The ethics statement of the Vancouver Forum on the live lung, liver, pancreas, and intestine donor.
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Biomedical subjects
Publications and source records attributed to Linda Wright.
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OBJECTIVE: To examine the association between intrauterine growth restriction (IUGR) status at birth among full-term infants, exposure to substance use during pregnancy, and risk of hypertension at 6 years of age. DESIGN: Prospective evaluation of high-risk children. SETTING: Four centers of the National Institute of Child Health and Human Development Neonatal Research Network. PARTICIPANTS: One thousand three hundred eighty-eight infants (600 cocaine exposed, 781 nonexposed, and 7 indeterminate, matched by gestational age, race, and sex), were enrolled at these sites. Nine hundred fifty children (415 exposed, 535 nonexposed) were followed up for 6 years. Intervention Right arm blood pressure was measured using the Dinamap portable adult/pediatric monitor with appropriate cuff size. Main Outcome Measure Blood pressure levels. Hypertension was defined as either systolic or diastolic blood pressure higher than the 95th percentile for sex, age, and height. RESULTS: Eight hundred ninety-one children had blood pressure data at 6 years of age: 516 were born at full term; 144 (28%) of the 516 children had a diagnosis of IUGR at birth. At 6 years of age, 93 (19%) of 516 children had hypertension. Of 144 children with IUGR, 35 (24%) had hypertension as compared with 58 (16%) of 372 children without IUGR (P<.05). Twenty percent of cocaine-exposed children had hypertension as compared with 16% of nonexposed children (P = .20). Intrauterine growth restriction status at birth was significantly associated with hypertension (relative risk, 1.8 [95% confidence interval, 1.2-2.7]) when multivariable Poisson regression analysis was performed adjusting for site; maternal race, education, and tobacco, marijuana, alcohol, and cocaine use during pregnancy; and child's current body mass index (calculated as weight in kilograms divided by height in meters squared). CONCLUSION: In term infants, IUGR is linked to risk of hypertension in early childhood, which may be a marker for adult cardiovascular disease.
BACKGROUND: A significant proportion of the health care administered to women in Latin American maternity hospitals during labor and delivery has been demonstrated to be ineffective or harmful, whereas effective interventions remain underutilized. The routine use of episiotomies and the failure to use active management of the third stage of labor are good examples. METHODS/DESIGN: The aim of this trial is to evaluate the effect of a multifaceted behavioral intervention on the use of two evidence-based birth practices, the selective use of episiotomies and active management of the third stage of labor (injection of 10 International Units of oxytocin). The intervention is based on behavioral and organizational change theories and was based on formative research. Twenty-four hospitals in three urban districts of Argentina and Uruguay will be randomized. Opinion leaders in the 12 intervention hospitals will be identified and trained to develop and implement evidence-based guidelines. They will then disseminate the guidelines using a multifaceted approach including academic detailing, reminders, and feedback on utilization rates. The 12 hospitals in the control group will continue with their standard in-service training activities. The main outcomes to be assessed are the rates of episiotomy and oxytocin use during the third stage of labor. Secondary outcomes will be perineal sutures, postpartum hemorrhages, and birth attendants' opinions.
To test whether indomethacin prophylaxis has sex-mediated effects on severe intraventricular hemorrhage (grade III and IV) and on long-term outcomes in extremely-low-birth-weight infants. A secondary analysis was performed in the entire "Trial of Indomethacin Prophylaxis in Preterms study" cohort. The results suggest a weak differential treatment effect of indomethacin by sex.
Organ transplantation centers have expanded and increased in the last 20 years as transplant recipient outcomes have improved steadily and transplantation has moved from experimentation to treatment of choice for several indications. Transplantation presents difficult ethical and legal challenges for the transplant community and society. These include declarations of death, consent to donation and allocation of a scarce societal resource, i.e. transplantable organs. Policy and practice reflect the law, societal beliefs and prevailing values. A bioethicist contributes to a transplant team by clarifying values held by various stakeholders or embodied in decisions and policies, conducting clinical consultations, developing and interpreting policy and researching the ethics of innovations for rationing and increasing available supply of organs for transplantation. The bioethicist's interdisciplinary education, preparation, experience and familiarity with ethics, law, sociology and philosophy and skills of mediation, communication and ethical analysis contribute to addressing and resolving many issues in transplantation. This paper outlines the various roles of a bioethicist on a transplantation service, using case examples to illustrate some of the ethical issues.
