Displaying 1-10 letters out of 612 published
Re:End of Life Decisions - Do we make them wisely?
Reply to End of Life Decisions - Do we make them wisely?: End of life decisions: How do we improve process? We thank Dr Cohn for his response to our paper and for voicing the issues it raised for him. Certainly one of the objectives of the study was to explore whether there were differences in approach to similar medical disorders in NICUs across Canada. We hoped that our finding of differences in what appear to be medically similar disorders would cause physicians and teams to reflect on how they come to EOL decisions and why variability exists. We agree that the working environment of an NICU may be a major factor in such decisions and defined the term 'ethical culture' of an NICU as the prevailing ethical consciousness and sensitivity to moral issues in an NICU. This, we believe is understood by the health care professionals as the readiness to engage in ethical discourse, the respect given to diverse views and values, the past experience of the unit and the awareness of the group as to the normative boundaries of deviation in ethical decision making. Although we, together with Dr Cohn, can only speculate that this 'culture' does have a strong influence on individual and team behavior, we were not able to probe this further via the design of our study. Only with very detailed, multidisciplinary (including parental perspectives) description of individual decisions one may be able to uncover how decisions are derived and to what degree they are a manifestation of "this is the way we do things here". As to the concern that consensus may have been achieved in the face of junior members of the team or even parents feeling unable to voice dissent, we specifically asked each responsible neonatologist to comment on the ease of the consensus-building process. We trustingly accepted their description on a spectrum of difficulty. As to the concern of how each individual deals with medical uncertainty, we hope to explore this aspect in a deeper analysis of the study findings. What we cannot agree with is Dr Cohn's "solution" that "ethics panels" judge these matters. It is not clear what is envisaged but a spectrum of bioethics committees and consultation services do exist in North America and elsewhere. Such committees may be decision making or more likely (certainly in Canada) more procedurally oriented in helping teams elucidate values, preferences, and the rightful voices to be heard to ensure fair process and help teams determine the ethical defensibility or vulnerability of different options. There may be other committees in which panels judge decisions but in Ontario this would only come into operation when intractable differences exist between parents and the team as to the best interest of the newborn infant. Here the Consent and Capacity Board can be called into action when the parents' role as substitute decision makers is questioned or the parents seek an alternate pathway to resolution of difference with the team. We firmly believe the safeguards Dr Cohn seeks remain in the integrity of neonatal physicians, parents and teams deriving decisions by open sharing of values, clarification of issues, moral reasoning and negotiation towards consensus (with bioethics consultation when necessary).
Authors: Jonathan Hellmann,1 Prakesh S Shah2 1 Department of Bioethics and Division of Neonatology, Hospital for Sick Children, Toronto 2 Department of pediatrics, Mount Sinai Hospital, Toronto.
Conflict of Interest:
Handheld Doppler use for measuring newborn HR has been described in the literature
We read this article with considerable interest as it confirms that Precordial Doppler Ultrasound (PDU) can detect the neonatal heart rate within seconds of birth, much earlier than is possible with oximetry and much more reliably than with auscultation. As the authors state "Handheld Doppler use for measuring newborn HR has been described in the literature" (by Goenka et al and by Hutchon) "but needs further investigation before being used clinically.". Dyson et al chose to use a Hadeco Smartdop 45 (Hadeco--2-7-11 Arima, Miyamae-ku, Kawasaki, 216-0003, Japan), which is a bidirectional handheld Doppler usually used for measuring arterial and venous blood flow in the extremities although it can also detect a fetal HR. In 2014 we demonstrated the use of a readily available and low cost dedicated fetal doppler machine and found the 2mHz probe readily detected the neonatal heart rate when placed on the chest(1). We reported on the Contec Sonoline C2 Pocket Fetal Doppler which also provides a digital display of heart rate and records the signal for subsequent computer download, and documentation and review.
We have also shown that if the transducer is separated from the hand held probe of the machine and connected with light flexible wiring, the lightweight transducer can sit on the neonate's chest held in place simply by the surface tension of the ultrasound gel. This allows hands-free use and avoids the risk of excessive pressure by a handheld probe on the neonate's chest. The position of the transducer on the chest is not critical and can easily be adjusted. By aligning with the skin the transducer automatically scans at 90 degrees.
