Miyaji Tempei, Iioka Yukiko, Kuroda Yujiro, Yamamoto Daigo, Iwase Satoru, Goto Yasushi, Tsuboi Masahiro, Odagiri Hiroki, Tsubota Yu, Kawaguchi Takashi, Sakata Naoko, Basch Ethan, Yamaguchi Takuhiro
1Department of Clinical Trial Data Management, Graduate School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655 Japan.
2Division of Health Care Research, QOL Research Group, Center for Public Health Sciences, National Cancer Center, 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045 Japan.
J Patient Rep Outcomes. 2017;1(1):8. doi: 10.1186/s41687-017-0012-7. Epub 2017 Dec 5.
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.
美国国立癌症研究所（NCI）已制定了患者报告的不良事件通用术语标准（PRO-CTCAE），以收集癌症临床试验中患者自我报告的症状性不良事件。本研究的目的是开发并在语言上验证PRO-CTCAE的日语翻译版本。进行了正向和反向翻译，并由日本临床肿瘤学会（JCOG）执行委员会和美国国立癌症研究所进行了独立审查。然后，我们对21名正在接受癌症治疗的患者进行了认知访谈。要求参与者填写PRO-CTCAE，并使用半结构化脚本和预先确定的探究问题进行访谈，以调查是否有任何项目难以理解或回答。访谈进行了录音和转录，并进行了主题分析。数据分为两类：1）对项目的评论和2）对问卷总体的评论。
2011年至2012年期间，在东京大学医院和关西医科大学枚方医院对21名正在接受化疗或激素治疗的癌症患者进行了访谈。至少有一名受访者将33个PRO-CTCAE项目评为“难以理解”，65个项目评为“难以回答”。然而，进一步调查发现，只有24条评论被归类为“理解困难”或“清晰度”问题。这些评论大多涉及患者在对个体症状事件的体验进行评分时遇到的困难。
该研究提供了初步证据，支持PRO-CTCAE日语版本在语言上的有效性。对于与性和焦虑相关的PRO-CTCAE项目以及严重程度属性项目的回答选项，有必要进行进一步的认知访谈。
