SRTR Center-Specific Reporting Tools: Posttransplant Outcomes

Measuring and monitoring performance—be it waiting list and posttransplant outcomes by a transplant center, or organ donation success by an organ procurement organization and its partnering hospitals—is an important component of ensuring good care for people with end-stage organ failure. Many parties have an interest in examining these outcomes, from patients and their families to payers such as insurance companies or the Centers for Medicare and Medicaid Services; from primary caregivers providing patient counseling to government agencies charged with protecting patients.
The Scientific Registry of Transplant Recipients produces regular, public reports on the performance of transplant centers and organ procurement organizations. This article explains the statistical tools used to prepare these reports, with a focus on graft survival and patient survival rates of transplant centers—especially the methods used to fairly and usefully compare outcomes of centers that serve different populations. The article concludes with a practical application of these statistics—their use in screening transplant center performance to identify centers that may need remedial action by the OPTN/UNOS Membership and Professional Standards Committee.     

Thoracic organ transplantation

This article presents an overview of factors associated with thoracic transplantation outcomes over the past decade and provides valuable information regarding the heart, lung, and heart-lung waiting lists and thoracic organ transplant recipients. Waiting list and post-transplant information is used to assess the importance of patient demographics, risk factors, and primary cardiopulmonary disease on outcomes.
The time that the typical listed patient has been waiting for a heart, lung, or heart-lung transplant has markedly increased over the past decade, while the number of transplants performed has declined slightly and survival after transplant has plateaued. Waiting list mortality, however, appears to be declining for each organ and for most diseases and high-severity subgroups, perhaps in response to recent changes in organ allocation algorithms. Based on perceived inequity in organ access and in response to a mandate from Health Resources and Services Administration, the lung transplant community is developing a lung allocation system designed to minimize deaths on the waiting list while maximizing the benefit of transplant by incorporating post-transplant survival and quality of life into the algorithm. Areas where improved data collection could inform evolving organ allocation and candidate selection policies are emphasized.     

Transplant data: sources, collection, and caveats

By examining the sources, quality and organization of transplant data available, as well as making observations about data reporting patterns and accuracy, we hope to improve understanding of existing results, help researchers with study design and stimulate new exploratory initiatives.
The primary data source, collected by the OPTN, has benefited from extensive recent technological advances. Transplant professionals now report patient and donor data more easily, quickly, and accurately, improving data timeliness and precision. Secondary sources may be incorporated, improving the accuracy and expanding the scope of analyses. For example, auxiliary mortality data allows more accurate survival analysis and conclusions regarding the completeness of center-reported post-transplant follow-up. Furthermore, such sources enable examination of outcomes not reported by centers, such as mortality after waiting list removal, providing more appropriate comparisons of waiting list and post-transplant mortality.
Complex collection and reporting processes require specific analytical methods and may lead to potential pitfalls. Patterns in the timing of reporting adverse events differ from those for 'positive' events, yielding the need for care in choosing cohorts and censor dates to avoid bias. These choices are further complicated by the use of multiple sources of data, with different time lags and reporting patterns.     

Report of a Consensus Conference on Transplant Program Quality and Surveillance

Public reports of organ transplant program outcomes by the US Scientific Registry of Transplant Recipients have been both groundbreaking and controversial. The reports are used by regulatory agencies, private insurance providers, transplant centers and patients. Failure to adequately adjust outcomes for risk may cause programs to avoid performing transplants involving suitable but high‐risk candidates and donors. At a consensus conference of stakeholders held February 13–15, 2012, the participants recommended that program‐specific reports be better designed to address the needs of all users. Additional comorbidity variables should be collected, but innovation should also be protected by excluding patients who are in approved protocols from statistical models that identify underperforming centers. The potential benefits of hierarchical and mixed‐effects statistical methods should be studied. Transplant centers should be provided with tools to facilitate quality assessment and performance improvement. Additional statistical methods to assess outcomes at small‐volume transplant programs should be developed. More data on waiting list risk and outcomes should be provided. Monitoring and reporting of short‐term living donor outcomes should be enhanced. Overall, there was broad consensus that substantial improvement in reporting outcomes of transplant programs in the United States could and should be made in a cost‐effective manner.     

Has Time Come for New Goals in Human Islet Transplantation?

