When the living and the deceased cannot agree on organ donation: a survey of US organ procurement organizations (OPOs).

The legal concept of first person authorization (FPA) is based on the principle that a decision by a person with decision-making capacity should be respected even after he or she dies. Although the transplant community largely supports this concept, its implementation has not been universal. We conducted a web-based survey of all 58 Organ Procurement Organization (OPO)executive directors in the United States to assess OPOs' procurement policies and practices in the context of family objections. All 58 respondents(100%) responded to our survey. All OPOs except one have an online donor registration website. Most OPOs(89%) (51 of 57 respondents) estimated that the frequency of family objecting to organ donation in cases of registered donors was <10%. No OPOs reported the frequency to be higher than 25%. Only 50% (27 of 54) of the OPOs have a written policy on handling family objections. Approximately 80% of the OPOs reported honoring FPA. However, in the past 5 years, 20 OPOs (35%) have not yet participated in organ procurement from a registered deceased donor over family objection. Further research to identify the barriers and possible solutions to implementing FPA is warranted.

A K-nearest neighbors survival probability prediction method.

We introduce a nonparametric survival prediction method for right-censored data. The method generates a survival curve prediction by constructing a (weighted) Kaplan-Meier estimator using the outcomes of the K most similar training observations. Each observation has an associated set of covariates, and a metric on the covariate space is used to measure similarity between observations. We apply our method to a kidney transplantation data set to generate patient-specific distributions of graft survival and to a simulated data set in which the proportional hazards assumption is explicitly violated. We compare the performance of our method with the standard Cox model and the random survival forests method.

Equal Opportunity Supplemented by Fair Innings: equity and efficiency in allocating deceased donor kidneys.

For 7 years, the Kidney Transplantation Committee of the United Network for Organ Sharing/Organ Procurement Transplantation Network has attempted to revise the kidney allocation algorithm for adults (≥18 years) in end-stage renal disease awaiting deceased donor kidney transplants. Changes to the kidney allocation system must conform to the 1984 National Organ Transplant Act (NOTA) which clearly states that allocation must take into account both efficiency (graft and person survival) and equity (fair distribution). In this article, we evaluate three allocation models: the current system, age-matching and a two-step model that we call "Equal Opportunity Supplemented by Fair Innings (EOFI)". We discuss the different conceptions of efficiency and equity employed by each model and evaluate whether EOFI could actually achieve the NOTA criteria of balancing equity and efficiency given current conditions of growing scarcity and donor-candidate age mismatch.

Good ethics requires good science: why transplant programs should not disclose misattributed parentage.

In 1996, I argued that the recommendation by the Institute of Medicine (IOM) to inform women when tests reveal misattributed paternity and not to disclose this information to the women's partners was morally wrong. I argued in favor of disclosure to both parties. It is a position that I still hold. But claims of misattributed paternity are not 'incidental findings' as it was called in the old genetics literature, but a rather serious indictment of biological infidelity. In this paper I argue that the tests used by transplant programs for living donor-recipient compatibility are inadequate to accurately determine misattributed paternity. Further I argue that it is not the responsibility of the transplant community to undertake such serious forensic evaluations. Genetic inconsistencies in ABO and HLA inheritance should be reported as variations. Families who want further clarification should be referred to a genetic professional.

What the medical excuse teaches us about the potential living donor as patient.

Since the inception of living donor kidney transplantation, physicians have expressed concern about the voluntariness of the donors and their ability to recuse themselves. The literature from the late 1960s and early 1970s reveals the practice of offering a false medical excuse, although more recent comments seem to focus more on a 'general statement of lack of suitability' or 'a blameless explanation'. Simmerling et al. argue that the provision of a medical excuse rests on deception, which is wrong on deontological grounds (that physicians should hold to a principle of veracity) and on consequential grounds (deception threatens to damage trust and the doctor-patient relationship and deception may have adverse impact on the donor's relationship with his family). In this paper I examine and reject these objections. I argue that a false medical excuse is morally unjustifiable, but the medical excuse understood as a 'general statement of lack of suitability' is morally permissible because it promotes donor autonomy (the donor's right to decide whether or not to donate), and protects and preserves the donor's rights to privacy and confidentiality (by affirming the donor as an independent patient).

How different conceptions of risk are used in the organ market debate.

