Concepts for a Collaborative Approach to Living Donor Data Collection
At a glance
The OPTN Living Donor Committee has been discussing opportunities to collect data in order to analyze long-term outcomes of living donation and barriers to living donation. Due to the barriers associated with collecting extended living donor follow-up data from transplant programs and the consensus that longer-term data are needed, the Committee determined that some other entity, such as a registry, is better situated to connect directly with living donors. As such, the Committee has been collaborating with the Scientific Registry of Transplant Recipients (SRTR) to develop a potential future state of living donor data collection. The concept paper explores and discusses the possibilities of this future state and seeks community feedback.
The paper details the concept of the OPTN requiring collection and reporting of living donor candidate and donation decision data. These data would be shared with the SRTR Living Donor Collective to establish a foundation in which the SRTR Living Donor Collective could directly follow-up with living donor candidates and living donors long-term at a national level.
- What it's expected to do
- Details a potential future state of living donor data collection in which the OPTN and SRTR collaborate to achieve long-term living donor data collection
- Provides education on the SRTR’s Living Donor Collective
- Details concepts related to the OPTN requiring data collection on “living donor candidates” and donation decision
- Details a possible definition for “living donor candidate” and estimates data collection for this population
- Provides updates on the Living Donor Committee’s granular review of OPTN living donor data collection
- Seeks feedback from the community on the concepts outlined in the paper
- What it won't do
- This concept paper is intended to describe potential changes to living donor data collection and solicit feedback; it will not result in a policy or data collection changes at this time.
Terms to know
- SRTR Living Donor Collective: A voluntary living donor registry in which participating transplant programs register living donors as well as individuals evaluated for living donation that do not proceed to donation (living donor candidates) to capture a control population. The SRTR Living Donor Collective collects data directly from living donor candidates and living donors and seeks to examine access and long-term outcomes attributable to living donation.
- Living Donor: A living individual from whom at least one organ is recovered for transplantation.
American Society of Nephrology | 09/19/2023
Dear Dr. Rudow and Dr. Elias:
On behalf of the more than 37,000,000 Americans living with kidney diseases and the 21,000 nephrologists, scientists, and other kidney health care professionals who comprise the American Society of Nephrology (ASN), thank you for the opportunity to respond to provide comment regarding the Organ Procurement and Transplantation Network (OPTN) concept paper “Concepts for a Collaborative Approach to Living Donor Data Collection.”
ASN commends the Living Donor Committee and OPTN for their work to conceptualize a future state of living donor data collection. The society strongly supports the ideas laid out in this concept paper, including requiring collection and reporting of living donor candidate and donation decision data, sharing that data with the Living Donor Collective, enabling the Living Donor Collective to directly follow-up with living donor candidates and living donors long-term on a national level.
Enabling the use of more organs to allow more patients to receive a transplant, including by better supporting living donors and mitigating the barriers they must overcome to successfully donate, is a top ASN policy goal. The vision articulated in this concept paper advances this objective on several levels, particularly by helping us to understand, monitor, and better meet the needs of both potential and actual living donors. As noted, while the benefits of living donation to recipients are well-documented, a more comprehensive understanding of the implications of living donation in the short- and long-term would fill knowledge gaps to better inform the decision-making process for individuals considering living donation.
Additionally, these data could, among other things, help researchers understand how to narrow the gap between the number of potentially interested living donors and actual living donors, providing inferences on how to address barriers to donation. While living donation is generally regarded as safe, the committee presents ample evidence that current living donor follow-up practices do not provide sufficient data to understand long-term outcomes. The Living Donor Collective, established as a long-term follow-up pilot in 2016 by the Scientific Registry of Transplant Recipients (SRTR), has proven to be an effective model. Its success should be leveraged and expanded upon on a nationwide basis, as suggested in this concept paper.
ASN supports the committee’s recommendation to define a living donor candidate as “an individual who was seen at a transplant program for evaluation.” The society appreciates the committee’s presentation of alternative approaches to this definition but agrees with the conclusion that this approach would provide a balance between meaningful data collection and data collection burden and would capture a group of individuals who are sufficiently invested in the process and may be more likely to engage in long-term follow-up, regardless of whether they proceeded with donation or not. This consideration is important given the objective of creating a comparator group other than the general population to serve as a control group against which to compare outcomes of living donors.
ASN strongly supports the Committee’s goal to maintain a single integrated approach in which there would be no redundancy in data entry across OPTN and SRTR multiple systems.
Data elements to collect:
A key goal of this effort is to generate a dataset that helps researchers, health professionals, and policymakers identify impediments to living donation that can potentially be addressed through policy change. Moreover, collecting information regarding barriers to donation can help us understand and bridge barriers that contribute to disparities in living donation along socioeconomic, geographic, and other lines. Accordingly, ASN supports the collection of robust demographic information to identify such potential barriers. ASN appreciates the committee’s inclination to collect the minimum essential data, but suggests that the collection of some element of socioeconomic status (or the ability to infer it with reasonable accuracy, such as based on ZIP code+4), and the candidate’s perception as to whether donation may present a financial hardship be prioritized.
This data could also help inform efforts to ensure appropriate funding for entities that provide financial assistance to cover the costs of living donation, such as through Congressional support for the National Living Donor Assistance Center. Similarly, ASN recommends consideration of a more specific question about whether candidates have the ability to take leave (paid or unpaid) from work, which would be invaluable in helping understand (and eventually address) barriers to donation for different types of employed individuals. Related, as the committee notes, insurance status is another element potentially affecting candidates’ ultimate ability to donate about which little is known.
Some ASN members report that barriers to donation arise when one family member wishes to donate to another, but that potential living donor is also the best-positioned (or only possible) member of the recipient’s network to provide post-operative care. While the Living Donor Collective wouldn’t be in the position of resolving the dilemma of lack of post-operative support within a family or social network for both recipient and living donor, asking donor candidates a question about availability of post-operative care could help us learn more about it and potentially point to future policy solutions.
The society notes that the crosswalk provided in Appendix A stipulates that “Additionally, all data elements in the table are required data elements.” ASN recommends that any data fields for which collected through the Living Donor Collective be mandatory: if only a subset of programs complete these fields, it becomes very to make meaningful comparisons based on a patchwork of data.
Data collection responsibility:
ASN supports the concept of requiring transplant programs to report donation decisions and reasons why for all living donor candidates to the OPTN, with the goal of creating a national understanding of access and barriers to living organ donation. This universal requirement would lay the foundation that would allow the Living Donor Collective to take on long-term follow-up of living donor candidates and living donors at a national level. Current OPTN policy requires that the Living Donor Registration (LDR) form be completed by the transplant center at 6-, 12-, and 24-month intervals.
ASN also believes the rationale presented for shifting the burden of data collection for 12- and 24-month follow-up from transplant centers to the Living Donor Collective makes sense, particularly in terms of balancing the reporting burden on transplant centers as they are (if the concept is eventually finalized) required to report donation decisions and reasons why for all living donor candidates. As the committee lays out, evidence suggests there are several reasons why transplant programs may not be the best vehicles for collecting these data long-term, including that living donors may not be local to the transplant program because they either traveled for donation or moved post-donation, or because financial coverage of the follow-up appointments may be an additional barrier. With the OPTN registering living donor candidates, it would allow the Living Donor Collective to pivot resources to support the shift in 12- and 24-month follow-up data collection and beyond.
Engaging with living donors:
ASN commends the committee for its emphasis on engaging living donors themselves to provide their feedback on how they seek to engage in long-term follow-up. ASN concurs that the data elements that health professionals find valuable may diverge from those living donors themselves are interested in, and seeking their input is imperative.
