To address the persistent challenges in surgical clinical research, we provide a comprehensive analysis of the series of articles on randomized controlled trials (RCTs) methodology guidance published in JAMA Surgery from 2022 to 2023. This section contents focus on critical aspects of RCTs, including trial design, selection criteria, ethical considerations, quality control, budgeting, and funding support. The objective is to enhance the understanding of RCTs among researchers, particularly surgeons, thereby guiding them in conducting high-quality and scientifically robust RCTs.
This article systematically reviews the series of articles on randomized controlled trial (RCT) methodology guidance published in JAMA Surgery between 2022 and 2023. It focuses on providing an overview and guidance on critical aspects such as trial implementation and oversight, participant recruitment, statistical applications, and key points in manuscript publication. The aim is to offer valuable insights and references for surgeons to conduct efficient clinical trials and successfully publish their research findings.
Objective To study the effect of alpha fetoprotein-tumor burden score (ATS) on the long-term prognosis of hepatocellular carcinoma (HCC) after resection. MethodsThe data of 2 907 patients with HCC who underwent first hepatectomy from West China Hospital of Sichuan University, West China Ziyang Hospital/Ziyang Central Hospital, The First People’s Hospital of Neijiang, West China Yibin Hospital/the Second People’s Hospital of Yibin, and the Affiliated Hospital of Chengdu University between 2015 and 2022, were retrospectively analyzed. The X-tile software was used to calculate the optimal truncation of the ATS score. Cox proportional hazard regression model was used to explore risk factors affecting postoperative recurrence-free survival (RFS) and overall survival (OS) in HCC patients, respectively. ResultsAll patients were followed-up with a median of 37 months (1–90 months), 1 364 cases (46.9%, the recurrence time was 1–89 months after surgery) of them experienced recurrence and 847 cases (29.1%) died (the death time was 1–88 months after surgery). The 1-, 2- and 3-year OS rates were 89.3%, 81.4% and 75.9%, respectively. The 1-, 2- and 3-year RFS rates were 76.0%, 64.3% and 57.2%, respectively. The 5-year RFS rate of HCC patients with low-, medium-, and high-ATS scores were 56.4%, 45.0% and 27.2%, respectively, and patients with low ATS score had better RFS (χ2=264.747, P<0.001). The 5-year OS rates of HCC patients with low-, medium-, and high-ATS scores were 78.0%, 59.8% and 38.8%, respectively, and patients with low-ATS score had better OS (χ2=372.685, P<0.001). Multivariate Cox proportional hazard regression model suggested that, in condition of adjusting other factors, medium-ATS score [RR=1.375, 95%CI (1.209, 1.564), P<0.001] and high-ATS score [RR=2.048, 95%CI (1.764, 2.377), P<0.001] were risk factors for postoperative RFS; the medium-ATS score [RR=1.779, 95%CI (1.499, 2.112), P<0.001] and high ATS score [RR=2.676, 95%CI (2.211, 3.239), P<0.001] were also risk factors affecting postoperative OS. ConclusionATS score can predict the prognosis of HCC patients after resection, patients with high ATS score had a higher incidence of postoperative recurrence and mortality.