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

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Open Access

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

Author(s) -

Bilal Alkhaffaf,

Aleksandra Metryka,

Jane Blazeby,

AnneMarie Glenny,

Ademola Adeyeye,

Paulo Costa,

Ismael Díez del Val,

Suzanne S. Gisbertz,

Ali Güner,

Simon Law,

HyukJoon Lee,

Zongyi Li,

Koji Nakada,

Daniel Reim,

Peter Vorwald,

Gian Luca Baiocchi,

William Allum,

M. Asif Chaudry,

Ewen A. Griffiths,

Paula Williamson,

Iain Bruce,

Shasha Li,

Yingli He,

Zhengfeng Xu,

Yingwei Xue,

Hailun Liang,

Guanghe Li,

Enfeng Zhao,

PJ Neumann,

Linda O’Neill,

Emer Guinan,

Daniela Zanotti,

Giovanni de Manzoni,

Eliza Hagens,

Mark I. van Berge Henegouwen,

P. Lages,

Susana Onofre,

Rafael Mauricio Restrepo Nuñez,

Gabriel Salcedo Cabañas,

M Posada Gonzalez,

C Marin Campos,

Bernard Candas,

Birdoğan Baki,

Muhammed Selim Bodur,

Reyyan Yıldırım,

Arif Burak Çekiç,

Julia Brown,

Kenneth A. Hayes,

Iyad N. Daher,

R H Gianchandani Moorjani,

Agodirin Olayide,

Alberto M. León-Takahashi,

A. Pueyo Rabanal,

Andrea Peri,

Alex Boddy,

Alexander Novotny,

Alexandros Charalabopoulos,

Ali Alemdar,

Amine Souadka,

A M Rodrigues Gomes,

André Lázaro,

A Maciel Da Silva,

A do Rosário da Conceição Silva e Santos,

Alessandro Guidi,

A J Silva Bernardes,

Aoife Quinn,

Arda Işık,

A A Slipek,

Altinbaş,

Bamidele Johnson Alegbeleye,

Bang Wool Eom,

Barbara Frittoli,

B Lonsdale,

Benedict D. Rogers,

Basil J. Ammori,

Beate Rau,

Beatrice Molteni,

Ben Byrne,

B A Villacís-Bermeo,

B E Villacís Gallardo,

Beyza Köse,

C J Sampedro Nogueira,

Cláudia Chaves Loureiro,

C M Oliveira de Sousa,

Chris Collins,

CN Ekwunife,

Chukwuemeka Osuagwu,

C L.-Y Wong,

C. Winkler,

Daniel Willy Kjær,

D. James Cooper,

Daniel Horner,

D Irvine,

David J. Bowrey,

D. Chuter,

Diane L. Elliot,

Damon McGhee,

Dániel Tóth,

Dietmar Öfner,

Dimitrios K. Manatakis,

D R Silveira Martins,

Eric J.T. Belt,

Elena Cattaneo,

Elgun Samadov,

Elif Çolak,

Elio Treppiedi,

Elisa Guglielmi,

Elisabeth Redondo-Villahoz,

Enrico Ciferri,

E Tiemens-de Graaf,

Eugenio Cocozza,

E. Pape,

E. S. Drozdov,

Fiorenza Enrico,

Fouzia Rashid,

Fabiano Di Marco,

F. Gómez De la Rosa,

F Mingol Navarro,

Fabio Perrotta,

Feng-Tse Chan,

Flávio Daniel Saavedra Tomasich,

Flávio Roberto Takeda,

Francis X. Farrell,

FunmilolaOlanike Wuraola,

Germán Rosero,

Generoso Bevilacqua,

G Baronio,

Giorgio Mura,

G D'Eugenio,

Gloria OrtegaPérez,

G Tilt,

Grant Sutcliffe,

Gian Francesco Mureddu,

Greeshma Jacob,

Giovanni Daneri,

H Olufemi Gbenga,

Hiroshi Okabe,

Ingrid Smith,

I Olawale Lateef,

I. Garosio,

İrem Hatipoglu,

Ines Gockel,

Ionuţ Negoi,

Insoon Min,

I M M Mesquita,

Janna Leemhuis,

James Gossage,

J Weindelmayer,

Jakob R. Izbicki,

