Task 5 Public Comments

Transplant Community Feedback

Regulator | 5/6/22

In response to the OPTN approval of new transplant program performance evaluation metrics, an internal review of historical SRTR data revealed pretransplant mortality as an opportunity for improvement. Since pretransplant mortality has myriad contributing factors, clinical and environmental variables were examined that are known to increase risk of mortality. Emphasis was placed on critical examination of health equity based on the timeliness of this topic within the transplant community. The health disparity of our own (N=144) waitlist transplant patients was evaluated and the unique needs identified were those patients who: reside in low food or transportation access areas; live below the poverty line; have barriers to exercise, nutrition, and mental health care. These variables didn’t differ statistically across counties despite the DRA distressed designation further highlighting the health equity needs across the state. Building on this research, we will examine common cause mortality of waitlisted patients and further assess a broader patient population such as those patients in the referral and evaluation phases. Our evaluation revealed unique opportunities to better care for and advocate on behalf of the patients seeking transplant care in Arkansas to our governing bodies. The USDA and DRA designate this region as lacking requisite resources and advocacy for additional risk adjustment due to regional disparities is needed when calculating the number of expected waitlisted deaths.

National Kidney Foundation | 5/5/22

The National Kidney Foundation (NKF) appreciates the opportunity to comment on the Task 5 Initiative’s request for transplant metrics. We applaud the Scientific Registry of Transplant Recipients’ (SRTR) efforts to develop quality measures that help the public, patients, their families, and other stakeholders better understand the transplant system and support their decision-making as they navigate their transplant journey.

As SRTR embarks to “identify metrics to assess national transplantation system performance and support informed decision-making by critical audiences,” we encourage you to prioritize measures that are of importance to patients and their families. Metrics must be uniform, patient-centered, and drive performance improvement at each step of the transplantation process: from referral to evaluation to waitlisting through transplant and post-transplantation follow-up. Measurement must be system-wide and include all stakeholders, including nephrologists, dialysis centers, transplant centers, donor hospitals, and Organ Procurement Organizations (OPOs). While NKF has provided recommendations for measures specific to each of these domains, our goals for these recommendations are to:

  • Increase access to the transplant waitlist
  • Maximize the number of organs procured and transplanted
  • Minimize the number of organs discarded
  • Increase the number of living donations
  • Drive continuous performance improvement across the transplant process

Further, NKF encourages you to leverage this opportunity to collect data and metrics that advance equity in transplant access across all racial and ethnic communities. As you know, Black/African American and Hispanic/Latino people, as well as people from other structurally disadvantaged groups, are less likely to access a kidney transplant than white patients. In particular, Black/African American patients are less likely to undergo transplant evaluation, are less likely to be placed on the waitlist for a transplant, spend more time on the transplant waitlist, are less likely to survive to receive a kidney transplant, and have lower rates of graft survival post-transplant. Better assessment of system performance – stratified by race and ethnicity – can inform policymaking and performance improvement activities and will assure equitable access for all prospective transplant recipients.

Organ Procurement Measures

Organ Procurement Organizations (OPO) are the only stakeholder within the transplant ecosystem responsible for the recovery of deceased organs. While they collect data, much of it is self-reported and not comparable from OPO to OPO. Better transparency and comparability could facilitate improvement by underperforming OPOs, resulting in the recovery of more organs for transplantation. With over 100,000 people on the transplant waitlist, it is imperative that UNOS collect and share OPO data through SRTR to drive accountability and equity in organ donation. Specifically, we encourage SRTR to collect and publicly share information about OPOs’ performance on the following:

  • Number of organ referrals broken down by donor hospital and zip code
  • Number of missed organ referrals for each donor hospital
  • Percentage of referrals that the OPO approached for organ donation per  donor hospital
  • Percentage of organ referrals who were first-person consent per donor hospital
  • Percentage of actual organ donors that were first-person consent per donor hospital
  • Number of organ referrals consented for organ donation, which was not first-person consent per donor hospital
  • All categorized by race, ethnicity, and age except as prohibited by confidentiality

Pre-Transplant Listing Measures

Patient access to the deceased donor waitlist has not increased in two decades and has fallen in socially vulnerable populations (1). Reporting on specific pre-listing data is vital to ensuring that all people are referred for transplantation regardless of race, ethnicity, socioeconomic status, and other demographic factors. Nephrology patients must be informed that dialysis is not the only treatment modality after kidney failure. While kidney transplantation is not a cure for kidney failure, it is the optimal treatment, untethering patients from dialysis machines and significantly improving their quality of life.

