<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/NCT04444323</url>
  </required_header>
  <id_info>
    <org_study_id>GN20HS300</org_study_id>
    <nct_id>NCT04444323</nct_id>
  </id_info>
  <brief_title>3D Telemedicine During COVID-19: Cohort Study</brief_title>
  <official_title>3D Telemedicine During COVID-19: Cohort Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NHS Greater Glasgow and Clyde</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Jean Brown Bequest Fund, Glasgow</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>NHS Greater Glasgow and Clyde</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>
      It is critical to establish an effective form of telemedicine during the Covid 19 pandemic,&#xD;
      that will allow safe social distancing of clinicians and patients. Canniesburn Regional&#xD;
      Plastic Surgery and Burns Unit serves as the regional plastic, burns and reconstructive&#xD;
      centre for West of Scotland, population 3 million. All face to face clinics have been&#xD;
      cancelled and converted to telephone/telemedicine only consultations. The research will&#xD;
      establish both 2D and 3D telemedicine as normal patient follow up practice during this&#xD;
      period.The project therefore aims to implement a 3D telemedicine system to facilitate patient&#xD;
      follow up and remote physiotherapy, that will act as if the patient is physically 'present'&#xD;
      in the room. Physiotherapy is crucial to patient outcomes after burns contractures, hand&#xD;
      trauma and cancer reconstruction. The 3D telemedicine system will be built by an industrial&#xD;
      partner, with CE marked equipment, specifically to help during the Covid-19 Pandemic.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. Background:&#xD;
&#xD;
           Telemedicine is critical during Covid pandemic. A seismic shift in clinical practice has&#xD;
           occurred in the UK, with nearly all medical clinics cancelled or converted to telephone&#xD;
           or telemedicine clinics (Attend Anywhere or Zoom). These fail to adequately substitute&#xD;
           for a face-to-face consultation, with the National Health Service (NHS) needing higher&#xD;
           quality, more clinically effective methods of remote patient interaction. This project&#xD;
           will be the world's first evaluation of a novel, potentially transformative form of 3D&#xD;
           telemedicine, facilitating telepresence as if the patient were in the room. This&#xD;
           state-of-the-art system has been developed by an industrial partner, specifically to&#xD;
           help with remote patient communication during Covid pandemic. This uses an array of 3D&#xD;
           cameras connected to fusion and render servers, allowing reconstruction of a 3D image in&#xD;
           real time. This may give more information about a patient's condition, particularly in&#xD;
           more visual specialties such as Plastic Surgery&#xD;
&#xD;
           The research will fulfil criteria for the European Commission's Model for Assessment of&#xD;
           Telemedicine applications (MAST, Kidholm 2012). This will include participatory design,&#xD;
           and evaluation with a preliminary cohort study, to shape the follow on research. This&#xD;
           will assess clinicians' and patients' perception of system usability, delivery of&#xD;
           therapies, clinical accuracy and interaction. On project completion, fulfilment of MAST&#xD;
           criteria will enable upscaling and lead onto a randomized trial. The study design will&#xD;
           be informed by participatory design prior to the start of the clinical study. This will&#xD;
           include clinical stakeholders (specialist nurses, doctors and physiotherapists), the&#xD;
           digital research team, and patient groups. The focus groups will collate user groups&#xD;
           opinions about the 3D system, functionality, risks, and applicability.&#xD;
&#xD;
           The clinical study will be a feasibility study involving clinician and patient feedback&#xD;
           on 3D telemedicine, and will additionally collect safety, reliability and fidelity data.&#xD;
           The study will be a mixed methods analysis assessing measures of usability,&#xD;
           satisfaction, presence, task load index, and accuracy. Clinicians and patients will&#xD;
           complete questionnaires and undergo a short interview on the use of both forms of&#xD;
           telemedicine. There are no data regarding the use of 3D telemedicine, but this will&#xD;
           leverage study design and validated questionnaires from other similar studies (Buvik&#xD;
           2016). The study will continue as post covid services are being established.&#xD;
&#xD;
        2. Aims&#xD;
&#xD;
           This study will refine and pilot the feasibility of introducing 3D telemedicine into&#xD;
           plastic surgery clinics and gain pilot data on the comparative efficacy and&#xD;
           acceptability compared to face-to-face clinics, from both a patient and clinician&#xD;
           perspective. The feasibility study will then inform the design and size of larger&#xD;
           randomised study to compare 2D and 3D telemedicine.&#xD;
&#xD;
        3. Research Questions Primary&#xD;
&#xD;
           • Understand the feasibility and acceptability of introducing 3D telemedicine into&#xD;
           plastic surgery clinics, in particular assessing safety, reliability and feedback data.&#xD;
&#xD;
           Secondary&#xD;
&#xD;
             -  Provide preliminary evidence regarding how 3D telemedicine compares to face-to-face&#xD;
                consultations using clinician and patient assessments&#xD;
&#xD;
             -  Assess the appropriate rating scales/instruments to take forward to a RCT&#xD;
&#xD;
