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

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.

Contributors

Anie Naqvi, Nadia Matias, Bilal Al-Khaffaf

Publication

Journal: Journal of Surgical Oncology
Volume:
Issue:
Pages: -
Year: 2024
DOI: 10.1002/jso.27613

Further Study Information

Current Stage: Completed
Date:
Funding source(s): NIHR Doctoral Research Fellowship


Health Area

Disease Category: Cancer, Gastroenterology

Disease Name: Gastric Cancer

Target Population

Age Range: 18 - 100

Sex: Either

Nature of Intervention: Any

Stakeholders Involved

Study Type

- Systematic review of outcomes measured in trials

Method(s)

- Systematic review

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.