Danton Char

All Publications

• Whether Designated as Research or Not, Who Resolves Ethical Considerations Emerging with Healthcare AI? The American journal of bioethics : AJOB Char, D. 2024; 24 (10): 93-95

  View details for DOI 10.1080/15265161.2024.2388752

  View details for PubMedID 39283381

• Ethical Considerations in the Design and Conduct of Clinical Trials of Artificial Intelligence. JAMA network open Youssef, A., Nichol, A. A., Martinez-Martin, N., Larson, D. B., Abramoff, M., Wolf, R. M., Char, D. 2024; 7 (9): e2432482

  Abstract

  Importance: Safe integration of artificial intelligence (AI) into clinical settings often requires randomized clinical trials (RCT) to compare AI efficacy with conventional care. Diabetic retinopathy (DR) screening is at the forefront of clinical AI applications, marked by the first US Food and Drug Administration (FDA) De Novo authorization for an autonomous AI for such use.Objective: To determine the generalizability of the 7 ethical research principles for clinical trials endorsed by the National Institute of Health (NIH), and identify ethical concerns unique to clinical trials of AI.Design, Setting, and Participants: This qualitative study included semistructured interviews conducted with 11 investigators engaged in the design and implementation of clinical trials of AI for DR screening from November 11, 2022, to February 20, 2023. The study was a collaboration with the ACCESS (AI for Children's Diabetic Eye Exams) trial, the first clinical trial of autonomous AI in pediatrics. Participant recruitment initially utilized purposeful sampling, and later expanded with snowball sampling. Study methodology for analysis combined a deductive approach to explore investigators' perspectives of the 7 ethical principles for clinical research endorsed by the NIH and an inductive approach to uncover the broader ethical considerations implementing clinical trials of AI within care delivery.Results: A total of 11 participants (mean [SD] age, 47.5 [12.0] years; 7 male [64%], 4 female [36%]; 3 Asian [27%], 8 White [73%]) were included, with diverse expertise in ethics, ophthalmology, translational medicine, biostatistics, and AI development. Key themes revealed several ethical challenges unique to clinical trials of AI. These themes included difficulties in measuring social value, establishing scientific validity, ensuring fair participant selection, evaluating risk-benefit ratios across various patient subgroups, and addressing the complexities inherent in the data use terms of informed consent.Conclusions and Relevance: This qualitative study identified practical ethical challenges that investigators need to consider and negotiate when conducting AI clinical trials, exemplified by the DR screening use-case. These considerations call for further guidance on where to focus empirical and normative ethical efforts to best support conduct clinical trials of AI and minimize unintended harm to trial participants.

  View details for DOI 10.1001/jamanetworkopen.2024.32482

  View details for PubMedID 39240560

• What Do We Do with Physicians When Autonomous AI-Enabled Workflow is Better for Patient Outcomes? The American journal of bioethics : AJOB Abramoff, M. D., Char, D. 2024; 24 (9): 93-96

  View details for DOI 10.1080/15265161.2024.2377111

  View details for PubMedID 39225989

• The Hemodynamic Effects of Bolus Dose Calcium in Patients Undergoing Pulmonary Artery Reconstruction and Unifocalization Surgery: A Pilot Study. Journal of cardiothoracic and vascular anesthesia Quiñónez, Z. A., Klein, A., Li, X., Lennig, M. A., Giustini, A. J., Boltz, M. G., Char, D. 2024

  Abstract

  To determine if bolus administration of calcium increases pulmonary artery pressures after unifocalization procedures or pulmonary artery reconstruction surgery.Retrospective cohort study using Stanford University's data warehouse.A large pediatric heart center within an academic quaternary care facility.All patients undergoing pulmonary artery reconstruction or unifocalization procedures identifiable in the data warehouse.Data were collected from Stanford University's data repository and formatted and analyzed using RStudio (v 2023.06.1+524).The primary outcome was the change in pulmonary artery systolic pressure (PASP) after a bolus administration of calcium. Secondary endpoints include changes in pulmonary arterial-to-systemic arterial pressure ratio, mean arterial pressure, right-sided filling pressure, and left atrial pressure. The Friedman test was used to assess differences and the Durbin-Conover rank-sum for pairwise comparisons. A difference in PASP after a bolus dose of calcium was found (Friedman X2 = 13.67, p = 0.003), with a higher PASP 5 minutes after calcium administration compared with 2 minutes before administration (35 mmHg v 33 mmHg, p = 0.01), and a higher PASP 10 minutes after calcium administration compared with2 minutes before administration (35 mmHg v 33 mmHg, p = 0.008).Calcium bolus administration led to an increase in pulmonary arterial pressure in patients after pulmonary artery reconstruction or unifocalization surgeries. It may be prudent to avoid bolus administration in this patient population immediately after repair or in patients with right ventricular dysfunction.

  View details for DOI 10.1053/j.jvca.2024.08.008

  View details for PubMedID 39227189

• Artificial Intelligence in Perioperative Care: Opportunities and Challenges. Anesthesiology Han, L., Char, D. S., Aghaeepour, N. 2024; 141 (2): 379-387

  View details for DOI 10.1097/ALN.0000000000005013

  View details for PubMedID 38980160

• Trajectories in Intensity of Medical Interventions at the End of Life: Clustering Analysis in a Pediatric, Single-Center Retrospective Cohort, 2013-2021. Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies Liesse, K. M., Malladi, L., Dinh, T. C., Wesp, B. M., Kam, B. N., Turturice, B. A., Pyke-Grimm, K. A., Char, D. S., Hollander, S. A. 2024

  Abstract

  OBJECTIVE: Pediatric deaths often occur within hospitals and involve balancing aggressive treatment with minimization of suffering. This study first investigated associations between clinical/demographic features and the level of intensity of various therapies these patients undergo at the end of life (EOL). Second, the work used these data to develop a new, broader spectrum for classifying pediatric EOL trajectories.DESIGN: Retrospective, single-center study, 2013-2021.SETTING: Four hundred sixty-one bed tertiary, stand-alone children's hospital with 112 ICU beds.PATIENTS: Patients of age 0-26 years old at the time of death.INTERVENTIONS: None.MEASUREMENTS AND MAIN RESULTS: Of 1111 included patients, 85.7% died in-hospital. Patients who died outside the hospital were older. Among the 952 in-hospital deaths, most occurred in ICUs (89.5%). Clustering analysis was used to distinguish EOL trajectories based on the presence of intensive therapies and/or an active resuscitation attempt at the EOL. We identified five simplified categories: 1) death during active resuscitation, 2) controlled withdrawal of life-sustaining technology, 3) natural progression to death despite maximal therapy, 4) discontinuation of nonsustaining therapies, and 5) withholding/noninitiation of future therapies. Patients with recent surgical procedures, a history of organ transplantation, or admission to the Cardiovascular ICU had more intense therapies at EOL than those who received palliative care consultations, had known genetic conditions, or were of older age.CONCLUSIONS: In this retrospective study of pediatric EOL trajectories based on the intensity of technology and/or resuscitation discontinued at the EOL, we have identified associations between these trajectories and patient characteristics. Further research is needed to investigate the impact of these trajectories on families, patients, and healthcare providers.

