Two decades of surgical randomized controlled trials: worldwide trends in volume and methodological quality

Abstract

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.

Methodological review to develop a list of bias items for adaptive clinical trials: Protocol and rationale

“…Conventional RCTs, however, can be burdened by high costs, early termination due to feasibility issues, and an overly rigid design that does not permit adjustments for unforeseen challenges [3]. These issues are amplified in surgical trials and as such, the annual number of published surgical trials remains stagnant [4, 5]. As a response to these challenges, researchers have begun using adaptive trial designs, which allow for dynamic protocol changes after beginning patient recruitment.…”

Exploration of registration and the risk of bias in acupuncture randomised controlled trials: a systematic review protocol

“…2 However, any bias in RCTs can affect the credibility of the study results 3 and may even mislead clinical practice and harm patients. 4 The revised Cochrane risk-of-bias tool (RoB 2) is the most common assessment tool for evaluating the risk-of-bias of RCTs, 5 it can help researchers judge the methodological quality of studies and determine the strength of evidence. 6 …”

Comment on: Two decades of surgical randomized controlled trials: worldwide trends in volume and methodological quality

“…Pronk et al . 1 reviewed surgical RCTs over a span of 20 years, finding an improvement in trial quality along with a rise in Asia, mostly led by China. Pronk et al .…”

“…Pronk et al . 1 focused on progress in reported methodology and study design, but did not consider improvements in terms of equity and, consequently, the generalizability of current trials, which ought to be considered a form of quality.…”

“…Pronk et al . 1 showed that, despite some geographical shift, only one lower-middle-income country (Egypt) was featured in the top 10 in terms of trial volume in 2019, whereas Africa and South America together represented the smallest number of trials at 6.8 per cent of the total volume, despite being home to nearly one-quarter of the world’s population. This challenges the generalizability of trials, as interventions that work within a given country or region do not account for cultural, political, and economical factors that may influence behaviours and outcomes elsewhere.…”