PATIENT-REPORTED ADVERSE EVENTS

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Abstract

Patient-reported outcome is recently regarded as an important matter in chemotherapy. Although evaluation of quality of life (QOL) is adapted to clinical trials, it is not applied to practical settings so far. Precise evaluation of adverse events, therefore, is necessary to continue chemotherapy effectively and safely, especially in outpatient clinic. Adverse event is commonly evaluated objectively by physicians, nurses or pharmacists using Common Terminology Criteria for Adverse Events (CTCAE). However, patient–physician agreement is reported to be difficult to get in evaluation of QOL, even if in evaluation of single symptom such as fatigue, nausea, appetite loss etc. We have developed the mark-sheet system to evaluate and record patients' adverse events by themselves. Evaluated items on the mark sheet are set according to the cancer site and chemotherapy regimen. Each item is graded into 4, and the text of each grade was created referred to the CTCAE by the members of the Chemotherapy Center in our hospital. It is handed to a patient on the first day of the cycle of chemotherapy, and he starts checking the items on the mark sheet every day in the cycle. Before the consultation on the first day of the next cycle, he scans his mark sheet at the Chemotherapy Center. It is printed out and is sent to the physician, the nurse and the pharmacist in charge. We think this system leads to the better compliance of the patients and the efficient consultation.

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