  View details for DOI 10.1097/PCC.0000000000003579

  View details for PubMedID 39023327

• Should SARS-CoV-2 Vaccination be Required for Heart Transplant Listing. The American journal of bioethics : AJOB Hollander, S., Char, D. 2024; 24 (7): 117-119

  View details for DOI 10.1080/15265161.2024.2353822

  View details for PubMedID 38913486

• The effect of socioeconomic status on pediatric heart transplant outcomes at a single institution between 2013 and 2022. Pediatric transplantation Armstrong, A., Liang, J. W., Char, D., Hollander, S. A., Pyke-Grimm, K. A. 2024; 28 (2): e14695

  Abstract

  Disparities in pediatric heart transplant outcomes based on socioeconomic status (SES) have been previously observed. However, there is a need to reevaluate these associations in contemporary settings with advancements in transplant therapies and increased awareness of health disparities. This retrospective study aims to investigate the relationship between SES and outcomes for pediatric heart transplant patients.Data were collected through a chart review of 176 pediatric patients who underwent first orthotopic heart transplantation (OHT) at a single center from 2013 to 2021. The Area Deprivation Index (ADI), a composite score based on U.S. census data, was used to quantify SES. Cox proportional hazards models and generalized linear models were employed to analyze the association between SES and graft failure, rejection rates, and hospitalization rates.The analysis revealed no statistically significant differences in graft failure rates, rejection rates, or hospitalization rates between low-SES and high-SES pediatric heart transplant patients for our single-center study.There may be patient education, policies, and social resources that can help mitigate SES-based healthcare disparities. Additional multi-center research is needed to identify post-transplant care that promotes patient equity.

  View details for DOI 10.1111/petr.14695

  View details for PubMedID 38433565

• Geospatial Analysis of the Proportion of Persons Defined as Underrepresented in Medicine for Each Medical School and Their Surrounding Core-Based Statistical Area. Health equity Quiñónez, Z. A., Benitez-Melo, A., Diaz, L. M., Lennig, M., Char, D., Smith, C. 2024; 8 (1): 132-137

  Abstract

  The current approach to increasing diversity in medical education fails to consider local community demographics when determining medical school matriculation.We propose that medical schools better reflect their surrounding community, both because racially/ethnically concordant physicians have been shown to provide better care and to repair the historical and current racist impacts of these institutions that have criminalized, displaced, and excluded local Black and Brown communities.In this study, we used geospatial analysis to determine that medical school enrollments generally fail to reflect their surrounding community, represented as their core-based statistical area, within which the individual medical schools reside.

  View details for DOI 10.1089/heq.2023.0221

  View details for PubMedID 38435025

  View details for PubMedCentralID PMC10908325

• President Biden's Executive Order on Artificial Intelligence-Implications for Health Care Organizations. JAMA Mello, M. M., Shah, N. H., Char, D. S. 2023

  View details for DOI 10.1001/jama.2023.25051

  View details for PubMedID 38032634

• Considerations for addressing bias in artificial intelligence for health equity. NPJ digital medicine Abràmoff, M. D., Tarver, M. E., Loyo-Berrios, N., Trujillo, S., Char, D., Obermeyer, Z., Eydelman, M. B., Maisel, W. H. 2023; 6 (1): 170

  Abstract

  Health equity is a primary goal of healthcare stakeholders: patients and their advocacy groups, clinicians, other providers and their professional societies, bioethicists, payors and value based care organizations, regulatory agencies, legislators, and creators of artificial intelligence/machine learning (AI/ML)-enabled medical devices. Lack of equitable access to diagnosis and treatment may be improved through new digital health technologies, especially AI/ML, but these may also exacerbate disparities, depending on how bias is addressed. We propose an expanded Total Product Lifecycle (TPLC) framework for healthcare AI/ML, describing the sources and impacts of undesirable bias in AI/ML systems in each phase, how these can be analyzed using appropriate metrics, and how they can be potentially mitigated. The goal of these "Considerations" is to educate stakeholders on how potential AI/ML bias may impact healthcare outcomes and how to identify and mitigate inequities; to initiate a discussion between stakeholders on these issues, in order to ensure health equity along the expanded AI/ML TPLC framework, and ultimately, better health outcomes for all.

  View details for DOI 10.1038/s41746-023-00913-9

  View details for PubMedID 37700029

  View details for PubMedCentralID 6941147

• Case Report: Parental Separation by Proxy Using Video Conference Between Patient and Parent for Induction of Anesthesia. A&A practice Quinonez, Z. A., Brandford, E., Char, D. 2023; 17 (7): e01696

  Abstract

  Anesthetic induction in children can have significant psychological and behavioral impacts. Strategies like premedication or parental presence for induction may reduce distress. In children who require ongoing procedural care into adulthood, like those who receive heart transplants, transitioning from these strategies toward independence may require intermediate steps. The use of parental presence by video may aid in this transition. It might also be a reasonable approach for those children who have adverse reactions to medications commonly used for anxiolysis before procedures.

  View details for DOI 10.1213/XAA.0000000000001696

  View details for PubMedID 37409741

• In Response. Anesthesia and analgesia Quiñónez, Z. A., Pyke-Grimm, K. A., Char, D. 2023; 136 (6): e29-e30

  View details for DOI 10.1213/ANE.0000000000006361

  View details for PubMedID 37205812

• A Bridge to Nowhere. The American journal of bioethics : AJOB Hollander, S., Char, D. 2023; 23 (6): 54-56

  View details for DOI 10.1080/15265161.2023.2201228

  View details for PubMedID 37220366

• Caregiver and provider attitudes toward family-centred rounding in paediatric acute care cardiology. Cardiology in the young Gal, D. B., Rodts, M., Hills, B. K., Kipps, A. K., Char, D. S., Pater, C., Madsen, N. L. 2023: 1-6

  Abstract

  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.

