Update Data Collection for Lung Mortality Models At a glance Current policy In lung allocation, estimates of a candidate’s medical urgency and post-transplant outcomes are calculated based on the candidate’s clinical information. This proposal is a piece of the Lung Committee’s continuing work to evaluate data collection. The collection of additional information on waitlisted candidates will allow the Committee to consider the impact of the information on a candidate’s medical urgency and post-transplant outcomes, and potentially include them as variables in future revisions of the lung composite allocation score. Supporting media Presentation View presentation Proposed changes Remove data collection fields that are no longer necessary Change data collection on five clinical criteria to more accurately reflect a candidate’s medical urgency and post-transplant outcomes Add data collection on 14 clinical criteria to evaluate a candidate’s medical history and current status Anticipated impact What it's expected to do Collect data that better reflects candidates’ medical conditions Provide more information/options/definitions so clinicians can more accurately report candidate data Inform future potential policy changes What it won't do Change the variables, coefficients, rating scales, or weights used to calculate the Composite Allocation Score Terms to know Composite Allocation Score (CAS): Formula that combines points from multiple candidate and donor attributes together, assigning a total score to a candidate on the wait list. The candidate’s CAS determines their place on a match run. Click here to search the OPTN glossary Comments OPTN Transplant Coordinators Committee | 09/29/2022 The OPTN Transplant Coordinators Committee thanks the Lung Transplantation Committee for their work and for the opportunity to comment on this proposal. One member asked if there was a way to predict what the candidate scores will be when placement efficiency is not factored in until the match run. Staff noted that each program will have the ability to view the calculated sub scores for all currently registered candidates starting on September 28, 2022. It will not include the score aspects that are calculated at the time of the match run. One member noted that when lung candidates are listed, they are given a functional status based on the walk distance and questioned how that will affect pulmonary hypertension candidates. The Committee member noted that those patients alone would use the New York Heart Association (NYHA) functional classification as part of the listing. She also noted that this is data collection to evaluate for possible inclusion in future mortality models. One member expressed support for the changes, as the data elements will more accurately reflect the risks that patients encounter and will hopefully end up in the mortality models. She added that the benefit of only removing 5 data elements and adding 14 new ones will hopefully outweigh the added data burden. Another member added that the risk of data entry errors are always a consideration when adding additional data. UC San Diego Health Center for Transplantation | 09/29/2022 The UC San Diego Health Center for Transplantation (CASD) appreciates the opportunity to provide public comment on the proposal to Update Data Collection for Lung Mortality Models. CASD strongly supports retiring data elements that are no longer pertinent as well as refining existing elements in order to improve data quality and more accurately estimate a candidate’s waitlist survival and post-transplant outcomes. We also agree that the data elements recommended for addition are more reflective of the challenges lung transplant candidates face which have not historically been captured in the mortality risk models. We would, however, urge the Committee to carefully analyze the outcomes of this additional data collection and retire any elements not proven to improve the mortality risk models before modifying policy to require them, as this additional reporting could prove burdensome over time. Attachment Region 6 | 09/28/2022 Sentiment: 5 strongly support, 11 support, 6 neutral/abstain, 0 oppose, 0 strongly oppose Region 10 | 09/28/2022 Sentiment: 2 strongly support, 6 support, 5 neutral/abstain, 1 oppose, 0 strongly oppose | Members of the region supported the proposal. One member noted that this proposal would increase the workload for lung programs. NATCO | 09/28/2022 NATCO thanks the OPTN Lung Transplantation Committee for the opportunity to provide feedback. The current lung model uses multiple factors to estimate the 1- and 5-year mortality, blood type, sensitization, height, age, prior transplant, travel efficiency and proximity efficiency. The current system uses the same data points to estimate the expected survival based on pre transplant and historical data. The proposal in the model will take additional data points to help better estimate the patients 1- and 5-year mortality. Removal of data that is not used in the calculation of the composite allocation score (CAS) or that which can derived of other collected data, as well as the revision of such collected data will help to improve its quality making it uniform across all organ groups. Additional and new data collection on waitlisted candidates will allow the committee to consider the impact of the information on candidate’s medical urgency and post-transplant outcomes. This data collection has the potential to include them as variable in future revisions to the CAS calculation. With the addition of these new data points, we would