Evaluating patient-reported outcomes in randomized controlled trials of targeted therapy and/or immunotherapy for liver cancer: a scoping review.

Objective: To assess the reporting characteristics and quality of patient-reported outcomes (PROs) in randomized controlled trials (RCTs) of targeted therapy and/or immunotherapy for liver cancer. Methods: We systematically searched six electronic databases for relevant RCTs published in English or Chinese from inception to April 17, 2025. The reporting quality of PROs was assessed using the CONSORT-PRO extension and the CONSORT 2010 guidelines. Results: We included 64 RCTs with 8,494 participants. Of these, 14 studies were confirmatory studies, 31 studies were exploratory studies and 19 studies were categorized as "Other" studies. 23.4% (15/64) of these RCTs reported PROs as the primary outcome. Twenty-seven patient-reported outcome measures (PROMs) about 17 relevant domains were observed in these studies. The domain with the highest reporting frequency was quality of life (53/64). Forty trials utilized a single PROM, while 24 trials employed multiple PROMs. The EORTC QLQ-C30 was the most often used PROM (25/53). Nineteen trials employed single-domain symptoms or specific functioning PROMs. Eight symptomatic adverse events were reported in less than 30% of studies. The mean score of the CONSORT-PRO adherence was 7.5 (3-14) for confirmatory studies, 5.8 (4-9) for exploratory studies and 6.0 (3-9) for other studies. The adherence to CONSORT 2010 was poor among the included trials. Only 3 trials achieved good reporting quality. Conclusion: Among the 64 included RCTs, the reporting of specific symptoms and the application of specific PROMs related to targeted and/or immunotherapy were poor. Meanwhile, the integration of PROs with clinical endpoints was suboptimal, and PRO data were seldom used to guide nursing practice. More importantly, the overall adherence to CONSORT-PRO among the included studies was low. Although confirmatory studies demonstrated higher scores than exploratory studies and other types of studies, there was considerable variation within this category. Future studies should prioritize the use of validated, standard disease-specific tools and strengthen the evaluation of treatment-related adverse events. Furthermore, we advocate establishing a collaborative framework that integrates medical, nursing, and patient perspectives. Future studies, particularly confirmatory studies and nursing intervention or supportive care studies, strictly adhere to the CONSORT-PRO guideline.