Selective resuscitation in premature twins: an ethical analysis

Selective resuscitation refers to the practice of providing resuscitative efforts to one or some (but not all) infants born in the setting of multiple gestation. When one fetus is known to have a severe anomaly or severe growth restriction, parents are sometimes offered this option. In the setting of extreme prematurity, in the absence of an anomaly or severe growth restriction, parents are generally expected to make one unified decision for all the infants involved. The introduction of the Outcome Estimator, a tool that provides the ability to make individual outcome predictions for each fetus in a multiple gestation at borderline gestational age, based on contributing variables such as weight and gender, has led to the ethical dilemma of whether parents in this setting should also be offered the option of selective resuscitation. No convincing ethical argument for denying the parents the right to decide for each individual infant is apparent

Human cloning laws, human dignity and the poverty of the policy making dialogue

BACKGROUND: The regulation of human cloning continues to be a significant national and international policy issue. Despite years of intense academic and public debate, there is little clarity as to the philosophical foundations for many of the emerging policy choices. The notion of "human dignity" is commonly used to justify cloning laws. The basis for this justification is that reproductive human cloning necessarily infringes notions of human dignity. DISCUSSION: The author critiques one of the most commonly used ethical justifications for cloning laws – the idea that reproductive cloning necessarily infringes notions of human dignity. He points out that there is, in fact, little consensus on point and that the counter arguments are rarely reflected in formal policy. Rarely do domestic or international instruments provide an operational definition of human dignity and there is rarely an explanation of how, exactly, dignity is infringed in the context reproductive cloning. SUMMARY: It is the author's position that the lack of thoughtful analysis of the role of human dignity hurts the broader public debate about reproductive cloning, trivializes the value of human dignity as a normative principle and makes it nearly impossible to critique the actual justifications behind many of the proposed policies

Whole-Exome Sequencing in the Differential Diagnosis of Primary Adrenal Insufficiency in Children.

Adrenal insufficiency is a rare, but potentially fatal medical condition. In children, the cause is most commonly congenital and in recent years a growing number of causative gene mutations have been identified resulting in a myriad of syndromes that share adrenal insufficiency as one of the main characteristics. The evolution of adrenal insufficiency is dependent on the variant and the particular gene affected, meaning that rapid and accurate diagnosis is imperative for effective treatment of the patient. Common practice is for candidate genes to be sequenced individually, which is a time-consuming process and complicated by overlapping clinical phenotypes. However, with the availability, and increasing cost effectiveness of whole-exome sequencing, there is the potential for this to become a powerful diagnostic tool. Here, we report the results of whole-exome sequencing of 43 patients referred to us with a diagnosis of familial glucocorticoid deficiency (FGD) who were mutation negative for MC2R, MRAP, and STAR the most commonly mutated genes in FGD. WES provided a rapid genetic diagnosis in 17/43 sequenced patients, for the remaining 60% the gene defect may be within intronic/regulatory regions not covered by WES or may be in gene(s) representing novel etiologies. The diagnosis of isolated or familial glucocorticoid deficiency was only confirmed in 3 of the 17 patients, other genetic diagnoses were adrenal hypo- and hyperplasia, Triple A, and autoimmune polyendocrinopathy syndrome type I, emphasizing both the difficulty of phenotypically distinguishing between disorders of PAI and the utility of WES as a tool to achieve this

Ethics Review Committee approval and informed consent: an analysis of biomedical publications originating from Sri Lanka

<p>Abstract</p> <p>Background</p> <p>International guidelines on research have focused on protecting research participants. Ethical Research Committee (ERC) approval and informed consent are the cornerstones. Externally sponsored research requires approval through ethical review in both the host and the sponsoring country. This study aimed to determine to what extent ERC approval and informed consent procedures are documented in locally and internationally published human subject research carried out in Sri Lanka.</p> <p>Methods</p> <p>We obtained ERC approval in Sri Lanka and the United Kingdom. Theses from 1985 to 2005 available at the Postgraduate Institute of Medicine (PGIM) library affiliated to the University of Colombo were scrutinised using checklists agreed in consultation with senior research collaborators. A Medline search was carried out with MeSH major and minor heading 'Sri Lanka' as the search term for international publications originating in Sri Lanka during 1999 to 2004. All research publications from CMJ during 1999 to 2005 were also scrutinized.</p> <p>Results</p> <p>Of 291 theses, 34% documented ERC approvals and 61% documented obtaining consent. From the international journal survey, 250 publications originated from Sri Lanka of which only 79 full text original research publications could be accessed electronically. Of these 38% documented ERC approval and 39% documented obtaining consent. In the Ceylon Medical Journal 36% documented ERC approval and 37% documented obtaining consent.</p> <p>Conclusion</p> <p>Only one third of the publications scrutinized recorded ERC approval and procurement of informed consent. However, there is a positive trend in documenting these ethical requirements in local postgraduate research and in the local medical journal.</p

Evidence for physical activity guidelines as a public health intervention: efficacy, effectiveness and harm – a critical policy sciences approach.

