Involving parents in paediatric clinical ethics committee deliberations: a current controversy.

In cases where the best interests of the child are disputed or finely balanced, Clinical Ethics Committees (CECs) can provide a valuable source of advice to clinicians and trusts on the pertinent ethical dimensions. Recent judicial cases have criticised the lack of formalised guidance and inconsistency in the involvement of parents in CEC deliberations. In Manchester University NHS FT v Verden [2022], Arbuthnot J set out important procedural guidance as to how parental involvement in CEC deliberations might be managed. She also confirmed substantive guidance on the role of parental views in determining the child's best interests. We agree that it is good practice to ensure that the patient voice is heard in ethics processes, but how that is achieved is controversial. Surely it is best that what matters most to a patient and their family, whether facts or values, is conveyed directly to those considering the moral issues involved, rather than via a prism of another party. The approach suggested in the Verden case has much in common with the process used by our CEC. In this article, we commend Arbuthnot J's approach, provide an example of its effective operation and consider what it might mean for ethics processes.

Ethical advice in paediatric care.

The need for local ethics advice during the COVID-19 pandemic has put a spotlight on clinical ethics committees (CECs) and services. In this review, we focus on paediatric CECs that raise both generic questions and specific issues. In doing this, we acknowledge the broader roles of education, research and staff support some bioethics teams have developed but focus on the main areas of clinical ethics support to clinical teams. We raise 12 questions about the role, remit and responsibilities of CECs, provide preliminary answers to these and set out the next steps for the development of ethics support both in paediatric practice and more generally.

COVID-19, children, clinical trials and compassion: The ethical case for using innovative or compassionate treatments.

AIM: Safe, effective SARS-CoV-2 treatment has not yet been determined, though some drugs have favourable mortality and morbidity benefits in specific situations. No treatments have been explicitly tested in children, who are, therefore, once again therapeutic orphans. METHOD: We echo calls to enrol patients, including children, into trials but those children recruited to date have largely been additions to adult studies. Few were recruited during the initial pandemic despite the emergence of PIMS-TS/MIS-C, which surely demands paediatric-specific research. RESULT: Must children be proscribed treatments effective in adults until child-specific data emerges, even in a pandemic? Will appropriately powered dedicated trials ever determine specific child-COVID-19 treatment pathways? Is the protracted time frame to assemble such data acceptable to children with severe COVID-19 today? Such factors are relevant in considering whether children should have access to compassionate, innovative, pandemic-disease treatment. CONCLUSION: We argue that children should be permitted, indeed have a right, to access innovative treatments early in any future pandemic, following an individual best interests consideration. This will remain the case until formal studies powered to determine children's optimal treatment commence, when the moral duty switches to ensuring children are enrolled, with any preceding innovative-use data made available to researchers.

Ethical responsibilities of European children's teams facing the resurgent COVID-19 pandemic.

The COrona VIrus Disease 2019 (COVID-19) pandemic is posing an unprecedented challenge to healthcare systems around the globe. Europe has been struggling for 1 year now, and despite some encouraging progress (above all, the beginning of vaccination), the second wave is ongoing. Even though children are less affected than adults, the COVID-19 pandemic-and in particular the measures to counter it-is having a considerable impact on the paediatric healthcare setting. It is, therefore, the duty of paediatric teams in Europe to prepare for the challenges ahead. We wish to contribute to this necessary preparedness in two ways: firstly, by assessing the direct and indirect impact of the pandemic on children and on the paediatric setting; secondly, and more importantly, by identifying the various responsibilities of paediatric healthcare professionals, in light of established ethical principles. Only abiding by these responsibilities will it be possible to ensure that ill children and their families are properly supported even in these difficult times and to grant that decisions about children's healthcare remain morally justified and lawful. What is Known: • The COVID-19 outbreak is posing an unprecedented challenge to healthcare systems around the globe • Despite the children are less affected than adults, the COVID-19 pandemic is having a huge impact also on paediatric setting What is New: • The COVID-19 pandemic lays out specific responsibilities of paediatric professionals towards our pa-tients, society and ourselves • The paediatric teams in Europe should assess the direct and indirect impact of the pandemic on the chil-dren and on the paediatric settings, ensuring consistency between centres and across regions in Europe.

Association Between Treatments and Short-Term Biochemical Improvements and Clinical Outcomes in Post-Severe Acute Respiratory Syndrome Coronavirus-2 Inflammatory Syndrome.

