Usefulness of Postnatal Echocardiograms in Patients with Omphaloceles Who Previously Had a Normal Fetal Echocardiogram.

INTRODUCTION: Neonates with omphaloceles routinely have a transthoracic echocardiogram (TTE) performed due to a high association with congenital heart defects (CHD). The utility of a TTE in these patients with a normal fetal echocardiogram is unknown. The primary objective of this study was to determine whether a critical CHD diagnosis was missed in patients with an omphalocele who had a normal fetal echocardiogram. The secondary objective of the study was to determine whether any CHD diagnosis was missed postnatally when a fetal echocardiogram was read as normal. METHODS: A retrospective chart review was performed of patients with omphaloceles born between January 1, 2008, and June 30, 2020. Patients were included if they had a fetal echocardiogram that was read as normal and had a postnatal echocardiogram performed. Baseline demographics, postnatal data echocardiographic findings, and hospital course were collected. Critical CHD was defined as CHD requiring neonatal cardiac intervention. RESULTS: Fifty-six fetal echocardiograms on patients with omphaloceles were performed, of which 24 patients met the inclusion criteria. No patient was diagnosed with a critical CHD postnatally (negative predictive value [NPV] = 100%). Two patients were diagnosed with ventricular septal defects (VSD) postnatally (NPV = 91.7%). One of the VSDs required closure with a patch at 4 months of life, while the other, a small muscular VSD, closed spontaneously within the first year of life. Both patients had a murmur on exam during their initial hospital stay. The patient that required surgery also had an abnormal electrocardiogram and chest X-ray. There were no mortalities due to cardiac causes in these patients. CONCLUSION: Critical CHD was not missed on any patient with an omphalocele who had a normal fetal echocardiogram. All other patients with omphaloceles who had CHD diagnosed postnatally had an abnormal clinical finding on postnatal evaluation. The routine performance of a postnatal TTE in patients with an omphalocele who had a normal fetal echocardiogram may not be needed in those with a normal clinical workup. Further studies evaluating echocardiographic imaging recommendations are needed to maximize care and optimize resource allocation in this complex patient population.

Breast Density Notification: An Australian Perspective.

Breast density, also known as mammographic density, refers to white and bright regions on a mammogram. Breast density can only be assessed by mammogram and is not related to how breasts look or feel. Therefore, women will only know their breast density if they are notified by the radiologist when they have a mammogram. Breast density affects a woman's breast cancer risk and the sensitivity of a screening mammogram to detect cancer. Currently, the position of BreastScreen Australia and the Royal Australian and New Zealand College of Radiologists is to not notify women if they have dense breasts. However, patient advocacy organisations are lobbying for policy change. Whether or not to notify women of their breast density is a complex issue and can be framed within the context of both public health ethics and clinical ethics. Central ethical themes associated with breast density notification are equitable care, patient autonomy in decision-making, trust in health professionals, duty of care by the physician, and uncertainties around evidence relating to measurement and clinical management pathways for women with dense breasts. Legal guidance on this issue must be gained from broad legal principles found in the law of negligence and the test of materiality. We conclude a rigid legal framework for breast density notification in Australia would not be appropriate. Instead, a policy framework should be developed through engagement with all stakeholders to understand and take account of multiple perspectives and the values at stake.

The ethical, legal and social implications of using artificial intelligence systems in breast cancer care.

Breast cancer care is a leading area for development of artificial intelligence (AI), with applications including screening and diagnosis, risk calculation, prognostication and clinical decision-support, management planning, and precision medicine. We review the ethical, legal and social implications of these developments. We consider the values encoded in algorithms, the need to evaluate outcomes, and issues of bias and transferability, data ownership, confidentiality and consent, and legal, moral and professional responsibility. We consider potential effects for patients, including on trust in healthcare, and provide some social science explanations for the apparent rush to implement AI solutions. We conclude by anticipating future directions for AI in breast cancer care. Stakeholders in healthcare AI should acknowledge that their enterprise is an ethical, legal and social challenge, not just a technical challenge. Taking these challenges seriously will require broad engagement, imposition of conditions on implementation, and pre-emptive systems of oversight to ensure that development does not run ahead of evaluation and deliberation. Once artificial intelligence becomes institutionalised, it may be difficult to reverse: a proactive role for government, regulators and professional groups will help ensure introduction in robust research contexts, and the development of a sound evidence base regarding real-world effectiveness. Detailed public discussion is required to consider what kind of AI is acceptable rather than simply accepting what is offered, thus optimising outcomes for health systems, professionals, society and those receiving care.

