The aim of this study was to translate and linguistically validate the U.S. National Cancer Institute’s Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE™) into Simplified Chinese for use in Singapore. All 124 items of the English source PRO-CTCAE item library were translated into Simplified Chinese using internationally established translation procedures. Two rounds of cognitive interviews were conducted with 96 cancer patients undergoing adjuvant treatment to determine if the translations adequately captured the PRO-CTCAE source concepts, and to evaluate comprehension, clarity and ease of judgement. Interview probes addressed the 78 PRO-CTCAE symptom terms (e.g. fatigue), as well as the attributes (e.g. severity), response choices, and phrasing of ‘at its worst’. Items that met the a priori threshold of ≥20% of participants with comprehension difficulties were considered for rephrasing and retesting. Items where < 20% of the sample experienced comprehension difficulties were also considered for rephrasing if better phrasing options were available. A majority of PRO-CTCAE-Simplified Chinese items were well comprehended by participants in Round 1. One item posed difficulties in ≥20% and was revised. Two items presented difficulties in < 20% but were revised as there were preferred alternative phrasings. Twenty-four items presented difficulties in < 10% of respondents. Of these, eleven items were revised to an alternative preferred phrasing, four items were revised to include synonyms. Revised items were tested in Round 2 and demonstrated satisfactory comprehension. PRO-CTCAE-Simplified Chinese has been successfully developed and linguistically validated in a sample of cancer patients residing in Singapore.

中文翻译：

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美国国家癌症研究所的患者报告的不良事件通用术语标准的简体中文版本的语言验证（PRO-CTCAE™）

这项研究的目的是将美国国家癌症研究所的患者报告的不良事件通用术语标准（PRO-CTCAE™）译成中文，并在语言上进行验证，以供在新加坡使用。英文源PRO-CTCAE项目库中的所有124个项目均使用国际公认的翻译程序翻译成简体中文。对接受辅助治疗的96位癌症患者进行了两轮认知访谈，以确定翻译是否充分体现了PRO-CTCAE的原始概念，并评估了理解力，清晰度和判断力。访谈探查解决了78个PRO-CTCAE症状术语（例如疲劳）以及属性（例如严重性），响应选择和“最坏情况”的措辞。满足先验阈值且≥20％的理解障碍参与者的项目被考虑重新措辞和重新测试。如果有更好的措词选项，则还考虑将少于20％的样本遇到理解困难的项目重新措词。在第1轮中，大多数PRO-CTCAE简体中文项目都被参与者很好地理解。其中一个项目带来了≥20％的困难，并进行了修订。有两个项目的困难度小于20％，但由于存在首选的替代措辞而被修订。在不到10％的受访者中，有24个项目存在困难。其中，将11项修订为替代的首选措辞，将4项修订为包含同义词。修订后的项目在第二轮中进行了测试，并显示出令人满意的理解力。