Alexander A. Kon

The Role of Empirical Research in Bioethics

There has long been tension between bioethicists whose work focuses on classical philosophical inquiry and those who perform empirical studies on bioethical issues. While many have argued that empirical research merely illuminates current practices and cannot inform normative ethics, others assert that research-based work has significant implications for refining our ethical norms. In this essay, I present a novel construct for classifying empirical research in bioethics into four hierarchical categories: Lay of the Land, Ideal Versus Reality, Improving Care, and Changing Ethical Norms. Through explaining these four categories and providing examples of publications in each stratum, I define how empirical research informs normative ethics. I conclude by demonstrating how philosophical inquiry and empirical research can work cooperatively to further normative ethics.

The Clinical and Translational Science Award (CTSA) Consortium and the Translational Research Model

The shift from isolated researchers working in their individual laboratories to diverse research teams working in collaboration towards a common goal is a fundamental element of the Clinical and Translational Science Award (CTSA) (http://www.ctsaweb.org/). What is often misunderstood, however, is the depth and breadth of the translational paradigm. The NIH Roadmap discusses two basic steps of translation. First, basic science research must be translated to humans (the so-called T1 translation), and then secondarily translated into clinical practice (T2 translation) (http://nihroadmap.nih.gov/). Further work has demonstrated that in fact this second phase of translation includes two separate steps, first knowledge from T1 translational studies must be translated to patients (T2), and then we must translate our knowledge into actual clinical practice (T3 translation) (Westfall et al. 2007). Closer scrutiny, however, reveals more complexity and the need for many levels of translation. In this essay, I will briefly outline some of the myriad levels of translation necessary, and provide some examples to illustrate why further work is needed at these levels. Further, I will briefly describe the CTSA Consortium and discuss how this new model of research is attempting to address some of these needs. Translation takes many forms. If we start with a finding in a basic science laboratory that might have applications to the care of humans, such knowledge must go through many steps before it can have clinical applications. Basic scientific data must be translated into animal models, often this translation may start with non-primate mammals with subsequent translation into non-human primates. These pre-human experiments represent many layers of translation and require the collaboration of many scientists working in different research laboratories. Next, under the T1 translation, clinical researchers must assess the clinical applications in limited clinical conditions through controlled early-phase clinical trials. Next, knowledge from these early clinical experiments must be applied more broadly through phase 3 trials. Once clinical applications have been demonstrated through this T2 translation, clinicians must find ways to move these findings into the daily care of patient (T3). Merely translating findings to the actual bedside, however, is not enough. Moving scientific knowledge into the public sector and thereby changing people’s everyday lives represents a major challenge (T4). While many focus heavily on T1 and T2 translation, without T3 translation we cannot bring the benefits of medical research to individual patients. There exist many examples where despite excellent clinical research demonstrating clear benefit, individual physicians are slow to adopt best practices. One such example is the evidence that despite the clear benefits of statins in patients with elevated cholesterol, many patients for whom statins are indicated are not placed on appropriate therapy (Pasternak et al. 2002). Further, we must also translate scientific knowledge into people’s everyday lives. Merely knowing that an intervention can

Healthcare Providers Must Offer Palliative Treatment to Parents of Neonates With Hypoplastic Left Heart Syndrome

H YPOPLASTIC LEFT heart syndrome (HLHS) affects approximately 1000 infants annually in the United States. Several treatment options exist, including the staged surgical approach, cardiac transplantation, banding of the pulmonary arteries, in utero balloon valvuloplasty, and other novel and experimental techniques aimed at prolonging life and minimizing sequelae. Alternatively, parents may believe that the burdens of these interventions outweigh the benefits and may decide that it is in their child’s best interest to pursue care that minimizes suffering without prolonging life. Such management has previously been termed comfort care. However, for reasons that will be described, it should be more

Instruction in the Responsible Conduct of Research: An Inventory of Programs and Materials within CTSAs