The success of kidney and liver transplantation is hindered by a shortage of organs available for transplantation. Although currently illegal in nearly all parts of the world, a living 'donor' or 'vendor' kidney market has been proposed as a means to reduce or even end this shortage. Physician members of the American Society of Transplantation, the American Society of Transplant Surgeons and the American Association for the Study of Liver Disease were surveyed regarding organ markets for both living kidney and living liver transplantation. The survey queried respondents about their attitudes toward directed living donation, nondirected living donation, the potential legalization of living donor organ markets and the reasons for their support or opposition to organ markets. Partial or completed surveys were returned by 346 of 697 eligible respondents (50%). While virtually all supported or strongly supported directed living donation (98% and 95% for kidney and liver lobes, respectively), the vast majority disagreed or strongly disagreed with the legalization of living donor organ markets (80% for kidneys and 90% for liver lobes). Both those who support and those who oppose a legalized living donor organ market rate risk to the donor among the most important factors to justify their position.

Neighborhood poverty, racial composition and renal transplant waitlist.

To date, no study has characterized the association between neighborhood poverty, racial composition and deceased donor kidney waitlist. Using the United States Renal Data System data linked to 2000 U.S. Census Data, we examined Whites (n = 152 788) and Blacks (n = 130 300) initiating dialysis between January 2000 and December 2006. Subjects' neighborhoods were divided into nine strata based on the percent of Black residents and percent poverty. Cox proportional hazards were used to determine the association between time to waitlist and neighborhood characteristics after adjusting for demographics and comorbid conditions. Individuals from poorer neighborhoods had a consistently lower likelihood of being waitlisted. This association was synergistic with neighborhood racial composition for Blacks, but not for Whites. Blacks in poor, predominantly Black neighborhoods (adjusted hazard ratio [HR] 0.57, 95% confidence intervals [CI] 0.53-0.62) were less likely to appear on transplant waitlist than those in wealthy, predominantly Black neighborhoods (HR 0.80, CI 0.67-0.96) and poor, predominantly White neighborhoods (HR 0.79, CI 0.70-0.89). All were all less likely to be waitlisted than their Black counterparts in wealthy, predominantly White or mixed neighborhoods (p < 0.05). Interventions targeted at individuals in poor and minority neighborhoods may represent an opportunity to improve equitable access to the deceased donor kidney waitlist.

When physicians forego the doctor-patient relationship, should they elect to self-prescribe or curbside? An empirical and ethical analysis.

BACKGROUND: The American Medical Association, the British Medical Association and the Canadian Medical Association have guidelines that specifically discourage physicians from self-prescribing or prescribing to family members, but only the BMA addresses informal prescription requests between colleagues. OBJECTIVE: To examine the practices of paediatric providers regarding self-prescribing, curbsiding colleagues, and prescribing and refusing to prescribe to friends and family. METHODS: 1086 paediatricians listed from the American Academy of Paediatrics 2007 web-based directory were surveyed. RESULTS: 44% (430/982) of eligible survey respondents returned usable surveys. Almost half (198/407) of respondents had prescribed for themselves. An equal number (198/411) had informally requested a prescription from a colleague. Three-quarters (325/429) stated they had been asked to prescribe a prescription drug for a first-degree or second-degree relative, and 51% (186/363) had been asked by their spouse. Eighty-six per cent (343/397) stated that they had refused to write a prescription on at least one occasion for a friend or family member. The following reasons "strongly influenced" their decision to refuse a prescription request: (1) outside of provider's expertise (88%); (2) patient's need for his or her own physician (70%); (3) not medically indicated (69%); (4) need for a physical examination (65%). CONCLUSION: These data confirm that most physicians have engaged in self-prescribing or curbside requests for prescriptions. It can be argued that curbsiding is more morally problematic than self-prescribing because it implicates a third party, and should be discouraged regardless of whether the requester is a colleague, family member or friend.

Ethical issues in increasing living kidney donations by expanding kidney paired exchange programs.