Precordial Doppler Ultrasound (PDU) can be readily adapted to provide a measurement of the neonatal heart rate at caesarean section without compromising the sterile surgical field. The Doppler machine is connected to a bluetooth transmitter and placed inside a sterile polythene bag ensuring that transducer is coated in ultrasound gel and in contact with the wall of the bag. The transducer can then be handled by a member of the scrubbed team and applied to the neonatal chest through a further application of ultrasound gel. The signal is received by a matching bluetooth receiver outside the sterile field. This can be used to provide an audible signal to the neonatologist and team and recorded for documentation and audit.
For the preterm neonate at risk of hypothermia it is important to avoid exposure of the skin and PDU can be carried out through the recommended polythene wrap without the exposure of the neonatal skin required by ECG or oximetry.
Although we reported on the Contec Sonoline C2 Pocket Fetal Doppler, other machines without a recording facility have been shown to be as effective. After a few minutes when oximetry is functional the PDU becomes redundant.
Goenka S, Khan M, Koppel RI, Heiman HS. Precordial Doppler Ultrasound Achieves Earlier and More Accurate Newborn Heart Rates in the Delivery Room. Pediatric Academic Societies and Asian Society for Pediatric Research 2014; 590p.
Hutchon DJR. Technological Developments in Neonatal Care at Birth. J Nurs Care 2014; 3: 218.
Conflict of Interest:
Re: Water births: adverse events for the baby are rare but devastating
We are grateful for the interest in our paper and the opportunity to refute the suggestion that it is falsely reassuring. Our paper provides a fair and accurate representation of the best available data; it concludes that "this systematic review and meta-analysis did not identify definitive evidence that waterbirth causes harm to neonates ... However, there is currently insufficient evidence to conclude that there are no additional risks or benefits for neonates".
It does indeed state that "existing evidence is not strong enough to examine the relative risk of rare and potentially devastating adverse events" as well as citing the risk of aspiration in a compromised baby who was born gasping (paragraph 8).
It is incorrect to suggest that the susceptibility to bias of different study designs was ignored and that results are reliant on poor quality retrospective studies. The entire meta-analysis was repeated, for every outcome, using data only from randomised controlled trials. These results were entirely consistent with the primary analysis and are available to view in supplementary file D.
There are a number of ways to examine safety and capture rare, serious adverse events. The merits and drawbacks of each approach must be carefully considered before any future study. We recognise the limitations of prospective cohort studies and agree that a large, adequately powered RCT would be ideal to determine the safety of waterbirth. However, there are significant ethical and practical issues with randomising enough women. In one UK pilot, of 40 women randomised to water birth, only 10 delivered in water. The National Institute for Health Research recently called for an observational study to address this question and stated the design 'should not involve randomisation given the rarity of adverse events'.
 Woodward J, Kelly SM. A pilot study for a randomised controlled trial of waterbirth versus land birth. BJOG: an international journal of obstetrics & gynaecology. 2004 Jun 1;111(6):537-45.
 National Institute for Health Research (NIHR). HTA commissioned funding opportunities, call 15_157 'Delivering babies in or out of water'. http://www.nets.nihr.ac.uk/funding/hta-commissioned
Conflict of Interest:
Re: Current debate about the limit of viability: the neglected majority
Neonatal mortality in poor countries
We appreciate Dr. Berger's astute observation that most of the babies in the world do not have access to neonatal intensive care. His statistics underestimate the extent of the problem. Around the world, 7 million infants die each year. Most die of diseases that are preventable or treatable. Their deaths are due to lack of access to the most basic medical care. This is not unique to premature babies. Most health outcomes are better in wealthier countries. This is a serious problem of distributice justice.
