Abstract
Background
Surgery is the primary treatment which 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 evidence synthesis difficult. To address this, we aimed to develop a core outcome set (COS) – a standardised 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 prioritising outcomes using a multi-language international Delphi survey which informed an international consensus meeting at which the COS was finalised.
Results
498 outcomes were identified from previously reported trials and patient interviews and rationalised into 56 items presented in the Delphi survey. 952 patients, surgeons and nurses enrolled into round 1 of the survey and 662 (70%) completed round 2. 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 serious adverse events.
Conclusions
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 we recommend is used in all future trials within this field to improve trial design and evidence synthesis. Researchers are encouraged to report additional outcomes which may be of relevance to their study and regional stakeholders.
Surgery is the primary treatment which 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 evidence synthesis difficult. To address this, we aimed to develop a core outcome set (COS) – a standardised 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 prioritising outcomes using a multi-language international Delphi survey which informed an international consensus meeting at which the COS was finalised.
Results
498 outcomes were identified from previously reported trials and patient interviews and rationalised into 56 items presented in the Delphi survey. 952 patients, surgeons and nurses enrolled into round 1 of the survey and 662 (70%) completed round 2. 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 serious adverse events.
Conclusions
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 we recommend is used in all future trials within this field to improve trial design and evidence synthesis. Researchers are encouraged to report additional outcomes which may be of relevance to their study and regional stakeholders.
| Original language | English |
|---|---|
| Article number | znab192 |
| Number of pages | 9 |
| Journal | British Journal of Surgery |
| Early online date | 24 Jun 2021 |
| DOIs | |
| Publication status | Published - 24 Jun 2021 |
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