INTRODUCTION: In 1997, Ross et al. proposed to increase the supply of living kidney donations by using kidneys from living ABO-incompatible donors through an exchange arrangement between two living kidney donor-recipient pairs. Although many transplant centers are exploring this option, only a small fraction of potential donor-recipient pairs are eligible for an exchange on the basis of ABO incompatibility. In this article, we explore three variations that have potentially great clinical relevance. METHODS: The three potential variations discussed are: (1) altruistically unbalanced living donor-recipient exchanges; (2) an indirect exchange (an exchange between a living donor-recipient pair with a cadaveric donor-recipient pair) on the basis of a positive crossmatch; and (3) an indirect exchange on the basis of ABO incompatibility. DISCUSSION: The goal of kidney paired exchange programs is to increase the supply of kidneys available for transplantation ethically. We acknowledge that all exchanges increase the potential for coercion, and we currently reject the proposal of altruistically unbalanced exchanges because of the potential for coercion. However, we believe that voluntary consent can be achieved for indirect exchanges. The indirect ABO-compatible exchange creates no new ethical concerns to our original living paired exchange program and we support its implementation. The indirect ABO-incompatible exchange does create a new ethical concern because it may increase the vulnerability of O blood group recipients. If mechanisms can be developed to avoid increasing the waiting time for blood group O recipients, we would support the implementation of the indirect ABO-incompatible exchange.

Primum non nocere: avoiding harm to vulnerable wait list candidates in an indirect kidney exchange.

BACKGROUND: One proposal to increase kidney transplantation is to exchange kidneys between pairs of ABO-incompatible (or cross-match-incompatible) living donors and their recipients. One variation that has greater potential exchanges living donor kidneys for cadaveric donor kidneys (indirect exchanges). A primary concern with indirect exchanges is the potential to disadvantage blood group O wait list candidates. Using wait list modeling, we examine whether this proposal would disadvantage cadaveric kidney blood group O wait list candidates, and present an approach for neutralizing these negative effects. METHODS: A probability model estimated the total number and blood type frequencies of donor-recipient pairs that would participate in indirect exchanges. A supply-to-demand model for the cadaveric kidney wait list estimated the mean wait time under different allocation policies and donor selection mechanisms for candidates on the wait list classified according to the candidates' race and blood type. RESULTS: Indirect exchanges will reduce the mean wait time for cadaveric kidney wait list candidates. The mean wait time of blood group O cadaveric kidney wait list candidates increases when the participating living donors self-select and when kidney allocation is determined by efficiency. This is neutralized when the transplant team preferentially selects blood group O living donors and cadaveric kidney allocation is determined by need. CONCLUSION: Indirect exchange programs will significantly shorten the wait times for cadaveric kidney wait list candidates. The wait times of blood group O candidates will not be affected adversely if blood group O living donors are selected preferentially and if allocation is based on need.

The ethics of preadoption genetic testing.

Developments in genetic technologies have greatly increased our ability to test for a wide variety of genetic disorders in children. These developments raise important ethical questions about the proper use of genetic testing. One context, in particular, where these questions have arisen is that of preadoption genetic testing. This article examines the current consensus view recently advanced by the American College of Medical Genetics and The American Society of Human Genetics on when pediatric testing is ethically permissible. We argue that the consensus view does not adequately recognize the special ethical responsibilities that arise in the preadoption context. Once these special ethical responsibilities are identified, they provide a compelling argument to revise the current standards to permit more preadoption genetic testing than is currently recommended.

Colposcopy and the CO2 laser for treatment of cervical intraepithelial neoplasia. An analysis of seven years' experience.

We performed a study to determine the efficacy of laser therapy for the three grades of cervical intraepithelial neoplasia. Two hundred ninety-two patients were studied. Over 90% of the cases occurred in women between 20 and 30 years of age. Among the 21 patients (7%) with persistent disease, 12 (86%) of the cases were diagnosed within the first six months after laser treatment. Those patients were retreated. The overall cure rate in the study population was 96%.

Religious exemptions to the immunization statutes: balancing public health and religious freedom.

Given the AAP's 1997 position statement on religious exemptions to medical care, authors consider whether failure to immunize a child is medical neglect. Although acknowledging that it is, they argue that parental decisions not to vaccinate on the basis of religious beliefs should be permitted.

Simultaneous determination of carbohydrates and products of carbohydrate metabolism in fermentation mixtures by HPLC.

