Not Just Rigor, But Relevance: Usefulness of RCTs on Transarterial Chemoembolization and Radioembolization

Randomized controlled trials (RCTs) are considered the gold standard for evaluating the efficacy of interventions in medicine. In interventional oncology—particularly in the treatment of hepatic malignancies using transarterial chemoembolization (TACE) and transarterial radioembolization (TARE)—numerous RCTs have been published over the past decade. While many of these trials are methodologically rigorous, their actual usefulness for clinical decision-making remains uncertain. Traditional evaluations of RCTs often emphasize internal validity and risk of bias but may overlook critical aspects such as clinical relevance, generalizability, patient-centeredness, and transparency. This research project aims to systematically evaluate the usefulness of RCTs investigating TACE and TARE for hepatic malignancies, published between January 1, 2004, and December 31, 2024. The study will apply the 13-item multidimensional framework developed by van ’t Hooft et al., which assesses usefulness across eight domains: health problem relevance, contextualization, informativeness, pragmatism, patient-centeredness, economic value, feasibility, and transparency. Each RCT will be assigned a total usefulness score (ranging from 0 to 26) based on its fulfillment of these criteria. Eligible RCTs will be identified through structured searches in Medline and Embase. Two reviewers will independently screen studies and extract data using a standardized, pilot-tested Google Form. In addition to usefulness criteria, we will collect key trial characteristics, including intervention type (TACE or TARE), sample size, funding source, journal, impact factor, and trial location. Risk of bias will be assessed using the Cochrane Risk of Bias 2.0 tool, supported by ChatGPT as a decision-aid to enhance consistency and efficiency. Descriptive statistics and regression analyses will be used to examine trends in usefulness scores over time and to identify predictors of higher or lower usefulness. We will also evaluate the relationship between transparency and other domains of usefulness. The purpose of this study is to provide a comprehensive overview of how clinically useful RCTs in TACE and TARE have been over the past decade. We anticipate identifying substantial variability in usefulness, with particular shortcomings in domains such as transparency and contextualization. Findings from this analysis will highlight design and reporting gaps, offering actionable guidance for researchers, funders, and journal editors seeking to enhance the real-world impact of future interventional oncology trials. By preregistering this protocol, we aim to uphold transparency, reproducibility, and methodological rigor throughout the research process.