Pediatric Decision Making: Consensus Recommendations.

Despite apparent disagreement in the scholarly literature on standards of pediatric decision making, a recognition that similar norms underpin many of the dominant frameworks motivated a June 2022 symposium "Best Interests and Beyond: Standards of Decision Making in Pediatrics" in St Louis, MO. Over the course of this 3-day symposium, 17 expert scholars (see author list) deliberated on the question "In the context of US pediatric care, what moral precepts ought to guide parents and clinicians in medical decision making for children?" The symposium and subsequent discussion generated 6 consensus recommendations for pediatric decision making, constructed with the primary goals of accessibility, teachability, and feasibility for practicing clinicians, parents, and legal guardians. In this article, we summarize these recommendations, including their justification, limitations, and remaining concerns.

Refusals of the Determination of Death by Neurologic Criteria: A Mixed Methods Study of Physician Perspectives on Refusals Cases.

OBJECTIVES: Refusals to allow examination for determination of death by neurologic criteria (DNC) challenge pediatric physicians and create distress for medical teams and families of patients suspected to meet criteria for DNC. The objective of this study was to inquire about and assess experiences with such refusals from the perspective of physicians. DESIGN: We conducted a mixed-methods survey and interview-based study to understand physicians' experiences with refusals. SETTING: An online survey was sent to pediatric intensivists and neurologists; phone interviews were conducted in a subset. PATIENTS/PARTICIPANTS: The study included 80 physician survey respondents and 12 interview physician respondents. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Refusals occur for many reasons regarding patients with both acute and progressive brain injury. The most common reasons were consistent in surveys and interviews and include "waiting on a miracle," not wanting to give up, religious objections and disbelief in brain death. Time was an important mediator in many cases. Physicians described several approaches to managing refusals, highlighting the impact on medical teams, distraction from other patients, and need for resources to support physicians. CONCLUSIONS: Refusals may have important sociodemographic associations that should be considered in managing complex cases. Physicians seek more guidance in law and policies to manage refusals.

Coding the Dead: Cardiopulmonary Resuscitation for Organ Preservation.

BACKGROUND: There is lack of consensus in the bioethics literature regarding the use of cardiopulmonary resuscitation (CPR) for organ-preserving purposes. In this study, we assessed the perspectives of clinicians in critical care settings to better inform donor management policy and practice. METHODS: An online anonymous survey of members of the Society of Critical Care Medicine that presented various scenarios about CPR for organ preservation. RESULTS: The email was sent to 10,340 members. It was opened by 5,416 (52%) of members and 405 members (4%) completed the survey with few missing data. A majority of respondents (81%) answered that donation status should not influence whether CPR is performed on an imminently dying patient. There was very strong agreement (>85%) that 1) CPR should be performed on a registered donor who experiences a cardiac arrest with an unknown code status before death by neurological criteria (DNC) and 2) CPR should be performed if the patient is not a registered donor and experiences cardiac arrest but the surrogate/power of attorney (POA) has not yet been approached regarding code status and donation. When a registered donor with a DNR order experiences cardiac arrest before DNC, 98% of respondents would not perform CPR. However, after DNC, respondents were evenly divided on whether they would (49%) or would not (51%) perform CPR on a registered donor with an undocumented code status. When asked whether consent should be required for CPR for organ-preserving purposes, 39% answered "Yes" when a patient arrests before DNC and 48% answered "Yes" when a patient arrests after DNC (P = 0.2). CONCLUSIONS: The majority of respondents did not consider donor status relevant to CPR decisions before DNC, and virtually all would respect a DNR order in a registered donor before DNC. Respondents were divided about the need for an affirmative consent for CPR for organ-preserving purposes both before and after DNC.

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.

Attitudes of Lay Stakeholders and Transplant Professionals About Disclosure to Living Kidney Donors in Exchanges and Chains.