hope that candidate’s mortality might be better projected and used as a guide to help transplant centers judge who would be acceptable lung transplant candidate. This data collection may also enhance the clinical criteria that may result in their inclusion in further models. Along with the data removals revisions and additions there will be data definition and assigned values to help with providing improved data quality collection across all transplant centers. The proposed data updates and addition changes seem to be well laid out. The data definition will need to be more detailed particularly when it comes to definition of exacerbations for disease diagnosis. There has been some concern related to the data entry burden for transplant centers, however this would help to understand what helps predict survival based on the new data points. After sufficient time we can analyze the pre and post implementation and extract all relevant data. However, the current number of data points does present a significant burden on transplant centers, generally transplant coordinators. NATCO urges UNOS and the committee to eliminate redundant and unessential data points in exchange for these new data points. Additionally, data integrity suffers when the overall number of data points is high. Currently, all data must be entered manually as there is no application programming interface (API) that will feed data from the electronic health record (EHR) directly into the initial registration. The current API could be used for waitlist management only but has not been adapted yet by any EHR that we are aware of. Having a useable API would decrease the data burden and enhance data integrity. NATCO recommends that the OPTN work with the major EHR vendors to make this available. Data as it relates to assisted ventilation and supplemental oxygen are required and have provided guidance about how to record oxygen values about assisted ventilation and supplemental oxygen if candidates are on HFNC or ECMO with the ability to enter the delivery device required. With the varying type of oxygen machines and delivery devices that are currently on the market, the standardization cannot be guaranteed across institutions or providers and should be considered. Taking this into account should be standardized but only using the fractioned oxygen percentage not the flow by liter per minute. Again, providing clear definitions will be key to consistent data collections. As for the diagnosis specific data definitions of exacerbations NATCO feels that more standardization for COPD, ILD/IPF, CF, and PAH is required. For example, PAH patients have recurrent admissions due to Right heart failure and would indicate that their disease is worsening. We also wonder if something else needs to be added to the definition such as “treatment required”. Again, clear definitions will be the key to obtaining meaningful and quality data collection.’ NATCO suggests that the Lung Transplant Committee remove the data fields that are no longer necessary along with incorporating the revision and assigned values with the definitions to improve data quality. This will require education to the transplant programs on data collection fields and revisions. The new data collection should be required data and not recommended fields if it is felt to impact the lung mortality models and in turn the CAS. As for diagnosis specific definitions of exacerbations, it will need to be clearly defined. There is concern that centers may game the system by listing patients as having an exacerbation so that they can acquire a higher CAS score. Education will be important so the clinical documentation clearly provides the documentation for those entering data into UNOS. We further suggest that refinements to the LAS and subsequent changes in the continuous distribution for the CAS, be updated to help the fair and equitable placement of organs to the patients that will benefit the most. These changes and subsequent data collected will help guide patient’s and transplant team to better understand what can increase patient survival or what would be a detriment to outcomes. Data collection is essential as we move forward. Anonymous | 09/28/2022 As the spouse of someone who died 10/1/2021 I did not appreciate our request for lung transplant following severe pneumonia/Covid protocol treatments (they blew his lungs out with intubation) being ignored; in fact the doctors and nurses laughed in our faces when we inquired about it. My husband was 74 yrs old, always healthy and the father of a 14 yr old and other (adult) children. The medical system ravages those over 60; age should be removed as a determinant to transplant. Region 8 | 09/27/2022 Sentiment: 0 strongly support, 8 support, 6 neutral/abstain, 2 oppose, 1 strongly oppose | Several members commented that this may be premature. A member explained that it is premature since it is not mandatory and it is unknown how long it will take to collect data. A member explained that they support of continuous quality improvement, but agree with other members’ comments that before the exercise begins, an analysis of utility and impact/bias needs to be completed in order to minimize bias. Several members pointed out that without mandatory data submission requirements, what value is added to the data collection and the ability to contribute to the distribution plan without introducing unintended bias. A member commented that the data collection for lung transplants is already oppressive, and what is really needed is implementation of lung API. A member explained that it