Given the amount of comments and discussion around each of the questions I have written down the main points/ recurring messages that came up during the hour. I have also included links to resources or papers that were mentioned during the tweetchat. If you have anything that would you like to contribute please add it to the comments for everyone to read.
This question had the most feedback and it was great to see collaborations being built on this topic during the tweetchat.
I had assumed that PPI was used everywhere but @LillyTrials said that there is no official term for it in the USA. It is referred to as patient and caregiver input. It was also interesting to see that some people asked what is meant by ‘PPI’ and how is PPI approached and implemented across different sites. I think that this raises a really good point – what are the basic, minimum, requirements that a site/ study need to demonstrate to show that they are using PPI? It was great to read of all the tweets on how different groups define and use PPI.
@GenrYPAGs said they would soon be announcing plans to develop links with other Young Person Advisory Groups (YPAG) & this will be shared on their website: http://generationr.org.uk/liverpool/
From the experience of the #WhyWeDoResearch community children preferred to be a in a separate PPI group to their parents, as they felt they could be more open without their parent(s) being there. But it was noted that this did depend on the activity.
People mentioned the challenges in designing and implementing clinical trials for neonates as one of the reason why most intervention studies are for older children.
The International Neonatal Consortium (https://c-path.org/programs/inc/) was mentioned as one pathway to reduce the disparity between age groups.
Everyone agreed that a child’s assent is just as important as the parent’s consent.
Those who did not work with children asked the most about assent: Assent is when you seek the opinions/ wishes of a person who is unable to provide consent. For children, who are legally not old enough to sign a consent form and/or do not have the ability to understand all the information, their assent to participate in the study must be obtained. If a child doesn’t provide their assent (but the parents have provided their consent) the child should not be enrolled in the study. It is also recommended that all parents agree for their child to participate in the study.
It was interesting to note the different requirements for parental consent / child assent and how it impacts on international studies: Lepola P et al (2016) Informed consent for paediatric clinical trials in Europe Archives of Disease in Childhood; 101:1017-1025
Most tweets mentioned the fixed-term nature of research studies which made recruitment and retention of research nurses across all areas difficult.
It was noted that this can affect the setting up and running of studies. It can also be difficult for children and parents to get know new nurses, especially when taking part in time consuming and complex studies.
CTAs (Clinical Trials Assistants) were shown as resource that can help with the clerical side of research studies, which can free up the time of research nurses. It was also tweeted that there is not enough research staff to offer and facilitate research opportunities requested by parents and children.
Various training / education courses were mentioned, such as the FDA’s Pediatric Investigator training course and those run face-to-face or online by the NIHR.
One point made was that student nurses should have a research placement, just as they have various clinical placements.
Veal GJ et al (2017) Investigating the roles and training of paediatric research nurses working across Europe: a questionnaire-based survey BMJ Paediatrics Open found that research nurses wanted more training with regulatory issues; clinical trial coordination & nursing procedures.
Some tweets mentioned concern over duplication of resources with having separate paediatric and adult networks.
Others said they liked trials with both an adult and paediatric arm but sometimes but that often sites don’t recruit both adults and children. The difficulties of dual recruitment (equipment, staff etc) was discussed.
Tweets also stated that very rare diseases could benefit hugely from combining adult and paediatrics, particularly where the survival age is increasing. This would increase the potential for knowledge sharing which would have a positive impact on patient experience.
Thank you for all your support for the #WhyWeDoResearch tweetchats & blogs.
Please leave a comment if there is anything you would like to add.