Access to the transplant waitlist is an issue of health equity. It is a disservice to patients to claim that because organ supply cannot meet the demand, patients should not be educated on and encouraged to pursue kidney transplantation. It is no fault of patients that we have not done everything possible to maximize the organ supply. To better understand the population in need of transplantation, we ask SRTR to facilitate the procurement of transplant referral data and patient waitlist death data, specifically, the:

  • Number of referrals to transplant programs from both nephrologists and dialysis centers
  • Demographic and socioeconomic characteristics of patients referred
  • Annual waitlist patient deaths with accompanying cause of death, demographic and socioeconomic characteristics

Waitlist Measures

NKF is troubled by the lack of transparency regarding organ offers declined on a patient’s behalf, often without their knowledge. Patients deserve to be active participants in their healthcare. We urge SRTR to create a quarterly report for waitlisted patients that details the number of times an organ was offered on their behalf, declined, and transplanted at another center within 500 nautical miles. The report should include information about the KDPI of kidneys that were offered for waitlisted patients if they were transplanted, and the reason the transplant center declined the offer.

While transplant centers are not the sole provider of direct patient care for waitlisted patients, transplant centers are responsible for communicating with patients, ensuring readiness for transplant, and providing education about living donation. Remaining active on the list, knowing their activation status and their time on the waitlist is paramount for patients. Capturing the percentage of waitlisted inactive patients and why they have become inactive are patient-centered measures of the patient’s process experience that we would like to see as a transplant metric.

The following metrics for transplant programs are also performance standards that would improve patient-centeredness and equity in the transplant process:

  • Percent of referred patients who complete the transplant evaluation
  • Average time from referral to evaluation
  • Average time from evaluation to listing
  • Percent of referred patients placed on the transplant waitlist
  • Demographics and socioeconomic status of patients on the waitlist
  • Demographics of patients denied access to the waitlist

Transplant Measures

Patient and graft survival, along with quality of life, are critical components that patients consider when they consider transplantation as a treatment option for organ failure. NKF appreciates the 1-month, 1-year, and 3-year post-transplant outcomes. SRTR should also capture 90-day graft survival, as it is critical for capturing safety concerns resulting from poor organ selection and patient management.

We also encourage SRTR to look beyond 1-year patient and graft survival. We appreciate the 3-year graft survival metric and would also advise SRTR to implement a 5-year transplant outcome measure. Though transplant centers are familiar with 1-year graft survival, the focus on relatively short-term survival of the patient and graft has contributed to a culture of risk-aversion at transplant centers. We are also concerned that 1-year graft survival may be misaligned with efforts to list and transplant more patients and accept and transplant more less-than-perfect kidneys. SRTR should also report 5-year outcomes compared with anticipated survival if patients remained on dialysis. This transplant benefit calculation is consistent with patient expectations. Any outcome measures should be acuity-adjusted so as not to disincentivize transplantation of higher-risk patients and should be measured relative to medical management.

While patients’ desired outcomes vary from patient to patient, SRTR can collect and share patient satisfaction data that reflects the transplant patient experience. We encourage SRTR to be thoughtful about collecting this data, as it can become nuanced with patients approving of one aspect of their care while disapproving of others. Transplant centers can also use this information to improve patient care and safety and as a resource for prospective organ recipients to use when scouting transplant centers.