In sum, ASN appreciates OPTN’s and the committee’s effort to seek early input from the community on practical approaches to collecting longitudinal living donor data on a national level. The society strongly supports these efforts and looks forward to additional updates and opportunities to provide feedback on this important endeavor. Please contact ASN Strategic Policy Advisor Rachel Meyer at email@example.com with any questions or to discuss this letter in more detail.
Michelle A. Josephson, MD, FASN
Jane Zill | 09/19/2023
OPTN Patient Affairs Committee | 09/19/2023
The OPTN Patient Affairs Committee would like to thank the OPTN Living Donor Committee for their work on this concept paper. PAC members include two living donors and multiple recipients of living donations. The committee has a unique perspective in that they personally understand both the need to increase living donation, and the barriers and concerns individuals have when deciding to become living donors. Potential living donors want to know if there is a risk of death during surgery, short-term risks and complications from surgeries, and long-term impacts, both physical and psychological, of donation. Potential living donors also want to know how this is going to impact their quality of life, their hobbies, and their families. They want to know what their health will look like in 5, 10, or even 20 years post donation. The data points discussed in this paper will go a long way in helping potential living donors better understand what they are signing up for. We do have some concern regarding the burden this could place on transplant centers. Inviting living donors to self-report frequently or for long periods of time could also be burdensome because they already give so much of their time to the process. Living donors are selfless individuals who willingly walk into a hospital healthy, and walk out compromised; simply asking them to provide more information that could help others make the decision to become living donors may be enough to get their buy in.
Colleen O'Donnell Flores | 09/19/2023
As the Committee looks to enhance living donor safety thru data collection, please may you also consider enhancing DonorNet to allow for a PDF/Organ Match form for living donor recipients, similar to what is enabled during a deceased donor transplant. This PDF/Organ Match form is an important step in OR safety. Thank you
Hospital of the University of Pennsylvania | 09/19/2023
This paper details important concepts, recommend additional details as to who is paying for this are needed.
OPTN Ad Hoc International Relations Committee | 09/19/2023
While the members of AHIRC expressed support for their concept paper, they would like the Living Donor Committee to consider non-U. S Citizens/Residents (NCR) when collecting data. Members also noted that it would be helpful to know the questions that will be included in the SRTR LDC survey ahead of time; otherwise, it’s difficult to provide critical feedback on the value of the data collection process. Members suggested that the survey questions be incorporated into the concept paper.
Lorrinda Gray-Davis | 09/19/2023
This is a tremendous need in the living donor space. This will be valuable for potential living donors when they are considering to be a donor.
Region 8 | 09/19/2023
When considering living donation, I can attest that when looking for data to help make an informed decision regarding transplant centers and what the long-term impacts to my health/lifestyle might be was non-existent. I think we all hope to live longer than 24 months so information beyond that is essential; and for potential living donors not otherwise involved in the organ and transplant community and who make data-based decisions not having access to longer term data could easily result in a decision to not donate. A member strongly supported that the 12- and 24-month follow-up remaining with the transplant centers where the donation occurred, and noted it is important to the donor to maintain a connection to the center and those involved in their donation. A member said he supports an opt-in, self-reporting approach, for example the CDC's opt-in vaccine tracking/follow-up program used during COVID. A member suggested it might be helpful initially at the five-year mark to have a "long-form" or an opportunity for the living donor to provide additional information that may not be captured in the annual survey questions and that may have developed, and feel is important or relevant to their experience. The evaluation of this additional information could help shape future data collection. An attendee said this is a burden on transplant programs, both large (number of patients) and small (scale of staff); and that the committee needs to identify exclusion criteria (radiographic, functional, and immunologic). A center said it needs to be clear that if centers are expected to report on potential living donor candidates, it needs to be in conjunction with reduced burden after donation. It seems that utilizing the Collective to reduce post donation burden is an opportunity for that. It would be beneficial to collect data about donor approval/decline, to be able to study practice patterns. However, need to be cognizant of potential for this data to be "used against" centers. There could be unforeseen consequences and need to avoid any possibility of leading to either potential donors or centers not considering living donation for as many candidates as possible.
Several members said that while they support the goal, transplant centers cannot be given an additional unfunded data mandate. This initiative must be implemented with the ability to automate data collection with existing software and explained that centers may need help at implementation. They said that the timing of living donor follow-up makes sense but agreed with others who expressed concern about donor candidates' privacy. An institution explained that while they agreed with the term living donor candidate and agreed that the definition is correct to only require registration for those seen at a transplant center it was unclear if this would change the transplant's program follow up requirements.
OPTN Transplant Administrators Committee | 09/19/2023
The OPTN Transplant Administrators Committee thanks the OPTN Living Donor Committee for their dedication and work on this project. The Committee appreciates the time and effort put into this concept paper and offers a few items for consideration as this project develops. In the interest of reducing burden on transplant centers and programs, improvement of the existing interfaces with the OPTN/UNOS systems and hospital EMRs would allow better data entry and flow. The Committee also recommends developing a more robust definition of “evaluation” as this varies amongst programs. Additionally, there is some concern that only being able to ultimately track living donor candidates who go on to donate could skew the data.
Region 9 | 09/19/2023
A member commented that collecting data on potential living donor candidates is a great idea and that long term follow up of living donors is also very important. Another attendee thought that this is a value proposition, as everyone supports collecting more data to help patients, but how much time/effort/resources do we want to put towards it. The attendee suggested that if we want to collect more data up front for potential living donors that this be added to the cost report so centers would be able to adequately staff for this work. Also, the attendee thought that “living donor candidate” needs to be more clearly defined because at their center, they had more than 200 living donor transplants with over 500 living donor “candidates”. A member was concerned about sharing confidential information about living donor candidates, especially related to psychosocial turndowns. An attendee expressed concern about adding the additional data collection burden on a center, particularly during the intense period of evaluating a living donor. Another attendee said that identifying living donor candidates starting when their EMR is created is too soon, as their program creates an EMR when they do a blood draw. A suggestion was made that if in the future, programs will be required to submit pre-transplant or perioperative data, allowing for the electronic PDF/organ verification link that is enabled during a deceased donor transplant match to expedite this data submission would be helpful. A member expressed concern that there is not more emphasis on living donor long term follow up. An attendee strongly supported this concept and applauded it as a much-needed effort. A member commented that shifting data collection upstream to OPTN and transplant centers would result in onerous financial burden and perhaps the outreach to donors should incorporate the patient portal, as well as traditional means to gather data.
National Kidney Foundation | 09/19/2023
Region 3 | 09/19/2023
Several attendees commented that they supported this initiative.
NATCO | 09/19/2023
NATCO supports the concept of longer term follow up of living donors and appreciates the value of comparators (candidates who did not donate) but we are concerned that this is another unfunded mandate that will add administrative burden on transplant coordinators.
• Is living donor candidate the correct term? Is the proposed definition appropriate?
Yes, living donor candidate could be the correct term. The point at which the donor candidate actually presents for an evaluation seems appropriate although many centers do preliminary diagnostic tests. We would suggest that candidates be defined as actually presenting at clinic (or remotely) for multidisciplinary evaluation.
• How do living donor programs define evaluation?
This varies by program.
• What is the minimum amount of data necessary to collect on living donor candidates? o What are the specific necessary data elements? o What organ-specific clinical data are necessary for living donor candidates?
