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



Alkhaffaf, B, Metryka, A, Blazeby, JM, Glenny, AM, Adeyeye, A, Costa, PM, del Val, I Diez, Gisbertz, SS, Guner, A, Law, S
et al (show 11 more authors) (2021) Core outcome set for surgical trials in gastric cancer (GASTROS study): international patient and healthcare professional consensus. BRITISH JOURNAL OF SURGERY, 108 (10). pp. 1216-1224.

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Abstract

<h4>Background</h4>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.<h4>Methods</h4>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.<h4>Results</h4>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.<h4>Conclusion</h4>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.

Item Type: Article
Uncontrolled Keywords: Clinical Research, Clinical Trials and Supportive Activities, Cancer, Digestive Diseases, Rare Diseases, Patient Safety, 7 Management of diseases and conditions, 7.3 Management and decision making, Cancer, 3 Good Health and Well Being
Divisions: Faculty of Health and Life Sciences
Faculty of Health and Life Sciences > Institute of Population Health
Depositing User: Symplectic Admin
Date Deposited: 08 Dec 2021 10:53
Last Modified: 16 Mar 2024 02:29
DOI: 10.1093/bjs/znab192
Open Access URL: http://doi.org/10.1093/bjs/znab192
Related URLs:
URI: https://livrepository.liverpool.ac.uk/id/eprint/3144935