Caregiver and provider attitudes toward family-centred rounding in paediatric acute care cardiology.

Family-centered rounding has emerged as the gold standard for inpatient paediatrics rounds due to its association with improved family and staff satisfaction and reduction of harmful errors. Little is known about family-centered rounding in subspecialty paediatric settings, including paediatric acute care cardiology.In this qualitative, single centre study, we conducted semi-structured interviews with providers and caregivers eliciting their attitudes toward family-centered rounding. An a priori recruitment approach was used to optimise diversity in reflected opinions. A brief demographic survey was completed by participants. We completed thematic analysis of transcribed interviews using grounded theory.In total, 38 interviews representing the views of 48 individuals (11 providers, 37 caregivers) were completed. Three themes emerged: rounds as a moment of mutual accountability, caregivers' empathy for providers, and providers' objections to family-centered rounding. Providers' objections were further categorised into themes of assumptions about caregivers, caregiver choices during rounds, and risk for exacerbation of bias and inequity.Caregivers and providers in the paediatric acute care cardiology setting echoed some previously described attitudes toward family-centered rounding. Many of the challenges surrounding family-centered rounding might be addressed through access to training for caregivers and providers alike. Hospitals should invest in systems to facilitate family-centered rounding if they choose to implement this model of care as the current state risks erosion of provider-caregiver relationship.

President Biden's Executive Order on Artificial Intelligence-Implications for Health Care Organizations.

This Viewpoint discusses a recent executive order by US President Joe Biden about the development and implementation of AI, including the role of government vs the private sector and how the order may affect health care.

End-of-Life in Pediatric Patients Supported by Ventricular Assist Devices: A Network Database Cohort Study.

OBJECTIVES: Most pediatric patients on ventricular assist device (VAD) survive to transplantation. Approximately 15% will die on VAD support, and the circumstances at the end-of-life are not well understood. We, therefore, sought to characterize patient location and invasive interventions used at the time of death. DESIGN: Retrospective database study of a cohort meeting inclusion criteria. SETTING: Thirty-six centers participating in the Advanced Cardiac Therapies Improving Outcomes Network (ACTION) Registry. PATIENTS: Children who died on VAD therapy in the period March 2012 to September 2021. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Of the 117 of 721 patients (16%) who died on VAD, the median (interquartile range) age was 5 years (1-16 yr) at 43 days (17-91 d) postimplant. Initial goals of therapy were bridge to consideration for candidacy for transplantation in 60 of 117 (51%), bridge to transplantation in 44 of 117 (38%), bridge to recovery 11 of 117 (9%), or destination therapy (i.e., VAD as the endpoint) in two of 117 (2%). The most common cause of death was multiple organ failure in 35 of 117 (30%), followed by infection in 12 of 117 (10%). Eighty-five of 92 (92%) died with a functioning device in place. Most patients were receiving invasive interventions (mechanical ventilation, vasoactive infusions, etc.) at the end of life. Twelve patients (10%) died at home. CONCLUSIONS: One-in-six pediatric VAD patients die while receiving device support, with death occurring soon after implant and usually from noncardiac causes. Aggressive interventions are common at the end-of-life. The ACTION Registry data should inform future practices to promote informed patient/family and clinician decision-making to hopefully reduce suffering at the end-of-life.

Bereaved Caregiver Perspectives on the End of Life in Pediatric Patients With Ventricular Assist Devices.

OBJECTIVES: Ventricular assist devices (VADs) are increasingly used in pediatric heart failure as bridges to heart transplantation, although 25% will die with VADs. Family experiences in this population are not well-described. The objective is to understand bereaved families' perspectives on VAD and end-of-life decision-making. DESIGN: Semistructured interviews with bereaved caregivers of pediatric VAD patients. SETTING: Tertiary children's hospital. PATIENTS: Families of six pediatric VAD patients who died from 2014 to 2020. INTERVENTIONS: Not available. MEASUREMENTS AND MAIN RESULTS: Applying a grounded theory framework, interviews were coded by two independent readers using qualitative software. Themes were discussed in iterative multidisciplinary meetings. Participants were interviewed at a median 2.4 years after their child died. Three major themes emerged: 1) "lack of regret" for VAD implantation despite the outcome; 2) "caregiver-child accord" (via patient's verbal assent or physical cues) at implantation and end-of-life was important in family decision-making; and 3) development of a "local surrogate family" (medical team and peer families) provided powerful support. CONCLUSIONS: Bereaved families' perspectives provide insight into quality decision-making for major interventions and end-of-life care in pediatric patients with chronic illness who face decisions regarding technology dependence.

Parental Attitudes Toward Clinical Genomic Sequencing in Children With Critical Cardiac Disease.

