Are the Priorities of Patients & Researchers Aligned in the Reporting of Outcomes in Gastric Cancer Surgery Trials?


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Bilal Alkhaffaf1,Iain Bruce1,Anne-Marie Glenny2,Paula Williamson3,Jane Blazeby4,Rebecca Morris2
1Central Manchester University Hospitals NHS Foundation Trust,2University of Manchester,3MRC North West Hub for Trials Methodology Research, University of Liverpool,4Centre for Surgical Research, School of Social & Community Medicine, University of Bristol

Abstract

Background

Gastric cancer remains a leading cause of cancer-related deaths worldwide and little improvement has been made in long-term survival over the last four decades. Gastrectomy is currently the only treatment modality which can be employed with curative intent, yet surgery is associated with significant short and long-term complications. Surgical trials in this field aim to identify interventions which minimise complications whilst prolonging survival. However, to make research relevant to all key stakeholders, the views of patients should be considered when choosing outcomes to report in these trials.

Our study aimed to identify outcomes important to patients and compare them to those reported by researchers in trials to highlight areas of improvement which may reduce research waste in this field.

Method

Twenty in-depth, semi-structured qualitative interviews were undertaken with patients at different stages of recovery following gastric cancer surgery with curative intent. A thematic analysis of interview transcripts was used to identify surgery-related outcomes important to patients. These were compared against outcomes identified from a systematic review of 32 trials examining therapeutic surgical interventions for gastric cancer over the last 20 years.

Results

Over 50 unique outcomes were identified from patient interviews. The five most frequently referenced were survival, recurrence, complete tumour resection, fatigue and diet-related issues. Survival was reported by 66% of trials. Recurrence, complete resection and diet-related issues were reported by 25%. No trial reported fatigue as an outcome. Three trials reported quality of life after surgery. Trial outcomes were poorly defined and heterogeneous in terms of when and how they were reported.

Conclusion

Outcome reporting in gastric cancer surgery trials is inconsistent and does not adequately represent the priorities of patients. A consensus approach involving key stakeholders including researchers and patients is required to prioritise a well-defined standardised group of outcomes for trials in this field.