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      Core outcome set for surgical trials in gastric cancer (GASTROS study): international patient and healthcare professional consensus

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          Abstract

          Background

          Surgery is the primary treatment that can offer potential cure for gastric cancer, but is associated with significant risks. Identifying optimal surgical approaches should be based on comparing outcomes from well designed trials. Currently, trials report different outcomes, making synthesis of evidence difficult. To address this, the aim of this study was to develop a core outcome set (COS)—a standardized group of outcomes important to key international stakeholders—that should be reported by future trials in this field.

          Methods

          Stage 1 of the study involved identifying potentially important outcomes from previous trials and a series of patient interviews. Stage 2 involved patients and healthcare professionals prioritizing outcomes using a multilanguage international Delphi survey that informed an international consensus meeting at which the COS was finalized.

          Results

          Some 498 outcomes were identified from previously reported trials and patient interviews, and rationalized into 56 items presented in the Delphi survey. A total of 952 patients, surgeons, and nurses enrolled in round 1 of the survey, and 662 (70 per cent) completed round 2. Following the consensus meeting, eight outcomes were included in the COS: disease-free survival, disease-specific survival, surgery-related death, recurrence, completeness of tumour removal, overall quality of life, nutritional effects, and ‘serious’ adverse events.

          Conclusion

          A COS for surgical trials in gastric cancer has been developed with international patients and healthcare professionals. This is a minimum set of outcomes that is recommended to be used in all future trials in this field to improve trial design and synthesis of evidence.

          Abstract

          Outcomes in surgical trials for gastric cancer are reported heterogeneously and do not sufficiently reflect the priorities of key stakeholders, including patients. This contributes to outcome reporting bias and research waste. To address these challenges, a core outcome set—a minimum group of critically important outcomes to be reported in future trials— has been developed through an international consensus process involving patients and healthcare professionals.

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          Most cited references34

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          The COMET Handbook: version 1.0

          The selection of appropriate outcomes is crucial when designing clinical trials in order to compare the effects of different interventions directly. For the findings to influence policy and practice, the outcomes need to be relevant and important to key stakeholders including patients and the public, health care professionals and others making decisions about health care. It is now widely acknowledged that insufficient attention has been paid to the choice of outcomes measured in clinical trials. Researchers are increasingly addressing this issue through the development and use of a core outcome set, an agreed standardised collection of outcomes which should be measured and reported, as a minimum, in all trials for a specific clinical area. Accumulating work in this area has identified the need for guidance on the development, implementation, evaluation and updating of core outcome sets. This Handbook, developed by the COMET Initiative, brings together current thinking and methodological research regarding those issues. We recommend a four-step process to develop a core outcome set. The aim is to update the contents of the Handbook as further research is identified. Electronic supplementary material The online version of this article (doi:10.1186/s13063-017-1978-4) contains supplementary material, which is available to authorized users.
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            How to select outcome measurement instruments for outcomes included in a “Core Outcome Set” – a practical guideline

            Background In cooperation with the Core Outcome Measures in Effectiveness Trials (COMET) initiative, the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) initiative aimed to develop a guideline on how to select outcome measurement instruments for outcomes (i.e., constructs or domains) included in a “Core Outcome Set” (COS). A COS is an agreed minimum set of outcomes that should be measured and reported in all clinical trials of a specific disease or trial population. Methods Informed by a literature review to identify potentially relevant tasks on outcome measurement instrument selection, a Delphi study was performed among a panel of international experts, representing diverse stakeholders. In three consecutive rounds, panelists were asked to rate the importance of different tasks in the selection of outcome measurement instruments, to justify their choices, and to add other relevant tasks. Consensus was defined as being achieved when 70 % or more of the panelists agreed and when fewer than 15 % of the panelists disagreed. Results Of the 481 invited experts, 120 agreed to participate of whom 95 (79 %) completed the first Delphi questionnaire. We reached consensus on four main steps in the selection of outcome measurement instruments for COS: Step 1, conceptual considerations; Step 2, finding existing outcome measurement instruments, by means of a systematic review and/or a literature search; Step 3, quality assessment of outcome measurement instruments, by means of the evaluation of the measurement properties and feasibility aspects of outcome measurement instruments; and Step 4, generic recommendations on the selection of outcome measurement instruments for outcomes included in a COS (consensus ranged from 70 to 99 %). Conclusions This study resulted in a consensus-based guideline on the methods for selecting outcome measurement instruments for outcomes included in a COS. This guideline can be used by COS developers in defining how to measure core outcomes. Electronic supplementary material The online version of this article (doi:10.1186/s13063-016-1555-2) contains supplementary material, which is available to authorized users.
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              Rating the methodological quality in systematic reviews of studies on measurement properties: a scoring system for the COSMIN checklist

