The GASTROS Study: Standardising Outcome Reporting in Gastric Cancer Surgery Research


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Bilal Alkhaffaf1,Iain Bruce1,Anne-Marie Glenny2,Paula Williamson3,Jane Blazeby4
1Central Manchester University Hospitals NHS Foundation Trust,2University of Manchester,3University of Liverpool,4University of Bristol

Abstract

Background

Partial or total gastrectomy is the mainstay of treatment with curative intent for gastric cancer. Surgery, however, is associated with complications and a significant impact on quality of life. Identifying the best surgical approaches for gastric cancer includes comparing and synthesizing data from surgical studies in systematic reviews and meta-analyses. This is presently difficult as there is great heterogeneity in the reporting of outcomes in surgical trials. Many trials do not report ‘quality of life’ or ‘patient-reported outcomes’.

GASTROS (GAstric cancer Surgery Trials Reported Outcome Standardisation) is an international study which aims to develop a core outcome set (COS) – a minimum standardised group of outcomes – which should be reported by all future gastric cancer surgery trials to enable more accurate comparison of different surgical approaches. GASTROS is fully funded by the National Institute for Health Research and supported by the Medical Research Council's Hubs for Trials Methodology Research. Here we present our study protocol.

Method

The GASTROS study has 3 stages. Stage 1 involves undertaking a systematic review of RCTs to identify a ‘long-list’ of possible outcomes to include in the COS. Qualitative interviews with gastric cancer patients will be undertaken to identify any further outcomes which patients deem important. Stage 2 involves 3 rounds of a Delphi survey of key stakeholders (surgeons, cancer nurse specialists and patients) to determine which outcomes to include in the COS. Stage 3 will focus on identifying the most appropriate methods of measuring these outcomes.

Conclusion

This study will enable more reliable and accurate comparison of surgical interventions for gastric cancer. It will inform the design of future gastric cancer surgical trials, clinical practice and surgical audits by developing a standardised, well-defined group of outcomes which are important and relevant to both patients and clinicians.