  View details for DOI 10.1017/S104795112300118X

  View details for PubMedID 37198962

• Initiative to increase family presence and participation in daily rounds on a paediatric acute care cardiology unit CARDIOLOGY IN THE YOUNG Gal, D. B., Pater, C. M., McGinty, M., Lobes, G., Tuemler, C., Eldridge, P. M., Frakes, B., Marcuccio, E., Hanke, S. P., Gaies, M. G. 2023: 1-6

  Abstract

  Family-centred rounds benefit families and clinicians and improve outcomes in general paediatrics, but are understudied in subspecialty settings. We sought to improve family presence and participation in rounds in a paediatric acute care cardiology unit.We created operational definitions for family presence, our process measure, and participation, our outcome measure, and gathered baseline data over 4 months of 2021. Our SMART aim was to increase mean family presence from 43 to 75% and mean family participation from 81 to 90% by 30 May, 2022. We tested interventions with iterative plan-do-study-act cycles between 6 January, 2022 and 20 May, 2022, including provider education, calling families not at bedside, and adjustment to rounding presentations. We visualised change over time relative to interventions with statistical control charts. We conducted a high census days subanalysis. Length of stay and time of transfer from the ICU served as balancing measures.Mean presence increased from 43 to 83%, demonstrating special cause variation twice. Mean participation increased from 81 to 96%, demonstrating special cause variation once. Mean presence and participation were lower during high census (61 and 93% at project end) but improved with special cause variation. Length of stay and time of transfer remained stable.Through our interventions, family presence and participation in rounds improved without apparent unintended consequences. Family presence and participation may improve family and staff experience and outcomes; future research is warranted to evaluate this. Development of high level of reliability interventions may further improve family presence and participation, particularly on high census days.

  View details for DOI 10.1017/S1047951123001063

  View details for Web of Science ID 000980771800001

  View details for PubMedID 37138526

• Is the Algorithm Good in a Bad World, or Has It Learned to be Bad? The Ethical Challenges of "Locked" Versus "Continuously Learning" and "Autonomous" Versus "Assistive" AI Tools in Healthcare. The American journal of bioethics : AJOB Youssef, A., Abramoff, M., Char, D. 2023; 23 (5): 43-45

  View details for DOI 10.1080/15265161.2023.2191052

  View details for PubMedID 37130390

• A framework to identify ethical concerns with ML-guided care workflows: a case study of mortality prediction to guide advance care planning. Journal of the American Medical Informatics Association : JAMIA Cagliero, D., Deuitch, N., Shah, N., Feudtner, C., Char, D. 2023

  Abstract

  Identifying ethical concerns with ML applications to healthcare (ML-HCA) before problems arise is now a stated goal of ML design oversight groups and regulatory agencies. Lack of accepted standard methodology for ethical analysis, however, presents challenges. In this case study, we evaluate use of a stakeholder "values-collision" approach to identify consequential ethical challenges associated with an ML-HCA for advanced care planning (ACP). Identification of ethical challenges could guide revision and improvement of the ML-HCA.We conducted semistructured interviews of the designers, clinician-users, affiliated administrators, and patients, and inductive qualitative analysis of transcribed interviews using modified grounded theory.Seventeen stakeholders were interviewed. Five "values-collisions"-where stakeholders disagreed about decisions with ethical implications-were identified: (1) end-of-life workflow and how model output is introduced; (2) which stakeholders receive predictions; (3) benefit-harm trade-offs; (4) whether the ML design team has a fiduciary relationship to patients and clinicians; and, (5) how and if to protect early deployment research from external pressures, like news scrutiny, before research is completed.From these findings, the ML design team prioritized: (1) alternative workflow implementation strategies; (2) clarification that prediction was only evaluated for ACP need, not other mortality-related ends; and (3) shielding research from scrutiny until endpoint driven studies were completed.In this case study, our ethical analysis of this ML-HCA for ACP was able to identify multiple sites of intrastakeholder disagreement that mark areas of ethical and value tension. These findings provided a useful initial ethical screening.

  View details for DOI 10.1093/jamia/ocad022

  View details for PubMedID 36826400

• End-of-Life in Pediatric Patients Supported by Ventricular Assist Devices: A Network Database Cohort Study. Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies Hollander, S. A., Pyke-Grimm, K. A., Shezad, M. F., Zafar, F., Cousino, M. K., Feudtner, C., Char, D. S. 2022

  Abstract

  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.

  View details for DOI 10.1097/PCC.0000000000003115

  View details for PubMedID 36398973

• Sharing Decisions When Withdrawing a Technology Is Not the Same as Withholding It. The American journal of bioethics : AJOB Char, D., Gal, D., Hollander, S. 2022; 22 (11): 69-72

  View details for DOI 10.1080/15265161.2022.2123976

  View details for PubMedID 36332051

• Bereaved Caregiver Perspectives on the End of Life in Pediatric Patients With Ventricular Assist Devices. Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies Bui, C. M., Schneider, L. M., Brown, M. R., Char, D. S., McIlvennan, C. K., Hollander, S. A. 2022

  Abstract

  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.

  View details for DOI 10.1097/PCC.0000000000003089

  View details for PubMedID 36194025

• Could, Should Families Watch Their Loved One's Surgeries and, If So, When? Anesthesia and analgesia Quinonez, Z. A., Pyke-Grimm, K. A., Char, D. 2022; 135 (4): 704-707

  View details for DOI 10.1213/ANE.0000000000005801

  View details for PubMedID 36108184

• Could, Should Families Watch Their Loved One's Surgeries and, If So, When? ANESTHESIA AND ANALGESIA Quinonez, Z. A., Pyke-Grimm, K. A., Char, D. 2022; 135 (4): 704-707

  View details for DOI 10.1213/ANE.0000000000005908

  View details for Web of Science ID 000853940600017

• Family-centered care and acute care cardiology: borrowing lessons from other disciplines. Cardiology in the young Gal, D. B., Char, D. S., Anderson, J. B., Cooper, D. S., Madsen, N. L. 2022: 1-3

  View details for DOI 10.1017/S1047951122003080

  View details for PubMedID 36154673

• Important Design Questions for Algorithmic Ethics Consultation. The American journal of bioethics : AJOB Char, D. 2022; 22 (7): 38-40

  View details for DOI 10.1080/15265161.2022.2075054

  View details for PubMedID 35737487

• Challenges of Local Ethics Review in a Global Healthcare AI Market. The American journal of bioethics : AJOB Char, D. 2022; 22 (5): 39-41