We hope that SRTR can strike the right balance between ensuring patient safety coupled with an optimal experience and giving transplant centers the flexibility to make the acceptance decision that aligns with each patient’s values and preferences. SRTR should adopt the following transplant metrics to share with patients who are evaluating transplantation as the next phase in their healthcare treatment:

  • 90-day graft survival
  • 5-Year transplant outcomes
  • Patient-reported satisfaction with their transplant experience

Organ Discards

Far too many potential donor organs are discarded due to inefficiencies and perverse incentives in the transplant system. In 2018, 3,755 recovered kidneys were untransplanted, and that number grew to 4,460 in 2019 (2). Many of these organs were clinically viable and could have offered renewed hope and health to kidney patients. Instead, they were thrown away. This is a disservice to the patients who rely on the transplant system and a tragedy for donor families whose loved ones’ sacrifices were squandered. To increase the number of organs procured and transplanted, SRTR should collect data on:

  • The number of organs recovered for transplant that are discarded and never transplanted
  • The reason why each transplant center declined an organ offer (organ decline code)
  • Percentage of organs declined by each transplant center
  • Outcome of organs declined by the transplant center
  • Utilization of higher risk donor organs by center
  • Procurement of organs from high-risk donors by OPO

Final Consideration

SRTR must share data with the public in a patient-facing way that is easy to decipher. The program-specific reports (PSR), including the interactive reports, are valuable tools for patient use, and we would encourage SRTR to make them easier for patients to understand. We recommend asking patients for their input on how SRTR can disseminate data in a digestible way. We would also suggest eliminating specific epidemiological terminology/measures such as “person years” and reconsidering the use of rate ratio estimates in favor of a more straightforward method. Sharing data reporting as close to real-time as possible is imperative for patients to make appropriately informed decisions about transplantation. There is a significant delay in the metrics presented to the public, which could create a false picture of transplant performance, and this is something SRTR should amend expeditiously. Lastly, we cannot stress enough the importance of the patient voice. If SRTR is looking to improve transplant metrics for the public, it is critical to find meaningful ways to include patients in these kinds of conversations to allow them to inform the data collecting and sharing process.

We appreciate the chance to offer our commentary to SRTR on meaningful transplant metrics for patients. We hope that collecting this data will help identify opportunities for improvement within the organ donation and transplant system and inspire and facilitate the development of system-wide best practices.

 

Sincerely,

                              

Kevin Longino                             Paul Palevsky, MD
CEO and transplant patient           President

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(1) doi:10.1681/ASN.2020060888, (2) doi:10.1111/ajt.16491 

DhruvaMukesh Sharma, Transplant Provider | 5/3/22

Indeed, a great effort on the part of the entire team. I am thankful, as the contents help me update existing knowledge about organ transplant programs. I am looking forward to being a part of and contributing in a better way to the organ donation and transplant cause.

American Society of Transplant Surgeons (ASTS) | 5/2/22

On behalf of the American Society of Transplant Surgeons (ASTS), I am pleased to have the opportunity to respond to the Scientific Registry of Transplant Recipients (SRTR) solicitation of comments on the Task 5 Initiative. We understand that the goal of this initiative is to “identify metrics to assess national transplantation system performance and support informed decision-making by critical audiences.”

Our recommendations regarding SRTR metrics were provided to the SRTR in oral comments on September 23, 2021 (1) and are available here. However, since that time, there have been important developments that we believe warrant consideration. In particular:

  • The Centers for Medicare and Medicaid Services (CMS) issued a Request for Information (RFI) soliciting information on changes that should be made to the Transplant Center Conditions of Participation (CoPs), especially with respect to metrics and transparency of information provided to patients;
  • The Health Resources and Services Administration (HRSA) also issued an RFI soliciting comments on potential changes in the role and responsibilities of the Organ Procurement and Transplantation Network (OPTN) (including potential changes in the OPTN’s data collection and management systems and the need for increased focus on transparency with respect to information provided to patients); and
  • The National Academies of Sciences, Engineering and Medicine (NASEM) issued a comprehensive report setting forth a blueprint for improvements in the national transplantation system (including, among other things, the need to establish national transplantation goals and a “dashboard” to chart progress towards these goals).

