Key result
Proportion of low-bias surgical RCTs increases ~50% over a decade despite stable overall volume.
Why the study?
Randomized controlled trials are essential to guide clinical decisions but are difficult to perform, particularly in surgery, prompting an evaluation of trends in their volume and methodological quality over two decades.
Systematic Review (n=1,188)
Yes
Absolute Event Rate: 22.1% vs 14.7%
p-value: p=0.004
The volume of published surgical RCTs worldwide remained stable in the past decade, but their methodological quality improved, with significant geographical shifts toward Asia.
Clinicians may place greater confidence in recent surgical trial results; confirms gradual gains in methodological quality.
BACKGROUND: RCTs are essential in guiding clinical decision-making but are difficult to perform, especially in surgery. This review assessed the trend in volume and methodological quality of published surgical RCTs over two decades. METHODS: PubMed was searched systematically for surgical RCTs published in 1999, 2009, and 2019. The primary outcomes were volume of trials and RCTs with a low risk of bias. Secondary outcomes were clinical, geographical, and funding characteristics. RESULTS: Some 1188 surgical RCTs were identified, of which 300 were published in 1999, 450 in 2009, and 438 in 2019. The most common subspecialty in 2019 was gastrointestinal surgery (50.7 per cent). The volume of surgical RCTs increased mostly in Asia (61, 159, and 199 trials), especially in China (7, 40, and 81). In 2019, countries with the highest relative volume of published surgical RCTs were Finland and the Netherlands. Between 2009 and 2019, the proportion of RCTs with a low risk of bias increased from 14.7 to 22.1 per cent (P = 0.004). In 2019, the proportion of trials with a low risk of bias was highest in Europe (30.5 per cent), with the UK and the Netherlands as leaders in this respect. CONCLUSION: The volume of published surgical RCTs worldwide remained stable in the past decade but their methodological quality improved. Considerable geographical shifts were observed, with Asia and especially China leading in terms of volume. Individual European countries are leading in their relative volume and methodological quality of surgical RCTs.
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Pronk et al. (2023) conducted a systematic review in Surgical RCTs (n=1,188). Publication year (1999, 2009, 2019) vs. Earlier publication years was evaluated on Volume of trials and RCTs with a low risk of bias (p=0.004). The worldwide volume of published surgical RCTs remained stable over the past decade, but the proportion of trials with a low risk of bias increased from 14.7% in 2009 to 22.1% in 2019 (P=0.004).
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