  View details for DOI 10.1080/15265161.2022.2055214

  View details for PubMedID 35475961

• Foundational Considerations for Artificial Intelligence Utilizing Ophthalmic Images. Ophthalmology Abramoff, M. D., Cunningham, B., Patel, B., Eydelman, M. B., Leng, T., Sakamoto, T., Blodi, B., Grenon, S. M., Wolf, R. M., Manrai, A. K., Ko, J. M., Chiang, M. F., Char, D., Collaborative Community on Ophthalmic Imaging Executive Committee and Foundational Principles of Ophthalmic Imaging and Algorithmic Interpretation Working Group 2021

  Abstract

  IMPORTANCE: The development of Artificial Intelligence (AI) and other machine diagnostic systems, also known as Software as a Medical Device (SaMD), and its recent introduction into clinical practice, requires a deeply-rooted foundation in bioethics, for consideration by regulatory agencies and other stakeholders around the globe.OBJECTIVES: Initiate a dialogue on the issues to consider when developing a bioethically sound foundation for AI in medicine, based on images of eye structures, for discussion with all stakeholders.EVIDENCE REVIEW: The scope of the issues and summaries of the discussions under consideration by the Foundational Principles of Ophthalmic Imaging and Algorithmic Interpretation Working Group, as first presented during the Collaborative Community on Ophthalmic Imaging inaugural meeting on September 7, 2020, and afterwards in the working group.FINDINGS: AI has the potential to fundamentally improve the access to healthcare and patient outcomes, while decreasing disparities, lowering cost, as well as enhancing the care team. Nevertheless, substantial concerns exist. Ethicists, AI algorithm experts, as well as the Food and Drug Administration (FDA) and other regulatory agencies, industry, patient advocacy groups, clinicians and their professional societies, other provider groups, payors, and other healthcare stakeholders working together in collaborative communities to resolve such issues as non-maleficence, autonomy and equity, is essential to attain this potential, and impacts all levels of the design, validation and implementation of AI in medicine. Design, validation and implementation of AI warrant meticulous attention.CONCLUSIONS AND RELEVANCE: The development of a bioethically sound foundation may be possible if it is based in non-maleficence, autonomy and equity, for considerations for the design, validation and implementation for AI systems. Achieving such a foundation will be helpful for continuing successful introduction into medicine, before consideration by regulatory agencies around the globe.Fundamental improvements in accessibility and quality of healthcare, decrease in health disparities, and lower cost can thereby be achieved. These considerations should be discussed with all stakeholders and expanded upon as a useful initiation of this dialogue.

  View details for DOI 10.1016/j.ophtha.2021.08.023

  View details for PubMedID 34478784

• Compassionate Deactivation of Ventricular Assist Devices in Children with Heart Failure. ASAIO journal (American Society for Artificial Internal Organs : 1992) Char, D. S., Hollander, S. A., Feudtner, C. 2021

  View details for DOI 10.1097/MAT.0000000000001545

  View details for PubMedID 34352820

• Parental Attitudes Toward Clinical Genomic Sequencing in Children With Critical Cardiac Disease. Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies Gal, D. B., Deuitch, N., Lee, S. S., Simon, R. T., Char, D. S. 2021

  Abstract

  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.

  View details for DOI 10.1097/PCC.0000000000002669

  View details for PubMedID 33591072

• Compassionate Deactivation of Pediatric Ventricular Assist Devices: A Review of 14 Cases. Journal of pain and symptom management Hollander, S. A., Kaufman, B. D., Bui, C. n., Gregori, B. n., Murray, J. M., Sacks, L. n., Ryan, K. R., Ma, M. n., Rosenthal, D. N., Char, D. n. 2021

  Abstract

  Compassionate deactivation (CD) of ventricular assist device (VAD) support is a recognized option for children when the burden of therapy outweighs the benefits.To describe the prevalence, indications, and outcomes of CD of children supported by VADs at the end of life.Review of cases of CD at our institution between 2011-2020. To distinguish CD from other situations where VAD support is discontinued, patients were excluded from the study if they died during resuscitation (including ECMO), experienced brain or circulatory death prior to deactivation, or experienced a non-survivable brain injury likely to result in imminent death regardless of VAD status.Of 24 deaths on VAD, 14 (58%) were CD. Median age was 5.7 (IQR 0.6, 11.6) years; 6 (43%) had congenital heart disease; 4 (29%) were on a device that can be used outside of the hospital. CD occurred after 40 (IQR: 26, 75) days of support; none while active transplant candidates. CD discussions were initiated by the caregiver in 6 (43%) cases, with the remainder initiated by a medical provider. Reasons for CD were multifactorial, including end-organ injury, infection, and stroke. CD occurred with endotracheal extubation and/or discontinuation of inotropes in 12 (86%) cases, and death occurred within 10 (IQR: 4, 23) minutes of CD.CD is the mode of death in more than half of our VAD non-survivors and is pursued for reasons primarily related to noncardiac events. Caregivers and providers both initiate CD discussions. Ventilatory and inotropic support is often withdrawn at time of CD with ensuing death.

  View details for DOI 10.1016/j.jpainsymman.2021.01.125

  View details for PubMedID 33910026

• A Framework to Evaluate Ethical Considerations with ML-HCA Applications-Valuable, Even Necessary, but Never Comprehensive. The American journal of bioethics : AJOB Char, D., Abramoff, M., Feudtner, C. 2020; 20 (11): W6–W10

  View details for DOI 10.1080/15265161.2020.1827695

  View details for PubMedID 33103985

• Identifying Ethical Considerations for Machine Learning Healthcare Applications. The American journal of bioethics : AJOB Char, D. S., Abramoff, M. D., Feudtner, C. 2020; 20 (11): 7–17

  Abstract

  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.

  View details for DOI 10.1080/15265161.2020.1819469

  View details for PubMedID 33103967

• Parents Demand and Teenager Refuses Epidural Anesthesia. Pediatrics Berkowitz, I., Burgart, A., Truog, R. D., Mancuso, T. J., Char, D., Lantos, J. D. 2020

  Abstract

  A 15-year-old girl is scheduled to undergo an upper lobectomy to debulk metastatic Ewing sarcoma. The anesthesiologist recommended placement of a thoracic epidural catheter to provide postoperative analgesia. The patient did not want a needle to be placed near her spine. She was terrified that the procedure would be painful and that it might paralyze her. Although the anesthesiologist reassured her that sedation and local anesthesia would make the procedure comfortable, she remained vehemently opposed to the epidural procedure. The parents spoke privately to the anesthesiologist and asked for placement of the epidural after she was asleep. They firmly believed that this would provide optimal postoperative analgesia and thus would be in her best interest. Experts discuss the pros and cons of siding with the patient or parents.

