Development of Evaluation Criteria for Patient-Reported Outcomes on Side Effects of Cancer Chemotherapy

DOI Open Access
  • Yamamoto Hiroyuki
    from Shizuoka Cancer Center Research Institute, Nursing Care Research Division
  • Kitamura Yuko
    from Shizuoka Cancer Center Research Institute, Nursing Care Research Division

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Other Title
  • 患者報告アウトカムを得るためのがん薬物療法における 副作用評価基準開発の試み

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Abstract

<p>Abstract</p><p>In this study, we aimed to develop evaluation criteria for patient reported outcomes on the side effects of can cer chemotherapy, and to make these criteria available to patients. We developed criteria based on 13 side effects with versatility, and these were evaluated by medical staff and patients. We then examined the usefulness of these criteria in clinical practice, and considered including further side effects within the criteria. In the first stage, we developed a draft based on a review of existing literature. Physicians involved in the treatment of cancer patients (i.e., specialists) checked the draft twice (first check, 86 specialists; second check, 224 specialists). In the second stage, we interviewed 20 patients and refined the draft based on the interview findings. In the third stage, we asked 40 specialists to examine if the draftʼs expressions and classifications were appropriate. We then obtained a consensus from specialists and completed the evaluation criteria for side effects, which included 13 items for the evaluation of four phases (Grades 0 to 3). We interviewed 20 patients (median age, 65 years) and extracted the following 4 categories: “a review and pre diction of side effects”, “physical condition management”, “communication with medical staff”, and “difficulties in recording data”. The development of these criteria was useful to patients for managing their physical condition and promoting communication with medical staff, and to medical staff for appreciating the impact of side effects and providing ap propriate supportive care. We were able to find further side effects for inclusion within the criteria, including those which patients were both reluctant and eager to suggest. We then devised appropriate ways to evaluate each side effect.</p>

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