Abstract
Surgery is the primary treatment that can offer potential cure for gastric cancer, but is associated with significant risks. Identifying optimal surgical approaches should be based on comparing outcomes from well designed trials. Currently, trials report different outcomes, making synthesis of evidence difficult. To address this, the aim of this study was to develop a core outcome set (COS)-a standardized group of outcomes important to key international stakeholders-that should be reported by future trials in this field. Stage 1 of the study involved identifying potentially important outcomes from previous trials and a series of patient interviews. Stage 2 involved patients and healthcare professionals prioritizing outcomes using a multilanguage international Delphi survey that informed an international consensus meeting at which the COS was finalized. Some 498 outcomes were identified from previously reported trials and patient interviews, and rationalized into 56 items presented in the Delphi survey. A total of 952 patients, surgeons, and nurses enrolled in round 1 of the survey, and 662 (70 per cent) completed round 2. Following the consensus meeting, eight 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 'serious' adverse events. A COS for surgical trials in gastric cancer has been developed with international patients and healthcare professionals. This is a minimum set of outcomes that is recommended to be used in all future trials in this field to improve trial design and synthesis of evidence.
Highlights
Gastric cancer is a significant global health burden which is associated with poor survival[1]
The GASTROS study conforms to standards established for the development of core outcome set (COS) as outlined by COS-STAD (Core Outcome Set—STAndards for Development)[18]
The 498 outcomes identified from the systematic review, patient-reported outcome measures, and patient interviews were rationalized by the Study Management Group (SMG) into 58 items, which were presented to the Study Advisory Group (SAG)
Summary
Gastric cancer is a significant global health burden which is associated with poor survival[1]. The adoption of multimodal therapy for the minority of patients who present with early-stage disease has improved prognosis, surgery remains the only treatment offering a potential cure[2]. Surgery is the primary treatment that can offer potential cure for gastric cancer, but is associated with significant risks. Identifying optimal surgical approaches should be based on comparing outcomes from well designed trials. Trials report different outcomes, making synthesis of evidence difficult. The aim of this study was to develop a core outcome set (COS)—a standardized group of outcomes important to key international stakeholders—that should be reported by future trials in this field
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