. 2018 Oct 17;8(10):e021796.

doi: 10.1136/bmjopen-2018-021796.

Reporting of outcomes in gastric cancer surgery trials: a systematic review

Bilal Alkhaffaf^{1

2

3}, Jane M Blazeby^{4

5}, Paula R Williamson⁶, Iain A Bruce^{7

8}, Anne-Marie Glenny⁹

Affiliations

¹ Department of Oesophago-Gastric Surgery, Manchester Royal Infirmary, Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK.
² Department of Oesophago-Gastric Surgery, Salford Royal Hospital, Salford Royal NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK.
³ Division of Cancer Sciences, School of Medical Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UK.
⁴ Centre for Surgical Research, University of Bristol, Bristol, UK.
⁵ National Institute for Health Research, Bristol Biomedical Research Centre, Bristol, UK.
⁶ MRC North West Hub for Trials Methodology Research, University of Liverpool, Liverpool, UK.
⁷ Paediatric ENT Department, Royal Manchester Children's Hospital, Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK.
⁸ Division of Infection, Immunity and Respiratory Medicine, School of Biological Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UK.
⁹ Division of Dentistry, School of Medical Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UK.

PMID: 30337308
PMCID: PMC6196805
DOI: 10.1136/bmjopen-2018-021796

Reporting of outcomes in gastric cancer surgery trials: a systematic review

Bilal Alkhaffaf et al. BMJ Open. 2018.

. 2018 Oct 17;8(10):e021796.

doi: 10.1136/bmjopen-2018-021796.

Authors

Bilal Alkhaffaf^{1

2

3}, Jane M Blazeby^{4

5}, Paula R Williamson⁶, Iain A Bruce^{7

8}, Anne-Marie Glenny⁹

Affiliations

¹ Department of Oesophago-Gastric Surgery, Manchester Royal Infirmary, Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK.
² Department of Oesophago-Gastric Surgery, Salford Royal Hospital, Salford Royal NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK.
³ Division of Cancer Sciences, School of Medical Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UK.
⁴ Centre for Surgical Research, University of Bristol, Bristol, UK.
⁵ National Institute for Health Research, Bristol Biomedical Research Centre, Bristol, UK.
⁶ MRC North West Hub for Trials Methodology Research, University of Liverpool, Liverpool, UK.
⁷ Paediatric ENT Department, Royal Manchester Children's Hospital, Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK.
⁸ Division of Infection, Immunity and Respiratory Medicine, School of Biological Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UK.
⁹ Division of Dentistry, School of Medical Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UK.

PMID: 30337308
PMCID: PMC6196805
DOI: 10.1136/bmjopen-2018-021796

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 and 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 randomised controlled trials, published between 1996 and 2016.

Intervention: Therapeutic surgical interventions for gastric cancer. Outcomes were listed verbatim, categorised into groups (outcome themes) and examined for definitions and measurement instruments.

Results: Of 1919 abstracts screened, 32 trials (9073 participants) were identified. A total of 749 outcomes were reported of which 96 (13%) 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 five different definitions. 6 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, standardised 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.

Keywords: delphi technique; outcome assessment; outcome reporting; patient reported outcome measures; stomach neoplasms; surgical oncology.

PubMed Disclaimer

Conflict of interest statement

Competing interests: None declared.

Figures

**Figure 1**
Study selection and inclusion.

**Figure 2**
Outcome themes reported in (A) gastric cancer surgery trials and (B) in future trials based on study protocols.

See this image and copyright information in PMC

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Reporting of outcomes in gastric cancer surgery trials: a systematic review

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Reporting of outcomes in gastric cancer surgery trials: a systematic review

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