While we understand that Task 5 charges the SRTR with the development of system metrics, we strongly concur with the NASEM Report recommendation that metrics should be formulated to track progress toward specified goals, and the establishment and prioritization of the system goals should precede efforts to design metrics: Otherwise, the exercise risks becoming “measurement for measurement’s sake.” We further believe that the establishment and prioritization of goals is a task that should involve agencies beyond HRSA, including most notably CMS, but also including the FDA, NIH, and other offices within HHS. The establishment of national goals—and especially the ranking of priorities—is not as easy an exercise as it might at first appear, since there are inevitably tradeoffs and tensions among various goals. For example, there are potential tensions between the goal of maintaining and improving transplant outcomes and increasing utilization of hard to place organs; between increasing transparency and expediting decision making; and between increasing organ sharing and lowering the cost of transplantation. In our view, the balancing of priorities among various important system goals should precede the establishment of metrics to measure progress toward those goals. For this reason, we urge SRTR to actively involve other agencies with jurisdiction over transplantation in the establishment of goals and the weighting of priorities as a precursor to establishing the metrics called for by the Task 5 initiative.

Because of the complexity of the transplantation process, we also request that SRTR consider the potential unintentional consequences of any metrics that emerge as a result of the Task 5 initiative. In the field of transplantation, it has been shown that metrics drive behavior, and, in fact, they are often intended to do so. However, behavior changes incentivized by new metrics may have consequences that were not intended, and we believe that any recommendation to establish new metrics should be accompanied by a “SWOT analysis” that identifies potential unintended consequences.

More generally, we believe that new and continued data collection activities moving forward should comply with the following principles:

  • Data collection should be clearly tied to, and necessary for the achievement of, a clearly stated goal or objective that is one of the National Transplantation Goals.
  • New data collection should be authorized only if the data is unavailable from any existing data source.
  • The appropriate audience for the data should be clearly identified and consulted about the utility of the proposed data collection before data collection is instituted.
  • How data is used should also be considered and any new metrics should be classified as to their purpose. For instance, will the data be compared to other data on a national or local level, or by center to center? Will the data be presented on a curve or by using a minimal baseline? We believe any patient facing public information should be distinguished from program quality metrics.
  • The potential inadvertent repercussions of data use and dissemination should be thoroughly considered in advance.
  • The data collection administrative burden on transplant centers should not be increased: If additional data elements are to be collected, an effort should be made to reduce or eliminate other data collection requirements that may be unnecessary, obsolete, or not tied to a national transplant system goal.

We appreciate the opportunity to provide input to the SRTR with respect to the Task 5 initiative and look forward to participating in the Consensus Conference this summer.


Sincerely yours,

A. Osama Gaber, MD, FACS
President, American Society of Transplant Surgeons

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(1) See ASTS virtual presentation to the SRTR Task 5 Steering Committee, Thursday, September 23, 2021 (https://asts.org/docs/default-source/regulatory/asts-presentation-to-srtr-task5-steering-committee-september-23-2021.pdf?sfvrsn=500a47d3_2). 

Patient | 5/1/22

As a family member of a potential liver transplant recipient, this was one of my first websites I researched. Thank you for the work you do. In this scary, unknown time, it's grounding to look at statistics and data to help us feel more confident in the decisions we make. Thank you.  

Catherine Campbell, Patient | 1/18/22

I’d like to recommend a metric that includes weekend transplants and discarded kidneys over the weekend.

Richard Barmore, Patient | 1/6/22

A lot of good professional healthcare databases, but I am not quite sure on the procurement dates of the data. There is a mixture of current and past data which makes it difficult to review a solid answer and recommend reviews.

Dr. Dhruva Sharma, Transplant Provider | 12/27/21

Thanks for providing us an opportunity to contribute from India.

