Abstract

Background: Childhood cancer has been ranked the most common cause of death due to non-communicable disease among 5- to 14-year-old children in India. Ethical concerns have been identified in the care of children with cancer in India, yet there is a paucity of ethical standards for clinical practice to help address these concerns. For example, emerging research has demonstrated that many children are distressed when they are impeded from participating in discussions and decisions regarding their cancer care. Therefore, we sought to create an ethical framework to guide practice with this population.

Methods: We developed this ethical framework by conducting (a) a normative analysis of relevant documents that articulate norms for healthcare providers working with children in India and (b) stakeholder consultations with childhood cancer survivors, parents, and clinicians.

Results: The ethical framework is structured according to twelve key ethical principles and corresponding challenges or implications for clinical practice. We discuss how this ethical framework can help address three leading ethical concerns that we have identified within the care of children with cancer in India: (a) communication problems; (b) inadequate care of symptoms or promotion of comfort; and (c) injustices or inequities related to limited financial means or poverty.

Conclusion: Ethical concerns that have been related to the care of children with cancer in India can be prevented or at least mitigated through the integration of this ethical framework in everyday clinical practice.

Keywords: cancer, children, ethics, paediatric

Introduction

Childhood ethics is an emerging field of inquiry that is striving to advance (a) empirical research on ethical concerns that affect young people, as well as (b) normative research aiming to develop ethical standards for clinical practice that can attend to these concerns [1]. VOICE (Views On Interdisciplinary Childhood Ethics) is an internationally-recognised research programme in childhood ethics affiliated with the team that conducted the inquiry reported in this article [1, 2] .

An important childhood ethics concern relates to the role of children in discussions and decisions about their healthcare. This concern is especially prominent within the care of children with cancer, where treatment decisions can entail significant impacts — therapeutic effects as well as adverse effects — that are borne by the children.

Globally, 82% of childhood cancer diagnoses come from low- and middle-income countries, including India [3]. India’s prioritisation of the prevention and treatment of communicable diseases [4] has led to a significant decrease in the under-five mortality rate [5]. This reduction has unmasked the impact of non-communicable diseases, such as cancer; the proportion of under-five mortality related to non-communicable diseases has therefore increased [5]. Childhood cancer was ranked the most common cause of death due to non-communicable disease among 5- to 14-year-old children in India [6]. Despite this, childhood cancer has not been highlighted as a health priority in India [7]. Further, little research has been conducted to identify the leading ethical concerns associated with the care of this population [8]. Moreover, there is a paucity of ethical standards of practice that have been developed to help orient clinical practices with this population of children.

Behan et al, which also include authors of this article, conducted one of the few empirical ethics studies published with this population [9]. This study sought to better understand the participation of children with cancer (aged 3-17 years old) in decisions, discussions, and actions. Based in three oncology settings in New Delhi, India, all participating children demonstrated interest in participating in various aspects of their cancer care. This participation, however, was impeded, to varying degrees, by contextual factors (eg, staff communication practices). Further, some children were distressed when they were not given sufficient information about their treatment, and when they were not given opportunities to enhance their understanding.

One important conclusion from this research was the absence of national ethical standards for clinical care for children with cancer in India. Therefore, together with clinicians, researchers, parents and children, we sought to create such an ethical framework, which we present below.

Methods

We developed this ethical framework for clinical practice with children with cancer in India through two principal steps: by conducting, first, a normative analysis and second, stakeholder consultations.

We started by collecting all relevant documents that articulate norms (ie, what should be done) for healthcare providers working with children in India (NB: for further details on our normative analysis methods, see Bubadué et al, 2017 [10]). We specifically sought texts that provided legal, ethical and professional norms, and which included both children in general and children with cancer. To do so, documents were identified through a snowball technique, first by consulting clinical and community organisation leaders who work with children with cancer within India — including three clinical leaders with bioethics expertise — and then also using the references cited within the recommended documents to increase the sample. Following a review for relevance, 19 documents were retained, as listed in Table 1 [11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29]. Retained documents were then coded by a research assistant and one of the investigators (FAC) who has advanced training in clinical ethics as well as normative analysis. Coding involved content analysis: for example, all statements that articulated “what should be done” when working with children in India were highlighted as codes. Relevant codes and data were extracted into tables to be reviewed by the investigators to verify soundness. Codes were then categorised into principal themes (see Table 2). The investigators then drafted an ethical framework based on the results of this normative analysis.

