Using Children's Voice to Optimize Pediatric Participation in Medical Decision Making

In the target article, Olszewski and Goldkind discuss how and when to involve children in medical decision making, and relate this to competency and context (Olszewski and Goldkind 2018). An essential element we believe is missing in this discussion is the voice of children themselves. The UN Convention on the Rights of the Child (CRC) (United Nations 1989) explicitly requires involving children's voices in situations they are involved in and doing justice to the autonomy of children. We believe it is necessary that children become more actively involved in pediatric health care to empower their position. It therefore is remarkable that in discussions on children's roles in medical decision making, such as in the target article, children often are not consulted.

Together, Grootens-Wiegers, Hein, and Staphorst form the research group Children in Research. With our research we aim to improve the position of children in research (and clinical care). We thereby focus on listening to children's voices and inquiring about their perspectives, from which we have learned important lessons that can be applied to decision making in many situations in pediatric health care.

DECISION-MAKING COMPETENCE

Until recently, little empirical evidence existed on children's competence to consent to treatment or clinical research. Yet problems did arise when, for instance, pediatric patients did not agree with a recommended treatment, or when, in a research context, it remained unclear how to do justice to children's vulnerable status.

As it stands, children's competence to consent is usually assessed implicitly. However, lacking a gold standard, children's competence has continuously been assessed in an unstructured way leading to inconsistent outcomes. Age standards prescribed by law may have had too much influence in clinicians' assessments. To complicate matters, legal age standards vary widely between countries. In addition, competence assessments are often influenced by the clinicians' idea of what is in the child's best interest.

In order to optimize policies regarding children's decision making in clinical situations, we aimed to perform research with children themselves. In this project we developed a standardized tool for assessing children's competence to consent, offering empirical evidence to underpin age limits for alleged competence in children.

Initially, we identified the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR) as the best assessment tool available in terms of reliability and validity. Subsequently, the MacCAT-CR was adjusted for use in children aged 6–18 years, which included using plain language suitable for children, and additional questions on the influence of relationships with parents and peers. The tool was then implemented among pediatric patients visiting inpatient and outpatient clinics of pediatric departments (Hein, Troost and Lindeboom 2014).

We demonstrated that children's competence to consent to clinical research can be assessed validly and reliably using the MacCAT-CR. We identified that age limits for children to be deemed competent to decide on research participation could be estimated as follows: children of 11.2 years and above generally appeared to be competent, whereas children of 9.6 years and younger were generally not competent and a changeover occurred between 9.6 and 11.2 years (Hein et al. 2015). Concluding, we have learned from directing our study to children that children can be formally involved in decision making at a younger age than was previously assumed.

INFORMING AND INVOLVING CHILDREN

Meaningful participation in decision making requires an adequate level of understanding of what is at stake. However, a fundamental problem arises as oral communication and textual information are often primarily directed at adults, or aimed at minors but not connected to their perspective. In order to address this issue in the context of medical-scientific research, we have developed novel information material for minors together with the end-users: children and adolescents aged 10–16 years. In the Netherlands, where this project took place, minors aged 12–16 years have a legal position in decision making about research participation in a shared consent procedure together with their parent(s). A specific informed consent form for minors is legally required and needs approval by the ethics committee. However, these forms are often very lengthy, containing difficult language, and not in tune with the health literacy level of the receiver. In order to more clearly explore this problem, children were consulted about their perspective on the currently available information material. In addition, we examined in what way visual support could alleviate the existing issues with the textual information. According to the children, current forms are “clearly written by an adult,” too lengthy, boring, and complicated. However, careful use of visuals would improve these texts according to the children.

In order to support comprehension of research information, we subsequently developed a comic-strip booklet together with children, explaining the essential concepts of research participation. Details on the development process have been described elsewhere (Grootens-Wiegers et al. 2015). The essential element in this project was the participation of children, both healthy and sick, with and without research experience. In multiple iterative rounds the booklet was revised, incorporating children's input and perspectives. The children provided us with insights that we could not have had without them, and at times even contradicted the feedback from adults involved (parents and medical professionals). Eventually, information material was produced that was comprehensible and appealing according to the children. In conclusion, throughout the developmental process, the voices of children and adolescents were an essential guide to create adequate information and thereby empower minors to participate in decision making.

CHILDREN'S VIEWS ON DISCOMFORT IN RESEARCH

Ethics committees evaluate the acceptability of discomfort in pediatric research. However, children are rarely involved in this discussion, which is striking given that they are the participants undergoing the research procedures and therefore can provide crucial information. Our research project aimed at more structurally involving children's views on discomfort in the review process of pediatric research. For this, a standardized instrument was developed for assessing children's discomfort during medical research procedures. Children actively participated in this project, which is described in detail elsewhere (Staphorst et al. 2015; 2017).

As there is no clear definition of “discomfort,” we discussed with children participating in research what discomfort encompasses to them (Staphorst et al. 2015). Although the consulted children varied in age, medical conditions, and studies in which they participated, their experiences related to discomfort were remarkably similar. The majority—particularly healthy children—mentioned psychological forms of discomfort, such as being bored. This was a surprising insight as discussions on discomfort often focus on physical discomfort alone.

The interviews with children on discomfort contributed for the uppermost part to the development of a questionnaire measuring children's discomfort in research: DISCO-RC (DISCOmfort in Research with Children) (Staphorst et al. 2017). After a concept for the DISCO-RC was developed, both children and health care professionals in the field of pediatric research were consulted on their perspective on the content and practical aspects. During pretesting of the DISCO-RC, children contradicted some of the professionals' suggestions: they considered some of their recommended questions for the DISCO-RC to be irrelevant.

In this project, children were consulted and gave advice about their perspective on discomfort. We also informed them on how their input was being used in the project and will be used to optimize decision-making processes on pediatric research by ethics committees. The involved children expressed the importance and necessity of being actively consulted about their views on pediatric research. Their input left a fundamental mark on the project, which could not have been reached without them.

CHILDREN ARE ESSENTIAL PARTNERS IN PEDIATRIC HEALTH CARE

Children are valuable and essential partners in forwarding our insights for optimizing pediatric participation in medical decision making. It is therefore vital that we, as professionals working in pediatric health care, should take due account of and actively incorporate children's perspectives in pediatric care. When inquiring about when and how children may participate in decision making, we should first ask ourselves whether we consider children as essential partners, and whether we are doing justice to their position. This may even start by asking children about their perspective on participation (Grootens-Wiegers et al. 2017).

We agree with Olszewski and Goldkind that participation in clinical care and clinical research may require a somewhat different approach. In general, more participative research and case studies are necessary in all types of decision-making contexts ranging from the complex situations as described by Olszweski and Goldkind to the involvement of children in everyday hospital consultations. Acknowledging partnership and listening to children's voices is an indispensable first step in order to increase our insights and stimulate participation of children. This partnership also includes the role of parents in decision making because of their important position in the child's life.

There are different methods and positions in which children can partner in research, described by Hart's Ladder of Participation (Hart 1992). Different research projects may have different possibilities for the level of participation, but we argue that ultimately it is important for all researchers who are talking about children that they also talk to children and listen to them.

Regarding the target article, we suggest Olszewski and Goldkind consulting children to provide feedback on their framework. This will strengthen the design of the framework, as well as creating support among the targeted group of children and empowering them in medical decision making.