             -  Provide preliminary objective data to assess the accuracy of 3D telemedicine to&#xD;
                determine clinical measurements (where applicable e.g. angles of contracture in&#xD;
                hand) and outcome scoring scales (where applicable e.g. validated Unilateral Cleft&#xD;
                Score Surgical Outcomes Evaluation Scale - UCLSOE)&#xD;
&#xD;
             -  Provide preliminary data for machine learning training to Strathclyde University&#xD;
&#xD;
             -  Safety and reliability measures of the system (number of failed and interrupted 3D&#xD;
                telemedicine consultations).&#xD;
&#xD;
             -  To assess if clinical outcomes determined by 3D Telemedicine are similar to&#xD;
                face-to-face&#xD;
&#xD;
        4. Study Design&#xD;
&#xD;
      Pre-study protocol optimisation will include data from a patient feedback study and a&#xD;
      clinician feedback study. This will provide feedback for incremental system improvement and&#xD;
      baseline outcome data. This will be followed by a Clinician Cohort Trial.&#xD;
&#xD;
      4A. Patient Feedback Study&#xD;
&#xD;
      Focus groups will co-design the features and functionality of the 3D Telemedicine, and inform&#xD;
      clinical/patient feedback questionnaires. Clinical stakeholders (specialist nurses, doctors&#xD;
      and physiotherapists), the digital research team and patient groups (existing user groups in&#xD;
      breast cancer, sarcoma, cleft, hand surgery and physiotherapy) will be invited to participate&#xD;
      in focus groups. The discussion will explore user groups opinions and ideas about the 3D&#xD;
      system, functions that they would like to see implemented, and scenarios where this may be&#xD;
      advantageous over a standard 2D system, and potential risks, using open ended questions. The&#xD;
      patient group will consist of 40 patients sampled from existing user groups and will include&#xD;
      patients already known to the research team. These patients will be invited to participate in&#xD;
      a feedback study and will be examined by both 3D and 2D Telemedicine by their usual care&#xD;
      clinician, and without any randomisation. They will be then asked to complete a feedback&#xD;
      questionnaire and interview. Patient outcomes assessed will include:&#xD;
&#xD;
      Satisfaction: Visual Analogue Scale 0-100 Mental Effort Rating Scale - single instrument&#xD;
      Likert scale (Paas 1996) System Usability Scale - 10 item industry standard technology scale&#xD;
      Single Item Presence Questionnaire - This will ask patients the question &quot;To which extent did&#xD;
      you feel present in the virtual clinic, as if you were really there?&quot;. This is a single item&#xD;
      evaluation of presence validated by Bouchard et al 2004.&#xD;
&#xD;
      Telehealth Usability Questionnaire - 21 item scale - assessment of telemedicine (TUQ,&#xD;
      Parmanto 2016) Semi Structured exit interview - will discuss with participant their views on&#xD;
      the telemedicine system, using &quot;Keep, Lose and Change&quot; feedback prompts to help in&#xD;
      incremental system improvements.&#xD;
&#xD;
      4B. Clinician Feedback Study&#xD;
&#xD;
      A group of 25 clinicians including nurses, doctors and physiotherapists, will be invited to&#xD;
      assess both 3D and 2D Telemedicine systems without randomisation, with a member of the&#xD;
      research team acting as a &quot;patient&quot;. They will be then asked to complete a feedback&#xD;
      questionnaire and interview. Clinician outcomes assessed will include:&#xD;
&#xD;
      Satisfaction: Visual Analogue Scale 0-100 Mental Effort Rating Scale - single instrument&#xD;
      Likert scale (Paas 1996) System Usability Scale - 10 item industry standard technology scale&#xD;
      Presence Questionnaire - 29 item scale - assessment of presence in the system/virtual&#xD;
      environment (PQ, Witmer 2005).&#xD;
&#xD;
      Telehealth Usability Questionnaire - 21 item scale - assessment of telemedicine (TUQ,&#xD;
      Parmanto 2016) Semi Structured exit interview - will discuss with participant their views on&#xD;
      the telemedicine system, using &quot;Keep, Lose and Change&quot; feedback prompts to help in&#xD;
      incremental system improvements.&#xD;
&#xD;
      4C. Cohort Study&#xD;
&#xD;
      Patient Identification Patients will be recruited for this study from plastic surgery&#xD;
      clinics, including breast cancer, sarcoma, head &amp; neck reconstruction, flap reconstruction,&#xD;
      limb reconstruction, hand trauma, burns and cleft lip. Clinicians recruited to the study be&#xD;
      from Canniesburn Regional Plastic Surgery and Burns Unit. The wide spectrum of clinical cases&#xD;
      including in this cohort trial will allow increased generalizability of the results.&#xD;
&#xD;
      Inclusion criteria&#xD;
&#xD;
        -  Patients 1-95 years old (children will include post-cleft lip repair)&#xD;
&#xD;
        -  Patients able to read and understand English&#xD;
&#xD;
        -  Patients able to give informed consent&#xD;
&#xD;
      Exclusion criteria&#xD;
&#xD;
        -  Patients not meeting the inclusion criteria&#xD;
&#xD;
        -  Patients who do not have capacity to consent&#xD;
&#xD;
        -  Patients who are registered blind or deaf&#xD;
&#xD;
      Consent The patient information sheets (PIS) will be sent to the patients for their&#xD;
      consideration prior to them attending their clinic appointment. The nurse will then take the&#xD;
      patient into a private telemedicine clinic room to go through the PIS with them and answer&#xD;
      any questions. If the patient wishes to participate, the nurse will provide a consent form&#xD;
      which has some statements to agree to and sign. The patient can keep a copy of the signed&#xD;