  View details for DOI 10.1542/peds.2019-3295

  View details for PubMedID 32398328

• Considerations for Triaging Elective Cases in Children with Cardiac Disease in a Time of Crisis. Circulation Gal, D. B., Char, D. S. 2020

  View details for DOI 10.1161/CIRCULATIONAHA.120.047087

  View details for PubMedID 32282242

• Pectoral Nerve Blocks Decrease Postoperative Pain and Opioid Use After Pacemaker or Implantable Cardioverter-Defibrillator Placement in Children. Heart rhythm Yang, J. K., Char, D. S., Motonaga, K. S., Navaratnam, M., Dubin, A. M., Trela, A., Hanisch, D. G., McFadyen, G., Chubb, H., Goodyer, W., Ceresnak, S. R. 2020

  Abstract

  BACKGROUND: Pectoral nerve blocks (PECS) can reduce intra-procedural anesthetic requirements and postoperative pain. Little is known on the utility of PECS in reducing pain and narcotic use after pacemaker (PM) or implantable cardioverter defibrillator (ICD) placement in children.OBJECTIVE: 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 2015-2020 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 underwent PECS and those who underwent conventional local anesthetic (CONTROL).RESULTS: A total of 74 patients underwent PM or ICD placement with 20 patients (27%) undergoing 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%-CI 0.8-2.2) vs CONTROL 3.1 (95%-CI 2.7-3.5); P<0.001] and lower total opioid use [PECS 6.0 MME/m2 (95%-CI 3.4-8.6) vs CONTROL 15.0 MME/m2 (95%-CI 11.8-18.2); P=0.001] over the 24-hours post-implant.CONCLUSIONS: Pectoralis nerve blocks 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.

  View details for DOI 10.1016/j.hrthm.2020.03.009

  View details for PubMedID 32201270

• Machine Learning Implementation in Clinical Anesthesia: Opportunities and Challenges. Anesthesia and analgesia Char, D. S., Burgart, A. n. 2020

  View details for DOI 10.1213/ANE.0000000000004656

  View details for PubMedID 31922996

• Lessons learnt about Autonomous AI: Finding a safe, efficacious and ethical path through the development process. American journal of ophthalmology Abramoff, M. D., Tobey, D. n., Char, D. S. 2020

  Abstract

  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. 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.Case study with literature review and bioethical analysis.Online library search for articles with AI and ethics as subject. Definition of terminology. Review of bioethical principles, and derivation of evaluation rules for Autonomous AI. Case study with an FDA de novo authorized Autonomous AI system.Preliminary evaluation rules derived from bioethical principles include patient outcome, validation, reference standard, design, data usage, and accountability for medical liability. Application of the rules explains successful FDA de novo authorization.Physicians need to become competent in understanding the limitations and risks as well as the potential benefits of autonomous AI, and understand its design, safety, efficacy and equity, validation, liability, and how its data was obtained. The Autonomous AI evaluation rules introduced here can support this process.

  View details for DOI 10.1016/j.ajo.2020.02.022

  View details for PubMedID 32171769

• How Anesthesiologists Experience and Negotiate Ethical Challenges from Drug Shortages. AJOB empirical bioethics Sinow, C. n., Burgart, A. n., Char, D. S. 2020: 1–8

  Abstract

  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.

  View details for DOI 10.1080/23294515.2020.1839596

  View details for PubMedID 33124970

• The opioid crisis should lead pediatric anesthesiologists to a broader vision of opioid stewardship. Paediatric anaesthesia Burgart, A. M., Char, D. 2019; 29 (11): 1078–80

  View details for DOI 10.1111/pan.13730

  View details for PubMedID 31677337

• Use of genetic risks in pediatric organ transplantation listing decisions: A national survey PEDIATRIC TRANSPLANTATION Graf, M., Char, D., Hanson-Kahn, A., Magnus, D. 2019; 23 (4)

  View details for DOI 10.1111/petr.13402

  View details for Web of Science ID 000470844700003

• Use of genetic risks in pediatric organ transplantation listing decisions: A national survey. Pediatric transplantation Graf, M., Char, D., Hanson-Kahn, A., Magnus, D. 2019: e13402

  Abstract

  There is a limited supply of organs for all those who need them for survival. Thus, careful decisions must be made about who is listed for transplant. Studies show that manifesting genetic disease can impact listing eligibility. What has not yet been studied is the impact genetic risks for future disease have on a patient's chance to be listed. Surveys were emailed to 163 pediatric liver, heart, and kidney transplant programs across the United States to elicit views and experiences of key clinicians regarding each program's use of genetic risks (ie, predispositions, positive predictive testing) in listing decisions. Response rate was 42%. Sixty-four percent of programs have required genetic testing for specific indications prior to listing decisions. Sixteen percent have required it without specific indications, suggesting that genetic testing may be used to screen candidates. Six percent have chosen not to list patients with secondary findings or family histories of genetic conditions. In hypothetical scenarios, programs consider cancer predispositions and adult-onset neurological conditions to be relative contraindications to listing (61%, 17%, and 8% depending on scenario), and some consider them absolute contraindications (5% and 3% depending on scenario). Only 3% of programs have formal policies for these scenarios, but all consult genetic specialists at least "sometimes" for results interpretation. Our study reveals that pediatric transplant programs are using future onset genetic risks in listing decisions. As genetic testing is increasingly adopted into pediatric medicine, further study is needed to prevent possible inappropriate use of genetic information from impacting listing eligibility.

