Abstract
Background
The development of clinical guidelines for the surgical management of gastric cancer should be based on robust evidence from well-designed trials. Being able to reliably compare and combine the outcomes of these trials is a key factor in this process.
Objectives
To examine variation in outcome reporting by surgical trials for gastric cancer; to identify outcomes for prioritisation in an international consensus study to develop a core outcome set in this field.
Data Sources
Systematic literature searches (Evidence Based Medicine, MEDLINE, EMBASE, CINAHL, ClinicalTrials.gov and WHO ICTRP) and a review of study protocols of randomized controlled trials, published between 1996 and 2016.
Intervention
Therapeutic surgical interventions for gastric cancer. Outcomes were listed verbatim, categorized into groups (outcome themes) and examined for definitions and measurement instruments
Results
Of 1919 abstracts screened, 32 trials (9,073 participants) were identified. A total of 749 outcomes were reported of which 96 (13 per cent) were accompanied by an attempted definition. No single outcome was reported by all trials. ‘Adverse events’ was the most frequently reported ‘outcome theme’ in which 240 unique terms were described. 12 trials (38%) classified complications according to severity, with 5 (16%) using a formal classification system (Clavien-Dindo or Accordion scale). Of 27 trials which described ‘short-term’ mortality, 15 (47%) used one of 5 different definitions. Six out of the 32 trials (19%) described ‘patient-reported outcomes’.
Conclusion
Reporting of outcomes in gastric cancer surgery trials is inconsistent. A consensus approach to develop a minimum set of well-defined, standardized outcomes to be used by all future trials examining therapeutic surgical interventions for gastric cancer is needed. This should consider the views of all key stakeholders, including patients.
The development of clinical guidelines for the surgical management of gastric cancer should be based on robust evidence from well-designed trials. Being able to reliably compare and combine the outcomes of these trials is a key factor in this process.
Objectives
To examine variation in outcome reporting by surgical trials for gastric cancer; to identify outcomes for prioritisation in an international consensus study to develop a core outcome set in this field.
Data Sources
Systematic literature searches (Evidence Based Medicine, MEDLINE, EMBASE, CINAHL, ClinicalTrials.gov and WHO ICTRP) and a review of study protocols of randomized controlled trials, published between 1996 and 2016.
Intervention
Therapeutic surgical interventions for gastric cancer. Outcomes were listed verbatim, categorized into groups (outcome themes) and examined for definitions and measurement instruments
Results
Of 1919 abstracts screened, 32 trials (9,073 participants) were identified. A total of 749 outcomes were reported of which 96 (13 per cent) were accompanied by an attempted definition. No single outcome was reported by all trials. ‘Adverse events’ was the most frequently reported ‘outcome theme’ in which 240 unique terms were described. 12 trials (38%) classified complications according to severity, with 5 (16%) using a formal classification system (Clavien-Dindo or Accordion scale). Of 27 trials which described ‘short-term’ mortality, 15 (47%) used one of 5 different definitions. Six out of the 32 trials (19%) described ‘patient-reported outcomes’.
Conclusion
Reporting of outcomes in gastric cancer surgery trials is inconsistent. A consensus approach to develop a minimum set of well-defined, standardized outcomes to be used by all future trials examining therapeutic surgical interventions for gastric cancer is needed. This should consider the views of all key stakeholders, including patients.
| Original language | English |
|---|---|
| Article number | e021796 |
| Number of pages | 13 |
| Journal | BMJ Open |
| Volume | 8 |
| Issue number | 10 |
| Early online date | 17 Oct 2018 |
| DOIs | |
| Publication status | Published - Oct 2018 |
Research Groups and Themes
- Centre for Surgical Research
Keywords
- Surgical Oncology
- Stomach Neoplasms
- Outcome Assessment
- Delphi Technique
- Patient Reported Outcome Measures
- Treatment Outcome
- Outcome reporting
Access to Document
- Full-text PDF (final published version)
This is the final published version of the article (version of record). It first appeared online via BMJ at https://bmjopen.bmj.com/content/8/10/e021796.info . Please refer to any applicable terms of use of the publisher.
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