Background:Providing oncological care to children is demanding and ethical issues concerning what is best for the child can contribute to moral distress.Objectives:To explore healthcare professionals’ experiences of situations that generate moral distress in Swedish paediatric oncology.Research design:In this national study, data collection was conducted using the Swedish Moral Distress Scale-Revised. The data analysis included descriptive statistics and non-parametric analysis of differences between groups.Participants and research context:Healthcare professionals at all paediatric oncology centres in Sweden were invited to (...) participate. A total of 278 healthcare professionals participated. The response rate was 89%.Ethical considerations:In its advisory statement, the Regional Ethical Review Board decided that the study was of such a nature that the legislation concerning ethical reviews was not applicable. All participants received written information about the aim of the study and confidentiality. Participants demonstrated their consent by returning the survey.Findings:The two situations with the highest moral distress scores concerned lack of competence and continuity of personnel. All professional groups reported high levels of disturbance. Nurses rated significantly higher frequencies and higher total Moral Distress Scale scores compared to medical doctors and nursing assistants.Discussion:Lack of competence and continuity, as the two most morally distressing situations, confirms the findings of studies from other countries, where inadequate staffing was reported as being among the top five morally distressing situations. The levels of total Moral Distress Scale scores were more similar to those reported in intensive care units than in other paediatric care settings.Conclusion:The two most morally distressing situations, lack of competence and continuity, are both organisational in nature. Thus, clinical ethics support services need to be combined with organisational improvements in order to reduce moral distress, thereby maintaining job satisfaction, preventing a high turnover of staff and ensuring the quality of care. (shrink)

Background: It is stated that the communication and disease experiences of paediatric patients, especially paediatric oncology patients, with healthcare professionals are completely different from those of adults. Objective: The aim of this study was to determine the definitions of a good physician and good nurse provided by elementary school-age oncology patients. Research design: In this qualitative research, data were collected through semi-structured individual interviews. The data were evaluated thorough thematic analysis. Participants and research context: Eighteen children (...) hospitalised due to cancer in paediatric oncology and haematology clinics of a university hospital in Turkey. Ethical considerations: Permission to conduct the study was obtained from the Institution’s Ethics Committee. The objectives of this study were explained to the participants and families, and written consent was obtained from them. Also, participants were assured that necessary measures would be taken to protect their anonymity and confidentiality. Findings: The definitions of children were based on five main themes: interpersonal relationships, virtues, professional responsibility, security and individual characteristics. Conclusion: Children conveyed important messages to health professionals. They emphasised that a good physician and good nurse should communicate well, not only with themselves but also with their family. In addition, children were sensitive about health professionals who played with them and actively participated in the treatment by informing them about the disease. Meeting the expectations of children can be possible by improving the communication skills of physicians and nurses and by adding games and activities to the treatment and care plan. (shrink)

In paediatric oncology, research and treatments are often closely combined, which may compromise voluntary informed consent of parents. We identified two key scenarios in which voluntary informed consent for paediatric oncology studies is potentially compromised due to the intertwinement of research and care. The first scenario is inclusion by the treating paediatric oncologist, the second scenario concerns treatments confined to the research context. In this article we examine whether voluntary informed consent of parents for research (...) is compromised in these two scenarios, and if so whether this is also morally problematic. For this, we employ the account of voluntary consent from Nelson and colleagues, who assert that voluntary consent requires substantial freedom from controlling influences. We argue that, in the absence of persuasion or manipulation, inclusion by the treating physician does not compromise voluntariness. However, it may function as a risk factor for controlling influence as it narrows the scope within which parents make decisions. Furthermore, physician appeal to reciprocity is not controlling as it constitutes persuasion. In addition, framing information is a form of informational manipulation and constitutes a controlling influence. In the second scenario, treatments confined to the research context qualify as controlling if the available options are restricted through manipulation of options. Although none of the influences is morally problematic in itself, a combination of influences may create morally problematic instances of involuntary informed consent. Therefore, safeguards should be implemented to establish an optimal environment for parents to provide voluntary informed consent in an integrated research-care context. (shrink)

In paediatric oncology, research and treatments are often closely combined, which may compromise voluntary informed consent of parents. We identified two key scenarios in which voluntary informed consent for paediatric oncology studies is potentially compromised due to the intertwinement of research and care. The first scenario is inclusion by the treating paediatric oncologist, the second scenario concerns treatments confined to the research context. In this article we examine whether voluntary informed consent of parents for research (...) is compromised in these two scenarios, and if so whether this is also morally problematic. For this, we employ the account of voluntary consent from Nelson and colleagues, who assert that voluntary consent requires substantial freedom from controlling influences. We argue that, in the absence of persuasion or manipulation, inclusion by the treating physician does not compromise voluntariness. However, it may function as a risk factor for controlling influence as it narrows the scope within which parents make decisions. Furthermore, physician appeal to reciprocity is not controlling as it constitutes persuasion. In addition, framing information is a form of informational manipulation and constitutes a controlling influence. In the second scenario, treatments confined to the research context qualify as controlling if the available options are restricted through manipulation of options. Although none of the influences is morally problematic in itself, a combination of influences may create morally problematic instances of involuntary informed consent. Therefore, safeguards should be implemented to establish an optimal environment for parents to provide voluntary informed consent in an integrated research-care context. (shrink)