  View details for PubMedID 31012250

• The Decision to Withdraw in Children With Ventricular Assist Devices. The American journal of bioethics : AJOB Char, D., Hollander, S. A. 2019; 19 (3): 61-62

  View details for DOI 10.1080/15265161.2018.1563655

  View details for PubMedID 31543046

• The Decision to Withdraw in Children With Ventricular Assist Devices AMERICAN JOURNAL OF BIOETHICS Char, D., Hollander, S. A. 2019; 19 (3): 61–62

  View details for DOI 10.1080/15265161.2018.1563655

  View details for Web of Science ID 000461885300022

• Translating genomic testing results for pediatric critical care: Opportunities for genetic counselors. Journal of genetic counseling Deuitch, N. n., Soo-Jin Lee, S. n., Char, D. n. 2019

  Abstract

  Genomic sequencing (GS), such as whole genome and exome sequencing, is rapidly being integrated into pediatric critical care settings. Results are being used to make high impact decisions including declarations of futility, withdrawal of care, and rationing of scarce resources. In this qualitative study, we conducted interviews with clinicians involved in the care of critically ill children with congenital heart disease (CHD) to investigate their views on implementation of GS into clinical practice. Interviews were transcribed and inductively analyzed for major themes using grounded theory and thematic analysis. Three major themes emerged surrounding the use of genomic information in the high-stakes, time pressured decision making that characterizes clinical care of critically ill children with CHD: (a) that clinicians felt they did not have sufficient training to accurately assess genetic results despite pressure to incorporate results into clinical decisions; (b), that they desire knowledge support from genetic specialists, such as genetic counselors, who both understand the critical care context and are available within the time constraints of critical care clinical pressures; and (c), that clinicians feel a pressing need for increased genetics education to be able to safely and appropriately incorporate GS results into clinical decisions Our data suggest that genetics specialists may need a stronger presence in the pediatric critical care setting.

  View details for DOI 10.1002/jgc4.1182

  View details for PubMedID 31701594

• Surveillance and Digital Health. The American journal of bioethics : AJOB Martinez-Martin, N., Char, D. 2018; 18 (9): 67–68

  View details for PubMedID 30235099

• Implementing Machine Learning in Health Care - Addressing Ethical Challenges NEW ENGLAND JOURNAL OF MEDICINE Char, D. S., Shah, N. H., Magnus, D. 2018; 378 (11): 981–83

  View details for PubMedID 29539284

  View details for PubMedCentralID PMC5962261

• Anticipating uncertainty and irrevocable decisions: provider perspectives on implementing whole-genome sequencing in critically ill children with heart disease. Genetics in medicine : official journal of the American College of Medical Genetics Char, D. S., Lee, S. S., Magnus, D. n., Cho, M. n. 2018

  Abstract

  PurposeTo 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.MethodsWe 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.ResultsIn 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.ConclusionDespite 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.Genet Med advance online publication, 1 March 2018; doi:10.1038/gim.2018.25.

  View details for PubMedID 29493583

• The Advance of Rescue Technologies and the Border of Viability. The American journal of bioethics : AJOB Char, D. 2017; 17 (8): 40-41

  View details for DOI 10.1080/15265161.2017.1340995

  View details for PubMedID 28768128

• Genomic Contraindications for Heart Transplantation. Pediatrics Char, D. S., Lázaro-Muñoz, G., Barnes, A., Magnus, D., Deem, M. J., Lantos, J. D. 2017

  Abstract

  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.

  View details for DOI 10.1542/peds.2016-3471

  View details for PubMedID 28255068

  View details for PubMedCentralID PMC5369679

• CPR and Ventricular Assist Devices: The Challenge of Prolonging Life Without Guaranteeing Health. American journal of bioethics Magnus, D., Char, D. 2017; 17 (2): 1-2

  View details for DOI 10.1080/15265161.2016.1276752

  View details for PubMedID 28112616

• Pediatric Acute Care Decision Implications of Genetically Discoverable Mental Disorders AMERICAN JOURNAL OF BIOETHICS Char, D. 2017; 17 (4): 32-33

  View details for DOI 10.1080/15265161.2017.1284926

  View details for Web of Science ID 000397005600013

  View details for PubMedID 28328359

• Can Destination Therapy be implemented in children with heart failure? A study of provider perceptions. Pediatric transplantation Char, D. S., Lee, S. S., Ikoku, A. A., Rosenthal, D., Magnus, D. 2016; 20 (6): 819-824

  Abstract

  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.

  View details for DOI 10.1111/petr.12747

  View details for PubMedID 27357389

• Anesthesia Intraoperative Handoffs: Is Decision Ownership Compatible With Transitions of Care Providers? American journal of bioethics Char, D. 2016; 16 (9): 19-20

  View details for DOI 10.1080/15265161.2016.1197341

  View details for PubMedID 27471931

• 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. A & A case reports Char, D. S., Yarlagadda, V., Maeda, K., Williams, G. 2016; 6 (10): 308-310

  Abstract

  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.

  View details for DOI 10.1213/XAA.0000000000000300

  View details for PubMedID 27002753

• Cognitive Dysfunction in Children with Heart Disease: The Role of Anesthesia and Sedation. Congenital heart disease Char, D., Ramamoorthy, C., Wise-Faberowski, L. 2016; 11 (3): 221-229

  Abstract

  As physicians and caregivers of children with congenital heart disease, we are aware of the increasing need for procedures requiring anesthesia. While these procedures may be ideal for medical and cardiac surgical management, the risks and benefits must be assessed carefully. There are well known risks of cardiovascular and respiratory complications from anesthesia and sedation and a potentially under-appreciated risk of neurocognitive dysfunction. Both animal and human studies support the detrimental effects of repeated anesthetic exposure on the developing brain. Although the studies in humans are less convincing of this risk, the Society of Pediatric Anesthesia jointly with SmartTots provided a consensus statement on the use of anesthetic and sedative drugs in infants and toddlers when speaking to families. (www.pedsanesthesia.org; http://smarttots.org/wp-content/uploads/2015/10/ConsensusStatementV910.5.2015.pdf). An excerpt of the statement is "Concerns regarding the unknown risk of anesthetic exposure to your child's brain development must be weighed against the potential harm associated with cancelling or delaying a needed procedure. Each child's care must be evaluated individually based on age, type, and urgency of the procedure and other health factors. This review provides a summary of the current evidence regarding anesthesia-induced neurotoxicity and the developing brain and its implications for children with congenital heart disease.

  View details for DOI 10.1111/chd.12352

  View details for PubMedID 27228360

• Accuracy of Pulse Oximeters Intended for Hypoxemic Pediatric Patients. Pediatric critical care medicine Harris, B. U., Char, D. S., Feinstein, J. A., Verma, A., Shiboski, S. C., Ramamoorthy, C. 2016; 17 (4): 315-320

  Abstract

  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%.Prospective observational study.Single institution; cardiac catheterization laboratory, and operating room.Fifty patients weighing 3-20 kg with baseline saturations less than 90% undergoing surgical or catheterization procedure.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%.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.