OBJECTIVES: To 1) analyze the short-term biochemical improvements and clinical outcomes following treatment of children with post-severe acute respiratory syndrome coronavirus-2 inflammatory syndrome (multisystem inflammatory syndrome in children/pediatric inflammatory multisystem syndrome temporally associated with severe acute respiratory syndrome coronavirus-2) admitted to U.K. PICUs and 2) collate current treatment guidance from U.K. PICUs. DESIGN: Multicenter observational study. SETTING: Twenty-one U.K. PICUs. PATIENTS: Children (< 18 yr) admitted to U.K. PICUs between April 1, 2020, and May 10, 2020, fulfilling the U.K. case definition of pediatric inflammatory multisystem syndrome temporally associated with severe acute respiratory syndrome coronavirus-2. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Routinely collected, deidentified data were analyzed. Propensity score and linear mixed effects models were used to analyze the effect of steroids, IV immunoglobulin, and biologic agents on changes in C-reactive protein, platelet counts, and lymphocyte counts over the course of PICU stay. Treatment recommendations from U.K. clinical guidelines were analyzed. Over the 6-week study period, 59 of 78 children (76%) received IV immunoglobulin, 57 of 78 (73%) steroids, and 18 of 78 (24%) a biologic agent. We found no evidence of a difference in response in clinical markers of inflammation between patients with multisystem inflammatory syndrome in children/pediatric inflammatory multisystem syndrome temporally associated with severe acute respiratory syndrome coronavirus-2 who were treated with IV immunoglobulin, steroids, or biologics, compared with those who were not. By the end of the study period, most patients had received immunomodulation. The 12 patients who did not receive any immunomodulators had similar decrease in inflammatory markers as those treated. Of the 14 guidelines analyzed, the use of IV immunoglobulin, steroids, and biologics was universally recommended. CONCLUSIONS: We were unable to identify any short-term benefit from any of the treatments, or treatment combinations, administered. Despite a lack of evidence, treatment guidelines for multisystem inflammatory syndrome in children/pediatric inflammatory multisystem syndrome temporally associated with severe acute respiratory syndrome coronavirus-2 have become very similar in advising step-wise treatments. Retaining clinical equipoise regarding treatment will allow clinicians to enroll children in robust clinical trials to determine the optimal treatment for this novel important condition.

Challenging misconceptions about clinical ethics support during COVID-19 and beyond: a legal update and future considerations.

The pace of change and, indeed, the sheer number of clinical ethics committees (not to be confused with research ethics committees) has accelerated during the COVID-19 pandemic. Committees were formed to support healthcare professionals and to operationalise, interpret and compensate for gaps in national and professional guidance. But as the role of clinical ethics support becomes more prominent and visible, it becomes ever more important to address gaps in the support structure and misconceptions as to role and remit. The recent case of Great Ormond Street Hospital for Children NHS Foundation Trust v MX, FX and X ([2020] EWHC 1958 (Fam), [21]-[23] and [58]) has highlighted the importance of patient/family representation at clinical ethics committee meetings. The court viewed these meetings as making decisions about such treatment. We argue that this misunderstands the role of ethics support, with treatment decisions remaining with the clinical team and those providing their consent. The considered review by clinical ethics committees of the moral issues surrounding complex treatment decisions is not a matter of determining a single ethical course of action. In this article, we consider current legal understandings of clinical ethics committees, explore current concepts of ethics support and suggest how they may evolve, considering the various mechanisms of the inclusion of patients and their representatives in ethics meetings which is not standard in the UK.

Work of a paediatric bioethics centre during the COVID-19 pandemic first phase.

OBJECTIVES: Decisions with an ethical component have been controversial during the COVID-19 pandemic, whether leaked intensive care unit (ICU)-rationing documents, transfer of people to care-homes to 'protect the National Health Service' or the duty to treat patients despite inadequate personal protective equipment. To counter criticism of ethics per se, and to help those planning ethics support we describe the practical work of a children's hospital bioethics team in supporting children, families and clinicians during this unprecedented period. DESIGN/SETTING: Three phases of activity: (i) preparation: we composed several documents to support/guide hospital teams and, together with colleagues, provided them to regional inpatient, community and hospice settings. We adapted existing mechanisms to combat workforce moral injury; (ii) activity (March-June 2020): was highest in our rapid response service where children/families consider difficult treatment decisions with medical teams. Education provided 'pandemic webcasts' on decision-making and broader child-health concerns. Staff support was essential, especially for those deployed to overwhelmed local adult ICUs. Research ascertained young people's views on the pandemic; (iii) reflection: focussed on (a) research about future re-deployment to adult services and minimisation of moral distress/injury, (b) remote video-conferencing-parents'/participants' experience/ability to consider complex ethical issues and (c) role of faith/non-faith in society's recovery and children's views. MAIN OUTCOME/CONCLUSIONS: Our bioethics team's role during the pandemic included: case reviews via video-conferencing, many involving innovative therapy for severely unwell children with COVID-19/Paediatric-Inflammatory-Multisystem Syndrome-Temporally associated with SARS-CoV-2 together with their parents; processes to protect healthcare staff from moral harm and research/educational activity focused on paediatric-specific ethical arising during the pandemic.