OBJECTIVES: Through improving diagnostics and prognostics genomic sequencing promises to significantly impact clinical decisions for children with critical cardiac disease. Little is known about how families of children with critical cardiac disease perceive the impact of genomic sequencing on clinical care choices. DESIGN: Qualitative interview study. SETTING: A high-volume, tertiary pediatric heart center. SUBJECTS: Families of children with critical cardiac disease. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Thematic analysis of interview response content. Thirty-five families were interviewed. Three themes emerged: 1) benefits versus challenges of having genomic sequencing results, and 2) fears of clinical applications of genomic sequencing, and 3) nonclinical fears related to genomic sequencing. Participants struggled with perceived uses of genomic sequencing-derived knowledge. They described comfort in foreknowledge of their child's likely disease course but articulated significant apprehension around participating in care decisions with limited knowledge of genomic sequencing, genomic sequencing uses to inform clinical resource rationing decisions, and genomic sequencing uses by third parties impacting financial pressures families experience caring for a child with critical cardiac disease. CONCLUSIONS: Families' perceptions of genomic sequencing uses in critical cardiac disease appear to strain their overall trust in the health system. Erosion of trust is concerning because the potential of genomic sequencing in critical cardiac disease will be unrealized if families are unwilling to undergo genomic sequencing, let alone to participate in the ongoing research needed to link genomic sequencing variants to clinical outcomes. Our findings may have implications for genomic sequencing use in children with other critical, high-acuity diseases.

How Anesthesiologists Experience and Negotiate Ethical Challenges from Drug Shortages.

BACKGROUND: In the face of ongoing drug shortages, anesthesiologists have been described as having to become "Iron Chefs, challenged to create safe patient outcomes with missing ingredients. Unfortunately, developing responsive ethical guidance for how anesthesiologists should best handle ethical concerns with ongoing and mutable drug shortages is limited by the dearth of studies examining how bedside clinicians actually experience drug shortages and what ethical challenges they encounter. In order to better understand what ethical concerns individual anesthesiologists experience around drug shortages and how they negotiate them, we undertook this qualitative interview study. Methods: We conducted semi-structured interviews with anesthesiologists at three field sites: an academic tertiary care adult hospital that performs approximately 46,000 anesthetics annually comprising cases ranging across all surgical disciplines; the affiliated veteran's affairs hospital that performs 12,000 anesthetics annually; and, the affiliated children's hospital that performs 20,500 anesthetics annually. Results: 29 anesthesiologists were interviewed (17 adult and 12 pediatric anesthesiologists), representing a spectrum of practice areas in clinical anesthesia: general, pediatric, regional, pain, critical care, obstetrics, liver transplant, and palliative medicine. Three themes emerged: (1) uncertainty about responsibility for clinical decisions made in consequence to a shortage; (2) creativity, and its limits, in choosing anesthetic plans; and, (3) disclosure of concerns about shortages (to patients and colleagues). Conclusions: Our data suggests anesthesiologists have unmet needs for ethical guidance on how to approach drug shortages. First is managing responsibility for decisions stemming from a drug shortage. Second, interviewees struggled with disclosure of their concerns, both to patients and to surgical colleagues. A formal shared decision making approach may present the best solution, since the act of structuring a shared decision making conversation or creating a decision making tool will have to incorporate the views of all stakeholders around shortages and their potential clinical consequences.

Identifying Ethical Considerations for Machine Learning Healthcare Applications.

Along with potential benefits to healthcare delivery, machine learning healthcare applications (ML-HCAs) raise a number of ethical concerns. Ethical evaluations of ML-HCAs will need to structure the overall problem of evaluating these technologies, especially for a diverse group of stakeholders. This paper outlines a systematic approach to identifying ML-HCA ethical concerns, starting with a conceptual model of the pipeline of the conception, development, implementation of ML-HCAs, and the parallel pipeline of evaluation and oversight tasks at each stage. Over this model, we layer key questions that raise value-based issues, along with ethical considerations identified in large part by a literature review, but also identifying some ethical considerations that have yet to receive attention. This pipeline model framework will be useful for systematic ethical appraisals of ML-HCA from development through implementation, and for interdisciplinary collaboration of diverse stakeholders that will be required to understand and subsequently manage the ethical implications of ML-HCAs.

Pectoral nerve blocks decrease postoperative pain and opioid use after pacemaker or implantable cardioverter-defibrillator placement in children.

