janssen/DRY/screenshots_surgery/form_data.json

{
  "form_id": "10",
  "patient_code": "CZ1-01",
  "listing_cells": [
    "CZ1-01",
    "Male",
    "Subject",
    "16/02/2024",
    "28/02/2024",
    "17/04/2024",
    "CZ1 - Fakultní Thomayerova nemocnice",
    "VISIT0",
    "V0 : Implantation Visit",
    "0",
    "1",
    "1",
    "",
    "",
    "",
    "28/02/2024",
    "Accepted",
    "",
    "",
    "0",
    "",
    "0",
    "",
    "",
    "1",
    "Open",
    ""
  ],
  "fields": [
    {
      "key": "Date of surgery (or date of the attempt)",
      "value": "28/02/2024",
      "valueClass": "valeur DTET0"
    },
    {
      "key": "Has the patient been implanted with ARTUS®?",
      "value": "Yes",
      "valueClass": "valeur "
    },
    {
      "key": "How many implantation attempts have there been?",
      "value": null,
      "valueClass": ""
    },
    {
      "key": "Please explain why and describe the difficulty(ies) experienced:",
      "value": null,
      "valueClass": ""
    },
    {
      "key": "The results of the 24-hour Pad Weight Test have been entered in the Baseline visit to validate the inclusion of the subject",
      "value": "Yes",
      "valueClass": "valeur "
    },
    {
      "key": "Was the clinical examination performed",
      "value": "Yes",
      "valueClass": "valeur "
    },
    {
      "key": "Exam date",
      "value": "27/02/2024",
      "valueClass": "valeur DTEEXAM"
    },
    {
      "key": "Weight",
      "value": "114   kg",
      "valueClass": "valeur WGT"
    },
    {
      "key": "Body Mass Index",
      "value": "32.3   kg/cm²",
      "valueClass": "valeur BMI"
    },
    {
      "key": "Explain why clinical examination was not performed",
      "value": null,
      "valueClass": ""
    },
    {
      "key": "The charge of the TWO Remote Controls was done correctly before the surgery (for 5 hours each)",
      "value": "Yes",
      "valueClass": "valeur "
    },
    {
      "key": "Describe the difficulty(ies) experienced and alternative or solution provided",
      "value": null,
      "valueClass": ""
    },
    {
      "key": "All steps for the \"Start procedure\" of the two Remote Controls have been completed",
      "value": "Yes",
      "valueClass": "valeur "
    },
    {
      "key": "Describe the difficulty(ies) experienced and alternative or solution provided",
      "value": null,
      "valueClass": ""
    },
    {
      "key": "Comments",
      "value": null,
      "valueClass": ""
    },
    {
      "key": "All steps for \"Pairing procedure\" of the Remote Control and the Control Unit have been completed",
      "value": "Yes",
      "valueClass": "valeur "
    },
    {
      "key": "Describe the difficulty(ies) experienced and alternative or solution provided",
      "value": null,
      "valueClass": ""
    },
    {
      "key": "Comments",
      "value": null,
      "valueClass": ""
    },
    {
      "key": "All the steps of the 'Calibration procedure' have been completed",
      "value": "Yes",
      "valueClass": "valeur "
    },
    {
      "key": "Describe the difficulty(ies) experienced and alternative or solution provided",
      "value": null,
      "valueClass": ""
    },
    {
      "key": "Comments",
      "value": null,
      "valueClass": ""
    },
    {
      "key": "LOT of the ARTUS® Cuff S",
      "value": "22-0224",
      "valueClass": "valeur CUFF"
    },
    {
      "key": "SN of the ARTUS® Control Unit",
      "value": "210011",
      "valueClass": "valeur CONTSN"
    },
    {
      "key": "SN of the ARTUS® Remote Control #1",
      "value": "052300185",
      "valueClass": "valeur REMOSN"
    },
    {
      "key": "SN of the ARTUS® Remote Control #2",
      "value": null,
      "valueClass": ""
    },
    {
      "key": "The Back-up Material was used",
      "value": "No",
      "valueClass": "valeur "
    },
    {
      "key": "LOT of the ARTUS® Cuff S",
      "value": null,
      "valueClass": ""
    },
    {
      "key": "SN of the ARTUS® Control Unit",
      "value": null,
      "valueClass": ""
    },
    {
      "key": "SN of the ARTUS® Remote Control",
      "value": null,
      "valueClass": ""
    },
    {
      "key": "Beginning of the surgery, start of the incision (hh:mm)",
      "value": "10:00",
      "valueClass": "valeur START"
    },
    {
      "key": "End of the surgery, closure of the incision (hh:mm)",
      "value": "11:15",
      "valueClass": "valeur STOP"
    },
    {
      "key": "What type of anesthesia performed ?",
      "value": "General",
      "valueClass": "valeur "
    },
    {
      "key": "Size of Foley catheter used",
      "value": "14 CH",
      "valueClass": "valeur "
    },
    {
      "key": "Did a surgical dissection of the bulbospongiosus muscle has been performed?",
      "value": null,
      "valueClass": ""
    },
    {
      "key": "Locking Position of the cuff around the urethra",
      "value": "1",
      "valueClass": "valeur "
    },
    {
      "key": "Tightening of the urethra",