Background: Ethical climate and moral distress have been shown to affect nurses’ ethical behaviour. Despite the many ethical issues in paediatric oncology nursing, research is still lacking in the field. Research aim: To investigate paediatric oncology nurses’ perceptions of ethical climate and moral distress. Research design: In this cross-sectional study, data were collected using Finnish translations of the Swedish Hospital Ethical Climate Survey–Shortened and the Swedish Moral Distress Scale–Revised. Data analysis includes descriptive statistics and non-parametric analyses. (...) Respondents and research context: Ninety-three nurses, working at paediatric oncology centres in Finland, completed the survey. Ethical considerations: According to Finnish legislation, no ethical review was needed for this type of questionnaire study. Formal research approvals were obtained from all five hospitals. Return of the questionnaire was interpreted as consent to participate. Results: Ethical climate was perceived as positive. Although morally distressing situations were assessed as highly disturbing, in general they occurred quite rarely. The situations that did appear often reflected performing procedures on school-aged children who resist such treatment, inadequate staffing and lack of time. Perceptions of ethical climate and frequencies of morally distressing situations were inversely correlated. Discussion: Although the results echo the recurrent testimonies of busy work shifts, nurses could most often practise nursing the way they perceived as right. One possible explanation could be the competent and supportive co-workers, as peer support has been described as helpful in mitigating moral distress. Conclusion: Nurturing good collegial relationships and developing manageable workloads could reduce moral distress among nurses. (shrink)

BackgroundIn paediatric oncology, healthcare professionals face moral challenges. Clinical ethics support services, such as moral case deliberation, aim to assist them in dealing with these challenges. Yet, healthcare professionals can have different expectations and goals related to clinical ethics support services.MethodsIn this study, the perceptions held by healthcare professionals regarding the importance of possible outcomes of MCDs, prior to implementation of MCDs, were investigated. A multisite, cross-sectional, quantitative study was performed at all six Paediatric Oncology Centres (...) in Sweden. Healthcare professionals answered the Euro-MCD instrument with 26 potential MCD outcomes using a scale from Not important to Very important. Descriptive and comparative statistical analyses were carried out.ResultsAll outcomes were rated high, i.e., between 3.12 and 3.78. More open communication, developing skills to analyse ethically difficult situations, better mutual understanding, and deciding on concrete actions were rated as most important. Understanding of ethical theories and critical examination of policies were rated less important. Most often nursing assistants rated higher and physicians lower than the other professions did. Women and participants without previous experience of MCDs perceived outcomes as more important. There were differences between centres as one centre had significantly higher, and one centre had significantly lower ratings compared to the others.ConclusionIt is clear that healthcare professionals want MCDs to improve teamwork and skills in order to analyse and manage ethically difficult situations. When comparing to previous research about important MCD outcomes, there were similarities in what healthcare professionals consider to be important when handling moral challenges regardless of country and potential differences in healthcare settings and systems, such as paediatric vs. adult care. (shrink)

The goal is to present how shared decision-making in paediatric oncology occurs from the viewpoints of parents and physicians. Eight Swiss Pediatric Oncology Group centres participated in this prospective study. The sample comprised a parent and physician of the minor patient. Surveys were statistically analysed by comparing physicians’ and parents’ perspectives and by evaluating factors associated with children’s actual involvement. Perspectives of ninety-one parents and twenty physicians were obtained for 151 children. Results indicate that for six aspects (...) of information provision examined, parents’ and physicians’ perceptions differed. Moreover, parents felt that the children were more competent to understand diagnosis and prognosis, assessed the disease of the children as worse, and reported higher satisfaction with decision-making on the part of the children. A patient’s age and gender predicted involvement. Older children and girls were more likely to be involved. In the decision-making process, parents held a less active role than they actually wanted. Physicians should take measures to ensure that provided information is understood correctly. Furthermore, they should work towards creating awareness for systematic differences between parents and physicians with respect to the perception of the child, the disease, and shared decision-making. (shrink)

