Time for Reform in Transplant Program–specific Reporting

AST/ASTS Transplant Metrics Taskforce

Anil Chandraker; Kenneth A. Andreoni; Robert S. Gaston; John Gill; Jayme E. Locke; Amit K. Mathur; Douglas J. Norman; Rachel E. Patzer; Abbas Rana; Lloyd E. Ratner; Jesse D. Schold; Timothy L. Pruett; on behalf of the AST/ASTS Transplant Metrics Taskforce

Disclosures

American Journal of Transplantation. 2019;19(7):1888-1895. 

In This Article

Abstract and Introduction

Abstract

In accordance with the National Organ Transplant Act and Department of Health and Human Services' Final Rule, the Scientific Registry of Transplant Recipients (SRTR) publicly releases biannual program-specific reports that include analyses of transplant centers' risk-adjusted waitlist mortality, organ acceptance ratios, transplant rates, and graft and patient survival. Since the inception of these center metrics, 1-year posttransplant graft and patient survival have improved, and center variation has decreased, casting uncertainty on their clinical relevance. The SRTR has recently modified center evaluations by ranking centers into 5 tiers rather than 3 tiers in an attempt to discriminate between programs performing within a tight range, further exacerbating this uncertainty. The American Society of Transplantation/American Society of Transplant Surgeons convened an expert taskforce to examine both the utility and unintended consequences of transplant center metrics. Estimates of center variation in outcomes in adjacent tiers are imprecise and fleeting, but can result in consequential changes in clinician and center behavior. The taskforce has concerns that current metrics, based principally on 1-year graft and patient survival, provide minimal if any benefit in informing patient choice and access to transplantation, with the untoward effect of decreased utilization of organs and restriction of research and innovation.

Introduction

Publicly released performance comparisons of transplant programs, and their use for regulatory oversight by the Organ Procurement and Transplantation Network (OPTN) and the Centers for Medicare and Medicaid Services (CMS), have changed the delivery of transplant care in the United States. This has had both intended beneficial outcomes and unanticipated ramifications. A prominent "center effect" in kidney transplantation was first noted 40 years ago with documentation of wide variability of outcomes among centers.[1] In response to this heterogeneity, along with other issues affecting outcomes, standards were developed and promulgated, culminating in the Department of Health and Human Services (HHS) Final Rule in 1999, which established the framework for the OPTN. Over time, broad application of improved therapeutics and greater homogeneity in practice patterns resulted in better short-term outcomes, and the variability among centers diminished. However, the concept of public comparisons of transplant programs, and the transparency it represents, is now firmly embedded. Given recent debate over changes in the public release of center metrics, and their implications, transplant professionals identified an opportunity to reassess the purpose, composition, and future direction of transplant center quality metrics. We affirm that a system of transparency is essential for national trust, upon which the donation/transplantation system rests. We also acknowledge that incentives are often misaligned with what is best for patient care. Transplant providers must ethically counsel patients on what is best for them, but must also maintain performance standards and take only "risk-adjusted" risks, which may not be in the patient's interest. While risk-adjusted models evaluating center outcomes are valid statistically, there are concerns that these models fail to capture many critically important factors that contribute to patient outcomes. Furthermore, these underlying characteristics may vary among centers, creating potential bias in measuring quality.[2–6] Though "risk adjustment" is necessary in a system where both patient and donor characteristics affect outcomes, a very small difference in observed compared to expected outcomes can lead to being labeled as an "underperforming center." Since overall program performance lies within a narrow range, there is evidence that a degree of "randomness" exists in which one third of all unique US kidney transplant centers are deemed underperformers in a 3-year period.[7] Moreover, we share the concern of many that processes and implications of publicly released comparisons of US transplant programs have the unintended consequence of reducing organ utilization and limiting availability of care, while doing little to enhance patient choice and access to transplantation. What does it mean to be among the "best" or the "worst" programs in the country, and what are the implications for patients and practitioners of basing those judgments on "risk-adjusted" metrics?

The task force affirms the continued need for transparent reporting of center-level outcomes to ensure patient safety and adherence to allocation rules. However, the task force asserts that the current publicly reported short-term outcome metrics are no longer reflective of the quality of delivered care, and have unintended consequences including limiting organ utilization and excluding high-risk patients who would benefit from transplantation. Furthermore, the existing metrics fail to enable patient decision-making by not informing issues such as access to transplantation, and impact of transplant center choice on the care of their coexisting health concerns.

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