The enthusiasm regarding clinical islet transplantation has been dampened by the long-term results. Concerns about the associated risks of life-long immunosuppression and the striking imbalance between potential recipients and available donor pancreata warrant changes in some of the current goals.
Islet transplantation will never be a cure of type 1 diabetes in the majority of patients with no secondary complications, but is a valid option for a limited number of patients with brittle diabetes waiting for an organ or after organ transplantation. Furthermore, insulin independence should not be the main goal of islet transplantation, but avoidance of severe hypoglycemia and good glycemic control, which can be achieved with a relatively small functional beta-cell mass. Therefore, initially one islet infusion is sufficient. Retransplantation at a later time point remains an option, if glucose control deteriorates.
Efforts to improve islet transplantation should no longer focus on islet isolation and immunosuppression, but rather on the low posttransplant survival rate of islets caused by activation of the coagulation pathway and the limited oxygen delivery to the islets. Transplantation of smaller islets be it naturally small or size tailored reaggregated islets has the potential to facilitate these processes.     

CMS oversight,OPOs and transplant centers and the law of unintended consequences

Abstract: The Health Resources and Services Administration launched collaboratives with the goals of increasing donation rates, increasing the number of organs transplanted, eliminating deaths on the waiting list and improving outcomes. The Center for Medicare and Medicaid Services (CMS) recently published requirements for organ procurement organizations (OPOs) and transplant centers. Failure to meet CMS performance measures could result in OPOs losing their service area or transplant centers losing their CMS certification. CMS uses analyses by the Scientific Registry of Transplant Recipients (SRTR) to evaluate a transplant center’s performance based on risk‐adjusted outcomes. However, CMS also uses a more liberal (one‐sided) statistical test rendering more centers likely to qualify as low performing. Furthermore, the SRTR model does not incorporate some important patient variables in its statistical model which may result in biased determinations of quality of care. Cumulatively, there is much unexplained variation for transplant outcomes as suggested by the low predictive ability of survival models compared to other disease contexts. OPOs and transplant centers are unlikely to quietly accept their elimination. They may take certain steps that can result in exclusion of candidates who might otherwise benefit from transplantation and/or result in fewer transplants through restricted use of organs thought to carry higher risk of failure. CMS should join with transplant organizations to ensure that the goals of the collaborative are not inhibited by their performance measures.     

Specialty Clinics for the Dermatologic Care of Solid-Organ Transplant Recipients

Background. Solid-organ transplant recipients constitute a complex patient population that experiences numerous and aggressive skin cancers. Proactive, comprehensive, ongoing, and effective dermatologic care of these patients is a necessity.
Objective. The objective of this study was to emphasize the need for organized dermatologic care for transplant recipients and to collect and present various proactive paradigms established in and designed for different practice settings to manage organ transplant recipients at high risk for skin cancer.
Methods. Information about practice setting, patient demographics, and the care model used was obtained through questionnaires sent to a selection of 12 physicians known to care for transplant recipients in various practice settings.
Results. All 12 physicians completed the questionnaire. The organized dermatologic care of transplant recipients occurs in three basic clinic settings: multidisciplinary transplant clinics, designated dermatology transplant subspecialty clinics, and integration of transplant recipient care within existing dermatology clinics.
Conclusions. Various practice settings offer both advantages and disadvantages in providing preventive and therapeutic care of organ transplant recipients at risk for skin cancer. Regardless of the clinic design used, an organized and firmly established clinic model to allow proactive and ongoing care for these patients is important for education, prevention, and early intervention.     

The 20-Minute Rapid MART-1 Immunostain for Malignant Melanoma Frozen Sections

BACKGROUND Immunohistochemical staining has been used to help detect malignant melanoma on Mohs surgery frozen sections. Previous investigators have developed protocols for reliable MART-1 immunostaining of frozen sections, but these protocols are time-consuming.
OBJECTIVE The objective was to report a rapid 20-minute MART-1 immunostaining protocol for frozen sections.
METHODS The protocol was utilized on 30 melanomas treated with Mohs micrographic surgery.
RESULTS The stain clearly highlighted normal background melanocytes, as well as melanocytic hyperplasia and malignant melanoma.
CONCLUSIONS The 20-minute protocol provides a rapid and reliable method for immunostaining of malignant melanoma. The availability of more rapid immunostaining methods improves efficiency of the Mohs laboratory and significantly reduces patient and physician waiting time.     

Living With Survival Analysis in Orthopedics

Time to event data occur commonly in orthopedics research and require special methods that are often called “survival analysis.” These data are complex because both a follow-up time and an event indicator are needed to correctly describe the occurrence of the outcome of interest. Common pitfalls in analyzing time to event data include using methods designed for binary outcomes, failing to check proportional hazards, ignoring competing risks, and introducing immortal time bias by using future information. This article describes the concepts involved in time to event analyses as well as how to avoid common statistical pitfalls. Please visit the following https://youtu.be/QNETrx8B6IU and https://youtu.be/8SBoTr9Jy1Q for videos that explain the highlights of the paper in practical terms.     