The National Institutes of Health (NIH) require instruction in the responsible conduct of research (RCR) as a component of any Clinical and Translational Science Award (CTSA). The Educational Materials Group of the NIH CTSA Consortiums Clinical Research Ethics Key Function Committee (CRE‐KFC) conducted a survey of the 38 institutions that held CTSA funding as of January 2009 to determine how they satisfy RCR training requirements. An 8‐item questionnaire was sent by email to directors of the Clinical Research Ethics, the Educational and Career Development, and the Regulatory Knowledge cores. We received 78 completed surveys from 38 CTSAs (100%). We found that there is no unified approach to RCR training across CTSAs, many programs lack a coherent plan for RCR instruction, and most CTSAs have not developed unique instructional materials tailored to the needs of clinical and translational scientists. We recommend collaboration among CTSAs and across CTSA key function committees to address these weaknesses. We also requested that institutions send electronic copies of original RCR training materials to share among CTSAs via the CTSpedia website. Twenty institutions submitted at least one educational product. The CTSpedia now contains more than 90 RCR resources.

Home Pediatric Compassionate Extubation: Bridging Intensive and Palliative Care

Compassionate home extubation for pediatric patients is a topic that seldom appears in the literature and is of unknown clinical importance. However, standards in pediatric intensive care unit (PICU) and among pediatric critical care physicians regarding end-of-life decisions are changing, including where and when patient extubation occurs. The authors’ hospice recently consulted on an infant with spinal muscular atrophy in the PICU requiring mechanical ventilation, for whom further life-sustaining care was deemed futile. In consultation with the family, nursing staff, physicians, and the ethics committee, and following protocol guidelines, arrangements were made for this infant and his parents to be transported home. Once comfortable with his family, a small amount of lorazepam was given and the endotracheal tube removed. The infant died quietly about 20 minutes later. This case prompted the authors to review the current state of published articles covering this topic, suggest a protocol for implementing home extubation, realize imposed barriers, and discuss potential solutions. A well-developed plan for home extubation procedures may improve interactions with PICU and hospice services and at the same time provide additional choices for parents and patients wishing to maximize end-of-life quality outside the hospital setting.

Burnout assessment in house officers: Evaluation of an intervention to reduce stress

Background: Medical house officers are at increased risk for stress related symptoms leading to professional burnout. Aims: Measure burnout in house officers and establish whether utilization of a psychotherapeutic tool individually by physicians reduces symptoms characteristic of burnout. Method: Two groups of pediatric house officers at the University of California Davis Health System completed a Maslach Burnout Survey (MBS) at the beginning and end of a three-month period in 2003. An Intervention group (7 of 15 enrolled) was trained in the use of a self-administered psychotherapeutic tool. Outcome Measures were MBS scores and a qualitative interview of intervention group members. Results: There were no significant differences between the two groups, prior to the study or over time. Qualitative interviews revealed that subjects experience stressors in relation to their professional activities, but already utilize some elements of the tool and were too busy to implement the entire tool systematically. Conclusions: Pediatric trainees did not seem to manifest burnout symptoms based upon the MBS; interviews suggested that some do experience significant stress, although manifestations and responses were varied, some may be at risk. Methods identifying individuals at risk for burnout, and interventions to cope with stress may be valuable to their training.

The "window of opportunity:" helping parents make the most difficult decision they will ever face using an informed non-dissent model

At times, the anticipated future quality of life of a patient is so poor that parents and healthcare providers agree that withdrawing life-prolonging interventions is most appropriate. Unfortunately, some physicians (particularly many in the United States) believe that their role is to merely present facts (e.g., anticipated prognosis) and options (e.g., continue or remove life-support), and let the parents choose the interventions that will and will not be provided to the child based on the family’s values and beliefs. This model of decision-making has occurred for many reasons (a full discussion of which is beyond the scope of this essay), and has left many parents feeling abandoned when they must alone bear the burdens of making agonizing choices (Loewy 1998). In 2004, and international consensus statement on decision-making specified that a shared decision-making model, in which patients (or parents for the sake of this essay) and physicians jointly reach decisions regarding goals of treatment (Carlet et al. 2004). While the move away from a strict autonomy-based decision-making process towards a shared decision-making standard is moving slowly, already several states in the United States have adopted legislation allowing physicians to unilaterally limit or withdraw lifeprolonging interventions even over the objection of the patient or surrogate (Texas explicitly, and California implicitly) thereby ’giving teeth’ to the shared decision-making model (California Probate Code; Texas 1999). As we move towards a shared decision-making model, United States physicians are becoming more comfortable being active participants in the decision-making process. While the roles of physicians and parents are different, both are agents in the decision-making process. As such, physicians are gradually bearing more of the burden of decisionmaking, and such a move may help to unburden some parents. The key to an effective and appropriate use of the shared decision-making model is to have open and honest communication between all stakeholders, mutual respect,

We cannot accurately predict the extent of an infant's future suffering: the Groningen Protocol is too dangerous to support.

