論文

目的：本研究の目的は，患者の意思決定の葛藤をスクリーニングするSURE（Sure of myself; Understand information; Risk-benefit ratio; Encouragement）test日本語版を，言語的妥当性を踏まえ開発することである．方法：SURE test日本語版は，第1段階：2名による順翻訳，第2段階：順翻訳統合，第3段階：2名による逆翻訳，第4段階：研究者協議（暫定版作成），第5段階：一般市民，医療者への調査，第6段階：再検討，を経て開発した．結果：暫定版作成後，第5段階の一般市民と医療者32名の調査において，「わかりやすい」と回答した割合は各項目で47%から78%であった．第6段階にて言語的妥当性を再検討し，日本語版を確定した．結論：一連の過程を経て，言語的妥当性を踏まえたSURE test日本語版を開発した．

Objective Decision aids (DAs) are useful in providing information for decision-making on using epidural anesthesia during birth. To date, there has been little development of DAs for Japanese pregnant women. Herein, we investigated the effect of a DA on the decision of pregnant women whether to have epidural anesthesia or not for labor during vaginal delivery. The primary outcome was changes in mean decision conflict score. Methods In this non-randomized controlled trial, 300 low-risk pregnant women in an urban hospital were recruited by purposive sampling and assigned to 2 groups: DA (intervention) and pamphlet (control) groups. Control enrollment was started first (until 150 women), followed by intervention enrollment (150 women). Pre-test and post-test scores were evaluated using the Decision Conflict Scale (DCS) for primary outcome, knowledge of epidural anesthesia and satisfaction with decision making for secondary outcomes, and decision of anesthesia usage (i.e., with epidural anesthesia, without epidural anesthesia, or undecided). Results Women in the DA group (n = 149: 1 excluded because she did not return post-test questionnaire) had significantly lower DCS score than those in the pamphlet group (n = 150) (DA: -8.41 [SD 8.79] vs. pamphlet: -1.69 [SD 5.91], p < .001). Knowledge of epidural anesthesia and satisfaction with decision-making scores of women who used the DA were significantly higher than those of women who used the pamphlet (p < .001). Women in the DA group showed a significantly lower undecided rate than those in the pamphlet group. The number of undecided women in the DA group significantly decreased from 30.2% to 6.1% (p < .001), whereas that in the pamphlet group remained largely unchanged from 40.7% to 38.9%. Conclusion This study indicates that a DA can be useful in helping women make a decision whether to have epidural anesthesia or not for labor during vaginal delivery.

Abstract Background Hormone therapy is one option for some types of prostate cancer. Shared decision making (SDM) is important in the decision making process, but SDM between prostate cancer patients receiving hormone therapy and physicians is not fully understood. This study tested hypotheses: “Patients’ perception of SDM is associated with treatment satisfaction, mediated by satisfaction with physicians’ explanations and perceived effective decision making” and “The amount of information provided to patients by physicians on diseases and treatment is associated with treatment satisfaction mediated by patients’ perceived SDM and satisfaction with physicians’ explanations.” Methods This cross-sectional study was conducted using an online panel via a private research company in Japan. The participants in this study were patients registered with the panel who had received or were currently receiving hormone therapy for prostate cancer and physicians registered with the panel who were treating patients with prostate cancer. Measures used in this study included a nine-item Shared Decision Making Questionnaire, levels of satisfaction with physicians’ explanations and treatment satisfaction, and effective decision making for patients (feeling the choice is informed, value-based, likely to be implemented and expressing satisfaction with the choice), and a Shared Decision Making Questionnaire for Doctors. The hypotheses were examined using path analysis. Results In total, 124 patients and 150 physicians were included in the analyses. In keeping with our hypotheses, perceived SDM significantly correlated with the physicians’ explanations and perceived effective decision making for patients, and satisfaction with physicians’ explanations and perceived effective decision making for patients were both related to treatment satisfaction. Although the amount of information provided to patients was correlated with the perceived SDM, it was indirectly related to their satisfaction with physicians’ explanations. Conclusions When physicians encourage patients to be actively involved in making decisions about treatment through the SDM process while presenting a wide range of information at the start of hormone therapy, patients’ effective decision making and physicians’ explanations may be improved; consequently, the patients’ overall treatment satisfaction may be improved. Physicians who treat patients with prostate cancer may have underestimated the importance of SDM before starting hormone therapy, even greater extent than patients.

目的:本研究の目的は,患者の意思決定の葛藤をスクリーニングするSURE(Sure of myself;Understand information;Risk-benefit ratio;Encouragement)test日本語版を,言語的妥当性を踏まえ開発することである.方法:SURE test日本語版は,第1段階:2名による順翻訳,第2段階:順翻訳統合,第3段階:2名による逆翻訳,第4段階:研究者協議(暫定版作成),第5段階:一般市民,医療者への調査,第6段階:再検討,を経て開発した.結果:暫定版作成後,第5段階の一般市民と医療者32名の調査において,「わかりやすい」と回答した割合は各項目で47%から78%であった.第6段階にて言語的妥当性を再検討し,日本語版を確定した.結論:一連の過程を経て,言語的妥当性を踏まえたSURE test日本語版を開発した.(著者抄録)

ディシジョン・エイド(DA)の質基準を用いた説明文書評価と関係者へのインタビュー分析を行った。治験を含む臨床試験の説明文書20件を収集し分析したところ、DAとしての各説明文書のスコアは平均12.55点であり、全体として半数以上の評価項目の記載がなかった。DQ standards項目の記載については、領域1:意思決定のための選択肢に関する十分かつ詳細な情報提供のうち、「不参加」による利益および不利益に関する記載、「利益・不利益を比較する図表・工夫」に関してすべての説明文書に記載がなかった。また、患者7名、Institutional Review Board委員2名、治験責任医師2名、臨床研究コーディネータ3名、治験依頼者2名、計16名を対象にインタビューを実施した結果、「患者の利益・不利益の判断は暖昧」な場合があることや「不参加による利益・不利益の記載は不適切」という問題提起が見出された。