WBDE

Question 18: Inotropes at time of ‘harvest’

• Changed the word ‘harvest’ to ‘procurement’

Question 7: Intravascular Ultrasound Performed

• Revised questions that display if ‘yes’ is selected to only ask for Stanford Score once rather than for each vessel. Highest Stanford score reported previously has been mapped to this new question

Question 4a: Indicate ISHLT CAV Score

• Question removed, this score will be calculated rather than the user entering the score

Question 4a: Angio Results (previously 4b)

• A new row has been added to the bottom of this grid that ask ‘Severe Branch Stenosis’. This has been added for the columns LAD, LCx, and RCA

Question 4b: Hemodynamics – NEW QUESTION

• RAm
• PCW/LV EDP
• C.I.

Question 7: Intervention

• The free text of surgical therapy has been changed to a dropdown list of options

Question 9b: Details of Sequelae – NEW QUESTION

• This was previously a free text when SLTS was selected in question 8 (Outcome at 30 Days Post Date of Infection). Now a list of checkbox options is provided.

Question 8: Medications

• Free text has been changed to a ‘check all that apply’ and existing free text entries have been mapped to the appropriate checkboxes

Question 9: Hypertension

• An additional question has been added asking if patient has hypertension and treatment for hypertension

Question 2: Cause of Death

• Question text has been changed to ask “Mode of Death’
• ‘Other, specify’ entries have been mapped to appropriate check boxes
• A few new answer options added

Question 3b.i and 3b.iii: VAD Brands

• Added answer option of HeartMate III

Question 13: Primary Etiology

• The list of congenital etiologies has been expanded to include some of the historical options from previous form revisions. A complete list is available on the printable forms and in the form manual.

Question 17: Donor Serologies

• The order of donor serologies has been changed to match the order these are collected in UNOS.

Question 9: Blood Type

• ABO compatibility grid added above this question on the data entry screen.

Question 6e: Was patient listed for an ABO incompatible transplant?

• ABO compatibility grid added above this question on the data entry screen.

Question 7e: Was patient listed for an ABO incompatible transplant?

• ABO compatibility grid added above this question on the data entry screen.

Question 6e: Was patient transplanted with an ABO incompatible transplant?

• ABO compatibility grid added above this question on the data entry screen.

Question 18: Technique of Transplant

• This field previously allowed all three answer options to be checked. This will now only allow one box to be checked.

Question 11: Donor Blood Type

• ABO compatibility grid added above this question on the data entry screen.

Question 8c: Left Ventricular Ejection Fraction

• This field used to allow all numbers to be entered including decimals. This is now limited to whole numbers between 1 and 100.

Question 5: Indicate date of the end of the rejection episode

• Added explanation text under the question that reads: “If rejection is ongoing at the time of death, the death date should be entered as the end date. A death form should also be completed.”

Question 14: Laboratory Values

• Added range checks to all labs to indicate an abnormal values and impossible values.
• Added additional data entry fields under each lab for values in other units to be entered

Question 12: Donor Specific Antigens and Results

• Corrected typo changing ‘Antigens’ to ‘Antibodies’

Question 13: Laboratory Values

• Added range checks to all labs to indicate an abnormal values and impossible values.
• Added additional data entry fields under each lab for values in other units to be entered.

Question 15: Laboratory Values

• Added range checks to all labs to indicate an abnormal values and impossible values.
• Added additional data entry fields under each lab for values in other units to be entered

Question 8b: Donor Cause of death

• Changed answer option ‘Cerebrovascular’ to ‘Cerebrovascular/Stroke’

Question 8c: Donor Mechanism of Death

• Added answer option ‘Cerebral Embolism’
• Added answer option ‘Intracranial Hemorrhage/Stroke (ICH)’

Question 12: Laboratory Values

• Added range checks to all labs to indicate an abnormal values and impossible values.
• Added additional data entry fields under each lab for values in other units to be entered

Question 4a (Follow-up status change)

• Change data entry view to display in rows to allow users to see multiple status changes on the screen.

