Abstract: Objective To establish an adverse drug reaction (ADR) trigger tool for anti-tumor drugs in elderly patients, and to provide a reference for the active monitoring and prevention of ADRs of anti-tumor drugs in elderly patients. Methods Based on the model of the “IHI Global Trigger Tool for Measuring Adverse Events” (referred to as the GTT white paper), referring to the instructions and relevant domestic and foreign literature, using the Delphi expert consultation method, an ADR active monitoring trigger tool for anti-tumor drugs in elderly patients was established. The established trigger tool was used to randomly retrospectively review the elderly patient cases of anti-tumor drug treatment in Nantong Tumor Hospital from January to December, 2023, and the efficacy of the trigger tool was evaluated. Results Through the preliminary preparation, 50 triggers were initially drafted. After two rounds of Delphi expert consultation, 48 trigger items were finally determined, including 25 laboratory indicators, 12 clinical symptoms, 9 antidotes, and 2 intervention measures. Among the 300 reviewed cases, all 48 trigger items had positive triggers, with an ADR detection rate of 67.33%(202/300), and the overall positive predictive value of the trigger tool was 54.01% (829/1535). Conclusions The ADR trigger tool for anti-tumor drug in elderly patients developed in this study is well-designed and verified to be effective,and can provide a reference for medical institutions to conduct active monitoring of anti-tumor drugs in elderly patients and improve clinical medication safety.

Key words: aged, trigger tool, Delphi method, antineoplastic drug, adverse drug reaction, active monitoring