The data points in the proposal seem reasonable. However, a key part of implementation will be working with vendors of EHRs to make as much of this data reporting uploadable to OPTN, minimizing manual abstraction.
• What are the transplant communities' recommendations related to shifting 12- and 24- month follow-up from the OPTN to the Living Donor Collective?
This element of the proposal would ease the administrative burden on transplant programs, however, this may shift the burden to the patients. Many transplant centers pay for the post donation labs and write these expenses off (not allowable on the Medicare cost report). The Collective would rely on self-report. On the other hand, 12 month and 2-year laboratory data are not very helpful in all organ donors, particularly kidney donors who may develop ESRD years after donation. How would programs be informed if donors developed donation related problems?
• How do living donor programs recommend operationalizing data collection on living donor candidates and donation decision to reduce burden?
We would recommend limiting the data required and working with EHR vendors to create APYs to avoid manual abstraction. The candidates should only be those evaluated by the full multidisciplinary team. Some recipients literally have 100’s of donor candidates. The donors who are screened off early should not be included. It would be an unsustainable burden.
• What data do potential living donors need to inform decision-making and post-donation health care?
The standard is to advise them of the need for life-long health care and screening and provide individualized risk assessment with shared decision making.
• What recommendations do transplant coordinators have on updates to OPTN living donor data collection forms? See other comments.
o What data elements and data definitions require modifications or deletions?
Eliminate citizenship, Karnokfsy scale, functional status, insurance status (other than losing insurance). Experts in each organ donor group should be consulted for important data elements.
o What data elements are missing from current OPTN living donor data collection forms?
Region 10 | 09/19/2023
Members of the region voiced some support for data collection, the prevailing sentiment among the comments was caution and concern regarding the increased burden on transplant centers and the potential impact on patient care. There was acknowledgment of the challenge of motivating living donors to participate in follow-up, with the sentiment that willing donors would comply while others would decline regardless. The distinction between voluntary and mandatory follow-up was noted, with a caution that starting with voluntary follow-up would lead to mandatory. Standardizing the education provided to potential donors who have been turned down was suggested, emphasizing the right to seek evaluation at another center. While the goal of understanding long-term outcomes for living donors was appreciated, an attendee noted that may not be practical. Larger centers, with high donor volumes, questioned the responsibility of caring for thousands of donors over the long term. The project’s impact on center burden and the need for clear definitions and data were highlighted. Concerns were raised about the practicality of data collection, especially for pre-donation potential candidates. Some advocated for evidence-based acceptance criteria and collaboration with professional organizations. Support for the project was expressed, but the administrative burden and potential for punitive actions were concerning. Lastly, resource allocation for data collection and follow-up was questioned, particularly given the challenges in achieving even the current 2-year follow-up. The burden on transplant resources and the potential impact on living donor transplant opportunities were major considerations.
UC San Diego Health | 09/19/2023
While the UC San Diego Health Center for Transplantation applauds the OPTN Living Donor Committee’s goal of closing the current gaps in data collection and subsequent knowledge related to barriers to and long-term outcomes of living donation, we also recognize that operationalizing such an effort will be a tremendous task.
With regards to the feedback specifically solicited:
• We agree that living donor candidate is the most appropriate term.
• We agree that data is important to share with potential living donor candidates during the phases of donation, to further support their ability to make an informed decision.
• The Center for Medicare and Medicaid Services interpretive guidelines published in 2019, which accompany the Conditions of Participation, define the phases of care for transplant and living donation. The Evaluation Phase is generally considered to be “from the first point of presentation by the potential donor until the time they enter the OR for the donation surgery.” Programs may debate what constitutes “first presentation” as many individuals may self-refer as a means to gather information about the process but either decide not to move forward or may be screened out via preliminary testing conducted prior to physical presentation to the program. However, the Committee has already made clear that they do not intend to request or require information on all donor inquiries and or referrals – their focus is donors who actually began the evaluation process. Although the Conditions of Participation and Interpretive Guidelines do not explicitly detail what constitutes a donor evaluation, CMS’s intentions were made clear during a phone conference with Melissa Rice and Valerie Caldwell-Jackson on 5/14/19. While addressing the new guideline which require “Every potential living donor must be assigned to and have an interview with an Independent Living Donor Advocate (ILDA)…prior to the initiation of the evaluation,” that an evaluation included any testing (including pre-screening) to determine the potential donor’s candidacy. Further, where CMS regulation does not explicitly detail what constitutes a donor evaluation, OPTN Policy 14 does. Therefore, it seems reasonable for the Committee to consider any potential donor who was educated, consented and underwent any of the consultations or testing defined in this policy to have begun the evaluation process whether they physically presented to the program or not.
• In our experience, living donors strongly prefer following-up via electronic means, such as telehealth, and/or by phone as opposed to being seen in person, absent any donation related concerns they may have.
• Collecting data around the barriers to donation and long-term outcomes would be invaluable if we as a community are interested in reducing those barriers and ethically promoting living donations as a means to reduce the waiting list. While we do not currently have a detailed opinion as to what the minimum amount of data necessary to collect would be, we do urge the Committee to consider limiting unnecessary burden on programs. For example, while general demographic information is reasonable, if the barrier to donation is donor choice not to proceed we do not feel that it would be justifiable to require programs to provide a significant amount of clinical data on that donor obtained during the evaluation process. In this instance it is irrelevant whether medically, surgically and psychosocially the individual would be a “good candidate” because they have chosen to exercise their protected right to withdraw consent and not proceed with donation. For candidates who are evaluated and subsequently ruled out for medical or surgical reasons, an H&P as well as standard testing results (normal/abnormal) including a metabolic panel, urine test, imaging, specific health maintenance testing, chest x-ray, ekg and or echo may be appropriate to request.
• It is also worth noting that living donor candidates will have to consent to sharing this information. It may be more effective if a non-affiliated entity allowed for donors to securely and independently provide this information, to protect their confidentiality.
• Aside from maintaining a relationship with the donor, we presume that most centers are likely to support shifting the 12- and 24-month follow-up to the Living Donor Collective simply as a means to improve data collection without adding additional reporting burden to their own staff. We would not support mandating programs continue to collect and report data beyond the current 24-months, particularly if there is any consideration of establishing new minimum reporting thresholds for this extended timeframe.
• Regardless of whether the 12- and 24-month follow-up is shifted to the Living Donor Collective, we would urge the Committee to consider reducing the redundancy in data collection that currently exists, if at all possible.
We look forward to the Committee’s continued exploration of this important project.
Transplant Families | 09/18/2023
Transplant Families endorses the concept paper for the Living Donor Collection, as it has the potential to open doors to valuable insights and advancements in this field.
We have noticed the lack of progress in research related as it pertains to living donors. It is imperative that we take significant steps towards understanding the enduring health implications of living organ donation. Developing a holistic understanding of how donation affects the health of the donor is of utmost importance. Furthermore, this knowledge could illuminate the factors influencing potential donors' decisions not to contribute—an equally crucial aspect. By addressing these obstacles, we have the opportunity to get more support for living donations and help more on the waiting list get their second chance at life. We would also add that educating potential patients about techniques such as laparoscopic removal of donation could help even more. Thank you to the committee for their work.
Anonymous | 09/18/2023
I endorse the concept paper for the Living Donor Collection, as it has the potential to open doors to valuable insights and advancements in this field.
