Standardising the reporting of outcomes in gastric cancer surgery trials: protocol for the development of a core outcome set and accompanying outcome measurement instrument set (the GASTROS study)

Abstract

BackgroundGastric cancer is one of the leading causes of cancer-related deaths worldwide. Whilst surgery is the mainstay of curative treatment, it is associated with significant risks. Surgical strategies for treating gastric cancer should be based on evidence from systematic reviews of well-designed randomised controlled trials. However, inconsistencies in the reporting of outcomes from these trials makes evidence synthesis unreliable. We present a protocol for an international consensus study to develop a standardised set of outcomes and measurement tools – a ‘core outcome set’ (COS) – to be used by all future trials examining therapeutic surgical interventions for gastric cancer. The GASTROS study aims to standardise the reporting of outcomes in gastric cancer surgery trials through an international consensus process of key stakeholders including health care professionals and patients.MethodsThe first of three stages in the study will identify a ‘long-list’ of potentially important outcomes to be prioritised. These will be extracted from a systematic review of relevant academic literature and patient interviews. Stage 2 will comprise an eDelphi survey which will consider the views of patients, nurse specialists and surgeons to prioritise the most important outcomes. A meeting of stakeholder representatives will ratify the COS.Stage 3 will focus on identifying appropriate instruments to measure the prioritised outcomes by means of quality assessment of available measurement instruments and stakeholder consultation.DiscussionThis study aims to standardise the reporting of outcomes in future trials examining therapeutic surgical interventions for gastric cancer. It is anticipated that standardisation of outcome reporting in these surgical effectiveness trials will enhance the evidence base for clinical practice. Highlighting outcomes of greatest importance to patients will ensure that their perspectives are central to research in this field.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-017-2100-7) contains supplementary material, which is available to authorized users.

Core Rehabilitation Outcome Set for Single Sided Deafness (CROSSSD) study: protocol for an international consensus on outcome measures for single sided deafness interventions using a modified Delphi survey

“…One of the earliest examples of an attempt to standardise outcomes is an initiative by the World Health Organisation in the 1970s relating to cancer trials [79]. More recent projects are the IMMPACT (Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials) study for chronic pain [80], the OMERACT (Outcome Measures in Rheumatoid Arthritis Clinical Trials) consensus initiative for many rheumatologic conditions [81], the HOME (Harmonizing Outcome Measures for Eczema) framework in dermatology [82], the GASTROS (Standardising Outcome Reporting in Gastric Cancer Surgery Research) study for reporting outcomes in gastric cancer surgery [83], and the COMi-T'ID (Core Outcome Measures in Tinnitus International Delphi) initiative for chronic subjective tinnitus [84]. It is vital that all stakeholders, such as healthcare users, with lived experience of the condition, as well as healthcare professionals, commercial representatives or budget holders, are involved in the development of relevant COS [23,85].…”

Facilitating International Participation in Core Outcome Set Development: A Proposed Approach for Multi-language Delphi Surveys, a Review of Current Practice and Issues to Consider

“…The study protocol and findings from previous study stages 3,5,6 were presented at targeted national and international meetings which were well-attended by potential healthcare participants. This was integral to generating interest and support for our study and ensured that participants understood the premise for GASTROS long before the Delphi survey opened for recruitment.…”

“…This paper aims to address this need by presenting an approach to develop a multi-language Delphi-survey adapted from international consensus guidelines on the translation and cultural adaptation of patient-reported outcomes 4 . The survey forms an integral part of the GASTROS study (GAstric Cancer Surgery TRials Reported Outcome Standardisation) which aims to develop an international COS for surgical trials in gastric cancer 5 . The scope and design of the GASTROS study has been previously detailed 5 .…”

“…The survey forms an integral part of the GASTROS study (GAstric Cancer Surgery TRials Reported Outcome Standardisation) which aims to develop an international COS for surgical trials in gastric cancer 5 . The scope and design of the GASTROS study has been previously detailed 5 . In summary, following a systematic review of randomized control trials 3 and a series of in-depth patient interviews 6 , a long-list of potentially important outcomes was rationalized into a list of 56 outcomes.…”

“…One of the strengths of our Delphi survey was that it was able to recruit over 1000 patients and healthcare professionals from nearly 60 countries in round one. From the study's inception, the study team recognised the importance of developing a clear networking and dissemination strategy 5 . We hypothesised that this was necessary to achieve broad stakeholder participation both nationally and internationally.…”