      consent form as well as the PIS.&#xD;
&#xD;
      Additional consent will be taken for opting into photo or video recordings. Telemedicine data&#xD;
      may be used in further research, including machine learning. The PIS will make it clear to&#xD;
      the patient that a copy of their identifiable images will be held for research purposes.&#xD;
&#xD;
      The PIS and consent will also explain that the our industrial partner will have access to the&#xD;
      data, system and images (covered by a data processing agreement and 3rd Party Access&#xD;
      agreement) to resolve any image quality, render, fusion, or transmission problems.&#xD;
&#xD;
      Study procedures&#xD;
&#xD;
      All patients will be assessed first face-to-face, and subsequently with 3D telemedicine by a&#xD;
      separate clinician. In addition to the standard consultation, all patients will have the&#xD;
      range of motion of the right and left elbows measured face-to-face with blinded (scales&#xD;
      hidden) goniometers, and on the 3D system with a blinded on-screen goniometer. Patients will&#xD;
      fill in a questionnaire and undertake a short exit interview after completion of&#xD;
      consultations. Clinicians involved in this study will be asked to fill in a clinician consent&#xD;
      form, and will be provided with a clinician information sheet prior to the study. The&#xD;
      clinician fills in a questionnaire on the use of telemedicine for each patient, and undergoes&#xD;
      an exit interview just once at the end of the study. The data for the elbow range of motion&#xD;
      will be stored on computer and the clinician will re-measure at 1 week (patient does not need&#xD;
      to return).&#xD;
&#xD;
      The Clinician telemedicine questionnaire will be filled in once per patient and comprises 71&#xD;
      items from the following rating scales.&#xD;
&#xD;
      Mental Effort Rating Scale - single instrument Likert scale (Paas 1996) University of North&#xD;
      Northway - 5 item - telemedicine questionnaire (UNN, Buvik 2016) System Usability Scale - 10&#xD;
      item industry standard technology scale Presence Questionnaire - 29 item scale - assessment&#xD;
      of presence in the system/virtual environment (PQ, Witmer 2005).&#xD;
&#xD;
      Telehealth Usability Questionnaire - 21 item scale - assessment of telemedicine (TUQ,&#xD;
      Parmanto 2016) NASA task load index (NASA TLX) - 5 item modified scale - an indication of the&#xD;
      ease of performing a task and frustration levels.&#xD;
&#xD;
      Semi Structured exit interview - will discuss with participant their views on the&#xD;
      telemedicine system, what went well, and what can be improved.&#xD;
&#xD;
      The clinician conducting the face-to-face will complete a shortened questionnaire with the&#xD;
      UNN scale only. The patient will fill also fill in a shortened questionnaire with a maximum&#xD;
      of 37 items, including the Mental Effort Rating Scale, Telehealth Usability Questionnaire,&#xD;
      NASA TLX and System Usability Scale.&#xD;
&#xD;
      The telemedicine consultation will include clinical outcome scales (where applicable e.g.&#xD;
      unilateral cleft outcome scoring) recorded as part of normal practice. This will be compared&#xD;
      to actual clinical outcomes taken in clinic on the same day (to provide &quot;ground truth&quot; for&#xD;
      comparison with telemedicine measurements).&#xD;
&#xD;
      Safety and reliability data will be collected throughout the study, incuding:&#xD;
&#xD;
        1. Failed 3D telemedicine visits - failure and interruption, including reasons e.g.&#xD;
           network/ software/ hardware. In event of failure a face to face consultation will still&#xD;
           take place.&#xD;
&#xD;
        2. Image aberration - record of subjective distortion/ noise.&#xD;
&#xD;
        3. Correlation of face-to-face and telemedicine patient outcomes and findings&#xD;
&#xD;
      The 3D system will be permanently set up in a locked clinic room in a non-covid hospital. The&#xD;
      system can be switched to 2D if required.&#xD;
&#xD;
      The 3D telemedicine system will comprise:&#xD;
&#xD;
        -  80/20 aluminium frame support for cameras&#xD;
&#xD;
        -  8 3D cameras&#xD;
&#xD;
        -  2 Patient LED screens&#xD;
&#xD;
        -  Fusion and render computers&#xD;
&#xD;
        -  At 'receiving' end - standard computer and LED screen&#xD;
&#xD;
      The system will be simple to use - 3D images will be viewed on a screen and can be&#xD;
      manipulated in space, enlarged, and frozen using mouse controls. The research team's&#xD;
      industrial partner will have provided training of clinic staff on how to operate the&#xD;
      equipment and support of the equipment during the data collection activity. Training of the&#xD;
      participating clinicians will take the form of a short introductory session by the research&#xD;
      team at the start of each research clinic. The patient will likewise be shown how to use the&#xD;
      system, but there will be no need for the patient to use any controls or interface.&#xD;
&#xD;
      Follow Up&#xD;
&#xD;
      There is no follow up required - patients are only required to attend an extended clinic&#xD;
      visit and complete the study questionnaires.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 10, 2021</start_date>
  <completion_date type="Actual">March 31, 2022</completion_date>
  <primary_completion_date type="Actual">March 31, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Single cohort patients seen face-to-face and then by 3D telemedicine</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>Data analysis will be masked</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Presence Questionnaire</measure>
    <time_frame>Single time point at day 1 (Clinician assesses telemedicine system once after seeing patient) ]</time_frame>
