Verification of the Usefulness of an Assessment and Risk Control Sheet that Promotes Management of Cancer Drug Therapy

Abstract

Background: Proper management of adverse events is crucial for the safe and effective implementation of anticancer drug treatment. Showa University Hospital uses our interview sheet (assessment and risk control [ARC] sheet) for the accurate evaluation of adverse events. On the day of anticancer drug treatment, a nurse conducts a face-to-face interview. As a feature of the ARC sheet, by separately describing the symptoms the day before treatment and the day of treatment and sharing the information on the medical record, it is possible to clearly determine the status of adverse events. In this study, we hypothesized that the usefulness and points for improvement of the ARC sheet would be clarified by using and evaluating a patient questionnaire. Methods: This study included 174 patients (144 at Showa University Hospital (Hatanodai Hospital) and 30 at Showa University Koto Toyosu Hospital (Toyosu Hospital) who underwent pre-examination interviews by nurses and received cancer chemotherapy at the outpatient center of Hatanodai and Toyosu Hospital. In the questionnaire survey, the ARC sheet's content and quality, respondents' satisfaction, structural strengths, and points for improvement were evaluated on a five-point scale. Results: The patient questionnaire received responses from 160 participants, including the ARC sheet use group (132 people) and the non-use group (28 people). Unlike the ARC sheet non-use group, the ARC sheet use group recognized that the sheet was useful to understand the adverse events of aphthous ulcers (p = 0.017) and dysgeusia (p = 0.006). In the satisfaction survey questionnaire, there was a high sense of security in the pre-examination interviews by nurses using the ARC sheet. Conclusions: The ARC sheet is considered an effective tool for comprehensively evaluating adverse events. Pre-examination interviews by nurses using ARC sheets accurately determined the adverse events experienced by patients with anxiety and tension due to confrontation with physicians.

Keywords: adverse event; assessment; common terminology criteria for adverse events; drug therapy; nursing; pre-examination.

FIGURE 1

(A): Adverse events in which patients in the ARC sheet use group and non-use group answered that the adverse events they wanted to communicate to medical staff were well communicated. Gastrointestinal symptoms included symptoms of nausea, decreased appetite, mouth ulcers, diarrhea, and constipation. There is no significant difference between the ARC sheet use group and the non-ARC sheet use group in terms of symptoms other than stomatitis and taste disorder. (B): Comparison of satisfaction with the ease of communicating taste disorder adverse events between the ARC sheet use group and the non-use group. The use of the ARC sheet is useful in understanding taste disorder. (C): Comparison of satisfaction with the ease of communicating adverse events of stomatitis between the ARC sheet use and non-use groups. The use of the ARC sheet is useful in understanding oral mucositis.

FIGURE 2

(A): Patients’ satisfaction with the ability of the ARC sheet to relieve their anxiety about being able to communicate adverse events to their doctors. The ARC sheet group tended to have less anxiety about whether adverse events would be communicated, although the difference was not significant. (B): In the group using the ARC sheet, the mean CTCAE grade of adverse events obtained from the ARC sheet was compared with the satisfaction with the ease of communicating adverse events obtained from the patient questionnaire. Increased adverse events affected satisfaction with pre-examination interviews.

FIGURE 3

The results for the ARC sheet use group are shown. Assessment and risk control (ARC) sheets reflect differences in adverse events according to drugs used. (A): Mean grade of CTCAE for each adverse event in the nivolumab use group up to the treatment date. Up to treatment day, patients in the nivolumab group had lower Common Terminology Criteria for Adverse Events (CTCAE) grades of oral mucositis, diarrhea, skin disorders, paronychia, hair loss, and general malaise than did those in the non-use group. (B): Mean grade of CTCAE for each adverse event in the group using nivolumab on the day of treatment. On treatment day, patients in the nivolumab group had lower CTCAE grades of nausea, loss of appetite, oral mucositis, skin disorders, paronychia, hair loss, peripheral neuropathy, and general malaise than did those in the non-use group. (C): Mean grade of CTCAE for each adverse event in the nivolumab-free group up to the treatment date. Up to treatment day, patients in the nivolumab-free group had a CTCAE grade mean for each adverse event compared to patients in the nivolumab-use group. (D): Mean grade of CTCAE grade for each adverse event in the nivolumab-free group on treatment day. At the treatment date, patients in the nivolumab-free group had a higher mean CTCAE grade for each adverse event. (E): Comparison of the mean CTCAE grade for each adverse event between the nivolumab-using and non-nivolumab-using groups up to the date of treatment. The severity of mouth ulcers and paronychia up to treatment day is significantly different between patients who received nivolumab and those who did not. (F): Comparison of the mean grade of CTCAEs for each adverse event between the nivolumab-using and non-nivolumab-using groups on the day of treatment. The severity of mouth ulcers and paronychia on treatment day is significantly different between patients who received nivolumab and those who did not.