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[Development of the new system to appropriately assess health related quality of life in patients with bladder cancer survivor using patient reported outcome.]

Original in Japanese: Development of the new system to appropriately assess health related quality of life in patients with bladder cancer survivor using patient reported outcome.

Funder: Japan Society for the Promotion of Science

Funding period
JPY 4.3 M
USD 39 K
Funding amount
[「Bladder Cancer Index (BCI)」Specific for bladder cancer patients developed in the United StatesQOLIt is a measure. The reliability and validity of the questionnaire has been verified (Gilbert, J. Urol 2010), Is also widely used clinically. To make this questionnaire available to Japanese patients with bladder cancerBCIA Japanese version was created and used for actual Japanese patients to verify the content validity and internal consistency. We conducted a pre-test on postoperative patients with bladder cancer who were visiting our department to identify and correct problems in implementation and answers. For each question item, the question from the subject, the opinions from the urologist, and the clinical psychologist were analyzed and the content validity was examined. Furthermore, the Cronbach's α coefficient was obtained and the internal consistency was examined. In conducting this studyIRBApproved by (015-0504)。BCIOf the question items ofValidationされたExpanded Prostate Cancer Index Composite (EPIC)Items that duplicated the Japanese version of the question items were used as is with permission. on the other hand,EPICと異なりBCISince is a gender-unique questionnaire, it was necessary to revise the terms of the question items of sexual function, especially in the process of forward translation and backward translation, as pointed out by the original author. The pretest subjects were 14 (average age 69.5 years, 9 males, 5 females). Six patients underwent total cystectomy + urinary diversion and eight underwent transurethral resection of the bladder tumor, and the median postoperative follow-up period was 31.5 (11-272) months. The Cronbach's α coefficient for the urinary function, defecation function, and sexual function domains was 0.86, 0.73, and 0.92, respectively, indicating good internal consistency. In the course of the pretest, reflect the opinions of the patient as much as possible, and finally the Japanese versionBCIWas completed.]
Original in Japanese
「Bladder Cancer Index (BCI)」は米国において開発された膀胱がん患者の特異的QOL尺度である。質問票の信頼性と妥当性は検証され(Gilbert, J. Urol 2010)、臨床的にも広く用いられている。本質問票を日本人膀胱癌患者にも使用できるようにするためBCI日本語版を作成、実際の日本人患者に用いて内容妥当性、内的整合性を検証した。当科に通院中の膀胱がん術後患者に対しプレテストを行い、実施上の問題点や回答上の問題点を抽出、修正した。各質問項目について対象者からの質問、泌尿器科医、臨床心理士からの意見を分析し内容妥当性を検討した。さらに、クロンバックのα係数を求め、内的整合性を検討した。本研究の実施にあたっては当院のIRBの承認を受けた(015-0504)。BCIの質問項目のうち、筧らによりValidationされたExpanded Prostate Cancer Index Composite (EPIC)日本語版の質問項目と重複するものについては、許諾を得た上でそのまま使用した。一方、EPICと異なりBCIは男女共用の質問票であるため、特に性機能の質問項目について順翻訳と逆翻訳の過程で原作者の指摘により語句の改訂が必要であった。プレテストの対象者は14名(平均年齢は69.5歳、男性9名、女性5名)であった。膀胱全摘除術+尿路変向術施行例6名、経尿道的膀胱腫瘍切除術施行例8名で、術後経過観察期間の中央値は31.5(11-272)ヶ月であった。排尿機能、排便機能、性機能の各ドメインに関するクロンバックのα係数はそれぞれ0.86、0.73、0.92で良好な内的整合性が示された。プレテストの過程で、患者から出た意見を出来るだけ反映させ、最終的に日本語版BCIを完成させた。
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