Title: Selection, definition and evaluation of important early morbidities associated with paediatric cardiac surgery
Funder: Department of Health and Social Care

Abstract: AIM We aim to identify the surgical morbidities following paediatric cardiac surgery that present the greatest burden on patients and health services and to develop and pilot routine monitoring and feedback of these key morbidities. PLAN OF INVESTIGATION Our study will take place over 50 months at 5 UK paediatric cardiac surgery centres serving over half the patient population, starting 1 January 2014. The study is designed with several work streams, each tackling one of the objectives towards our overarching aim. OBJECTIVE 1: to identify the key surgical morbidities following paediatric heart surgery We will conduct a systematic review to identify a long list of surgical morbidities. With the help of the Children’s Heart Federation, we will run 3 focus groups and an online forum to incorporate the views of patients and carers on surgical morbidities. Both activities will feed into 2 consensus group meetings including family representatives, surgeons, nurses and other health professionals to shortlist and select surgical morbidities for monitoring in routine practice. We will use a modified nominal group technique as a structured way of eliciting and prioritising views. A final meeting in year 4 will discuss the findings of the incidence and impact studies and select the final set of surgical morbidities for routine audit. OBJECTIVE 2: To develop operational definitions for routine morbidity monitoring We will convene a surgical morbidity definition group including representatives from each centre. This group will build on the consensus group meetings by establishing the diagnostic criteria and defining the measurement protocol for each selected morbidity. In year 4, this group will finalise a recommended protocol for monitoring the selected morbidities. OBJECTIVE 3: To validate a tool for identifying neurological disability In year 1 we will validate a new tool (the BDA questionnaire) suitable for detecting neurological morbidities in children following heart surgery. Assessing development in children is very different at different stages, so it needs be validated in 6 separate age bands. The validation study involves recruitment of 200 children in each age band from preadmission and outpatient clinics at Great Ormond Street and Evelina Children’s hospitals in London, for a total of 1200 patients. A psychology assistant (PA) (with the parents) will administer the BDA and the ‘gold standard assessment tests’. Independently, and blinded to the results obtained by the first PA, a second PA will complete the BDA as a measure of inter-rater reliability. One of the PAs will perform a later retest on 56 children in each age band to measure intra-rater reliability. OBJECTIVE 4: To measure the incidence of defined morbidities in the UK patient population All children under 16 years undergoing heart surgery in each of the 5 participating centres over an 18 month period will be included (3000 – 3300 children). Dedicated Band 7 research nurses in collaboration with the consultant surgeon at each participating centre will monitor each child for the presence of the selected morbidities. The overall incidence of each selected morbidity, both as a single and a multiple morbidity (2 or more morbidities), will be estimated with 95% confidence intervals. We will use multilevel multinomial regression to investigate the effects of factors such as age, diagnosis, procedure type and existing co-morbidities on the incidence of surgical morbidities. OBJECTIVE 5: To measure the impact of morbidities During the incidence study, research nurses will recruit 36 patients that have one of the selected morbidities to a prospective matched cohort study designed to measure the impacts associated with the presence of morbidities. Each patient will be matched to a patient without a morbidity. Depending on the number of selected morbidities, this could be up to 10 sets of 36 pairs (a maximum of 720 children). Children with more than one morbidity will be recruited as a separate group of ‘multiple morbidity’ patients, with the goal being to recruit as many of these children as possible. They will also be matched to controls with no morbidity. Depending on the shortlist of morbidities included and based on reported rates of ‘multiple morbidity’ (6) the likely number of ‘multiple morbidity’ matched pairs in the study period is 120, but could be higher. Cases and controls will be matched within the individual centres on age, single or double-ventricle status and (where possible) similar complexity of surgical procedure. Band 7 research nurses will follow up with each patient 4 times: at (first) discharge from hospital, 6 weeks, 3 months and 6 months following the primary procedure. The impact of morbidity will be measured: on quality of life using age specific questionnaires; costs to the NHS and families; the number of days a child spends at home in the first 6 months following the primary procedure. For each outcome, multilevel modelling will be used to make comparisons within case control pairs. OBJECTIVE 6: To develop and pilot sustainable methods for monitoring and feedback Discussions between clinical staff, analysts and data managers will identify logistical processes for collecting and storing data on morbidities in routine practice. The incidence study will identify any extra training needs and modifications to protocols that might be needed before routine monitoring is feasible. These will feed into the final morbidity definition group meeting in year 4. We will develop graphical summaries to distil the new knowledge. One set of graphical summaries will be used to inform patients and their families about morbidity, presenting information separately for different patient subgroups to help families identify the information most relevant to them. A second set of graphical summaries, and software to generate them, will be developed to help clinical teams monitor morbidities routinely. Finally, we will pilot the developed protocol and graphical monitoring tools within each centre. KNOWLEDGE MOBILISATION The work will be reported in detail to national audit bodies, with a view to adding morbidity measures to national audit. Each participating centre will be able to continue routine monitoring of morbidity following the pilot period and we will offer the protocols, graphical tools and software to the remaining UK centres for their use. We will share results with patients and families with the help of the Children’s Heart Federation.

