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Randomized controlled trials in children's heart surgery in the 21st century: a systematic review
Nigel E Drury1,2, Akshay J Patel1, Nicola K Oswald1
1Department of Paediatric Cardiac Surgery, Birmingham Children's Hospital, Birmingham, UK.
Insights
Few high-quality clinical trials exist in pediatric cardiac surgery. Most studies lack adherence to reporting standards, indicating a need for robust, multicenter trials to improve evidence-based practice.
Area of Science:
- Cardiovascular Surgery
- Pediatric Surgery
- Clinical Trials
Background:
- Randomized controlled trials (RCTs) are crucial for evaluating healthcare interventions but are infrequent in pediatric cardiac surgery.
- A systematic review was conducted to assess the scope and quality of existing international literature on clinical trials in this field.
Purpose of the Study:
- To evaluate the scope and quality of the current international literature on randomized controlled trials in pediatric cardiac surgery.
- To identify trends and deficiencies in the reporting and methodology of these trials.
Main Methods:
- A systematic literature search was performed across MEDLINE, CENTRAL, and LILACS databases.
- Studies published since January 2000 were screened for eligibility, excluding secondary publications and those with inseparable adult data.
- The Cochrane Risk of Bias tool was utilized to assess potential biases in eligible trials.
Main Results:
- A total of 333 trials from 34 countries involving 23,902 children were identified.
- The majority of trials were early-phase (94.0%), with a median of 45 participants, and only 3.3% directly evaluated surgical interventions.
- Key reporting standards were met by a minority of trials: sample size calculation (32.7%), CONSORT diagram (15.6%), public registration (15.3%), and Data Monitoring Committee (7.5%).
- The overall risk of bias was low in 6.6%, high in 20.7%, and unclear in 72.7% of the studies.
Conclusions:
- The current body of literature in pediatric cardiac surgery features a scarcity of late-phase clinical trials.
- Most published trials exhibit suboptimal adherence to established reporting standards, contributing to a high proportion of unclear or high risk of bias.
- There is a critical need for high-quality, multicenter clinical trials to establish a robust evidence base for current pediatric cardiac surgical practices.
Objectives:
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.
Methods:
We 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.
Results:
We 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%).
Conclusions:
The 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.