The paediatric Moral Distress Scale-Revised was previously translated and adapted to Swedish paediatric oncology. Cognitive interviews revealed five not captured situations among the 21 items, resulting in five added items: 22) Lack of time for conversations with patients/families, 23) Parents’ unrealistic expectations, 24) Not to talk about death with a dying child, 25) To perform painful procedures, 26) To decide on treatment/care when uncertain. The aim was to explore experiences of moral distress in the five added situations (...) in the Swedish paediatric MDS-R, among healthcare professionals in paediatric oncology. In this national cross-sectional survey, the Swedish paediatric MDS-R, including five added items, were used. Descriptive statistics, non-parametric analysis of differences between professions and a MDS-R score for each item were calculated. Internal consistency was tested using Cronbach’s alpha and inter-item correlation test. HCPs at all six Swedish paediatric oncology centres participated. The Regional Ethical Review Board had no objections. Consent was assumed when the survey was returned. Nursing assistants reported higher intensity and lower frequency on all added items; registered nurses reported a higher frequency on item 22–25; medical doctors reported higher MDS-R score on item 26. On item 22, intensity was moderate for RNs and MDs and high for NAs, and frequency was high among all. Item 22, had the second highest MDS-R score of all 26 for all professional groups. On item 23, the level of disturbance was low but it occurred often. The 26-item version showed good internal consistency for the overall sample and for all professional groups. However, item 22 and 24 could be viewed as redundant to two of the original 21. In accordance with other studies, the intensity was higher than the frequency, however, the frequency of the added items was higher than of the original items. In line with previous research, item 22 and 23 are important elements of moral distress. RNs experience the situations more often while NAs find them more disturbing. The results indicate that the added items are important in capturing moral distress in paediatric oncology. (shrink)

One of the difficulties nurses experience in clinical practice in relation to ethical issues in connection with young oncology patients is moral distress. In this descriptive correlational study, the Moral Distress Scale-Paediatric Version (MDS-PV) was translated from the original language and tested on a conventional sample of nurses working in paediatric oncology and haematology wards, in six north paediatric hospitals of Italy. 13.7% of the total respondents claimed that they had changed unit or hospital due (...) to moral distress. The items with the highest mean intensity in the sample were almost all connected with medical and nursing competence and have considerably higher values than frequency. The instrument was found to be reliable. The results confirmed the validity of the MDS-PV (Cronbach’s alpha = 0.959). This study represents the first small-scale attempt to validate MDS-PV for use in paediatric oncology-ematology nurses in Italy. (shrink)

Given advances in the science of fertility preservation and the link between fertility choices and wellbeing, it is time to reframe our ethical thinking around fertility preservation procedures for children and young people with cancer. The current framing of fertility preservation as a possible offer may no longer be universally appropriate. There is an increasingly pressing need to discuss the ethics of failing to preserve fertility, particularly for patient groups for whom established techniques exist. I argue that the starting point (...) for deliberating about a particular patient should be a rebuttable presumption that fertility preservation ought to be attempted. Consideration of the harms applicable to that specific patient may then override this presumption. I outline the benefits of attempting fertility preservation; these justify a presumption in favour of the treatment. I then discuss the potential harms associated with fertility preservation procedures, which may justify failing to attempt fertility preservation in an individual patient's particular case. Moving from a framework of offer to one of rebuttable presumption in favour of fertility preservation would have significant implications for medical practice, healthcare organizations and the state. (shrink)

BackgroundWhile fertility preservation is recommended practice for paediatric oncology patients, it is increasingly being considered for transgender children and young people in paediatric care. This raises ethical issues for clinicians, particularly around consent and shared decision-making in this new area of healthcare.MethodsA systematic review of normative literature was conducted across four databases in June 2020 to capture ethical considerations related to fertility counselling and preservation in paediatric transgender healthcare. The text of included publications was analysed inductively, (...) guided by the Qualitative Analysis Guide of Leuven.ResultsTwenty-four publications were identified for inclusion. Four key ethical considerations emerged from this literature: access to fertility preservation, conscientious objection, decision-making capacity of children and young people, and shared decision-making.ConclusionIn the identified literature, there is consensus that transgender children and young people should not be refused access to fertility preservation services solely due to their gender identity, and that clinicians with conscientious objections to fertility preservation for this group have an obligation to refer on to willing providers. Factors that create ethical complexity in this area of paediatric care include the child’s age, mental health, and parents’ views. (shrink)

Duty of candour legislation was introduced in Scotland in 2018. However, literature and experience of duty of candour when applied to infection control incidents/outbreaks is scarce. We describe clinician and parental perspectives with regard to duty of candour and communication during a significant infection control incident in a haemato-oncology ward of a children’s hospital. Based on the learning from this incident, we make recommendations for duty of candour and communication to patients and families during future infection control incidents. These (...) include the need to consider a crisis management approach, the importance of not underestimating psychological harm in incidents of a prolonged duration and embedding the existing legislation pertaining to the rights of the child. (shrink)

The world literature shows that empirical research regarding the process of decision-making when cancer in adolescents is no longer curable has been conducted in High-income, English speaking countries. The objective of the current study was to explore in-depth and to explain the decision-making process from the perspective of Mexican oncologists, parents, and affected adolescents and to identify the ethical principles that guide such decision-making. Purposive, qualitative design based on individual, fact-to-face, semi-structured, in-depth interviews. The participants were thirteen paediatric oncologists, (...) 13 parents or primary carers, and six adolescents with incurable cancer. The participants were recruited from the paediatric oncology services of three national tertiary-care medical centres in Mexico City. The oncologists stated that they broach the subject of palliative management when they have determined that curative treatment has failed. Respect for autonomy was understood as the assent of the parent/adolescent to what the oncologist determined to be in the best interest of the adolescent. The oncologists thought that the adolescent should be involved in the decision-making. They also identified the ability to count on a palliative care clinic or service as an urgent need. For the parents, it was essential that the oncologist be truly interested in their adolescent child. The parents did not consider it necessary to inform the child about impending death. The adolescents stated that the honesty of their oncologists was important; however, several of them opted for a passive role in the decision-making process. The findings of this study evidence that to achieve good medical practice in low-middle income countries, like Mexico, it is urgent to begin effective implementation of palliative care, together with appropriate training and continuing education in the ethics of clinical practice. (shrink)