It is terrible to watch a child suffer. Like many others who care for children in the intensive care unit (ICU), I have too often witnessed what I considered to be intolerable suffering. Watching a dying child undergo painful procedures or anxiety-provoking interventions when there is no hope for cure or even providing prolongation of life with symptom improvement can be unbearable for care providers and parents. When medical interventions merely prolong dying and the care providers and parents agree that limiting or withdrawing life-prolonging measures is most consistent with the child’s best interest, then doing so is appropriate and well-accepted. Indeed, most children who die in United States hospitals do so after life-prolonging interventions have been limited or withdrawn (Garros et al. 2003). Also troubling to healthcare providers is performing invasive life-prolonging procedures on a child who is deemed to have no reasonable chance for a meaningful life. Although less well published, I have often heard physicians, nurses, and others in the ICU question whether it is reasonable to perform cardiac surgery on a child with severe chromosomal abnormalities, place a tracheostomy and surgical feeding tube in a child with profound neurodevelopmental delay, or even correct a tracheoesophageal fistula in a child with trisomy 21 (as was the question in the famed Baby Doe case). In such cases providers, and at times parents, question the appropriateness of invasive life-prolonging interventions. The Groningen Protocol, however, goes one step further and creates a system whereby healthcare providers and parents may choose to terminate the life of a child based on the judgment that the child’s future quality of life is so low that death is a better option than life. Like Jotkowitz and colleagues (Jotkowitz et al. 23), it is clear to me that the Dutch protocol has been used, and is meant to be used, solely for infants who are not terminally ill (Verhagen et al.

Evaluation of Race and Ethnicity on Alcohol and Drug Testing of Adolescents Admitted with Trauma

OBJECTIVES To describe the incidence of alcohol and drug testing in adolescents admitted for traumatic injury and to analyze these results with reference to race, ethnicity, and gender differences. METHODS Data were collected on adolescents (aged 12 through 17 years) from the National Trauma Data Bank. Testing statuses for alcohol and drugs were the two primary outcome variables. The results of these tests were the secondary outcome variables. Additional casemix variables included: race, ethnicity, gender, age, Glasgow Coma Scale score, Injury Severity Score, day and time of arrival, and payment source. Hierarchical, multivariable logistic regression models were used to assess the relationship of race, ethnicity, and gender with the primary and secondary outcome variables. RESULTS Differences noted in the likelihood of alcohol and drug testing among the different racial, ethnic, and gender groups demonstrated an increased likelihood of Hispanic males and African American females to receive alcohol testing (odds ratio [OR]: 1.48; 95% CI = 1.06 to 2.06; and OR: 1.30; 95% CI = 1.01 to 1.67, respectively). Results of testing revealed that females of all races were less likely than males to test positive for alcohol and drugs. Drug and alcohol testing was more common during evenings, nights, and weekends, as well as in the presence of neurologic injury. CONCLUSIONS Whereas small disparities in alcohol and drug testing were noted in some minority race-based groupings, systematic racial bias is not evident in adolescent trauma patients.

Complex bioethics consultation in rural hospitals: using telemedicine to bring academic bioethicists into outlying communities.

Bioethics consultations are necessary to ensure excellent patient care and all US hospitals are required to provide access to bioethics consultants for cases raising ethical or moral dilemmas. However, there is a paucity of trained clinical ethicists. While assistance from trained bioethicists may be obtained via telephone or email, such methods of contact do not allow a bioethicist to engage fully with all members of the health-care team, the patient and family members. In two recent cases, rural hospitals contacted our centre for assistance with complex ethics cases. We provided a clinical ethics consultation via videoconferencing. The outcomes of the consultations would probably have been inferior had they been performed via telephone. For example, the non-verbal cues allowed the consultants to have a better understanding of the team dynamics, and led them to ask important questions that directly affected the recommendations which were made. Because patients are likely to benefit significantly from access to bioethicists when ethical questions arise, rural and community hospitals should consider teleconsultation when local ethics committees decide that further assistance is warranted.