Statistical Analysis of Surgical Dog-Ear Regression

BACKGROUND Several methods have been developed to prevent or correct dog-ears. Most of these methods, however, result in prolonged scars and operative times.
OBJECTIVE We observed dog-ears without correction to examine the regression of dog-ears with time.
METHODS The study was performed on 43 cases of dog-ears in 26 patients. Linear regression analysis was performed to examine the correlation between various factors and the height of the dog-ears (%). We produced a regression equation to allow prediction of the height of the dog-ears (%). In addition, we estimated the initial height of the dog-ears that should be removed during surgery.
RESULTS The height of dog-ears regressed with time, and this response was better in younger and female patients. It was predicted that the time taken for a dog-ear to reduce to 50% of its original height was 20.697 days; the median time at which dog-ears completely regressed was 132 days. The odds of regression of dog-ears with an initial height of ≤8 mm was 4.667 times greater than that of larger dog-ears.
CONCLUSIONS If the height of a dog-ear is ≤8 mm, we recommend observation rather than immediate surgical removal.     

Lung allocation in the United States, 1995-1997: an analysis of equity and utility.

BACKGROUND: Waiting time for organ transplantation varies widely between programs of different sizes and by geographic regions. The purpose of this study was to determine if the current lung-allocation policy is equitable for candidates waiting at various-sized centers, and to model how national allocation based solely on waiting time might affect patients and programs. METHODS: UNOS provided data on candidate registrations; transplants and outcomes; waiting times; and deaths while waiting for all U.S. lung-transplant programs during 1995-1997. Transplant centers were categorized based on average yearly volume: small (< or = 10 pounds sterling transplants/year; n = 46), medium (11-30 transplants/year; n = 29), or large (>30 transplants/year; n = 6). This data was used to model national organ allocation based solely on accumulated waiting time for candidates listed at the end of 1997. RESULTS: Median waiting time for patients transplanted was longest at large programs (724-848 days) compared to small and medium centers (371-552 days and 337-553 days, respectively) and increased at programs of all sizes during the study period. Wait-time-adjusted risk of death correlated inversely with program size (365 vs 261 vs 148 deaths per 1,000 patient-years-at-risk at small, medium, and large centers, respectively). Mortality as a percentage of new candidate registrations was similar for all program categories, ranging from 21 to 25%. Survival rates following transplantation were equivalent at medium-sized centers vs large centers (p = 0.50), but statistically lower when small centers were compared to either large- or medium-size centers (p < or = 0.05). Using waiting time as the primary criterion lung allocation would acutely shift 10 to 20% of lung-transplant activity from medium to large programs. CONCLUSIONS: 1) Waiting list mortality rates are not higher at large lung-transplant programs with long average waiting times. 2) A lung-allocation algorithm based primarily on waiting-list seniority would probably disadvantage candidates at medium-size centers without improving overall lung-transplant outcomes. 3) If fairness is measured by equal distribution of opportunity and risk, we conclude that the current allocation system is relatively equitable for patients currently entering the lung-transplant system.     

Cross sectional survey on the concerns and anxiety of patients waiting for organ transplants

Aim: We aimed to gain an understanding of patient concerns while on a transplantation waiting list in areas with long transplant waiting time. Methods: The study population comprised patients with organ failure on the transplant waiting list in Hong Kong. They were invited to complete a questionnaire survey. Demographic data and waiting time were collected. Respondents rated their chance of getting transplanted, their subjective concerns and feelings, level of happiness and support received. Results: A total of 442 patients on the waiting list for kidney, liver, lung and heart‐lung transplants completed the questionnaire survey. The majority of patients (93.0%) were waiting for kidney transplantation. More than half of the respondents (63.3%) had been waiting for more than 3 years. Patients with longer transplant waiting times had lower self‐estimated chance of receiving a transplant (P = 0.004). Self‐estimated chance of getting transplanted was positively associated with the happiness score (P < 0.0001). Issues of most concerns to the patients waiting for organ transplants were: inconvenience of therapy (48.2%), disease progression (47.9%), burden to family (59.5%) and financial difficulties (52.3%). More female patients on the waiting list (50.0% vs 25.7% in male) reported concerns about suffering associated with the illnesses. 21.7% of patients considered the level of support received inadequate. Conclusions: Our patients had long waiting time for transplantation, which is associated with a lower perceived chance of getting a transplant. Attention to more psychosocial support to these patients waiting for organ transplant is important. Promoting and improving organ donation would be the ultimate way to help these patients.     