Lay abstract: Partly through sharing data and building an understanding of deaths following surgery, the teams caring for the 5000 children that undergo heart surgery in the UK per year have achieved notable improvements in survival rates. However, this surgery remains risky and at least 500 children per year experience “surgical morbidities” such as brain injury or serious infection within the breastbone. These events, some of which are potentially avoidable, can have major short and long-term impacts on a child’s health and development. At present, it is not possible to estimate accurately the true scale of the impact of surgical morbidity on children and families, or of the considerable costs to the NHS. This is because there is little solid information on how often such events occur, which patients are most at risk and what the precise impacts are. Evidence from the US suggests that brain injury and delayed child development is a substantial problem but efforts to gather information on this in UK audit have not been successful so far. This general lack of good quality information disadvantages patients and carers as they cannot be fully informed about the chances of suffering these morbidities. Crucially, this lack of information also hampers clinical teams wanting to devise, target and evaluate initiatives to reduce surgical morbidity and improve further the safety and quality of the service delivered to patients. We want to rectify this. Our ambitious study will take place across 5 UK paediatric cardiac surgery centres and will involve surgeons, representatives from the Children’s Heart Federation (the main umbrella patient and family group for children’s heart diseases), intensive care doctors, nurses, experts in clinical governance, data managers, psychologists, health economists, statisticians and other analysts. The effects of post-operative morbidities on children and families go beyond the extra medical attention required to treat them, extending into the realm of patient experience and quality of life. Therefore the selection of the most important morbidities to monitor needs to be made together with patient representatives, and consider patient reported outcomes as well as clinical ones. With the help of the Children’s Heart Federation, we are going to run 3 focus groups to get the perspectives of patients and carers on which morbidities are most important to them, as well as asking patient and family views via an online forum. At the same time two experienced doctors will review the existing academic literature on morbidities after heart surgery. Together, we will compile a long list of morbidities that are considered important and might be suitable for tracking routinely. A group of experts including doctors, nurses and psychologists as well patient representatives will then meet to decide on a short list of morbidities that we will track over 18 months in each of the 5 centres. A separate clinician group will collaborate to produce objective definitions and measurement protocol for the chosen morbidities so that we can be sure that each centre is measuring the morbidities in the same way. We are almost certain that neurological complications after surgery will be on the shortlist of morbidities, but at the moment there is no easy way to measure them routinely and only the most severe tend to be picked up. So in year 1 we will test a new way for nurses to assess child development before and after surgery. Since this approach will make it more likely that injury to the brain is detected following heart surgery, this should improve the chances of children being referred for treatment promptly. In years 2 and 3, we will record how often the shortlisted morbidities occur, gathering enough data on around 3000 surgical patients to tell us which morbidities happen to which patients and how they depend on the child’s diagnosis, age and other factors. Importantly, we will also measure how often a child develops more than one morbidity, which we expect to have an especially large impact on the child and their family. When morbidities do happen, we will measure the impact of these on the child and their family over 6 months, in terms of quality of life and extra time away from home as well as any extra expense borne by the family or the health service as a result. To make a fair assessment of the impact, each patient that develops a morbidity will be matched with a similar patient that did not have a morbidity. In parallel, we will work out the best approach to display and feed back the rates of morbidity to clinical teams and families. Firstly, we need to invent an intuitive and visual method for letting patients and families know the risk of morbidities for their children so they can be better informed of what might happen after surgery. Secondly, we need to invent other visual methods so that clinical teams can quickly and easily review how things are going in their unit in terms of morbidity. This will help teams target interventions that might reduce morbidity and quickly identify areas of practice that might need extra attention. The ability for units to monitor morbidity could help to improve the service to patients and families and we will pilot these methods in all the 5 centres at the end of the project to check the feasibility of monitoring morbidities routinely. Finally, we’ll make proposals for which morbidities should be routinely tracked and how these complex data can be presented clearly so trends can be spotted, lessons learned and improvements made. We will share these proposals with national audit bodies, all UK paediatric heart centres and patients and families through the Children’s Heart Federation. In summary, we will generate valuable new knowledge about the surgical morbidities considered most important by patients, carers and clinicians and will test a method likely to improve access to assessment of brain injury. This work will inform better quality assurance, will enable improvement initiatives and provide better information for patients and families on what they can expect following heart surgery. For these reasons, we think our work is very much in line with the HS&DR programme’s mission to produce rigorous and relevant evidence on the quality and organisation of health services that enables improvement.

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