"She was finally mine": the moral experience of families in the context of trisomy 13 and 18- a scoping review with thematic analysis.

INTRODUCTION: The value of a short life characterized by disability has been hotly debated in the literature on fetal and neonatal outcomes. METHODS: We conducted a scoping review to summarize the available empirical literature on the experiences of families in the context of trisomy 13 and 18 (T13/18) with subsequent thematic analysis of the 17 included articles. FINDINGS: Themes constructed include (1) Pride as Resistance, (2) Negotiating Normalcy and (3) The Significance of Time. INTERPRETATION: Our thematic analysis was guided by the moral experience framework conceived by Hunt and Carnevale (2011) in association with the VOICE (Views On Interdisciplinary Childhood Ethics) collaborative research group. RELEVANCE: This article will be of interest and value to healthcare professionals and bioethicists who support families navigating the medically and ethically complex landscape of T13/18.

Surgical waitlist management: Perspectives from surgeons on surgical prioritization at a paediatric hospital.

Globally exacerbated surgical waitlists have provided the opportunity to reflect on prioritization and resource allocation decisions. The unique circumstances of paediatric surgery and consequences of surgical delay prompted the study reported in this paper. As part of a larger project to attend to prioritization in our surgical waitlists, we conducted a Quality Improvement study, the purpose of which is to understand surgeon's perspectives regarding the ethical and practical realities of surgical prioritization at our institution. The study comprises semi-structured interviews with nine full-time paediatric surgeons from a variety of subspecialties conducted at our institution, which is a tertiary paediatric hospital with ten surgical subspecialties in a publicly funded healthcare system. Participants articulated how they prioritize their waitlists, and how they understand ethical prioritization. These findings resonate with the growing public concern for ethical practice in healthcare delivery and transparency in prioritization and resource allocation practices. Specifically, more transparency, consistency, and support is required in prioritization practices. This work highlights the importance of institutional dialogue regarding surgical case prioritization. Because quality improvement work is necessarily site-specific, concrete generalizations cannot be offered. However, the insights gleaned from these interviews and the process by which they were gleaned are a valuable knowledge-sharing resource for any institution that is interested in ongoing quality improvement work. The objectives here were to clarify the goals of prioritization within the institution, improve prioritization practices, and make them more ethical and transparent.

Navigating disagreement and conflict in the context of a brain-based definition of death.

In this paper, we discuss situations in which disagreement or conflict arises in the critical care setting in relation to the determination of death by neurologic criteria, including the removal of ventilation and other somatic support. Given the significance of declaring a person dead for all involved, an overarching goal is to resolve disagreement or conflict in ways that are respectful and, if possible, relationship preserving. We describe four different categories of reasons for these disagreements or conflicts: 1) grief, unexpected events, and needing time to process these events; 2) misunderstanding; 3) loss of trust; and 4) religious, spiritual, or philosophical differences. Relevant aspects of the critical care setting are also identified and discussed. We propose several strategies for navigating these situations, appreciating that these may be tailored for a given care context and that multiple strategies may be helpfully used. We recommend that health institutions develop policies that outline the process and steps involved in addressing situations where there is ongoing or escalating conflict. These policies should include input from a broad range of stakeholders, including patients and families, as part of their development and review.

RéSUMé: Dans cet article, nous discutons des situations dans lesquelles un désaccord ou un conflit survient dans le contexte des soins intensifs en ce qui concerne une détermination de décès selon des critères neurologiques, y compris le retrait de la ventilation et d'autres assistances somatiques. Compte tenu de l'importance pour toutes les personnes impliquées de déclarer une personne décédée, un objectif primordial est de résoudre les désaccords ou les conflits de manière respectueuse et, si possible, de préserver les relations. Nous décrivons quatre catégories différentes de raisons causant ces désaccords ou conflits : 1) le chagrin, des événements inattendus et le besoin de temps pour accepter ces événements; 2) les malentendus; 3) la perte de confiance; et 4) les différences religieuses, spirituelles ou philosophiques. Les aspects pertinents du milieu des soins intensifs sont également identifiés et discutés. Nous proposons plusieurs stratégies pour gérer ces situations, en étant conscients que celles-ci peuvent être adaptées à un contexte de soins donné et que plusieurs stratégies peuvent être utiles à appliquer. Nous recommandons que les établissements de santé élaborent des politiques qui décrivent le processus et les étapes nécessaires pour faire face aux situations où il y a un conflit en cours ou qui s'intensifie. Dans le cadre de leur élaboration et de leur examen, ces politiques devraient inclure les commentaires d'un large éventail d'intervenants, y compris les patients et les familles.

