera, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kings College Hospital NHS Trust, London</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kings College Hospital NHS Trust</name>
      <address>
        <city>London</city>
        <zip>SE5 9RS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <reference>
    <citation>Stecker MM. A review of intraoperative monitoring for spinal surgery. Surg Neurol Int. 2012;3(Suppl 3):S174-87. doi: 10.4103/2152-7806.98579. Epub 2012 Jul 17.</citation>
    <PMID>22905324</PMID>
  </reference>
  <reference>
    <citation>Jameson LC, Sloan TB. Monitoring of the brain and spinal cord. Anesthesiol Clin. 2006 Dec;24(4):777-91. doi: 10.1016/j.atc.2006.08.002.</citation>
    <PMID>17342964</PMID>
  </reference>
  <reference>
    <citation>Arnold PM. Use of intraoperative monitoring in children. J Neurosurg Pediatr. 2014 Jun;13(6):589. doi: 10.3171/2013.9.PEDS13439. Epub 2014 Apr 4. No abstract available.</citation>
    <PMID>24702618</PMID>
  </reference>
  <reference>
    <citation>Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet. 1986 Feb 8;1(8476):307-10.</citation>
    <PMID>2868172</PMID>
  </reference>
  <results_reference>
    <citation>Jameson LC, Janik DJ, Sloan TB. Electrophysiologic monitoring in neurosurgery. Anesthesiol Clin. 2007 Sep;25(3):605-30, x. doi: 10.1016/j.anclin.2007.05.004.</citation>
    <PMID>17884710</PMID>
  </results_reference>
  <results_reference>
    <citation>Soghomonyan S, Moran KR, Sandhu GS, Bergese SD. Anesthesia and evoked responses in neurosurgery. Front Pharmacol. 2014 Apr 14;5:74. doi: 10.3389/fphar.2014.00074. eCollection 2014. No abstract available.</citation>
    <PMID>24782777</PMID>
  </results_reference>
  <results_reference>
    <citation>Cabraja M, Stockhammer F, Mularski S, Suess O, Kombos T, Vajkoczy P. Neurophysiological intraoperative monitoring in neurosurgery: aid or handicap? An international survey. Neurosurg Focus. 2009 Oct;27(4):E2. doi: 10.3171/2009.7.FOCUS0969.</citation>
    <PMID>19795951</PMID>
  </results_reference>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>October 10, 2018</study_first_submitted>
  <study_first_submitted_qc>June 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 23, 2020</study_first_posted>
  <last_update_submitted>June 19, 2020</last_update_submitted>
  <last_update_submitted_qc>June 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Postoperative Complications</mesh_term>
    <mesh_term>Intraoperative Complications</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Anonymised qualitative and quantitative data</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>November 20, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/65/NCT04443465/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT04443465
org study id: IRAS 239002
nct id: NCT04443465
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Resection of brain tumours forms a large proportion of work in brain surgery. One important
      aspect is to minimize damage to normal brain structures during this process. This improves
      patient outcomes and reduces complications. To identify normal brain structures from the
      abnormal tumours, the brain surgeons use a 'guidance' technique called intraoperative
      neuro-monitoring (IONM).

      IONM uses various electrodes to observe spontaneous electrical activity of the brain or its
      reaction to a stimulus such as muscle contraction, light or sound. It is now becoming common
      practice for neurosurgeons to use this tool during brain and spinal surgery to provide a
      real-time feedback under anaesthesia to help them minimise injury to important and normal
      brain and spine structures.

      IONM interpretation needs fulfilment of multiple preconditions and major modifications to the
      anaesthetic to reduce its inaccuracies. This invites added risks and complications such as
      awareness, convulsions and heart problems under anaesthesia. A team approach between the
      surgeon, anaesthetist and neurophysiologist (IONM specialist) is also crucial to obtain
      meaningful results. Therefore, the usefulness of this technique is still not perfect.

