Reporting of core outcomes in gastric cancer surgery trials over the past 25 years (systematic review)

J Surg Oncol. 2024 Mar 6. doi: 10.1002/jso.27613. Online ahead of print.

Abstract

Background: Gastric cancer, a leading cause of cancer-related mortality worldwide, has seen limited improvement in survival over the past 3 decades. Surgical resection is the cornerstone of curative management but the optimal approach remains unclear. Decision-making is hindered by inconsistent outcome reporting limiting data synthesis between trials. International consensus between healthcare professionals and patients has formed a core outcome set to be reported as a minimum. We appraised outcomes previously reported.

Methods: Evidence Based Medicine Reviews, MEDLINE, EMBASE and CINAHL were searched for randomised controlled trials (RCTs) and systematic reviews of RCTs during years 1995-2021. We searched trial registries for protocols of ongoing and future trials.

Results: Ninety-nine articles from 64 studies and 69 trial protocols were included. No study reported all core outcomes: average reported per trial was 4 (interquartile range: 2). 'Serious' adverse events were reported by 98%, completeness of tumour removal by 85% and surgery-related death by 74%. Outcomes important to patients were reported least: quality of life (22%) and nutritional effects (15%). Defining outcomes and time frames used was variable.

Conclusions: Critically important outcomes are poorly reported in the literature and the status has not improved in future trials. Further work is required to improve uptake.

Keywords: gastrectomy; health care or treatment outcome; outcome assessment; stomach neoplasms; systematic review [publication type].