Neonatal Organ and Tissue Donation for Research: Options Following Death by Natural Causes.

The donation of organs and tissues from neonates (birth to 28 days) for transplantation has been a relatively infrequent occurrence. Less common has been the use of neonatal organs and tissues for research. Specific ethical and legal questions beg for rational and transparent guidelines with which to evaluate referrals of potential donors. Donation of organs and tissues from a neonate can play a key role in the care and support provided to families by health care professionals around the time of a neonate's death. We report on the recovery of neonatal organs and tissues for research. A working group made up of bioethicists, neonatologists, lawyers, obstetric practioners as well as organ procurement and tissue banking professionals evaluated legal, ethical and medical issues. Neonatal donor family members were also consulted. Our primary goals were (a) to ensure that referrals were made in compliance with all applicable federal and state laws, regulations and institutional protocols, and (b) to follow acceptable ethical standards. Algorithms and policies designed to assist in the evaluation of potential neonatal donors were developed. Neonatal donation is proving increasingly valuable for research into areas including diabetes, pulmonary, gastrointestinal, genitourinary and neurological development, rheumatoid arthritis, autism, childhood psychiatric and neurologic disorders, treatment of MRSA infection and pediatric emergency resuscitation. The development of policies and procedures will assist medical professionals who wish to offer the option of donation to family members anticipating the death of a neonate.

When slippery slope arguments miss the mark: a lesson from one against physician-assisted death.

In 1989, Susan Wolf convincingly warned of a troublesome consequence that should discourage any movement in American society towards physician-assisted death-a legal backlash against the gains made for limiting life-sustaining treatment. The authors demonstrate that this dire consequence did not come to pass. As physician-assisted suicide gains a foothold in USA and elsewhere, many other slippery slope arguments are being put forward. Although many of these speculations should be taken seriously, they do not justify halting the new practice. Instead, our courts, regulatory agencies, journalists, professional organisations and researchers should carefully monitor and study it as it unfolds, allowing continuous improvement just as our society has done in implementing the practice of limiting life-sustaining treatment.

A Pilot Evaluation of Portfolios for Quality Attestation of Clinical Ethics Consultants.

Although clinical ethics consultation is a high-stakes endeavor with an increasing prominence in health care systems, progress in developing standards for quality is challenging. In this article, we describe the results of a pilot project utilizing portfolios as an evaluation tool. We found that this approach is feasible and resulted in a reasonably wide distribution of scores among the 23 submitted portfolios that we evaluated. We discuss limitations and implications of these results, and suggest that this is a significant step on the pathway to an eventual certification process for clinical ethics consultants.

The Texas Advanced Directive Law: Unfinished Business.

The Texas Advance Directive Act allows physicians and hospitals to overrule patient or family requests for futile care. Purposefully not defining futility, the law leaves its determination in specific cases to an institutional process. While the law has received several criticisms, it does seem to work constructively in the cases that come to the review process. We introduce a new criticism: While the law has been justified by an appeal to professional values such as avoiding harm to patients, avoiding the provision of unseemly care, and good stewardship of medical resources, it is applied incompletely. It allows physicians and institutional committees to refuse "futile" treatments desired by patients and families while at the same time providing no way of regulating physicians who recommend or even push "futile" treatments in similar cases. In this sense, the TADA is incomplete on its own terms.

Patient-satisfaction surveys on a scale of 0 to 10: improving health care, or leading it astray?

Patient-satisfaction surveys can call attention to the importance of treating patients with dignity and respect, but good ratings depend more on manipulable patient perceptions than on good medicine. In fact, the pressure to get good ratings can lead to bad medicine.

Two distinct Do-Not-Resuscitate protocols leaving less to the imagination: an observational study using propensity score matching.

BACKGROUND: Do-Not-Resuscitate (DNR) patients tend to receive less medical care after the order is written. To provide a clearer approach, the Ohio Department of Health adopted the Do-Not-Resuscitate law in 1998, indicating two distinct protocols of DNR orders that allow DNR patients to choose the medical care: DNR Comfort Care (DNRCC), implying DNRCC patients receive only comfort care after the order is written; and DNR Comfort Care-Arrest (DNRCC-Arrest), implying that DNRCC-Arrest patients are eligible to receive aggressive interventions until cardiac or respiratory arrest. The aim of this study was to examine the medical care provided to patients with these two distinct protocols of DNR orders. METHODS: Data were collected from August 2002 to December 2005 at a medical intensive care unit in a university-affiliated teaching hospital. In total, 188 DNRCC-Arrest patients, 88 DNRCC patients, and 2,051 non-DNR patients were included. Propensity score matching using multivariate logistic regression was used to balance the confounding variables between the 188 DNRCC-Arrest and 2,051 non-DNR patients, and between the 88 DNRCC and 2,051 non-DNR patients. The daily cost of intensive care unit (ICU) stay, the daily cost of hospital stay, the daily discretionary cost of ICU stay, six aggressive interventions, and three comfort care measures were used to indicate the medical care patients received. The association of each continuous variable and categorical variable with having a DNR order written was analyzed using Student's t-test and the χ2 test, respectively. The six aggressive interventions and three comfort care measures performed before and after the order was initiated were compared using McNemar's test. RESULTS: DNRCC patients received significantly fewer aggressive interventions and more comfort care after the order was initiated. By contrast, for DNRCC-Arrest patients, the six aggressive interventions provided were not significantly decreased, but the three comfort care measures were significantly increased after the order was initiated. In addition, the three medical costs were not significantly different between DNRCC and non-DNR patients, or between DNRCC-Arrest and non-DNR patients. CONCLUSIONS: When medical care provided to DNR patients is clearly indicated, healthcare professionals will provide the medical care determined by patient/surrogate decision-makers and healthcare professionals, rather than blindly decreasing medical care.