      Although, benefits of IONM are obvious, information on associated complications and patient
      experience are not commonly found in the literature. Information on other effects such as
      hormonal balance and tumour recurrence are also scarce. In general, these aspects have little
      scientific exploration.

      There are anecdotal reports of recurrent seizures during IONM leading to serious heart
      problems, teeth and tongue damage due to grinding and postoperative calf muscle injury
      necessitating further surgery to save limbs. Neither of these is in the literature including
      unorthodox treatments such as the use of cold saline to control IONM triggered fits.

      This study is designed to observe complications and outcome and explore patient experiences
      following IONM in an observational capacity not interfering with the clinical management or
      treatment of these patients. The investigators intend to interview the participants after
      surgery, at a convenient time before leaving hospital to understand their views and
      experiences during and after surgery and their general progress in the following one year.
INTRODUCTION Intraoperative neuro-monitoring (IONM) is a 'SAT NAV' used by neurosurgeons to
      prevent injury to normal structures during brain and spinal surgery under anaesthesia. It
      involves the use of surface and implanted electrodes to observe spontaneous electrical
      activity of the brain or evoked responses to an electrical stimulus (motor, visual or
      auditory). This requires major modifications to the anaesthetic that provides lighter planes
      of anaesthesia with no muscle relaxation inviting added risks and complications such as
      awareness, seizures and cardiac events.

      This cohort study over a period of one year will include a qualitative enquiry of patient
      experience and a quantitative evaluation of the immediate postoperative course and
      complications at 28 days and 1 year. It will explore the relatively unknown area of emotional
      experiences of participants under anaesthesia who undergo various types of neuro stimulation
      and related post-operative sequelae. The results are expected to assist improve patient
      experiences and outcomes.

      BACKGROUND AND RATIONALE Resections of brain tumours constitute a significant proportion of
      work in neurosurgery. One important aspect is minimizing injury to normal neural structures
      during this process to improve outcomes of such operations and reduce complications. This
      involves intraoperative neuro-monitoring (IONM).

      IONM uses surface and implanted electrodes to observe spontaneous electrical activity of the
      brain or evoked response to a motor, visual or auditory stimulus. It is now becoming common
      practice for neurosurgeons to use this tool during brain and spinal surgery to provide a
      real-time feedback under anaesthesia to help them minimise injury to critical and normal
      neural structures by 'mapping' normal from abnormal areas of the brain.

      IONM interpretation needs fulfilment of multiple preconditions and major modifications to the
      anaesthetic to reduce its inaccuracies. This invites added risks and complications such as
      awareness, seizures and cardiac events. A team approach is also crucial to obtain meaningful
      results. Therefore, the utility of this technique is still evolving based on personal
      experiences and perceptions and the understanding between the surgeons, anaesthetists and
      neurophysiologists.

      Although, benefits of IONM are obvious, data on associated post-operative morbidity and
      patient experience and complications are scarce. The data is also scarce on tumour recurrence
      or tumour behaviour following IONM guided neurosurgery. More precise excision may reduce
      tumour recurrence. On the other hand IONM related electrical stimulation may impose humoral
      effects on tumour behaviour. These aspects have little scientific exploration.

      There are anecdotal reports of recurrent seizures during IONM leading to cardiac events such
      as asystole, teeth grinding and damage and tongue injury in the absence of a 'bite block' and
      postoperative calf muscle necrosis necessitating fasciotomies. Neither of these is in the
      literature including the unorthodox effective treatments used such as pouring 'cold' saline
      on the surface of the brain to control seizures.

      The study will take place in a major neurosurgical centre in the UK that uses IONM.
      Therefore, the study population is vast for appropriate sampling and recruitment.

      STUDY DESIGN This is an observational cohort study based on data retrieved from clinical
      notes and direct patient interview in hospital. The qualitative enquiry will address
      emotional aspects and the process experience. The quantitative survey will investigate
      morbidity (post-operative recovery, complications) and outcomes including mortality at 28
      days and 1-year follow-up.