Question 3: Laboratory Values

• Added range checks to all labs to indicate an abnormal values and impossible values.
• Added additional data entry fields under each lab for values in other units to be entered

Question 5: Specify cardiac surgery prior to listing.

• Revised answer option ‘AP Shunt’ to be ‘AP Shunt (including BT Shunt, Modified BT Shunt, Waterson Shunt, Pott’s Shunt, Central Shunt, and MEE procedure)’

Question 5a: Specify cardiac surgery during listing.

• Revised answer option ‘AP Shunt’ to be ‘AP Shunt (including BT Shunt, Modified BT Shunt, Waterson Shunt, Pott’s Shunt, Central Shunt, and MEE procedure)’

Question 2c: Date of last dialysis related to this event.

• Added missing reason of ‘Ongoing’. If dialysis is ongoing, the user may select this option and revise the form at a later date once dialysis has stopped.

Question 3b: VAD Type

• Added additional answer option of ‘Systemic VAD’ (for single ventricle patients only)

Question 1: Is the patient under the age of 18 at time of listing?

• If “no”, a warning message will appear that the patient is not eligible for PHTS and the submit button will not be displayed.

Questions 2: Was Informed Consent and HIPAA Authorization Obtained?

• If “no”, a warning message will appear that the patient is not eligible for PHTS and the submit button will not be displayed.

Question 3: Was the patient listed for a heart/lung transplant?

• If “yes”, a warning message will appear that the patient is not eligible for PHTS and the submit button will not be displayed.

Question 13: Exercise test

• Adding answer option of “Not Routinely Done”

Question 5: Main Reason for Re-Listing

• Adding answer option of “graft dysfunction <30 days in the absence of rejection, pulmonary hypertension or surgical complications”

Question 6: Contributing Reason for Re-Listing

• Adding answer option of “graft dysfunction <30 days in the absence of rejection, pulmonary hypertension or surgical complications”
• Adding answer option of “No Contributing Cause”

Question 14: Exercise test

• Adding answer option of “Not Routinely Done”

Question 1 and 2: Infection Definition

• Revised definition to be one question that reads, “Is this infection a severe infection that requires IV therapy, hospitalization for infection >2 days, or escalation of care in an already hospitalized patient?”

Question 6 and 6a: Type of Infection and Infection Organism

• Removed question 6 and free text in question 6a. Replaced with a list of options as a ‘check all that apply’. All existing entries have been mapped to the appropriate check box. A complete list of organism options is available on the printed data collection forms and the form manual with the 1.1.4 release.

Question 8: Location of Patient

• Removed answer option of “Emergency Care, no admit”

Question 9: Intervention

• Added answer option “Supportive Care Only”

Question 10: Exercise test

• Adding answer option of “Not Routinely Done”

Question 4: Status Changes

• Users will not be able to select the same status for the old status and the new status. Only patient status changing from one status to a different status should be reported here.

At the launch of the web based data entry system, all answer choices for all questions were sorted alphabetically. This caused all yes/no questions to have the answer options as No/Yes/Unknown. Questions that have been added since launch have had the answer options added in the order of Yes/No/Unknown which has created some inconsistency. All Yes/No questions now have the answer options in the order of Yes/No/Unknown.

This release will have the addition of “sticky notes” and sticky note reporting to the web based data entry system. Users will have a new grid that will display at the bottom of their site dashboard which will show (1) active (2) resolved and (3) archived sticky notes. Sticky notes will be able to be assigned by both the user and the DCC to individual questions on any form. Users will be able to send sticky notes to other users at their site or to the DCC. The DCC will send sticky notes to sites for data integrity checks.

The “Compliance” tab released in version 1.1.2 has been renamed as a “Reports” tab. This tab will now allow the user to generate sticky note reports in addition to the compliance reporting.

This release will contain a password reset option for the user to reset their password.

Question 5: Is this a Japanese-American Transfer Patient

• Additional question added to track patients that come from Japan to the US for transplant. This will only apply to a select group of centers that have patients transfer from Japan.