Background The world literature shows that empirical research regarding the process of decision-making when cancer in adolescents is no longer curable has been conducted in High-income, English speaking countries. The objective of the current study was to explore in-depth and to explain the decision-making process from the perspective of Mexican oncologists, parents, and affected adolescents and to identify the ethical principles that guide such decision-making. Methods Purposive, qualitative design based on individual, fact-to-face, semi-structured, in-depth interviews. The participants were thirteen (...) class='Hi'>paediatric oncologists, 13 parents or primary carers, and six adolescents with incurable cancer. The participants were recruited from the paediatric oncology services of three national tertiary-care medical centres in Mexico City. Results The oncologists stated that they broach the subject of palliative management when they have determined that curative treatment has failed. Respect for autonomy was understood as the assent of the parent/adolescent to what the oncologist determined to be in the best interest of the adolescent. The oncologists thought that the adolescent should be involved in the decision-making. They also identified the ability to count on a palliative care clinic or service as an urgent need. For the parents, it was essential that the oncologist be truly interested in their adolescent child. The parents did not consider it necessary to inform the child about impending death. The adolescents stated that the honesty of their oncologists was important; however, several of them opted for a passive role in the decision-making process. Conclusion The findings of this study evidence that to achieve good medical practice in low-middle income countries, like Mexico, it is urgent to begin effective implementation of palliative care, together with appropriate training and continuing education in the ethics of clinical practice. (shrink)

BACKGROUND: Researchers have a moral responsibility to offer to return research results to participants, but the needs and attitudes of parents and adolescents with cancer in paediatric oncology regarding the issue are relatively unknown.OBJECTIVES: To explore the needs of potential research participants or their guardians with respect to the offer of a return of research results. METHODS: A questionnaire was used in a focus group and in telephone interviews with eight adolescents and 12 parents of children with cancer. (...) The participants were asked to respond to the questions and to comment on the inclusiveness of the questionnaire.RESULTS: The majority of participants (18 of 20) wished to receive research results. Two somewhat unexpected findings are described. First, all participants in the present study felt that it was the primary responsibility of the participant to retain contact with the researchers for the purpose of obtaining research results. Second, few participants (n=2) indicated that the Internet would be a satisfactory way of transmitting these results. One-half of the participants wished to have face-to-face communication of results.CONCLUSIONS: These results provide preliminary guidance for the return of research results to participants and validate the use of the questionnaire in a larger study of this issue. (shrink)

Throughout this paper PJ Kearney attempts to balance the risks and benefits of different approaches in paediatric oncology. Decisions have to be considered both in the short and the long term. Where religious beliefs, such as those held by Jehovah's Witnesses in relation to blood transfusions, conflict with normal medical practice the decision is often removed from the doctor, parents or patient to the courts. This sort of solution can be counter-productive, especially as good health care and subsequent (...) recovery rely, to a large extent, on good relationships between and among the parties concerned. Destruction of these relationships, for whatever reason, often has a detrimental effect on the patient, in whose best interest everyone believes they are acting. (shrink)

Objectives: To quantify the use of do-not-resuscitate orders in a tertiary-care children’s hospital and to characterise the circumstances in which such orders are written.Design: Retrospective study conducted in a 500-bed children’s hospital in Taiwan.Patients: The course of 101 patients who died between January 2002 and December 2005 was reviewed. The following data were collected: age at death, gender, disease and its status, place of death and survival. There were 59 males and 42 females with a median age of 103 months (...) . 50 children had leukaemias, and 51 had malignancies other than leukaemia. The t test and the χ2 test were applied as appropriate.Results: The study found that 44% of patient deaths occurred in the paediatric oncology ward; 29% of patient deaths occurred in the intensive care unit; and 28% of patients died in their home or at another hospital. Other findings included the following: 46 of 101 patients died after attempted cardiopulmonary resuscitation and 55 died with a DNR order in effect. The mean age at death was 9.8 years in both groups with or without DNR orders.Conclusions: From the study of patient deaths in this tertiary-care children’s hospital, it was concluded that an explicit DNR order is now the rule rather than the exception, with more DNR orders being written for patients who have been ill longer, who have solid tumours, who are not in remission and who are in the ward. (shrink)