Factors associated with two different protocols of do-not-resuscitate orders in a medical ICU*.

OBJECTIVE: The State of Ohio in the United States has the legislation for two different protocols of do-not-resuscitate orders. The objective of this study was to examine the clinical/demographic factors and outcomes associated with the two different do-not-resuscitate orders. DESIGN: Data were concurrently and retrospectively collected from August 2002 to December 2005. The clinical/demographic factors of do-not-resuscitate patients were compared with those of non-do-not-resuscitate patients, and the clinical/demographic factors of do-not-resuscitate comfort care-arrest patients were compared with those of do-not-resuscitate comfort care patients. SETTING: An ICU in a university-affiliated hospital located at Northeast Ohio in the United States. PATIENTS: A sample of 2,440 patients was collected: 389 patients were do-not-resuscitate; and 2,051 patients were non-do-not-resuscitate. Among the 389 do-not-resuscitate patients, 194 were do-not-resuscitate comfort care-arrest patients and 91 were do-not-resuscitate comfort care patients. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: The factors associated with do-not-resuscitate were older age, race and ethnicity with white race, more severe clinical illness at admission to the ICU, and longer stay before admission to the ICU. Comparing do-not-resuscitate comfort care-arrest patients with do-not-resuscitate comfort care patients, those with more severe clinical illness, longer ICU stay before making a do-not-resuscitate decision, and being cared for by only one intensivist during ICU stay were significantly associated with do-not-resuscitate comfort care decisions. For 149 do-not-resuscitate patients who eventually survived to hospital discharge and 86 do-not-resuscitate patients who eventually did not, only eight (5.4%) and 23 (26.7%) had the order written within 48 hours before the end of ICU stay, respectively. CONCLUSIONS: Our study showed that some clinical/demographic factors predicted do-not-resuscitate comfort care orders. This study also suggested that Ohio's Do-Not-Resuscitate Law, clearly indicating two different protocols of do-not-resuscitate orders, facilitated early do-not-resuscitate decision.

Ethics guidelines for research with the recently dead.

The objective of the multidisciplinary expert Consensus Panel on Research with the Recently Dead (CPRRD) was to craft ethics guidelines for research with the recently dead. The CPRRD recommends that research with the recently dead: (i) receive scientific and ethical review and oversight; (ii) involve the community of potential research subjects; (iii) be coordinated with organ procurement organizations; (iv) not conflict with organ donation or required autopsy; (v) use procedures respectful of the dead; (vi) be restricted to one procedure per day; (vii) preferably be authorized by first-person consent, though both general advance research directives and surrogate consent are acceptable; (viii) protect confidentiality; (ix) not impose costs on subjects' estates or next of kin and not involve payment; (x) clearly explain ultimate disposition of the body.

Informed consent to tissue donation: policies and practice.

Nearly 10 years ago, the tissue industry's informed consent practices with donor families in the United States were criticized. In response, the industry, along with the Inspector General of the Department of Health and Human Services, suggested elements to be included in the informed consent process. This study examines which of these elements were present in the informed consent documents of 45 (78%) of the nation's 58 Organ Procurement Organizations (OPOs). Some elements, such as involvement of for-profit companies, were present in almost all. Others, such as labeling tissue as a gift from donor families, never were. The authors conclude that the time is ripe for reexamination of the informed consent process with an eye to meaningful consent that promotes the benefits of tissue transplantation and at the same time protects the rights and interests of donor families; can be realistically implemented; and, maintains the trust of the American public.

Clinical ethics consultation: examining how American and Japanese experts analyze an Alzheimer's case.

BACKGROUND: Few comparative studies of clinical ethics consultation practices have been reported. The objective of this study was to explore how American and Japanese experts analyze an Alzheimer's case regarding ethics consultation. METHODS: We presented the case to physicians and ethicists from the US and Japan (one expert from each field from both countries; total = 4) and obtained their responses through a questionnaire and in-depth interviews. RESULTS: Establishing a consensus was a common goal among American and Japanese participants. In attempting to achieve consensus, the most significant similarity between Japanese and American ethics consultants was that they both appeared to adopt an "ethics facilitation" approach. Differences were found in recommendation and assessment between the American and Japanese participants. In selecting a surrogate, the American participants chose to contact the grandson before designating the daughter-in-law as the surrogate decision-maker. Conversely the Japanese experts assumed that the daughter-in-law was the surrogate. CONCLUSION: Our findings suggest that consensus building through an "ethics facilitation" approach may be a commonality to the practice of ethics consultation in the US and Japan, while differences emerged in terms of recommendations, surrogate assessment, and assessing treatments. Further research is needed to appreciate differences not only among different nations including, but not limited to, countries in Europe, Asia and the Americas, but also within each country.