Rationing scarce organs for transplantation: healthcare provider perspectives on wait‐listing and organ allocation

Ongoing debate about how to maximize the benefit of scarce organs while maintaining equity of access to transplantation exists. This study aims to synthesize healthcare provider perspectives on wait‐listing and organ allocation. MEDLINE, Embase, and PsycINFO were searched till February 21, 2011. Quantitative data were extracted, and a qualitative synthesis of the studies was conducted. Twenty studies involving 4254 respondents were included. We identified two goals underpinning healthcare provider preferences for organ allocation: (i) maximize clinical benefit (quality of life gains, patient survival, treatment adherence, and graft survival) and social outcomes (social support, productivity, and valuation); (ii) achieve equity (waiting time, patient preferences, access to live donation, and medical urgency). Maximizing clinical or social outcomes meant organs would be preferentially given to patients expected to achieve good transplant outcomes or wider social gain. Achieving equity meant all patients should have an equal chance of transplant, or patients deemed more urgent receive higher priority. A tension between equity and efficiency is apparent. Balanced against dimensions of efficiency were considerations to instill a degree of perceived fairness in organ allocation. Ongoing engagement with stakeholders is needed to enhance transparency, a reasonable balance between efficiency and equity, and avoid discrimination against specific populations.     

Costs related to hip disease in patients eligible for total hip arthroplasty

This study was designed to estimate direct and indirect costs incurred by hip disease in patients eligible for total hip arthroplasty (THA). Before THA, 2635 patients completed a questionnaire regarding the use of resources because of their hip disease. Costs were assigned using official statistical sources or market prices. Annual costs amounted to US$ 7666 per patient. In a regression analysis, higher annual costs were associated with working age, female gender, comorbidity, and operation waiting time more than 90 days (P < .005). The burden of disease for THA candidates is extensive, where loss of productivity is the principal cost. Long wait for surgery is associated with increased costs. This study provides baseline cost data, which will be useful for further health economic analyses and could provide guidance for health care decision makers.     

Techniques to Ameliorate the Impact of Second Warm Ischemic Time on Kidney Transplantation Outcomes

Anastomosing the renal artery and vein in transplant recipients without a cooling mechanism exposes the kidney to temperatures exceeding the metabolic threshold (15°C to 18°C), at which the protective effects of renal hypothermia are lost. This anastomotic time, or second warm ischemic time, can be deleterious to graft outcomes, especially if it is prolonged. Techniques to ameliorate organ warming prior to reperfusion have been designed, and range from simpler surface cooling techniques, to organ immersion in bags of ice slush, and the application of ‘jackets’ that incorporate their own internal cooling mechanism. The efficacy of these methods with respect to the minimization of kidney temperature prior to reperfusion and subsequent effects on graft outcomes are discussed using clinical and experimental data, in the setting of open, laparoscopic, and robotic kidney transplantation.     

Basic concepts of statistical analysis for surgical research

Appropriate statistical analyses are an integral part of surgical research. The purpose of this work is to assist surgeons and clinicians with the interpretation of statistics by providing a general understanding of the basic concepts that lead to choosing an appropriate statistical test for common study designs. It is extremely important to understand the nature of the data before embarking on a statistical analysis. A researcher must design an appropriate study around the research hypothesis. Initially, data should be inspected using frequency distributions and graphical techniques. If the data are continuous, the normality of the distribution must be assessed. In addition, the data must be defined as independent or dependent. For normally distributed and independent samples, a two-sample t test is appropriate. A paired t test should be used for dependent data. The nonparametric counterpart to the t test is the Mann-Whitney U and the paired counterpart is the Wilcoxon signed rank. For binary data, contingency table methods such as a chi2 test apply unless the expected value is < 5; then, use the Fisher's exact test. The McNemar test applies to paired binary data. Correlation coefficients assess the association between two continuous distributions. Linear regression assesses trend. Multiple regression analysis is appropriate for multivariate analyses with a continuous outcome variable. Logistic regression methods would apply for binary outcomes. The quality of the analysis and subsequent results of any research project depend on an appropriate study design, data collection, and analysis to make meaningful conclusions.     

Pediatric transplantation, 1994–2003

This article uses OPTN/SRTR data to review trends in pediatric transplantation over the last decade. In 2003, children younger than 18 made up 3% of the 82,885 candidates for organ transplantation and 7% of the 25,469 organ transplant recipients. Children accounted for 14% of the 6,455 deceased organ donors. Pediatric organ transplant recipients differ from their adult counterparts in several important aspects, including the underlying etiology of organ failure, the complexity of the surgical procedures, the pharmacokinetic properties of common immunosuppressants, the immune response following transplantation, the number and degree of comorbid conditions, and the susceptibility to post-transplant complications, especially infectious diseases. Specialized pediatric organ transplant programs have been developed to address these special problems, The transplant community has responded to the particular needs of children and has provided them special consideration in the allocation of deceased donor organs. As a result of these programs and protocols, children are now frequently the most successful recipients of organ transplantation; their outcomes following kidney, liver, and heart transplantation rank among the best. This article demonstrates that substantial improvement is needed in several areas: adolescent outcomes, outcomes following intestine transplants, and waiting list mortality among pediatric heart and lung candidates,