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

Alkhaffaf, B; Metryka, A; Blazeby, J M; Glenny, A-M; Adeyeye, A; Costa, P M; Diez Del Val, I; Gisbertz, S S; Guner, A; Law, S; Lee, H-J; Li, Z; Nakada, K; Reim, D; Vorwald, P; Baiocchi, G L; Allum, W; Chaudry, M A; Griffiths, E A; Williamson, P R; Bruce, I A; Li, S.; Yl, He; Xu, Z.; Xue, Y.; Liang, H.; Li, G.; Zhao, E.; Neumann, P.; O’Neill, L.; Guinan, E.; Zanotti, D.; de Manzoni, G.; Hagens, Erc.; van Berge Henegouwen, Mi.; Lages, P.; Onofre, S.; Restrepo Nunez, Rm.; Salcedo Cabanas, G.; Posada Gonzalez, M.; Marin Campos, C.; Candas, B.; Emre Baki, B.; Selim Bodur, M.; Yildirim, R.; Burak Cekic, A.; Brown, J.; Hayes, K.; Daher, I.; Gianchandani Moorjani, Rh.; Adetoyese Adeyeye, A.; Sulaiman Olayide, A.; Mitsuo Leon-Takahashi, A.; Pueyo Rabanal, A.; Peri, A.; Boddy, A.; Novotny, A.; Charalabopoulos, A.; Alemdar, A.; Souadka, A.; Rodrigues Gomes, Am.; Lazaro, A.; Maciel Da Silva, A.; do Rosario da Conceicao Silva e Santos, A.; Guidi, A.; Silva Bernardes, Aj.; Quinn, A.; Isik, A.; A Slipek, A.; Candas Altinbas, B.; Johnson Alegbeleye, B.; Wool Eom, B.; Frittoli, B.; Lonsdale, B.; Rogers, B.; Ammori, Bj.; Rau, B.; Molteni, B.; Byrne, Be.; Villacıs- Bermeo, Ba.; Villacıs Gallardo, Be.; Kose, B.; Sampedro Nogueira, Cj.; Loureiro, C.; Oliveira de Sousa, Cm.; Collins, Cg.; Nonso Ekwunife, C.; Chukwunwendu Osuagwu, C.; Wong, Cly.; Winkler, C.; Reim, D.; Kjær, Dw.; Cooper, D.; Horner, D.; Irvine, D.; Bowrey, Dj.; Chuter, Dj.; Elliot, D.; Mcghee, D.; Toth, D.; Ofner, D.; Manatakis, Dk.; Silveira Martins, Dr.; Belt, Ejt.; Cattaneo, E.; Samadov, E.; Colak, E.; Treppiedi, E.; Guglielmi, E.; Redondo- Villahoz, E.; Ciferri, E.; Tiemens-de Graaf, E.; Cocozza, E.; Pape, E.; Drozdov, Es.; Enrico, F.; Rashid, F.; Sandri, Marco; Rosa, F.; Mingol Navarro, F.; Simionato Perrotta, F.; Chan, Fsy.; Saavedra Tomasich, Fd.; Takeda, Fr.; Farrell, F.; Olanike Wuraola, F.; 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, H.; Olufemi Gbenga, H.; Okabe, H.; Kingsford Smith, I.; Olawale Lateef, I.; Garosio, I.; Hatipoglu, I.; Gockel, I.; Negoi, I.; Min, Ish.; Mesquita, Imm.; Diez del Val, I.; Leemhuis, Jhf.; Gossage, Ja.; Weindelmayer, J.; Izbicki, Jr.; McKenzie Manson, J.; Kelly, J.; Stoot, Jhmb.; Haveman, Jw.; Brown, Jd.; Sultan, J.; Hassall, J.; van Sandick, J.; Saunders, Jh.; Clarke, Jk.; Heisterkamp, J.; Vargas, Ji.; Couselo Villanueva, Jm.; Ingmire, J.; Mcewen, J.; Galindo Alvarez, J.; Turner, J.; Peng, J.; Roberts, K.; Brandon, Kg.; Mitchell, K.; Mccarthy, K.; Akhtar, K.; Mikhailovich, Kn.; Corbelli, L.; Medeiros Milhomem, L.; Solaini, L.; Fengyuan, L.; Xinchun, L.; Timmermans, L.; Porritt, L.; Taglietti, L.; Bonavina, L.; F. Pinheiro L.,; de los Angeles Mayo Ossorio, M.; Schiavo, M.; Marchesiello, M.; das Dores Vieira Leite, M.; Demois, M.; Posada Gonzalez, M.; Di Felice, Mt.; van Berge Henegouwen, Mi.; de Sousa, Md.; Takahashi, M.; Forshaw, M.; Berselli, M.; Paro, M.; Usta, Ma.; Yan, Mh.; Pinchin, M.; Caprioli, M.; Rubbini, M.; Cowen, M.; Herrera Servin, Ma.; Li, Mz.; Sasako, M.; Shukri Jahit, M.; Ngonyoku Muhinga, M.; Tareen, Ma.; Ahmad, Mf.; Bodur, Ms.; Kaban, M.; Farooq, N.; Coburn, N.; Cooper, N.; Blencowe, Ns.; Loria, N.; de Vries, N.; Adami Andreollo, N.; Koksal, N.; Zanini, N.; Kreuser, N.; Okkabaz, N.; Damiana, O.; Afuwape, O.; Kayode Fasiku, O.; Comensoli, O.; F. Koroye O.,; Capener, P.; Morgagni, P.; Pernadas Lages, Pm.; Wilkerson, Pm.; Turner, P.; Dutton, P.; Hayes, P.; Vorwald, P.; Singh, P.; Gan, Q.; Kottayasamy Seenivasagam, R.; Ayloor Seshadri, R.; Guevara Castro, R.; Douglas, R.; Koshy, Rm.; Yıldırım, R.; Skipworth, Rje.; Gould, Ra.; Wetherill, Rc.; Shaw, R.; Burley, Ra.; Palatucci, R.; Racalbuto, R.; Correia Casaca, Rm.; Lagarde, Sm.; Gana, S.; Marietti, S.; Qureshi, S.; Morales-Conde, S.; Molfino, S.; Barreto, Sg.; Turkyilmaz, S.; Turan-Trabzon, S.; Frisch, S.; Castoldi, S.; Belloni, S.; Flisi, S.; Galloway, S.; Maria, Sr.; Royston, S.; Boyle, T.; Sezer, T.; Mengardo, V.; Concepcion Martın, V.; Lee Wills, V.; Owen-Holt, V.; Casagrande, V.; Al-Khyatt, W.; Jansen, W.; Wang, W.; Eshuis, W.; Polkowski, Wp.; Huang, X.; Wang, X.; Chen, Xz.; Gonzalez Dominguez, Y.; Wang, Y.; Viswanath, Yks.; He, Yl.; Demir, Z.; Na, Z.

doi:10.1093/bjs/znab192

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.