The Potential Value of the U.N. Convention on the Rights of the Child in Pediatric Bioethics Settings.

This article provides support for the use of a particular international human rights law document, the U.N. Convention on the Rights of the Child (CRC), in contemporary pediatric bioethics practice without relying on the legally binding force of the document. It first demonstrates that the CRC's core commitments and values substantially overlap with the core commitments and values of mainstream bioethics and with the laws of many domestic jurisdictions where mainstream bioethics are currently practiced. It then explores some implications of this overlap. For instance, the substantial international human rights law scholarship on how to understand these commitments and values can be helpful in suggesting ways to operationalize them in domestic bioethics practice and can offer insightful, internationally generated ethical perspectives that may not have been considered. The article also argues that the CRC can help health-care organizations develop policies consistent with the best interests of children and that the CRC can serve as a common language of values for transnational health-care collaborations. However, as a final case discussion demonstrates, whatever the merits of the CRC, one may face practical difficulties in trying to use it.

Developing a bioethics curriculum for medical students from divergent geo-political regions.

BACKGROUND: The World Health Organization calls for stronger cross-cultural emphasis in medical training. Bioethics education can build such competencies as it involves the conscious exploration and application of values and principles. The International Pediatric Emergency Medicine Elective (IPEME), a novel global health elective, brings together 12 medical students from Canada and the Middle East for a 4-week, living and studying experience. It is based at a Canadian children's hospital and, since its creation in 2004, ethics has informally been part of its curriculum. Our study sought to determine the content and format of an ideal bioethics curriculum for a culturally diverse group of medical students. METHODS: We conducted semi-structured interviews with students and focus groups with faculty to examine the cultural context and ethical issues of the elective. Three areas were explored: 1) Needs Analysis - students' current understanding of bioethics, prior bioethics education and desire for a formal ethics curriculum, 2) Teaching formats - students' and faculty's preferred teaching formats, and 3) Curriculum Content - students' and faculty's preferred subjects for a curriculum. RESULTS: While only some students had received formal ethics training prior to this program, all understood that it was a necessary and desirable subject for formal training. Interactive teaching formats were the most preferred and truth-telling was considered the most important subject. CONCLUSIONS: This study helps inform good practices for ethics education. Although undertaken with a specific cohort of students engaging in a health-for-peace elective, it may be applicable to many medical education settings since diversity of student bodies is increasing world-wide.

Standard of Care in Pediatrics: Integrating Family-Centred Care and Social Determinants of Health.

In pediatric healthcare, there is a recognized need to address social determinants of health (SDOH) to positively influence child health and development. In addition, family-centred care (FCC) recognizes the value of the family unit in affecting individual patient experiences of illness and care. However, pediatric healthcare that incorporates principles of FCC and SDOH may be interpreted as calling on clinicians to deviate from or add to practices that form an accepted standard of care. This paper explores the legal and ethical considerations of doing so and describes practical responses to these challenging situations.

Identifying prioritization criteria to supplement critical care triage protocols for the allocation of ventilators during a pandemic influenza.

The purpose of this study was to identify supplementary criteria to provide direction when the Ontario Health Plan for an Influenza Pandemic (OHPIP) critical care triage protocol is rendered insufficient by its inability to discriminate among patients assessed as urgent, and there are insufficient critical care resources available to treat those in that category. To accomplish this task, a Supplementary Criteria Task Force for Critical Care Triage was struck at the University of Toronto Joint Centre for Bioethics. The task force reviewed publically available protocols and policies on pandemic flu planning, identified 13 potential triage criteria and determined a set of eight key ethical, legal and practical considerations against which it assessed each criterion. An online questionnaire was distributed to clinical, policy and community stakeholders across Canada to obtain feedback on the 13 potential triage criteria toward selecting those that best met the eight considerations. The task force concluded that the balance of arguments favoured only two of the 13 criteria it had identified for consideration: first come, first served and random selection. The two criteria were chosen in part based on a need to balance the clearly utilitarian approach employed in the OHPIP with equity considerations. These criteria serve as a defensible "fail safe" mechanism for any triage protocol.

Institutional Priority-Setting for Novel Drugs and Therapeutics: A Qualitative Systematic Review.

