CJC open · 2020
The TRIVIA Cohort for Surgical Management of Tetralogy of Fallot: Merging Population and Clinical Data for Real-World Scientific Evidence.
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Blais Samuel, Marelli Ariane, Vanasse Alain, Dahdah Nagib, Dancea Adrian, Drolet Christian, Dallaire Frederic
Аннотация
BACKGROUND: Guidelines for surgical management of tetralogy of Fallot (TOF) are often based on low-quality evidence due to the many challenges of congenital heart disease: heterogeneous cardiac anatomy, consequences from surgical interventions arising years later, and scarcity of hard outcomes. The overarching goal of the Tetralogy of Fallot Research for Improvement of Valve replacement Intervention: A Bridge Across the Knowledge Gap (TRIVIA) study is to evaluate the long-term impact of the surgical management strategies in TOF. The specific objectives are: (1) to describe the long-term outcomes of TOF according to the native anatomy and the presence of genetic conditions, (2) to evaluate the long-term outcomes of surgical repair according to associated residual lesions, and (3) to evaluate the impact of paediatric pulmonary valve replacements on the long-term outcomes.
METHODS: The TRIVIA study is a population-based cohort including all subjects with TOF in the province of Québec between 1980 and 2017. It links patient-level granular clinical data with long-term administrative health care data. We will evaluate mortality, cardiovascular interventions, and hospitalizations for adverse cardiovascular events using survival Cox models and marginal mean/rates models for recurrent events, respectively. Multivariate multilevel models will correct for potential confounders, and risk score matching will mitigate the potential of confounding by indication.
RESULTS: The current TRIVIA cohort includes 1001 eligible subjects with TOF with complete lifelong follow-up for > 98%. The median follow-up is 17.1 years, totalling > 17,000 patient-years.
CONCLUSIONS: Universal health insurance data combined with granular clinical data enable the development of population-based cohorts, to which contemporary statistical methods are applied to address important research questions in congenital heart disease research.
METHODS: The TRIVIA study is a population-based cohort including all subjects with TOF in the province of Québec between 1980 and 2017. It links patient-level granular clinical data with long-term administrative health care data. We will evaluate mortality, cardiovascular interventions, and hospitalizations for adverse cardiovascular events using survival Cox models and marginal mean/rates models for recurrent events, respectively. Multivariate multilevel models will correct for potential confounders, and risk score matching will mitigate the potential of confounding by indication.
RESULTS: The current TRIVIA cohort includes 1001 eligible subjects with TOF with complete lifelong follow-up for > 98%. The median follow-up is 17.1 years, totalling > 17,000 patient-years.
CONCLUSIONS: Universal health insurance data combined with granular clinical data enable the development of population-based cohorts, to which contemporary statistical methods are applied to address important research questions in congenital heart disease research.