Caring for Critically Ill Children With Suspected or Proven Coronavirus Disease 2019 Infection: Recommendations by the Scientific Sections' Collaborative of the European Society of Pediatric and Neonatal Intensive Care.

OBJECTIVES: In children, coronavirus disease 2019 is usually mild but can develop severe hypoxemic failure or a severe multisystem inflammatory syndrome, the latter considered to be a postinfectious syndrome, with cardiac involvement alone or together with a toxic shock like-presentation. Given the novelty of severe acute respiratory syndrome coronavirus 2, the causative agent of the recent coronavirus disease 2019 pandemic, little is known about the pathophysiology and phenotypic expressions of this new infectious disease nor the optimal treatment approach. STUDY SELECTION: From inception to July 10, 2020, repeated PubMed and open Web searches have been done by the scientific section collaborative group members of the European Society of Pediatric and Neonatal Intensive Care. DATA EXTRACTION: There is little in the way of clinical research in children affected by coronavirus disease 2019, apart from descriptive data and epidemiology. DATA SYNTHESIS: Even though basic treatment and organ support considerations seem not to differ much from other critical illness, such as pediatric septic shock and multiple organ failure, seen in PICUs, some specific issues must be considered when caring for children with severe coronavirus disease 2019 disease. CONCLUSIONS: In this clinical guidance article, we review the current clinical knowledge of coronavirus disease 2019 disease in critically ill children and discuss some specific treatment concepts based mainly on expert opinion based on limited experience and the lack of any completed controlled trials in children at this time.

The Birkenhead drill suggests 'women and children first': government and society's reversal of the drill during the COVID-19 pandemic, left children last and cannot be allowed to continue.

The Birkenhead drill states that in the time of crisis, the correct action is to prioritise the weakest and most vulnerable, in that example, women and children. Ethically this has been well analysed in terms of the intrinsic value of the human versus any utilitarian calculus of worth to society's function. We do not attempt to re-analyse this but do note that standard pandemic planning often disadvantages the weak and vulnerable in terms of allocation of resources to those with a greater chance of functional survival. We more argue from a debt that society owes its children in terms of the sacrifices they have made in terms of school, social life, healthcare and overall welfare during the pandemic from which they were at markedly less risk than adults. Society owes a debt to its young, and this on top of pre-existing commitments to the them that most nations fail to realise, calls for prioritisation of children and young people's issues as society rebuilds. The effects of poverty and systemic racism on many children must be tackled; so too the existential threats of climate change and pollution. COVID-19 provides a once in a generation opportunity to create a kinder, fairer society. Early signs are not good: Pub re-opening prioritised over school re-opening; no significant investment in children's services or women's health, a significant determinant of children's welfare. We highlight the way COVID-19 has, and continues, to harm children and argue that the contemporary erosion of the Birkenhead principle is simply amoral.

Young people's views on their role in the COVID-19 pandemic and society's recovery from it.

OBJECTIVE: There has been little formal exploration of how young people see their role in the COVID-19 pandemic. DESIGN/SETTING: Focus-group discussion with 15 Children's Hospital Young People's Forum members (23/5) to explore their perspective on the impact of COVID-19 on both their lives and those of their community, on school closures, and the role they wished to play in society's recovery from the pandemic. Audio recordings were transcribed verbatim using NVivo Software and analysed using an inductive thematic analysis approach. OUTCOME: Four major themes identified: (1) Awareness of pandemic's impact on others: participants showed mature awareness of the effects on broader society, especially the elderly, socially disadvantaged and parents. (2) Perceived impact on their own lives: principal concerns were the educational and practical repercussions of school closures and social isolation, including effects on educational prospects. (3) Views about school reopening: young people understood the broader rationale for school reopening and were generally positive about it, but expressed concerned about their safety and that of others. (4) Communication issues: a need for clear, concise, understandable information readily accessible for young people was expressed. Up to now, they felt passive recipients rather than participants. CONCLUSION: Young people were concerned about their future, their family and broader society, consistent with a high level of moral development. They want to be active participants in social recovery, including concepts around return to school but require appropriate information and a means by which their voices can be heard. The alternative suggested roles as pawns or pathfinders were discounted.

Infant With SARS-CoV-2 Infection Causing Severe Lung Disease Treated With Remdesivir.

