Point-of-care testing in Paediatric settings in the UK and Ireland: a cross-sectional study

Background Point-of-care testing (POCT) is diagnostic testing performed at or near to the site of the patient. Understanding the current capacity, and scope, of POCT in this setting is essential in order to respond to new research evidence which may lead to wide implementation. Methods A cross-sectional online survey study of POCT use was conducted between 6th January and 2nd February 2020 on behalf of two United Kingdom (UK) and Ireland-based paediatric research networks (Paediatric Emergency Research UK and Ireland, and General and Adolescent Paediatric Research UK and Ireland). Results In total 91/109 (83.5%) sites responded, with some respondents providing details for multiple units on their site based on network membership (139 units in total). The most commonly performed POCT were blood sugar (137/139; 98.6%), urinalysis (134/139; 96.4%) and blood gas analysis (132/139; 95%). The use of POCT for Influenza/Respiratory Syncytial Virus (RSV) (45/139; 32.4%, 41/139; 29.5%), C-Reactive Protein (CRP) (13/139; 9.4%), Procalcitonin (PCT) (2/139; 1.4%) and Group A Streptococcus (5/139; 3.6%) and was relatively low. Obstacles to the introduction of new POCT included resources and infrastructure to support test performance and quality assurance. Conclusion This survey demonstrates significant consensus in POCT practice in the UK and Ireland but highlights specific inequity in newer biomarkers, some which do not have support from national guidance. A clear strategy to overcome the key obstacles of funding, evidence base, and standardising variation will be essential if there is a drive toward increasing implementation of POCT.

Ethical Considerations in Conducting Paediatric Research

Health research is a moral duty because it is the foundation for evidence-based care by all health care practitioners. Hence, paediatric research is essential for improving health outcomes of children. Waiting for adult studies before conducting paediatric studies may prolong the denial of effective treatment for children. The CIOMS and other guidelines clearly allow research procedures that involve a low degree of risk. However, the critical need for pediatric research on drugs and biological products underscores the responsibility to ensure that children are enrolled in clinical research that is both scientifically necessary and ethically sound. Even in a resource poor setting of a developing country like Bangladesh, the things that should be taken under considerations are the status of children as a vulnerable population; the appropriate balance of risk and potential benefit in research; ethical considerations underlying study design, including clinical equipoise, placebo controls, and non-inferiority designs; the use of data; compensation; and parental permission and child assent where applicable to participate in research. Such ethical dilemmas are more evident in paediatric research especially when a collaborative research is done by a developed country in a developing country setting. It is the role of the health policy makers, and community of paediatric physicians, nurses, and caregivers to advocate not only for more research for children but also to ensure that the research conducted is of the highest quality from ethical viewpoint. CBMJ 2020 July: Vol. 09 No. 02 P: 54-58

Utilising the International Human Rights Framework to Access the Benefits of Paediatric Research in The covid Era: A Wales Case Study

This article uses Wales as a case study to discuss the challenges to accessing the benefits of paediatric research before and during the covid-19 pandemic. Due to the rapidly changing political and legislative landscape, it is critical that health professionals working for the benefit of children can utilise international human rights treaties and the most relevant General Comments that offer a bridge between legalistic provisions and practice. Additionally, it is vital for health professionals to interpret and understand domestic children’s rights legislation, including tools for implementation for realising children’s rights. This article shares learning from the Children’s Hospital for Wales, Children and Young Adult Research Unit’s endeavour to challenge the Welsh Government to pay due regard to the rights of the child in ensuring children can access the benefits of paediatric research; including research concerning children’s role in infection and transmission, during the pandemic.

