Validation of the German patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE™)
Validation of the German patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE™)
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DOI：
10.1093/annonc/mdw422
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发表时间：
2016-12-01
影响因子：
50.5
通讯作者：
Jaehde, U.
中科院分区：
文献类型：
--
作者：
Hagelstein, V.;Ortland, I.;Jaehde, U.
背景：整合患者的观点已成为不良事件报告的一个日益重要的组成部分。美国国家癌症研究所开发了不良事件通用术语标准(PRO-CTCAE(TM))的患者报告结果版本。该工具已被翻译成德语并进行了语言验证，但其定量测量特性尚未得到评估。患者和方法：在德国和奥地利的10个癌症治疗机构分发了一项德语调查，包括31个专业CTCAE项目，以及EORTC QLQ-C30和口腔粘膜炎每日问卷(OMDQ)。项目质量通过可接受性和可理解性分析进行评估。结果：在分发给研究中心的660份调查问卷中，回收271份，回收率为41%，262份数据可供分析。参与者的中位年龄为59.7岁，其中69.5%的患者是女性。对项目质量的分析支持了31个项目的可理解性。信度非常好；Cronbach‘sα相关系数几乎对所有的项目群都是0.9。通过主成分分析识别出10个具有概念意义的项目簇，验证了PRO-CTCAE核心项目集的结构效度。此外，MTMM的结构效度也得到了验证：单性状与异质方法比较显示出100%的高度相关，而异质与单方法比较显示出0%的高度相关。已知群体的效度得到支持；与健康相关的生活质量受损的人相比，PRO-CTCAE得分显著降低。结论：从德国PRO-CTCAE项目库中提取的31个项目具有良好的测量特性。这些发现增加了PRO-CTCAE提供了一种严格的方法来捕获患者对症状毒性的自我报告用于癌症临床试验的证据。
Background: Integrating the patient's perspective has become an increasingly important component of adverse event reporting. The National Cancer Institute has developed a Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE (TM)). This instrument has been translated into German and linguistically validated; however, its quantitative measurement properties have not been evaluated.Patients and methods: A German language survey that included 31 PRO-CTCAE items, as well as the EORTC QLQ-C30 and the Oral Mucositis Daily Questionnaire (OMDQ), was distributed at 10 cancer treatment settings in Germany and Austria. Item quality was assessed by analysis of acceptability and comprehensibility. Reliability was evaluated by using Cronbach's' alpha and validity by principal components analysis (PCA), multitrait-multimethod matrix (MTMM) and known groups validity techniques.Results: Of 660 surveys distributed to the study centres, 271 were returned (return rate 41%), and data from 262 were available for analysis. Participants' median age was 59.7 years, and 69.5% of the patients were female. Analysis of item quality supported the comprehensibility of the 31 PRO-CTCAE items. Reliability was very good; Cronbach's' alpha correlation coefficients were >0.9 for almost all item clusters. Construct validity of the PRO-CTCAE core item set was shown by identifying 10 conceptually meaningful item clusters via PCA. Moreover, construct validity was confirmed by the MTMM: monotrait-heteromethod comparison showed 100% high correlation, whereas heterotrait-monomethod comparison indicated 0% high correlation. Known groups validity was supported; PRO-CTCAE scores were significantly lower for those with impaired versus preserved health-related quality of life.Conclusion: A set of 31 items drawn from the German PRO-CTCAE item library demonstrated favourable measurement properties. These findings add to the body of evidence that PRO-CTCAE provides a rigorous method to capture patient self-reports of symptomatic toxicity for use in cancer clinical trials.