  View details for DOI 10.1097/PCC.0000000000000660

  View details for PubMedID 26914626

• Supervised Controlled Substance Use. American journal of bioethics Char, D. 2016; 16 (4): 56-58

  View details for DOI 10.1080/15265161.2016.1145290

  View details for PubMedID 26982927

• Accuracy of Pulse Oximeters Intended for Hypoxemic Pediatric Patients PEDIATRIC CRITICAL CARE MEDICINE Harris, B. U., Char, D. S., Feinstein, J. A., Verma, A., Shiboski, S. C., Ramamoorthy, C. 2016; 17 (4): 315-320

  Abstract

  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%.Prospective observational study.Single institution; cardiac catheterization laboratory, and operating room.Fifty patients weighing 3-20 kg with baseline saturations less than 90% undergoing surgical or catheterization procedure.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%.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.

  View details for DOI 10.1097/PCC.0000000000000660

  View details for Web of Science ID 000373211600006

• How should whole-genome sequencing be implemented in children? A consideration of the current limitations PERSONALIZED MEDICINE Char, D. S. 2016; 13 (1): 33-42

  View details for DOI 10.2217/pme.15.44

  View details for Web of Science ID 000368163400006

• How should whole-genome sequencing be implemented in children? A consideration of the current limitations. Personalized medicine Char, D. S. 2016; 13 (1): 33-42

  Abstract

  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.

  View details for DOI 10.2217/pme.15.44

  View details for PubMedID 29749866

• Parental Refusal of Newborn Screening for Congenital Hearing Loss. American journal of bioethics Char, D. 2016; 16 (1): 33-35

  View details for DOI 10.1080/15265161.2015.1115145

  View details for PubMedID 26734745

• Negotiating the dilemma of anaesthesia and sedation in NICUs. The Lancet. Respiratory medicine Char, D. S. 2015; 3 (10): 741-742

  View details for DOI 10.1016/S2213-2600(15)00368-9

  View details for PubMedID 26420018

• Ethics of Disclosure Regarding Drug Shortages That Affect Patient Care. Anesthesia and analgesia Char, D. S., Magnus, D. 2015; 121 (2): 262-263

  View details for DOI 10.1213/ANE.0000000000000842

  View details for PubMedID 26197365

• Whole-genome sequencing in critically ill infants and emerging ethical challenges. The Lancet. Respiratory medicine Char, D. S. 2015; 3 (5): 333-335

  View details for DOI 10.1016/S2213-2600(15)00151-4

  View details for PubMedID 25937000

• Whole genome sequencing in critically ill children. The Lancet. Respiratory medicine Char, D. S., Cho, M., Magnus, D. 2015; 3 (4): 264-266

  View details for DOI 10.1016/S2213-2600(15)00006-5

  View details for PubMedID 25704991

• Preventive Genomic Sequencing and Care of the Individual Patient. American journal of bioethics Char, D. 2015; 15 (7): 32-33

  View details for DOI 10.1080/15265161.2015.1039725

  View details for PubMedID 26147263

• Ethical concerns raised among pediatric heart failure clinicians. American journal of bioethics Char, D. S. 2015; 15 (5): 36-37

  View details for DOI 10.1080/15265161.2015.1021971

  View details for PubMedID 25970391

• Are preoperative B-type natriuretic peptide levels associated with outcome after pulmonary artery banding and the double switch operation in patients with congenitally corrected transposition of the great arteries: A pilot study JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY Char, D. S., Shiboski, S. C., Hanley, F. L., Fineman, J. R. 2014; 148 (5): 2434-2436

  View details for DOI 10.1016/j.jtcvs.2014.07.003

  View details for Web of Science ID 000345132600141

• Are preoperative B-type natriuretic peptide levels associated with outcome after pulmonary artery banding and the double switch operation in patients with congenitally corrected transposition of the great arteries: a pilot study. journal of thoracic and cardiovascular surgery Char, D. S., Shiboski, S. C., Hanley, F. L., Fineman, J. R. 2014; 148 (5): 2434-2436

  View details for DOI 10.1016/j.jtcvs.2014.07.003

  View details for PubMedID 25135237

• Preoperative B-type natriuretic peptide levels are associated with outcome after total cavopulmonary connection (Fontan). journal of thoracic and cardiovascular surgery Radman, M., Keller, R. L., Oishi, P., Datar, S. A., Wellnitz, K., Azakie, A., Hanley, F., Char, D., Hsu, J., Amrinovin, R., Adatia, I., Fineman, J. R. 2014; 148 (1): 212-219

  Abstract

  The study objective was to determine the association between preoperative B-type natriuretic peptide levels and outcome after total cavopulmonary connection. Surgical palliation of univentricular cardiac defects requires a series of staged operations, ending in a total cavopulmonary connection. Although outcomes have improved, there remains an unpredictable risk of early total cavopulmonary connection takedown. The prediction of adverse postoperative outcomes is imprecise, despite an extensive preoperative evaluation.We prospectively enrolled 50 patients undergoing total cavopulmonary connection. We collected preoperative clinical data, preoperative plasma B-type natriuretic peptide levels, and postoperative outcomes, including the incidence of an adverse outcome within 1 year of surgery (defined as death, total cavopulmonary connection takedown, or the need for cardiac transplantation).The mean age of patients was 4.7 years (standard deviation, 2.1 years). The median (interquartile range) preoperative B-type natriuretic peptide levels were higher in patients who required total cavopulmonary connection takedown and early postoperative mechanical cardiac support (n = 3; median, 55; interquartile range, 42-121) compared with those with a good outcome (n = 47; median, 11; interquartile range, 5-17) (P < .05). A preoperative B-type natriuretic peptide level of 40 pg/mL or greater was highly associated with the need for total cavopulmonary connection takedown (sensitivity, 100%; specificity, 93%; P < .05), yielding a positive predictive value of 50% and a negative predictive value of 100%. Higher preoperative B-type natriuretic peptide levels also were associated with longer intensive care unit length of stay, longer hospital length of stay, and increased incidence of low cardiac output syndrome (P < .05).Preoperative B-type natriuretic peptide blood levels are uniquely associated with the need for mechanical support early after total cavopulmonary connection and total cavopulmonary connection takedown, and thus may provide important information in addition to the standard preoperative assessment.

  View details for DOI 10.1016/j.jtcvs.2013.08.009

  View details for PubMedID 24079880

  View details for PubMedCentralID PMC3968237

• General anesthesia treatment of propriospinal myoclonus in a patient with fibrodysplasia ossificans progressiva. A & A case reports Char, D. S., Hutchison, H. T., Kitterman, J. A., Gregory, G. A. 2014; 3 (1): 6-8

  Abstract

  Fibrodysplasia ossificans progressiva, a rare and severely disabling genetic condition, is characterized clinically by progressive ossification of skeletal muscle and connective tissue and congenital malformations of the great toes. Recurrent episodes of heterotopic ossification (flare-ups) lead to increasing loss of mobility as joints become progressively affected. We report the case of a young woman with fibrodysplasia ossificans progressiva who had recurrent, debilitating myoclonus that was refractory to conventional therapies but was relieved for prolonged periods after general anesthesia was administered.

