The Development of a Core Outcome Set for Surgical Trials in Gastric Cancer

Abstract

BACKGROUND: Gastric cancer is a leading cause of cancer-related deaths worldwide. Whilst surgery is the mainstay of curative treatment, it is associated with significant risks. Identifying optimal surgical strategies for gastric cancer should be based on evidence from well-designed trials. However, inconsistencies in the reporting of outcomes from these trials makes evidence synthesis unreliable. This PhD study aims to address these challenges by developing a core outcome set (COS) - a standardised group of important outcomes - which should be reported as a minimum by future trials in this field. METHODS: The COS was developed over two stages employing methodological principles based on established guidelines from the field of COS development. Stage 1 involved identifying potentially important outcomes from previous trials and a series of patient interviews. In stage 2, potentially important outcomes were prioritised using a Delphi survey which informed a consensus meeting at which the COS was finalised. RESULTS: 498 outcomes were identified from previously reported trials (n=454) and patient interviews (n=70) and rationalised into 56 items presented in the Delphi survey. International stakeholder participation was facilitated through the establishment of collaborative networks and translation of the surveys using an approach adapted from international guidelines. 952 patients (n=268), surgeons (n=445) and nurses (n=239) from 6 continents enrolled into round 1 of the survey and 662 completed round 2. Demographic and regional differences did not impact on how participants prioritised outcomes in the survey. Following the consensus meeting, 8 outcomes were included in the COS - disease-free survival, disease-specific survival, surgery-related death, recurrence, completeness of tumour removal, overall quality of life, nutritional effects, and complications. CONCLUSION: A COS for surgical trials in gastric cancer has been developed with international patients and healthcare professionals. This PhD study has also described key methodological considerations for COS development.

Date of Award	1 Aug 2021
Original language	English
Awarding Institution	The University of Manchester
Supervisor	Anne-Marie Glenny (Supervisor), Iain Bruce (Supervisor) & Paula Williamson (Supervisor)