is unclear how long it will take to collect sufficient data to incorporate these data elements (especially because it appears that entering the new data elements will be optional). The member suggested that it would be helpful for the SRTR to provide an estimate and if it will be more than one to two years from implementation, then the member’s program recommends the committee to propose a mechanism where retrospective data collection could be performed in order to provide parameter estimates to be used in the interim (historically, this was done with PCO2 and bilirubin). Additionally, the member’s program is reluctant to support new data collection without some consideration about whether the data elements could be transmitted automatically through an interface. Ideally, the ultimate goal would be to provide no net additional work for transplant centers. Further, some of the proposed data elements, particularly "exacerbations" appear somewhat subjective. The member’s program encourages the committee to provide evidence based definitions of what will be used for these elements. A member’s program suggested that regarding to the deletions / updates to the existing proposals we provide a couple of minor comments: (The proposal suggests removal of both absolute and percent predicted post bronchodilator FEV1 but the rationale for the latter includes the comment that the value can be calculated. This isn't correct if the absolute value isn't available. Currently, post-BD FEV1 is not utilized in models but the member wanted to make sure this was the intent. For patients on high flow nasal cannula, the proposal suggests using the maximum of flow rate or calculated flow rate based on FiO2 (from their existing formula). The member suggested that it would be better to directly calculate the true oxygen flow rate by multiplying the two. The member explained that if DLCO will be collected it will be important to collect values corrected for VA and Hb.) The member believes that the cost-benefit of doing this (especially if the data collection isn't mandatory) doesn't make sense. The member recommend considering whether a similar investment in a project with Epic and/or Cerner, to retrospectively collect the data from their EHRs, match it to the existing OPTN/SRTR data, and reconstruct the models, would achieve the same goals in a much shorter period of time. International Society for Heart and Lung Transplantation | 09/27/2022 Please see attachment for comment from PVD IDN. Attachment Region 7 | 09/27/2022 Sentiment: 3 strongly support, 10 support, 0 neutral/abstain, 0 oppose, 0 strongly oppose | Members of the region support the proposal. One member noted that collecting useful data and reducing the collection of superfluous data is a worthwhile effort if it improves lung allocation with a more accurate CAS score. If approved, the data collected from this proposal should be closely analyzed and reviewed to ensure it accomplishes the goal of accurately assessing patients in order to equitably place them on the match run. Any endeavor that accomplishes this goal should be promoted. This initiative proposes adding 14 criteria that the evaluation of which could help explain a patients expected outcome and will thus affect his or her place on the wait list. Again, a thorough review is necessary to ensure the correct data is selected and is accomplishing the equitable outcomes. Another member stated that the diffusing value could be difficult to use if not corrected for hemoglobin, which might have a lot of variability that won’t necessarily reflect severity. American Society of Transplantation | 09/27/2022 The American Society of Transplantation (AST) offers the following comments in response to the proposal “Update Data Collection for Lung Mortality Models:” •The AST supports improving the models but we are concerned the proposed approach will not accomplish the stated goals. Unless power analysis demonstrates that sufficient, unbiased data can be collected within 1-2 years of implementation, the AST recommends leveraging EHRs for retrospective data collection to accomplish the same goals. •The AST is reluctant to support new data collection without some consideration about whether the data elements could be transmitted automatically through an interface. Ideally, data would be collected without additional work for transplant centers. •Some of the proposed data elements, particularly “exacerbations,” are somewhat subjective. The OPTN should provide evidence-based definitions to describe what is expected for providing these data. •The AST recommends data collection, including donor characteristics, that adequately capture elements to assess pre- and post-mortality for elderly lung candidates. Attachment OPTN Disease Transmission Advisory Committee (Ad Hoc) | 09/27/2022 The Ad Hoc Disease Transmission Advisory Committee thanks the Lung Transplantation Committee for their proposal. The Committee suggests the addition of Lomentospora under reportable multi-drug resistant organisms due to change in nomenclature. The Committee also emphasized the need to clarify a definition of multi-drug resistant organisms within the proposal. Members voiced concern about the list of the five multi-drug resistant organisms able to be selected under microbiology. A member explained as far as fungal infections there is not specific data to favor these organisms, so she suggests making the list reflect groups and be less specific. A member suggested collecting data on immunodeficiency, such as hypogammaglobulinemia or if a patient has undergone an allogenic