Table 1: Documents Analysed (Children’s Participation in Discussions & Decisions in Paediatric Oncology)

Table 2. Normative Analysis Results — Principal themes identified

We then asked stakeholders with diverse perspectives to critically examine the draft framework. Stakeholders included childhood cancer survivors and parents (given that they bear the greatest impacts of clinical practices), followed by clinicians (see Table 3 for stakeholder details). Some of the clinicians also contributed bioethics expertise. We began by holding a consultation meeting with a group of childhood cancer survivors and parents, organised by a community organisation working with this population. The discussion was led by one of the investigators (FAC). See Supplementary File 1 for illustrative verbatim excerpts from childhood cancer survivor and parent stakeholders.

Table 3. Stakeholder Participant Information

The draft framework was then adapted and distributed to a broader stakeholder group using an online Microsoft Form to allow anonymised comments. Participating stakeholders were invited to (a) rate each of the 12 principles on a 4-point Likert scale (4 = Strongly agree; 3 = Agree; 2 = Disagree; 1 = Strongly disagree) and (b) provide comments regarding each principle. The average approval rating for each ethical principle was at least three. Moreover, comments were supportive of each principle. Some stakeholders highlighted challenges that could be encountered and particular considerations that had to be addressed when applying some of the ethical principles in practice. These challenges and considerations are summarised within the ethical framework.

Following this process, we concluded that the proposed ethical framework, which is presented below, was strongly endorsed by the stakeholders and did not require additional modifications.

An ethical framework for the care of children with cancer in India

The ethical framework is structured according to key ethical principles, which were identified and formulated through the processes described above. For the purposes of this framework, “children” refers to all legal minors in India (ie, below the age of 18).

Ethical frameworks aim to articulate what should be the practice, not what the practice actually is. There will frequently be discrepancies between “what is” and “what should be”; which highlights the basis of an ethical problem. Highlighting ethical problems or concerns is a principal purpose for creating an ethical framework, so that it can help identify these problems or concerns and hopefully lead to discussion and some solutions. Mindful of these “is/should be” tensions and the difficulties that can arise in attempts to apply an ethical framework, we have provided practice challenges or considerations that were identified by stakeholders. In stating these challenges and considerations, stakeholders were not implying that the corresponding ethical principles were any less important. These challenges are listed here to help readers anticipate and navigate them as they use this framework in practice [Table 4] [12, 30].

Table 4. Ethical framework for the care of children with cancer in India

Discussion

Stakeholders consulted for this project highlighted that while our normative analysis reported relevant norms already existing in India, the results are “at significant variance with what is practised in India” (as quoted by a physician stakeholder). This sentiment led to calls among stakeholders for initiatives that strive to redress this “gap” between “what should be practised” and “what is actually practised”. Thus, this investigation raises important implications for (a) clinical practice, (b) institutional and higher-level policies, (c) education (ie, basic education and continuing education of healthcare professionals and educational preparation for community workers and advocates), (d) community advocacy work, and (e) research.

Given the transparent, rigorous process that we have followed, we propose that professional societies and groups in India focused on paediatric oncology (eg, Haematology and Oncology Chapter of the Indian Academy of Paediatrics) or paediatric ethics (eg, Indian Academy of Pediatrics National Independent Ethics Committee) actively promote the use of this ethical framework. These societies and groups can promote the ethical framework as a standard for clinical practice. This can be facilitated through formalisation of this ethical framework within institutional practice policies (eg, clinical practice policies within oncology centres that include actionable steps that demonstrate how the ethical principles should be operationalised in those settings) as well as curricular updates within education programmes (university as well as continuing education in clinical settings) for all relevant healthcare providers (eg, physicians, nurses, among others).

We call for open forums (eg, work groups) to create opportunities for professional societies (eg, Haematology and Oncology Chapter of the Indian Academy of Paediatrics) to engage in meaningful exchanges with community organisations (eg, CanKids) to identify specific actions that should be undertaken to close this gap between “what should be practised” and “what is actually practised”.

Advocacy efforts to promote respect for the rights of children with cancer and their families can call for changes based on the results of this study. Specifically, community-based stakeholders, including community organisations such as CanKids, can empower and mobilise initiatives that can help children with cancer and their families become more aware of ways that ethical standards can be advanced to be more inclusive of children’s voices, experiences, and participation — actively promoting patient and family advocacy and calling for changes entailed by the results of this investigation. It may be beneficial to create a “translation” of this framework, adapted to the spoken language of children and families, that can be used by community organisations.

