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

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

要旨

　がん薬物療法において副作用の患者報告アウトカムを得る評価基準の開発を最終目標とし，本研究は，副作用全般の評価基準の開発に向けて，最初の取り組みとして汎用性のある副作用13項目について医療者評価と患者評価を得た．そして，臨床における有用性と，副作用項目の追加・拡大について検討した．

　第1段階は，文献検討などから原案を作成し，がん薬物療法に関わるスペシャリストら（1回目86人，2回目224人）の意見を基に修正・洗練を行い，副作用評価基準（案）を作成した．第2段階は，がん薬物療法を受ける患者に，この副作用評価基準（案）を用いて副作用を自己評価してもらい，患者評価を基に修正・洗練した．第3段階は，再度，がん薬物療法に関わるスペシャリストら40人に表現やGrade分類の適切性の確認を依頼し，コンセンサスを得てGrade 0〜3の4段階評価を得る13項目の副作用評価基準の完成とした．

　患者評価は，20人（年齢中央値65歳）を対象にインタビュー調査から得た．自己評価した感想から，【副作用の振り返り・予測】【体調管理】【医療者とのコミュニケーション】【記録の負担】の4カテゴリーを抽出した．

　副作用評価基準の開発は，患者の体調管理や医療者とのコミュニケーションの促進，医療者の副作用の効率的な把握や細やかな支持療法の介入に有用である．副作用項目の拡大に向けて，患者評価を積極的に受ける項目と難しい項目の種別，それに合った評価の工夫を見出せた．

　In this study, we aimed to develop evaluation criteria for patient reported outcomes on the side effects of cancer 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 draft's 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 prediction 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 appropriate 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.