GASTROS - eDelphi Survey
Research type
Research Study
Full title
Identification of critically important outcomes for the development of a core outcome set to be used in studies examining therapeutic surgical interventions for gastric cancer.
IRAS ID
240108
Contact name
Bilal Alkhaffaf
Contact email
Sponsor organisation
Manchester University NHS Foundation Trust
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
Aims: Partial or total gastrectomy (removal of the stomach) is the mainstay of treatment with curative intent for gastric cancer. Surgery, however, is associated with complications and a significant impact on quality of life. Identifying the best surgical approaches for gastric cancer includes comparing and synthesising data from surgical studies in systematic reviews and meta-analyses. This is presently difficult as there is great heterogeneity in the reporting of outcomes in surgical trials. Many trials do not report ‘quality of life’ or ‘patient-reported outcomes’.
GASTROS (GAstric cancer Surgery Trials Reported Outcome Standardisation) is a study which aims to develop a core outcome set (COS) – a minimum standardised group of outcomes – which should be reported by all future gastric cancer surgery trials to enable more accurate comparison of different surgical approaches. GASTROS is fully funded by the National Institute for Health Research and supported by the Medical Research Council's Hubs for Trials Methodology Research.
Methods: The GASTROS study has 3 stages. Stage 1 involves undertaking a systematic review of RCTs to identify a ‘long-list’ of possible outcomes to include in the COS. Qualitative interviews with gastric cancer patients will be undertaken to identify any further outcomes which patients deem important. This submission relates to stage 2 of the study which involves 2 rounds of a Delphi survey of key stakeholders (surgeons, cancer nurse specialists and patients) to determine which outcomes to include in the COS. Stage 3 will focus on identifying the most appropriate methods of measuring these outcomes.
Anticipated Benefits: This study will enable more reliable and accurate comparison of surgical interventions for gastric cancer. It will inform the design of future gastric cancer surgical trials, clinical practice and surgical audits by developing a standardised, well-defined group of outcomes which are important and relevant to both patients and clinicians.
REC name
North West - Greater Manchester East Research Ethics Committee
REC reference
18/NW/0347
Date of REC Opinion
7 Jun 2018
REC opinion
Further Information Favourable Opinion