We would suggest, however, that resource allocation decisions in both poor countries and rich consistently favor adults and older children over neonates. The systematic devaluation of neonates, prevalent in high- income countries, also exists in emerging economies. For example, the Disease Control Priorities Project, an ongoing effort to produce evidence- based analysis and resource materials to inform health policymaking in developing countries, suggests that the death of a 20 year old is worse than the death of a neonate: "An individual life acquires value only as it acquired self-awareness [...] an individual life acquired value as it develop bonds with others." An Institute of Medicine (1985) review of vaccine development priorities judged that the prevention of a death at age 20 should be valued at about two times the value of preventing an infant death. Some studies suggest that the lives of older people are worth three or four times the value of the life of a baby.
Our comment focused on the data from a study of NICU decisions in France. We suspect that we would find a parallel phenomenon at a different point on the cost/age curve in lower income countries. It seems unlikely to us that the solution to infant mortality in poorer countries is to let more babies die in richer countries. Instead, the solution is to insist that, throughout the world, babies' lives should be valued as highly as those of adults and older children.
1. Jamison DT, Shahid-Salles SA, Jamison J, Lawn JE Zupan J. Incorporating deaths near the time of birth into estimates of the global burden of disease. In Jamison DT, et al (Editors) Disease Control Priorities in Developing Countries. 2nd edition. Washington (DC): World Bank; 2006.
2. Institute of Medicine. Committee on Issuees PfNVD. Division of Health Promotion and Disease Prevention. New Vaccine Development: Establishing Priorities. The National Academies Press, Washington, DC. 1985.
3. Johannesson M, Johansson PO. Is the valuation of a QALY gained independent of age? Some empirical evidence. J Health Econ. 1997 Oct;16(5):589-99
Conflict of Interest:
Current debate about the limit of viability: the neglected majority
It is with great interest that I read the editorial entitled "Delivery room practices for extremely preterm infants: the harms of the gestational age label" by Janvier and Lantos (1) analysing the results of the EPIPAGE-2 study (2). The two authors question the appropriateness of the French non-intervention approach towards infants born at 22, 23 and 24 weeks for whom NICU admission was withheld in 96%, 91% and 38% of cases, respectively. They emphasise that such policies do not just reflect outcomes, but also shape them. In addition, they highlight that three common arguments for non-intervention policies are severely flawed: treatment of extremely preterm infants is neither futile nor too expensive, and the majority of survivors are not disabled. They conclude that taking life and death decisions based on 7-day-periods of gestational age is scientifically flawed and ethically questionable.
While I agree with their arguments for industrialised countries in principle, I feel uncomfortable when I consider them from a global perspective. In 2015, an estimated 2.8 million neonates died worldwide; 99% of these deaths occurred in low- and middle-income countries (LMICs) (3). In these countries, the vast majority of infants born at less than 28 -30 weeks' gestation die: this means that the limit of viability for most neonates who are born prematurely is at least six weeks above the limit discussed by the editorialists. Even for more mature infants with respiratory distress, birth asphyxia or infection the prognosis is grim in most LMICs. In this context, Janvier's and Lantos' view that "treatment of neonates born at 22 and 23 weeks is clearly not futile" appears flawed. Most of published research in neonatology focuses on improving outcome of neonates born in industrialised countries. Neglecting the fate of the majority of neonates born worldwide is what is truly ethically questionable.
Thomas M. Berger Neonatal and Paediatric Intensive Care Unit Children's Hospital of Lucerne Lucerne, Switzerland
1. Janvier A, Lantos J. Delivery room practices for extremely preterm infants: the harms of the gestational age label. Arch Dis Child Fetal Neonatal Ed Online First, published on April 8, 2016
2. Parlbarg J, Ancel PY, Koshnod B, et al. Delivery room management of extremely preterm infants: the EPIPAGE-2 study. Arch Dis Child Fetal Neonatal Ed 2016 Feb 2, 2016 [Epub ahead of print]
3. Statistics Division of the United Nations Department of Economic and Social Affairs. The millennium development goals report 2015. http://www.un.org/millenniumgoals/2015_MDG_Report/pdf/MDG%202015%20rev%20(July%201).pdf (accessed May 7, 2016)
Conflict of Interest:
Water births: adverse events for the baby are rare but devastating
The overall tone of this systematic review is to reassure the reader that waterbirths are safe; this is not justified by the results which rely almost exclusively on extremely poor quality retrospective cohort studies. Different study designs have significant differences in their susceptibility to bias and the authors have largely ignored this issue. Larger, non-randomised studies, more prone to bias, carry more weight ; no meta-analysis should have been done with these data.
