Reporting of Outcomes in Gastric Cancer Surgery Trials: A Systematic Review

Bilal Alkhaffaf, Jane Blazeby, Paula R Williamson, Iain Bruce, Anne Marie Glenny

Research output: Contribution to journalArticle (Academic Journal)peer-review

5 Citations (Scopus)
283 Downloads (Pure)

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.
Original languageEnglish
Article numbere021796
Number of pages13
JournalBMJ Open
Volume8
Issue number10
Early online date17 Oct 2018
DOIs
Publication statusPublished - Oct 2018

Structured keywords

  • Centre for Surgical Research

Keywords

  • Surgical Oncology
  • Stomach Neoplasms
  • Outcome Assessment
  • Delphi Technique
  • Patient Reported Outcome Measures
  • Treatment Outcome
  • Outcome reporting

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