The US National Cancer Institute (NCI) has developed the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) to capture patients’ self-reported symptomatic adverse events in cancer clinical trials. The aim of this study was to develop and linguistically validate a Japanese translation of PRO-CTCAE. Forward- and back-translations were produced, and an independent review was performed by the Japan Clinical Oncology Group (JCOG) Executive Committee and the US NCI. We then conducted cognitive interviews with 21 patients undergoing cancer treatment. Participants were asked to complete the PRO-CTCAE and were interviewed using semi-structured scripts and predetermined probes to investigate whether any items were difficult to understand or answer. The interviews were recorded and transcribed, and a thematic analysis was performed. The data were split into two categories: 1) remarks on the items and 2) remarks on the questionnaire in general. Twenty-one cancer patients undergoing chemotherapy or hormone therapy were interviewed at the University of Tokyo Hospital and the Kansai Medical University Hirakata Hospital during 2011 and 2012. Thirty-three PRO-CTCAE items were evaluated as “difficult to understand,” and 65 items were evaluated as “difficult to answer” by at least one respondent. However, on further investigation, only 24 remarks were categorized as “comprehension difficulties” or “clarity” issues. Most of these remarks concerned patients’ difficulties with rating their experience of individual symptomatic events. The study provides preliminary evidence supporting the linguistic validity of the Japanese version of PRO-CTCAE. Further cognitive interviewing is warranted for PRO-CTCAE items relating to sexuality and anxiety and for response options on severity attribute items.

目的：看護職の経験学習を促進するリフレクションマッププログラム（RMP）を開発し，その効果を検証する．方法：RMPはALACTモデルを基盤とし，ブレインストーミングから抽出したテーマや問いを配置した5段階プログラムとして開発した．RMPに参加した看護職を対象に単群前後比較の準実験研究を行った．RMP開始前と直後に看護師レジリエンス尺度や心理的ストレス反応尺度等を含めた質問紙調査を行った．研究倫理審査の承認を得て行った．結果：260名のデータを分析した．前後比較では看護師レジリエンス尺度得点が有意に増加した．看護に対するモチベーション3項目，自己肯定感2項目，看護実践に対する困難感2項目の得点に有意差があった．心理的ストレス反応尺度得点が有意に減少した．プログラム評価は満足度や役立ち度等が7点以上だった．結論：RMPはレジリエンスの向上や心理的ストレス緩和の効果があることが示された．

In the classification of premenstrual disorders (PMDs), premenstrual exacerbation (PME) is listed as one of the variants of PMDs, along with core PMD. However, the incidence of PME and its impact on mental health and quality of life have not been investigated. Therefore, we investigated the proportion of PME among women seeking treatment for premenstrual symptoms in Japan and compared the levels of anxiety, depression and quality of life between women with PME and those with core PMD. Women who presented to the Department of Obstetrics and Gynaecology of a single institute for treatment of premenstrual symptoms and were diagnosed with PMDs using patient diaries were included in the study. Based on the diagnosis, patients were divided into two groups (core PMD and PME) and their responses to a questionnaire on mental health and quality of life at the first visit were analysed. A total of 32 women were diagnosed with PMDs (22 with core PMD and 10 with PME). All underlying medical conditions in women with PME were psychiatric disorders. There were no significant differences in various factors between the two groups. In terms of mental health, the PME group had higher levels of anxiety and depression than the core PMD group. Regarding quality of life, the PME group had lower scores than the core PMD group in all domains except physical and social functioning. Patients seeking treatment for premenstrual symptoms included many PME. Women with PME were more anxious and depressed than those with core PMD, and their quality of life was low in both physical and psychological domains. Patients with PME should be diagnosed and treated more appropriately.

目的：日本のがん看護外来の具体的な看護実践を明らかにすることである．がん看護外来は，がん患者やその家族等に対し，生活に伴う症状の改善や自己管理の支援等を医師や他職種と連携して看護職が主導して行う外来をさし，がん相談支援センターは除外した． 方法：がん診療拠点病院等427施設のがん看護外来担当看護師を対象に，がん看護外来の運営状況，看護実践の設問を含めた横断的質問紙調査を行った．倫理審査委員会の承認を得て行った． 結果：288部の返信からがん看護外来開設がない172部を除き116部を分析した．がん看護外来は，がん看護専門看護師等が担当し，予約制で毎日開催が多かった．看護実践は〔患者・家族の思いの整理支援〕〔課題解決のための他部署との連携〕〔療養生活の支援〕等の6因子が抽出された． 結論：がん看護外来の具体的な看護実践は，患者・家族の思いの整理支援や課題解決のための他部署との連携等だった．