In contrast to the use of immersion in the first stage of labour, waterbirth confers no benefit to the mother or baby and puts the baby at unacceptable risk; current trials are too small to rule this out. Adverse events for the baby are rare but devastating. A hypoxic-ischaemic fetus will aspirate water when gasping while immersed.
The authors have deemed that a large, prospective, cohort study is an acceptable approach to determining the benefit/harm ratio for waterbirth. Such non-randomised studies are prone to significant bias. The control group would be fundamentally different to the waterbirth group, and such differences would undermine the major principle that both groups should be as similar as possible with respect all other factors that may be related to treatment and outcomes except for the intervention. With non-random assignment in a cohort study, equally eligible women with different risks for adverse outcomes will be assigned the intervention group (consciously or unconsciously) based on how the women themselves or their caregivers perceive the risk of adverse outcome -large numbers of women enrolled in this way will seriously imbalance the treatment groups with regard to factors affecting outcomes.
An appropriately sized, good quality RCT with longterm follow-up remains the only reliable way to assess both the efficacy and the safety of waterbirths.
Conflict of Interest:
I was a peer reviewer for this paper.
Staffing in NICUs is more that a 1:1 nurse to patient ratio
I read the article by Watson et al and the accompanying Editorial. While it is an interesting concept to link nurse patient ratios with mortality this does not take into account the individual nurses and their experiences. I would challenge the authors to demonstrate how retrospective data measures acuity and nursing experience. The authors presented the 1:1 ratio as measured by the percentage of ICU days where there was one nurse per patient. Realistically each patient has a different level of acuity and this will determine the nurse to patient ratio. However even with a one to one ratio each nurse also has a different level of experience. With the critical shortage of nurses in acute care areas in both the UK and Australia the practice is to recruit less experienced nurses and many NICUs take first year nurse graduates. How these nurses are supported and supervised to provide a level of safe practice would be a more meaningful measure to link with mortality or indeed morbidity in this vulnerable patient population.. If there is inadequate supervision from senior nurses or clinical nurse educators then the novice nurses learn from each other, indeed an unsafe practice. Perhaps a more useful measure would be for researchers to assist clinicians in auditing practices so we know what is actually being practiced and then look at morbidity and mortality as an outcome. As an experienced neonatal nurse I would challenge researchers that mortality is not a reliable measure of nursing work - we need to develop a set of outcome measures that are meaningful measures of nursing work in the NICU. By clinicians and researchers working together we can then strive to ensure the NICU is a safe environment and we would have measures to improve practice and outcomes for the infants and their families.
Conflict of Interest:
The Dr Isaac 'Harry' Gosset Collection
The 'Dr Isaac 'Harry' Gosset Collection' a repository of UK General Paediatric and Premature Baby Care 1947-1965 is now on line.
Conflict of Interest:
I am the author of the paper I am replying to
End of Life Decisions - Do we make them wisely?
Hellman, Knigthon et Al and Carter in the accompanying editorial raise many issues dealing with the end of life care of sick newborn babies. Although consensus within multidisciplinary teams in each centre is recorded as being achieved relatively easily, the wide variation between centres in how each deals with the issue of withholding life saving treatments, particularly where there are 'quality of life issues' underscores a wider lack of consensus amongst practicing neonatologists.
This raises a number of issues. The most challenging of which is why, when there is such variation between units is there such agreement within them? This could be because like-minded people work together, or more likely people who work together become like minded. More disturbingly, it raises the possibility that the consensus may not be as great as perceived with particularly junior members of the decision making team- perhaps even the parents- feeling unable to voice dissent.