J McKenzie Manson,

J Kelly,

J H M B Stoot,

Jan-Willem Haveman,

Jonathan Brown,

J Sultan,

J Hassall,

Johanna van Sandick,

Jimmy Saunders,

J.K. Clarke,

J Heisterkamp,

Jayalakshmi .R,

J M Couselo Villanueva,

Julie Ingmire,

J. McEwen,

Julián Álvarez,

Jane Turner,

Juan Peng,

Kim Roberts,

K G Brandon,

Kristina Mitchell,

K. C. McCarthy,

Khurshid Akhtar,

Katja Mikhailovich,

L Corbelli,

Leonardo Medeiros Milhomem,

L Solaini,

L Fengyuan,

Xinchun Li,

L Timmermans,

Lord Porritt,

Lucio Taglietti,

Luigi Bonavina,

L.F. Pinheiro,

Marta Ossorio,

Massimo Schiavo,

M Marchesiello,

Maurilo Leite,

M DeMois,

M T Di Felice,

M D de Sousa,

Masato Takahashi,

M Forshaw,

Mattia Berselli,

M.M. Kardum Paro,

M A Usta,

M.-H Yan,

M Pinchin,

M. Caprioli,

M Rubbini,

Mark E. Cowen,

M A Herrera Servin,

Michael Li,

Mitsuru Sasako,

Mohammad Shukri Jahit,

Morris Muhinga,

M A Tareen,

M F Ahmad,

Mia Audia Br Kaban,

Naheed Farooq,

Natalie G. Coburn,

Nichola Cooper,

Natalie Blencowe,

N Loria,

Nathalie de Vries,

NA Andreollo,

Nurhan Köksal,

Nicola Zanini,

Nicole Kreuser,

Nuri Okkabaz,

O Damiana,

OludolapoO Afuwape,

O Kayode Fasiku,

O Comensoli,

Oyintonbra Koroye,

P Capener,

Paolo Morgagni,

Paul M Wilkerson,

Paul Turner,

Peter Dutton,

Paul D. Hayes,

Prashant Singh,

Qihong Gan,

Rajkumar Kottayasamy Seenivasagam,

Ramakrishnan Ayloor Seshadri,

R Guevara Castro,

Robert Douglas,

Reshma M. Koshy,

Ruken Yıldırım,

Richard J.E. Skipworth,

Rob Gould,

R C Wetherill,

Rajib Shaw,

Ryan Burley,

R Palatucci,

R Racalbuto,

Rui Casaca,

Sjoerd M. Lagarde,

Simone Gana,

Sara Marietti,

Samera Azeem Qureshi,

Salvador MoralesConde,

Sarah Molfino,

Savio George Barreto,

Serdar Türkyılmaz,

S Turan-Trabzon,

Suzy Frisch,

Simone Castoldi,

Silvia Belloni,

Sara Flisi,

Stacey Galloway,

Suzy Maria,

Simon Royston,

T Boyle,

Taylan Özgür Sezer,

Valentina Mengardo,

V Concepción Martín,

Vanessa Wills,

Vikki Owen-Holt,

Viviana Casagrande,

Waleed AlKhyatt,

Wilma Jansen,

Wei Wang,

Wietse J. Eshuis,

Wojciech Polkowski,

Xi Huang,

Xiaodong Wang,

Xueyin Chen,

Y Gonzalez Dominguez,

Alex Wang,

Y K S Viswanath,

Zeynep Demir,

Z Na

Publication year - 2021

Publication title -

british journal of surgery

Language(s) - English

Resource type - Journals

SCImago Journal Rank - 2.202

H-Index - 201

eISSN - 1365-2168

pISSN - 0007-1323

DOI - 10.1093/bjs/znab192

Subject(s) - medicine , delphi method , clinical trial , health care , quality of life (healthcare) , family medicine , medline , outcomes research , disease , alternative medicine , intensive care medicine , nursing , pathology , statistics , mathematics , political science , law , economics , economic growth

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.

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