Question 13 Exercise Test

• Added “not done” as a missing reason option for Max VO2% Predicted for Age, Max VO2, and Respiratory Value at Peak.

Questions 1 and 2 (criteria for when the form should be completed) are now treated as parent/child questions. The form will not display unless “yes” is answered to at least one question. If the answer is “no” to both, the form is not required.

Question 4: Drug Therapy at time of Infection

• This has been changed from a repeating section to a ‘check all that apply’

Patient Summary

• Follow up calendar year has been replaced with the expected follow-up window. A window will not be displayed on follow-ups that fall outside of the window.

Question 1: Was patient seen for follow-up this year?

• New answer option added: Previously, transferred care could only be reported in question 7b. New answer option of “No, patient transferred care to another center (not at time of annual follow-up)” will allow for transfers to be reported that were not at the time of the follow-up, therefore not requiring the remainder of the form.

Question 1: Was the patient seen for follow-up this year (NEW Question added).

• If no, the form will function similar to the post-transplant follow-up (i.e. the remainder of the form will not be required).

Question 5: Previous Cardiac Surgery

• Answer option “other, specify” added to drop down when “Valve Replacement” is selected.

There will now be a button at the top left of the data entry screen next to the “Screen Patient” button that is called “Compliance. This page will now show all users at a site in real time their annual follow-up form submission compliance for both pre and post transplant for three time points:

1. Up to the current year (currently shows compliance since the center joined PHTS through December 2016. Will be updated automatically each January 1st to add the previous year)
2. The previous calendar year (currently just shows 2016, will be updated automatically each January to the previous calendar year)
3. Quarterly follow-up: Two quarters that have passed for the current year (currently we are in the third quarter. Data submission for all events through the second quarter (June 30th) was due on July 31st.) This will be updated automatically at the quarterly deadline (30 days after each calendar quarter).

Explanations of each column of each tab and how they are calculated are included at the bottom of each tab in the system.

The fourth tab is called “All Followups”. If the user visits this tab and clicks “Download Followups”, an Excel file will be downloaded with all of the pre and post transplant follow-up forms for that site. The user can then filter the different columns to look at a number of different subsets such as missing follow-up forms. Please note that this is NOT a data download of the data actually entered into the follow-up forms. Instead, it includes key information about the follow-up forms such as the patient information and the follow-up date and form status to help the user better keep up with expected and completed annual follow-up forms.

Question 10: Other immunosuppressants

• This question has been changed to a repeating section so multiple immunosuppressants can be added.

Save For Later

• Each form in the system has a “Save for Later” button at the bottom of the form. This button has now been moved to directly above the “Session Time Remaining” which sits in the bottom right corner of the webpage so the user can click this button at any point during the form.
• This button also now serves a second purpose. Once this is clicked, the screen will return to the patient summary. A green pop-up will show in the top middle of the patient summary that says “Form Saved: Click here to continue editing”. This will appear for 10 seconds. Once clicked, it will return the user to the form that was just saved.

Patient Header

• On each form, the patient header will now display the 1st, 2nd, and 3rd listing and transplant information (if applicable). If not applicable, only the listing and transplant information entered will appear in the header.

Patient List Grid

• This grid will now default to only display the “Active” patients. Filter options have been added for the user to filter between Active, Inactive, Dead, Removed from List, Transferred, and Transplanted.

In Progress Forms Grid

• This grid will now have a column for “Old Patient Number”. A column has also been added for “Updated By” where the username will display of the last person that updated the form.

Question 4: Is the patient being transplanted at an institution in which they will not receive any follow-up care after surgery?

• Question removed from form. This criteria is no longer part of the inclusion/exclusion criteria

This form now has a limit of one form per patient. Once a Form 1 has been added, the option will be blocked out in the “Add Form” dropdown.

Question 5: Surgery Details

• If Valve Replacement is selected there is a drop down of four options. “Other, specify” has been added to this list of options.