    <description>Version 3 of PQ, 29 item rating scale of &quot;presence&quot;. Witmer 2005</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>University Hospital of North Northway Questionnaire</measure>
    <time_frame>Single time point at day 1 (Clinician assesses telemedicine system once after seeing patient) ]</time_frame>
    <description>5 item questionnaire on telemedicine quality. UNN Buvik 2016.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Telehealth Usability Questionnaire</measure>
    <time_frame>Single time point at day 1 (Clinician assesses telemedicine system once after seeing patient) ]</time_frame>
    <description>21 item scale - assessment of telemedicine (TUQ, Parmanto 2016)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>System Usability Scale</measure>
    <time_frame>Single time point at day 1 (Clinician assesses telemedicine system once after seeing patient) ]</time_frame>
    <description>10 item industry standard technology scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mental Effort Rating Scale</measure>
    <time_frame>Single time point at day 1 (Clinician assesses telemedicine system once after seeing patient) ]</time_frame>
    <description>Single instrument Likert scale (Paas 1996)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>NASA TLX</measure>
    <time_frame>Single time point at day 1 (Clinician assesses telemedicine system once after seeing patient) ]</time_frame>
    <description>Measure of task load index - 5 item modified scale - an indication of the ease of performing a task and frustration levels.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Range of Motion measurements for elbow joint</measure>
    <time_frame>Single time point at day 1 (Clinician assesses telemedicine system once after seeing patient) ]</time_frame>
    <description>Range of Motion measurements for elbow joint measured with face-to-face goniometer or on computer (telemedicine)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Reliability</measure>
    <time_frame>Single time point at day 1 (whether telemedicine is successful)</time_frame>
    <description>Proportion of completed, successful telemedicine consultations</description>
  </other_outcome>
  <other_outcome>
    <measure>Image distortion</measure>
    <time_frame>Single time point at day 1 (whether telemedicine has distortion)</time_frame>
    <description>Proportion of telemedicine consultations suffering image quality distortion</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Telemedicine</condition>
  <condition>Surgery, Plastic</condition>
  <arm_group>
    <arm_group_label>3D Telemedicine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single arm. All patient seen face-to-face and then with 3D telemedicine.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>3D Telemedicine</intervention_name>
    <description>The intervention is a consultation conducted using a 3D form of telemedicine</description>
    <arm_group_label>3D Telemedicine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with breast cancer reconstruction&#xD;
&#xD;
          -  Patients with sarcoma&#xD;
&#xD;
          -  Patients with head &amp; neck reconstruction&#xD;
&#xD;
          -  Patients with flap reconstruction&#xD;
&#xD;
          -  Patients with limb reconstruction&#xD;
&#xD;
          -  Patients with hand trauma&#xD;
&#xD;
          -  Patients with burns&#xD;
&#xD;
          -  Patients with cleft lip&#xD;
&#xD;
          -  Patients able to read and understand English&#xD;
&#xD;
          -  Patients able to give informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients not meeting the inclusion criteria&#xD;
&#xD;
          -  Patients who do not have capacity to consent&#xD;
&#xD;
          -  Patients who are registered blind or deaf&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>95 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Canniesburn Regional Plastic Surgery and Burns Unit</name>
      <address>
        <city>Glasgow</city>
        <state>Scotland</state>
        <zip>G4 0SF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>June 20, 2020</study_first_submitted>
  <study_first_submitted_qc>June 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 23, 2020</study_first_posted>
  <last_update_submitted>May 24, 2022</last_update_submitted>
  <last_update_submitted_qc>May 24, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 26, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>3-D</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No plan to share data</ipd_description>
  </patient_data>
  <!-- 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/NCT04444323
org study id: GN20HS300
nct id: NCT04444323
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
It is critical to establish an effective form of telemedicine during the Covid 19 pandemic,
      that will allow safe social distancing of clinicians and patients. Canniesburn Regional
      Plastic Surgery and Burns Unit serves as the regional plastic, burns and reconstructive
      centre for West of Scotland, population 3 million. All face to face clinics have been
      cancelled and converted to telephone/telemedicine only consultations. The research will
      establish both 2D and 3D telemedicine as normal patient follow up practice during this
      period.The project therefore aims to implement a 3D telemedicine system to facilitate patient
      follow up and remote physiotherapy, that will act as if the patient is physically 'present'
      in the room. Physiotherapy is crucial to patient outcomes after burns contractures, hand
      trauma and cancer reconstruction. The 3D telemedicine system will be built by an industrial
      partner, with CE marked equipment, specifically to help during the Covid-19 Pandemic.
1. Background:

           Telemedicine is critical during Covid pandemic. A seismic shift in clinical practice has
           occurred in the UK, with nearly all medical clinics cancelled or converted to telephone
           or telemedicine clinics (Attend Anywhere or Zoom). These fail to adequately substitute
           for a face-to-face consultation, with the National Health Service (NHS) needing higher
           quality, more clinically effective methods of remote patient interaction. This project
           will be the world's first evaluation of a novel, potentially transformative form of 3D
           telemedicine, facilitating telepresence as if the patient were in the room. This
           state-of-the-art system has been developed by an industrial partner, specifically to
           help with remote patient communication during Covid pandemic. This uses an array of 3D
           cameras connected to fusion and render servers, allowing reconstruction of a 3D image in
           real time. This may give more information about a patient's condition, particularly in
           more visual specialties such as Plastic Surgery

           The research will fulfil criteria for the European Commission's Model for Assessment of
           Telemedicine applications (MAST, Kidholm 2012). This will include participatory design,
           and evaluation with a preliminary cohort study, to shape the follow on research. This
           will assess clinicians' and patients' perception of system usability, delivery of
           therapies, clinical accuracy and interaction. On project completion, fulfilment of MAST
           criteria will enable upscaling and lead onto a randomized trial. The study design will
           be informed by participatory design prior to the start of the clinical study. This will
           include clinical stakeholders (specialist nurses, doctors and physiotherapists), the
           digital research team, and patient groups. The focus groups will collate user groups
           opinions about the 3D system, functionality, risks, and applicability.