An improved procedure for separating and quantitating carbohydrates, alcohols, and organic acids in fermentation mixtures metabolized by intestinal microflora is described. The high-pressure liquid chromatographic method is efficient, reproducible, and sensitive. A column packed with cation-exchange resin in the hydrogen form, eluted isocratically with 0.028 M H2SO4 at 40 degrees C separates the compounds of interest. The eluate is monitored with ultraviolet and refractive index detectors in series. On-line acquistion and storage of detector output by a computer allows post-analysis data manipulation and quantitation. Using this method, the metabolic profiles for the fermentation of glucose, fructose, lactose, and sucrose by several intestinal microorganisms are characterized and compared.

Health care decisionmaking by children. Is it in their best interest?

The argument for children's rights in health care has been long in the making. The success of this position is reflected in the 1995 American Academy of Pediatrics recommendations for the role of children in health care decisionmaking, which suggest that children be given greater voice as they mature. But there are good moral and practical reasons for exercising caution in these health care situations, especially when the child and parents disagree. Parents need the moral and legal space within which to make decisions that will facilitate their child's long-term autonomy, not only her present-day autonomy. Moreover, third-party intrusion, by physicians or the state, should be resisted unless negligent and abusive decisions are in the making.

SU-E-E-03: Ethics and Professionalism Education in Medical Physics: A Needs Assessment Study.

PURPOSE: To perform a needs assessment survey of ethics/professionalism education in medical physics and ethical/professional challenges in clinical,research and educational settings with the intent of supplementing and customizing TG159 recommended ethics curriculum for medical physics trainees. METHODS: A web-based survey was conducted among AAPM members to assess current practices, attitudes and perceptions pertaining to ethics/professionalism education and ethical/professional misconduct or questionable behavior and practices in the field. RESULTS: The survey was distributed by AAPM to 7708 members via email; 1362 (17.7%) responded. Seventy-five percent of the respondents were male. Sixty percent (805/1345) stated they received no education in ethics/professionalism. Eighty-one percent (126/155) of current trainees received instruction in ethics/professionalism, as opposed to 35% (392/1130) of those who are post-training. There was strong support (>90%) for continuing education in ethics/professionalism; seventy-five percent (1019/1354) supported sessions on ethics and professionalism at national meetings. Most preferred method of ethics instruction was periodic discussion sessions involving faculty and trainees, with the least interest expressed for a separate course. Many reported direct personal knowledge of one or more instances of a variety of professional/ethical misconduct or questionable behavior. Thirty eight percent (458/1192) reported poor mentorship, with women reporting this concern more often than men (129/281,46% versus 316/877, 36%, p<.05). Over one-fourth of respondents reported being asked to perform low educational value tasks and expressed concerns about fairness. A significant minority also reported questionable behavior with respect to authorship assignment (346/920, 38%), data fabrication (107/924, 12%), data falsification (94/919, 10%); concerns about research subject privacy and confidentiality were lower (64/887, 7%). CONCLUSIONS: Data gathered through the survey is guiding our efforts to develop a case-based ethics curriculum and instructional materials for medical physics trainees at our institution. This effort may be useful to other medical physics programs which offer ethics training/education. This work has been funded in part by a grant from the National Institutes of Health, T32 EB002103-22S1.

Population screening for genetic disorders in the 21st century: evidence, economics, and ethics.

BACKGROUND: Proposals for population screening for genetic diseases require careful scrutiny by decision makers because of the potential for harms and the need to demonstrate benefits commensurate with the opportunity cost of resources expended. METHODS: We review current evidence-based processes used in the United States, the United Kingdom, and the Netherlands to assess genetic screening programs, including newborn screening programs, carrier screening, and organized cascade testing of relatives of patients with genetic syndromes. In particular, we address critical evidentiary, economic, and ethical issues that arise in the appraisal of screening tests offered to the population. Specific case studies include newborn screening for congenital adrenal hyperplasia and cystic fibrosis and adult screening for hereditary hemochromatosis. RESULTS: Organizations and countries often reach different conclusions about the suitability of screening tests for implementation on a population basis. Deciding when and how to introduce pilot screening programs is challenging. In certain cases, e.g., hereditary hemochromatosis, a consensus does not support general screening although cascade screening may be cost-effective. CONCLUSION: Genetic screening policies have often been determined by technological capability, advocacy, and medical opinion rather than through a rigorous evidence-based review process. Decision making should take into account principles of ethics and opportunity costs.