Abstract
OBJECTIVESRandomized controlled trials are the gold standard for evaluating health care interventions, yet are uncommon in children’s heart surgery. We conducted a systematic review of clinical trials in paediatric cardiac surgery to evaluate the scope and quality of the current international literature.METHODSWe searched MEDLINE, CENTRAL and LILACS, and manually screened retrieved references and systematic reviews to identify all randomized controlled trials reporting the effect of any intervention on the conduct or outcomes of heart surgery in children published in any language since January 2000; secondary publications and those reporting inseparable adult data were excluded. Two reviewers independently screened studies for eligibility and extracted data; the Cochrane Risk of Bias tool was used to assess for potential biases.RESULTSWe identified 333 trials from 34 countries randomizing 23 902 children. Most were early phase (313, 94.0%), recruiting few patients (median 45, interquartile range 28–82), and only 11 (3.3%) directly evaluated a surgical intervention. One hundred and nine (32.7%) trials calculated a sample size, 52 (15.6%) reported a CONSORT diagram, 51 (15.3%) were publicly registered and 25 (7.5%) had a Data Monitoring Committee. The overall risk of bias was low in 22 (6.6%), high in 69 (20.7%) and unclear in 242 (72.7%).CONCLUSIONSThe recent literature in children’s heart surgery contains few late-phase clinical trials. Most trials did not conform to the accepted standards of reporting, and the overall risk of bias was low in few studies. There is a need for high-quality, multicentre clinical trials to provide a robust evidence base for contemporary paediatric cardiac surgical practice.
Highlights
Congenital heart disease is the commonest type of congenital anomaly, affecting 12 children born in the UK every day [1]
Randomized controlled trials are the gold standard for evaluating health care interventions, yet are uncommon in children’s heart surgery
We conducted a systematic review of clinical trials in paediatric cardiac surgery to evaluate the scope and quality of the current international literature
Summary
Congenital heart disease is the commonest type of congenital anomaly, affecting 12 children born in the UK every day [1]. There is a marked heterogeneity of structural cardiovascular defects, often leading to cyanosis or heart failure and requiring complex surgery in early childhood. Despite these challenges, advances in paediatric cardiac surgery have been rapid, founded on the work of visionary pioneers and improved incrementally through adjustments in operative technique, supported by developments in imaging, anaesthesia, intensive care, surgical technology and hybrid approaches to management. Surgery is a high-tech, highstakes intervention that radically alters the natural history of congenital heart disease, especially for those at an early stage in their life trajectory with the most to gain. We conducted a systematic review of all RCTs assessing the outcomes of heart surgery in children to identify the scope and quality of the current literature
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