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Challenges and solutions to recruitment of neonates and children having cardiac surgery into a study using a novel
Terrie Walker-Smith1, Daniel Fudulu2,3, Aravind Ramesh2,3
1Bristol Trials Centre, University of Bristol, Bristol, UK.
Insights
Delivering pediatric cardiac surgery research with a novel hormone collection device presents unique challenges. Solutions involve integrating research into clinical care and educating teams on device use.
Area of Science:
- Pediatric Cardiac Surgery
- Clinical Research
- Biomedical Device Technology
Background:
- Conducting non-commercial research in pediatric cardiac surgery is complex.
- Novel subcutaneous hormone collection devices offer potential benefits but require specific implementation strategies.
Purpose of the Study:
- To describe the challenges and solutions for a non-commercial study involving pediatric cardiac surgery patients.
- To evaluate the use of a novel subcutaneous hormone collection device in this population.
Main Methods:
- Narrative description of study delivery.
- Focus on challenges in pediatric healthcare research and device-specific issues.
Main Results:
- Challenges in pediatric research are addressed by integrating research into clinical care.
- Device-specific challenges (insertion, maintenance) are manageable with clinical team education and support.
- Commercial research incentives might simplify similar studies.
Conclusions:
- Integrating research into routine pediatric cardiac care is crucial for success.
- Effective training and support are key to overcoming challenges with novel collection devices.
- Non-commercial studies require tailored strategies for device implementation and research conduct.
Objective:
To narratively describe the challenges and solutions required in delivering a non-commercial study of children undergoing cardiac surgery using a novel subcutaneous hormone collection device.
Results:
The challenges faced by the research team are divided into those of conducting healthcare research in children and those specific to this study. Many of the issues of conducting healthcare research in children can and have been overcome by structural and institutional culture change-normalising and embedding research as part of good clinical care. The issues specific to insertion and maintenance of the novel collection device can be overcome by education and support of the clinical teams. The increased incentives and resources of commercial research may have overcome many of these.
