Preoperative Risk Evaluation for Cancer Treatment (PREdiCT): protocol for an international cohort study evaluating a trimodal screening tool to predict outcomes following gastrointestinal cancer surgery.
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Reeves Jack, Koh Cherry, Alexander Kate, Solomon Michael, Karunaratne Sascha, Petridis Alexandria, Carey Sharon, Dhillon Haryana, White Kate, Pillinger Neil, Gillis Chelsia, Hirst Nicholas, Shadid Zaid, Rahman Md Ishraque, Boden Ianthe, Mahoney Alison, Woodfield John, Vagg Daniel, De Boer Hans D, Sutton Paul, Pereira Leani, Drummond-Lage Ana Paula, Mcloughlin Santiago, Alvarez Adrian, Pirie Katrina, Hii Michael W, Suliman Alsadig, Uçaner Burak, Schizas Dimitrios, Nassim Kyrillos, Albatool Raga'a, Ali Khloud, Triantafyllou Tania, Styliana Apostolaki, Merlini Ilenia, Van Daele Elke, Mulita Francesk, Bell Max, Martinez-Palli Graciela, Koch Christian, Falconi Massimo, Garmanova Tatiana, Deng Niantao, Tirelli Flavio, Lubbers Tim, Chwat Carina, Costales Alfredo, Hanna Nader M, Petrova Andriana, Khamees Almu'atasim, Beard David, Granger Catherine L, PREdiCT Study Investigators, Steffens Daniel
Аннотация
METHODS: This prospective international cohort study will recruit 1214 adults undergoing elective gastrointestinal cancer surgery across 35 sites from 19 countries. Participants will complete an online screening tool developed through a comprehensive, multistep, predefined process. The screening tool comprises the Duke Activity Status Index, Patient-Generated Subjective Global Assessment Short Form and the Patient Health Questionnaire-4, in English, Spanish, French or Portuguese. These tools were selected based on a scoping review, followed by an international Delphi consensus process. The primary outcomes include rate of postoperative complications, major complications (Clavien-Dindo Classification grade III-V) and overall complication severity assessed by the Comprehensive Complications Index; all assessed 30 days postoperatively. Secondary outcomes include hospital length of stay, readmission rate within 30 days, discharge destination (home vs other), days at home and alive in 30 days postsurgery, 30-day all-cause mortality and 12-month survival. Primary analyses will establish optimal screening tool cut-points to stratify patients into clinically actionable risk categories for postoperative complications and examine the independent predictive value of these screening scores after adjusting for established clinical risk factors.
ETHICS AND DISSEMINATION: This study has received ethical approval from the Sydney Local Health District Human Research and Ethics Committee (X25-0333 and 2025/ETH02465) and has been registered on the Open Science Framework (10.17605/OSF.IO/HVCGD). The results of Preoperative Risk Evaluation for Cancer Treatment will be submitted to reputable journals and presented at national and international conferences.