OBJECTIVES: Necrotizing enterocolitis (NEC) is a significant complication for the premature infant. However, subsequent neurodevelopmental and growth outcomes of extremely low birth weight (ELBW) infants with NEC have not been well described. We hypothesized that ELBW infants with surgically managed (SurgNEC) are at greater risk for poor neurodevelopmental and growth outcomes than infants with medically managed NEC (MedNEC) compared with infants without a history of NEC (NoNEC). The objective of this study was to compare growth, neurologic, and cognitive outcomes among ELBW survivors of SurgNEC and MedNEC with NoNEC at 18 to 22 months' corrected age. METHODS: Multicenter, retrospective analysis was conducted of infants who were born between January 1, 1995, and December 31, 1998, and had a birth weight <1000 g in the National Institute of Child Health and Human Development Neonatal Research Network Registry. Neurodevelopment and growth were assessed at 18 to 22 months' postmenstrual age. chi2, t test, and logistic regression analyses were used. RESULTS: A total of 2948 infants were evaluated at 18 to 22 months, 124 of whom were SurgNEC and 121 of whom were MedNEC. Compared with NoNEC, both SurgNEC and MedNEC infants were of lower birth weight and had a greater incidence of late sepsis; SurgNEC but not MedNEC infants were more likely to have received a diagnosis of cystic periventricular leukomalacia and bronchopulmonary dysplasia and been treated with postnatal steroids. Weight, length, and head circumference <10 percentile at 18 to 22 months were significantly more likely among SurgNEC but not MedNEC compared with NoNEC infants. After correction for anthropometric measures at birth and adjusted age at follow-up, all growth parameters at 18 to 22 months for SurgNEC but not MedNEC infants were significantly less than for NoNEC infants. SurgNEC but not MedNEC was a significant independent risk factor for Mental Developmental Index <70 (odds ratio [OR]: 1.61; 95% confidence interval [CI]: 1.05-2.50), Psychomotor Developmental Index <70 (OR: 1.95; 95% CI: 1.25-3.04), and neurodevelopmental impairment (OR: 1.78; 95% CI: 1.17-2.73) compared with NoNEC. CONCLUSIONS: Among ELBW infants, SurgNEC is associated with significant growth delay and adverse neurodevelopmental outcomes at 18 to 22 months' corrected age compared with NoNEC. MedNEC does not seem to confer additional risk. SurgNEC is likely to be associated with greater severity of disease.
In the 199os, Hewlett-Packard's PC business was struggling to turn a dollar, despite the company's success in winning market share. By 1997, margins on its PCs were as thin as a silicon wafer, and some product lines hadn't turned a profit since 1993. The problem had everything to do with the PC industry's notoriously short product cycles and brutal product and component price deflation. A common rule of thumb was that the value of a fully assembled PC decreased 1% a week. In such an environment, inventory costs become critical. But not just the inventory costs companies traditionally track, HP found, after a thorough review of the problem. The standard "holding cost of inventory"--the capital and physical costs of inventory--accounted for only about 10% of HP's inventory costs. The greater risks, it turned out, resided in four other, essentially hidden costs, which stemmed from mismatches between demand and supply: Component devaluation costs for components still held in production; Price protection costs incurred when product prices drop on the goods distributors still have on their shelves; Product return costs that have to be absorbed when distributors return and receive refunds on overstock items, and; Obsolescence costs for products still unsold when new models are introduced. By developing metrics to track those costs in a consistent way throughout the PC division, HP has found it can manage its supply chains with much more sophistication. Gone are the days of across-the-board measures such as,"Everyone must cut inventories by 20% by the end of the year," which usually resulted in a flurry of cookie-cutter lean production and just-in-time initiatives. Now, each product group is free to choose the supply chain configuration that best suits its needs. Other companies can follow HP's example.
