I recall writing my nursing degree dissertation 30 years ago on the “Passive Role of the Patient.” I was concentrating on diabetic patients in hospital undergoing treatment for reasons other than their diabetes. Management of their diabetes was taken away from them the moment they put on a gown and slippers. Upon discharge from hospital, control returned and they resumed as masters of their condition! Now working in clinical trials, I am pleased to see that the terms ‘patient centricity’ or ‘patient empowerment’ are becoming common in our day to day language.
The time when all clinical trial visits were conducted at site has passed. We now see a hybrid between site and the home. The associated popularity of mobile research nursing services is widely seen as a positive move. We can now design clinical trials to better suit the needs and desires of the patients and give sites the support they deserve.
When it comes to trials involving paediatrics, only limited information is available on the views of children taking medicines and participating in clinical trials. These views may contribute to a better understanding of what can be improved on in the development of medicines from their perspective.[1]
There are many ethical and legal issues to consider when involving children and young people in research, Consent being a vital aspect.
Consent is a legally defined decision given by someone who is competent, who has been adequately informed (and has adequate understanding), and who is free from undue influence enabling them to make a voluntary decision. The person can provide consent themselves (provided they are competent). Alternatively, a substitute who is empowered by law can provide it (e.g. a parent in the case of children). A child who is not capable of giving consent alone can still be involved in the decision-making process, provided others who are defined in law, give consent.
Assent is an agreement given by a child, or others who are not legally empowered to give consent. It is important to provide children with information that matches their capacity when seeking assent.
Most clinical trials involving visits off- site (in the case of children, school or home), will see subjects consented/assenting within the site by the Principal Investigator (or designee), rather than at home. However, the consent form and information leaflet should include language around the choice to have certain visits performed off-site if the protocol allows. It is also critical that the language surrounding the off-site research nursing service is included and provided in an age-appropriate way. I think we sometimes underestimate that children are interested in learning more and giving their opinions on clinical trials. This is especially true if their schooling or friendship groups are disrupted through unnecessary visits to site.
It is universally established that written communication, combined with verbal interaction, may enhance children’s understanding of their participation in a clinical research.[2]
At Illingworth, we have developed a variety of different materials to be utilised during the information giving session by the site staff and followed up during consenting. Details explaining the mobile nursing service is available in a variety of different formats and for different age groups. This includes a child friendly flowchart showing our mascot, ‘Illingworth Bear’, an animated figure dressed as a nurse, visiting a child’s home to conduct a trial visit. Colourful pictures in combination with appropriate language helps the children feel part of the decision-making process.
We even offer an animated video explaining the service which is voiced by a child.
Example of an image we use in the child literature in the Middle East region.
Since our nurses conduct clinical trial visits in the home in many countries worldwide, we present the bear in a very diverse way, in culturally suitable settings and representing the population with whom we work. We also ensure that the literature is translated into the local language. Age in itself is a crude measure of a child’s ability to understand, as it can depend on cultural differences, level of education, and many other factors.
Child friendly appointment cards and stickers
Children enjoy being praised and the use of progress and sticker charts is well known to encourage behavioural change such as tidying up their room or helping reduce the frequency of bed wetting.
In a clinical trial setting, once consented, our mobile research nurses continue to engage with the children. They provide child friendly appointment cards and carry different stickers which the children may choose at the end of a visit.
We can provide a progress chart to map the completion of the off-site visits if they wish to put the stickers on a chart, or simply stick them on their clothing or favourite teddy! Some stickers have ‘well done’ or ‘excellent’ in the local language and others are image only. We need to take into consideration that not all children will be literate. In a trial environment, one must ensure that the stickers are not seen as any inducement to complete the visits, they are simply small tokens to encourage and praise.
Home can be considered a safe space and it is important that the child feels suitably involved in the decision-making process in conjunction with their parents or carers. It is vital that they are comfortable with the nurse coming to their house. A simple gesture such as taking our Illingworth bear with us for them to cuddle and other child friendly items to distract them can be useful tools in a mobile research nurse’s kit.
Helen Springford, Chief Executive Officer
References
[1] The Management of Clinical Trials Edited by Hesham Abdeldayem, Menoufia University
Children’s views on taking medicines and participating in clinical trials
Sofia Nordenmalm1, Elin Kimland2, Franca Ligas3, Birka Lehmann4, Joana Claverol5, Begonya Nafria5, Ann Marie Tötterman6, Benjamin Pelle3
[2] Ungar D, Joffe S, Kodish E. Children are not small adults: Documentation of assent for research involving children. The Journal of Pediatrics. 2006;149:s31-ss3