We have noticed the lack of progress in research related as it pertains to living donors. It is imperative that we take significant steps towards understanding the enduring health implications of living organ donation. Developing a holistic understanding of how donation affects the health of the donor is of utmost importance. Furthermore, this knowledge could illuminate the factors influencing potential donors' decisions not to contribute—an equally crucial aspect. By addressing these obstacles, we have the opportunity to get more support for living donation and help more on the waiting list get their second chance at life. We would also add that educating potential patients about techniques such as laparoscopic removal of donation could help even more. Thank you to the committee for their work.
OPTN Minority Affairs Committee | 09/18/2023
The OPTN Minority Affairs Committee thanks the OPTN Living Donor Committee for their work and the opportunity to comment on their concept paper.
The MAC supports the Living Donor Committee’s data collection efforts and agrees that better data will help guide decision-making. Members recommended that the Living Donor Committee have specific measures in place to protect the participants’ data.
OPTN Membership & Professional Standards Committee | 09/18/2023
The Membership and Professional Standards Committee (MPSC) thanks the Living Donor Committee for their time and effort in developing and presenting this concept paper. Members were intrigued by this new concept and interested in seeing how it develops into a policy proposal to provide more concise and specific feedback. A member recommended collecting vast amounts of data, if individually voluntary, to develop a large database of information that will provide the granularity of data that can accomplish the Living Donor Committee’s goals. A member who participated in the Living Donor Collective voiced their support for the collaborative nature and the added value of this data. As the project moves forward, members recommended considering how to conduct follow-ups with potential living donors who become a noncandidate due to psychological issues to not retraumatize the individual. The MPSC also recommends considering how the data can be electronically submitted through the transplant hospital’s electronic medical record (EMR) system to reduce manual reentry and support this additional data collection. The MPSC also highlighted that without submitting follow-up data directly to the OPTN, there will be less monitoring and enforcement that can occur at the program level. Overall, the MPSC generally supports this proposal and is looking forward to providing more granular feedback on monitoring and compliance in the future.
Region 7 | 09/18/2023
Overall, attendees were supportive of collecting data related to living donors and their experiences, but there were concerns about the potential burden on transplant centers and the need to carefully design data collection methods to ensure their value and effectiveness. An attendee noted there being a benefit of informing potential donors about the long-term outcomes of living donation, suggesting that this information could serve as an incentive for more individuals to consider living donation. Several attendees raised concerns about the impact of increased administrative requirements on living donation rates. Attendees questioned how the data would be collected and expressed worries that additional data burdens might discourage centers from engaging in living donor evaluations. Another attendee noted that there needs to be a better understanding of the barriers to living donation, particularly for individuals who want to become living donors but encounter obstacles in the process. There was a recommendation for the OPTN to provide a secure portal for patients to self-report their experiences, potentially reducing the burden on transplant centers. Another attendee noted their support for collecting living donor data but raised concerns about the practical implementation. They stressed the importance of carefully selecting the data to collect and avoiding overburdening transplant programs. Additionally, there was strong support for a national registration for living donors and for lifelong tracking of organ donors. There was a suggestion of a voluntary system with automatic reminders for donors to input data. Lastly, it was suggested that for individuals who undergo evaluations but ultimately choose not to donate there should be a voluntary survey available for these individuals to provide feedback on their decision.
Becky Gustamante | 09/18/2023
Anytime you can eliminate redundancy it’s positive. A collaborative approach appears beneficial and logical as opposed to having required reporting for OPTN and voluntary reporting to SRTR.
The paper clearly explains the need for long term data on living donors. Trying to wrap my head around the arduous undertaking is difficult to even fathom. I can certainly see where data from living donor candidates would be an asset to the transplant centers. It’s just the mere numbers that is mind boggling and who/how will the data be collected. What comes to my mind in data collection are the diverse patients and how the approach could possibly differ. In particular, I’m imaging the uneducated from underserved communities. I’ve often worked with such populations and often times the approach is different to assure they’re comfortable even participating and understanding.
As a living kidney donor who belongs to several donor groups I find the same questions being asked by those considering donation and those scheduled for donation. Questions that consistently come up are pertaining to physical activity post recovery, having children, various psychological concerns, and complications.
I also believe there needs to be a plan to keep living donors engaged for longer term data collection. The 6, 12, and 24 month follow ups are not enough to gauge long term living donor outcomes. It also gives the perception that they don’t care about us (living donors).
The living donor candidate group has the potential to dramatically help transplant centers to identify donation barriers. I see a potential issue being active participation.
Region 1 | 09/15/2023
Overall attendees were supportive of this concept. An attendee expressed support for this idea and encouraged the committee to think of ways to motivate donors to provide feedback, as many are doing so well, they don’t have any interest in follow up. They added that the additional data collection suggested is important, but it is a significant amount of additional work. A member stated that just as a lot of disparities exist prior to listing a candidate for transplant, who makes it to evaluation for living donation and what factors impact that are equally important. Another attendee contemplated what resources might be needed to collect this data. A member shared that they were part of a pilot project where they were able to build an EPIC poll automatically and something like that could be connected directly to the SRTR. An attendee also added their support for the initiative.
Region 6 | 09/15/2023
Several attendees commented that they supported this initiative. Some attendees were concerned about consent from potential living donors and living donors. They added that some potential living donors may not want to be monitored this closely over time. One attendee was concerned about the administrative burden this may add to living donor programs. They commented that there will need to be a balance between collecting data and adding work for program staff.
OPTN Ethics Committee | 09/15/2023
The OPTN Ethics Committee thanks the OPTN Living Donor Committee for their work on this concept paper and the chance to provide feedback. Overall, the Committee strongly supports this effort as well as the concepts put forth for a collaborative approach to living donor data collection. Collection of long-term data is valuable, as it could reveal unknown inequities and barriers to donation; it will help potential future living donors in making informed decisions by having outcome data; and it will help centers and the public understand the reasoning behind why some candidates are declined as living donors. Also, this project could lead to a better understanding of the safety of living donation for donors several years after donation, something about which we still don’t have a full understanding. The Committee asks the Living Donor Committee to keep the following feedback in mind as the development of this project moves forward.
While members felt it important to track those who were interested in donation but then did not end up donating, it is hard to precisely define “living donor candidate.” Centers have different processes for living donor evaluation and keeping up with those who were declined as living donors through follow-up is difficult. Often, the two-year follow-up is challenging for transplant centers to complete; however, it is important for tracking long-term outcomes. Members recommended leveraging technology to automate follow-up to increase participation and ensure that the sample size is large enough to draw accurate conclusions. Given the difficulties with obtaining longer-term data of living donors, how missing data would impact the robustness of potential associations would be an important consideration.
The Committee feels there is a balance that needs to be struck between effort in collecting information from living donor candidates, on the one hand, and the likelihood of obtaining solid and helpful data to better inform living donation, on the other. One thing that the Living Donor Committee should consider is trying to get more information about what kinds of long-term health outcomes, barriers to donation, and equity considerations are expected to be revealed through the data collection. Understanding and solutioning around barriers to donation is a potentially separate issue from collecting data on living donor candidates, and more study and thought is needed in this area. Collection of data on living donor candidates should not be done at the expense of ensuring patient safety and long-term outcomes of actual donors.
There is a need for a comprehensive ethics review of consent, disclosure, and privacy protections related to the registry and the associated data collection. Implications of collecting long-term (and potentially, life-long) data without adequate understanding and consent for what data is collected, how it will be collected, and how it will be shared and used is ethically concerning. The necessity and usefulness of each item collected in Appendix B should be scrutinized to minimize risk and burden, and the Committee asks the Living Donor Committee to carefully consider the collection of items such as citizenship status and social security numbers, as well any potential modifications to the items to better get at the purpose of collection (the switch from marital status to social support is a good example). The Committee agrees that there is a need for tracking long-term outcomes from donors, and asks the Living Donor Committee to think through how to obtain this data quickly and efficiently (for example, perhaps by starting with reaching out to those who are already known living donors).