      The eligible patients will be identified by the published elective neurosurgery lists and
      approached for informed consent before surgery at the time of preoperative assessment.

      The anaesthetist or the surgeon directly involved with his/her clinical care will first
      approach the patient and subsequently introduced to the medical student for post-operative
      data collection. Their demographic data, disease data, and neurological assessment scores
      will be obtained from medical records. Direct patient interviews will be carried out by the
      investigators postoperatively, using a structured open questionnaire format. This activity
      will merge with the postoperative clinical rounds where possible.

      All patients undergoing elective neurosurgery guided by IONM will be eligible for the study
      and recruited with informed consent. The exclusion criteria shall be aged less than 10 years,
      lack of informed consent and who are unable to communicate verbally.

      A convenient sample of 50 is a realistic number of patients who can be recruited within a
      3-month period at this centre. However, the qualitative enquiry may be stopped at an earlier
      time if the data collected is felt to be at the saturation point by the investigators. The
      participants shall be followed up at 28 days and 1-year post surgery.

      Continuous data will be described and analysed based on their distribution, be it parametric
      or non-parametric. Dichotomous data will be described as number of patients/episodes and
      percentage.The patient experiences reported will be subjected to a thematic analysis
      following the principles of qualitative research grounded theory.
observational model: Cohort
time perspective: Prospective
measure: Experiences of participants who undergo intra-operative neurophysiological monitoring under anaesthesia
time frame: 2 years
description: A qualitative study of patient experiences by thematic analysis
measure: IONM related postoperative sequel during post surgical recovery in hospital
time frame: 2 years
description: Perioperative adverse events description
measure: Mortality at 28 day and 1 year follow up
time frame: 2 years
description: Mortality rates at 28 days and 1 year
measure: Morbidity at 28 days and 1 year follow up
time frame: 2 years
description: Residual weaknesses and disability
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 10 Years
maximum age: N/A
last name: Chulananda Goonasekera, PhD
role: Principal Investigator
affiliation: Kings College Hospital NHS Trust, London
facility: 
country: United Kingdom
citation: Stecker MM. A review of intraoperative monitoring for spinal surgery. Surg Neurol Int. 2012;3(Suppl 3):S174-87. doi: 10.4103/2152-7806.98579. Epub 2012 Jul 17.
PMID: 22905324
citation: Jameson LC, Sloan TB. Monitoring of the brain and spinal cord. Anesthesiol Clin. 2006 Dec;24(4):777-91. doi: 10.1016/j.atc.2006.08.002.
PMID: 17342964
citation: Arnold PM. Use of intraoperative monitoring in children. J Neurosurg Pediatr. 2014 Jun;13(6):589. doi: 10.3171/2013.9.PEDS13439. Epub 2014 Apr 4. No abstract available.
PMID: 24702618
citation: Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet. 1986 Feb 8;1(8476):307-10.
PMID: 2868172
citation: Jameson LC, Janik DJ, Sloan TB. Electrophysiologic monitoring in neurosurgery. Anesthesiol Clin. 2007 Sep;25(3):605-30, x. doi: 10.1016/j.anclin.2007.05.004.
PMID: 17884710
citation: Soghomonyan S, Moran KR, Sandhu GS, Bergese SD. Anesthesia and evoked responses in neurosurgery. Front Pharmacol. 2014 Apr 14;5:74. doi: 10.3389/fphar.2014.00074. eCollection 2014. No abstract available.
PMID: 24782777
citation: Cabraja M, Stockhammer F, Mularski S, Suess O, Kombos T, Vajkoczy P. Neurophysiological intraoperative monitoring in neurosurgery: aid or handicap? An international survey. Neurosurg Focus. 2009 Oct;27(4):E2. doi: 10.3171/2009.7.FOCUS0969.
PMID: 19795951
responsible party type: Sponsor
mesh term: Postoperative Complications
mesh term: Intraoperative Complications
sharing ipd: Undecided
ipd description: Anonymised qualitative and quantitative data
provided document: 