BACKGROUND: There is a lack of guidance on approaches to formulary management and funding for high-cost drugs and therapeutics by individual healthcare institutions. The objective of this review was to assess institutional approaches to resource allocation for such therapeutics, with a particular focus on paediatric and rare disease populations. METHODS: A search of Embase and MEDLINE was conducted for studies relevant to decision-making for off-formulary, high-cost drugs and therapeutics. Abstracts were evaluated for inclusion based on the Simple Multiple-Attribute Rating Techniques (SMART) criteria. A framework of 30 topics across 4 categories was used to guide data extraction and was based on findings from the initial abstract review and previous health technology assessment (HTA) publications. Reflexive thematic analysis was conducted using QSR NVivo 12 software. RESULTS: A total of 168 studies were included for analysis. Only 4 (2%) focused on paediatrics, while 21 (12%) centred on adults and the remainder (85%) did not specify. Thirty-two (19%) studies discussed the importance of high-cost therapeutics and 34 (23%) focused on rare/orphan drugs. Five themes were identified as being relevant to institutional decision-making for high-cost therapeutics: institutional strategy, substantive criteria, procedural considerations, guiding principles and frameworks, and operational activities. Each of these themes encompassed several sub-themes and was complemented by a sixth category specific to paediatrics and rare diseases. CONCLUSION: The rising cost of novel drugs and therapeutics underscores the need for robust, evidence-based, and ethically defensible decision-making processes for health technology funding, particularly at the hospital level. Our study highlights practices and themes to aid decision-makers in thinking critically about institutional, substantive, procedural, and operational considerations in support of legitimate decisions about institutional funding of high-cost drugs and therapeutics, as well as opportunities and challenges that exist for paediatric and rare disease populations.

Priority-setting for hospital funding of high-cost innovative drugs and therapeutics: A qualitative institutional case study.

OBJECTIVES: Rising costs of innovative drugs and therapeutics (D&Ts) have led to resource allocation challenges for healthcare institutions. There is limited evidence to guide priority-setting for institutional funding of high-cost D&Ts. This study sought to identify and elaborate on the substantive principles and procedures that should inform institutional funding decisions for high-cost off-formulary D&Ts through a case study of a quaternary care paediatric hospital. METHODS: Semi-structured, qualitative interviews, both virtual and in-person, were conducted with institutional stakeholders (i.e. staff clinicians, senior leadership, and pharmacists) (n = 23) and two focus groups at The Hospital for Sick Children in Toronto, Canada. Participants involved in, and impacted by, high-cost off-formulary drug funding decisions were recruited through stratified, purposive sampling. Participants were approached for study involvement between July 27, 2020 and June 7, 2022. Data was analysed through reflexive thematic analysis. RESULTS: Institutional resource allocation for high-cost D&Ts was identified as ethically challenging but critical to sustainable access to novel therapies. Important substantive principles included: 1) clinical evidence of safety and efficacy, 2) economic considerations (direct costs, opportunity costs, value for money), 3) ethical principles (social justice, professional/organizational responsibility), and 4) disease-specific considerations. Multidisciplinary deliberation was identified as an essential procedural component of decision-making. Participants identified tension between innovation and the need for evidence-based decision-making; clinician and institutional responsibilities; and value for money and social justice. Participants emphasized the role of health system-level funding allocation in alleviating the financial and moral burden of decision-making by institutions. CONCLUSIONS: This study identifies values and processes to aid in the development and implementation of institutional resource allocation frameworks for high-cost innovative D&Ts.

Facilitating innovation in the clinical setting: a pathway for operationalizing accountability.

Innovation is essential to ongoing improvements in quality healthcare, yet healthcare institutions continue to struggle with the challenge of how best to operationalize the multiple commitments to risk minimization, accountability, the defensible use of resources and quality innovative practices. An ideal pathway would be one that adheres to both the ethical values of the institution in which the innovation is being introduced and relevant legal standards in a way that preserves the innovators' imagination and enthusiasm while ensuring scientific rigour and accountability. An interdisciplinary team at the Hospital for Sick Children in Toronto, Ontario, developed a policy-entrenched pathway f or managing the introduction of innovative procedures in surgery. This article describes the innovation pathway and the steps; taken in its development.

Prenatal HIV testing: women's experiences of informed consent in Toronto, Ontario.

