Association of Transplant Center With Survival Benefit Among Adults Undergoing Heart Transplant in the United States.

Importance: In the United States, the number of deceased donor hearts available for transplant is limited. As a proxy for medical urgency, the US heart allocation system ranks heart transplant candidates largely according to the supportive therapy prescribed by transplant centers. Objective: To determine if there is a significant association between transplant center and survival benefit in the US heart allocation system. Design, Setting, and Participants: Observational study of 29 199 adult candidates for heart transplant listed on the national transplant registry from January 2006 through December 2015 with follow-up complete through August 2018. Exposures: Transplant center. Main Outcomes and Measures: The survival benefit associated with heart transplant as defined by the difference between survival after heart transplant and waiting list survival without transplant at 5 years. Each transplant center's mean survival benefit was estimated using a mixed-effects proportional hazards model with transplant as a time-dependent covariate, adjusted for year of transplant, donor quality, ischemic time, and candidate status. Results: Of 29 199 candidates (mean age, 52 years; 26% women) on the transplant waiting list at 113 centers, 19 815 (68%) underwent heart transplant. Among heart transplant recipients, 5389 (27%) died or underwent another transplant operation during the study period. Of the 9384 candidates who did not undergo heart transplant, 5669 (60%) died (2644 while on the waiting list and 3025 after being delisted). Estimated 5-year survival was 77% (interquartile range [IQR], 74% to 80%) among transplant recipients and 33% (IQR, 17% to 51%) among those who did not undergo heart transplant, which is a survival benefit of 44% (IQR, 27% to 59%). Survival benefit ranged from 30% to 55% across centers and 31 centers (27%) had significantly higher survival benefit than the mean and 30 centers (27%) had significantly lower survival benefit than the mean. Compared with low survival benefit centers, high survival benefit centers performed heart transplant for patients with lower estimated expected waiting list survival without transplant (29% at high survival benefit centers vs 39% at low survival benefit centers; survival difference, -10% [95% CI, -12% to -8.1%]), although the adjusted 5-year survival after transplant was not significantly different between high and low survival benefit centers (77.6% vs 77.1%, respectively; survival difference, 0.5% [95% CI, -1.3% to 2.3%]). Overall, for every 10% decrease in estimated transplant candidate waiting list survival at a given center, there was an increase of 6.2% (95% CI, 5.2% to 7.3%) in the 5-year survival benefit associated with heart transplant. Conclusions and Relevance: In this registry-based study of US heart transplant candidates, transplant center was associated with the survival benefit of transplant. Although the adjusted 5-year survival after transplant was not significantly different between high and low survival benefit centers, compared with centers with survival benefit significantly below the mean, centers with survival benefit significantly above the mean performed heart transplant for recipients who had significantly lower estimated expected 5-year waiting list survival without transplant.

Developing an ethics framework for living donor transplantation.

Both living donor transplantation and human subjects research expose one set of individuals to clinical risks for the clinical benefits of others. In the Belmont Report, the National Commission for the Protection of Human Subjects of Biomedical and Behavior Research (National Commission) articulated three principles to serve as the basis for a research ethics framework: respect for persons, beneficence and justice. In contrast, living donor transplantation lacks a framework. In this manuscript, we adapt the three principles articulated in the Belmont Report to serve as the foundation for an ethics framework for living donor transplantation which we supplement with the principles of vulnerability and responsibility. The National Commission supported additional protections for vulnerable groups of potential research participants. In 2001, Kenneth Kipnis effectively argued that the concept of vulnerable groups failed to explore in what ways particular groups of people were vulnerable, thereby risking unnecessary protections for some and inadequate protections for others. He proposed a taxonomy that explored different types of vulnerabilities that all research participants may experience to provide a more robust framework for human subjects protections, which we adapt to living donors. Robert Goodin claims that health professionals, who stand in special relationship with patients, are responsible for promoting and protecting their well-being. In living donor transplantation, the donor transplant team is responsible for empowering prospective donors to address their vulnerabilities and/or for protecting those who cannot by disqualifying them from donation.

Teaching and assessment of ethics and professionalism: a survey of pediatric program directors.

OBJECTIVE: The Accreditation Council for Graduate Medical Education requires residency programs to provide instruction in and evaluation of competency in ethics and professionalism. We examined current practices and policies in ethics and professionalism in pediatric training programs, utilization of newly available resources on these topics, and recent concerns about professional behavior raised by social media. METHODS: From May to August 2012, members of the Association of Pediatric Program Directors identified as categorical program directors in the APPD database were surveyed regarding ethics and professionalism practices in their programs, including structure of their curricula, methods of trainee assessment, use of nationally available resources, and policies regarding social media. RESULTS: The response rate was 61% (122 of 200). Most pediatric programs continue to teach ethics and professionalism in an unstructured manner. Many pediatric program directors are unaware of available ethics and professionalism resources. Although most programs lack rigorous evaluation of trainee competency in ethics and professionalism, 30% (35 of 116) of program directors stated they had not allowed a trainee to graduate or sit for an examination because of unethical or unprofessional conduct. Most programs do not have formal policies regarding social media use by trainees, and expectations vary widely. CONCLUSIONS: Pediatric training programs are slowly adopting the educational mandates for ethics and professionalism instruction. Resources now exist that can facilitate curriculum development in both traditional content areas such as informed consent and privacy as well as newer content areas such as social media use.

Whether and why pediatric researchers report race and ethnicity.

BACKGROUND: Recently, specific policy statements have been published in pediatric journals that question the use of race and ethnicity (R/E) in health care research. OBJECTIVES: To determine why researchers may or may not collect R/E data and to find out their opinion on the importance of R/E and SMs to their research. METHODS: All full-length articles published in the print edition of 3 general pediatric journals published between July 1, 1999, through June 30, 2000, were collected and reviewed. Articles were excluded if they did not include at least 1 US researcher, all subjects at US institutions, some prospective data collection, or enrolled less than 8 or more than 10 000 subjects. We recorded whether the articles documented R/E, socioeconomic markers (SMs), or both in the "Results" section and whether they discussed their significance. Corresponding authors (or researchers) were surveyed to clarify the R/E data, to determine why they had or had not collected R/E data, and to elicit their opinion on the importance of R/E and SMs to their research. RESULTS: One hundred ninety-two studies qualified for further review. One hundred fourteen (59%) reported R/E but only 44 (23%) discussed it. Even fewer 74 (39%) reported both R/E and SMs, and only 33 (17%) discussed both. Researchers collected R/E data because they thought it was relevant and because it described the subject population. Seventy-five percent of the researchers who responded to the survey thought R/E and 63% thought SMs were relevant to their research, and this influenced whether they reported and discussed R/E (P<.001, chi2 test) and whether they discussed SMs (P<.001, chi2 test). CONCLUSIONS: Pediatric statements will require that researchers not mention R/E or explore the extent to which R/E disparities are confounded by other SMs. This will require a cultural shift because many researchers believe that R/E is relevant to their research, and yet, they infrequently report SMs.