           The clinical study will be a feasibility study involving clinician and patient feedback
           on 3D telemedicine, and will additionally collect safety, reliability and fidelity data.
           The study will be a mixed methods analysis assessing measures of usability,
           satisfaction, presence, task load index, and accuracy. Clinicians and patients will
           complete questionnaires and undergo a short interview on the use of both forms of
           telemedicine. There are no data regarding the use of 3D telemedicine, but this will
           leverage study design and validated questionnaires from other similar studies (Buvik
           2016). The study will continue as post covid services are being established.

        2. Aims

           This study will refine and pilot the feasibility of introducing 3D telemedicine into
           plastic surgery clinics and gain pilot data on the comparative efficacy and
           acceptability compared to face-to-face clinics, from both a patient and clinician
           perspective. The feasibility study will then inform the design and size of larger
           randomised study to compare 2D and 3D telemedicine.

        3. Research Questions Primary

           • Understand the feasibility and acceptability of introducing 3D telemedicine into
           plastic surgery clinics, in particular assessing safety, reliability and feedback data.

           Secondary

             -  Provide preliminary evidence regarding how 3D telemedicine compares to face-to-face
                consultations using clinician and patient assessments

             -  Assess the appropriate rating scales/instruments to take forward to a RCT

             -  Provide preliminary objective data to assess the accuracy of 3D telemedicine to
                determine clinical measurements (where applicable e.g. angles of contracture in
                hand) and outcome scoring scales (where applicable e.g. validated Unilateral Cleft
                Score Surgical Outcomes Evaluation Scale - UCLSOE)

             -  Provide preliminary data for machine learning training to Strathclyde University

             -  Safety and reliability measures of the system (number of failed and interrupted 3D
                telemedicine consultations).

             -  To assess if clinical outcomes determined by 3D Telemedicine are similar to
                face-to-face

        4. Study Design

      Pre-study protocol optimisation will include data from a patient feedback study and a
      clinician feedback study. This will provide feedback for incremental system improvement and
      baseline outcome data. This will be followed by a Clinician Cohort Trial.

      4A. Patient Feedback Study

      Focus groups will co-design the features and functionality of the 3D Telemedicine, and inform
      clinical/patient feedback questionnaires. Clinical stakeholders (specialist nurses, doctors
      and physiotherapists), the digital research team and patient groups (existing user groups in
      breast cancer, sarcoma, cleft, hand surgery and physiotherapy) will be invited to participate
      in focus groups. The discussion will explore user groups opinions and ideas about the 3D
      system, functions that they would like to see implemented, and scenarios where this may be
      advantageous over a standard 2D system, and potential risks, using open ended questions. The
      patient group will consist of 40 patients sampled from existing user groups and will include
      patients already known to the research team. These patients will be invited to participate in
      a feedback study and will be examined by both 3D and 2D Telemedicine by their usual care
      clinician, and without any randomisation. They will be then asked to complete a feedback
      questionnaire and interview. Patient outcomes assessed will include:

      Satisfaction: Visual Analogue Scale 0-100 Mental Effort Rating Scale - single instrument
      Likert scale (Paas 1996) System Usability Scale - 10 item industry standard technology scale
      Single Item Presence Questionnaire - This will ask patients the question "To which extent did
      you feel present in the virtual clinic, as if you were really there?". This is a single item
      evaluation of presence validated by Bouchard et al 2004.

