Morbidity after paediatric cardiac surgery
Research type
Research Study
Full title
Selection, definition and evaluation of important early morbidities associated with paediatric cardiac surgery
IRAS ID
136403
Contact name
Katherine L Brown
Contact email
Sponsor organisation
R and D Office, Great Ormond Street Hospital
Research summary
We will undertake a study to select, define and evaluate important early morbidities (which are acquired and to some extent preventable complications) associated with paediatric cardiac surgery.
Our multidisciplinary study will take place over 42 months across 5 UK paediatric cardiac surgery centres that together serve over half of the patient population.
We will:Review existing literature and professional guidance and run focus groups to get the perspectives of patients and their carers on which morbidities are most important to them. A multi-disciplinary group with patient and carer involvement will then rank and select a shortlist of key morbidities, informed by clinical views on definitions and feasibility of routine monitoring;
Validate a new, nurse-administered questionnaire for assessing pre- and post-operative child development to screen for peri-operative brain injury;
Measure the incidence of the selected morbidities among 3000-3300 patients over 18 months and explore the relationship between these and potential risk factors including cardiac diagnosis, operation type and co-morbid conditions;
Recruit up to 430 patients with surgical morbidity as cases into a matched cohort study over 18 months to measure impact at 6 months on quality of life, clinical burden and costs to the NHS and families, with an equal number of controls recruited from similar patients with no surgical morbidity.
Develop and pilot methods suitable for routine in-house monitoring of morbidity in the context of multi-disciplinary mortality and morbidity conferences. These methods will be designed through repeated prototyping and engagement with clinicians, patient representatives and other stakeholders;
Propose which morbidities should be routinely monitored and how these complex data can be clearly presented. Overall incidence of morbidities will be fed back to patient and carer groups via the Children’s Heart Federation.
REC name
London - Bromley Research Ethics Committee
REC reference
13/LO/1442
Date of REC Opinion
8 Nov 2013
REC opinion
Further Information Favourable Opinion