The Committee also encourages the Living Donor Committee to think through how the concepts explained in this paper are best communicated to a broad audience. Acronyms and references to specific forms are digestible to professionals, but may not be to the general public.
American Society of Transplantation | 09/15/2023
The American Society of Transplantation (AST) is generally supportive of what is outlined in the concept paper, “Concepts for a Collaborative Approach to Living Donor Data Collection,” and offers the following comments for consideration:
•The AST applauds this effort, and believes it is relevant to highlight an American Journal of Transplantation paper by Dr. Sanjay Kulkarni et al. regarding how the healthcare system and community engagement can be leveraged for long term donor follow-up (Am J Transplant. 2016;16(12):3385-3391).
• The AST believes it is reasonable to shift donor follow up from the OPTN to the Living Donor Collective (LDC).
• There are significant concerns that implementing some version of this concept will pose an increased burden on transplant hospital staff, as well as the donors who may not want to be contacted for an indefinite period. Either of these factors could negatively affect completeness of data collection, particularly at longer time points, and dampen the goals of the initiative. IT solutions to automate data transfer to LDC would help alleviate this additional burden and improve compliance.
• Due to concerns around increased staff and donor burden, a lack of adequate resources for reporting, and varied definitions for the beginning of a living donor evaluation, the AST believes it is essential to make participation in this program voluntary for each transplant hospital and each individual living donor candidate.
• Living donor candidates will have to consent to participate and provide this information. Transplant programs may not be the appropriate collector of these data as the donor’s decision, to donate or not to donate, is confidential. It may be more effective if a non-affiliated entity allowed donors to provide this information securely, independently, and confidentially.
• To make meaningful improvements in rates of living donation, it will be important to clearly define the beginning of the living donor evaluation, and use consistent nomenclature to support this definition, i.e., living donor candidate versus potential living donor (the AST suggests that “living donor candidate” is the most appropriate term). The living donor evaluation process is heterogenous among programs based on volume, geography, and patient characteristics. The AST believes it is reasonable to consider any living donor candidate who was educated, consented, and underwent any of the consultations or testing defined in OPTN Policy 14 to have begun the evaluation process whether they physically presented to the program or not.
• It will also be important to capture reasons why donors who have expressed interest (e.g., by submitting a health history questionnaire) are not selected for evaluation.
• The AST recommends that the OPTN also include the collection of pre-donation cystatin C, urine albumin to creatinine ratio, and psychosocial outcomes after donation.
American Society for Histocompatibility and Immunogenetics | 09/14/2023
This proposal is not pertinent to ASHI or its members.
Region 5 | 09/13/2023
Several attendees agreed with the concept, intent of the proposal, and collecting long term data on living donor outcomes. An attendee supported the proposal and suggested a focus on healthcare disparities. Specifically, an attendee commented that the definition is inaccurate for living donors. They explained the proposal mentions that different programs have different operations with screening, especially with MKR, and the variation will lead to data collection disparities. The attendee suggested the committee look at existing guidelines, and believed that whether or not the donor is physically seen, on site, is irrelevant. Identifying barriers moving forward by taking lab values before coming into the clinic is helpful. Several attendees suggested the committee focus on defining who is a living donor and creating a narrow definition for a living donor.
Region 11 | 09/12/2023
Several members commented that this has the potential to increase burden to transplant programs especially if it included potential donors ruled out before being seen. Members encouraged a universal database, automated data extraction, and incorporating PCPs/other healthcare providers into the process. A member commented that data collection on living donors is important to their post op care. A member stated that this is important work and that it's incumbent upon us to know and be able to share outcomes beyond 2 years. They added that collaboration with SRTR will make the pool being followed bigger and more relevant and that they have more tools for long-term follow up than transplant centers do and even short-term follow up has been difficult for transplant centers. A member commented that they support the addition of analyzing barriers to donation. A member commented that it would be helpful to see the knowledge gaps that are intended to be filled, what patients will be selected for comparison, what type of analysis will be used, etc. to be sure the effort is worthwhile. They asked if those declined for medical reasons are the right comparator for outcomes and are those responding a biased population? Members commented that this data collection adds risk for the potential donor and the OPTN by housing PHI for patients no longer connected to the system and housed by a third party; whether or not this would require IRB review should be looked at carefully.
OPTN Vascularized Composite Allograft Transplantation Committee | 09/12/2023
The OPTN Vascularized Composite Allograft Transplantation Committee thanks the OPTN Living Donor Committee for their time and dedication to this project. The Committee supports this concept paper and the intention to pursue more robust data collection on living donor candidates and is enthusiastic about the inclusion of the SRTR for long-term data collection. They recommend that the Living Donor Committee consider how to mitigate non-receptivity of living donor candidates in any future proposals, as well as potentially providing some form of incentive as a mitigative means. The Committee advises considering “an individual who showed up at one’s transplant center” as a definition of “evaluation”. The Committee suggests including the OPTN Pediatric Committee in future developments as pediatric transplant centers often rely heavily on living donors.
American Nephrology Nurses Association (ANNA) | 09/11/2023
ANNA supports the need for more long-term data collection but without increasing the burden of each transplant center. We believe analyzing long term outcomes is important for the future growth and success of kidney living dnation.
Region 2 | 09/05/2023
Attendees expressed support for the project goals but acknowledged challenges in collecting meaningful long-term data on living donor candidates. An attendee voiced support for the project as it stands out for its randomized approach of comparing living donors to those who end up not donating. However, they noted challenges currently with obtaining data from living donors, so it seems that it would be even more difficult to collect similar longitudinal data from non-donors. The need for long-term follow-up of living donors was emphasized, while a critical stance was taken toward subjecting non-donors to the same level of follow-up. Protecting non-donors' anonymity and their ability to withdraw without giving a reason was deemed crucial due to potential discomfort, privacy concerns, and data breaches. A few attendees did express opposition to the project, describing it as unnecessary, costly, and burdensome for patients who don't proceed to donation. It was suggested that the evaluation process should be excluded from the project’s requirements, and patients should have the option to remain in the study for life instead of being mandated to follow-up for two years. Lastly, there was a suggestion for an independent registry, separate from the transplant program, as a way to potentially increase willingness among donors to share information. Additionally, direct contact with living donors and exploring data collection from big data/insurance claims based on donor diagnoses were proposed as potential strategies.
Michael Murphy | 09/04/2023
Thank you for the opportunity to provide input on the initial concepts. My comments are from the perspective of a living kidney donor and long-time donor advocate. I’m responding to what I perceive to be the two main questions of the paper – what data should be collected, and how?
What Data To Collect
I believe the answer to this question should be guided by the principle of “keeping the end in mind” by anticipating how the data will be used. I’m thinking, in general, the data should: (1) answer the kinds of questions living donor candidates ask (or should ask) to support “informed consent,” and (2) provide health care professionals with the information that can help them assess and improve the delivery of services to donors and donor candidates. I’ll leave the latter up to the professionals.