      Telehealth Usability Questionnaire - 21 item scale - assessment of telemedicine (TUQ,
      Parmanto 2016) Semi Structured exit interview - will discuss with participant their views on
      the telemedicine system, using "Keep, Lose and Change" feedback prompts to help in
      incremental system improvements.

      4B. Clinician Feedback Study

      A group of 25 clinicians including nurses, doctors and physiotherapists, will be invited to
      assess both 3D and 2D Telemedicine systems without randomisation, with a member of the
      research team acting as a "patient". They will be then asked to complete a feedback
      questionnaire and interview. Clinician outcomes assessed will include:

      Satisfaction: Visual Analogue Scale 0-100 Mental Effort Rating Scale - single instrument
      Likert scale (Paas 1996) System Usability Scale - 10 item industry standard technology scale
      Presence Questionnaire - 29 item scale - assessment of presence in the system/virtual
      environment (PQ, Witmer 2005).

      Telehealth Usability Questionnaire - 21 item scale - assessment of telemedicine (TUQ,
      Parmanto 2016) Semi Structured exit interview - will discuss with participant their views on
      the telemedicine system, using "Keep, Lose and Change" feedback prompts to help in
      incremental system improvements.

      4C. Cohort Study

      Patient Identification Patients will be recruited for this study from plastic surgery
      clinics, including breast cancer, sarcoma, head & neck reconstruction, flap reconstruction,
      limb reconstruction, hand trauma, burns and cleft lip. Clinicians recruited to the study be
      from Canniesburn Regional Plastic Surgery and Burns Unit. The wide spectrum of clinical cases
      including in this cohort trial will allow increased generalizability of the results.

      Inclusion criteria

        -  Patients 1-95 years old (children will include post-cleft lip repair)

        -  Patients able to read and understand English

        -  Patients able to give informed consent

      Exclusion criteria

        -  Patients not meeting the inclusion criteria

        -  Patients who do not have capacity to consent

        -  Patients who are registered blind or deaf

      Consent The patient information sheets (PIS) will be sent to the patients for their
      consideration prior to them attending their clinic appointment. The nurse will then take the
      patient into a private telemedicine clinic room to go through the PIS with them and answer
      any questions. If the patient wishes to participate, the nurse will provide a consent form
      which has some statements to agree to and sign. The patient can keep a copy of the signed
      consent form as well as the PIS.

      Additional consent will be taken for opting into photo or video recordings. Telemedicine data
      may be used in further research, including machine learning. The PIS will make it clear to
      the patient that a copy of their identifiable images will be held for research purposes.

      The PIS and consent will also explain that the our industrial partner will have access to the
      data, system and images (covered by a data processing agreement and 3rd Party Access
      agreement) to resolve any image quality, render, fusion, or transmission problems.

      Study procedures

      All patients will be assessed first face-to-face, and subsequently with 3D telemedicine by a
      separate clinician. In addition to the standard consultation, all patients will have the
      range of motion of the right and left elbows measured face-to-face with blinded (scales
      hidden) goniometers, and on the 3D system with a blinded on-screen goniometer. Patients will
      fill in a questionnaire and undertake a short exit interview after completion of
      consultations. Clinicians involved in this study will be asked to fill in a clinician consent
      form, and will be provided with a clinician information sheet prior to the study. The
      clinician fills in a questionnaire on the use of telemedicine for each patient, and undergoes
      an exit interview just once at the end of the study. The data for the elbow range of motion
      will be stored on computer and the clinician will re-measure at 1 week (patient does not need
      to return).

      The Clinician telemedicine questionnaire will be filled in once per patient and comprises 71
      items from the following rating scales.

      Mental Effort Rating Scale - single instrument Likert scale (Paas 1996) University of North
      Northway - 5 item - telemedicine questionnaire (UNN, Buvik 2016) System Usability Scale - 10
      item industry standard technology scale Presence Questionnaire - 29 item scale - assessment
      of presence in the system/virtual environment (PQ, Witmer 2005).

      Telehealth Usability Questionnaire - 21 item scale - assessment of telemedicine (TUQ,
      Parmanto 2016) NASA task load index (NASA TLX) - 5 item modified scale - an indication of the
      ease of performing a task and frustration levels.

      Semi Structured exit interview - will discuss with participant their views on the
      telemedicine system, what went well, and what can be improved.

