Title: Congenital Heart Audit: Measuring Progress In Outcomes Nationally (CHAMPION)
Funder: Department of Health and Social Care

Abstract: Background Congenital heart disease (CHD) requires lifelong clinical input and significant healthcare utilisation. In 2015, NHS England called for better reporting of quality in CHD services, beyond the current focus on 30-day survival following paediatric cardiac surgery. In particular, methods are needed to enable routine reporting of procedure-based outcomes for adults and long-term outcomes by diagnosis: Fair reporting of procedure-based outcomes for adult CHD (ACHD) requires risk-adjustment for case-mix, but no gold standard method exists. Direct extrapolation from the existing paediatric risk-adjustment method is not possible because ACHD and paediatric CHD populations have different risk factors, there lacks consensus on which set of procedures constitute ACHD practice, and timing of ACHD procedures play a greater role in outcome. Reporting long term outcomes (LTOs) by diagnosis is difficult because of the heterogeneity of conditions, difficulty in rigorously identifying patients with specific diagnoses from procedure level retrospective datasets, and lack of consensus on appropriate outcomes and associated measurement time-frames. Aim To develop tools for routinely measuring CHD outcomes (including risk-adjusted survival in adults following intervention and long-term outcomes by diagnosis) that are considered meaningful and appropriate by stakeholders and can inform the delivery and commissioning of CHD services. Methods Our primary dataset is the national congenital heart disease audit (NCHDA) linked to adult and paediatric intensive care audits, secondary hospital care and death registry data. Our independent expert panel, comprising clinicians, academics, managers, commissioners and patient representatives, will provide advice throughout. Using iterative data analysis, clinical expertise, the academic literature and consensus processes, we will: Establish which cardiac procedures should be considered &ldquo;ACHD procedures&rdquo; for national reporting, which outcomes are appropriate for assessing and comparing quality, which risk factors need taking into account, and develop methods that adjust for these factors (including logistic and linear regression and Cox proportional hazards models as appropriate to each outcome). We will investigate methods for displaying and comparing risk-adjusted outcomes by institution, producing funnel plots based on random-effects models. [Workstream 1]; Identify key diagnoses for which outcomes should be reported, establish appropriate outcome metrics and associated time-frames, identify risk factors for adverse outcomes, define and measure off-pathway procedures for each diagnosis and develop analytical means to measure and report these outcomes routinely [Workstream 2]. For Workstream 3, three national charities will run online forums over nine months to elicit the perspectives of patients and families on meaningful outcomes for Workstreams 1 and 2, with thematic analysis of these feeding directly into outcome selection. For Workstream 4 will we build prototype software tools that specify the automated mechanisms required to generate and visualise the new outcomes from routinely collected data, including any required data transformations (e.g. risk-adjustment), using human-centred co-design methods. Impact and dissemination This research will provide stakeholders including commissioners with better tools to assure the quality of CHD services. We will publish peer-reviewed articles and leverage our impressive team network to engage professional bodies including NCHDA, BCCA, HQIP and the CQC to ensure rapid translation from research into practice.

Lay abstract: Aim To improve how the quality of congenital heart services is measured and reported in England. Background Almost 6000 babies are born with congenital heart disease (CHD) every year in England. It is a complex, lifelong condition and many problems cannot be fully cured. Every year about 7,500 procedures are performed on children and 3,000 on adults with CHD. Measuring quality in CHD services is difficult and all hospitals submit data to a central audit database. The proportion of children surviving at one month after surgery is publicly reported for each hospital, using a statistical equation (which our team developed) to take account of each child s risk. However, reporting children s survival at one month is not an ideal way of spotting better or worse than expected outcomes as nearly all children survive at least this long (98%). Reporting gaps NHS England highlighted two main reporting gaps: 1) What happens to adults after operations? The numbers of adults surviving certain procedures are publicly reported, but there is no overview by hospital because there is currently no way to account for each adult s risk. 2) What happens in the longer-term for a person? It is more relevant to understand what happens to people over the longer-term (and possibly multiple operations) than just one month after surgery. What we will do Our team includes academics, doctors, nurses, psychologists, charities and an adult researcher living with CHD. We are currently linking the national heart data to other NHS datasets to build a combined dataset with information on all operations for CHD patients, their stays in any English hospital and their life status. We will save money and time by using this dataset for our project as well. 1) Adults: We will define the scope of adult CHD procedures for national reporting; identify what outcomes to measure (including one month survival); explore potential risk factors; and develop a fair way of reporting surgical outcomes. 2) Longer-term outcomes: We will choose representative diagnoses and track people with each of these through the combined dataset, describing their long-term survival, how many operations they have and how many operations are outside the anticipated treatment plan. 3) Patient and family views are crucial to measuring outcomes that matter and make sense. We are working with three CHD charities, 2 for children and 1 for adults with CHD, to run online forums to capture their perspectives on all aspects 1 and 2 of this project. 4) We will develop prototype software tools to calculate and display longer-term and adult outcomes. An expert group from the national CHD community will help throughout, which includes representatives from four charities, 2 adults living with CHD and 2 family members of children with CHD.

Research activity codes: 7.3 MANAGEMENT AND DECISION MAKING;8.1 ORGANISATION AND DELIVERY OF SERVICES
Health categories: GENERIC HEALTH RELEVANCE;CARDIOVASCULAR