As for the former, I suggest a content analysis of living donation social media groups, a review of past research surveys of living donors, and input from transplant teams (predonation) and donors’ physicians (post donation) on the questions that come up before and after donation. Anecdotally, a review of a couple years of posts in living donor Facebook groups reveals several common topics about the consequences of donation: the ability to continue physically demanding activities (e.g., running/marathons, Iron Man competitions, weight lifting); how long a donated organ lasts; the ability to have children and the risks of pregnancy; restrictions on the use of medications for pain management (migraines, PMS, muscle soreness, etc.) and treatment of disease (e.g., cancer, arthritis); the need for and/or use of supplements; what is a “normal” post-donation eGFR (at various time intervals after donation); changes in physical characteristics (e.g., frequency of urination, tolerance for alcohol, weight gain or loss); changes in relationships – with the recipient, family members, friends, employers, the transplant center; the ability to eat certain foods, use tobacco products, use marijuana, drink alcohol, drink coffee, etc.; denial of insurance, loss of coverage, or paying of higher (substandard) premiums; termination of support from the transplant center especially if there have been complications from the donation; concerns about a recipient’s expected compliant behavior (taking antirejection medications, avoiding alcohol, managing diabetes, etc.); concerns about ESRD or needing a transplant in the future; and concerns about donating now if a family member or friend might need a transplant in the future.
A key take-away is that many of these topics are not solely clinical; they also fall into the financial and psychosocial realms. Consequently, I believe the Committee should not shortchange collection of information in these categories. Failure to collect data that addresses nonclinical issues means significant gaps will remain in a donor candidate’s understanding and risk assessment of the consequences of donation, which is at odds with an overarching goal of this project. I recognize this means more data collection than today, and commenters have already expressed concerns about the existing burden. But I think a questionnaire on post-donation topics for living donors can cover most, if not all, of these issues, and (if I understand the proposed model correctly) the burden would fall on the donor with support from the Living Donor Collective (LDC), not the transplant center.
How To Collect The Data
I’m a bit fuzzy on the model’s data collection steps and responsibilities; my (vague) interpretation is that responsibility for clinical and other data collection is handed off from the transplant center to the donor and the LDC after the six-month visit. My “ideal” arrangement would be for living donors to have annual physical exams, from which a donor’s clinical results are submitted by the primary care physician (PCP). (If the donor is insured, the exam should be covered at 100% under current law.) Perhaps the PCP could be given a standard data request in advance so the doctor knows what tests to order, as well as the means for reporting the data to the registry. The donor would also complete an online (mobile friendly) financial and psychosocial survey. The LDC would monitor each donor’s expected data reporting anniversary, prompt the donor regularly to stay involved and to schedule an exam, develop a relationship with the donor’s PCP (to facilitate clinical data reporting), and maybe even issue a report to the donor each year with individualized longitudinal results relative to benchmarks. (I can dream, can’t I?)
As other commenters have pointed out, the ability to keep donors engaged in the program can be a challenge especially over time. Therefore, I encourage the Committee to research techniques other long-term data collection projects have used to keep participants involved. I also suggest getting a signed statement from donor candidates, perhaps incorporated into the informed consent statement, that the donor candidate understands there is an expectation of a lifetime commitment to data collection through the LDC (even if legally unenforceable). Donors are altruistic by nature, so long-term compliance might be bolstered if this “condition” for donating can be positioned as helping current and future donors, which it clearly is.
- Consider benchmarking other living donor registries, such as the Norwegian National Hospitals Living Donor Registry, to learn from them what has worked… and what hasn’t.
- Provide more detail on the mechanics of the model, for example process maps with steps, timing, and responsibilities.
- Rather than requesting only the “minimum necessary amount of data,” ask for “must have” and “nice to have” data elements. That way, if additional resources are available, the Committee isn’t limited in its awareness of all the types of data that would be valued.
- Explain how this project will be funded – initial implementation, ongoing maintenance, and periodic assessments and redesign. Several commenters have already expressed concerns about “unfunded mandates.” Explaining funding should help dispel (or confirm) those concerns.
- Is the intent to collect data only from prospective living donors? Is there an interest in enrolling existing living donors in the registry?
- It would be useful to see how the Committee sees the registry’s data being accessed, analyzed, and reported. Will SRTR have those responsibilities? Will medical researchers have access (maybe at a cost)? Will there be annual general reports similar to what SRTR creates now? In my view, the value of the registry is what gets reported out, so ideas on how that would work should be an essential component of the “business case” for the registry.
- Incorporate change management strategies to assist with implementation, overcome resistance, and make the changes stick.
- There is a lot to the current conceptual model. (Congratulations!) As the Committee refines the model and bounces it up against available resources – time, people, technology, money – think about how the complete vision of the model might need to be implemented in phases.
I hope these comments are helpful, and I look forward to the ongoing development and eventual implementation of the registry!
Lois Shepherd | 09/01/2023
The paper does a good job explaining the need for long-term data on living donors—the lack of data has been noted for a long time and it Is time to do something about it. Future living donor candidates would certainly benefit from having more long-term outcomes data to inform their decision to donate or not. I had basically four concerns listening to the presentation and reading the proposal:
1. A comprehensive ethics review should be conducted on the questions of consent, disclosure, and privacy protections relating to information that will be contained in the registry about living donors and living donor candidates (whether sought from those persons or other sources—e.g., the idea of linking prescription data over a lifetime raised serious ethical concerns for me).
2. In looking at Appendix B, I appreciated the modification from data about marital status to social support. I wondered why social security numbers and citizenship are being collected—for what purpose? Is this necessary? The necessity and usefulness of each item of information to be collected should be carefully scrutinized in order to minimize burden and risk.
3. As a living donor, I appreciated the transplant center’s medical follow-up at 12 and 24 months and would oppose removing this responsibility. Speaking for myself, knowing that careful follow-up was going to take place gave me some ease of mind in making the decision to donate. I would not favor any “trade-off” of eliminating these transplant center responsibilities in order to put more resources into life-time data collection of donor candidates. I think patient safety and long-term outcomes of actual donors should be heavily prioritized over trying to collect information from living donor candidates.
4. I agree with comments already made that it seems like a lot of resources will go into collecting information on living donor candidates with little likelihood of achieving solid and helpful data on many such candidates (for reasons others have mentioned). I also question, as have others who have commented, whether they would be a reasonable comparative group.
Region 4 | 08/30/2023
Several attendees supported this concept and collecting more comprehensive data on living donors. Those who supported collecting more data also commented that this needed to be done in a way to minimize burden to transplant programs through eliminating redundancy
in other aspects of living donor data collection. Several attendees were concerned with requiring consent from the living donor (or potential living donor) adding that it would add burden and needed resources for the transplant programs. Other attendees supported a national registry for living donors to self-report their status. One added that providing quick access to respond to surveys or entering a survey online would provide the opportunity to capture more variables to access wellbeing. One attendee was very supportive of the data collection, adding that we do a disservice to living donors by not caring about their long-term outcomes. They added that lack of long term and more detailed living donor data means that clinicians have no facts to utilize to answer living donor candidates' questions about outcomes and lifestyle choices post-donation. They went on to comment that if we learn from those that consider donation, but do not donate, we may be more effective in recruiting living donors in the future. They added that we also need non-donor control comparisons. One attendee commented that this data collection seems like yet another unfunded research mandate for transplant centers who are already struggling with existing data burdens and proving actual care for their patients. They added that we need to focus on removing barriers to living donation rather than adding them.
Kari Rancourt | 08/29/2023
As a living donor transplant coordinator, as well as a living donor, I fully support the idea of long term follow up for interested donors. The idea of the SRTR Living Donor Collective is a great solution to data collection to decrease burden to the transplant programs. I have reservations about registering “living donor candidates” to the registry as I believe this creates an excessive amount of data entry burden to transplant centers without a clearly logical reason. Despite data burden being “shifted downstream” this will not be an even exchange of data reporting requirements.