Question 6b: Status Details

• Current question is a ‘check all that apply’. The ‘check all that apply’ has been changed to the format of individual questions as follows:
  • 6b. Was patient in or out of hospital at time of listing? (In Hospital/Out of Hospital)
  • 6b.i. Was patient in the ICU at time of listing? (No/Yes/Unknown)
  • 6b.ii. Did patient require continuous invasive mechanical ventilation? (No/Yes/Unknown)
  • 6c. Did the patient require continuous inotropes at time of listing? (No/Yes/Unknown)
  • 6c.i. Inotropes Dose? (Dose Unknown/High Dose or Multiple IV)
  • 6d. Did the patient have ductal dependent pulmonary or systemic circulation with ductal patency maintained by stent of prostaglandin infusion? (No/Yes/Unknown)
  • 6e. Was patient listed for ABO Incompatible? (No/Yes/Unknown)
  • 6f: Was patient on VAD or ECMO at time of listing? (VAD/ECMO/Not on support at time of listing)
  • 6g. Was patient listed for DCD (Donation after Cardiac Death) organ? (No/Yes/Unknown/This is not current practice at our center)

Question 6b: Status Details

• Current question is a ‘check all that apply’. The ‘check all that apply’ has been changed to the format of individual questions as follows:
  • 7b. Was patient in or out of hospital at time of listing? (In Hospital/Out of Hospital)
  • 7b.i. Was patient in the ICU at time of listing? (No/Yes/Unknown)
  • 7b.ii. Did patient require continuous invasive mechanical ventilation? (No/Yes/Unknown)
  • 7c. Did the patient require continuous inotropes at time of listing? (No/Yes/Unknown)
  • 7c.i. Inotropes Dose? (Dose Unknown/High Dose or Multiple IV)
  • 7d. Did the patient have ductal dependent pulmonary or systemic circulation with ductal patency maintained by stent of prostaglandin infusion? (No/Yes/Unknown)
  • 7e. Was patient listed for ABO Incompatible? (No/Yes/Unknown)
  • 7f: Was patient on VAD or ECMO at time of listing? (VAD/ECMO/Not on support at time of listing)
  • 7g. Was patient listed for DCD (Donation after Cardiac Death) organ? (No/Yes/Unknown/This is not current practice at our center)

Question 6b: Status Details

• Current question is a ‘check all that apply’. The ‘check all that apply’ has been changed to the format of individual questions as follows:
  • 6b. Was patient in or out of hospital at time of transplant? (In Hospital/Out of Hospital)
  • 6b.i. Was patient in the ICU at time of transplant? (No/Yes/Unknown)
  • 6b.ii. Did patient require continuous invasive mechanical ventilation? (No/Yes/Unknown)
  • 6c. Did the patient require continuous inotropes at time of transplant? (No/Yes/Unknown)
  • 6c.i. Inotropes Dose? (Dose Unknown/High Dose or Multiple IV)
  • 6d. Did the patient have ductal dependent pulmonary or systemic circulation with ductal patency maintained by stent of prostaglandin infusion? (No/Yes/Unknown)
  • 6e. Was patient transplanted as ABO Incompatible? (No/Yes/Unknown)
  • 6f: Was patient on VAD or ECMO at time of transplant? (VAD/ECMO/Not on support at time of listing)

Question 11: B Cell and T Cell Results

• Changed to grid format.

Annual Follow-up Form Generation

• Form 8s are due at the time of the transplant anniversary +/- 90 days. This form will now generate automatically each night for transplanted patients at the time of the transplant anniversary. The date of follow-up will pre-populate as the patient’s transplant anniversary and should be edited to reflect the actual follow-up date. The generated form will appear in the “In Progress Forms” grid on the Site Dashboard with a status of “Not started”. The form will also indicate the follow-up year (Year 1, Year 2, etc). This form can still be added manually if needed.

Question 1: Was patient seen for follow-up this year

• Answer choices have been revised to be:
  • No, patient was not seen this year or the patient follow-up falls outside of the follow-up window (+/- 90 days of the transplant anniversary)
  • Yes, patient was seen this year

Question 8: Follow-up Medications

• Added instructional text “Do not have to include PRN, topical, inhaled, or nebulizer medications.”

