Danish Translation and Linguistic Validation of the US National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Danish Translation and Linguistic Validation of the US National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
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DOI：
10.1016/j.jpainsymman.2016.02.008
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发表时间：
2016-08-01
影响因子：
4.7
通讯作者：
Johansen, Christoffer
中科院分区：
文献类型：
--
作者：
Baeksted, Christina;Nissen, Aase;Johansen, Christoffer
上下文不良事件通用术语标准（CTCAE）是癌症临床试验中基于临床医师的标准化不良事件分级和报告的基础。美国国家癌症研究所已经开发了CTCAE的患者报告结局版本（PRO-CTCAE），以纳入患者自我报告的症状性不良事件。该研究的目的是翻译和语言验证的PRO-CTCAE的丹麦语版本。使用前后向程序将美国英语PRO-CTCAE翻译成丹麦语，并进行核对。PRO-CTCAE丹麦语的语言有效性在两轮连续的半结构化认知访谈中进行了检查，样本为56例患者，按性别和癌症类型（前列腺癌、头颈癌、肺癌、乳腺癌、妇科癌、胃肠道癌和血液癌）平均分布，目前正在接受癌症治疗。在第一轮语言验证（n = 42）中，调整了五种症状毒性的措辞，并在第二轮访谈（n = 14）中重新测试了精炼的措辞。在第二轮谈判中，就文化上可接受和语义上可理解的措辞达成了一致意见。参与者描述PRO-CTCAE症状毒性含义的陈述支持与美国英语版本的概念等效性。结论。NCI PRO-CTCAE的英语以外语言版本的可用性将支持癌症治疗副作用自我报告的国际一致性。采用严格的方法开发PRO-CTCAE丹麦语版本。结果为在包括丹麦语使用者的癌症临床试验中使用PRO-CTCAE提供了初步支持。(C)2016年美国临终关怀和姑息医学学会。爱思唯尔公司出版All rights reserved.
Context. The Common Terminology Criteria for Adverse Events (CTCAE) is the basis for standardized clinician-based grading and reporting of adverse events in cancer clinical trials. The U.S. National Cancer Institute has developed the PatientReported Outcomes version of the CTCAE (PRO-CTCAE) to incorporate patient self-reporting of symptomatic adverse events.Objectives. The aim of the study was to translate and linguistically validate a Danish language version of PRO-CTCAE.Methods. The U.S. English language PRO-CTCAE was translated into Danish using forward and backward procedures with reconciliation. The linguistic validity of the PRO-CTCAE Danish was examined in two successive rounds of semistructured cognitive interviews in a sample of 56 patients equally distributed by gender and cancer type (prostate, head and neck, lung, breast, gynecological, gastrointestinal, and hematological cancer), and who were currently undergoing cancer treatment.Results. In the first round of linguistic validation (n = 42), the phrasing of five symptomatic toxicities was adjusted, and the refined phrasing was retested in a second round of interviews (n = 14). Agreement about phrasing that was both culturally acceptable and semantically comprehensible was achieved in the second round. Statements from participants describing the meaning of the PRO-CTCAE symptomatic toxicities support conceptual equivalence to the U.S. English language version.Conclusion. Availability of the NCI PRO-CTCAE in languages beyond English will support international congruence in selfreporting of side effects of cancer treatment. A rigorous methodology was used to develop the Danish language version of PRO-CTCAE. Results provide preliminary support for the use of PRO-CTCAE in cancer clinical trials that include Danish speakers. (C) 2016 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.