Communication about diagnosis and medical treatment for children suffering from life-threatening illnesses is complex. It is a primary step in involving underage patients and families in care and lays the foundation for obtaining parental permission and patient assent for treatment. In practice child participation in care is often difficult to obtain due to patients' different and sometimes fluctuating preferences, but also parents' protective strategies. Physicians may be susceptible to parental wishes to limit information and feel uncomfortable discussing issues related to (...) uncertainty of cure with patients. A qualitative study in Romanian paediatric oncology units was conducted to explore children's involvement from the perspectives of parents and oncologists. Interviews with participants discussed 18 patient cases. Data were transcribed and thematic analysis was used to interpret and mine patients' involvement during treatment. Different facets of patient participation were identified: restricting, widening and enhancing involvement. A fourth category, unintentional involvement, occurred for all patients due to children's observations during long-term hospitalisations and access to Internet. Uncertainty overarched parental attitudes regarding the extent to which children should be included. Physicians usually complied with parental wishes to limit involvement, but together with parents involved patients at least in a practical way. Adults' protective attitude may backfire, as adolescents' online searches often expose patients to worse-case scenarios. Further research should acknowledge the hazards of restricted diagnosis disclosure and develop clinician tools to support families in communicating with patients. This should be paralleled by physician efforts to elicit patients' needs regarding participation. (shrink)

The image of “the good nurse” is mainly studied from the perspective of nurses, which often does not match the image held by patients. Therefore, a descriptive study was conducted to examine oncology patients’ perceptions of “the good nurse” and the influence of patient- and context-related variables. A cross-sectional, comparative, descriptive design was used. The sample comprised 557 oncology patients at one of six Flemish hospitals, where they were treated in an oncology day-care unit, oncology hospital (...) ward, or palliative care unit. Data were collected using the Flemish Care-Q instrument. Factor analysis summarised the most important characteristics of “the good nurse”. We reassessed the reliability and construct validity of the Flemish Care-Q and examined the influence of patient- and context-related variables on patient perceptions. Using factor analysis, we grouped the different items of the Flemish Care-Q according to three characteristics: “the good nurse” (I) has a supportive and communicative attitude towards patient and family, (II) is competent and employs a professional attitude, and (III) demonstrates personal involvement towards patient and family. Median factor scores of Factors I, II, and III, respectively, were 8.00, 9.00, and 8.00 (varying from 1, not important, to 10, very important). In order of importance, Factors II, I, and III were identified as valuable characteristics of “the good nurse”. Gender, care setting, and province were influential variables. As perceived by oncology patients, “the good nurse” has a broad range of qualities, of which competence and professionalism are the most valuable. (shrink)

The National Cancer Institute’s Thesaurus (NCIT) has been created with the goal of providing a controlled vocabulary which can be used by specialists in the various sub-domains of oncology. It is intended to be used for purposes of annotation in ways designed to ensure the integration of data and information deriving from these various sub-domains, and thus to support more powerful cross-domain inferences. In order to evaluate its suitability for this purpose, we examined the NCIT’s treatment of the kinds (...) of entities which are fundamental to an ontology of colon carcinoma. We here describe the problems we uncovered concerning classification, synonymy, relations and definitions, and we draw conclusions for the work needed to establish the NCIT as a reference ontology for the cancer domain in the future. (shrink)

Genomic sequencing (GS) is increasingly used in paediatric medicine to aid in screening, research and treatment. Some health systems are trialling GS as a first-line test in newborn screening programmes. Questions about what to do with genomic data after it has been generated are becoming more pertinent. While other research has outlined the ethical reasons for storing deidentified genomic data to be used in research, the ethical case for storing data for future clinical use has not been explicated. In (...) this paper, we examine the ethical case for storing genomic data with the intention of using it as a lifetime health resource. In this model, genomic data would be stored with the intention of reanalysis at certain points through one’s life. We argue this could benefit individuals and create an important public resource. However, several ethical challenges must first be met to achieve these benefits. We explore issues related to privacy, consent, justice and equality. We conclude by arguing that health systems should be moving towards futures that allow for the sequential interrogation of genomic data throughout the lifespan. (shrink)

This book provides the reader with a theoretical and practical understanding of two health care delivery models: the patient/child centred care and family-centred care. Both are fundamental to caring for children in healthcare organizations. The authors address their application in a variety of paediatric healthcare contexts, as well as the ethical and legal issues they raise. Each model is increasingly pursued as a vehicle for guiding the delivery of health care in the best interests of children. Such models of (...) health care delivery shape health care policies, programs, facility design, resource allocation decisions and day-to-day interactions among patients, families, physicians and other health care professionals. To maximize the health and ethical benefits these models offer, there must be shared understanding of what the models entail, as well as the ethical and legal synergies and tensions they can create. This book is a valuable resource for paediatricians, nurses, trainees, graduate students, practitioners of ethics and health policy. (shrink)