BACKGROUND: Evidence for the efficacy of physical activity in conferring health benefits is unequivocal, and this has led national governments to produce guideline recommendations for physical activity levels in their populations. AIM: To evaluate how far evidence for the efficacy, effectiveness and comparative effectiveness of current physical activity guideline recommendations as a public health intervention is considered in developing guideline recommendations, including a consideration of the extent to which, in comparison to alternatives, they may result in harm. METHODS: Utilising a critical policy sciences approach, national physical activity guideline recommendations in Australia, the UK and the USA, and those of the World Health Organisation, are examined, along with their stated underlying evidence bases, to analyse what evidence has been considered, how it has been interpreted, for what purpose, and with what outcomes. RESULTS: All current guidelines recommend 150 minutes moderate physical activity per week. However, efficacy evidence shows 60 minutes is sufficient to provide some health benefits. None of the guidelines consider effectiveness evidence nor potential effectiveness. No evidence could be found for the effectiveness of a recommendation of 150 minutes in improving population health, and none of the guidelines consider whether a recommendation at a lower but still sufficient level of efficacy (e.g. 60 minutes) would be a more effective public health intervention. CONCLUSIONS: Evidence considered in drawing up physical activity guidelines relates only to the efficacy of physical activity in conferring health benefits. The lack of effectiveness evidence, the failure to consider potential effectiveness, and related un-evidenced value judgements call into question the claim that the guidelines are evidence-based. Because neither effectiveness nor comparative effectiveness is considered, it is possible that current guidelines of 150 minutes may result in net harm to population health in comparison to the opportunity cost of recommendations at alternative levels

Public, private and personal: Qualitative research on policymakers' opinions on smokefree interventions to protect children in 'private' spaces

<p>Abstract</p> <p>Background</p> <p>Governments use law to constrain aspects of private activities for purposes of protecting health and social wellbeing. Policymakers have a range of perceptions and beliefs about what is public or private. An understanding of the possible drivers of policymaker decisions about where government can or should intervene for health is important, as one way to better guide appropriate policy formation. Our aim was to identify obstacles to, and opportunities for, government smokefree regulation of private and public spaces to protect children. In particular, to seek policymaker opinions on the regulation of smoking in homes, cars and public parks and playgrounds in a country with incomplete smokefree laws (New Zealand).</p> <p>Methods</p> <p>Case study, using structured interviews to ask policymakers (62 politicians and senior officials) about their opinions on new smokefree legislation for public and private places. Supplementary data was obtained from the Factiva media database, on the views of New Zealand local authority councillors about policies for smokefree outdoor public places.</p> <p>Results</p> <p>Overall, interviewees thought that government regulation of smoking in private places was impractical and unwise. However, there were some differences on what <it>was </it>defined as 'private', particularly for cars. Even in public parks, smoking was seen by some as a 'personal' decision, and unlikely to be amenable to regulation. Most participants believed that educative, supportive and community-based measures were better and more practical means of reducing smoking in private places, compared to regulation.</p> <p>Conclusions</p> <p>The constrained view of the role of regulation of smoking in public and private domains may be in keeping with current political discourse in New Zealand and similar Anglo-American countries. Policy and advocacy options to promote additional smokefree measures include providing a better voice for childrens' views, increasing information to policymakers about the harms to children from secondhand smoke and the example of adult smoking, and changing the culture for smoking around children.</p

Bridging consent: from toll bridges to lift bridges?

<p>Abstract</p> <p>Background</p> <p>The ability to share human biological samples, associated data and results across disease-specific and population-based human research biobanks is becoming increasingly important for research into disease development and translation. Although informed consent often does not anticipate such cross-domain sharing, it is important to examine its plausibility. The purpose of this study was to explore the feasibility of bridging consent between disease-specific and population-based research. Comparative analyses of 1) current ethical and legal frameworks governing consent and 2) informed consent models found in disease-specific and population-based research were conducted.</p> <p>Discussion</p> <p>Ethical and legal frameworks governing consent dissuade cross-domain data sharing. Paradoxically, analysis of consent models for disease-specific and population-based research reveals such a high degree of similarity that bridging consent could be possible if additional information regarding bridging was incorporated into consent forms. We submit that bridging of consent could be supported if current trends endorsing a new interpretation of consent are adopted. To illustrate this we sketch potential bridging consent scenarios.</p> <p>Summary</p> <p>A bridging consent, respectful of the spirit of initial consent, is feasible and would require only small changes to the content of consents currently being used. Under a bridging consent approach, the initial data and samples collection can serve an identified research project as well as contribute to the creation of a resource for a range of other projects.</p

Clinical review: Allocating ventilators during large-scale disasters – problems, planning, and process

Catastrophic disasters, particularly a pandemic of influenza, may force difficult allocation decisions when demand for mechanical ventilation greatly exceeds available resources. These situations demand integrated incident management responses on the part of the health care facility and community, including resource management, provider liability protection, community education and information, and health care facility decision-making processes designed to allocate resources as justly as possible. If inadequate resources are available despite optimal incident management, a process that is evidence-based and as objective as possible should be used to allocate ventilators. The process and decision tools should be codified pre-event by the local and regional healthcare entities, public health agencies, and the community. A proposed decision tool uses predictive scoring systems, disease-specific prognostic factors, response to current mechanical ventilation, duration of current and expected therapies, and underlying disease states to guide decisions about which patients will receive mechanical ventilation. Although research in the specifics of the decision tools remains nascent, critical care physicians are urged to work with their health care facilities, public health agencies, and communities to ensure that a just and clinically sound systematic approach to these situations is in place prior to their occurrence