OBJECTIVE: All Canadian jurisdictions have human immunodeficiency virus (HIV) testing programs requiring that clinicians discuss HIV testing with all pregnant women and seek their consent to be tested. Our goal was to evaluate how the informed consent process was being carried out in Ontario. METHODS: Between November 2002 and February 2004, women in postpartum wards in three Toronto teaching hospitals were invited to participate in the study. A structured questionnaire was administered on the ward, medical records were reviewed, and data from the Central Public Health Laboratory were examined to verify whether or not the women had been tested. RESULTS: Of 446 women invited, 299 (67%) participated. All except one participant had at least one prenatal visit, and 92% had more than five visits. Seventy-four percent of participants recalled a clinician talking to them about testing, and 70% of these felt that they were given the option to refuse the test. Twenty-one women overall (7%) believed that they were not tested during pregnancy or were not certain whether they had been tested or not, but actually had been tested. Women who felt that their care provider did not have an opinion about whether they should undergo testing were more likely to decline. Eighty-six percent were completely satisfied with the testing experience. CONCLUSION: Informed consent for prenatal HIV testing is generally being obtained in a manner consistent with provincial guidelines. Our findings raise concern, however, that a significant number of women are not offered testing or in some cases are tested without their consent. Increases in testing rates could be achieved by offering the test to all women and emphasizing that carrying out testing is a recommended part of medical care.

A qualitative study of the duty to care in communicable disease outbreaks.

Health care providers' (HCPs') duty to care during communicable disease outbreaks has resurfaced as an important and contentious topic. This renewed interest follows the re-emergence of communicable diseases, largely thought to have disappeared and therefore irrelevant to modern day practitioners. The 2003 SARS outbreak particularly presented propitious circumstances for reconsidering this issue. This study seeks to characterize the views of individuals on the nature and limits of this duty. The authors employed qualitative methods to gather lay and expert perspectives. Individual interviews were conducted with 67 participants consisting of HCPs, spiritual leaders, regulators, and members of the public from the greater Toronto area. Participants' views were analyzed and organized according to three main themes, constituting a framework that combines micro-, meso-, and macro-level structures and processes: the scope of obligations of HCPs, the roles of health care institutions, and the broader social context, respectively. Our data suggest that the duty to care must be placed in a wider context to include considerations that transcend individual provider obligations. It thus follows, based on our data, that the duty to care cannot be left to personal choice or an appeal to morality based on an ethic derived entirely from individual obligations. The micro-meso-macro analytical framework that we have developed can guide the articulation of accepted norms of duty to care during epidemics and the development of policy for public health crises. It can also enhance the focus of our current expectations of HCPs' duty during epidemics. This can be achieved by informing regulatory bodies, collaborating with policy makers and engaging the public.

Adoption of an innovation to repair aortic aneurysms at a Canadian hospital: a qualitative case study and evaluation.

BACKGROUND: Priority setting in health care is a challenge because demand for services exceeds available resources. The increasing demand for less invasive surgical procedures by patients, health care institutions and industry, places added pressure on surgeons to acquire the appropriate skills to adopt innovative procedures. Such innovations are often initiated and introduced by surgeons in the hospital setting. Decision-making processes for the adoption of surgical innovations in hospitals have not been well studied and a standard process for their introduction does not exist. The purpose of this study is to describe and evaluate the decision-making process for the adoption of a new technology for repair of abdominal aortic aneurysms (endovascular aneurysm repair [EVAR]) in an academic health sciences centre to better understand how decisions are made for the introduction of surgical innovations at the hospital level. METHODS: A qualitative case study of the decision to adopt EVAR was conducted using a modified thematic analysis of documents and semi-structured interviews. Accountability for Reasonableness was used as a conceptual framework for fairness in priority setting processes in health care organizations. RESULTS: There were two key decisions regarding EVAR: the decision to adopt the new technology in the hospital and the decision to stop hospital funding. The decision to adopt EVAR was based on perceived improved patient outcomes, safety, and the surgeons' desire to innovate. This decision involved very few stakeholders. The decision to stop funding of EVAR involved all key players and was based on criteria apparent to all those involved, including cost, evidence and hospital priorities. Limited internal communications were made prior to adopting the technology. There was no formal means to appeal the decisions made. CONCLUSION: The analysis yielded recommendations for improving future decisions about the adoption of surgical innovations. ese empirical findings will be used with other case studies to help develop guidelines to help decision-makers adopt surgical innovations in Canadian hospitals.