There will be a significantly increased number of individuals that data must be reported on that will not actually achieve the goals of the collective. The Living Donor Candidate group has been proposed to create a control group for long term outcomes as well as to identify barriers to donation. Individuals in this group would likely have been ruled out as candidates, therefore not a comparable control group, or decided not to proceed with donation. I believe the few who may be willing to participate will be small in number, not fully invested, and will not provide reliable data.
If data collection could be streamlined to interface with EMR, the burden of data entry would be significantly reduced. This still doesn’t address the skewed results potentially provided by a limited control group. The larger barrier for donation occurs outside the transplant program (public perceptions, myths, lack of knowledge, lack of access to care).
To address the specific questions asked of the community:
What are living donors’ preferences on how to engage with long-term follow-up?
-Most living donors prefer a simple follow up of self-reporting. However, it is important there are other options to meet all donors’ preferences.
Is living donor candidate the correct term? Is the proposed definition appropriate?
How do living donor programs define evaluation?
-We define evaluation when the potential donor passes the telephone screening and begins testing.
What is the minimum amount of data necessary to collect on living donor candidates?
-I’m not sure, as I have mixed feelings on data points for this cohort.
What are the transplant communities' recommendations related to shifting 12- and 24- month follow-up from the OPTN to the Living Donor Collective?
-I think there still should be some requirement for centers to follow donors for some time period or the incorrect but pervasive perception of centers “not caring about donors” will become worse. It would be great to minimize the requirements of data collection though. Even if the follow up could be a simple phone call to a donor to check in and leave the onus of data collection to willing participants of the collective.
How do living donor programs recommend operationalizing data collection on living donor candidates and donation decision to reduce burden?
-modernize the system to interface with existing EMRs
What data do potential living donors need to inform decision-making and post-donation health care?
-individualized risk modeling
What recommendations do transplant coordinators have on updates to OPTN living donor data collection forms?
-No strong opinions
Steve Weitzen | 08/28/2023
Living Donor Committee Concept Paper Review
The Living Donor Committee (the Committee) has provided us with a concept paper entitled “Concepts for a Collaborative Approach to Living Donor Data Collection”. The Committee proposes a collaborative future state where OPTN and SRTR share the duties of collecting data from living donors and and living donor candidates (i.e., individuals who are pre-screened and come (in-person or virtually) to a transplant center for living donor evaluation).
Below is (a) a view with respect to the proposal, (b) a view of the “considerations for the community”/questions for the community as requested by the Committee toward the end of the concept paper and (c) my concerns with the presentation of the concept paper/video summary which may affect how the proposal may be viewed.
The concept paper states “the benefit of living donation is clear and well demonstrated”. The proposal to perform follow up on living donors and living donor candidates is an excellent idea in order to provide a greater understanding on the long-term impact of donation on a living donor. The PROBLEM is that practicality/reality comes into play.
• Is the SRTR up to the challenge of long term follow up – after all, current follow up programs are far from exemplary, and SRTR has not performed this task before?
• Will transplant centers – who already overworked – have the ability to take on this plan which requires further work from them early within the process? Perhaps have SRTR take on once donation as occurred and thereafter?
• Will communication to living donor candidates and living donors through surveys by email, telephone or mail be effective – don’t surveys have a very low rate of response?
• Will this aggressive (although well-intentioned) plan result in burdensome data requirements to the point that living donation, in and of itself, will not be deemed worth it, and we will rely more heavily on deceased donation – making this whole proposal counterproductive?
• Perhaps instead of burdening transplant centers further to provide data to encourage living donation, we should use other techniques to inform the public of living donation and therefore encourage such donation in that way?
• Will living donor candidates be willing to provide long term information:
a) There are issues of lack of interest because they may not as invested as living donors
b) There are considerations of privacy
c) There is a difficulty in tracking people for long periods of time, especially if they decided not to donate
d) There is limited history of obtaining ANY information from living donor candidates. What makes us believe that a long term project could be effective?
So perhaps the proposal is not perfectly practical? Do we reject the ideas within it just because of it? There will be no perfect idea. That is not a reason to give in or give up. However, if a proposal is somewhat filled with problems/issues, perhaps it needs to be tweaked.
A possible suggestion of the tweaked version:
1. Uphold the proposal “as is” if you can find some data that would show that it could work to a significant extent without overburdening transplant centers.
2. If there is not enough data to prove that the proposal is likely to work, unburden the transplant centers and have SRTR take over at the point of donation, with a true consideration for abandoning the living donor candidate data collection if there is a dearth of evidence that will show it is likely to succeed – especially with respect to the follow up on living donor candidates who decided not to donate.
3. If the proposal is limited as noted above:
a) reallocate some resources of SRTR to collecting data beyond 24 months of donation. The more the information that is provided to prospective donors the more likely it will be that they will donate.
b) reallocate some resources to providing public education of living donation
4. Find a way to reach out to donors that is more likely to be successful than surveys by email, telephone and mail. Perhaps some of the human hours saved by limiting the proposal could free up humans to contact persons to obtain data. Perhaps by agreement to access their online medical records.
5. Reach out to living donors on an annual basis for information.
Considerations for the Community
Listed below are some possible answers/ideas:
· What are living donors’ preferences on how to engage with long-term follow-up?
a) a patient portal
b) combination of patient portal and human follow up
c) get donors agree to long-term follow up, with an opt out at any time, create a registry of these alone, have them agree to have a “contractor” access their medical records online so there is minimal person contact, get an agreement of when personal contact will be made for an interview – perhaps every 5 or 10 years.
· Is living donor candidate the correct term? Is the proposed definition appropriate?
· How do living donor programs define evaluation?
Not knowledgeable enough to answer
· What is the minimum amount of data necessary to collect on living donor candidates?
a) Leave this to the medical experts
b) Same data as on living donors, that is if we have the resources to do so
o What are the specific necessary data elements?
The functioning of the remaining organ and any other health/psychological issues experienced by the donor.
o What organ-specific clinical data are necessary for living donor candidates?
BUN and creatinine for kidneys, liver function tests for liver, PFTs for lungs. However, a lot of this data should be assessed for all donation types.
· What are the transplant communities' recommendations related to shifting 12- and 24- month follow-up from the OPTN to the Living Donor Collective?
a) I don’t care who does it, as long as it is done and available for analysis. The entity that does it should be the one who does it most effectively
b) It makes sense to have SRTR work on this after donation.
· How do living donor programs recommend operationalizing data collection on living donor candidates and donation decision to reduce burden?
· What data do potential living donors need to inform decision-making and post-donation health care?
a) Speaking to a previous donor
b) Baseline data you obtain from an annual physical
c) Risk of death during surgery; short-term risk of complications requiring additional surgeries; long term physical/psychological effects of donation; long term support for donation; percentage of living donors who later need donation, and support systems or advantages for living donors who later need donation; recovery time; worst and best case recovery situations; expected outcomes given personal demographics (age, general health, etc.); probability of recipient outcomes—a living donor might be less likely to donate to a person who had a low probability of a positive outcome; for liver donors, expected time of regeneration
· What recommendations do transplant coordinators have on updates to OPTN living donor data
Not knowledgeable enough to answer collection forms?
o What data elements and data definitions require modifications or deletions?
Not knowledgeable enough to answer
o What data elements are missing from current OPTN living donor data collection forms?