stem cell transplant prior, may be beneficial if the Lung Transplantation Committee hopes to collect data on post-transplant outcomes. Members explained that most of the data collected seems to focus on cystic fibrosis (CF), but the community is seeing more interstitial lung disease (ILD) related transplants regarding mixed connective tissue disease or connective tissue disease. These patients are exposed to different kinds of immunosuppressive drugs, so IgG deficiencies are something that must be considered. Region 11 | 09/26/2022 Sentiment: 3 strongly support, 7 support, 8 neutral/abstain, 0 oppose, 0 strongly oppose American Society of Transplant Surgeons | 09/26/2022 The American Society of Transplant is pleased to provide the following feedback to the OPTN Lung Transplantation Committee. Are the proposed data changes and data definitions clear? Yes, for the most part. Under prior lung surgery: VATS is a technique used for surgery and not a type of operation itself. The data collection should be modified to whether each of the surgeries performed was done VATS or open (i.e., VATS lobectomy vs. open lobectomy, VATS wedge resection vs. open wedge resection, etc.) What clinical parameters, if any, would you add to the diagnosis-specific data definitions of exacerbations? The need for hospitalization might be a marker for more serious deterioration and should be included for exacerbations of COPD and CF. For example: did some of the exacerbations require hospitalization (yes/no). Alternatively, the number of exacerbations that required hospitalization in the last year, as well as total number of exacerbations. Is it clear how data should be submitted related to assisted ventilation and supplemental oxygen, and how values entered in these fields or other assigned values will be incorporated into the lung CAS? Yes, the proposal is clear. The exact definitions will need to be made clear to programs at the site of data collection so that the individual entering the data is able to do so correctly. The data is burdensome, but it is understandable why it should be collected. In the future OPTN should seek to simplify this if possible. Are there any other clinical criteria that should be added to better estimate a candidate’s waiting list survival or post-transplant outcomes? Simple measures of frailty should be collected; there is growing literature that these may be predictive of waitlist mortality and perhaps post-transplant mortality. Should any of the proposed clinical criteria not be included in the OPTN Waiting List? No. Is there a need to retain any of the clinical criteria proposed for removal? No. Attachment Region 1 | 09/21/2022 Sentiment: 1 strongly support, 0 support, 4 neutral/abstain, 0 oppose, 0 strongly oppose | Comments: An attendee asked for more information about how data for exacerbations and ECMO will be collected (yes/no vs quantitative data over time) and commented that patients on ECMO for weeks have lower post-transplant outcomes than someone who is only on ECMO for a few days. Region 3 | 09/20/2022 Sentiment: 1 strongly support, 9 support, 4 neutral/abstain, 0 oppose, 0 strongly oppose | Comments: The region generally supported this proposal. There was some concern about the data entry burden. One attendee noted that there may be a need to define the machine being used for supplemental oxygen since the FiO2 varies based on the machine being used. Region 2 | 09/13/2022 Sentiment: 2 strongly support, 15 support, 4 neutral/abstain, 0 oppose, 0 strongly oppose One member noted that the proposal is laudable and the data elements are acceptable; however, transplant centers routinely resist unfunded data submission mandates. That said, the member is concerned that voluntary data that is not mandated will bias future modeling for organ allocation and outcomes and not serve the intended goal. Another member noted that mortality models don't change the allocation for candidates, just data collection for developing models down the line. Lastly, another member commented that for all data requests, there are so many fields that are valueless that any increase in data collection must be accompanied by a corresponding winnowing of the valueless fields. Region 9 | 09/12/2022 Sentiment: 2 strongly support, 6 support, 1 neutral/abstain, 0 oppose, 0 strongly oppose | Comments: Region 9 generally supported the proposal. One attendee commented that the template for the waitlist form should be make available to centers to help them evaluate the proposal. Region 5 | 09/08/2022 Sentiment: 7 strongly support, 11 support, 9 neutral/abstain, 0 oppose, 0 strongly oppose | Comments: A member inquired about how frequently the committee plans to update the data fields. And the speaker explained that the committee will be looking at modeling and plans to discuss. A member suggested for the committee to look at candidates with a LAS scores greater than 50 or 60 who are at the top of the wait list. He said there is a need to have data fields updated (like status 1 hearts) and the data should be current. He pointed out that these candidates are a totally different population, who need to be addressed. Region 4 | 08/26/2022 Sentiment: 1 strongly support, 15 support, 3 neutral/abstain, 0 oppose, 0 strongly oppose | Region 4 generally supported this proposal. One attendee commented that PAH patients should also be included in the disease specific definitions of exacerbations They added that recurrent admissions due to right heart failure would indicate that the disease is getting worse and is a sign of increased waiting list mortality.