Point-Of-Care Testing in Paediatric Settings in the UK and Ireland: a Cross-Sectional Study

Background: Point-of-care testing (POCT) is diagnostic testing performed at or near to the site of the patient. Understanding the current capacity, and scope, of POCT in this setting is essential in order to respond to new research evidence which may lead to wide implementation.Methods: A cross-sectional online survey study of POCT use was conducted between 6th January and 2nd February 2020 on behalf of two United Kingdom (UK) and Ireland-based paediatric research networks (Paediatric Emergency Research UK and Ireland, and General and Adolescent Paediatric Research UK and Ireland). Results: In total 91/109 (83.5%) sites responded, with some respondents providing details for multiple units on their site based on network membership (139 units in total). The most commonly performed POCT were blood sugar (137/139; 98.6%), urinalysis (134/139; 96.4%) and blood gas analysis (132/139; 95%). The use of POCT for Influenza/Respiratory Syncytial Virus (RSV) (45/139; 32.4%, 41/139; 29.5%), C-Reactive Protein (CRP) (13/139; 9.4%), Procalcitonin (PCT) (2/139; 1.4%) and Group A Streptococcus (5/139; 3.6%) and was relatively low. Obstacles to the introduction of new POCT included resources and infrastructure to support test performance and quality assurance.Conclusion: This survey demonstrates significant consensus in POCT practice in the UK and Ireland but highlights specific inequity in newer biomarkers, some which do not have support from national guidance. A clear strategy to overcome the key obstacles of funding, evidence base, and standardising variation will be essential if there is a drive toward increasing implementation of POCT.

Improving clinical paediatric research and learning from COVID-19: recommendations by the Conect4Children expert advice group

Background The COVID-19 pandemic has had a devastating impact on multiple aspects of healthcare, but has also triggered new ways of working, stimulated novel approaches in clinical research and reinforced the value of previous innovations. Conect4children (c4c, www.conect4children.org) is a large collaborative European network to facilitate the development of new medicines for paediatric populations, and is made up of 35 academic and 10 industry partners from 20 European countries, more than 50 third parties, and around 500 affiliated partners. Methods We summarise aspects of clinical research in paediatrics stimulated and reinforced by COVID-19 that the Conect4children group recommends regulators, sponsors, and investigators retain for the future, to enhance the efficiency, reduce the cost and burden of medicines and non-interventional studies, and deliver research-equity. Findings We summarise aspects of clinical research in paediatrics stimulated and reinforced by COVID-19 that the Conect4children group recommends regulators, sponsors, and investigators retain for the future, to enhance the efficiency, reduce the cost and burden of medicines and non-interventional studies, and deliver research-equityWe provide examples of research innovation, and follow this with recommendations to improve the efficiency of future trials, drawing on industry perspectives, regulatory considerations, infrastructure requirements and parent–patient–public involvement. We end with a comment on progress made towards greater international harmonisation of paediatric research and how lessons learned from COVID-19 studies might assist in further improvements in this important area.

A time to act: Anti-racist paediatric research

Research offers the potential for new treatments, programs and services, and underlies decisions about funding that can have profound implications for people’s lives. When racism in research is not addressed, children and their families will be unjustly impacted by systemic discrimination, exclusion, and inequity. With a growing acknowledgement that racism is a social determinant of health, and as COVID-19 reveals staggering racial disparities, we believe now is the time for intentional anti-racism initiatives throughout the research ecosystem to prevent further harms in patient care and the lives and futures of children. We aim to highlight this need for justice, and conclude with a series of practical recommendations, ranging from the collection and use of race-based data, to equity, diversity, and inclusion (EDI) education, to mentorship opportunities.

Drug Safety in Translational Paediatric Research: Practical Points to Consider for Paediatric Safety Profiling and Protocol Development: A Scoping Review

Translational paediatric drug development includes the exchange between basic, clinical and population-based research to improve the health of children. This includes the assessment of treatment related risks and their management. The objectives of this scoping review were to search and summarise the literature for practical guidance on how to establish a paediatric safety specification and its integration into a paediatric protocol. PubMed, Embase, Web of Science, and websites of regulatory authorities and learned societies were searched (up to 31 December 2020). Retrieved citations were screened and full texts reviewed where applicable. A total of 3480 publications were retrieved. No article was identified providing practical guidance. An introduction to the practical aspects of paediatric safety profiling and protocol development is provided by combining health authority and learned society guidelines with the specifics of paediatric research. The paediatric safety specification informs paediatric protocol development by, for example, highlighting the need for a pharmacokinetic study prior to a paediatric trial. It also informs safety related protocol sections such as exclusion criteria, safety monitoring and risk management. In conclusion, safety related protocol sections require an understanding of the paediatric safety specification. Safety data from carefully planned paediatric research provide valuable information for children, parents and healthcare providers.