              Background The COSMIN checklist is a standardized tool for assessing the methodological quality of studies on measurement properties. It contains 9 boxes, each dealing with one measurement property, with 5–18 items per box about design aspects and statistical methods. Our aim was to develop a scoring system for the COSMIN checklist to calculate quality scores per measurement property when using the checklist in systematic reviews of measurement properties. Methods The scoring system was developed based on discussions among experts and testing of the scoring system on 46 articles from a systematic review. Four response options were defined for each COSMIN item (excellent, good, fair, and poor). A quality score per measurement property is obtained by taking the lowest rating of any item in a box (“worst score counts”). Results Specific criteria for excellent, good, fair, and poor quality for each COSMIN item are described. In defining the criteria, the “worst score counts” algorithm was taken into consideration. This means that only fatal flaws were defined as poor quality. The scores of the 46 articles show how the scoring system can be used to provide an overview of the methodological quality of studies included in a systematic review of measurement properties. Conclusions Based on experience in testing this scoring system on 46 articles, the COSMIN checklist with the proposed scoring system seems to be a useful tool for assessing the methodological quality of studies included in systematic reviews of measurement properties.
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                Author and article information

                Contributors
                Journal
                Br J Surg
                Br J Surg
                bjs
                The British Journal of Surgery
                Oxford University Press
                0007-1323
                1365-2168
                October 2021
                24 June 2021
                24 June 2021
                : 108
                : 10
                : 1216-1224
                Affiliations
                Department of Oesophago-Gastric Surgery, Salford Royal Hospital, Salford Royal NHS Foundation Trust , Salford, UK
                Division of Cancer Sciences, School of Medical Sciences, Faculty of Biology, Medicine and Health, University of Manchester , Manchester, UK
                Paediatric Ear, Nose and Throat Department, Royal Manchester Children’s Hospital, Manchester University NHS Foundation Trust , Manchester, UK
                Centre for Surgical Research and Bristol and Weston National Institute for Health Research Biomedical Research Centre, University of Bristol , Bristol, UK
                Division of Dentistry, School of Medical Sciences, Faculty of Biology, Medicine and Health, University of Manchester , Manchester, UK
                University of Ilorin Teaching Hospital , Ilorin, Nigeria
                Cirurgia Geral, Hospital Garcia de Orta, Faculdade de Medicina da Universidade de Lisboa , Lisbon, Portugal
                Basurto University Hospital , Bilbao, Spain
                Department of Surgery, Cancer Centre, Amsterdam UMC, University of Amsterdam , Amsterdam, the Netherlands
                Department of General Surgery, Faculty of Medicine, Karadeniz Technical University , Trabzon, Turkey
                Department of Surgery, University of Hong Kong , Hong Kong, China
                Department of Surgery and Cancer Research Institute, Seoul National University College of Medicine , South Korea
                Peking University Cancer Hospital and Institute , Beijing, China
                Department of Laboratory Medicine, Jikei University School of Medicine , Tokyo, Japan
                Department of Surgery, TUM School of Medicine , Munich, Germany
                Hospital Universitario Fundación Jiménez Diaz , Madrid, Spain
                Department of Clinical and Experimental Sciences, University of Brescia , Brescia, Italy
                Department of Academic Surgery, Royal Marsden NHS Foundation Trust , London, UK
                Department of Academic Surgery, Royal Marsden NHS Foundation Trust , London, UK
                Department of Upper Gastrointestinal Surgery, University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital Birmingham , Birmingham, UK
                Medical Research Council North West Hub for Trials Methodology Research, University of Liverpool, Liverpool , UK
                Division of Cancer Sciences, School of Medical Sciences, Faculty of Biology, Medicine and Health, University of Manchester , Manchester, UK
                Division of Infection, Immunity and Respiratory Medicine, Faculty of Biology, Medicine and Health, University of Manchester , Manchester, UK
                Author notes
                Correspondence to: Department of Oesophago-Gastric and Bariatric Surgery, Salford Royal Foundation Trust, Salford Royal Hospital, Stott Lane, Salford M6 8HD, UK (e-mail: bilal.alkhaffaf@ 123456srft.nhs.uk )

                Members of the GASTROS International Working Group are co-authors of this study and are listed under the heading Collaborators.

                Author information
                https://orcid.org/0000-0001-5751-1846
                https://orcid.org/0000-0002-3354-3330
                https://orcid.org/0000-0002-9530-647X
                https://orcid.org/0000-0003-2402-2178
                Article
                znab192
                10.1093/bjs/znab192
                10364901
                34165555
                ad60f5a7-c377-4c76-a1e7-ed6b27c8837a
                © The Author(s) 2021. Published by Oxford University Press on behalf of BJS Society Ltd.

                This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( https://creativecommons.org/licenses/by/4.0/), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                : 20 January 2021
                : 04 May 2021
                : 20 October 2021
                Page count
                Pages: 9
                Funding
                Funded by: NIHR Doctoral Research Fellowship;
                Award ID: DRF-2015–08-023
                Funded by: NIHR Bristol Biomedical Research Centre, DOI 10.13039/100015250;
                Funded by: Medical Research Council, DOI 10.13039/501100000265;
                Funded by: ConDUCT-II Hub for Trials Methodology Research;
                Funded by: MRC North West Hub for Trials Methodology Research;
                Award ID: MR/K025635/01
                Categories
                Original Articles
                AcademicSubjects/MED00010
                AcademicSubjects/MED00910
                Bjs/5
                Bjs/2

                Surgery
                Surgery

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