An essential assumption for the usefulness of basing accident prevention measures on minor incidents is the common cause hypothesis: that causal pathways of near misses are similar to those of actual accidents (such as injuries and damages). The idea of a common cause hypothesis was originally proposed by Heinrich in his seminal book "Industrial Accident Prevention" [McGraw-Hill, New York]. In this paper, it is argued that the hypothesis of similarity of causes for major and minor accidents has become confounded with the interdependence of the ratio relationship between severity and frequency. This confounded view of the hypothesis has led to invalid tests of the hypothesis and erroneous conclusions. The evidence from various studies is examined and it is concluded that the hypothesis has not been properly understood or tested. Consequently, such a proper test was carried out using data from the UK railways which were analysed using the confidential incident reporting and analysis system (CIRAS) 21 cause taxonomy. The results provide qualified support for the common cause hypothesis with only three out of the 21 types of causes having significantly different proportions for the three consequence levels investigated: 'injury & fatality', 'damage' and 'near miss'.
Transplantation is an effective, life-prolonging treatment for organ failure. Demand has steadily increased over the past decade, creating a shortage in the supply of organs. In addition, the number of deceased organ donors has reached a plateau. Living-donor transplantation is increasingly an option, influenced by favourable clinical outcomes and increased waiting times at most transplant centres across North America. Living-donor kidney transplants have exceeded deceased-donor transplant rates at some centres. Organ donations from living donors have challenged transplant programs to develop a framework for determining donor acceptability. After a multidisciplinary consensus-building process of discussion and debate, the Multi-Organ Transplant Program of the University Health Network in Toronto has developed ethical guidelines for these procedures. These proposed guidelines address ethical concerns related to selection criteria and procedures, voluntariness, informed consent and disclosure of risks and benefits to both donor and recipient.
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Psychosocial evaluation of potential organ donors ensures that these patients are prepared for donation and that their psychosocial issues have been addressed. The determination that the decision to donate an organ has been made voluntarily by a competent individual is a primary concern for living donor transplant programs, which must work to the highest ethical standard in this unique area of medicine. Identification of potential vulnerabilities on the part of the donor permits monitoring and/or intercession both before and after donation. Ensuring the confidentiality of patient information is important and represents a cornerstone of social work practice. At our institution, social workers have developed an electronic recording tool for use in evaluating organ donors; this tool is designed to maximize quality and ease of information gathering, ensure standardization of practice across programs, simplify record keeping, and enhance communication while minimizing time investment and ensuring patient confidentiality.
Living donor kidney transplantation comprises approximately 30% of kidney transplantations in the United States and is an effective form of renal replacement therapy, with low risk to the donor. Twenty percent of living donors do not have a genetic relationship with their recipients. In the selection of living donors, guiding ethical principles include altruism, the absence of coercion or monetary reward, patient autonomy, beneficence, and nonmaleficence. In order for the benefit of living donor kidney transplantation to outweigh the risk, evidence that the proposed recipient will care for the transplanted organ must exist. Nonadherence to treatment has been identified as a major risk factor for graft rejection. When nonadherence to treatment regimens leads to loss of the graft, the consequences are felt by the recipient, donor, and the treatment team. The decision to transplant an organ to a noncompliant patient from a cadaveric or a living donor raises issues of patient autonomy, justice, paternalism, and benevolence versus nonmaleficence.
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Kidney transplantation from living donors is generally a safe, effective form of renal replacement therapy. When evaluating potential living donors and their intended recipients, a careful assessment process is followed in order to ensure that ethical standards are upheld. During this assessment, important medical information with serious consequences, which was not being sought as part of the donor/recipient evaluation, may be discovered. The information may or may not be relevant to the decision to donate. However, such a discovery raises the difficult questions of whether or not there is an obligation to disclose the information, to whom does the information belong, and what process should be used to resolve the issue? We present a case that forced us to confront these questions and raised issues of truth telling, autonomy, paternalism, confidentiality, and the nature of the relationship between patients and health care professionals.
The Internet serves as a meeting place where people in need of kidney transplants can find strangers willing to donate. While Good Samaritan donors located via the Internet increase the number of kidneys available for transplantation, they also raise ethical issues. This practice alters the pattern for distributing kidneys from unrelated living donors and raises questions of justice in the allocation of organs. It is unclear if commercial forces are at play in the arrangements made between potential donors and recipients via the Internet. While it is unfair that some recipients do not have suitable willing living donors, Web sites help to balance the inequity by increasing the opportunity to find a living donor; they also benefit other potential recipients by reducing the waiting list. However, although these Web sites are probably here to stay, Internet donor-recipient matches can have negative consequences that we need to minimize. Suggested strategies include regulated, monitored Web sites and the development of more anonymous organ donor programs.