Barriers to Personalized Medicine in Pediatrics: The Implementation of a New Pharmacogenomic Test for Pediatric Neuroblastoma

Laura Crimi MSc (c)1, Peter Nugus PhD1 and Gillian Bartlett PhD1

1. Department of Family Medicine, McGill University, 5858 Cote-des-Neiges, Suite 300, Montreal, Quebec, Canada H3S 1Z1 

ACKNOWLEDGEMENTS: This work was performed within the context of the I-CHANGE (International Childhood Astrocytoma Integrated Genomics and Epigenomics) Consortium and was supported by funding from Genome Canada, Génome Québec, the Institute for Cancer Research of the Canadian Institutes for Health Research (CIHR), McGill University and the Montreal Children's Hospital Foundation. This work was also funeded through the Réseau de Médecine Génétique Appliquée (RMGA), the Fonds de Recherche du Québec - Santé (FRQS) and the Canadian Institutes of Health Research (CIHR, Grant # TGF-96109) in all your publications

Context: Brain tumours, specifically high-grade astrocytoma (HGA), are the leading cause of death in children under the age of 20. A new pharmacogenomic test (PGx) has been developed that can diagnostically stratify those with the disease. This novel test can identify whether or not a child is a carrier of a genetic mutation causing immunity to all available treatment. Knowledge of this mutation can stream children into palliative care and prevent them from futile treatment, thus theoretically increasing their quality of life. Personalized medicine in pediatrics is often met with controversy; the practical and ethical barriers associated with this test must be explored prior to implementation.

Objective: The purpose of this investigation is to evaluate relevant communication barriers associated with the use of the PGx into clinical care that can be used to develop practice guidelines.

IRB-Review: IRB approval is being sought from the McGill University Health Network (MUHC).

Design: A mixed methods embedded design will be used to assess the anticipated communication barriers perceived by healthcare professionals (pediatric palliative care physicians and nurses, pediatric oncologists and pediatric oncology nurses, and social workers) regarding the use of the novel PGx as a standard of care. Deliberative consultations will be conducted to explore communication barriers. Quality deliberations are unique in that it promotes a space for open discussion, with a goal of generating meaningful exchange and rich dialogue with informed stakeholders. The deliberations will be followed by quantitative assessment using the Information Assessment Method (IAM) and the Deliberation Questionnaire, to measure the deliberation success. A thematic analysis of the deliberations will be conducted.

Setting: The study will take place in Montreal Children’s Hospital. Participants: 16 – 20 end users of the test, including pediatric oncologists and palliative care physicians, will be recruited for deliberative consultations.

Outcome: A better understanding of the communication barriers surrounding the use of this novel PGx.

Anticipated Results: Results will then be used in the creation of evidence-based practice guidelines surrounding the use of the PGx in clinical care. It is hoped that this framework for exploring the use of a PGx in clinical care can be generalized and used for other tests.

Conclusions: The study addresses communication barriers experienced by relevant stakeholders when using a novel PGx in clinical pediatric oncology.