This book provides the reader with a theoretical and practical understanding of two health care delivery models: the patient/child centred care and family-centred care. Both are fundamental to caring for children in healthcare organizations. The authors address their application in a variety of paediatric healthcare contexts, as well as the ethical and legal issues they raise. Each model is increasingly pursued as a vehicle for guiding the delivery of health care in the best interests of children. Such models of (...) health care delivery shape health care policies, programs, facility design, resource allocation decisions and day-to-day interactions among patients, families, physicians and other health care professionals. To maximize the health and ethical benefits these models offer, there must be shared understanding of what the models entail, as well as the ethical and legal synergies and tensions they can create. This book is a valuable resource for paediatricians, nurses, trainees, graduate students, practitioners of ethics and health policy. (shrink)

PurposeAdolescents develop their decision-making ability as they transition from childhood to adulthood. Participation in their medical care should be encouraged through obtaining assent, as recommended by the American Academy of Pediatrics (AAP). In this research, we aim to define the current knowledge of AAP recommendations and surgeon practices regarding assent for elective reconstructive procedures.MethodsAn anonymous electronic survey was distributed to North American paediatric surgeons and fellows through the American Pediatric Surgical Association (n=1353).ResultsIn total, 220 surgeons and trainees responded (16.3%). (...) Fifty per cent of the surgeons who are familiar with the concept of assent had received formal training; 12% of the respondents had not heard of assent before the survey. Forty-seven per cent were aware of the 2016 AAP policy statement regarding assent in paediatric patients. Eighty-nine per cent always include adolescents as part of the consent discussion. Seventy-seven per cent solicit an expression of willingness to accept the proposed care from the patient. The majority (74%) of the surgeons perceived patient cooperation/understanding as the biggest barrier to obtaining assent. Over half of the respondents would consider proceeding with elective surgery despite the adolescent patient’s refusal. Reasons cited for proceeding with elective surgery include surgeons’ perception of medical necessity, perceptions of disease urgency, and lack of patient maturity.ConclusionPaediatric surgeons largely acknowledge the importance of assent, but variably practice the principles of obtaining assent from adolescent patients undergoing elective reconstructive procedures. Fewer surgeons are explicitly aware of formal policy statements or received formal training. Additional surgeon education and institutional policies are warranted to maximise inclusion of adolescents in their medical care. (shrink)

Clinical trials of xenotransplantation may begin early in the next decade, with kidneys from genetically modified pigs transplanted into adult humans. If successful, transplanting pig hearts into children with advanced heart failure may be the next step. Typically, clinical trials have a specified end date, and participants are aware of the amount of time they will be in the study. This is not so with XTx. The current ethical consensus is that XTx recipients must consent to lifelong monitoring. While this (...) presents challenges to the right to withdraw in the adult population, additional and unanswered questions also linger in the paediatric population. In paediatric XTx, parents or guardians consent not only to the initial treatment of the child but also to lifelong monitoring, thus making a decision whose consequences will remain present as the child develops the capacity for assent, and finally the capacity for informed consent or refusal. This article presents and evaluates unanswered paediatric ethical questions in regard to the right to withdraw from XTx follow-up in the paediatric population. (shrink)

When a minor research participant reaches the age of majority or the level of maturity necessary to be granted legal decision-making capacity, reconsent can be required for ongoing participation in research or use of health information and banked biological materials. Despite potential logistical concerns with implementation and ethical questions about the trade-offs between maximising respect for participant agency and facilitating research that may generate benefits, reconsent is the approach most consistent with both law and research ethics.Canadian common law consent requirements (...) are expansive and likely compel reconsent on obtaining capacity. Common law doctrine recognises that children are entitled to decision-making authority that reflects their evolving intelligence and understanding. Health consent legislation varies by province but generally either compels reconsent on obtaining capacity or delegates the ability to determine reconsent to research ethics boards. These boards largely rely on the Canada’s national ethics policy, the Tri-Council Policy Statement, which states that, with few exceptions, reconsent for continued participation is required when minors gain capacity that would allow them to consent to the research in which they participate. A strict interpretation of this policy could require researchers to perform frequent capacity assessments, potentially presenting feasibility concerns. In addition, Canadian policy and law are generally consistent with the core principles of key international ethical standards from the United Nations and elsewhere.In sum, reconsent of paediatric participants upon obtaining capacity should be explicit and informed in Canada, and should not be presumed from continued participation alone. (shrink)