A further issue is the weight given to medical opinion in making ethical and moral judgements. In common with most doctors, I received little or no formal training in ethics. I can use technical language to make my forthright opinions sound ethical, but in an era increasingly asking for evidence I have little to back these up. Historically the medical profession has not always cloaked itself in glory when trying to play society's moral arbiter. We can often lapse into a language of certainty and authority which makes it difficult for others to challenge our positions.
I have another difficult personal issue, which being late to the table I have only just realised. In common with most doctors of my generation I was not encouraged to think about why I do what I do. I see that there are many different types of doctors, many of us in hospital seem to be 'fixing' doctors in that we see ourselves as people that make problems better. If we could cope with uncertainty and some degree of failure we may be in different specialties. Patients that will not or cannot be fixed can challenge me as a doctor and make me feel in some way 'undermined.' In these situations I worry that decisions that I make or recommend may be as much for my benefit as they are for my patients or their family. As a 'fixer' it is easier to discard rather than live with broken things. These are incredibly complex feelings to acknowledge but they certainly do exist.
The obvious solution, as is available in much of North America and other countries in the world would be to establish Ethics panels who could judge these matters. These could be hospital based, regional or supra regional and would include members with proper training in Ethics and legal knowledge. Undoubtedly their deliberations would be heavily informed by medical evidence and input, in much the same way that medical input informs but does not make, safeguarding decisions which are ultimately in the gifts of the courts and their agents. This would provide safeguards for patients, families and the medical teams who look after them.
Conflict of Interest:
Incostintencies in defining "Work of breathing"
We read with great interest the recent article by Shetty et al (Arch Dis Child Fetal Neonatal Ed 2016;0:F1-F4) who showed that continuous positive airway pressure (CPAP) and humidified high-flow nasal cannula (HHFNC) in infants with evolving or established bronchopulmonary dysplasia (BPD) have similar effects on work of breathing (WOB).1 Like many other articles in this field, Shetty's paper unfortunately suffers from inconsistencies in defining WOB, which we wish to clarify. The definition "WOB" used throughout the paper, as a proxy for respiratory effort, seems misleading insofar Shetty et al actually assessed not WOB but the pressure time product (PTP) of the diaphragm (PTPdi). WOB and PTP, expressed either as esophageal pressure PTP or PTPdi, are two independent physical variables that address distinctly different features related to respiratory effort. In physics, the term "WOB" refers to the work done during each respiratory cycle and is mathematically expressed as WOB = ? Ppl x dVt. The Campbell diagram depicts the dynamic relationship between these two variables.2 In respiratory physiology, WOB describes the energy required as inspiratory flow begins to perform the task of ventilation. The term WOB might therefore be inaccurate to indicate the actual effort necessary for the patient to breathe, because it overlooks the energy expended during the isometric phase of respiration (muscle contraction without volume displacement). More properly, Shetty et al determined PTP, a variable that directly measures energy expenditure during the dynamic and isometric respiratory phases. PTP comprises the average inspiratory pressure starting from the onset of respiratory effort and the end of inspiration (Pavg): PTP = Pavg ? Ti.3 Because research into respiratory mechanics in spontaneously breathing infants is an exciting new field of study that increasingly attracts students, researchers, and physicians we need a concerted effort to clarify terminology that they might find confusing. Especially confusing is the tendency to use WOB as a proxy for respiratory effort when the variable measured is actually PTP. To prevent further confusion, we suggest defining respiratory effort in a consistent manner, keeping WOB and PTP as the variables for quantifying it physically. We hope that the research community will support this proposal and look forward to reading articles that put it into practice. Paola Papoff, MD Fabio Midulla, MD Francesco Montecchia, PhD References 1) Shetty S, Hickey A, Rafferty GF, et al. Work of breathing during CPAP and heated humidified high-flow nasal cannula. Arch Dis Child Fetal Neonatal Ed 2016; 0:F1-F4. 2) Cabello B, Mancebo J. Work of breathing. Intensive Care Med 2006;32:1311-4. 3) Grinnan DC1, Truwit JD. Clinical review: respiratory mechanics in spontaneous and assisted ventilation. Crit Care 2005;9:472-84.
Conflict of Interest:
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