      The clinician conducting the face-to-face will complete a shortened questionnaire with the
      UNN scale only. The patient will fill also fill in a shortened questionnaire with a maximum
      of 37 items, including the Mental Effort Rating Scale, Telehealth Usability Questionnaire,
      NASA TLX and System Usability Scale.

      The telemedicine consultation will include clinical outcome scales (where applicable e.g.
      unilateral cleft outcome scoring) recorded as part of normal practice. This will be compared
      to actual clinical outcomes taken in clinic on the same day (to provide "ground truth" for
      comparison with telemedicine measurements).

      Safety and reliability data will be collected throughout the study, incuding:

        1. Failed 3D telemedicine visits - failure and interruption, including reasons e.g.
           network/ software/ hardware. In event of failure a face to face consultation will still
           take place.

        2. Image aberration - record of subjective distortion/ noise.

        3. Correlation of face-to-face and telemedicine patient outcomes and findings

      The 3D system will be permanently set up in a locked clinic room in a non-covid hospital. The
      system can be switched to 2D if required.

      The 3D telemedicine system will comprise:

        -  80/20 aluminium frame support for cameras

        -  8 3D cameras

        -  2 Patient LED screens

        -  Fusion and render computers

        -  At 'receiving' end - standard computer and LED screen

      The system will be simple to use - 3D images will be viewed on a screen and can be
      manipulated in space, enlarged, and frozen using mouse controls. The research team's
      industrial partner will have provided training of clinic staff on how to operate the
      equipment and support of the equipment during the data collection activity. Training of the
      participating clinicians will take the form of a short introductory session by the research
      team at the start of each research clinic. The patient will likewise be shown how to use the
      system, but there will be no need for the patient to use any controls or interface.

      Follow Up

      There is no follow up required - patients are only required to attend an extended clinic
      visit and complete the study questionnaires.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Single cohort patients seen face-to-face and then by 3D telemedicine
primary purpose: Other
masking: None (Open Label)
masking description: Data analysis will be masked
measure: Presence Questionnaire
time frame: Single time point at day 1 (Clinician assesses telemedicine system once after seeing patient) ]
description: Version 3 of PQ, 29 item rating scale of "presence". Witmer 2005
measure: University Hospital of North Northway Questionnaire
time frame: Single time point at day 1 (Clinician assesses telemedicine system once after seeing patient) ]
description: 5 item questionnaire on telemedicine quality. UNN Buvik 2016.
measure: Telehealth Usability Questionnaire
time frame: Single time point at day 1 (Clinician assesses telemedicine system once after seeing patient) ]
description: 21 item scale - assessment of telemedicine (TUQ, Parmanto 2016)
measure: System Usability Scale
time frame: Single time point at day 1 (Clinician assesses telemedicine system once after seeing patient) ]
description: 10 item industry standard technology scale
measure: Mental Effort Rating Scale
time frame: Single time point at day 1 (Clinician assesses telemedicine system once after seeing patient) ]
description: Single instrument Likert scale (Paas 1996)
measure: NASA TLX
time frame: Single time point at day 1 (Clinician assesses telemedicine system once after seeing patient) ]
description: Measure of task load index - 5 item modified scale - an indication of the ease of performing a task and frustration levels.
measure: Range of Motion measurements for elbow joint
time frame: Single time point at day 1 (Clinician assesses telemedicine system once after seeing patient) ]
description: Range of Motion measurements for elbow joint measured with face-to-face goniometer or on computer (telemedicine)
measure: Reliability
time frame: Single time point at day 1 (whether telemedicine is successful)
description: Proportion of completed, successful telemedicine consultations
measure: Image distortion
time frame: Single time point at day 1 (whether telemedicine has distortion)
description: Proportion of telemedicine consultations suffering image quality distortion
arm group label: 3D Telemedicine
arm group type: Experimental
description: Single arm. All patient seen face-to-face and then with 3D telemedicine.
intervention type: Other
intervention name: 3D Telemedicine
description: The intervention is a consultation conducted using a 3D form of telemedicine
arm group label: 3D Telemedicine
criteria: 
gender: All
minimum age: 1 Year
maximum age: 95 Years
healthy volunteers: No
facility: 
country: United Kingdom
responsible party type: Sponsor
sharing ipd: No
ipd description: No plan to share data