BackgroundAlthough patient advocates have developed templates for standard consent forms, evaluating patient preferences for first in human (FIH) and window of opportunity (Window) trial consent forms is critical due to their unique risks. FIH trials are the initial use of a novel compound in study participants. In contrast, Window trials give an investigational agent over a fixed duration to treatment naïve patients in the time between diagnosis and standard of care (SOC) surgery. Our goal was to determine the patient-preferred presentation (...) of important information in consent forms for these trials.MethodsThe study consisted of two phases: (1) analyses of oncology FIH and Window consents; (2) interviews of trial participants. FIH consent forms were analyzed for the location(s) of information stating that the study drug has not been tested in humans (FIH information); Window consents were analyzed for the location(s) of information stating the trial may delay SOC surgery (delay information). Participants were asked about their preferred placement of the information in their own trial’s consent form. The location of information in the consent forms was compared to the participants’ suggestions for placement. Results34 [17 FIH; 17 Window] of 42(81%) cancer patients approached participated. 25 consents [20 FIH; 5 Window] were analyzed. 19/20 FIH consent forms included FIH information, and 4/5 Window consent forms included delay information. 19/20(95%) FIH consent forms contained FIH information in the risks section 12/17(71%) patients preferred the same. Fourteen (82%) patients wanted FIH information in the purpose, but only 5(25%) consents mentioned it there. 9/17(53%) Window patients preferred delay information to be located early in the consent, before the “Risks” section. 3/5(60%) consents did this.ConclusionsDesigning consents that reflect patient preferences more accurately is essential for ethical informed consent; however, a one-size fits all approach will not accurately capture patient preferences. We found that preferences differed for FIH and Window trial consents, though for both, patients preferred key risk information early in the consent. Next steps include determining if FIH and Window consent templates improve understanding. (shrink)

Gilles de la Tourette syndrome (TS) is a childhood neuropsychiatric disorder characterised by the presence of motor and vocal tics. Patients with malignant TS experience severe disease sequelae; risking morbidity and mortality due to tics, self-harm, psychiatric comorbidities and suicide. By definition, those cases termed ‘malignant’ are refractory to all conventional psychiatric and pharmacological regimens. In these instances, deep brain stimulation (DBS) may be efficacious. Current 2015 guidelines recommend a 6-month period absent of suicidal ideation before DBS is offered to (...) patients with TS. We therefore wondered whether it may be ethically justifiable to offer DBS to a minor with malignant TS. We begin with a discussion of non-maleficence and beneficence. New evidence suggests that suicide risk in young patients with TS has been underestimated. In turn, DBS may represent an invaluable opportunity for children with malignant TS to secure future safety, independence and fulfilment. Postponing treatment is associated with additional risks. Ultimately, we assert this unique risk-benefit calculus justifies offering DBS to paediatric patients with malignant TS. A multidisciplinary team of clinicians must determine whether DBS is in the best interest of their individual patients. We conclude with a suggestion for future TS-DBS guidelines regarding suicidal ideation. The importance of informed consent and assent is underscored. (shrink)

The objective of this study was to determine whether consent forms in oncology clinical trials of commercially available treatments inform subjects that they may be able to obtain the treatments being investigated without participating in research. We acquired consent forms from a random sample of U.S. oncology clinical trials in the ClinicalTrials.gov database. We then examined a subgroup of the sample consisting of studies in which the treatments under investigations were commercially available. Less than 20% of the consent (...) forms in that group disclosed to subjects that they may be able to obtain the treatment being investigated without participating in the study . Our results suggest that potential research subjects are frequently not informed about important alternatives to research participation in studies involving commercially available treatments, which is a violation of both ethical and regulatory standards. (shrink)

OBJECTIVES: To investigate the need for hospital clinical ethics committees by studying the frequency with which ethical dilemmas arose, the perceived adequacy of the process of their resolution, and the teaching and training of staff in medical ethics. DESIGN: Interviews with individuals and three multidisciplinary teams; questionnaire to randomly selected individuals. SETTING: Two major London children's hospitals. RESULTS: Ethical dilemmas arose frequently but were resolved in a relatively unstructured fashion. Ethical concerns included: the validity of consent for investigations and treatment; (...) lack of children's involvement in consent; initiation of heroic or futile treatments; resource allocation. Staff expressed the need for a forum which would provide consultation on ethical issues, develop guidelines for good ethical practice, undertake teaching and training, and provide ethical reflection outside the acute clinical setting. CONCLUSION: Multidisciplinary, accountable and audited clinical ethics committees with predominantly advisory, practice development and educational roles could provide a valuable contribution to UK clinical practice and perhaps in other countries that have not developed hospital clinical ethics committees. (shrink)

BackgroundDiagnosis and treatment of differentiated thyroid carcinomas cause anxiety and depression. Additionally, these patients suffer hormonal alterations that are associated with psychological symptoms. This study aims to evaluate the effectiveness of a psycho-oncological intervention based on counseling to reduce anxiety and depression related to the treatment in patients with DTC.MethodsA non-randomized controlled study, with two groups [experimental group, n = 37, and control group, n = 38] and baseline and posttreatment measures, was designed. Patients in the EG received a psycho-oncological (...) intervention based on counseling in addition to the standard treatment. The independent variable was the assigned group and the dependent one was the evolution of anxiety and depression, which were analyzed separately, and both were evaluated using the Hospital Anxiety and Depression Scale. Other relevant covariables related to the quality of life were also analyzed using Short Form-36 Health Survey and Psychological General Wellbeing Index scales.ResultsThe difference of the posttreatment-baseline variation showed a statistically significant reduction in anxiety and depression in the EG in relation to the CG. The mean of the Psychological General Wellbeing Index scales score increased significantly in the EG and decreased significantly in the CG. All the baseline and the posttreatment scores of the variables evaluated showed a statistically significant improvement in the EG vs. the CG.ConclusionThis study demonstrates significant benefits of psycho-oncological intervention based on counseling in anxiety, depression, QoL, and wellbeing of the patient with differentiated thyroid carcinomas. (shrink)

