TY - JOUR
T1 - Two decades of surgical randomized controlled trials
T2 - worldwide trends in volume and methodological quality
AU - Pronk, Aagje J. M.
AU - Roelofs, Anne
AU - Flum, David R.
AU - Bonjer, H. Jaap
AU - Abu Hilal, Mohammed
AU - Dijkgraaf, Marcel G. W.
AU - Besselink, Marc G.
AU - Ahmed Ali, Usama
N1 - Funding Information: Interestingly, this review also identified a significant shift in trial funding. Over the past 20 years, fewer RCTs have been funded by industry. This review identified an industry funding rate of 11.4 per cent in contrast with 33 per cent in another review of surgical RCTs (2008–2020). Several studies have shown that industry funding leads to overestimation of positive outcomes, which clearly affects the interpretation of results. On the other hand, funding of surgical RCTs may become increasingly difficult in future years with declining support from industry. , Publisher Copyright: © 2023 The Author(s).
PY - 2023/10
Y1 - 2023/10
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85169847964&partnerID=8YFLogxK
U2 - https://doi.org/10.1093/bjs/znad160
DO - https://doi.org/10.1093/bjs/znad160
M3 - Review article
C2 - 37379487
SN - 0007-1323
VL - 110
SP - 1300
EP - 1308
JO - The British journal of surgery
JF - The British journal of surgery
IS - 10
ER -