Core outcome set for surgical trials in gastric cancer (GASTROS study): international patient and healthcare professional consensus
Author:
Alkhaffaf B12ORCID, Metryka A3, Blazeby J M4ORCID, Glenny A -M5, Adeyeye A6, Costa P M7, Diez del Val I8, Gisbertz S S9, Guner A10, Law S11, Lee H -J12ORCID, Li Z13, Nakada K14, Reim D15, Vorwald P16, Baiocchi G L17ORCID, Allum W18, Chaudry M A18, Griffiths E A19, Williamson P R20, Bruce I A221, Li S, He Y L, Xu Z, Xue Y, Liang H, Li G, Zhao E, Neumann P, O'Neill L, Guinan E, Zanotti D, de Manzoni G, Hagens E R C, van Berge Henegouwen M I, Lages P, Onofre S, Restrepo Nuñez R M, Cabañas G Salcedo, Gonzalez M Posada, Campos C Marin, Candas B, Baki B Emre, Bodur M Selim, Yildirim R, Cekic A Burak, Brown J, Hayes K, Daher I, Gianchandani Moorjani R H, Adeyeye A Adetoyese, Olayide A Sulaiman, Leon-Takahashi A Mitsuo, Rabanal A Pueyo, Peri A, Boddy A, Novotny A, Charalabopoulos A, Alemdar A, Souadka A, Rodrigues Gomes A M, Lázaro A, Da Silva A Maciel, do Rosário da Conceição Silva e Santos A, Guidi A, Silva Bernardes A J, Quinn A, Isik A, Slipek A A, Candaş B, Altinbaş , Alegbeleye B Johnson, Eom B Wool, Frittoli B, Lonsdale B, Rogers B, Ammori B J, Rau B, Molteni B, Byrne B E, Villacís-Bermeo B A, Villacís Gallardo B E, Köse B, Sampedro Nogueira C J, Loureiro C, Oliveira de Sousa C M, Collins C G, Ekwunife C Nonso, Osuagwu C Chukwunwendu, Wong C L.-Y, Winkler C, Reim D, Kjær D W, Cooper D, Horner D, Irvine D, Bowrey D J, Chuter D J, Elliot D, McGhee D, Toth D, Öfner D, Manatakis D K, Silveira Martins D R, Belt E J T, Cattaneo E, Samadov E, Colak E, Treppiedi E, Guglielmi E, Redondo-Villahoz E, Ciferri E, Graaf E Tiemens-de, Cocozza E, Pape E, Drozdov E S, Enrico F, Rashid F, Marco F, Rosa F, Navarro F Mingol, Perrotta F Simionato, Chan F S.-Y, Saavedra Tomasich F D, Takeda F R, Farrell F, Wuraola F Olanike, Rosero G, Bevilacqua G, Baronio G, Mura G, de Manzoni G, D'Eugenio G, Ortega-Perez G, Tilt G, Sutcliffe G, Mureddu G, Guerra Jacob G, Daneri G H, Gbenga H Olufemi, Okabe H, Smith I Kingsford, Lateef I Olawale, Garosio I, Hatipoğlu İ, Gockel I, Negoi I, Min I S.-H, Mesquita I M M, del Val I Diez, Leemhuis J H F, Gossage J A, Weindelmayer J, Izbicki J R, Manson J McKenzie, Kelly J, Stoot J H M B, Haveman J W, Brown J D, Sultan J, Hassall J, van Sandick J, Saunders J H, Clarke J K, Heisterkamp J, Vargas R J I, Couselo Villanueva J M, Ingmire J, McEwen J, Álvarez J Galindo, Turner J, Peng J, Roberts K, Brandon K G, Mitchell K, McCarthy K, Akhtar K, Mikhailovich K N, Corbelli L, Milhomem L Medeiros, Solaini L, Fengyuan L, Xinchun L, Timmermans L, Porritt L, Taglietti L, Bonavina L, Pinheiro L F, de los Angeles Mayo Ossorio M, Schiavo M, Marchesiello M, das Dores Vieira Leite M, DeMois M, Gonzalez M Posada, Di Felice M T, van Berge Henegouwen M I, de Sousa M D, Takahashi M, Forshaw M, Berselli M, Paro M, Usta M A, Yan M.-H, Pinchin M, CapriolI M, Rubbini M, Cowen M, Herrera Servin M A, Li M.