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A Systematic Review of Contemporary Randomized Trials in Cardiothoracic Surgery
N Bryce Robinson1, Mohamed Rahouma1, Katia Audisio1
1Department of Cardiothoracic Surgery, Weill Cornell Medicine, New York, New York.
Insights
This study analyzed cardiothoracic surgery randomized controlled trials (RCTs) from 2008-2020. While many trials were pragmatic, few controlled for surgeon experience or monitored interventions, indicating potential quality gaps.
Area of Science:
- Cardiothoracic Surgery
- Clinical Trials Methodology
- Evidence-Based Medicine
Background:
- Characterizing contemporary randomized controlled trials (RCTs) in cardiothoracic surgery is crucial for understanding current research practices.
- Analysis focuses on RCTs published in high-impact journals between 2008 and 2020.
Purpose of the Study:
- To characterize contemporary randomized controlled trials (RCTs) in cardiothoracic surgery.
- To evaluate the quality, reporting, and design features of these trials.
Main Methods:
- Selection of RCTs from top-tier medical, general surgery, and cardiothoracic surgery journals (2008-2020).
- Summarization and comparison of trial characteristics, reporting standards, and quality metrics.
- Assessment of registration, primary outcome reporting, blinding, intervention monitoring, risk of bias, funding, crossover rates, fragility index, and spin.
Main Results:
- Ninety-three RCTs were included; 47.3% were prospectively registered, with 31.8% showing outcome discrepancies.
- Most trials used superiority designs (89.1%) with composite primary outcomes (88.2%) and major clinical events (72.0%).
- Infrequent blinding, lack of surgeon experience control (79.5%), high risk of bias (25.8%), and a median fragility index of 2.0 were noted. Spin was present in 17.0% of trials.
Conclusions:
- Contemporary cardiothoracic surgery trials are largely pragmatic with low patient attrition.
- However, few trials adequately ensured intervention quality or controlled for surgeon experience.
- The presence of reporting spin was infrequent, but the fragility index suggests potential for results to be non-significant with minor outcome changes.
Background:
This analysis was conducted to characterize contemporary randomized controlled trials (RCTs) in cardiothoracic surgery.
Methods:
We selected randomized controlled trials published in the journals with the highest impact factor in medicine, general surgery, and cardiothoracic surgery and published between 2008 and 2020. Trial characteristics as well as measures of reporting and quality were summarized and compared.
Results:
Ninety-three trials were included; 44 (47.3%) were prospectively registered and 14 (31.8%) had a discrepancy between the registered and published primary outcome. Most trials (n = 83 [89.1%]) used a superiority design, a composite primary outcome (n = 82 [88.2%]), and a major clinical event as the primary end point (n = 67 [72.0%]). Blinding was used infrequently, and most trials did not control for surgeon experience (n = 74 [79.5%]) or monitor the intervention (n = 90 [96.7%]). Twenty-four (25.8%) trials had high risk of bias. Twenty-one (27.3%) trials were funded by industry. A median 1.62% of patients (interquartile range, 0.00-3.70) crossed over between trial arms. Most trials reported a favorable outcome (n = 53 [58.9%]). For eligible trials, the median fragility index was 2.0 (interquartile range, 0.0-4.0), meaning the change of 2 patient outcomes would render the significant result insignificant. Spin, or distortion in reporting, was identified in 9 of 53 trials (17.0%). The median number of citations was 25 (10-56).
Conclusions:
Contemporary trials in cardiothoracic surgery are pragmatic with low rates of loss to follow-up and crossover. Few trials implemented measures to ensure quality of the intervention, and the presence of spin was infrequent.
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