BACKGROUND: Pectoral nerve blocks (PECs) can reduce intraprocedural anesthetic requirements and postoperative pain. Little is known about the utility of PECs in reducing pain and narcotic use after pacemaker (PM) or implantable cardioverter-defibrillator (ICD) placement in children. OBJECTIVE: The purpose of this study was to determine whether PECs can decrease postoperative pain and opioid use after PM or ICD placement in children. METHODS: A single-center retrospective review of pediatric patients undergoing transvenous PM or ICD placement between 2015 and 2020 was performed. Patients with recent cardiothoracic surgery or neurologic/developmental deficits were excluded. Demographics, procedural variables, postoperative pain, and postoperative opioid usage were compared between patients who had undergone PECs and those who had undergone conventional local anesthetic (Control). RESULTS: A total of 74 patients underwent PM or ICD placement; 20 patients (27%) underwent PECs. There were no differences between PECs and Control with regard to age, weight, gender, type of device placed, presence of congenital heart disease, type of anesthesia, procedural time, or complication rates. Patients who underwent PECs had lower pain scores at 1, 2, 6, 18, and 24 hours compared to Control. PECs patients had a lower mean cumulative pain score [PECs 1.5 (95% confidence interval [CI] 0.8-2.2) vs Control 3.1 (95% CI 2.7-3.5); P <.001] and lower total opioid use [PECs 6.0 morphine milligram equivalent (MME)/m2 (95% CI 3.4-8.6) vs Control 15.0 MME/m2 (95% CI 11.8-18.2); P = .001] over the 24 hours postimplant. CONCLUSION: PECs reduce postoperative pain scores and lower total opioid usage after ICD or PM placement. PECs should be considered at the time of transvenous device placement in children.

Lessons Learned About Autonomous AI: Finding a Safe, Efficacious, and Ethical Path Through the Development Process.

Artificial intelligence (AI) describes systems capable of making decisions of high cognitive complexity; autonomous AI systems in healthcare are AI systems that make clinical decisions without human oversight. Such rigorously validated medical diagnostic AI systems hold great promise for improving access to care, increasing accuracy, and lowering cost, while enabling specialist physicians to provide the greatest value by managing and treating patients whose outcomes can be improved. Ensuring that autonomous AI provides these benefits requires evaluation of the autonomous AI's effect on patient outcome, design, validation, data usage, and accountability, from a bioethics and accountability perspective. We performed a literature review of bioethical principles for AI, and derived evaluation rules for autonomous AI, grounded in bioethical principles. The rules include patient outcome, validation, reference standard, design, data usage, and accountability for medical liability. Application of the rules explains successful US Food and Drug Administration (FDA) de novo authorization of an example, the first autonomous point-of-care diabetic retinopathy examination de novo authorized by the FDA, after a preregistered clinical trial. Physicians need to become competent in understanding the potential risks and benefits of autonomous AI, and understand its design, safety, efficacy and equity, validation, and liability, as well as how its data were obtained. The autonomous AI evaluation rules introduced here can help physicians understand limitations and risks as well as the potential benefits of autonomous AI for their patients.

Anticipating uncertainty and irrevocable decisions: provider perspectives on implementing whole-genome sequencing in critically ill children with heart disease.

PURPOSE: To investigate the potential impacts of whole-genome sequencing (WGS) in the pediatric critical-care context, we examined how clinicians caring for critically ill children with congenital heart disease (CHD) anticipate and perceive the impact of WGS on their decision-making process and treatment recommendations. METHODS: We conducted semistructured in-person and telephone interviews of clinicians involved in the care of critically ill children with CHD at a high-volume pediatric heart center. We qualitatively analyzed the transcribed interviews. RESULTS: In total, 34 clinicians were interviewed. Three themes emerged: (i) uncertainty about the accuracy of WGS testing and adequacy of testing validation; (ii) the use of WGS to facilitate life-limiting decisions such as futility, rationing, and selective prenatal termination; and (iii) moral distress over using WGS with a lack of decision support. CONCLUSION: Despite uncertainty about WGS testing, the interviewed clinicians were using, and anticipated expanding the use of, WGS results to justify declarations of futility, withdrawal of care, and rationing in critically ill children with CHD. This situation is causing moral distress in providers who have to make high-stakes decisions involving WGS results, with only partial understanding of them. Decision support for clinicians, and discussion with families of the risks of using WGS for rationing or withdrawal, is needed.

Genomic Contraindications for Heart Transplantation.

Genome sequencing raises new ethical challenges. Decoding the genome produces new forms of diagnostic and prognostic information; however, the information is often difficult to interpret. The connection between most genetic variants and their phenotypic manifestations is not understood. This scenario is particularly true for disorders that are not associated with an autosomal genetic variant. The analytic uncertainty is compounded by moral uncertainty about how, exactly, the results of genomic testing should influence clinical decisions. In this Ethics Rounds, we present a case in which genomic findings seemed to play a role in deciding whether a patient was to be listed as a transplant candidate. We then asked experts in bioethics and cardiology to discuss the implications of such decisions.