Greetings of the day,

I would request SRTR to involve us from our part of the world, so that we can keep ourselves updated with the global community.

Probably choosing one local professional involved in transplant activity can be given the duty to spread awareness and increase participation of the local transplant professional.

Chuck Zollinger, Organ Procurement Professional | 12/13/21

Dear SRTR and Steering Committee,

An additional category of stakeholders to consider is transportation. OPOs and transplant centers rely heavily upon the commercial airlines to safely and effectively transport kidneys across the US, but all too often, it seems, kidneys and prospective kidney recipients are negatively impacted by inefficiencies in the airline industry. We need them at the table to help us identify areas for improvement.

Robert Friedman, Patient | 12/3/21

With regard to the applicability of any database to the needs of the patient and caregiver populations, numerous factors diminish its usefulness: 1) the population that does not have internet access and/or access to suitable hardware; 2) the population that is not computer literate; 3) the population for whom physical disabilities render the ability to use the interface problematic; 4) the population whose ability to use written English, due to literacy or language issues, is a barrier; 5) the population that is lacking in the baseline awareness and education in transplantation, so as to understand the terminology, questions, and implications of the data; and 6) the population in acute crisis, with cognitive impairments and/or inability to process the quantitative data as a basis for decision-making.

If the above-mentioned groups, along the continuum of disease progression causing the need for a transplant, constitute 80% of the target population, the question arises if, regardless of the appropriateness of the data, is there a capacity to transmit it, even in its best arrayed and most relevant format, to the target population.

Of course, educational curriculum provided online by the major patient organizations is helpful. IPRO efforts at making UNOS data more patient friendly are somewhat helpful. Seminars and support groups can provide information in a more personalized way.

SRTR data can serve as a terrific basis for professionals, patients, and advocates to better facilitate informed decision-making, but with regard to the kidney community (my area of expertise), the core approach is flawed.

The expectation that practitioners will utilize the data is grossly unrealistic. In an ideal model, the doctor-patient relationship would have the doctor accessing the data and helping to inform and guide the patient, but too often patients are served by PCP's who lack the understanding of the transplant processes, eligibility, and options. Specialists too, face enormous demands upon their time, and the productivity demands of their practice preclude spending time with patients in what is essentially a counseling role. Current reimbursement from government and private insurers does not reward time spend in this area, despite the cost-benefit possible from transplantation.

Dialysis centers, under new CMS initiatives, are somewhat incentivized financially to promote transplantation, but the incentive may be insufficient to overcome economic, cultural, and staffing barriers. Many centers are staffed by nephrologists who have an ownership stake in the clinics, or a vested financial interest in maintaining their patient population. While patient hospitalizations and mortality disrupt the center operation, turnover from transplants also disrupt a model where the smallest number of patients needed to maintain chair utilization is the most manageable goal.

If the social worker, a mandated role in every center, is theoretically responsible for patient evaluation, care planning, and support, the reality is that most center staff are used in admissions, discharge planning, reporting and recordkeeping, and rarely have experience with transplants.

So how can these barriers be surmounted? Assuming that SRTR data can be immensely useful to patients, perhaps the challenge of translating it to the whole population, including the large number that I began by asserting are categorically unlikely to benefit, can be addressed as follows:

That a standardized curriculum be developed to train patient advocates, social workers, and transplant coordinators. Such training for peer counselors has heretofore focused upon empowering them to provide emotional support, and a very schematic view of outlining options, for fear of their providing misinformation. The level of patient expertise that resides in the ranks of the kidney patient organizations is such that mentors can far better help others to consider transplantation and "negotiate the system." In addition to patient peer mentors, a higher level of paid staff needs to be developed. "Certified Transplant Counselors."

In addition to a higher level of expertise suitable for medical social workers, nurses/physician assistants, or physicians, these persons would be trained specifically to access what is presently presented as the SRTR Patient Interface, and to translate the data in terms appropriate to the patient, while advising them, referring them, following up, and serving as a bridge between the patient and family, and the transplant system. In effect, what is needed to develop a stratum of ombudsmen, utilizing the front-end of the database as the AI component for computer-assisted counseling and advocacy.