Ethical concerns have been raised about the quality of informed consent by participants in phase 1 oncology trials. Interview surveys indicate that substantial proportions of trial participants do not understand the purpose of these trials—evaluating toxicity and dosing for subsequent efficacy studies—and overestimate the prospect of therapeutic benefit that they offer. In this article we argue that although these data suggest the desirability of enhancing the process of information disclosure and assessment of comprehension of the implications of study participation, (...) they do not necessarily invalidate consent by phase 1 trial participants. (shrink)

Interactive technology assessment is a novel approach to evaluating (health) technology, which philosophically draws from the works of Rawls and Habermas. That is, it seeks to organise a practical setting for discursive ethics in order to find a legitimate basis for policy to be pursued when the technology under scrutiny features a moral controversy. Interactive technology assessment involves a cycle of interviews with all stakeholders, who are explicitly asked to respond (anonymously) to the concerns and issues raised by other participants. (...) This cycle is completed repeatedly, so that a process of vicarious learning develops. This process aims at identifying issues agreed and disagreed upon, on the basis of which widely endorsed policy recommendations can be formulated. This chapter involves an interactive technology assessment of paediatric cochlear implantation. The rationale, the design, and the results are explained, as well as the main ethical aspects of the procedure. (shrink)

Medical care of critically ill and injured infants and children globally should be based on best research evidence to ensure safe, efficacious treatment. In South Africa and other low and middle-income countries, research is needed to optimise care and ensure rational, equitable allocation of scare paediatric critical care resources.

BackgroundThe complexity of decision-making in the paediatric context is well recognised. In the majority of cases, parents and healthcare professionals work together to decide which treatments the paediatric patient should receive. On occasions, however, parental wishes conflict with what clinicians think is best for the paediatric patient. Where persistent disagreement between clinicians and parents exists, clinicians must ascertain if they have a moral, professional, and legal obligation to overrule the parents' decision and implement their preferred option.PurposeFew decision-making (...) frameworks to assist in addressing the ethical issues that arise in clinical decision-making relate specifically to the paediatric context. Diekema's Harm Threshold Framework and the Zone of Parental Discretion Framework assist in determining whether parental decisions should or should not be overridden. This paper examines the similarities and differences between these frameworks.MethodsThe frameworks are analysed i... (shrink)

Until recently, cardiotoxicity in the setting of a malignant disease was attributed solely to the detrimental effects of chemo‐ and/or radio‐therapy to the heart. On this account, the focus was on the evaluation of well‐established cardiac biomarkers for the early detection of myocardial damage. Currently, this view has been revised. Cardiotoxicity is not restricted to a single organ but instead affects the endothelium as a whole. Indeed, it has come into light that not only cancer therapy but also malignant cells (...) per se can impair the cardiovascular system, through a paracrine and endocrine mode of action. Even more intriguingly, a clear interplay between molecular pathways involved in cancer and cardiovascular disease has become prevalent, suggesting a common nominator that governs the pathophysiology of these two entities. Taken together, our strategy in the quest of novel biomarkers in the emerging field of cardio‐oncology should be critically reshaped. (shrink)

Potential conflicts between the roles of physicians and researchers have been described at the theoretical level in the bioethics literature (Czoli, et al., 2011). Physicians and researchers are generally in mutually distinct roles, responsible for patients and participants respectively. With increasing emphasis on integration of research into clinical settings, however, the role divide is sometimes unclear. Consequently, physician–researchers must consider and negotiate salient ethical differences between clinical– and research–based obligations (Miller et al, 1998). This paper explores the subjective experiences and (...) perspectives of 30 physician–researchers working in three Canadian paediatric settings. Drawing on qualitative interviews, it identifies ethical challenges and strategies used by physician–researchers in managing dual roles. It considers whether competing obligations could have both positive and adverse consequences for both physician–researchers and patients. Finally, we discuss how empirical work, which explores the perspectives of those engaged in research and clinical practice, can lead the way to understanding and promoting best practice. (shrink)

Malaysia had its first four patients with COVID-19 on 25 January 2020. In the same week, the World Health Organization declared it as a public health emergency of international concern. The pandemic has since challenged the ethics and practice of medicine. There is palpable tension from the conflict of interest between public health initiatives and individual’s rights. Ensuring equitable care and distribution of health resources for patients with and without COVID-19 is a recurring ethical challenge for clinicians. Palliative care aims (...) to mitigate suffering caused by a life-limiting illness, and this crisis has led to the awareness and urgency to ensure it reaches all who needs it. We share here the palliative care perspectives and ethical challenges during the COVID-19 pandemic in Malaysia. (shrink)

This collection of essays by a group of international scholars focuses on specific issues in bioethics and paediatrics. It reflects interdisciplinary approaches to practical problems at the level of policy and practice.