      "value": null,
      "valueClass": ""
    },
    {
      "key": "If you have encountered difficulties, please describe the difficulty(ies) experienced and alternative or solution provided",
      "value": "no difficulties",
      "valueClass": "valeur ENCOUNT"
    },
    {
      "key": "Comment",
      "value": null,
      "valueClass": ""
    },
    {
      "key": "All steps for the \"Surgery Test procedure\" have been completed",
      "value": "Yes",
      "valueClass": "valeur "
    },
    {
      "key": "Describe the difficulty(ies) experienced and alternative or solution provided",
      "value": null,
      "valueClass": ""
    },
    {
      "key": "Comments",
      "value": null,
      "valueClass": ""
    },
    {
      "key": "All steps for the \"Implantation of the control unit\" have been completed",
      "value": "Yes",
      "valueClass": "valeur "
    },
    {
      "key": "Describe the difficulty(ies) experienced and alternative or solution provided",
      "value": null,
      "valueClass": ""
    },
    {
      "key": "Comments",
      "value": null,
      "valueClass": ""
    },
    {
      "key": "All steps for the \"Completion of implantation\" have been completed",
      "value": "Yes",
      "valueClass": "valeur "
    },
    {
      "key": "Describe the difficulty(ies) experienced and alternative or solution provided",
      "value": null,
      "valueClass": ""
    },
    {
      "key": "Comments",
      "value": null,
      "valueClass": ""
    },
    {
      "key": "Was a Picture of the Cuff final position around the urethra taken intra-operatively",
      "value": "Yes",
      "valueClass": "valeur "
    },
    {
      "key": "Was a Picture of the Control Unit final position taken intra-operatively",
      "value": "Yes",
      "valueClass": "valeur "
    },
    {
      "key": "Was the Pelvis radiography performed?",
      "value": "Yes",
      "valueClass": "valeur "
    },
    {
      "key": "Date of most recent pelvis radiography",
      "value": "04/03/2024",
      "valueClass": "valeur DTEPEL"
    },
    {
      "key": "Was the Usability Questionnaire Surgeon (intra-operative) performed",
      "value": "Yes",
      "valueClass": "valeur "
    },
    {
      "key": "Explain why Usability Questionnaire Surgeon was not performed",
      "value": null,
      "valueClass": ""
    },
    {
      "key": "1. The implantation of Artus® is technically simple",
      "value": "2 : Agree",
      "valueClass": "valeur "
    },
    {
      "key": "2. The handling of the shell screwed on the end of the transmission cable is easy",
      "value": "2 : Agree",
      "valueClass": "valeur "
    },
    {
      "key": "3. The cuff is easy to insert around the urethra",
      "value": "2 : Agree",
      "valueClass": "valeur "
    },
    {
      "key": "4. Positioning the Cuff around the urethra is easy to perform",
      "value": "3 : Not sure",
      "valueClass": "valeur "
    },
    {
      "key": "5. The Cuff loop around the urethra is easy to adjust",
      "value": "2 : Agree",
      "valueClass": "valeur "
    },
    {
      "key": "6. The implantation technique of the Control Unit in the abdominal wall is easy to perform",
      "value": "2 : Agree",
      "valueClass": "valeur "
    },
    {
      "key": "7. The fixing technique for the Control Unit in the abdominal wall is easy to perform",
      "value": "2 : Agree",
      "valueClass": "valeur "
    },
    {
      "key": "8. The connection of the transmission cable and the Control Unit is easy to perform",
      "value": "2 : Agree",
      "valueClass": "valeur "
    },
    {
      "key": "9. The remote control is easy to manipulate in the sterile bag",
      "value": "2 : Agree",
      "valueClass": "valeur "
    },
    {
      "key": "10. The sequence to be carried out to reach the screen proposing the password to access the Physician interface is simple",
      "value": "2 : Agree",
      "valueClass": "valeur "
    },
    {
      "key": "11. Matching between the Remote Control and the implanted Control Unit is easy to perform",
      "value": "2 : Agree",
      "valueClass": "valeur "
    },
    {
      "key": "12. Visual evaluation of the correct operation of the device (Surgery mode) is easy to perform",
      "value": "2 : Agree",
      "valueClass": "valeur "
    },
    {
      "key": "Do you have any comments regarding the intra-operative ARTUS implant and its use",
      "value": "No",
      "valueClass": "valeur "
    },
    {
      "key": "Please complete your comment below",
      "value": null,
      "valueClass": ""
    },
    {
      "key": "Device deficiency(ies) occurred during the procedure",
      "value": "No",
      "valueClass": "valeur "
    },
    {
      "key": "Is the subject receiving any concomitant medication",
      "value": "Yes",
      "valueClass": "valeur "
    },
    {
      "key": "Did new adverse event(s) occur since the informed consent signature",
      "value": "No",
      "valueClass": "valeur "
    }
  ]
}