Such a concept is not new. Where a class of patients has been systematically neglected, and in this case, I am referring to my own personal experience in the infamous "Willowbrook Case," in the 1970s, wherein a class action of residents in a state facility for the developmentally disabled sought relief for systematic abuse and neglect. As part of a court-approved consent decree, New York State established a Mental Health Information Service, to provide individualized representation and support to every resident of that facility. Whereas the consent decree mandated the establishment of community alternatives, the Information Service created a bridge between the goals of that decree, and the mechanics of insuring that every member of the class received appropriate care.

Today, in America, all metrics on kidney care clearly justify the assertion that the class of persons with advanced kidney disease are in a "Willowbrook-like" dilemma. From a policy perspective, the recent America's Kidney Health Executive Order recognized this, and CMS efforts have sought to address equity, allocation, incentivizing transplantation, and innovation. What is needed, in addition to expanding the pool of living donors and fast-tracking treatment options, is to formally create the apparatus to enable SRTR data to produce its intended outcome.

This will require funding, not just to compile and display evidence-based data, but to reimburse those who will enable patients and families to best access and use the data—a role that is presumably subsumed within current reimbursement, but which clearly does not happen often enough, as long as the time and effort involved is not supported through a discrete funding stream.    

Angela Cuozzo, Patient | 12/2/21

SRTR is new to me. I donated my kidney (nondirected), in 2010 and at that time, was not aware of this organization. It would have been a valuable resource to me in my research on being a living donor. The data is robust and I would think that this resource is a great tool in making decisions regarding the transplant centers available when becoming a living donor. However, all the data in the world that is made available to living donors prior to donation does not solve the problem of post donation follow-up statistics. I know that I am biased, but I have found that my concern is valid and prevalent in the community of living donors. Donor follow-up and support is grossly lacking globally. 

Transplant Provider | 11/24/21

Transplant metrics have handcuffed the whole transplant community. Centers can take very little risk and it gets less and less every year due to the general risk averse approach. As 1-year patient and graft survival continue to increase (because of largely lower risk recipients), fewer and fewer patients can be considered as "good candidates." Patients with perfectly acceptable risk have a very real risk of being declined if a center has had a few unexpected deaths or graft loss. The simple fact that ANY death unrelated to transplant (including MVA, suicide, murder, etc.) is counted in these very few allowable events can be catastrophic to a center and to patients hoping to be listed.

Metrics need to identify a program functioning below a standard of care. Standard of care needs to actually reflect real world and not defensive reflex practice.

Risk adjustment needs to account for ALL risk—not just what "most centers" are exposed to and not based on even just the risk averse cohort currently undergoing transplant. Currently someone with skin cancer gets the same risk adjustment as someone with CCA or other cancers.

Transplant metrics need an overhaul and get back to a patient focused approach—with a focus on providing lifesaving transplant to as many who would benefit from such a procedure.

Elizabeth Boehnlein, Transplant Provider | 11/23/21

We are hearing from our staff that patients are uncomfortable with all of the personal questions we are asking them. Pretransplant, the biggest issue is around citizenship, functional status, work status, and education history. Posttransplant, it continues with functional status as well as work status for the first 5 years. We are wondering if you already have an education document focused on these topics for patients that can be shared? Thank you!

Transplant Provider | 11/17/21

Please stop publishing metrics that rank programs based on statistical differences and not CLINICALLY RELEVANT differences. It hampers innovation and makes programs risk averse. There is no clinically meaningful difference between 97% and 94% 1-year survival (often the difference being 1 or 2 patient outcomes).

James Gleason, Patient | 11/15/21

Both as a heart recipient out 28 years and as president of TRIO (Transplant Recipients International Organization), I am very interested in supporting this effort in every way possible. I look forward to the July 2022 conference and plan to attend if invited.

Transplant Provider | 11/1/21

Interested in LOS index.