Not knowledgeable enough to answer
Concerns/further questions with the Concept Paper
I know that it's difficult to create a concept paper like this. However, there was some room for improvement in my mind:
1. The concept paper was much too complex in how it was presented. I must have read it a dozen times in whole or in part, and I am still confused to some extent.
2. I found the graphics confusing, especially Figures 3 and 4. In addition, I believe one of those figures, in its presentation at the Regional Meeting for Region 2 appeared different than it did in the concept paper. I am pretty confident that, although I cannot say with absolute definitiveness. I even mentioned it as a comment at the Regional Meeting.
3. Although it wasn't technically part of the concept paper, the video that was presented (which accompanied the proposal on the public comment page) was very confusing. I had a listen to it a number of times to understand the concepts.
4. Is there any evidence that SRTR can achieve success with respect to obtaining long-term data from living donor candidates?
5.What makes the Committee believe this proposal will not tax transplant centers beyond the degree that they can handle?
Perhaps, if there needs to be future presentation of both the paper and the video, they can be revised to deal with the above concerns and questions.
OPTN Transplant Coordinators Committee | 08/28/2023
The OPTN Transplant Coordinators Committee thanks the OPTN Living Donor Committee for their work and for the opportunity to comment on this proposal.
A member expressed support for this effort and emphasized the need for long-term follow-up, especially for living donors who donated with preexisting comorbidities. They said that most health issues that living donors experience do not occur until after two years post-donation, when the donor is no longer being monitored by the transplant program. Some of these issues include increases in weight, high blood pressure, resumption of smoking, and other factors that can increase other comorbidities. The member said they agree with the definition and terminology used in this proposal. They also said that informing potential living donors about what the Living Donor Collective is can be very important, as donors often receive lots of information and surveys that can be confusing and overwhelming.
A member stated that their program has data interface software which allows them to enter information that can be transferred into the OPTN living donor registration (LDR) forms. Another member agreed that long-term follow-up is extremely important and can be useful in determining future donation criteria. The member added that having a universal resource where donors can assess their risk would be beneficial, as there is variability in the information provided. They said that it is important to determine what the term “evaluation” means. The member asked how payment would work for donors who participate in life-long studies and testing and how engaging with donors long-term would work.
Another member supported the proposal as well as the importance of long-term follow up but is unsure how to get good engagement from potential donors who were turned down for donation. They also said it would be difficult for transplant hospitals to bear the costs of lifetime lab tests for living donors. Another member pointed out that although the Centers for Medicare and Medicaid Services (CMS) does not directly define the medical components for a living donor evaluation, the regulations generally define the phases of living donor care. The member urged the OPTN Living Donor Committee to consider whether a patient traveled to the transplant hospital for testing, as this can be vital information. The member continued to say that there may be some unintended consequences in the relationship between the transplant centers and donors if data reporting is transitioned to SRTR and having a transition period would be extremely important. A member echoed the importance of education as to why it’s important to engage in long-term follow-up to donors.
Anonymous | 08/24/2023
I am NOT in support of removing the required 12-month and 24-month follow up for living donors. This is not only for the purpose of data collection. It is a responsibility of the transplant center to verify the donor does not have any medical complications as a result of the donation. Removing the requirement to contact donors and collect medical information also removes the early identification of complications that could be addressed prior to the SRTR identifying something like a dialysis start date.
While this data collection is often difficult, it's the right thing to do for our donor community. My program consistently exceeds the OPTN required % follow up at each interval. It's absolutely possible and necessary.
National Kidney Donation Organization | 08/18/2023
My name is Ned Brooks, and I am Chairman of National Kidney Donation Organization (https://www.nkdo.org/). NKDO is the largest living donor advocacy organization in the country. Among our activities is a program we run in conjunction with the National Kidney Registry called Donor Connect, for which we have over 50 living kidney donors who mentor donor candidates at over 40 transplant centers across the country. This year we will reach out to roughly 30,000 donor candidates and help facilitate about 700 kidney transplants.
I am writing simply to give you the benefit of our experience in dealing with donor candidates so that you may have realistic expectations of the degree of compliance you can expect from donor candidates who do not proceed to donation for whatever reason. My concern is based on our experience with candidates who do not donate, which I would divide roughly into these categories:
1. Start the process and fail to complete the required paperwork.
2. Ruled out by the center.
3. Disappear along the way with no explanation.
4. Change their minds because of negative pressure from family members or others, or because they hear stories which give them pause.
5. Stop the process because their intended recipient received a transplant from someone else.
Groups 1 & 2 are not relevant to this discussion. Group 3 simply will not respond. Group 4 will be very difficult to enlist in any long-term study because they have feelings of guilt or shame that they dropped out, and they do not want to be reminded of that fact on a regular basis. In my non-medical, non-professional experience, your best bet for long term compliance will be group 5.
I don’t know the specifics of how you intend to identify and communicate with the candidates in group 5. Relative to the whole, they are a very small component. Perhaps you will be able to develop a meaningful cohort, and I hope that you do. We wish you success in this undertaking.
Anonymous | 08/07/2023
I donated a portion of my liver to my husband in 2014 and volunteered to be a participant in a study of living liver donor outcomes that was being conducted at our transplant center at the time. The study concluded after my one year surgery anniversary and I have always wished there was some way for me to continue providing information and anonymized medical data in order to better educate future living donors and transplant centers on outcomes.
My transplant center did an admirable job of preparing me for surgery and educating me on potential complications and outcomes, but they were limited by the amount of data they had access to. At my request, I was able to speak to another living living donor about her experience donating to her husband prior to my surgery and that conversation was invaluable for planning and for managing expectations.
While no amount of data or even personal testimony will ever be able to fully prepare someone for such a unique and personal experience, I truly believe the more information made available the better. Additionally, having a database that can be referred to by physicians, such a donor's PCP or other members of a donor's medical team who might not be familiar with the living donor process would be a huge help. I found myself having to attempt to familiarize my doctors outside of the transplant team with the surgery and recovery process of a not very common surgery and having a resource that I could refer them to would have been welcomed.
Francis Wheeler | 08/05/2023
During my decision process of donating a kidney, I was somewhat at a loss for credible information about the post operation results of the donor. I even looked to visit with a past donor and or recipient of a donation which I didn’t know anyone involved in the process and could not recall even seeing an article or news clip about a donation. Ultimately, I leaned on my faith for my decision and am blessed to be a very healthy kidney donor of over eight years.
I believe that providing potential donors, accurate researched outcomes from previous kidney donors, will be very insightful and informative for their decision-making process… the research for the Living Donor Collective is a must have for the future success of living donation growth.
Jill Brown, MPA | 08/02/2023
Ten years ago, I donated my kidney to my child as a living donor. Over the years, it appears that research on living donors hasn't changed much, and we must make strides in understanding the long-term health impacts of organ donation through living donation. Gaining a comprehensive understanding of the effects on the donor's health is vital. It can also shed light on the reasons why potential candidates might choose not to donate, which is equally important. Addressing these barriers could potentially increase support for living donation and inform policy efforts in this area. As such, I wholeheartedly support the concept paper of the Living Donor Collection, as it could pave the way for valuable insights and advancements in this field
Melissa Froelich | 07/27/2023
Collection of long term data on outcomes for living donors should be supported and prioritized so that people considering living donation can make choices with clearer data. The discussions with my family about my decision to donate to my fiancé would have been supported with more information about long term outcomes.
As a living donor, annual outreach and the ability for my PCP to complete the evaluation would give me flexibility. Currently, I could easily travel annually to the facility that preformed the transplant but if we move that would become challenging and I imagine that’s true for many donors.