BACKGROUND: Current policies require very limited informational disclosure between living kidney donors and recipients regardless of the relationship type. No specific policies exist to suggest that exchange/chain donors and their recipients should be treated differently. We surveyed transplant professionals (surgeons and nephrologists) and members of the National Kidney Foundation (NKF) to determine their support for disclosing to donors the health, health behavior, and social information of their exchange/chain donors and exchange/chain recipients. METHODS: Twenty questions regarding disclosing to donors information about both their exchange/chain donors and exchange/chain recipients were included in 2 larger surveys on disclosure about kidney transplantation. Survey A was sent electronically to NKF list-servs, and survey B was sent to transplant professionals both electronically and by postal mail. RESULTS: Survey A yielded 236 valid surveys from NKF donors and recipients (lay stakeholders). Survey B yielded 111 valid surveys from transplant professionals. Both sets of stakeholders support disclosing to donors some health and health behavior information of their exchange/chain donor and exchange/chain recipient, and mostly oppose disclosure of social information. Lay stakeholders favored disclosing significantly more information than transplant professionals. Among lay stakeholders, donor respondents were more supportive than recipient respondents in disclosing to donors health information about the exchange/chain recipient. Among transplant professionals, surgeons were more supportive than nephrologists in disclosing to donors information about the exchange/chain recipient that may impact graft survival. CONCLUSIONS: There is broad stakeholder support for disclosing some health and health behavior information to donors about their exchange/chain donors and recipients.

Living Kidney Donors Who Develop Kidney Failure: Excerpts of Their Thoughts.

BACKGROUND: Psychosocial data about living kidney donors have been collected for almost 5 decades now. To date, however, no study has provided any psychosocial follow-up of donors who developed a serious health problem such as end-stage renal disease (ESRD). METHODS: Donors who developed ESRD were invited to participate in a qualitative interview if they met one or both of the inclusion criteria: (1) developed ESRD within 10 years of donating and/or (2) lacked health insurance at the time of donation. We contacted 38 individuals who met these criteria, and 22 participated (58%). Two were subsequently excluded from analysis. RESULTS: Twenty qualitative interviews were analyzed. Five findings are described: (1) donors describe the decision-making process as spontaneous and fast; (2) donors describe lack of appreciation for the need for post-donation self-care; (3) donors do not regret donating despite the adverse outcome; (4) donors advise future donors to have in place emotional and physical support post donation; and (5) donors appreciate the opportunity to tell their story from being a living donor to living with ESRD, which virtually all perceive as 2 separate unrelated events. CONCLUSIONS: Most donors are positive about their donation decision and experience and would donate again, despite developing ESRD themselves. They propose some important changes to the decision-making and informed-consent processes. Our data are reassuring regarding lack of donor regret, but highlight the need for living donor transplant programs to ensure that living donors understand their long-term risks and receive appropriate life-long follow-up care to minimize these risks.

Reporting incidental findings in genomic scale clinical sequencing--a clinical laboratory perspective: a report of the Association for Molecular Pathology.

Advances in sequencing technologies have facilitated concurrent testing for many disorders, and the results generated may provide information about a patient's health that is unrelated to the clinical indication, commonly referred to as incidental findings. This is a paradigm shift from traditional genetic testing in which testing and reporting are tailored to a patient's specific clinical condition. Clinical laboratories and physicians are wrestling with this increased complexity in genomic testing and reporting of the incidental findings to patients. An enormous amount of discussion has taken place since the release of a set of recommendations from the American College of Medical Genetics and Genomics. This discussion has largely focused on the content of the incidental findings, but the laboratory perspective and patient autonomy have been overlooked. This report by the Association of Molecular Pathology workgroup discusses the pros and cons of next-generation sequencing technology, potential benefits, and harms for reporting of incidental findings, including the effect on both the laboratory and the patient, and compares those with other areas of medicine. The importance of genetic counseling to preserve patient autonomy is also reviewed. The discussion and recommendations presented by the workgroup underline the need for continued research and discussion among all stakeholders to improve our understanding of the effect of different policies on patients, providers, and laboratories.

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.

Ethics and professionalism in medical physics: a survey of AAPM members.