Device representatives in hospitals: are commercial imperatives driving clinical decision-making?

Despite concerns about the relationships between health professionals and the medical device industry, the issue has received relatively little attention. Prevalence data are lacking; however, qualitative and survey research suggest device industry representatives, who are commonly present in clinical settings, play a key role in these relationships. Representatives, who are technical product specialists and not necessarily medically trained, may attend surgeries on a daily basis and be available to health professionals 24 hours a day, 7 days a week, to provide advice. However, device representatives have a dual role: functioning as commissioned sales representatives at the same time as providing advice on approaches to treatment. This duality raises the concern that clinical decision-making may be unduly influenced by commercial imperatives. In this paper, we identify three key ethical concerns raised by the relationship between device representatives and health professionals: (1) impacts on healthcare costs, (2) the outsourcing of expertise and (3) issues of accountability and informed consent. These ethical concerns can be addressed in part through clarifying the boundary between the support and sales aspects of the roles of device representatives and developing clear guidelines for device representatives providing support in clinical spaces. We suggest several policy options including hospital provision of expert support, formalising clinician conduct to eschew receipt of meals and payments from industry and establishing device registries.

Pulmonary Vein Stenosis in Neonates with Severe Bronchopulmonary Dysplasia.

Objectives Pulmonary vein stenosis (PVS) is a rare, often lethal anomaly associated with poor outcomes. Given the association between bronchopulmonary dysplasia (BPD) and cardiovascular complications, we tested the hypotheses that (1) a subgroup of neonates with severe BPD develop PVS (BPD-PVS) and have worse outcomes than do neonates with severe BPD alone (BPD); (2) among a cohort of neonates with severe BPD-associated pulmonary hypertension (BPD-PH), PVS is an additional risk factor for adverse outcomes and mortality. Study Design We performed a retrospective review of neonates with severe BPD, based on the Eunice Kennedy Shriver National Institute of Child Health and Development (NICHD) criteria, at our institution between June 1, 2009, and June 30, 2013. PVS was determined based on serial review of echocardiograms performed during their hospitalization. Neonates with congenital heart disease or chromosomal anomalies were excluded. Results Of 213 patients with severe BPD, 10 (4.7%) were found to have PVS (BPD-PVS). Neonates with BPD-PVS had lower birth weight (634 ± 178 vs. 767 ± 165 g; p < 0.01) and were more likely to be intrauterine growth restricted (80 vs. 11%; p < 0.01) than neonates with BPD alone. Time on mechanical ventilation and length of hospitalization were longer in the BPD-PVS group than BPD group. Survival was lower in the BPD-PVS group than BPD group (5/10 [50%] vs. 196/203 [97%]; log-rank test p < 0.01). Among a subgroup of neonates with BPD-PH, survival was lower among infants with PVS than those without PVS (5/9 [56%] vs. 26/30 [86%]; log-rank test p = 0.01). Conclusions Compared with neonates with severe BPD alone, those with acquired PVS are at increased risk for worse outcomes, including higher mortality. Evidence-based recommendations regarding screening protocols and surveillance are needed in this high-risk subgroup of BPD neonates.

Consent to innovative treatment: No need for a new legal test.

The provision of advice prior to medical treatment raises the perennial question of how much information is sufficient and how can patients truly understand the nature of the risks and benefits of any proposed treatment? This issue is potentially heightened in the context of innovative treatment where health care providers themselves do not know the full range of risks and benefits and thus cannot hope to communicate these to the patient. This potential issue in turn raises the question of whether or not there needs to be a specific legal framework around consent to innovative treatment. This article draws together the findings of a study into innovation in surgery and an analysis of the existing legal framework to demonstrate that while concerns around consent to innovative treatment are valid they are not unique and apply equally to the provision of all health care. The article concludes that to suggest a framework which specifically addresses innovative treatment would be to add an artificial and unnecessary formality to any pre-treatment consultation. In short, the current legal framework adequately addresses the concerns raised by the surgeons in the study and there is no need for a new legal test.