-Z, Sasako M, Jahit M Shukri, Muhinga M Ngonyoku, Tareen M A, Ahmad M F, Bodur M S, Kaban M, Farooq N, Coburn N, Cooper N, Blencowe N S, Loria N, de Vries N, Andreollo N Adami, Köksal N, Zanini N, Kreuser N, Okkabaz N, Damiana O, Afuwape O, Fasiku O Kayode, Comensoli O, Koroye O F, Capener P, Morgagni P, Pernadas Lages P M, Wilkerson P M, Turner P, Dutton P, Hayes P, Vorwald P, Singh P, Gan Q, Seenivasagam R Kottayasamy, Seshadri R Ayloor, Castro R Guevara, Douglas R, Koshy R M, Yıldırım R, Skipworth R J E, Gould R A, Wetherill R C, Shaw R, Burley R A, Palatucci R, Racalbuto R, Correia Casaca R M, Lagarde S M, Gana S, Marietti S, Qureshi S, Morales-Conde S, Molfino S, Barreto S G, Turkyilmaz S, Turan-Trabzon S, Frisch S, Castoldi S, Belloni S, Flisi S, Galloway S, Maria S R, Royston S, Boyle T, Sezer T Ö, Mengardo V, Martín V Concepción, Wills V Lee, Owen-Holt V, Casagrande V, Al-Khyatt W, Jansen W, Wang W, Eshuis W, Polkowski W P, Huang X, Wang X, Chen X.-Z, Dominguez Y Gonzalez, Wang Y, Viswanath Y K S, He Y.-L, Demir Z, Na Z,
Affiliation:
1. Department of Oesophago-Gastric Surgery, Salford Royal Hospital, Salford Royal NHS Foundation Trust, Salford, UK 2. Division of Cancer Sciences, School of Medical Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UK 3. Paediatric Ear, Nose and Throat Department, Royal Manchester Children’s Hospital, Manchester University NHS Foundation Trust, Manchester, UK 4. Centre for Surgical Research and Bristol and Weston National Institute for Health Research Biomedical Research Centre, University of Bristol, Bristol, UK 5. Division of Dentistry, School of Medical Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UK 6. University of Ilorin Teaching Hospital, Ilorin, Nigeria 7. Cirurgia Geral, Hospital Garcia de Orta, Faculdade de Medicina da Universidade de Lisboa, Lisbon, Portugal 8. Basurto University Hospital, Bilbao, Spain 9. Department of Surgery, Cancer Centre, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands 10. Department of General Surgery, Faculty of Medicine, Karadeniz Technical University, Trabzon, Turkey 11. Department of Surgery, University of Hong Kong, Hong Kong, China 12. Department of Surgery and Cancer Research Institute, Seoul National University College of Medicine, South Korea 13. Peking University Cancer Hospital and Institute, Beijing, China 14. Department of Laboratory Medicine, Jikei University School of Medicine, Tokyo, Japan 15. Department of Surgery, TUM School of Medicine, Munich, Germany 16. Hospital Universitario Fundación Jiménez Diaz, Madrid, Spain 17. Department of Clinical and Experimental Sciences, University of Brescia, Brescia, Italy 18. Department of Academic Surgery, Royal Marsden NHS Foundation Trust, London, UK 19. Department of Upper Gastrointestinal Surgery, University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital Birmingham, Birmingham, UK 20. Medical Research Council North West Hub for Trials Methodology Research, University of Liverpool, Liverpool, UK 21. Division of Infection, Immunity and Respiratory Medicine, Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UK
Abstract
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.
Funder
NIHR Doctoral Research Fellowship NIHR Bristol Biomedical Research Centre Medical Research Council ConDUCT-II Hub for Trials Methodology Research MRC North West Hub for Trials Methodology Research
Publisher
Oxford University Press (OUP)
Cited by
14 articles.
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