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

Abstract

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. 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. 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. 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.