Question 15: Events since transplant or last Form 8

• Added text under each event: “If yes, complete form…”

Form 12s will now generate automatically at the time of the listing anniversary. This form can still be added manually if needed.

Question 7: Was patient permanently removed from the transplant waiting list since listing or last form 12?

• The option “Not applicable” has been added for patients that are removed from the list because of transplant or death.

Question 7: Infectious Disease Screening

• Changed to grid format

Question 8: Medical History, Mitochondrial Disorder

• Added child question with three options (Barth’s, Unspecified, and Other, specify)

Question 13: Respiratory Value at Peak

• Added descriptive text under question, “RER or Respiratory Quotient: R Value at peak is the respiratory quotient of carbon dioxide production divided by oxygen consumption, and is used as an index of how vigorously the patient exercised. A value above 1.05 is generally considered to represent an adequate effort.”

Question 8: Infectious Disease Screening

• Changed to grid format

Question 9: Medical History, Mitochondrial Disorder

• Added child question with three options (Barth’s, Unspecified, and Other, specify)

Question 14: Respiratory Value at Peak

• Added descriptive text under question, “RER or Respiratory Quotient: R Value at peak is the respiratory quotient of carbon dioxide production divided by oxygen consumption, and is used as an index of how vigorously the patient exercised. A value above 1.05 is generally considered to represent an adequate effort.”

System will automatically generate a Form 2 (Donor) and a Form 3 (Initial Immunosuppression) form when a Form 1t (Transplant) form is submitted

System will notify user if a Form 1t (Transplant), Form 2 (Donor), or Form 3 (Initial Immunosuppression) is missing for any patient.

Question 10a. 2: How long was therapy administered

• “specify” box added to drop down if the option “only for a pre-specified time/number of treatments, specify” is selected

Question 17: Donor Serologies

• Changed to grid format

Question 18: Donor on Inotropes, Pressors, or Thyroid Hormones at time of recovery/harvest

• Changed to grid format

Question 4: Angiography Results

• Changed to grid format to match the way this question was collected previously

Question 5c: Select Therapy Used

• “specify” box added as a drop down for “other, specify” option

Question 10: Respiratory Value at Peak

• Added descriptive text under question, “RER or Respiratory Quotient: R Value at peak is the respiratory quotient of carbon dioxide production divided by oxygen consumption, and is used as an index of how vigorously the patient exercised. A value above 1.05 is generally considered to represent an adequate effort.”

Question 14: Viral Studies

• Changed to grid format

Question 3b: VAD Side and Brand

• VAD brands have been customized for the Left side, Right side, and TAH.

Scrolling Timer
Demographics Form
Form 10 (Death)

Print View
Form 1t (Transplant)
Form 3 (Initial Immunosuppression)
Form 4 (Coronary Evaluation)
Form 5 (Rejection)
Form 12 (Pre Transplant Annual Follow-Up)

Question 5: Surgeries Prior to Listing

• “previous heart transplant” removed from answer choices
• Question “Valve Replacement, Aortic Valve” reworded to ask “Homograft Tissue in Aortic Valve Replacement? No/Yes/Unknown”
• Question “Valve Replacement, Pulmonary Valve” reworded to ask “Pulmonary Valve Replacement? No/Yes/Unknown”

Question 6a: Status at Listing

• Removed “2” as an answer choice for Brazil

Question 8a: Medical History: GI/Nutrition

• Added “Other, specify” option

Question 9: Primary Insurance

• Reordered answer choices
• Added descriptive text explaining each type of insurance