Further empirical research is needed to identify which ethical concerns are particularly problematic for children, parents, and healthcare providers, building on our team’s earlier research [9]. Such work could highlight areas where focused initiatives are required, such as further development or refinement of our ethical framework as well as educational initiatives that can bolster the use of ethical frameworks like the one described here. Empirical research can reveal existing barriers and facilitators to optimising ethical practice, which can further inform changes that should be mobilised. Also, more investigations should be conducted in multiple settings throughout India, to determine if the ethical framework requires any modifications to address any additional ethical concerns that were not identified in this study.

While conducting the stakeholder consultations, childhood cancer survivors and parent participants highlighted numerous situations they encountered that they considered ethically problematic. Upon analysis, three principal areas of ethical concern arose within this lived experience, as outlined below. We think these concerns provide exemplars of clinical situations where our proposed ethical framework can be used in practice.

This ethical concern refers to children and parents feeling that the way that clinicians describe the child’s medical condition, treatment plan, and/or prognosis can be inadequate and upsetting. Poor communication includes: use of medical jargon (eg, this may be incomprehensible for families with limited schooling); use of insensitive terms or speaking rudely (eg, speaking in ways that scare children and families or makes them feel humiliated or unsafe); incomplete or no explanations (eg, not being told about a diagnosis, initiation of a clinical trial, or an intervention, such as removal of a child’s eye); as well as frequent changes in medical team members (eg, this led to changes in treatment plans that were not explained). Communication concerns were seen to undermine the development of trust among families toward healthcare providers.

This ethical concern refers to situations where children and parents felt that healthcare providers have been inattentive or dismissive toward a child’s symptoms or comfort. This situation included: performing painful procedures without adequate or any analgesia or anaesthesia (eg, child screaming through a biopsy or bone marrow aspiration without any anaesthesia; inexperienced staff performing a venipuncture on children with difficult-to-access veins); parents forced away from a child’s side during painful procedures (eg, parent is unable to comfort the child); nonresponse to children’s expressed pain (eg, disregarding or distrusting a child’s expression of pain, no analgesia is given when a child is crying in pain); prescribing analgesia that is difficult to access for children with severe uncontrolled pain (eg, where a parent has to travel a great distance to obtain the prescription).

This ethical concern refers to situations where families felt they were impacted unfairly because of their financial disadvantages. Some families became financially impoverished or went bankrupt to pay for treatment (eg, some families cannot afford to pay for the prescribed treatments) while some children were unable to access some forms of necessary care (eg, cancer treatment or care of symptoms).

The ethical concerns described by survivors and parents can be prevented or at least mitigated through the integration of our ethical framework into everyday clinical practice. This would help ensure the continuous (a) provision of information regarding the child’s condition, treatment plan, and prognosis, adapted to the child’s and parents’ ways of understanding; (b) verification of how treatment is aligned with each child’s best interests (including active evaluation and effective treatment of each child’s current symptoms); (c) ascertaining that free (ie, uncoerced) and informed consent from parents and assent from children is obtained for all investigations and interventions that are undertaken (including the encouragement of children to participate in discussions and decisions about their care as much as they would like, respecting their privacy interests to the extent that is legally permissible, while also seeking their consent to care whenever they are legally permitted to do so); and (d) identifying inequities or injustices that can result from financial (or other) disadvantages, which can lead to unfair treatment of a child, and advocating for ways to redress this unfairness (eg, seeking financial supports or access to community organisation support for specific families).

Acknowledgements: We thank the teenage and young adult childhood cancer survivor group (KidsCan Konnect) and parent members of the Path Pradarshak Parivarik Sahayak Group — both with CanKids…KidsCan, India — for their valuable advisory contributions to this project. We also thank Dr Sanjiv Lewin, Dr Priya Pais, and Dr Bhavna Dhingra for their important advisory guidance. We acknowledge Manav Preet Singh Saini and Apoorva Sharma for assisting with the normative analysis.

Conflict of Interest: The authors have no conflicts of interest to declare.

Funding: This work was supported by an Insight Grant from the Social Sciences & Humanities Research Council of Canada (grant number: 239025).

Statement of similar work: The authors have no similar work to declare.

Data sharing: This work did not generate research data, so no data can be shared.