The Paediatric Research in Emergency Departments International Collaborative (PREDICT) is an active Clinical Trial Network that aims to investigate best approaches to emergency treatment, and to improve the care for all children attending emergency departments in Australia.
Due to the nature of emergency medicine, the network faces unique challenges when it comes to seeking consent for trial participation, but according to Associate Professor Ed Oakley, Executive Member of PREDICT, emergency practice also presents unique opportunities for conducting clinical trials.
“Because of the nature of emergency medicine, we’re able to focus on implementation science research to try and understand how to improve practice in emergency departments,” said A/Prof Oakley. “We’re able to translate knowledge into practice because essentially all of our trials are embedded into routine practice.”
One randomised controlled clinical trial currently in its recruitment stage is BellPIC—a trial that aims to assess the use of prednisolone versus placebo as a treatment for children presenting with Bell’s palsy.
The trial is crucial, as although there is strong data to show the therapy is effective in adults, there are theoretical reasons why the treatment may not be effective in children, and that suggest administering it to children may be more harmful than helpful.
The trial is in its final year of recruitment, and the team is expecting an overall recruitment of around 200 participants. Although the need for effective treatment is unquestionable, Bell’s palsy in children is relatively uncommon—and when children are diagnosed, many parents opt to start steroid treatment with their GP right away, despite the lack of evidence for current therapies in children.
Along with assessing the effectiveness of treatment, BellPIC assesses the secondary outcomes of the emotional and functional wellbeing of participants and their parents. By assessing these two outcomes concurrently, the team at PREDICT will develop a holistic view of the effects of prednisolone as a therapy on the entire immediate family.
The international collaborative is committed to finding therapies for conditions that are poorly researched or for which no current, appropriate therapies are available. This commitment is evident in the development of BIPED—a trial spanning Australia, New Zealand and Canada that aims to find an appropriate therapy for infants with bronchiolitis.
Bronchiolitis is a respiratory illness in children under one year old and is the most common reason for children under one attending emergency departments and being admitted to hospital. Currently, there is no proven therapy that is effective in the treatment of the condition.
“Bronchiolitis was actually one of our first research streams because it’s so frequent and there’s no good evidence for any interventions. People want to help, so they often give interventions that aren’t useful or for which there is no evidence. Patients get a lot of nursing care which is really important, but there’s no magic treatment, and we need good evidence based assessments of any new treatments. Right now, interventions are purely supportive,” said Ms Catherine Wilson, Research Network Coordinator for PREDICT.
Mandatory social distancing restrictions have had an interesting effect on bronchiolitis care, as the limitations presented by the COVID-19 virus give clinicians and researchers an incentive to scale back on ineffective treatment applications and only apply supportive care as needed.
Often, PREDICT has a delayed or waiver of consent where the research staff gain consent from families after enrolment in the study. If treatment is urgent and cannot be delayed, the team can’t gain consent prior to treatment. If it’s less urgent, they gain consent immediately prior to commencing the intervention. They see the family, get consent, and then immediately apply it. If care is of a critical nature, a waiver of consent must be sought, and the family must be informed while PREDICT seeks their consent to remain in the trial and use the data afterwards.
Due to the nature of emergency medicine and the requirement for administration of care in a very timely manner, the team at PREDICT is seeking ways to conduct research ethically with attention to consenting processes.
“We’re starting to involve consumers more and more; we get them involved in the development of the trial, and even earlier in asking for their input into what the research priorities might be for a particular condition. We’re also working with consumers on the acceptability of consent and recruitment methods, getting their input into patient related materials and in the selection of study outcomes that are relevant and important to them.
“We also ideally get them involved in communication of the findings of a study—wording it and describing it in a way that’s digestible for consumers,” said Ms Wilson.