Question 11a: Hemodynamics Prior to Listing

• Rs, PVRI changed to Rp, PVRI

Question 9: Medical History: GI/Nutrition

• Added “Other, specify” option

Question 10: Primary Insurance

• Added descriptive text explaining each type of insurance

Question 12a: Hemodynamics Prior to Relisting

• Rs, PVRI changed to Rp, PVRI

Question 14: Hemodynamics closest to transplant

• Fixed typos in descriptive text

Question 14: Hemodynamics at time of transplant

• Rs, PVRI changed to Rp, PVRI

Question 15: Inotropes, Pressors, and Thyroid Hormones

• Changed section from a ‘check only one’ repeating section to a ‘check all that apply’

Question 1: Induction Agents

• Previous free text field for induction agent changed to a list of choices to select agent from

Question 9: Dobutamine or Exercise Stress Echo

• Added parent question asking “was dobutamine or exercise stress echo performed? Yes/No/Unknown”

Question 5: Were Hemodynamics Performed

• Added parent question asking “Were hemodynamics performed? Yes/No/Unknown”

Date validations bug addressed. All date fields must be entered using a 4-digit year

Patient summary

• Made form status field a uniform width

All forms

• Bug fixed in confirmation message when user attempts to leave form

Question 1 (beginning date of rejection episode) removed

Question 3: Added section header “Biopsy Prior to Rejection Event”

Question 3: Biopsy prior to rejection event ACR scores

• Mapped previously collected ISHLT scores to 2004 ISHLT scoring system of 0, 1R, 2R, 3R, or Unknown

Question 4: Which antibodies were tested and what were the results

• Added “unknown” as an answer choice

Question 4: HLA class I and/or Class II DSA Result, positive

• Added “unknown” as an answer choice

Question 4: Non-HLA Ab Result, positive

• Added “unknown” as an answer choice

Question :4 HLA Class I and/or II DSA Result

• Added “unknown” as an answer choice

Question 4: Non HLA Ab Result

• Added “unknown” as an answer choice

Question 4: Isoagglutinin (A or Ab) to ABO-I graft

• Added “unknown” as an answer choice

Question 7: Baseline immunosuppressive therapy at time of resolution of rejection

• Parent yes/no question removed
• Change from a ‘check only one’ repeating section to a ‘check all that apply’
• Change “Other” to “Other, specify”
• Change “Cytoxan” to “Cytoxan (cyclophosphamide)”
• Rearrange order of answer choices

Question 6b: Status Details

• Answer choices modified to not allow “in hospital” and “out of hospital” to be checked at the same time

Question 6b: Requires continuous mechanical ventilation

• Answer choices not saving correctly. Bug fixed

Question 9: Primary Insurance

• Donation removed as an answer choice (Charitable Donation remains as an option)

Question 15: Laboratory Values

• “T Protein” changed to ask “Total Protein”

Question 15: Inotropes, Pressors and Thyroid Hormones

• Removed “levophed” as an answer choice
• Changed “Norepinephrine” to “Norepinephrine (Levophed)”

Question 2: Non Invasive test prior to this date indicated coronary disease, specify test

• Added “Exercise Stress Echo” as an answer choice

Question 4b: Left Main Coronary Artery (L Main)

• Answer choices modified to not allow “Normal” to be checked with any other options

Question 4b: Left Anterior Descending (LAD)

• Answer choices modified to not allow “Normal” to be checked with any other options

Question 4b: Left Circumflex (LAD)

• Answer choices modified to not allow “Normal” to be checked with any other options

Question 4b: Right Coronary Artery (RCA)

• Answer choices modified to not allow “Normal” to be checked with any other options

Question 4b: Posterior Descending Artery (PDA)

• Answer choices modified to not allow “Normal” to be checked with any other options

Question 5: Hemodynamics

• Removed RAP/CVP as a question

Question 15: Events

• “Malignancy” edited to ask “Malignancy/PTLD”

Question 4: Procedure

• Add “Other, specify”

Question 4: Comments on Procedure

• Add Missing Reason option of “None”

Question 5b: Status Details

• Answer choices modified to not allow “in hospital” and “out of hospital” to be checked at the same time

Question 5: Cardiac Surgery: d-transposition of the great vessels: Arterial Switch Operation While Listed

• Added Missing Reason option of “Unknown”