Title: Development of a Core Outcome Set for Gastric Cancer Surgery Effectiveness Trials
Funder: Department of Health and Social Care

Abstract: Background In the UK, the 5-year survival rate from gastric cancer remains extremely poor at 19%. Surgery remains the mainstay of treatment, yet only 1/3 of patients of UK patients with gastric cancer undergo surgery with curative intent. Even in this group, advancing tumour stage and age at diagnosis, the high prevalence of malnutrition and multiple co-morbidities mean that potentially curative surgery is associated with a relatively high mortality and post-operative complication rate (approximately 5 and up to 50 per cent respectively). Multiple studies have attempted to improve this picture by trialling, for example, minimal access surgical techniques and more radical surgery. In all these studies, several different outcomes have been reported. The lack of standardisation in reporting makes it difficult to accurately compare the results of these trials which makes evidence synthesis challenging. Consequently this makes the discussion regarding outcomes from different treatments difficult when consenting patients for their surgery.Aim I propose to develop a core outcome set (COS) - a minimum set of outcomes - which should be measured and reported in gastric cancer surgery trials. This should reflect the interest of patients and healthcare professionals. Question to be investigated Based on the research plan (see case for support '2'), the research questions are as follows: What outcomes have been reported in gastric cancer surgery trials? What outcomes are of most importance to healthcare professionals? What outcomes are of most importance to patients who have undergone gastric cancer surgery? What should a combined clinical and patient core outcome set consist of for gastric cancer surgery? How should these outcomes be measured? Plan of investigation For a more detailed explanation of each stage, please see 'Case for support - Part 2: 'Research Plan'. Please see figure 1 for an overview of my study, with an associated timeline and the different outputs. Stage 1: Identification of Possible Outcomes, Definitions and Outcome Measurement Tools Systematic review of literature to catalogue outcomes and outcome measurement tools Patient interviews Outcome inventory Stage 2: Determining the Core Outcome Set This will be determined using a Delphi survey. There will be three rounds of surveys for healthcare professionals and patients. This will be followed by a joint consensus meeting of key stakeholders to finalise the COS. Stage 3: Determining How Core Outcomes Should Be Measured Quality Assessment: Once the COS has been agreed, it is important to determine how the different outcomes should be measured. An assessment framework developed by the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) initiative will assess the quality of potential outcome measurement instruments identified in the systematic literature search in stage 1.1. Outcome definitions and high quality measurement instruments will be incorporated into the core outcome set. Stakeholder consultation and incorporation into the finalised recommendation about what and how to measure outcomes in gastric cancer surgery trials. Potential Benefit to Patients and NHS There is no COS for gastric cancer surgery. Incorporating a COS which reflects the opinions of key stakeholders into future trials, systematic reviews and clinical guidelines (NICE mandates the use of core outcome sets where available during evidence synthesis) will make a huge contribution to advancing the usefulness of research in informing clinical practice and subsequently enhancing patient care. More specifically, ensuring that patients contribute to what is measured by clinical trials means that outcomes from such studies are relevant to patients. Furthermore, by enabling effective trial comparison, the development of a COS will ensure that invaluable patient involvement in research is not wasted.

Lay abstract: Background Each year in the UK, approximately 7,000 patients are diagnosed with cancer of the stomach (gastric cancer), a disease linked with poor survival. For the small group of people who are able to undergo surgery with the intention of curing the cancer, treatment is often complex and involves chemotherapy. Surgery is the mainstay of treatment, but is associated with high risks including death and serious complications. Research studies from the UK and across the world have attempted to find ways to improve the survival from gastric cancer and reduce the risks of surgery. These studies however report their results (outcomes) in many different ways which makes it difficult to compare their results and answer the question 'what is the best treatment for gastric cancer?' Results from gastric cancer surgery are also used to measure the quality of treatment that NHS hospitals provide.Similarly there is no agreement as to which results should be reported and how this should be done. Aims This study aims to develop a 'core outcome set' (COS) that all gastric cancer surgery research trials should measure and report. A COS is an agreed standardised set of outcomes that should be measured and reported, as a minimum, in all clinical trials in specific areas of health or health care. It would mean that research is reported in the same way and proper comparisons can be made. In order that the results of future research studies are relevant to everyone, the type of results (outcomes) that are reported should be chosen by health professionals and patients. This study also aims to identify the most appropriate way to measure the outcomes from the COS. Design & Methods I aim to develop this COS in three stages: Stage 1: Identifying Possible Outcomes to Include I will examine the types of outcomes that have been reported in previous research through a systematic review. I will also interview patients who have had gastric cancer surgery to find out what types of outcomes are important to them that may be included in the COS. Stage 2: Agreeing on the COS I will use a Delphi survey to find out which outcomes (from the ones identified in stage 1) are the most important to health professionals and patients and should be included. A consensus meeting will then be held to decide on the final list of outcomes to include in the COS. Stage 3: Deciding How to Measure the Outcomes Once the COS has been agreed, I will then undertake more research to find the best way to measure these outcomes (definitions and measurement tools). Patient & Public Involvement Patients are at the core of this research and will be involved at all stages. All stages: Patient representatives will be part of the 'Study Advisory Group' who will be responsible for making sure that the aims of the research are met. Patient Resources: Patient representatives will be asked to review all information booklets for language and readability before they are sent to participants. COS development: Patients will be involved in deciding which outcomes should be included in the final COS by taking part in interviews, the Delphi survey and consensus meeting. Pilot Surveys: Patient representatives will pilot the Delphi surveys to make sure they are easily understood by patients. Publicising the Research: I will work with patient organisations and forums such as the Oesophageal Patients Association (who also help patients with gastric cancer) to spread news of my work through their local networks, newsletters, email lists and websites. Publicising My Work (Dissemination) I plan to publicise the results of my work as follows: Scientific Dissemination: Presentations at national and international meetings and publication in scientific journals. Professional Societies: I will work with healthcare groups such as COMET (an organisation established to promote the development of COS) and the Association of Upper Gastro-Intestinal Surgeons of Great Britain and Ireland (AUGIS) as well as cancer centres around the worrld to raise awareness of my work both nationally and internationally. Patient organisations & charities: I will work with the Oesophageal Patients Association (OPA) and other patient groups and cancer charities to highlight my work. Online: I will develop a website to highlight my research. Research Groups: I will contact Cancer Research UK to assign a representative to sit on our Study Advisory Group. Implementing the COS: I will contact all relevant cancer journals to highlight the importance of my work. The support of these journals will be important in implementing the COS in future trials.

Research activity codes: 6.4 SURGERY;8.4 RESEARCH DESIGN AND METHODOLOGIES (HEALTH SERVICES)
Health categories: CANCER AND NEOPLASMS