  View details for DOI 10.1213/XAA.0000000000000037

  View details for PubMedID 25612266

• Unintended effects on morale of mandatory postincident testing. American journal of bioethics Char, D. S. 2014; 14 (12): 42-44

  View details for DOI 10.1080/15265161.2014.964879

  View details for PubMedID 25369416

• The effects of ketamine on dexmedetomidine-induced electrophysiologic changes in children. Paediatric anaesthesia Char, D., Drover, D. R., Motonaga, K. S., Gupta, S., Miyake, C. Y., Dubin, A. M., Hammer, G. B. 2013; 23 (10): 898-905

  Abstract

  BACKGROUND: Dexmedetomidine is an alpha2-adrenergic agonist used for sedation and analgesia in children. We previously showed that dexmedetomidine depresses sinus and AV nodal function resulting in adverse hemodynamic effects such as bradycardia and increased blood pressure. We hypothesized that these effects of dexmedetomidine might be antagonized by co-administration of ketamine, which has sympathomimetic properties. METHODS: Twenty-two children (ages 5-17 years) undergoing electrophysiologic (EP) study and ablation for supraventricular tachycardia were enrolled. Patients were kept sedated with continuous infusion of propofol at a fixed rate. Hemodynamic and EP parameters were measured before and after a loading dose of dexmedetomidine (1 μg·kg(-1) ). A continuous infusion of dexmedetomidine (0.7 μg·kg(-1) ·h(-1) ) was initiated and a ketamine loading dose (1 mg·kg(-1) ), followed by continuous infusion (1 mg·kg(-1) ·h(-1) ), was given. A repeat set of hemodynamic and EP parameters were then measured at the time of projected peak tissue concentration for both drugs. RESULTS: A significant increase in mean arterial pressure (MAP) was seen compared with baseline after loading of dexmedetomidine. This returned to baseline after co-administration of ketamine (mean difference between baseline and after ketamine 1.8 mmHg; 95%CI, -7.8 to 4.3; P = <0.001). A decrease in heart rate was seen after dexmedetomidine followed by a return to baseline after co-administration of ketamine (mean difference between baseline and after ketamine -6.5 bpm; 95%CI, -11.2 to -1.8; P = 0.005). Sinus node recovery time was lengthened after dexmedetomidine but returned to baseline after ketamine (mean difference between baseline and after ketamine -16.2 ms; 95%CI, -63 to 30; P = 0.014). QT was prolonged after dexmedetomidine and returned to baseline after ketamine (mean difference between baseline and after ketamine -34.2 ms; 95%CI, -48.4 to -20.2; P = 0.004). AV nodal effective refractory period was also impaired after dexmedetomidine and showed weak evidence for return to baseline function after ketamine (mean difference between baseline and after ketamine -22.8 ms; 95%CI, -40.2 to -5.2; P = 0.069). CONCLUSION: The concurrent use of ketamine may mitigate the negative chronotropic effects of dexmedetomidine.

  View details for DOI 10.1111/pan.12143

  View details for PubMedID 23506472

• Volatile anesthetic rescue therapy in children with acute asthma: innovative but costly or just costly?*. Pediatric critical care medicine Char, D. S., Ibsen, L. M., Ramamoorthy, C., Bratton, S. L. 2013; 14 (4): 343-350

  Abstract

  : To describe volatile anesthesia (VA) use for pediatric asthma, including complications and outcomes.: Retrospective cohort study.: Children's hospitals contributing to the Pediatric Health Information System between 2004-2008.: Children 2-18 years old with a primary diagnosis code for asthma supported with mechanical ventilation.: Those treated with VA were compared to those not treated with VA or extracorporeal membrane oxygenation. Hospital VA use was grouped as none, <5%, 5-10% and >10% among intubated children.: One thousand five hundred and fifty-eight patients received mechanical ventilation at 40 hospitals for asthma: 47 (3%) received VA treatment at 11 (28%) hospitals. Those receiving a VA were significantly less likely to receive inhaled b-agonists, ipratropium bromide, and heliox, but more likely to receive neuromuscular blocking agents than patients treated without VA. Length of mechanical ventilation, hospital stay (length of stay [LOS]) and charges were significantly greater for those treated with VA. Aspiration was more common but death and air leak did not differ. Patients at hospitals with VA use >10% were significantly less likely to receive inhaled b agonist, ipratropium bromide, methylxanthines, and heliox, but more likely to receive systemic b agonist, neuromuscular blocking agents compared to those treated at hospitals not using VA. LOS, duration of ventilation, and hospital charges were significantly greater for patients treated at centers with high VA use.: Mortality does not differ between centers that use VA or not. Patients treated at centers with high VA use had significantly increased hospital charges and increased LOS.

  View details for DOI 10.1097/PCC.0b013e3182772e29

  View details for PubMedID 23439466

• Case report: airway and concurrent hemodynamic management in a neonate with oculo-auriculo-vertebral (Goldenhar) syndrome, severe cervical scoliosis, interrupted aortic arch, multiple ventricular septal defects, and an unstable cervical spine PEDIATRIC ANESTHESIA Char, D. S., Gipp, M., Boltz, M. G., Williams, G. D. 2012; 22 (9): 932-934

  Abstract

  We report the challenging case of a 1-week-old, term, 2.4 kg neonate with Goldenhar syndrome (including microcephaly, left microtia, left facial palsy, dextro-scoliosis of the cervical spine, and cervico-thoracic levoscoliosis), multiple ventricular septal defects, a type B interrupted aortic arch, a large patent ductus arteriosis, and radiographic and clinical signs concerning for an unstable cervical spine. Our anesthesia team was consulted for perioperative management of this patient during her surgical repair. This case report describes the use of the Air-Q size 1 laryngeal airway (LA) to assist fiberoptic intubation in an ASA 4 neonate with cardiac disease, an anticipated difficult airway with the addition of an unstable cervical spine, as well as the anesthetic techniques used to maintain hemodynamic stability while the airway was secured.

  View details for DOI 10.1111/j.1460-9592.2012.03915.x

  View details for Web of Science ID 000306900400017

  View details for PubMedID 22834469