Can Destination Therapy be implemented in children with heart failure? A study of provider perceptions.

DT is an established final therapeutic choice in adult patients with severe heart failure who do not meet criteria for cardiac transplantation. Patients are given VADs, without the prospect of care escalation to transplantation. VADs are now established therapy for children and are currently used as a bridge until transplantation can be performed or heart failure improves. For children who present in severe heart failure but do not meet transplantation criteria, the question has emerged whether DT can be offered. This qualitative study aimed to elicit the perspectives of early adopters of DT at one of the few institutions where DT has been provided for children. Responses were recorded and coded and themes extracted using grounded theory. Interviewees discussed: envisioning of the DT candidate; approach to evaluation for DT; contraindications to choosing DT; and concerns about choosing DT. Providers articulated two frameworks for conceptualizing DT: as a long bridge through resolution of problems that would initially contraindicate transplantation or, alternatively, as a true destination instead of transplantation. True destination, however, may not be the lasting concept for long-term VAD use in children given improvement in prognosis for current medical contraindications and improving VAD technology.

Anesthesia for Placement of a Paracorporeal Lung Assist Device and Subsequent Heart-Lung Transplantation in a Child with Suprasystemic Pulmonary Hypertension and End-Stage Respiratory Failure.

Pediatric patients with end-stage respiratory failure and pulmonary hypertension traditionally have poor outcomes when bridged with extracorporeal membrane oxygenation to lung or heart-lung transplantation. Therefore, several institutions have attempted paracorporeal lung assist devices as a bridge. However, given the small number of patients, little is known about approaches to anesthetic induction in these hemodynamically unstable patients either before placement of a device or anesthetic induction once a device is in situ. In this case report, we describe our anesthetic experience managing a 13-year-old boy for both paracorporeal lung assist device placement and subsequent heart-lung transplantation.

Accuracy of Pulse Oximeters Intended for Hypoxemic Pediatric Patients.

OBJECTIVES: Prior studies have shown inaccuracies in pulse oximetry readings at saturations less than 85%; however, no large studies have evaluated new sensors marketed for these low saturations. This study's purpose was to evaluate two sensors with claims of improved accuracy in children with saturations less than 85%. DESIGN: Prospective observational study. SETTING: Single institution; cardiac catheterization laboratory, and operating room. PATIENTS: Fifty patients weighing 3-20 kg with baseline saturations less than 90% undergoing surgical or catheterization procedure. MEASUREMENTS AND MAIN RESULTS: Data collected included demographics, diagnosis, continuous saturations from three different pulse oximeters (Masimo LNCS [Masimo, Irvine, CA], Masimo Blue [Masimo], and Nellcor Max-I [Medtronic, Dublin, Ireland]) and up to four blood samples for co-oximetry as the gold-standard arterial oxygen saturation. Analysis included scatter plots, smoothed regression estimates of mean continuous saturation levels plotted against corresponding arterial oxygen saturation values, and Bland-Altman plots. Bland-Altman analysis indicated increasing levels of bias and variability for decreasing arterial oxygen saturation levels for all three sensors, with a statistically significant increase in mean difference observed for decreasing arterial oxygen saturation level. The Masimo Blue sensor had the lowest mean difference, SD and Bland-Altman limits in patients with saturations less than or equal to 85%. At saturation range of less than or equal to 85% and greater than 75%, 14% of the samples obtained from Masimo Blue, 24% of the readings from the Nellcor, and 31% from the Masimo Standard sensors were greater than or equal to 5% points difference. All three sensors had a further increase in these differences for arterial oxygen saturation values less than 75%. CONCLUSIONS: The Masimo Blue sensor has improved accuracy at saturations 75-85% versus the Nellcor and Masimo Standard sensors. The accuracy of peripheral capillary oxygen saturation of the Masimo Blue sensor was within 5% points of the arterial oxygen saturation the majority of the time. Currently, at saturations less than or equal to 85%, pulse oximetry alone should not be relied on in making clinical decisions.

How should whole-genome sequencing be implemented in children? A consideration of the current limitations.

In children, whole-genome sequencing (WGS) is envisioned as a tool to improve diagnosis of undiagnosed diseases and to improve population-based screening. Pilot applications have shown benefits: genomic information has been used as a diagnostic aid; pharmacogenomics can reduce medicine-related adverse events; advanced knowledge of the potential for later-onset disease can target tests and appropriate therapies. However, emerging technical, conceptual and ethical challenges may limit WGS from fulfilling the current vision for future applications. WGS platforms still struggle with reliability and accuracy. The role of the genome in long-term organismal function and disease is still being established. Ethical implications of WGS in both undiagnosed disease and population screening, particularly potential impacts of testing on children and their families are still unresolved.