PURPOSE: To assess current education, practices, attitudes, and perceptions pertaining to ethics and professionalism in medical physics. METHODS: A link to a web-based survey was distributed to the American Association of Physicists in Medicine (AAPM) e-mail membership list, with a follow-up e-mail sent two weeks later. The survey included questions about ethics/professionalism education, direct personal knowledge of ethically questionable practices in clinical care, research, education (teaching and mentoring), and professionalism, respondents' assessment of their ability to address ethical/professional dilemmas, and demographics. For analysis, reports of unethical or ethically questionable practices or behaviors by approximately 40% or more of respondents were classified as "frequent." RESULTS: Partial or complete responses were received from 18% (1394/7708) of AAPM members. Overall, 60% (827/1377) of the respondents stated that they had not received ethics/professionalism education during their medical physics training. Respondents currently in training were more likely to state that they received instruction in ethics/professionalism (80%, 127/159) versus respondents who were post-training (35%, 401/1159). Respondents' preferred method of instruction in ethics/professionalism was structured periodic discussions involving both faculty and students/trainees. More than 90% (1271/1384) supported continuing education in ethics/professionalism and 75% (1043/1386) stated they would attend ethics/professionalism sessions at professional/scientific meetings. In the research setting, reports about ethically questionable authorship assignment were frequent (approximately 40%) whereas incidents of ethically questionable practices about human subjects protections were quite infrequent (5%). In the clinical setting, there was frequent recollection of incidents regarding lack of training, resources and skills, and error/incident reporting. In the educational setting, incidents of unethical or ethically questionable practices were only frequently recollected with respect to mentorship/guidance. With respect to professional conduct, favoritism, hostile work/learning environment, and maltreatment of subordinates and colleagues were frequently reported. A significantly larger proportion of women reported experiences with hostile work/learning environments, favoritism, poor mentorship, unfairness in educational settings, and concerns about student privacy and confidentiality. CONCLUSIONS: The survey found broad interest in ethics/professionalism topics and revealed that these topics were being integrated into the curriculum at many institutions. The incorporation of ethics and professionalism instruction into both graduate education and postgraduate training of medical physicists, and into their subsequent lifelong continuing education is important given the nontrivial number of medical physicists who had direct personal knowledge of unethical or ethically questionable incidents in clinical practice, research, education, and professionalism.

Attitudes and beliefs of sports medicine providers to sickle cell trait screening of student athletes.

OBJECTIVE: To describe the attitudes of members of the American Medical Society for Sports Medicine (AMSSM) toward the new National Collegiate Athletic Association (NCAA) policy to require all Division I student athletes be screened for sickle cell trait (SCT), have prior evidence of testing, or sign a waiver. DESIGN: Cross-sectional survey of members of the AMSSM electronic mailing list was conducted. Descriptive, McNemar, and χ2 statistics were performed. SETTING: Internet survey. PARTICIPANTS: Of the 1765 AMSSM e-mail list members, 370 returned partial or completed surveys. MAIN OUTCOME MEASURES: Dependent variables included familiarity with the NCAA policy, support of universal or targeted screening programs, preferences regarding screening methodologies, and athletic restrictions or modifications for student athletes identified with SCT. Respondents' gender, race/ethnicity, and involvement as an NCAA team physician were independent variables. RESULTS: Of the respondents, 76% were men, 85% were whites, and 53% served as NCAA Division I team physicians. Ninety percent were aware of the policy. There was greater support for targeted (76%, 267 of 353) compared with universal (39%, 137 of 353; P < 0.01) screening, with targeting based on race/ethnicity and sport. Respondents supported targeted screening of varsity and freshman athletes in all NCAA divisions, but most (88%) also supported waivers. Respondents favored using existing medical records (73%) or Sickledex screening (71%) methodologies despite concerns about inaccuracies (16% for each methodology). Most respondents agreed that there is discrimination in athletic participation and obtaining insurance. CONCLUSIONS: There is lack of consensus within the AMSSM regarding the current NCAA SCT screening policy. Implementation must take into consideration potential discrimination.

Are minority children under- or overrepresented in pediatric research?

OBJECTIVES: There is extensive documentation that minority adults are underrepresented in medical research, but there are scant data regarding minority children and their parents. METHODS: All full-length articles published in the paper edition of 3 general pediatric journals between July 1999 and June 2000 were collected and reviewed. Articles were excluded when they did not include at least 1 US researcher, all subjects at US institutions, parents or children as subjects, some prospective data collection, or between 8 and 10 000 subjects. We recorded the number and race/ethnicity (R/E) of all subjects, the type of research, and the type of data collected. Corresponding authors were surveyed to clarify R/E data. RESULTS: A total of 192 studies qualified. R/E data were reported in 114 (59%) studies, and survey data provided additional or new information in 25 studies resulting in R/E data in 128 (67%) articles accounting for 75% of the subjects. R/E was described by >10 different labels. There was an overrepresentation of black subjects and an underrepresentation of white and Hispanic subjects compared with the census data. When compared with research participation of child subjects, generally, black children were overrepresented and Hispanic children were underrepresented in clinical trials, and both were underrepresented in therapeutic research. Black and Hispanic children were overrepresented in potentially stigmatizing research. CONCLUSIONS: Overall, we found an overrepresentation of black subjects and an underrepresentation of white and Hispanic subjects with significant variations depending on the type of research.

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.