Title: Infant deaths in the UK community following successful cardiac surgery - building the evidence base for optimal surveillance
Funder: Department of Health (England)

Abstract: 1) Literature review: we will conduct a structured and comprehensive search of medical databases to identify evidence for post discharge risk factors in young children with CHD community based interventions for this population and the relationship between socio economic and ethnic factors and access to health care in young children with chronic health problems2) Quantitative analysis (see protocol for details): individual risk factors derived from the CCAD and PICANET datasets available at discharge including weight birth weight gestational age age sex ethnicity index of multiple deprivation cardiac diagnosis co-morbidities procedure type repeat procedures duration of hospital stay and duration of ventilation will be analysed for any relationship with the outcome measures using statistical modelling techniques. The sample size will be approximately 9600 with incidence of each of the two outcome measures between 3.5 and 7% (based on local audit and published information): detailed presentation of sensitivity and specificity is provided in the protocol. We propose to use a random effects logistic regression model for the primary outcome and a Poisson regression model for the secondary outcome. In order to validate the final models we propose to use the bootstrap algorithm. We aim to derive models that rank likely outcome according to patient characteristics rather than derive an absolute risk score for outcome. 3) Qualitative analysis (see protocol for details): these will draw on information gained in semi structured interviews with - parents of children that experienced the outcomes of interest and parents from high risk groups based on the risk models from stage 2) above; professionals from UK cardiac centres and helpline staff from the childrens heart federation. An online discussion forum using CHF Facebook site will invite comments from parents of children with CHD from across the UK regarding care access issues and acceptability of proposed interventions. We propose to use the approach of framework analysis. Options for intervention design will be discussed in two focus group sessions consisting of participants recruited by the CHF and professionals from the tertiary centres. 4) Intervention design: A series of workshops including two parent representative co researchers a primary care specialist a general paediatrician from a district hospital a psychologist two liaison nurses a quality improvement expert a hospital manager and two medical representatives from a tertiary centre will review key themes from the first 3 sections of the study. Later work shops will discuss potential interventions drafted by the advisory team with refinement of a final proposed complex intervention. Potential indicators of success including clinical measures such as mortality possible PREMS and costs will be considered. A final workshop for discussion of proposed options for an intervention will be held with professionals from the UK cardiac centres.


Research activity codes: 7.1 INDIVIDUAL CARE NEEDS;8.1 ORGANISATION AND DELIVERY OF SERVICES
Health categories: CARDIOVASCULAR