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. 2021 Jun 24;108(10):1216-1224.
doi: 10.1093/bjs/znab192. Online ahead of print.

Core outcome set for surgical trials in gastric cancer (GASTROS study): international patient and healthcare professional consensus

B Alkhaffaf  1   2 , A Metryka  3 , J M Blazeby  4 , A-M Glenny  5 , A Adeyeye  6 , P M Costa  7 , I Diez Del Val  8 , S S Gisbertz  9 , A Guner  10 , S Law  11 , H-J Lee  12 , Z Li  13 , K Nakada  14 , D Reim  15 , P Vorwald  16 , G L Baiocchi  17 , W Allum  18 , M A Chaudry  18 , E A Griffiths  19 , P R Williamson  20 , I A Bruce  2   21
Affiliations

Core outcome set for surgical trials in gastric cancer (GASTROS study): international patient and healthcare professional consensus

B Alkhaffaf et al. Br J Surg. .

Abstract

Background: 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.

Methods: 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.

Results: 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.

Conclusion: 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.

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Figures

Fig. 1
Fig. 1
Stages of the GASTROS study
Fig. 2
Fig. 2
Results from different stages of the GASTROS study COS, core outcome set.
See this image and copyright information in PMC

References

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