We describe an ex-premature infant presenting with severe acute respiratory syndrome coronavirus 2 infection in the fifth week of life. In current reports, researchers indicate that acute symptomatic severe acute respiratory syndrome coronavirus 2 infection is relatively rare and much less severe than in adults. This case highlights that infection can be associated with life-threatening pulmonary disease in young infants and that infection can follow a similar disease course to that described in adults. We provide first data on the use of the novel antiviral remdesivir in a young child and an innovative approach to expedited approval from a multidisciplinary clinical team and bioethics committee for compassionate access to the drug.

Clinical Characteristics of 58 Children With a Pediatric Inflammatory Multisystem Syndrome Temporally Associated With SARS-CoV-2.

Importance: In communities with high rates of coronavirus disease 2019, reports have emerged of children with an unusual syndrome of fever and inflammation. Objectives: To describe the clinical and laboratory characteristics of hospitalized children who met criteria for the pediatric inflammatory multisystem syndrome temporally associated with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (PIMS-TS) and compare these characteristics with other pediatric inflammatory disorders. Design, Setting, and Participants: Case series of 58 children from 8 hospitals in England admitted between March 23 and May 16, 2020, with persistent fever and laboratory evidence of inflammation meeting published definitions for PIMS-TS. The final date of follow-up was May 22, 2020. Clinical and laboratory characteristics were abstracted by medical record review, and were compared with clinical characteristics of patients with Kawasaki disease (KD) (n = 1132), KD shock syndrome (n = 45), and toxic shock syndrome (n = 37) who had been admitted to hospitals in Europe and the US from 2002 to 2019. Exposures: Signs and symptoms and laboratory and imaging findings of children who met definitional criteria for PIMS-TS from the UK, the US, and World Health Organization. Main Outcomes and Measures: Clinical, laboratory, and imaging characteristics of children meeting definitional criteria for PIMS-TS, and comparison with the characteristics of other pediatric inflammatory disorders. Results: Fifty-eight children (median age, 9 years [interquartile range {IQR}, 5.7-14]; 20 girls [34%]) were identified who met the criteria for PIMS-TS. Results from SARS-CoV-2 polymerase chain reaction tests were positive in 15 of 58 patients (26%) and SARS-CoV-2 IgG test results were positive in 40 of 46 (87%). In total, 45 of 58 patients (78%) had evidence of current or prior SARS-CoV-2 infection. All children presented with fever and nonspecific symptoms, including vomiting (26/58 [45%]), abdominal pain (31/58 [53%]), and diarrhea (30/58 [52%]). Rash was present in 30 of 58 (52%), and conjunctival injection in 26 of 58 (45%) cases. Laboratory evaluation was consistent with marked inflammation, for example, C-reactive protein (229 mg/L [IQR, 156-338], assessed in 58 of 58) and ferritin (610 µg/L [IQR, 359-1280], assessed in 53 of 58). Of the 58 children, 29 developed shock (with biochemical evidence of myocardial dysfunction) and required inotropic support and fluid resuscitation (including 23/29 [79%] who received mechanical ventilation); 13 met the American Heart Association definition of KD, and 23 had fever and inflammation without features of shock or KD. Eight patients (14%) developed coronary artery dilatation or aneurysm. Comparison of PIMS-TS with KD and with KD shock syndrome showed differences in clinical and laboratory features, including older age (median age, 9 years [IQR, 5.7-14] vs 2.7 years [IQR, 1.4-4.7] and 3.8 years [IQR, 0.2-18], respectively), and greater elevation of inflammatory markers such as C-reactive protein (median, 229 mg/L [IQR 156-338] vs 67 mg/L [IQR, 40-150 mg/L] and 193 mg/L [IQR, 83-237], respectively). Conclusions and Relevance: In this case series of hospitalized children who met criteria for PIMS-TS, there was a wide spectrum of presenting signs and symptoms and disease severity, ranging from fever and inflammation to myocardial injury, shock, and development of coronary artery aneurysms. The comparison with patients with KD and KD shock syndrome provides insights into this syndrome, and suggests this disorder differs from other pediatric inflammatory entities.

Children of COVID-19: pawns, pathfinders or partners?

Countries throughout the world are counting the health and socioeconomic costs of the COVID-19 pandemic, including the strategies necessary to contain it. Profound consequences from social isolation are beginning to emerge, and there is an urgency about charting a path to recovery, albeit to a 'new normal' that mitigates them. Children have not suffered as much from the direct effects of COVID-19 infection as older adults. Still, there is mounting evidence that their health and welfare are being adversely affected. Closure of schools has been a critical component of social isolation but has a far broader impact than the diminution of educational opportunities, as important as these are. Reopening of schools is therefore essential to recovery, with some countries already tentatively implementing it. Children's interests are vital considerations in any recovery plan, but the question remains as to how to address them within the context of how society views children; should they be regarded as pawns, pathfinders or partners in this enterprise?